Manuck Tracy A, Gyamfi-Bannerman Cynthia, Saade George
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC (Dr Manuck); Institute for Environmental Health Solutions, Gillings School of Global Public Health, Chapel Hill, NC (Dr Manuck).
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, San Diego, CA (Dr Gyamfi-Bannerman).
Am J Obstet Gynecol MFM. 2023 Oct;5(10):101108. doi: 10.1016/j.ajogmf.2023.101108. Epub 2023 Jul 30.
Spontaneous preterm birth is multifactorial, and underlying etiologies remain incompletely understood. Supplementation with progestogens, including 17-alpha hydroxyprogesterone caproate has been a mainstay of prematurity prevention strategies in the United States in the last 2 decades. Following a recent negative confirmatory trial, 17-alpha hydroxyprogesterone caproate was withdrawn from the US market and is currently available only through clinical research studies. This expert review summarized clinical and research data regarding the use of 17-alpha hydroxyprogesterone caproate in the United States from 2003 to 2023 for recurrent prematurity prevention. In 17-alpha hydroxyprogesterone caproate. The history of the use, mechanisms of action, clinical trial results, and efficacy by clinical and biologic criteria of 17-alpha hydroxyprogesterone caproate are presented. We report that disparate findings and conclusions between similarly designed rigorous studies may reflect differences in a priori risk and population incidence and extreme care should be taken in interpreting the studies and making decisions regarding efficacy of 17-alpha hydroxyprogesterone caproate for the prevention of preterm birth. The likelihood of improved obstetrical outcomes after receiving 17-alpha hydroxyprogesterone caproate may vary by clinical factors (eg, body mass index), plasma drug concentrations, and genetic factors, although the identification of individuals most likely to benefit remains imperfect. It is crucial for the medical community to recognize the importance of preserving the decades-long efforts invested in preventing recurrent preterm birth in the United States. Moreover, it is important that we thoroughly and thoughtfully evaluate 17-alpha hydroxyprogesterone caproate as a promising contender for future well-executed prematurity studies.
自发性早产是多因素导致的，其潜在病因仍未完全明确。在过去20年里，补充孕激素，包括己酸17-α羟孕酮，一直是美国预防早产策略的主要手段。在最近一项阴性验证性试验之后，己酸17-α羟孕酮已从美国市场撤出，目前仅通过临床研究项目才能获得。这篇专家综述总结了2003年至2023年期间美国使用己酸17-α羟孕酮预防复发性早产的临床和研究数据。介绍了己酸17-α羟孕酮的使用历史、作用机制、临床试验结果以及根据临床和生物学标准评估的疗效。我们报告称，设计相似的严谨研究之间存在不同的结果和结论，这可能反映了先验风险和人群发病率的差异，在解释这些研究以及就己酸17-α羟孕酮预防早产的疗效做出决策时应格外谨慎。接受己酸17-α羟孕酮后改善产科结局的可能性可能因临床因素（如体重指数）、血浆药物浓度和遗传因素而异，尽管确定最可能受益的个体仍不完善。医学界必须认识到保护美国在预防复发性早产方面投入数十年努力的重要性。此外，重要的是，我们要全面且深入地评估己酸17-α羟孕酮，它是未来执行良好的早产研究的一个有潜力的候选药物。
