agxАндрология и генитальная хирургияAndrology and Genital Surgery2070-97812412-890210.17650/2070-9781-2016-17-4-59-67agx-216Research ArticleОБЗОРНЫЕ СТАТЬИREVIEWВлияние терапии тестостероном (1 % трансдермальный гель) на качество жизни мужчин с андрогенодефицитом в условиях рутинной клинической практики: 6-месячное наблюдательное исследованиеInfluence of the testosterone therapy (1 % transdermal gel) on the life quality of men of androgen deficiency in terms of routing clinical practice: 6 months monitoring testВинаровА. З.VinarovA. Z.

Россия, 119991 Москва, ул. Трубецкая, 8, стр. 2

build. 2, 8 Trubetskaya St., Moscow 119991, Russia

avinarov@mail.ruСпивакЛ. А.SpivakL. A.

Россия, 119991 Москва, ул. Трубецкая, 8, стр. 2

build. 2, 8 Trubetskaya St., Moscow 119991, Russia

РохликовИ. М.RohlikovI. M.

Россия, 119991 Москва, ул. Трубецкая, 8, стр. 2

build. 2, 8 Trubetskaya St., Moscow 119991, Russia

ВасилевскийР. П.VasilevskyR. P.

Россия, 119991 Москва, ул. Трубецкая, 8, стр. 2

build. 2, 8 Trubetskaya St., Moscow 119991, Russia

РазоваЛ. В.RazovаL. V.

Россия, 119991 Москва, ул. Трубецкая, 8, стр. 2

build. 2, 8 Trubetskaya St., Moscow 119991, Russia

ФГБОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава РоссииРоссияI.M. Sechenov 1st Moscow State Medical University of the Ministry of Health of RussiaRussian Federation2016030220171745967Copyright © Винаров А.З., Спивак Л.А., Рохликов И.М., Василевский Р.П., Разова Л.В., 20172017Винаров А.З., Спивак Л.А., Рохликов И.М., Василевский Р.П., Разова Л.В.Vinarov A.Z., Spivak L.A., Rohlikov I.M., Vasilevsky R.P., Razovа L.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://agx.elpub.ru/jour/article/view/216Материалы и методы

Материалы и методы. Данное исследование являлось открытым многоцентровым наблюдательным неинтервенционным у мужчин с дефицитом тестостерона, применявших ежедневно 1 % гель тестостерона (Андрогель®) в дозе 50 или 100 мг (с возможностью титрации) в условиях рутинной клинической практики. Первичной конечной точкой являлось качество жизни, связанное с состоянием здоровья, оцениваемое при заполнении опросника симптомов старения мужчин (Aging Males’ Symptoms, AMS). Вторичными конечными точками были изменения общего балла шкалы Международного индекса эректильной функции (МИЭФ) и его доменов, изменения показателей индекса массы тела (ИМТ) и окружности талии, корреляция изменений в показателях качества жизни, определяемая с помощью опросника AMS, с лабораторными показателями уровней тестостерона и данными по шкале МИЭФ, демографические характеристики, а также исходные характеристики пациентов, анамнез диагностических и терапевтических процедур, причины прекращения лечения и любые нежелательные явления, возникшие в ходе лечения препаратом Андрогель®.

Результаты

Результаты. Данные о 196 из 202 включенных в исследование пациентов были доступны для обработки после 6 мес наблюдения. Средние значения уровня общего тестостерона в начале исследования составили 10,8 ± 0,3 (95 % доверительный интервал (ДИ) 10,2–11,4) нмоль/л, после 6 мес терапии – 21,1 ± 0,4 (95 % ДИ 20,4–21,9) нмоль/л. Значимые изменения были отмечены по шкале AMS, средний балл на 1-м визите составил 47,4 ± 1,0 (95 % ДИ 45,5–49,4), а на 4-м – 27,5 ± 0,8 (95 % ДИ 25,9–29,1); по шкале МИЭФ на 1-м визите – 33,0 ± 1,0 (95 % ДИ 31,0–35,0), на 4-м – 54,0 ± 1,0 (95 % ДИ 52,0–57,0). Дополнительные положительные эффекты отмечены в отношении ИМТ и окружности талии – уменьшение показателей на 1,2 кг/м2 и 5 см соответственно.

Выводы

Выводы. В ходе исследования отмечено достоверное уменьшение выраженности симптомов дефицита тестостерона, улучшение показателей качества жизни и сексуальной функции. За 6 мес наблюдения клинически значимых нежелательных явлений не выявлено.

Маterials and methods

Маterials and methods. The study hereunder was an open multicenter surveillance non-intervention study at men with testosterone deficiency, apllying daily 1 % testosterone gel (Аndrogel®) in the dosage of 50 or 100 mg (with possible titration) in terms of routine clinical practice. The initial end point was the life quality, referred to the health status, evaluated at the filling of the questionnaire on Aging Males’ Symptoms (AMS). As secondary end points served changes of the total score of the International Erectile Function Index (IEFE) and its domains, changes of body weight index (BWI) and of the waist circumference, correlation of changes in life quality indices, determined with AMS questionnaire, with laboratory indices of the testosterone level and of the data by the IEFE scale, demographic features, as well as original characteristics of patients, anamnesis of diagnostic and therapeutic procedures, reason for the treatment termination and any adverse effects, arising in the course of treatment with Androgel®.

Results

Results. The data on 196 of 202 patients, included in studies, was available for processing after 6 months of monitoring. Average values of the total testosterone level in beginning of studies were 10.8 ± 0.3 (95 % confidence interval (CI) 10.2–11.4) nmol/l after 6 months of therapy – 21.1 ± 0.4 (95 % CI 20.4–21.9) nmol/l. Significant changes were marked on the AMS scale, the average point at the 1st visit was 47.4 ± 1.0 (95 % CI 45.5–49.4), аnd at the 4th – 27.5 ± 0.8 (95 % CI 25.9–29.1); by IEFE scale at the 1st visit – 33.0 ± 1.0 (95 % CI 31.0–35.0), at the 4th – 54.0 ± 1.0 (95 % CI 52.0–57.0). Additional positive effects were marked as to BWI and the waist circumference – decrease of indices by 1,2 kg/m2 and 5 сm accordingly.

 

 

Conclusion

Conclusion. Studies have shown the authentic reduction of expressed symptoms of testosterone deficiency, improvement of the life quality indices and of the sexual function. During 6 months of monitoring no clinically significant adverse effects were revealed.

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The authors declare that there are no conflicts of interest present.