Li Tao, Wei Qiang, Wu Lin, Chen Meng, Zhang Li-Ping, Zhang Qian, Liu Xing-Hui
Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children of the Ministry of Education, Sichuan University, Chengdu 610041, China.
Sichuan Da Xue Xue Bao Yi Xue Ban. 2022 Mar;53(2):316-320. doi: 10.12182/20220360503.
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.
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.
The total bleeding volume at 2 h, 6 h and 24 h after delivery was significantly lower in the experimental group (<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 (>0.05).
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.
以缩宫素注射液为对照，评价马来酸麦角新碱注射液联合缩宫素注射液预防阴道分娩后产后出血的安全性和有效性。
选取2018年12月至2019年11月在中国16家医院行阴道分娩的305例产妇纳入全分析集（FAS）和安全性分析集（SS）。在完成试验的299例受试者中，277例纳入符合方案集（PPS）。受试者按1∶1比例随机分为两组，A组（试验组）152例，接受缩宫素注射液加马来酸麦角新碱注射液；B组（对照组）153例，接受缩宫素注射液。记录并比较两组产后2小时、6小时和24小时的总出血量。还比较了两组的其他指标，包括产后2小时和24小时额外使用宫缩剂和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、因子宫收缩乏力导致住院时间延长的受试者比例、生命体征、实验室检查指标以及两组的不良反应发生率。
试验组产后2小时、6小时和24小时的总出血量显著低于对照组（<0.05）。两组在产后2小时和24小时额外使用宫缩剂和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、心率、呼吸、实验室检查指标或不良反应发生率方面无显著差异（>0.05）。
马来酸麦角新碱注射液在预防阴道分娩后出血方面显示出明显的治疗效果，不良反应较少，安全性更高，因此在临床应用中具有广阔前景。
