Проведена оценка эффективности включения реамберина в комплексную реабилитацию пациентов, перенесших пневмонию, обусловленную SARS-CoV-2, на амбулаторном этапе. Проанализированы данные 162 пациентов, получивших реабилитационное лечение, включающее, помимо фармакологического пособия, лечебную физкультуру и вакуумный лабильный массаж. Кроме того, пациенты основной группы (n = 82) получили на протяжении 10 дней реамберин (1,5 %, внутривенно капельно в объеме 500 мл). В динамике исследовали биохимические показатели крови, с помощью проб Штанге и Генчи и пульсоксиметрии — оксигенацию. Качество жизни оценивали с помощью опросника SF-36. Включение реамберина в комплексную реабилитацию способствовало улучшению основных биохимических показателей крови (содержание трансаминоаспартатаминотрансферазы снизилось в 1,2 раза, аланинаминотрансферазы — в 1,7 раза, гамма-глутамилтранспептидазы в 1,9 раза, p ≤ 0,5), и более выраженному повышению функции внешнего дыхания в среднем по пробе Штанге на 8,4 с, по пробе Генчи — на 9,1 с, что сопровождалось положительной тенденцией показателей качества жизни (по опроснику SF-36) по показателям физического функционирования (на 5,1 балла) и общего состояния здоровья (на 3,76 балла). Выявленные клинико-лабораторные данные вместе с хорошей переносимостью препарата позволяют рекомендовать включение реамберина в схемы реабилитации пациентов с пневмонией, обусловленной SARS-CoV-2.
The aim of the work was to study the effectiveness of remaxol inclusion in treatment regimens designed for patients with comorbid tuberculosis and hepatotoxic response to etiotropic therapy.Materials and Methods. Case histories of 25 patients (21 men and 4 women) with a confirmed diagnosis of tuberculosis infection and hepatotoxic reactions to etiotropic treatment were analyzed. Of these, 9 patients had a comorbid (TB/HIV) pathology and 16 patients had TB/HIV with concomitant diseases. To stop the signs of hepatotoxicity, all patients were prescribed with remaxol: 400 ml intravenously on alternate days (course No. 5), then 1 time per week (course No. 4). In addition to the standard clinical and laboratory examination, all patients underwent follow-up (before and after the course of remaxol) examination of the levels of aspartate aminotransferase and total bilirubin in the blood, as well as the levels of interleukin production (1β, 4, 6 and 10) and tumor necrosis factors (TNF-α and TNF-γ). Standard regimens were used when conducting anti-tuberculosis chemotherapy.Results. It was noted that the presence of a comorbidity aggravates the course of tuberculosis and reduces the effectiveness of etiotropic therapy due to the development of hepatotoxicity. The inclusion of remaxol contributed to a decrease in the severity of hepatotoxic reactions and made it possible to avoid the correction of the main treatment course. The revealed positive dynamic in cytokine profile indicators can be regarded as a mediated immunological effect of the drug and requires further research.
Relevance. International non-proprietary name (INN) Ebastin is widely used in medical practice in the treatment of urticaria and allergic rhinitis. It is an antiallergic drug, which belongs to the second generation of H1-histamine receptor blocker, it is necessary to emphasize that Ebastin is effective when taken orally. As part of the registration of trade name Allergostin, a clinical study of its bioequivalence with Kestin was conducted with the participation of 26 healthy volunteers. Aim. The aim of this publication is summarize results of the clinical study of the comparative pharmacokinetics and bioequivalence, safety and tolerability of Allergostin, film-coated tablets, 20 mg (NTFF POLYSAN LLC, Russia), and Kestin, film-coated tablets, 20 mg (Almiral S.A., Spain), in healthy volunteers after a single oral dose on an empty stomach. Materials and methods. To confirm bioequivalence, an open, randomized, two-period, cross-over study of comparative pharmacokinetics and bioequivalence of drugs with a single oral intake on an empty stomach in adult healthy male and female volunteers was conducted. During the study, blood plasma samples were taken from volunteers. Each sample was tested by using a validated high performance liquid chromatography with tandem mass spectrometry method, the concentrations of ebastine and the active metabolite carabastin were determined. Based on obtained data , pharmacokinetic and statistical analysis was carried out, 90% confidence intervals (CI) were calculated for the ratio of the geometric mean values of the pharmacokinetic parameters Cmax and AUC0-72 for carabastin. Results. Based on results of statistical analysis, it was shown that the pharmacokinetic parameters of the test (Allergostin) and reference (Kestin) drug are characterized by high similarity. For the estimated pharmacokinetic parameters of carabastin, 90% CI ranged from 80-125% for AUC0-t and Cmax. Conclusion. Thus, according to the applied criteria, the drugs are recognized as bioequivalent.
The aim of the study was to evaluate the effectiveness of including remaxol in the medical rehabilitation of elderly and senior patients with COVID-19-associated pneumonia and changes in liver enzyme activity.Material and methods: 116 patients (56 men and 60 women) were examined. All patients underwent a complex of medical rehabilitation on an outpatient basis on the 10–12th day after discharge from the hospital and in the presence of 2 negative results of PCR tests for SARS-CoV-2, which included, in addition to the recommended measures (drug therapy and exercise therapy), vacuum labile massage according to the author's methodology and a course of hepatoprotective drugs. Depending on the latter, the patients were divided into two groups: I — the main group (n=60) — received remaxol in the drug treatment regimen: 400 ml, intravenously, drip, in a course of 10 days, II – comparison (n=56) — ademetionine: 400 ml, intravenously, drip, in 0.9% saline, in a course 10 days. Before rehabilitation and at its end, the following tests were carried out: Stange and Genchi tests; quality of life was assessed using the SF-36 questionnaire. Laboratory studies included determination of the following indicators levels: ALT, AST, their ratio, alkaline phosphatase, GGT, total and direct bilirubin, LDH, albumin and total protein levels.Results. The inclusion of hepatoprotectors in the medical rehabilitation of the patients of this group contributes to a decrease in cytolytic and cholestatic syndromes, which is more pronounced in patients who received remaxol: (a decrease in AST by 1.5 times (from 35.4±1.4 to 23.5±l), and ALT — by 1.8 times (from 38.7±1.3 to 21.5±0.4 IU/l), as well as normalization of bilirubin metabolism: a decrease of total bilirubin by 2.1 times (from 32.1± 0.6 to 14.8±0.9 µmol/l) and of direct — by 2.5 times (from 7.1±0.6 to 2.8±0.1 µmol/l). A pronounced increase in resistance to hypoxia was noted during the therapy with the drug (according to Stange and Genche), which contributed to an improvement in psychophysiological indicators of patients’ quality of life (according to the SF-36 questionnaire). The obtained results, along with the safety of the drug, allow us to recommend its use in patients with this pathology.
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