培毓颗粒对接受胚胎移植女性早期流产的影响：一项随机、双盲、安慰剂对照试验
Effect of the Peiyu granules on early miscarriage among women undergoing embryo transfer: a randomized, double-blind, placebo-controlled trial.
作者信息
He Dandan, Lyu Tianyi, Wang Xiaonan, Ma Yanmin, Lan Yonglian, Yang Xiaokui, Jia Chanwei, Zhou Liying, Liang Yu, Li Ying, Dai Yinmei, Yue Wentao, Liu Ruixia, Liu Zhen, Ma Chen, Liu Dan, Wu Ying, Yin Chenghong
机构信息
Department of Acupuncture, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, China.
Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing, China.
出版信息
Front Endocrinol (Lausanne). 2025 Sep 9;16:1631313. doi: 10.3389/fendo.2025.1631313. eCollection 2025.
OBJECTIVE
To evaluate the efficacy and safety of the Peiyu Granules (PYG) compared with placebo on early miscarriage rates among women undergoing embryo transfer.
METHODS
A double-blind, parallel-group randomized clinical trial between February 15, 2017, and June 17, 2019, within 10 months of pregnancy follow-up until March 2020. This clinical trial was conducted at Beijing Obstetrics and Gynecology Hospital, Capital Medical University. A total of 886 women were included in this study. The intervention group (n = 443) received PYG on the night of Embryo Transfer (ET) until the day of the hCG test. If it was negative, the patient stopped taking medicine. In contrast, the treatment continued until 70 days after ET. The women in the control group (n = 443) consumed the same amount of placebo as the intervention group. All women enrolled were subject to the same follow-up protocols. The primary outcome was early miscarriage rate. The secondary outcomes were clinical intrauterine pregnancy rate and live birth rate.
RESULTS
Among the 886 randomized women (mean [SD] age, 32.8 [3.6] years), 854 women (96.4%) underwent ET and followed the treatment of random grouping. Early miscarriage occurred among 17 of 133 women (12.8%) receiving PYG compared with 35 of 156 women (22.4%) receiving placebo (relative risk[RR], 0.51 [95% CI, 0.27 to 0.95], P = 0.02). Clinical intrauterine pregnancy rates were 30.0% (133 of 443) in the intervention group and 35.2% (156 of 443) in the control group (relative risk[RR], 0.79 [95% CI, 0.60 to 1.05], P = 0.10). Live-birth rates were 25.3% (112 of 443) in the intervention group and 25.7% (114 of 443) in the control group (relative risk[RR], 0.98 [95% CI, 0.72 to 1.32], P = 0.88). Live birth rates in the clinical pregnant population were 84.2% (112/133) in the intervention group and 73.7% (115/156) in the control group (relative risk [RR], 1.14 [95% CI, 1.01 to 1.29], P = 0.03).
CONCLUSION
The findings suggested that PYG reduced early miscarriage rates among women undergoing embryo transfer. However, there were no significant improvement in clinical pregnancy rates and live birth rates.
CLINICAL TRIAL REGISTRATION
https://www.chictr.org.cn/showproj.html?proj=12343 identifier, ChiCTR-inr-16010087.
目的
评估培元颗粒（PYG）与安慰剂相比，对接受胚胎移植女性早期流产率的疗效和安全性。
方法
一项双盲、平行组随机临床试验，于2017年2月15日至2019年6月17日进行，孕期随访10个月直至2020年3月。该临床试验在北京妇产医院（首都医科大学）开展。本研究共纳入886名女性。干预组（n = 443）在胚胎移植（ET）当晚开始服用PYG，直至进行hCG检测当天。若检测结果为阴性，患者停止服药。相反，若检测结果为阳性，则治疗持续至ET后70天。对照组（n = 443）服用与干预组等量的安慰剂。所有纳入的女性均遵循相同的随访方案。主要结局指标为早期流产率。次要结局指标为临床宫内妊娠率和活产率。
结果
在886名随机分组的女性中（平均[标准差]年龄为32.8[3.6]岁），854名女性（96.4%）接受了ET并遵循随机分组治疗。接受PYG治疗的133名女性中有17名发生早期流产（12.8%），而接受安慰剂治疗的156名女性中有35名发生早期流产（22.4%）（相对危险度[RR]，0.51[95%置信区间，0.27至0.95]，P = 0.02）。干预组的临床宫内妊娠率为30.0%（443名中的133名），对照组为35.2%（443名中的156名）（相对危险度[RR]，0.79[95%置信区间，0.60至1.05]，P = 0.10）。干预组的活产率为25.3%（443名中的112名），对照组为25.7%（443名中的114名）（相对危险度[RR]，0.98[95%置信区间，0.72至1.32]，P = 0.88）。干预组临床妊娠人群的活产率为84.2%（112/133），对照组为73.7%（115/156）（相对危险度[RR]，1.14[95%置信区间，1.01至1.29]，P = 0.03）。
结论
研究结果表明，PYG降低了接受胚胎移植女性的早期流产率。然而，临床妊娠率和活产率没有显著提高。
临床试验注册
https://www.chictr.org.cn/showproj.html?proj=12343标识符，ChiCTR-inr-16010087 。
Zotero 插件