Ruzam - a new approach in the treatment and prevention of allergic diseases (experimental and clinical data)

Special instructions for use

To date, the interaction of Ruzam with other pharmacological agents has not been clinically established.
This medicine may be prescribed together with various antihistamines, antibiotics or glucocorticosteroids. Also, the drug does not affect a person’s concentration in any way, which allows vehicle drivers to take it freely and operate various complex mechanisms.

If you have impaired renal or liver function, the use of this drug should be under the close supervision of a physician with regular testing.

Directions for use and doses

Reviews of the drug procto-glivenol

Ruzam is available in the pharmacological form of a solution intended for injection under the skin. How to do them to get the most effective results?

The medicine should be injected into the upper shoulder, from the outside. The injection is not accompanied by pain or discomfort, so even small patients can easily tolerate it.

The dosage is selected by the doctor individually and depends on the age of the patient:

• children from 4 to 6 years old – 0.1 ml;
• children over 6 years old – 0.2 ml;
• adult patients – 0.2 ml.

Injections are given once a week

. In this case, the duration of the course of treatment can last up to 9–10 weeks, that is, the entire course of therapy consists of 9–10 injections.

In the chronic form of an allergic disease, the patient may be prescribed 3-4 courses throughout the year with pauses of no more than 3 weeks. For severe, acute types of allergies, the dosage of the drug can be increased to 0.3 ml at a time, the frequency of injections is once every 5 days.

If a person is diagnosed with allergic hay fever, it is recommended to begin therapy with this drug approximately 7–8 weeks before the plant begins to flower.

, which causes the development of an allergic reaction. The attending physician will advise you on the specific timing of treatment.

Attention! The antiallergic solution Ruzam is highly effective in treating various forms and severity of allergic diseases, but this pharmacological agent is considered most effective in the initial forms of pathological processes

Cream "Ruzam": description

The drug has antiallergic and anti-inflammatory effects. Available in different forms - injection solution (injected subcutaneously) and cream (used externally only).

The active ingredient in both cases is thermophilic strains of the bacterium Staphylococcus aureus (in the form of an extract). The product can be stored at moderately high temperatures up to 20 degrees (preferably in the refrigerator). Avoid exposure to sunlight and keep away from children. The general shelf life is 4 years from the date of production.

RUZAM

Release form, composition and packaging

Reviews about the drug Detralex

allergies. Everything was before

​most importantly, it eliminates very quickly. Use this medicine during a chronic focus of infection, short-term

​ plants; with frequent respiratory and angioedema, atopic

​0.5 ml​A drug with an antiallergic effect​What else do I find very ​bitter or dark​ in the exhaled air. Indications: Seasonal ones were already much easier to buy. at the moment

All allergic manifestations.

​pregnancy and during the period of increased cough with bronchitis ml.

​and other allergic dermatitis,​Excipients: sodium chloride (solution

​- I like the extract from the thermophilic culture, because this is it, chocolate (it’s healthier and tastier), ​ (hay fever) and year-round allergic dexamethasone and inject it.

pharmachologic effect

​ Breastfeeding is prohibited.​ (chronic) and increased rashes​ Injections are carried out 7 times in​ and other forms of allergic​ medicine has an antiallergic effect and the medication is referred to as “Ruzam”. Instructions​ 4 years.​ in spring and autumn.​ frequent respiratory infections.​ d/injections 0.9%), phenol (0.025-0.05%). bronchial asthma, urticaria

• Unpleasant reactions after contact
• ​The solution remaining after use in​
• on the skin with

Indications

​day. This treatment can have dermatitis and anti-inflammatory effects. Its use according to application, reviews, features The drug is available with a prescription.

Contraindications

​Increase in body temperature to subfebrile​Hypersensitivity to the drug, pregnancy​0.5 ml - ampoules (5)​ aureus, strain C-2) (non​ I don’t have. I have to pay.))​

​and Quincke's edema, atopic

And also a hormone! But 1 tablet 1 time with pollen, it is noted that it is not recommended to use the ampoule.

Dosage

​skin allergies. ​​last

​Instructions for use of "Ruzama" claim​​ helps to
​​ and analogues of the drug are presented​ ​The drug
​​ numbers, weakness, exacerbation of chronic​ and the period of breastfeeding,​​ -

contour appropriated) many expensive remedies for I feel weak, dizzy, nothing and other allergic dermatitis, one doctor I know advised a day. But the last undesirable symptoms during the period It should be disposed of. All of the listed symptoms are usually mild. During the year it is allowed that this medicine is not

Side effects

​and mucous membranes, and​ further.​ light and inaccessible to the source of infection, short-term enhancement​ children under 4​ (1) - cardboard packs.​ Solution for subcutaneous administration​ of allergies immediate effect (immediately after​ I don’t understand in this

Drug interactions

Frequent respiratory infections. We should pierce the ruza. We bought the pills for a while and stopped helping, their plants started flowering. This product is sold in the pharmacy

special instructions

​ are pronounced and are transient.​ to carry out from one to​ has many serious contraindications.​ also to reduce the level of obesity​ What form is inherent in the drug “Ruzam”?​

​children place with cough temperature in chronic bronchitis,

Use in childhood

• ​taking the first pill), but​
• ​world, tired eyes - here they are,​
• ​Its price used to be​
• ​punctured it, 0.2 ml​ had no effect​

​ are still marked. However, networking is only by prescription

Storage conditions and periods

​ four similar courses. When It cannot be prescribed to degranulated cells and eosinophils. The instructions for use state that

​from 4 to 20°C​ increased skin rash in active form, decompensated

Indications and contraindications

Reviews of the drug witch hazel

Ruzam is prescribed for a number of diseases, and the dosage of the injection is calculated individually, in accordance with the instructions.

Depending on the calculated dosage, the price for the full course of treatment also varies. According to the instructions, the drug is effective for:

• food allergies;
• rhinitis;
• hay fever;
• dermatitis;
• insect bites;
• reactions to medications.

A number of indications indicated in the instructions also include urticaria, antioneurotic edema, and bronchial asthma. In addition, the medicine Ruzam can be prescribed by a doctor for other similar diseases that are of an allergic nature.

The instructions indicate that Ruzam injections against allergies cannot be given if the patient has recently been vaccinated, he has been diagnosed with the development of a viral or chronic disease, and due to the disease, asthmatic attacks occur, during which the exhalation rate is significantly (up to 80%) reduced.

Injection of the drug Ruzam

How to give injections

Vitamin B12 injections

can be done in different ways:

• subcutaneously;
• intramuscularly;
• intravenously;
• into the spinal cord.

The instructions say that cyanocobalamin cannot be used simultaneously with drugs that increase blood clotting, as well as with vitamins B1 and B6. If you have an allergy to B1, then B12 can make it worse.

Administer the drug intramuscularly and intravenously

you can do it yourself. For injection into the spinal cord, you should consult an experienced doctor.

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Instructions for use

Ruzam injections are administered under the skin to both children and adults. The dosage for children over 6 years old is 0.2 ml, and from 4 to 6 years old – 0.1 ml. The injection should be given no more than once every 7 days. The course of treatment is 5-10 weeks. During the year, the number of courses can reach up to 4. The minimum interval between courses must be at least 20 days.

For hay fever, injections should be given 6-8 weeks before the flowering of plants that cause an allergic reaction. If respiratory infections are frequent, then Ruzam is used for prevention in spring and autumn.

It is permissible to increase the dose of the drug to 0.3 ml, if necessary. In this case, injections are administered every 5 days.

How long the treatment will take depends on the decision of the attending physician.

The drug may cause individual intolerance, and this occurs very rarely. It also practically does not cause any side effects.

Possible side effects from using the drug:

• If there is a chronic infectious disease, the symptoms intensify.
• With bronchitis, the cough becomes stronger.
• The temperature rises.

It is worth noting that even the presence of one or more side effects is not a cause for concern. They only indicate the start of the healing process. Therefore, you should not stop using the drug. Over time, the symptoms will completely disappear.

Ruza is contraindicated:

• Pregnant women, as well as while breastfeeding.
• Children under 4 years of age.
• For acute infectious diseases and tuberculosis.
• With decompensation of internal organs.

Cyanocobalamin treatment regimen

When vitamin B12 is prescribed, instructions for use

will help you calculate the correct dosage. The treatment plan looks like this:

• For the prevention of anemia and vitamin deficiency - from 200 to 500 mcg per day. The course of treatment ranges from 7 to 15 days.
• For the treatment of diseases of the central nervous system - 200 mcg per day daily for the first 3 days. Then 300 mcg daily for 4 days.
• If cyanocobalamin is used in complex therapy, the dosage is from 200 to 500 mcg per day.

Take vitamin B12

It is necessary only in the dosage recommended by the doctor. It is not recommended to use the drug on your own, since it is quite difficult to determine an individual treatment regimen.

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What can replace the drug?

There are no drugs based on the same component as Ruzam. Therefore, there are no analogues to this medicine. But in the same situations, the doctor may prescribe antihistamines, which are widely used to relieve allergy symptoms.

Table: overview of Ruzam analogues by action

Ruzam's analogs

Currently, the drug is considered unique in its properties. Structural analogues of Ruzam with the same active ingredient are not available.

To combat allergy symptoms, antihistamines are often used in tablets, spray, drops or gel form. Injections are used much less frequently. Injections are necessary for acute forms of allergies, as well as for prevention.

Ruzam is considered one of the effective medications on the market. Today it has no analogues. Using it, you can effectively stop the development of many types of allergic reactions.

Issues injections to Ruza. The drug is both an antiallergic and an anti-inflammatory agent. Using it you can:

• Eliminate a number of allergy symptoms and alleviate the course of the disease.
• Block mast cell degranulation.
• Reduce the number of eosinophils in places where the inflammatory process occurs.
• Reduce swelling in the mucous membranes of the nose and respiratory organs.
• Reduce skin swelling.
• Reduce the amount of immunoglobulin E in the blood if its level is higher than normal.
• Increase the amount of secretory immunoglobulins A in the mucous membranes, because They protect the body from viruses and bacteria, and neutralize them upon penetration.
• Reduce the accumulation of nitric oxide, which is an allergy marker, in the exhaled air flow.

The role of vitamin B12 in the body

Cyanocobalamin (vitamin B12)

was first opened in 1948. Scientists isolated a new substance from raw liver and prescribed it to treat pernicious anemia.

Over the past 70 years, cyanocobalamin has been well studied by scientists and doctors, as a result of which it was possible to establish its effect on the body:

• blocking stress hormones;
• improvement of blood clotting;
• amino acid synthesis;
• reducing the amount of cholesterol in the blood;
• detoxification of the body during alcoholism;
• improving liver function.

Cyanocobalamin helps athletes withstand heavy loads, accelerates weight loss and prevents the development of cardiovascular diseases.

It plays a special role in the functioning of the central nervous system. The vitamin complements the main therapy for cerebral palsy in children, Down's disease, intercostal neuralgia, etc.

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Ruzam. Who knows?

My son was prescribed an injection with the drug Ruzam. I bought it first and then read the instructions. AND . I'm sitting crying. The side effects are described - it doesn’t seem like much: flu-like illness, increased cough, urticaria and many, many. Who used it? How was it? What effect? I spent a thousand and a half, but I’m afraid to use it.

Everyone's body is different, and so is everyone's reaction to medications.

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Cost of the product

Ruzam is an innovative drug that is characterized by maximum effectiveness and provokes the development of side effects after use only in rare cases.

It is thanks to its safety and rapid action that it is recommended to be used both as a preventive measure and for the treatment of various forms of allergies; it is popular among patients despite its rather high price.

You can buy the drug only at pharmacies, where it is delivered by official representatives of the supplier, upon presentation of a prescription written by a doctor; the original drug is not available for free sale.

The cost of 1 package of ruzam, consisting of 5 ampoules, varies between 1200-1800 rubles. To complete the full course, it is most often necessary to purchase 2-3 packages; accordingly, the price of treatment will be about 5 thousand rubles.

In Ukraine, the average price of the drug is 1,465 UAH; it can also be purchased at pharmacies. You can find out detailed information about the composition, action and price of ruzam on the manufacturer’s official website.

Ruzam is an allergy medicine that is highly effective, quickly eliminating the symptoms and causes of allergic reactions.

If Ruzam is not suitable for the patient or cannot be purchased, for example, due to the high price, you should consult a doctor to select a replacement drug.

Analogues of the drug according to the level 4 ATC code are:

Another analogue of the drug that is worth paying attention to is Allegard drops, they are created from extracts of medicinal herbs and do not contain side effects

Dedicated to all allergy sufferers. An ampoule worth half a thousand.. Is the investment justified?

My son has been suffering from allergies since birth, either to food, or to pollen, or to fabric. It was still not clear, but from the age of three months he began to have bright, red spots on his face, which also peeled and itched.

At the same time, I was exclusively breastfed. I didn’t eat anything forbidden, no sweets or other allergenic foods. There were moments that I almost sat on the water with bread.

But the allergy still did not go away.

We were prescribed and prescribed, we drank and drank. The rashes went away and then appeared again.

By the age of two, everything somehow passed successfully and was forgotten. Then there was a lull for several years and a CONTROL SHOT at about 7 years old - allergies began in the spring, during the flowering period..

We had:

1. Red, swollen eyes that are always itchy and swollen;
2. Stuffy nose and inability to breathe normally;
3. Reduced immunity, and hence frequent headaches, cough;
4. Yes, and heaps of allergic bronchitis.

They treated, but at this moment it is only hiding the symptoms.

You need tests, consultation with an allergist and treatment. complete. plus diet.

And this is all done exclusively in the fall, when there are no allergens and the irritant is identified.

I had to wait six months. until autumn.

In the fall and winter, we took a special blood test from a vein, as a result of which the main allergen was identified - tree pollen, in particular birch, as well as dog hair.

We don’t have a dog and don’t expect to have one, but birch trees grow right next to the house and it’s during the period when the brunettes are swelling that our most terrible allergies begin.

Next, a consultation with an allergist (repeated) and treatment for one year, since in a year they planned to give the allergen itself and develop immunity.

We were prescribed a list of medications, for literally everything: in the nose, drops in the eyes, tablets to drink, as well as injections to inject.

RUZAM, LLC “RUZAM-M” - INJECTIONS.

And the price is truly prohibitive.

QUESTION PRICE.

A package consisting of 5 ampoules of 0.2 ml each costs an average of 2,500 rubles, that is, one injection cost us 500 rubles

As they say: “When you need treatment, the price no longer matters.”

DESCRIPTION.

Ampoules are sold in a cardboard box.

Shelf life: 4 years.

To fully familiarize yourself with the medicine, I advise you to read the instructions or search for information on the Internet.

The instructions are impressive in size and contain all the necessary information.

The solution is a light, slightly yellowish liquid.

Contained in ampoules, for single use only.

MAIN COMPONENT.

The main component is an EXTRACT FROM THE CULTURE OF A THERMOPHILIC STRAIN OF STAPHYLOCOCCUS AURUS.

PURPOSE.

In our case, seasonal allergic rhinitis plus allergic bronchitis against this background.

METHOD AND FREQUENCY OF INJECTIONS.

A course of injections is recommended before flowering begins, that is, before the start of stormy spring.

In our case, February-March.

I think that everything is individual, so check with your doctor.

Injections are given once a week, so plan ahead to avoid the blooming season of the main allergens.

OUR APPLICATION.

My son received injections as directed at the clinic, and went every week, day after day.

Injections are given in the shoulder. My son is already 8 years old, so it doesn’t hurt him at all, and in general they take the smallest needle, since the volume is generally tiny - only 0.2 ml.

EFFECT AND SUMMARY.

To be honest, I can’t say one hundred percent about the effect, since we gave Ruzam injections in combination with other drugs (and there is no other way).

First, injections, then pills, plus drops in the eyes and nose, and they even drank Suprastin, but there was still an allergy.

The same red eyes, hoarse voice, constant sneezing, but only this year we are experiencing all this to a lesser extent, more easily. and I boil it down to the effect of the injections given to Ruza.

That year, without treatment, the child could not even go to school, and could not go outside during the flowering period. (April-early May).

And this year we even go to school, although our eyes still get red and itchy.

I understand perfectly well that if my son is not cured now, the allergy will remain for life.

And “RUZAM” injections in our case are preparation and the beginning of large-scale treatment.

I'm afraid to imagine what would have happened if we hadn't injected them. a year earlier, my son was even taken away in an ambulance. against the background of allergies there is also allergic bronchitis.

And here we even go for walks in the evenings. It’s difficult for him, of course. diet plus all sorts of medications, but the goal has been set - MANDATORY RE-TREATMENT AND HOPE FOR COMPLETE RECOVERY.

I recommend ROOZAM, since it is not a PANACEA FOR ALLERGIES, but one of the important stages in its treatment.

HUGE MINUS - Ruzam is an expensive medicine. but they don’t skimp on children.

Also, do not forget about dietary restrictions, no foods that cause allergies.

For example, we were banned from kiwi, nuts, and raw carrots.

Evaluation of doctors and patients

Reviews from doctors and patients about the allergy drug Ruzam are mostly good. Its high efficiency is noted.

My medical practice, which is more than 15 years, has shown that Ruzam is able to significantly reduce the manifestations of seasonal allergies. Many patients report significant relief from the second week of the course.

At the same time, those who have individual sensitivity to its individual components should approach the use of this product with caution.

Alexey Ivchenkov, allergist

For me, the main advantage of Ruzam is that this drug is a non-hormonal drug with a pronounced effect. With his help I got rid of my atopic dermatitis. The course of treatment lasted two months, during which I went to the clinic for an injection once a week. To achieve the full effect of the cure, I had to undergo three two-month courses of treatment with this drug, after which I felt real relief from getting rid of my problem. Now my skin has regained its healthy appearance and I am no longer bothered by constant itching. Of course, my disease is recurrent, so it is impossible to cure it completely, but thanks to Ruzam, I have been in stable remission for almost three years. Maria, 45 years old

I have suffered from allergies since childhood. After I unsuccessfully tried a bunch of different medications while self-medicating, I finally decided to go to an allergist. The doctor prescribed me an appointment with Ruzam. At first, I really began to notice some improvement in my condition. When I repeated the course, I no longer observed any particular positive effect. The same can be said about the third one. For this reason, I had to stop using Ruzam due to the fact that this drug works extremely poorly for me.

Victoria, 25 years old

According to patient observations, taking Ruzam does not make contact with plant pollen safe. For this reason, you should be very careful during the period of active flowering of plants and keep traditional antihistamines with you.

It is also important to be under close medical supervision when taking a course of Ruzam in case of chronic inflammatory kidney diseases, since sometimes patients note a deterioration in the condition of these organs

The main advantage of this drug is its effectiveness with rare injections. Also, its advantages often include the fact that it is not a hormonal agent.

As for the disadvantages of Ruzam, they include a fairly extensive list of side effects, although they appear quite rarely. Often, while taking this drug, there is an increase in body temperature and, as a result, chills, accompanied by a headache. Also, many are not satisfied with the relatively high cost of this drug in comparison with other antiallergic pharmacological agents.

Indications for use of cyanocobalamin

Vitamin B12 in ampoules

used as adjunctive therapy. It enhances the effect of drugs and helps the body overcome many diseases. In rare cases, it is prescribed as the only means to prevent anemia.

Indications for use of vitamin B12:

• chronic migraine;
• Down syndrome;
• cerebral palsy;
• neuralgia;
• radiation sickness;
• alcohol poisoning;
• dystrophy;
• anemia;
• radiculitis;
• diseases of the pancreas and liver;
• gastritis;
• photodermatosis;
• sclerosis.

Taking cyanocobalamin is indicated for vitamin deficiency and frequent respiratory diseases. A lack of substance in the body leads to deterioration of the condition of hair, nails and teeth. For this reason, the drug is taken in ampoules not only for therapeutic purposes, but also for cosmetic purposes.

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Ruzam

Go to the Catalog of medical terms

Return to Medicines Catalog

A B C D E F G H I K L M N O P R

S T U V H C CH W SCH E Y

Indications

Allergic rhinitis (seasonal, year-round), bronchial asthma, urticaria, Quincke's edema, allergic dermatitis, recurrent respiratory infections.
Contraindications
Acute infection, active tuberculosis, decompensated diseases of internal organs, pregnancy.
Pharmacological action
Pharmacological action - immunomodulatory, antiallergic. Reduces the reaction of passive cutaneous anaphylaxis, the level of reagin antibodies in the blood, promotes the activation of cellular immunity, and has an anti-inflammatory effect.

Found in 156 questions:

allergo-immunologist May 29, 2022 / Victoria... / Krasnodar

Hello! Please tell me what drug can I replace Ruzam

(was appointed an allergist for year-round rhinoconjunctivitis with sensitization to weed pollen - ragweed, wormwood)? The time for therapy is already approaching, and the drug is in ... open

allergo-immunologist March 19, 2022 / Elena / Khilok

tell me what we should do, they started putting RUZAM

three injections were given, tolerates it well, should be given, the fourth child is ill, can I give
RUZAM
further for my 8-year-old son to open

allergo-immunologist March 14, 2016 / Ruslan / Sergeevskoe

Is it possible to combine two treatments? Take anti-infective tablets for allergies and tablets for gastritis. I was prescribed to take Dezal and Ruzam

. And for gastritis Ursosan and Trimedat. open

allergo-immunologist February 26, 2016 / Lyudmila / Nizhnevartovsk

...fly. There are no parasites. Hormones and other globulins are also normal. The thyroid gland is also normal. What to do? Now they have prescribed injections for the Ruzas

1 injection per week since there is no antiallergic immunoglobulin anywhere and in gasoline 3 tablets 3 times 2 months open

allergo-immunologist February 20, 2016 / Sergey

Dear doctors!

Ruzam was prescribed

from year-round allergic rhinitis (to dust). Today I had my first injection. It seems to have gone well. Are there any restrictions on doing physical exercise? And if so, which ones?

Thank you. ... open

03-Ambulance August 29, 2015 / Sergey / Shadrinsk

hello! please tell me where to give the injection - ruzam

? open

allergo-immunologist December 10, 2014 / Anonymous

A 2 year 10 month old child with bronchial asthma was prescribed the drug Ruzam

dose 0.1 and once a week the instructions say that it starts at 4 years old, isn’t it too early? open

allergo-immunologist June 30, 2014 / Denis / Krasnoyarsk

Hello, I have hay fever (birch, alder), the doctor prescribed ruza

10 ampoules for 2.5 months, i.e. one ampoule once a week. Tell me whether I should follow a diet, and if so, what should be excluded from the diet? And is it possible to drink alcohol? open

allergo-immunologist February 13, 2014 / Svetlana...

Ruzam injections during a child with a fever or sore throat?

? They've already injected me 3 times... open

allergo-immunologist January 27, 2014 / Asya / Kazakhstan, Karaganda

... antiallergic human Histoglobulin No. 5 was prescribed, this drug is not available in Kazakhstan and Russia (we ordered the drug Ruzam

, seems to be an analogue of Histoglobulin). After this, they prescribed a course of prednisolone, and then Lycopid. We also underwent ... open

January 27, 2014 / Dr. Sergey...

Everything is correct, there is only hope for Ruza

Acupuncture - unlikely. Remove all household chemicals and plants and soil from the house. While you can save yourself with injections of prednisolone 30-60 mg - keep it on hand!

allergo-immunologist October 13, 2013 / Kristina... / Voronezh

Hello! A child aged 4 years 9 months was prescribed Ruza

, we have allergic rhinitis, upper respiratory tract allergies (exacerbations begin in autumn and spring). Is it possible to inject it at this age or can we do without it? I have no doubt about the doctor’s competence, ... open

allergo-immunologist September 8, 2013 / Evgeniy / Moscow

Hello!!! I have been worried about aquagenic urticaria for a long time, I don’t know how to cure it. I even tried “ Ruzam”

". Please tell me whether it is possible to completely get rid of it, or just muffle its symptoms with antiallergic H1-blocker tablets... open

The prevalence of allergic diseases (AD) is currently in the nature of a pandemic. In Europe alone, about 150 million people have one type of allergy or another, 30% of Europeans suffer from allergic rhinitis and conjunctivitis, 20% have bronchial asthma (BA), 15% have skin AD [1]. Prognostic studies indicate a further increase in the prevalence and incidence of AD. Currently, there is a wide selection of modern pharmacological drugs that effectively control the symptoms of various ADs. However, the search for means and methods of immunomodulatory effects that will prevent the worsening of the disease, the development of exacerbations and complications, remains a priority task of modern allergology and immunology. A striking example is allergen-specific immunotherapy (ASIT), which has long been successfully used in the treatment of ADs such as allergic rhinoconjunctivitis, atopic asthma, and allergic reactions to insect bites. However, not all patients are able to undergo this type of treatment and not all patients achieve the desired effect. Therefore, nonspecific immunotherapy using regulatory natural and recombinant peptides is a popular area of ​​clinical and experimental allergology.

In our country, a representative of this class of drugs is the polypeptide drug Ruzam®, which has antiallergic and anti-inflammatory activity. The first research in the search for a fundamentally new antiallergic drug began in 1978, when B.L. Mazur and E.B. Galkin proposed a method for the rapid cultivation of thermophilic strains of microorganisms. The drug Ruzam was developed at the Research Institute of Pulmonology by a group of Russian scientists led by Academician of the Russian Academy of Medical Sciences A.G. Chuchalin and Professor N.A. Kolganova. It is a filtrate of a culture of the thermophilic strain Staphylococcus aureus, obtained using original technology (patent No. 2641293 and/c 873684 and 43320 38/28-14 1978 and 1987). Using ion exchange chromatography, it was established that, according to its chemical structure, Ruzam is a lipoprotein. It does not contain microorganisms and is a waste product of the thermophilic strain of S. aureus. Under the influence of Ruzam, the reaction of passive cutaneous anaphylaxis and the level of reagin antibodies in the blood decrease, thereby reducing the severity of allergic reactions. Ruzam promotes the activation of cellular immunity and has an anti-inflammatory effect. It has been proven that Ruzam leads to a decrease in the level of immunoglobulin E (IgE) [2, 3].

For more than 10 years, the drug Ruzam has been successfully used by allergists in our country to treat the following ADs:

• hay fever;
• bronchial asthma;
• seasonal and year-round rhinitis;
• atopic dermatitis;
• recurrent urticaria and angioedema;
• latex and food allergies;
• insect allergy;
• prevention of frequent respiratory infections in patients with AD.

To date, the drug is registered in the form of a solution for subcutaneous administration (LS 000791 251110), although active research on the use of nasal and inhalation forms of the drug continues [4, 5].

Use of the drug Ruzam® in patients with asthma

AD remains a common disease affecting children, adolescents and adults. Despite the availability of modern pharmacological drugs for the treatment of asthma, most patients have insufficient disease control and a high frequency of exacerbations [6]. The difficulty of achieving control over asthma is due to the great heterogeneity of clinical forms and variability of the course of the disease.

Phenotypic heterogeneity of AD

The heterogeneity of asthma is manifested in different severity of bronchial obstruction, different frequency of exacerbations, different response to bronchodilators and drugs for long-term control. Therefore, modern therapy for asthma requires an in-depth analysis of the factors responsible for the progression of the disease and the development of exacerbations, as well as the development of targeted therapy for the disease, taking into account the clinical and biological phenotypes of the disease.

The importance of this approach is reflected in the latest revision of GINA (Global Initiative for Asthma 2014 –

Global Initiative on Bronchial Asthma) [6] with the following asthma phenotypes, which can be quite easily identified in routine clinical practice:

Allergic asthma: The most easily recognized phenotype, which often begins in childhood, is associated with a history or family history of AD (atopic dermatitis, allergic rhinitis, food or drug allergies). Examination of induced sputum before treatment of patients with this asthma phenotype often reveals eosinophilic airway inflammation. Patients with an allergic asthma phenotype usually respond well to inhaled corticosteroid (ICS) therapy.

Nonallergic asthma: Some adults have asthma that is not related to allergies. The profile of airway inflammation in patients with this asthma phenotype can be neutrophilic, eosinophilic, or paucigranulocytic. These patients often do not respond well to ICS.

Late-onset asthma: Some patients, especially women, first develop asthma in adulthood. These patients are more often not allergic and require higher doses of ICS or are relatively refractory to GCS therapy.

Asthma with fixed airway obstruction: Some patients with a long history of asthma develop fixed airway obstruction, which appears to be due to bronchial wall remodeling.

Asthma in Obese Patients: Some obese patients with asthma have significant respiratory symptoms and mild eosinophilic inflammation.

Another important phenotype in terms of disease outcome is asthma with frequent exacerbations. Frequent exacerbations in patients with asthma are associated with a more pronounced decrease in lung function, and severe exacerbations, in addition, are associated with a risk of death [7, 8].

In a study by TR Bai et al. [7] assessed pulmonary function and the frequency of exacerbations in 93 adult patients with moderate to severe asthma over 11 years. The study results showed that patients with frequent exacerbations of asthma had lower lung function and an accelerated decline in forced expiratory volume in 1 second (FEV1) on average per year (30.2 ml) compared with patients with rare exacerbations of asthma (16, 9 ml). Persistent uncontrolled asthma symptoms are associated with the risk of developing a severe exacerbation of asthma, and a significant predictor of a severe exacerbation is a previous history of asthma that required the use of oral corticosteroids or hospitalization or emergency care, as well as a low FEV1/FVC (forced vital capacity) in the previous year. , high bronchial hyperreactivity and eosinophilia of blood and sputum [8].

Respiratory viral infections are triggers for exacerbation of asthma

Among the causes of exacerbations of asthma, respiratory viral infections occupy the first place. About 85% of all exacerbations of asthma in children and more than 50% in adults are provoked by respiratory viruses, and studies show that patients with asthma suffer more severely from respiratory infections compared to healthy people, which indicates a violation of their antiviral immune response [9–11]. Synergistic relationships can develop between the allergen and the virus in patients with atopic asthma, increasing the risk of exacerbations several times. In studies with a specific allergen challenge, it has been shown that respiratory viruses can cause inflammation in the airways, which leads to an increased immune response to an allergen stimulus, thereby causing an exacerbation of asthma [12, 13]. There is a definite association between the allergic phenotype and a reduced antiviral immune response, demonstrated by patients with atopic asthma [12]. Dendritic cells from patients with allergic asthma produced significantly less interferon-α (IFN-α) in response to influenza virus exposure compared to healthy donors. A number of other studies have revealed impaired synthesis of IFN-γ, IFN-β and IFN-λ, which correlated with the severity of asthma symptoms, decreased pulmonary function and markers of inflammation [10, 14–16]. In addition, impaired regulation of Toll-like receptors (TLR3, TLR7, TLR8, TLR9), which recognize the RNA of respiratory viruses and stimulate the production of interferons, was revealed in patients with atopic asthma [16].

As can be seen from the above, there are at least four asthma phenotypes in which a reduced effect of therapy with the main class of anti-inflammatory anti-asthmatic drugs, ICS, may be observed. In addition, some patients with asthma have a high incidence of respiratory viral infections and associated exacerbations of asthma. Therefore, for these patients, there is a natural need for additional treatment (to the main pharmacotherapy), one of the options for which may be the use of immunoregulatory peptides, in particular the drug Ruzam.

Clinical effectiveness of Ruzam in asthma

Specific antiviral strategies for preventing exacerbations of asthma exist so far only against the influenza virus and involve vaccination. However, research is being conducted to find and study the effectiveness of potential antiviral drugs, incl. interferons and their inducers. One of these treatment methods is peptide immunotherapy, which includes the drug Ruzam®.

Clinical studies of the drug Ruzam® in the treatment of patients with asthma have been conducted since the early 1990s. It has been shown that when administered subcutaneously, Ruzam reduces the intensity and frequency of attacks of bronchial obstruction and reduces the amount of necessary drug therapy for patients suffering from BA [17]. Therapy with Ruzam in patients with latex-induced asthma helped reduce the intensity and severity of asthma attacks; 31% of patients sensitized to latex noted stable remission within a year after treatment with Ruzam [18]. In an extensive scientific study by N.A. Kolganova treated 302 patients with asthma with Ruzam. As a result of the therapy, a positive effect was noted in 93% of cases, of which in 61% the treatment results were rated as excellent or good. In the comparison group (patients received only basic anti-asthma therapy), the positive effect of treatment was in 84% of cases (the difference with Ruzam is insignificant), however, upon detailed analysis, the percentage of excellent and good results in these patients was significantly lower - in 48% of patients (the difference is significant ) [19].

Another study assessed the antiallergic and anti-inflammatory effects of the drug Ruzam in 64 patients with persistent mild to moderate asthma.

After a 10-week course of treatment, the total index of asthma symptoms and the need for symptomatic therapy, the level of cytological markers of allergic inflammation (eosinophils in induced sputum), IgE levels in the blood serum, and the level of nitric oxide in exhaled air decreased significantly [20]. In a study by G.L. Osipova analyzed the effectiveness of Ruzam in 257 patients with mild and moderate asthma. During treatment, patients managed to reduce the amount of drug therapy by 2 times; they showed positive dynamics of symptoms; in 65% of patients there was an increase in the period of remission of the disease to an average of 2–3 years. In 60% of patients, the IgE level decreased by 1.5 times and the IgG level increased [21].

Prevention of asthma exacerbations using the drug Ruzam

Recently published studies conducted by the authors of this article demonstrated the possibility of preventing exacerbations of asthma associated with acute respiratory infections (ARI) using therapy with the drug Ruzam, used in the form of subcutaneous injections [22] and inhalation form (the inhalation form of Ruzam is not yet registered for clinical use). applications) [4].

In the study by N.A. Novikova et al. [22] included 32 patients with atopic asthma aged 18 to 65 years who received basic anti-asthmatic therapy with ICS as monotherapy or in combination with long-acting β-agonists (LABAs). Before the start of the study, all patients underwent an immunological examination, a study of pulmonary function, the level of asthma control was determined (AST test), the number of inhalations of short-acting β-agonists (SABA) was taken into account, and the number of exacerbations of asthma and episodes of ARI over the previous year was assessed. Treatment with Ruzam began in late August - early September, the first course consisted of 10 injections of 0.2 ml subcutaneously once a week against the background of unchanged basic therapy. The second course of Ruzam was carried out according to the same scheme from the beginning of February. Patients were monitored for a year.

As a result of the treatment, the number of cases of ARI per year decreased by 2.5 times in patients, while patients noted a milder course of ARI. None of the patients had exacerbations of asthma during the year, either against the background of an acute respiratory infection or during the flowering season of causally significant allergens; the volume of basic therapy in winter and during the flowering season did not increase, and in 6 patients the volume of basic therapy in summer was reduced by 2 times. Patients noted an improvement in their well-being, the average AST test score at the end of August increased from 21 to 24 a year later, complete asthma control was achieved in 26 patients (compared to 6 in the previous year) without increasing the volume of basic therapy. In addition, a decrease in the number of relapses of herpes infection was noted (Herpes labialis on average in all patients from 14 to 2 episodes per year) [22].

The clinical effectiveness of treatment with Ruzam in this study was confirmed by the results of an immunological examination, which was carried out before the first course of Ruzam, at the end of the course, one month and 2 months after the first course. The following changes in the immune status of patients were identified: the level of total IgE and the level of IgG-containing circulating immune complexes decreased significantly a month after completion of the course. The number of T-helper cells (CD4) significantly increased a month after the course, and subsequently their concentration returned to the original value. The subpopulation of NK cells (CD3-CD16-CD56+), on the contrary, significantly increased a month after the course of treatment, but subsequently also returned to the initial values. The percentage of naïve T-helper cells (CD4+CD45RA+) significantly decreased by the time the course of treatment was completed, remaining reduced over the next month. The third order immunoregulatory index - the ratio of naive and rewarded T-lymphocytes (CD4+CD45RA+/CD4+CD45RO+) - significantly decreased 2 months after the course of treatment.

All these changes indicate an increase in the effectiveness of the anti-infective defense of the immune system of patients who received two courses of Ruzam therapy, as well as the anti-inflammatory and antiallergic effects of Ruzam. At the same time, the noted changes in the immunogram indicate the following: 2 months after the first course of Ruzam, a second course is required at the same total dose to achieve a stable clinical effect [22].

It is noteworthy that all patients noted good tolerability of Ruzam. Among the side effects, local reactions were recorded in the form of hyperemia without itching and swelling at the injection site in 8 patients, 6 patients noted a general mild malaise within 24 hours after the injection without fever. These side effects did not require additional treatment [22]. Other clinical studies of the injection form of Ruzam also noted its good tolerability: among the side effects were low-grade fever (9.5%), nasal congestion (7.4%), pain and hyperemia at the injection site (5.3%). These phenomena resolved independently and did not require additional drug treatment [18, 20, 21, 23].

The purpose of the study by N.M. Nenasheva and D.V. Terekhova [4] studied the effectiveness and safety (immediately and 6 months after the end of the course of treatment) of the inhaled form of the drug Ruzam (currently not registered for widespread clinical use) in 63 adult patients with persistent mild to moderate atopic asthma in an open randomized placebo -controlled clinical trial. All patients received basic therapy with ICS in the form of mono- or combination therapy with LABA in accordance with GINA recommendations.

To study the effect of the drug Ruzam on the frequency of ARI (a virological study was not conducted), this indicator was assessed one year before treatment and one year after. As can be seen from Fig. 1, in patients who received inhalation therapy with Ruzam in combination with ICS, the number of cases of ARI significantly decreased: before treatment - 3.9 (1.8) per patient per year, during the year after treatment - 1.96 (0.94 ); p = 0.00034). In the same patients, a significant increase in the content of IFN-γ in induced sputum was noted (before treatment - 55 [28.5÷84.5], after treatment - 268 [128÷385] pg/ml; p = 0.011). In the group of patients receiving placebo, the incidence of ARI did not change: before treatment - 2.3 (1.7) per year, during the year after treatment - 2.15 (1.19); p = 0.44) [4].

As discussed above, ARIs are the most common cause of asthma exacerbations, so reducing their incidence remains an important component of achieving stable asthma control and preventing exacerbations. In patients receiving Ruzam + ICS, before treatment, the average number of asthma exacerbations per year per patient was 1.05 (0.35), a year after treatment – ​​0.29 (0.46); p = 0.000027: 8 patients had moderate exacerbations, one had severe exacerbations that required hospital treatment (Fig. 1).

In the placebo + ICS group, the frequency of asthma exacerbations did not change - before treatment, the average number of exacerbations per patient was 0.94 (0.48) per year, after a year - 0.9 (0.46), p = 0.79: in 26 patients had moderate exacerbations, three had severe exacerbations that required hospital treatment. We found that for patients receiving therapy with Ruzam, the risk of developing exacerbations of asthma was reduced by 23 times (OR = 23, 95% CI – 9.4–35.6) [4]. Combination therapy with Ruzam and ICS led to a significant decrease in the number of eosinophils and eosinophil cationic protein in induced sputum and, on the contrary, to an increase in the level of IFN-γ, and also effectively reduced the level of non-invasive markers of inflammation in the respiratory tract: nitric oxide in exhaled air (NOex) and bronchial hyperreactivity [4].

Thus, the use of the drug Ruzam in combination with traditional pharmacotherapy for patients with asthma leads to a decrease in symptoms of the disease, the need for bronchodilator therapy and improved control of asthma. An important observation was the prolonged effect of Ruzam therapy, manifested by a decrease in the frequency of ARI in patients and associated exacerbations of asthma, which is likely due to the immunoregulatory and anti-inflammatory effects of Ruzam.

Clinical effectiveness of Ruzam® in other ADs

The most common AD remains allergic rhinitis (AR), which affects 12 to 24% of the population of our country [24]. The effectiveness of Ruzam was studied in a comparative, prospective, randomized, double-blind, placebo-controlled study of the antiallergic effect of the drug on clinical parameters and markers of allergic inflammation in 64 adult patients with persistent AR [25].

After inclusion in the study and completion of the 2-week introductory period, patients were randomized into one of two parallel groups: the first received a treatment course of Ruzam® 0.2 ml subcutaneously in the upper third of the shoulder once a week; the second group was given placebo (0.9% NaCI) in the same dosage according to a similar schedule. The total duration of the study was 12 weeks. The effectiveness of treatment was assessed during three planned visits: at the beginning of randomization, at the 6th and 10th weeks of the treatment period, and included an assessment of the clinical symptoms of rhinitis (using self-monitoring diaries), an analysis of the patient’s need for additional symptomatic therapy by counting the days of taking oral antihistamines drugs, measuring the level of NO in exhaled air (Logan Research), the level of eosinophils in peripheral blood, assessing the cellular composition of fingerprint smears from the nasal mucosa and the contents of nasal lavage. The level of IgE in the blood serum was determined before inclusion in the study and at the end of the treatment period (week 10). In Fig. Figures 2 and 3 show the dynamics of AR symptoms and the need for additional medications (nasal decongestants and oral antihistamines) as a result of Ruzam therapy. As can be seen from the figures, the difference in the positive dynamics of rhinitis symptoms and the need for additional symptomatic drugs when comparing Ruzam and placebo was significant and in favor of the drug Ruzam. Researchers and patients noted that Ruzam® had an effect on all symptoms of AR and only in terms of nasal obstruction there was no significant difference when compared with placebo. Determination of IgE content initially demonstrated a fairly high level in all patients included in the study: 528.4 IU/ml in the Ruzam® group and 552.1 in the placebo group (p = 0.38). The study of IgE at the end of the treatment period revealed a significant difference in the parameters of the parallel groups: the IgE level in the Ruzam® group decreased almost 2 times, while in the placebo group there was practically no decrease in the IgE level, which once again indicates the immunoregulatory effect of Ruzam on IgE synthesis . There was a decrease in the number of eosinophils and neutrophils in nasal lavage fluid and impression smears from the nasal mucosa obtained from patients treated with Ruzam, when compared with patients taking placebo.

Thus, a comparative placebo-controlled study demonstrated the clinical effectiveness of the drug Ruzam in persistent AR, manifested in the reduction of all symptoms of the disease and due to its anti-inflammatory as well as immunoregulatory actions.

The studies concerning the combined use of Ruzam with ASIT are worthy of attention [26]. The combination of specific and nonspecific immunotherapy helped to reduce the sensitivity threshold of shock organs to allergens and reduced the level of IgE and eosinophilic cationic protein in the blood serum.

As is known, in real clinical practice, when performing ASIT in patients with AR and polyvalent sensitization, local and systemic allergic reactions to the introduction of an allergen occur 2 times more often than in patients with monovalent sensitization. This entails a reduction in the total dose of the allergen during the course of treatment and an insufficient effect of ASIT. Currently N.V. Novikova, one of the authors of this article, is conducting a study of the effectiveness of Ruzam and ASIT in this group of patients (42 adult patients included). Ruzam is used in the form of subcutaneous injections before the start of ASIT. ASIT was performed sublingually or by injection (immediately after completion of the Ruzam course) with the most clinically significant allergen of the entire spectrum identified for this patient. The tolerability and effectiveness of ASIT were assessed. The effect of treatment was assessed using symptom severity questionnaires and the number of medications used after the first year (course) of ASIT. According to preliminary data, the study group of patients managed to undergo ASIT without complications, and the standard total allergen dose per course of treatment was achieved.

As a result, patients experienced a significant reduction in AR symptoms and a twofold reduction in the need for symptomatic therapy during the flowering season. Moreover, a decrease in the manifestations of AR was noted upon contact with all other clinically significant allergens, in addition to those who underwent ASIT.

In 2005, a new form of the drug Ruzam – nasal drops – was registered for clinical trials. T.N. Antonova conducted a comparative assessment of the effectiveness of the drug Ruzam (nasal drops) with intranasal specific immunotherapy with allergoids and combined therapy with Ruzam (nasal drops) with intranasal specific immunotherapy with allergoids in the treatment of AR [5]. The study showed that intranasal therapy with Ruzam is comparable in effectiveness to intranasal specific immunotherapy with allergoids. In all three treatment groups, there was a positive trend in clinical symptoms, indicators of bronchial hyperreactivity, interleukin-4, sIgA in nasal secretions, and IgE in blood serum [5].

These studies and observations suggest the effectiveness and feasibility of using a course of Ruzam therapy in the form of subcutaneous injections before a course of ASIT in patients with polyvalent clinically significant sensitization. Preliminary treatment with Ruzam will help reduce IgE, reduce the severity of early and late allergic reactions, and therefore make ASIT safer and more effective.

When assessing the long-term results of Ruzam therapy in patients with asthma, AR, atopic dermatitis, urticaria and angioedema, it was shown that in the vast majority of patients the course of AD was milder, there were no repeated exacerbations, the frequency of respiratory infections decreased, while an increase in the effectiveness of therapy was noted after several courses of treatment with Ruzam [4, 17, 21–23].

Regimen and schemes for using Ruzam

The optimal dosage regimen for the drug is 1 subcutaneous injection per week in a dose of 0.2 ml for adults and children over 12 years of age, 10 injections per course. For children 4–6 years old, the dose of the drug is reduced to 0.1 ml, and the course of treatment can be reduced to 6–8 injections [27]. There is no experience with the use of Ruzam in children under 4 years of age.

For seasonal manifestations of allergies (hay fever), Ruzam courses are carried out pre-seasonally 4–8 weeks before the pollination period with continued administration of the drug during the flowering season. For AD without seasonal exacerbations, at least 2 courses of Ruzam are administered per year with an interval of 3–4 months. The minimum interval between injections can be 5 days, the maximum – 20 [27]. Therapy with Ruzam can be combined with pharmacotherapy of AZ.

Initiated therapy with Ruzam should be temporarily discontinued in the following cases:

• in the event of an acute respiratory infection or exacerbation of a chronic disease until recovery or a period of remission is achieved;
• during exacerbation of asthma;
• during vaccination [27].

Conclusion

The domestic drug Ruzam®, which is an immunoregulatory peptide, has anti-inflammatory and antiallergic properties, reduces the level of IgE in the blood serum of patients with various ADs and shows clinical effectiveness in the complex therapy of AD, AR, chronic urticaria and angioedema, and atopic dermatitis. As a result of treatment with Ruzam, the frequency of respiratory infections and associated exacerbations of asthma decreases. Combined nonspecific immunotherapy with Ruzam and ASIT for patients with polyvalent clinically significant sensitization contributes to safer and more effective ASIT.