Vol 23, No 12 (2021)


Interview with Evgenii L. Nasonov


Interview with Academician of the Russian Academy of Sciences, President of the All-Russian Public Organization "Association of Rheumatologists of Russia", Chief Freelance Specialist-Rheumatologist of the Ministry of Health the Russian Federation, scientific director of the Federal State Budgetary Scientific Institution “Nasonova Research Institute of Rheumatology”, Editor-in-Chief of the "Scientific and Practical Rheumatology" journal, editor of the “Issues of Rheumatology " issue of the “Terapevticheskii Arkhiv” journal.

Consilium Medicum. 2021;23(12):903-904
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Different approaches to change gut microbiota and its influence on metabolic disorders

Shestakova E.A., Pokrovskaya E.V., Samsonova M.D.


Obesity and type 2 diabetes mellitus (T2D) are two non-infectious pandemics of the XXI century. Despite a large number of studies devoted to the development of obesity and T2D, it seems complicated to overcome the ongoing growth in the number of cases. In these situations it is necessary to investigate new approaches for the prevention and treatment of such diseases. One of these approaches is to study the role of gut microbiota in the disturbance of carbohydrate and lipid metabolism. This manuscript describes the role of the microbiota in obesity and T2D. The aim of the review was to describe various approaches to change the composition of the gut microbiota and to determine its impact on metabolic risks. To assess the relationship between T2D development and changes of microbiota composition we considered a number of studies devoted to the consequence of these pathophysiologic mechanisms in various situations: the effect of drug treatment, bariatric surgery and microbiota transplantation. Possible metabolically protective gut microbiota composition is discussed.

Consilium Medicum. 2021;23(12):905-909
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Surgical tactics for acute abdominal complications of primary hyperparathyroidism. Clinical case

Morozov V.P., Boriskova M.E., Bykov M.A., Did-Zurabova E.S., Kulikov D.V., Ramazanova E.A., Kelbetova B.R.


Primary hyperparathyroidism (PH) is one of the most common diseases of the endocrine system that requires surgical treatment. The most common cause of PH is parathyroid adenoma, which occurs in 85–90% of cases, in 5–10% – multiple adenomas or hyperplasia of several or all parathyroid glands. Surgical treatment is the only radical and effective method of treating PH, however, the variability of the anatomy of the parathyroid glands, the possibility of their ectopic location, as well as the close connection with the thyroid gland, in some cases, complicate the intraoperative verification of the parathyroid adenoma. All this can lead to inadequate volumes with parathyroidectomy. In this article, the presented clinical case demonstrates how the complexity of intraoperative verification of the parathyroid glands during parathyroidectomy led to intra-abdominal life-threatening complications – acute duodenal ulcer with subsequent perforation and acute cholecystitis against the background of persistent hypercalcemia and perioperative stress. Also, on the example of this case, surgical tactics are demonstrated, taking into account the pathogenesis of abdominal complications.

Consilium Medicum. 2021;23(12):910-913
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The activity of the renin-angiotensin-aldosterone system before and after parathyroidectomy in patients with primary hyperparathyroidism

Yanevskaya L.G., Pogosian K.A., Semenova A.N., Chernikov R.A., Buzanakov D.M., Belyaeva O.D., Grineva E.N., Karonova T.L.


Background. The relationships between renin-angiotensin-aldosterone system (RAAS) and elevated parathyroid hormone levels in primary hyperparathyroidism (PHPT) is being actively discussed. But the way how parathyroid hormone interacts with renin and aldosterone currently is not clear.

Materials and methods. Forty patients aged 18 to 70 years with a confirmed diagnosis of PHPT were involved in the study. All patients were tested for the main parameters of phosphorus-calcium metabolism and the RAAS parameters (plasma renin, plasma aldosterone) before and 2 weeks after parathyroidectomy.

Results. Sixty percent of patients had any cardiovascular disease (CVD) and hypertension was the most common. Patients CVD in comparison with patients without CVD were older (61 and 41 years, respectively; p<0.001), had a higher body mass index (28.9 and 21.9 kg/m2, respectively; p<0.001) and had a lower aldosterone-to-renin ratio – ARR (1.78 and 5.42, respectively; p=0.030). Patients with hypertension were older than patients with normal blood pressure (63 and 41 years, respectively; p<0.001), had a higher body mass index (28.1 and 23.5 kg/m2, respectively; p=0.005), a lower ARR (1.46 and 5.82, respectively; p=0.001), as well higher levels of plasma renin (109.2 and 20.3 pg/ml, respectively; p=0.007) and serum total calcium (2.84 and 2.71 mmol/l, respectively; p=0.041). Correlation analysis showed that in patients with PHPT and CVD, the concentration of aldosterone is associated with the level of 24-hour urinary calcium (r=0.829, p=0.042), and in patients with symptomatic PHPT and CVD, the level of aldosterone correlated with the level of ionized calcium (r=-0.812, p=0.05). We found no significant differences between the levels of renin, aldosterone and ARR before and 2 weeks after parathyroidectomy. However, in the postoperative period, there were no differences in the levels of renin and ARR among patients with hypertension and without hypertension.

Conclusion. In our study we found that the levels of plasma renin and serum total calcium were higher in patients with PHPT and hypertension compared to patients with normal blood pressure. Also, we found the associations between plasma aldosterone and levels of ionized calcium and 24-hour urinary calcium. But the relationships between RAAS parameters and parameters of phosphorus-calcium metabolism need further investigations.

Consilium Medicum. 2021;23(12):914-919
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Clinical equivalence of generic and brand-name drugs used in cardiology: what do we know?

Leonova M.V.


The problem of using generics in the treatment of patients with cardiovascular diseases remains relevant for more than a decade. The concern of doctors, pharmacists and patients is not diminishing with the constant rise in cardiovascular morbidity and mortality worldwide. Based on a systematic review of 186 publications, physicians identified concerns about the quality, reliability and replaceability of original drugs; pharmacists have shown the highest level of generic approval. Patients’ distrust of generics was revealed, caused by a lack of information, concerns about packaging, and negative experience of replacing the original drug. Three meta-analyzes compared generic and original drugs of cardiovascular groups in terms of efficacy and safety. A 2008 meta-analysis (47 studies, 9 classes of cardiovascular drugs) assessed the effect on mild outcomes, a 2016 meta-analysis (74 studies, 7 classes of drugs) also assessed side effects. The cumulative effect revealed a small and nonsignificant difference, which indicated that there was no superiority of original drugs over generics; there were no differences in the frequency and severity of side effects between generics and original drugs. A 2020 meta-analysis (72 studies, 9 drug classes) assessed the frequency of hospital admissions (including emergency department consultations, hospitalizations) and found a significant increase in the risk for generics for any reason (14%), but not for cardiac vascular diseases. A review of 8 cohort studies evaluating antihypertensive drugs for long-term cardiovascular outcomes, duration of retention, and substitution effect did not find significant differences between generics and brands. In a systematic review of studies comparing warfarin and generics, there were no significant differences in international normalized ratio and the incidence of thromboembolic and hemorrhagic complications; however, in one study, the frequency of hospital visits was 10% higher for generics. A systematic review of studies comparing clopidogrel versus generics shows drug comparability for major cardiovascular events and mortality. A review of 5 cohort studies evaluating originator statins and generics showed comparable rates of all-cause mortality and major cardiovascular events, except for one study with conflicting results. Meta-analyzes and large observational studies indicate that generics are not the worst efficacy, sometimes even surpass that of original drugs and can be justifiably used in clinical practice.

Consilium Medicum. 2021;23(12):920-927
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Contrast-induced acute kidney injury after computed tomography with contrast media in patients with cardiovascular diseases

Vasin A.A., Mironova O.I., Fomin V.V.


Aim. To assess the frequency of contrast-induced acute kidney injury (CI-AKI) in patients with cardiovascular diseases (CVD) undergoing computed tomography (CT) with intravenous contrast media.

Materials and methods. In prospective observational study (ClinicalTrials.gov ID NCT04666389) were included 51 patients with CVD undergoing CT with intravenous contrast media administration. The primary endpoint was CI-AKI according to KDIGO criteria [the 25% rise (or 0.5 mg/dl) of serum creatinine from baseline assessed 48–72 hours after administration of contrast media]. There were 51% of women included in the study. The average age was 61.74±1.5. The most frequent cardiovascular disease was hypertension in both men and women – 52 and 39% respectively.

Results. CI-AKI was diagnosed in 2 (3.92%) patients. At the same time, it was not possible to establish statistically significant relationship (p<0.05) between risk factors and the development of CI-AKI.

Conclusion. Cardiovascular diseases may increase the risk of CI-AKI after CT with intravenous contrast media administration. Therefore, it is recommended to evaluate the serum creatinine concentration in such patients.

Consilium Medicum. 2021;23(12):928-930
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Clinical and economic analysis of using dapagliflozin in patients with chronic kidney disease in the Russian Federation

Nedogoda S.V., Salasyuk A.S., Barykina I.N., Smirnova V.O., Popova E.A.


Aim. To evaluate the clinical and economic efficiency of the use of dapagliflozin in patients with chronic kidney disease (CKD) stages 2–4 in Russian Federation.

Materials and methods. Cost-effectiveness (utility) analysis has been carried out. Mathematical model has been developed, adapted to the healthcare system of the Russian Federation by using Russian cost and patients characteristics inputs. Life years (LYG) and quality-adjusted life years (QALY) were used as efficiency criteria. Only direct medical costs were taken into account. Cost-effectiveness (utility) analysis was carried out in the short-term (3 years) and long-term horizons (10 years).

Results. The use of dapagliflozin in addition to standard therapy (ST) versus ST for CKD stage 2–4 in the short term (3 years) is cost effective: it allows you to additionally receive 0.042LYGs/0.035QALYs, while the incremental cost of an additional year of life is 827,399 rubles, an additional year of life adjusted for quality is 988,424 rubles, which does not exceed the threshold of willingness to pay according to World Health Organization recommendations 2 191,061 rubles. In the long term (10 years), the use of dapagliflozin in addition to ST will provide an additional 0.437LYGs/0.356QALYs and lead to a decrease of direct medical costs by 96,546 rubles on average for 1 patient. Thus, in the horizon of 10 years, the dapagliflozin + ST regimen is strictly preferred or dominant – at the same time more effective and less costly.

Conclusion. The use of dapagliflozin in addition to ST for the treatment of patients with CKD stages 2–4 in the long-term horizon (10 years) allows to extend the stay in the pre-dialysis stages of CKD by 8 months an average of 1 patient. Dapagliflozin therapy regimen and ST in a cohort of 1,000 patients with CKD stages 2–4 on the horizon of 10 years will avoid 30 hospitalizations due to heart failure (namber needed to treat – NNT – 34), 59 cases of acute kidney injury (NNT – 18), 73 deaths from all causes (NNT – 14).

Consilium Medicum. 2021;23(12):932-938
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Hepatic impairment as a risk factor of adverse drug reactions

Ostroumova O.D., Pereverzev A.P.


There are a lot of clinical variants of hepatic impairment ranging from asymptomatic increase in transaminases to acute liver failure and fulminant hepatitis. Hepatic impairment is a polietiologic syndrome. According to the epidemiological study conducted in the United States (1998–2008), the main causes of hepatic impairment were paracetamol overdose (46%), idiopathic liver dysfunction (14%), other drugs (excluding paracetamol, 11%), viral hepatitis B (7%), other infectious and non-infectious diseases with liver damage (except for viral hepatitis) – 7%, autoimmune hepatitis (5%), ischemic hepatitis (syn. hypoxic hepatitis, liver infarction) – 4%, viral hepatitis A (3%) and Wilson's disease (2%). Hepatic impairment have a direct impact on the pharmacokinetics and pharmacodynamics of drugs decreasing clearance, elimination and excretion of drugs. Also Transjugular intrahepatic porto-systemic shunts, which are often used to treat portal hypertension in patients with liver cirrhosis, can significantly reduce the presystemic elimination of drugs, thereby increasing their absorption. Moreover, in patients with liver cirrhosis, concomitant renal dysfunction also requires an adjustment of the dose of drugs. Correction of pharmacotherapy in accordance to pharmacokinetic and pharmacodynamic changes of drugs ingested by patients with impaired liver function will improve the quality of medical care and reduce the risks of adverse drug reactions.

Consilium Medicum. 2021;23(12):939-948
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Intranasal corticosteroid use in patients with allergic rhinitis

Starostina S.V., Toldanov A.V.


Allergic rhinitis (AR) is one of the most common diseases in the world, which is based on IgE-mediated inflammation that develops after exposure to various allergens. About 40% of people suffer from the same or other allergic diseases, every third inhabitant of the Earth has symptoms of AR and every tenth has bronchial asthma. According to the ARIA classification, ARs are divided: by the nature of the flow, by the severity of the flow and by the stage of the flow; for symptoms, the proposed therapy, consisting of sequential steps. Groups of drugs include: systemic or topical blockers of histamine H1 receptors, intranasal and systemic corticosteroids, mast cell stabilizers (intranasal cromones), M-antagonists, antagonists of leukotriene receptors. Medicines do not give a lasting effect after their cancellation, therefore, with persistent AR, treatment should be prolonged; methods of application – more often oral or intranasal. The advantages of the pharmacological antiallergic effect of InHCS are the simultaneous inhibition of both the early and late phases of the allergic response and the inhibition of all AR symptoms. The advantage of InHCS over oral administration is the minimal risk of developing systemic side effects against the background of the creation of adequate concentrations of the substance in the nasal mucosa, which allows to control the symptoms of AR. Based on data from a number of studies, the advantages of intrasal corticosteroids for AR, in particular fluticasone propionate, are used.

Consilium Medicum. 2021;23(12):950-955
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New classification of EAONO/JOS cholesteatoma and SAMEO-ATO middle ear surgery: relevance and clinical significance

Pchelenok E.V., Tarasova O.Y., Kosyakov S.Y.


Middle ear cholesteatoma (MEC) is a common problem of modern otology. The European Academy of Otology and Neurootology in cooperation with the Japanese Otological Society (EAONO/JOS) published consensus recommendations on the definition, classification and stages of MEC in 2017. In 2018, the classification of middle ear surgery was presented under the auspices of the International Otology Outcome Group. The leading problem of MEC surgery remains the high recurrence rate, which ranges from 5 to 32% depending on the type of surgical intervention. The main purpose of this article is to describe the new EAONO/JOS classification of MEC and SAMEO-ATO middle ear surgical interventions with an analysis of their possible clinical significance in determining the risk of cholesteatoma recurrence as well as the prognosis for hearing recovery after surgery.

Consilium Medicum. 2021;23(12):956-960
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Atopic skin lesions in pregnant women: how to help patients

Niewozinska Z.A., Dvoriankova E.V., Tkachenko O.I., Korsunskaya I.M.


Many pregnant women experience skin symptoms caused by immunological, metabolic or other changes that occur in their body during pregnancy. One of the most common complaints of pregnant women is itchy skin. In about 20% of cases, itching in pregnant women is associated with atopic skin lesions. Histologically, these lesions are indistinguishable from atopic dermatitis, which also tends to worsen during pregnancy. It is believed that these lesions are due to increased production of Th2 cytokines (interleukin-4 and -10) in the body of a pregnant woman. Topical glucocorticosteroids and skin care products are best treatments for atopic skin lesions of pregnant women and exacerbation of atopic dermatitis. In cases of limited rashes or mild dermatitis, only care products with a strong moisturizing effect can be used. Using moisturizers can help minimize itching and skin discomfort. One of these agents that we use in practice is XeraCalm A.D Lipid-Replenishing cream, the unique formula of which not only has a regenerating and antipruritic effect, but also enhances the natural immunity of the skin.

Consilium Medicum. 2021;23(12):961-964
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Possibilities for correcting diffuse alopecia associated with prior coronavirus infection (COVID-19)

Shperling N.V., Shperling M.I., Gnatiuk I.I.


Diffuse alopecia (DA) is a disease characterized by a diffuse hair loss associated with alterations in physiological hair cycle due to an exposure of hair follicles to various endogenous and exogenous factors. The disease is mainly caused by alterations in the cyclicity of hair follicle phases – anagen, telogen and catagen. Pathogenetic therapy for DA is based on the initiation and lengthening of the anagen phase, in particular, via inhibition of catagen. Given a high prevalence of DA following a new coronavirus infection (COVID-19), the search for an effective medicine for the SARS-CoV-2 virus-associated DA is extremely important. The use of drugs derived from natural products can have a beneficial effect on the disease following COVID-19. The study was aimed to assess the efficacy of the combination of Selencin (homeopathic drug) and Selencin Peptide Active (peptide lotion) for the treatment of DA associated with prior coronavirus infection (COVID-19). A total of 34 patients with a confirmed diagnosis of telogen/anagen DA, who noted the relationship between DA and a new coronavirus infection, were treated with both systemic (pills) and topical (peptide lotion) Selencin for 2 months. The study showed a high efficacy of the treatment, i.e., a significant reduction in hair loss, as well as restoration of their structure and increase in volume. Also, after 2 and 4 months of treatment, there was a normalization of dermatoscopic picture of the scalp and an improvement in the special tests (PULL test). Thus, the use of the combined drug Selencin for SARS-CoV-2 virus-associated DA has a pronounced therapeutic effect. The drug can be used as the main treatment for this disease if it associated with COVID-19.

Consilium Medicum. 2021;23(12):965-968
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Capabilities of combined peptide drugs in the correction of male infertility (literature review)

Prokopev I.V., Abdrakhmanov A.R.


Acute and chronic urogenital infections are associated with male infertility. Besides "traditional" sexually transmitted infections, there is a significant increase in inflammatory diseases of reproductive system caused by opportunistic pathogens. Studies show that sperm fertility is influenced by direct exposure to sexually transmitted infections, as well as dysfunction of the blood-testicular barrier, leading to autoimmune infertility. In a number of clinical trials, Prostatilen® AC was shown to have benefitial effects on the ejaculate.

Consilium Medicum. 2021;23(12):970-976
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Phytoneering in clinical practice

Tsukanov A.I., Matveev E.V.


The discovery of antibiotics almost 100 years ago seemed to have forever solved the issue of treating infectious diseases for humanity. However, the avalanche-like growth in antibiotic resistance requires the search for alternative methods of treatment, one of which is treatment with herbal products created according to the phytoneering concept. It is a technology that combines the enormous potential of medicinal plants (phyto) with the knowledge and methodology of modern pharmaceutical research (engineering). The article presents 2 clinical cases of the use of the herbal product Canephron N for the prevention of cystitis and acute urolithiasis – common disorders in the practice of a urologist.

Consilium Medicum. 2021;23(12):977-980
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Tongue cancer in a patient with pulmonary tuberculosis. Case report

Kulchavenya E.V., Myshkova E.P., Dementieva E.I., Baranchukova A.A.


Tuberculosis and malignant neoplasms are a global threat, these diseases claim millions of lives and cause tremendous suffering to people worldwide. Tuberculosis can mask cancer and create preconditions for carcinogenesis. The article presents a clinical case of tongue cancer in a patient with pulmonary tuberculosis. Patient B.N., 45 years old, was admitted to the FSBI “Novosibirsk Tuberculosis Research Institute” with complaints of a "sore place" on the tongue, pain in the right half of the tongue, enlargement of the submandibular lymph nodes on the right The tongue hurts for about 1,5 years, but over the last 2 months, condition has worsened. The patient noticed an increase in the size of lesion on the tongue and increased pain, especially during meals (he can eat only after pain relief, for which he takes Nimesulide 4 pills a day). In recent days, he felt also epigastric pain for which he didn’t visit a doctor. Tongue biopsy was performed, and histological analysis revealed cancer. The patient was diagnosed with fibrous-cavernous tuberculosis of the upper lobe of the right lung, infiltration and seeding phase; mycobacterium tuberculosis (+); broad drug resistance (HRSECmKmPasCsOfl); gastric ulcer (0,5 cm), exacerbation stage; chronic erosive gastritis, exacerbation stage; malignant neoplasm of the floor of the mouth on the right T3(4)N1M1. With this diagnosis, the patient was discharged for further treatment by oncologists. Physicians need to have a high alertness for cancer in patients with tuberculosis, especially those in the high-risk group. A minimum of standard diagnostic procedures will allow you to verify the diagnosis timely.

Consilium Medicum. 2021;23(12):982-985
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Organization of medical care in the oncology profile to patients outside the territory of their insurance in the context of changes in the regulatory rulemaking

Ognerubov N.A., Zelepukin R.V.


Background. Currently, there are large-scale changes in providing medical care in the oncology profile, that are reflected in the regulatory legal acts of the Ministry of Health of Russia, which will come into force in 2022 and will guide the classification of medical organizations providing services, as well as the features of diagnosing diseases, and standards for equipping hospitals, departments and specialized offices. At the same time, the issues of features of a procedure for providing medical care outside the territory of patients' insurance remain unresolved.

Aim. To identify issues and prospects of the new procedure for providing care in the "oncology" profile outside the territory of patients' insurance using the analysis of the legal regulation established by orders of the Ministry of Health of Russia that are coming into force, and law-enforcement practice.

Materials and methods. The analysis of the sources of legal regulation of the procedure for providing medical care to cancer patients, which are coming into force in the near future, was carried out. The analysis with the formal legal method allowed us to identify the essence, content, and legal consequences of the implementation of the norms governing the relations under discussion.

Conclusion. The analysis of the prospects for the implementation of the new regulatory legal acts allowed us to formulate a series of proposals. First, it is recommended to provide informing patients and their relatives about the procedure for getting medical services outside the territory of their insurance. Secondly, it is proposed to ensure that medical organizations of the constituent entities of the Russian Federation and their officials are prohibited from restricting the patient's right to choose a doctor and a medical organization, such as refusing to issue a referral or misinformation about not having patient's right to independently seek medical help from a medical organization in another region. Third, the authors consider the practice of limiting the provision of medical care in the "oncology" profile in special federal centers by compiling lists of such organizations to be unreasonable and inappropriate. We also propose to create a unified specialized hospital stoke for the treatment of oncological diseases in the constituent entities of the Russian Federation and to establish the volume of medical care in the "oncology" profile in the constituent entities of the Russian Federation on the basis of medical organizations which participate in territorial compulsory health insurance programs, given real resources and the needs of medical services.

Consilium Medicum. 2021;23(12):986-990
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COVID-19: long-term health impacts

Badalyan K.R., Solovyeva E.I.


Several studies have recently been conducted showing persistent COVID-19 symptoms in patients recovering after the acute phase of the disease. Energy imbalance plays a leading role in the pathogenesis of post-COVID syndrome. The choice of a metabolic cytoprotection drug with anti-asthenic activity will be decisive for the further tactics of managing the patient not only in the hospital, but also during the entire further period of recovery after the infection.

Consilium Medicum. 2021;23(12):993-999
pages 993-999 views

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