摘要目的:评价宫血宁胶囊在减少人工流产术后出血的有效性和安全性。方法:采用多中心随机双盲研究。11家分中心于2022年5月31日至2023年3月31日期间纳入484例宫内早孕接受负压电吸人工流产术的患者，1∶1按照中心区组随机方式分配到对照组和研究组。对照组术后口服安慰剂9 d，研究组术后口服宫血宁胶囊9 d，观察比较两组术后受试者阴道出血量、阴道出血时间、子宫内膜厚度、月经复潮时间及并发症等情况。结果:①研究入组受试者484例，完成研究472例。450例受试者纳入有效性分析集，对照组224例，研究组226例；468例受试者纳入安全性分析集，对照组236例，研究组232例，两组受试者一般资料具有可比性（均 P>0.05）。②研究组阴道出血量为（13.30±12.14）mL，对照组阴道出血量为（19.00±17.67）mL，组间差异有统计学意义（ P<0.001）。研究组出血天数小于4 d的受试者比例［29.65%（67/226）］高于对照组［19.20%（43/224）， P=0.010］。③月经复潮时间、子宫内膜厚度两组间差异均无统计学意义（均 P>0.05）。④研究组有3例受试者发生非疗效相关并发症，对照组有11例受试者发生，研究组非疗效相关并发症发生率［1.29%（3/232）］低于对照组［4.66%（11/236）］，差异有统计学意义（ P=0.033）。 结论:人工流产术后女性使用宫血宁胶囊治疗，可明显减少阴道出血量，且安全性良好，易为受试者接受。

abstractsObjective:To assess the efficacy and safety of Gongxuening Capsules in reducing post-abortion bleeding following artificial abortion.Methods:A multicenter, randomized, double-blind study was conducted. From May 31, 2022 to March 31, 2023, 484 women who underwent vacuum aspiration abortion for early intrauterine pregnancy were enrolled in 11 centers and randomly assigned to control group and the study group at a 1∶1 ratio using a center-block randomization method. Control group were administered a placebo of Gongxuening Capsules for 9 d, while the study group received the actual Gongxuening Capsules for the same duration. The outcomes measured included vaginal bleeding volume, duration of vaginal bleeding, endometrial thickness, time to menstrual recovery, and complications.Results:1) A total of 484 subjects were enrolled, and 472 completed the study. Totally 450 subjects were included in the efficacy analysis set, with 224 in control group and 226 in the study group; 468 subjects were included in the safety analysis set, with 236 in control group and 232 in the study group. The baseline characteristics of the two groups were comparable (all P>0.05). 2) The vaginal bleeding volume was lower in the study group [(13.30±12.14) mL] than in control group [(19.00±17.67) mL, P<0.001]. The proportion of subjects in the study group with bleeding days less than 4 d [29.65% (67/226)] was higher than that in control group [19.20% (43/224), P=0.010]. 3) No significant differences were observed between the two groups in terms of time to menstrual recovery and endometrial thickness (all P>0.05). 4) In the study group, 3 subjects experienced non-therapeutic-related complications, while 11 subjects in control group. The incidence of complications was lower in the study group [1.29% (3/232)] than in control group [4.66% (11/236), P=0.033]. Conclusion:The administration of Gongxuening Capsules to women following artificial abortion significantly reduced vaginal bleeding volume and was associated with good safety, with the treatment being well-tolerated by the subjects.