Актуальность. Сегодня в фокусе внимания ис-следователей находятся такие проблемы, как метаболический синдром и процессы формиро-вания неалкогольной жировой болезни печени, выявление факторов, влияющих на скорость развития дистрофических и фибротических изменений в ткани печени. Настоящее иссле-дование демонстрирует попытку более деталь-ного изучения метаболических нарушений и состояния ткани печени в постхолецистэкто-мическом периоде у пациентов с изначально регистрируемым метаболическим синдромом. Цель -изучить влияние холецистэктомии в мо-лодом возрасте на течение метаболического синдрома у женщин. Материал и методы. Проведено ретроспективное аналитическое исследование. В выборку включены 57 пациен-ток с признаками метаболического синдрома (критерии IDF 2005 г.) в возрасте от 18 до 44 лет (молодой возраст согласно определению Всемирной организации здравоохранения). Из них 27 пациенток, страдающих желчнока-менной болезнью, составили основную группу, 30 пациенток, перенесших холецистэктомию в этот возрастной промежуток, вошли в группу сравнения. Проанализированы данные анамне-за, клинического обследования, лабораторные показатели, данные ультразвукового исследо-вания органов брюшной полости, эзофагога-стродуоденоскопии, водородного дыхатель-ного теста с лактулозой, а также результаты пункционной биопсии печени. Результаты. Неалкогольный стеатогепатит в постхоле-цистэктомическом периоде ассоциирован с избыточным бактериальным ростом в тонкой кишке (р = 0,026), ультразвуковыми признака-ми холангита (р = 0,041), синдромом диареи (р = 0,027). Фиброз статистически значимо чаще регистрировался в сочетании с хронической диареей (р = 0,034) и клиническими проявле-ниями постхолецистэктомического синдрома в анамнезе (р = 0,044). Выявлена сильная пря-мая корреляционная связь между степенью фи-броза и длительностью постхолецистэктомиче-ского периода (r = 0,77; р = 0,047). Заключение. Холецистэктомия в молодом возрасте является предиктором прогрессирования метаболиче-ских расстройств у женщин с метаболическим синдромом.Ключевые слова: желчнокаменная болезнь, метаболический синдром, холецистэктомия, неалкогольная жировая дистрофия печени Для цитирования: Лебедева ОВ, Буеверов АО, Буеверова ЕЛ, Никитина ЛО. Влияние холецистэк-томии в молодом возрасте на течение метаболиче-ского синдрома у женщин. Альманах клинической медицины. 2017;45(5):384-91.

The clinical review of international data about morbidity and mortality of children with very low and extremely low birth weight is presented in this article. The risk factors of unfavorable outcomes and increasing possibilities for survival were analyzed. It was defined that the morbidity and mortality of very preterm infants, especially with the extreme degree of immaturity, vary greatly and depend on the socio-economic background, level of medical care and baseline characteristics of the newborn. However, every newborn, even in relatively equal conditions, has a "degree of stability", which is determined by biological and genetic factors, the characteristics of the course of the perinatal period and numerous external reasons. The author focuses on the most vulnerable and challenging population of children born in the zone limit of viability earlier than 25 weeks of gestation and weighing less than 700g. She noted that the detailed analysis of the causes of death with the release of the risk factors of adverse outcome is extremely important, especially for relatively promising group of children born with a gestational age of 25 weeks or more. They are the reserve on ways to further reduce neonatal and infant mortality in Russia.

Introduction. A fixed dose combination of telmisartan and hydrochlorothiazide is indicated for treatment of in the treatment of arterial hypertension. The combination of these substances causes an additive effect that helps to reduce blood pressure. A bioequivalence study of Telzap® Plus compared with MikardisPlus® was conducted with 63 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of the fixed dose combination drug product Telzap® Plus (tablets 80 mg + 12,5 mg, Zentiva KS company, Czech Republic) compared with drug products MikardisPlus® (telmisartan+hydrochlorothiazide, tablets 80 mg + 12,5 mg, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany) in healthy volunteers after a single administration under fasting.Materials and methods. To prove bioequivalence, an open label, comparative, randomized, crossover fourperiod replicate single-center clinical trial was conducted. The concentrations of hydrochlorothiazide and telmisartan in plasma samples were determined with a validated HPLC-MS/MS method. A pharmacokinetic and statistical analysis was performed and confidence intervals for the pharmacokinetic parameters Cmax and AUC0-72 were calculated.Results and discussion. It can be concluded that the studied formulations are bioequivalent in terms of pharmacokinetic parameters of hydrochlorothiazide and telmisartan. All 90 % confidence intervals for the estimated pharmacokinetic parameters of hydrochlorothiazide were in the range of 80–125 %, 90 % confidence intervals for telmisartan were within the bioequivalence range of 80–125 % for AUC0-72, and 79,30–126,11 % for Cmax.Conclusion. Thus, according to the criteria used in the study, the formulations are proved to be bioequivalent.

Introduction. Telmisartan is widely used in clinical practice during hypertension treatment. It is a specific angiotensin II receptor antagonist (type AT1), effective at oral intake, A bioequivalence study of Telzap® and Mikardis® was conducted with 60 volunteers.Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of Mikardis® (telmisartan, tablets 80 mg, Boehringer Ingelheim International GmbH, Germany) and Telzap® (telmisartan, tablets 80 mg, Zentiva KS company, Czech Republic) in healthy volunteers after a single administration under fasting.Materials and methods. To prove bioequivalence, an open label, comparative, randomized, crossover four-period replicate single-center clinical trial was conducted. The concentrations of telmisartan in plasma samples were determined by a validated HPLC-MS/MS method. A pharmacokinetic and statistical analysis was performed and confidence intervals for the pharmacokinetic parameters Cmax and AUC0-72 were calculated.Results and discussion. It can be concluded that the studied formulations are bioequivalent in terms of pharmacokinetic parameters of test and reference drug. All 90 % confidence intervals of were within the bioequivalence range of 80–125 % for AUC0-72 and 73,07–136,85 % for Cmax.Conclusion. Thus, according to the criteria used in the study, the formulations are proved to be bioequivalent.

Introduction. The advantages of fixed-dose combination losartan + amlodipine + rosuvastatin compared to mono-drugs and two-component combinations are to increase the therapeutic efficacy, to reduce the cost of the product and to make the drug easier to take which helps to improve patient adherence to therapy. A bioequivalence study of the three-component fixed-dose combinations Losartan + amlodipine + rosuvastatin Sanofi with coadministered Lozap® AM (Losartan+Amlodipine) and Crestor® (Rosuvastatin) was conducted.   Aim. The purpose of the bioequivalence trial was a comparative study of the pharmacokinetics and evidence of the bioequivalence of two strengths of fixed-dose combination: 1) Losartan + amlodipine + rosuvastatin Sanofi (tablets, 50 mg + 5 mg + 10 mg) in comparison with coadministrated drugs Lozap® AM (losartan + amlodipine, tablets, 50 mg + 5 mg,) and Crestor® (rosuvastatin, tablets, 10 mg) in fasting healthy volunteers after a single administration; 2) Losartan + amlodipine + rosuvastatin Sanofi (tablets, 100 mg + 5 mg + 20 mg) in comparison with coadministrated drugs Lozap® AM (losartan + amlodipine, tablets, 100 mg + 5 mg) and Crestor® (rosuvastatin, tablets, 20 mg) in fasting healthy volunteers 18–45 years old after a single dose.   Materials and methods. To prove bioequivalence, an open label, comparative, randomized, crossover four-period clinical trial was conducted for each strengths of fixed-dose combination. The concentrations of losartan, amlodipine and rosuvastatin in blood plasma samples obtained from volunteers were determined by a validated HPLC-MS/MS method. A pharmacokinetic and statistical analysis was performed and confidence intervals (CI) for the pharmacokinetic parameters Сmax, AUC0-72 (for amlodipine) and AUC0-t (for losartan and rosuvastatin) were calculated.      Results and discussion. Based on the results of statistical and pharmacokinetic analysis, it was shown that the studied formulations are bioequivalent in terms of pharmacokinetic parameters of losartan, amlodipine and rosuvastatin. 90 % CI were in the acceptable range for Сmax (of amlodipine), AUC0-72 (of amlodipine) and AUC0-t (of losartan and rosuvastatin). 90 % CI for Сmax of losartan and rosuvastatin were in the acceptable extended calculated range according to the protocol.   Conclusion. Thus, according to the criteria used in the studies, the three-component fixed-dose combinations Losartan + amlodipine + rosuvastatin Sanofi are proved to be bioequivalent in comparison with coadministered Lozap® AM and Crestor®.