Venetis Christos A, Mol Ben W
Centre for Big Data Research in Health & Discipline of Obstetrics and Gynaecology, Faculty of Medicine & Health, University of New South Wales, Sydney 2000, New South Wales, Australia; IVFAustralia, Alexandria 2015, New South Wales, Australia.
Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia; Aberdeen Centre for Women's Health Research, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.
Drug Discov Today. 2023 Feb;28(2):103425. doi: 10.1016/j.drudis.2022.103425. Epub 2022 Nov 1.
Biosimilars of follitropin alfa have been introduced in many countries as more affordable alternatives to the reference product for patients undergoing ovarian stimulation for assisted reproductive technology cycles. A recent meta-analysis, by reviewing available evidence originating from randomised controlled trials, has shown that based on the best available evidence, biosimilars of follitropin alfa are associated with lower live birth, ongoing and clinical pregnancy rates compared to the reference product. A subsequently published opinion paper challenges the methodology and results of this meta-analysis and suggests that these data should be ignored. In the present paper, it is clearly demonstrated why this criticism is largely unfounded and in stark contradiction with basic principles of evidence-based medicine. Furthermore, it is presented why the results of this meta-analysis provide the best available evidence to date and therefore the base that should inform clinical practice and, importantly, stimulate further research.
对于接受辅助生殖技术周期卵巢刺激的患者而言，促卵泡素α生物类似药已在许多国家作为参考产品更经济实惠的替代品推出。最近一项荟萃分析通过回顾来自随机对照试验的现有证据表明，基于现有最佳证据，与参考产品相比，促卵泡素α生物类似药的活产率、持续妊娠率和临床妊娠率较低。随后发表的一篇观点论文对该荟萃分析的方法和结果提出质疑，并建议应忽略这些数据。在本文中，明确证明了为何这种批评在很大程度上是没有根据的，并且与循证医学的基本原则完全矛盾。此外，还阐述了为何该荟萃分析的结果提供了迄今为止最佳的现有证据，因此应作为指导临床实践的依据，重要的是，还能激发进一步的研究。
