بررسی اثر مقایسه‌ای نیتروگلیسیرین و میزوپروستول واژینال بر روی آمادگی سرویکس قبل از هیستروسکوپی: یک کارآزمایی بالینی تصادفی شده

نوع مقاله : اصیل پژوهشی

نویسندگان

1 دانشیار گروه زنان و زایمان، دانشکده پزشکی، دانشگاه علوم پزشکی ایران، تهران، ایران.

2 استاد گروه زنان و زایمان، مرکز تحقیقات اندمتریوزیس، دانشکده پزشکی، دانشگاه علوم پزشکی ایران، تهران، ایران.

3 دکتری داروسازی، دانشکده داروسازی، دانشگاه آزاد اسلامی، تهران، ایران.

4 استادیار گروه زنان و زایمان، دانشکده پزشکی، دانشگاه علوم پزشکی بیرجند، بیرجند، ایران.

5 دانشیار گروه زنان و زایمان، مرکز توسعه تحقیقات بالینی فیروزآبادی، دانشکده پزشکی، دانشگاه علوم پزشکی ایران، تهران، ایران.

6 متخصص زنان و زایمان، دانشکده پزشکی، دانشگاه علوم پزشکی ایران، تهران، ایران.

10.22038/ijogi.2025.80918.6128

چکیده

مقدمه: هیستروسکوپی برای ارزیابی آسیب‌شناسی داخل رحم قبل و بعد از یائسگی به‌خصوص در مواردی که فرد از خونریزی غیرطبیعی رحمی شکایت داشته، بیماران نابارور و ناهنجاری­ های مشکوک رحمی استفاده می­شود. داروهای آزاد کننده نیتریک اکسید مانند ایزوسورباید مونونیترات، ایزوسورباید دینیترات، نیتروگلیسیرین و نیتروپروساید سدیم بدون ایجاد انقباض رحم، باعث آمادگی سرویکس شده و می‌تواند به‌صورت سرپایی استفاده شوند. مطالعه حاضر با هدف بررسی مقایسه اثر نیتروگلیسیرین با میزوپروستول بر آمادگی سرویکس قبل از هیستروسکوپی انجام شد.
روشکار: این مطالعه کارآزمایی بالینی دوسوکور در سال 1402-1401 بر روی 90 نفر از بیماران کاندید هیستروسکوپی مراجعه کننده به بیمارستان رسول اکرم (ص) تهران انجام شد. در گروه مداخله اول (A) قرص نیتروگلیسیرین و در گروه مداخله دوم (B) دو عدد قرص میزوپروستول استفاده شد و میزان رایپنینگ سرویکس با دیلاتورهای درجه‌بندی شده در هر دو گروه بررسی گردید. تجزیه و تحلیل داده­ ها با استفاده از نرم‌افزار آماری SPSS (نسخه 22) و آزمون‌های تی دانشجویی، من ویتنی یو، کای اسکوئر و آزمون دقیق فیشر انجام شد. میزان p کمتر از 05/0 معنی‌دار در نظر گرفته شد.
یافته ­ها: دو گروه از نظر ویژگی‌های پایه مانند سن، شاخص توده بدنی، سابقه زایمان و وضعیت دهانه رحم مشابه بودند و اختلاف آماری معنی‌داری نداشتند (05/0>p). اگرچه هر دو دارو در ایجاد آمادگی سرویکس برای هیستروسکوپی مؤثر بودند، اما گروه میزوپروستول، عوارض جانبی قابل توجهی مانند کرامپ شکمی و تهوع (9/91%) را گزارش کردند، در حالی که گروه نیتروگلیسیرین، هیچ عارضه‌ای نداشتند. علاوه بر این، خونریزی پس از عمل در گروه نیتروگلیسیرین (8/17%) در مقایسه با گروه میزوپروستول (6/95%) به‌طور معناداری کمتر بود (001/0=p).
نتیجه ­گیری: با توجه به اثربخشی مشابه دو داروی نیتروگلیسیرین و میزوپروستول در میزان دیلاتاسیون سرویکس بدون مقاومت، استفاده از نیتروگلیسیرین واژینال به‌دلیل اثربخشی بهتر در کاهش درد بیمار، کاهش خونریزی پس از عمل هیستروسکوپی و عدم وجود عارضه جانبی، نسبت به داروی میزوپروستول واژینال ارجحیت دارد.

کلیدواژه‌ها

موضوعات


عنوان مقاله [English]

Comparative Effect of Vaginal Nitroglycerin and Misoprostol on Cervical Preparation before Hysteroscopy: A Randomized Clinical Trial

نویسندگان [English]

  • Shahla Mirgaloybayat 1
  • Abolfazl Mehdizadehkashi 2
  • Mahmoodreza Madadian 3
  • Farahnaz Farzaneh 1
  • Maryam Yazdizadeh 4
  • Samaneh Saghafian Larijani 5
  • Melika Ansarin 6
1 Associate Professor, Department of Obstetrics and Gynecology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
2 Professor, Department of Obstetrics and Gynecology, Endometriosis Research Center, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
3 PhD of Pharmacy, School of Pharmacy, Islamic Azad University, Tehran, Iran.
4 Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.
5 Associate Professor, Department of Obstetrics and Gynecology, Firoozabadi Clinical Research Development Unit (FACRDU), Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
6 Gynecologist, Department of Obstetrics and Gynecology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
چکیده [English]

Introduction: Hysteroscopy is used to evaluate intrauterine pathology before and after menopause, especially in cases of abnormal uterine bleeding, infertile patients, and suspected uterine abnormalities. Nitric oxide-releasing drugs such as isosorbide mononitrate, isosorbide dinitrate, nitroglycerin, and sodium nitroprusside prepare the cervix without causing uterine contractions and can be used as outpatient. The present study was conducted with aim to compare the effects of nitroglycerin with misoprostol on cervical preparation before hysteroscopy.
Methods: This double-blind clinical trial was conducted in 2022-2023 on 90 patients who were candidates for hysteroscopy and referred to Rasoul Akram Hospital in Tehran. In the first intervention group (A), nitroglycerin tablets were used, and in the second intervention group (B), two misoprostol tablets were used, and the rate of cervical ripening was examined with graded dilators in both groups. Data analysis was performed using SPSS statistical software (version 22) and Student's t-test, Mann-Whitney U, Chi-square, and Fisher's exact tests. P<0.05 was considered significant.
Results: The two groups were similar in terms of baseline characteristics such as age, body mass index, previous childbirth, and cervical status, and there were no statistically significant differences (p>0.05). Although both drugs were effective in preparing the cervix for hysteroscopy, the misoprostol group reported significant adverse events such as abdominal cramps and nausea (91.9%), while the nitroglycerin group had no complications. In addition, postoperative bleeding was significantly less in the nitroglycerin group (17.8%) compared with the misoprostol group (95.6%) (p=0.001).
Conclusion: Given the similar effectiveness of nitroglycerin and misoprostol in the rate of unresisted cervical dilation, the use of vaginal nitroglycerin is preferable to vaginal misoprostol due to its better effectiveness in reducing patient pain, reducing bleeding after hysteroscopy, and the absence of side effects.

کلیدواژه‌ها [English]

  • Cervical Preparation
  • Hysteroscopy
  • Vaginal Misoprostol
  • Vaginal Nitroglycerin
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