Vidaeff Alex C, Belfort Michael A
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.
Patient Prefer Adherence. 2013 Jul 11;7:683-91. doi: 10.2147/PPA.S35612. Print 2013.
Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the "magic bullet" in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC) supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by administration of 17OH-PC. Therefore, extending the use of 17OH-PC to unstudied populations or for indications that are not evidence-based is inadvisable outside of a research protocol.
预防早产是当代产科的一项主要需求，也是社会的必然要求。实现这一目标的方法仍然难以捉摸。自20世纪70年代以来，人们一直试图使用孕酮来预防早产，但最初积累的证据结果不一，且大多基于样本量不足、纳入标准各异的研究，其中包括将自然流产史作为治疗指征。最近的随机对照临床试验重新激发了人们对补充孕酮的兴趣，表明孕酮可能对早产率产生有利影响。早产是一种复杂的疾病，因此，一种通用的预防策略不太可能对所有患者都有效。此外，在将孕酮视为预防早产的“神奇药物”方面，另一个障碍是其作用机制尚未完全明确，最佳剂型、给药途径和剂量也有待确定。在本综述中，我们关注了己酸17α-羟孕酮（17OH-PC）补充剂预防早产的最新情况。我们的目的是在全面、公正地回顾现有文献的基础上，强调这种干预措施的有效性、安全性和患者可接受性。目前，尚无足够数据表明17OH-PC优于或劣于天然孕酮。基于现有证据，我们建议采用差异化方法，根据产科病史和宫颈监测情况，优先考虑使用17OH-PC或其他孕激素。目前，已发表的证据不支持对当前妊娠中除早产史和/或宫颈短之外的危险因素进行孕激素治疗。迄今为止，17OH-PC的使用经验表明，有部分人群可能会因使用17OH-PC而受到伤害。因此，在研究方案之外，将17OH-PC的使用扩展到未研究人群或用于缺乏循证依据的指征是不可取的。
