马来酸麦角新碱注射液预防阴道分娩产后出血的多中心临床研究

Multicenter,Randomized,Double-Blind,and Positive Drug-Controlled Clinical Trial on Prevention of Postpartum Hemorrhage after Vaginal Delivery with Ergometrine Maleate

目的评价马来酸麦角新碱注射液与缩宫素注射液联用,用于预防阴道分娩产后出血的安全性和有效性。方法2018年12月–2019年11月在全国16家中心就诊的选取产妇入组,共计入组305例,纳入全分析集(full analysis set,FAS)和安全数据集(safety analysis set,SS)。完成试验299例,其中277例受试者纳入符合方案集(per-protocol set,PPS)。按1∶1随机分配分为A、B组。A组(试验组:马来酸麦角新碱注射液+缩宫素注射液)152例、B组(对照组:缩宫素注射液)153例。记录并比较各组产后2 h、6 h和24 h总出血量的差异;比较各组产后2 h和24 h额外使用宫缩剂、止血药物或其他止血措施的比例;比较各组需要输血的受试者比例、胎盘滞留时间;比较各组因子宫收缩不良,导致住院时间延长的受试者比例;比较各组生命体征、实验室指标以及不良反应发生率。结果试验组产妇的产后2 h、6 h和24 h总出血量较对照组低,差异有统计意义(P<0.05);两组产妇产后2 h和24 h额外使用宫缩剂、止血药物或其他止血措施的比例、需要输血的受试者比例、胎盘滞留时间差异均无统计学意义(P>0.05);两组产妇的心率、呼吸、实验室指标以及不良反应发生率差异均无统计学意义(P>0.05)。结论马来酸麦角新碱注射液与缩宫素注射液联用预防阴道分娩产妇产后出血疗效显著,不良反应少,安全性高,值得临床推广应用。

Objective To evaluate the safety and efficacy of using ergometrine maleate injection combined with oxytocin injection,with oxytocin injection as the control,to prevent postpartum hemorrhage after vaginal delivery.Methods A total of 305 cases who underwent vaginal delivery between December 2018 and November 2019 in 16 hospitals across China were enrolled and included in the full analysis set(FAS)and the safety analysis set(SS).Among the 299 subjects who completed the trial,277 were included in the per protocol set(PPS).The subjects were randomly assigned by 1∶1 ratio to two groups,152 cases in Group A,the experimental group receiving oxytocin injection plus ergometrine injection,and 153 cases in Group B,the control group,receiving oxytocin injection.The difference in total bleeding volume at 2 h,6 h and 24 h postpartum in the two groups was documented and compared.Other measures were also compared between the two groups,including the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum,the proportion of subjects needing blood transfusion,the time of placenta retention,proportion of subjects with prolonged hospital stay due to uterine asthenia,the vital signs,lab test indicators and the incidence of adverse reactions in the two groups.Results The total bleeding volume at 2 h,6 h and 24 h after delivery was significantly lower in the experimental group(P<0.05).There was no significant difference between the two groups in the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum,the proportion of subjects needing blood transfusion and the time of placenta retention,heart rate,respiration,lab test indicators,or the incidence of adverse reaction(P>0.05).Conclusion Ergometrine maleate injection showed evident therapeutic efficacy in preventing hemorrhage after vaginal delivery,causing fewer adverse reactions and ensuring greater safety,and therefore,presenting promising prospects for clinical application.