College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.
Integrative Medicine Research Centre of Reproduction and Heredity, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
Front Endocrinol (Lausanne). 2020 Sep 23;11:581719. doi: 10.3389/fendo.2020.581719. eCollection 2020.
In the past decade, the number of frozen-thawed embryo transfer (FET) has increased dramatically with the expansion of surgical indications and the improvement of freezing related technologies. How to improve the success rate and reduce the adverse effects of FET is our research priorities. This study aimed to investigate the safety and effectiveness of Gushen'antai pills (GSATP) by measuring the ongoing pregnancy rate (OPR) in patients from FET and hormone therapy (HT) cycle. From November 2019 to May 2020, 5 Chinese hospitals conducted a multi-center, randomized, double-blind, placebo-controlled study. In total, 271 HT FET cycles in patients were randomly divided (1:1 ratio) to receive GSATP (6 g, tid) or placebo (6g, tid) for 12 weeks of pregnancy. Patients, clinicians, and researchers were blinded to treatment allocation. The primary endpoint was the OPR at week 12 of pregnancy. The secondary endpoints were vaginal bleeding or brown discharge rate, implantation rate (IR), clinical pregnancy rate (CPR) and abortion rate (AR). Adverse events were recorded during the treatment period. The results showed that the OPR remained higher in the GSATP group when compared to placebo group (56.62% vs. 44.44%, = 0.045). Vaginal bleeding or brown discharge rate was lower in the GSATP group than the placebo group (10% vs. 23.08%, = 0.032), while the IR (35.16% vs. 27.64%, = 0.070), CPR (58.82% vs. 48.15%, = 0.078), incidence of total adverse events (8.09% vs. 3.22%, = 0.051) and AR (3.75% vs. 7.69%, = 0.504) were similar between GSATP and placebo groups. Subgroup analysis showed that there were significant differences in CPR (74.19% vs. 54.17%, = 0.004) and OPR (72.04% vs. 51.04%, = 0.003) between GSATP group and Placebo group when the patient was younger than 35 years old. This multi-center, randomized, double-blinded, placebo-controlled clinical study showed for the first evidence that GSATP may have potential to improve the OPR and decrease vaginal bleeding or brown discharge rate in HT FET cycle patients.
在过去的十年中，随着手术适应证的扩大和冷冻相关技术的提高，冻融胚胎移植（FET）的数量急剧增加。如何提高 FET 的成功率并降低其不良影响是我们的研究重点。本研究旨在通过测量来自 FET 和激素治疗（HT）周期的患者的持续妊娠率（OPR）来评估 固肾安胎丸的安全性和有效性。
2019 年 11 月至 2020 年 5 月，5 家中国医院进行了一项多中心、随机、双盲、安慰剂对照研究。共有 271 个 HT FET 周期的患者被随机分为（1:1 比例）接受固肾安胎丸（6g，tid）或安慰剂（6g，tid）治疗 12 周的妊娠。患者、临床医生和研究人员对治疗分配均不知情。主要终点为妊娠第 12 周的 OPR。次要终点为阴道出血或褐色分泌物率、着床率（IR）、临床妊娠率（CPR）和流产率（AR）。在治疗期间记录不良事件。
结果显示，与安慰剂组相比，固肾安胎丸组的 OPR 仍较高（56.62%比 44.44%，=0.045）。固肾安胎丸组阴道出血或褐色分泌物发生率低于安慰剂组（10%比 23.08%，=0.032），而 IR（35.16%比 27.64%，=0.070）、CPR（58.82%比 48.15%，=0.078）、总不良事件发生率（8.09%比 3.22%，=0.051）和 AR（3.75%比 7.69%，=0.504）在固肾安胎丸组和安慰剂组之间相似。亚组分析显示，在年龄小于 35 岁的患者中，固肾安胎丸组与安慰剂组的 CPR（74.19%比 54.17%，=0.004）和 OPR（72.04%比 51.04%，=0.003）差异有统计学意义。
这项多中心、随机、双盲、安慰剂对照的临床研究首次表明，固肾安胎丸可能有潜力提高 HT FET 周期患者的 OPR，并降低阴道出血或褐色分泌物发生率。
