مقایسه اثرات قرص‌های اتیسترون و کنتراسمین بر یافته‌های بالینی و بیوشیمیایی هیپرآندروژنیسم و پارامترهای متابولیک بیماران مبتلا به سندرم تخمدان پلی‌کیستیک: یک کارآزمایی بالینی تصادفی

نوع مقاله : اصیل پژوهشی

نویسندگان

1 استادیار غدد تولید مثل، مرکز تحقیقات اندوکرینولوژی تولید مثل، پژوهشکده علوم غدد درون‌ریز و متابولیسم شهید بهشتی، دانشکده پزشکی، دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران.

2 دکترای تخصصی آمار زیستی، مرکز تحقیقات اندوکرینولوژی تولید مثل، پژوهشکده علوم غدد درون‌ریز و متابولیسم شهید بهشتی، دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران.

3 دانشیار گروه مامایی و بهداشت باروری، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران.

4 استاد غدد تولید مثل، مرکز تحقیقات اندوکرینولوژی تولید مثل، پژوهشکده علوم غدد درون‌ریز و متابولیسم، دانشکده پزشکی، دانشگاه علوم پزشکی شهید بهشتی، تهران، ایران.

چکیده

مقدمه: امروزه انتخاب کنتراسپتیو با بیشترین اثرات ضد آندروژنی، یک چالش مهم در درمان بیماران مبتلا به سندرم تخمدان پلی‌کیستیک (PCOS) است. مطالعه حاضر با هدف مقایسه اثربخشی قرص‌های اتیسترون و کنتراسمین بر پیامدهای PCOS انجام شد.
روش‌کار: این مطالعه کارآزمایی بالینی تصادفی در سال 96-1394 بر روی 108 بیمار مبتلا به PCOS مراجعه‌کننده به درمانگاه غدد پژوهشکده غدد درون‌ریز و متابولیسم دانشگاه علوم پزشکی شهید بهشتی تهران انجام شد. بیماران به‌صورت تصادفی در یکی از گروه‌های مداخله با قرص‌های اتیسترون یا کنتراسمین قرار گرفتند. پیامدهای مورد بررسی شامل: پارامترهای آندروژنیک، بالینی و متابولیک در وضعیت پایه، ماه سوم و ششم درمان بود. اندازه‌گیری‌های بالینی، هورمونی و متابولیک، با استفاده از پرسشنامه‌های استاندارد، ابزارهای بیوفیزیولوژیک و کیت‌های تشخیصی آزمایشگاهی انجام شد. به‌منظور بررسی اختلاف بین دو گروه درمان از مدل آماری معادلات برآورد تعمیم یافته استفاده شد. میزان p کمتر از 05/0 معنی‌دار در نظر گرفته شد.
یافته‌ها: پس از 3 ماه درمان، میزان آندروژن‌ها بین دو گروه درمان تفاوت معنی‌داری نداشت (05/0<p)، در‌‌حالی‌که پس از 6 ماه درمان، میزان تستوسترون در بیماران درمان شده با اتیسترون در مقایسه با کنتراسمین کمتر بود (029/0=p). 3 ماه پس از درمان، پارامترهای متابولیک بین دو گروه تفاوت معنی‌داری نداشتند (05/0<p)، در‌حالی‌که در ماه ششم درمان، بیماران درمان شده با اتیسترون در مقایسه با کنتراسمین میزان تری‌گلیسیرید بیشتری داشتند (049/0=p). در پایان ماه سوم و ششم درمان، فشارخون دیاستولیک در بیماران درمان شده با اتیسترون در مقایسه با کنتراسمین به‌طور معنی‌داری بیشتر بود (05/0>p).
نتیجه‌گیری: مصرف کنتراسپتیوهای حاوی سیپروترون استات در مقایسه با فرآورده‌های حاوی دروسپیرنون با بهبود بییشتر هیپرآندروژنیسم بیوشیمیایی همراه است، در‌حالی‌که این ترکیبات می‌توانند موجب دیس‌لیپیدمی و افزایش فشارخون در بیماران مبتلا به PCOS گردند.

کلیدواژه‌ها


عنوان مقاله [English]

Effects of Etisterone and Contrasmine pills on clinical and biochemical findings of hyperandrogenism and metabolic parameters of patients with polycystic ovary syndrome: A randomized clinical trial

نویسندگان [English]

  • Mina Amiri 1
  • Razieh Bidhendi-Yarandi 2
  • Fatemeh Nahidi 3
  • Fahimeh Ramezani Tehrani 4
1 Assistant Professor, Department of Reproductive Endocrinology, Reproductive Endocrinology Research Center, Shahid Beheshti Research Institute for Endocrine Sciences and Metabolism, Faculty of Medicine, Shahid Beheshti University of
2 Ph.D. of Epidemiology and Biostatistics, Reproductive Endocrinology Research Center, Shahid Beheshti Research Institute for Endocrine Sciences and Metabolism, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
3 Associate Professor, Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
4 Professor, Department of Reproductive Endocrinology, Reproductive Endocrinology Research Center, Shahid Beheshti Research Institute for Endocrine Sciences and Metabolism, Faculty of Medicine, Shahid Beheshti University of Medical Sciences,
چکیده [English]

Introduction: Nowadays, selection of a contraceptive with most anti-androgenic effects is an important challenge in treatment of patients with polycystic ovary syndrome (PCOS). This study was performed with aim to compare the effects of Etisterone and Contrasmine pills on PCOS outcomes.
Methods: This randomized clinical trial was conducted between 2016 and 2018, and enrolled 108 patients with PCOS referred to Research institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. The patients were randomly assigned to one of the intervention groups with Etisterone or Contrasmine pills. The studied outcomes included androgenic, clinical and metabolic parameters at baseline, third and sixth months of treatment. Data collection tools included standard questionnaires, bio-physiologic instruments, and laboratory diagnostic kits. To investigate the differences between the two treatment groups, the statistical model of generalized estimating equations was used. P-value less than 0.05 was considered significant.
Results: After 3 months of treatment, the androgens levels was not significantly different between the two treatment groups (p>0.05), while after 6 months of treatment, the patients treated with Etisterone had lower testosterone levels, compared to those treated with Contrasmine (p=0.029). After 3 months of treatment, the metabolic parameters was not significantly different between the two groups (p>0.05), whereas in 6th month of treatment, patients treated with Etisterone had higher triglyceride levels than those taking Contrasmine (p=0.049). At the end of 3rd and 6th months of treatment, diastolic blood pressure was significantly higher in patients treated with Etisterone, compared to those treated with Contrasmine (p < 0.05).
Conclusion: Use of contraceptives containing cyproterone acetate (CPA) is associated with greater improvement in biochemical hyperandrogenism compared to drospirenone containing products (DRSP), while these compounds can induce hypertriglyceridemia and hypertension in patients with PCOS.

کلیدواژه‌ها [English]

  • contraceptive
  • Hyperandrogenism
  • Polycystic ovary syndrome (PCOS)
  • progestin
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