马来酸麦角新碱预防剖宫产术产妇产后出血的多中心随机双盲对照临床研究  

A multicenter,double-blind,randomized controlled clinical trial comparing ergometrine with oxytocin and oxytocin alone for prevention of postpartum hemorrhage at cesarean section

作　　者：何国琳 潘天颖 刘兴会 贺晶[2] 张松英[3] 冯玲[4] 张卫社[5] 何津[6] 辛虹[7] 周玮[8] 曹引丽 何晓春[10] 严丽 游一平 崔洪艳[13] 方芳[14] 梁旭霞[15] 蔡庆华[16] 陈锰 李涛 吴琳 He Guolin;Pan Tianying;Liu Xinghui;He Jing;Zhang Songying;Feng Ling;Zhang Weishe;He Jin;Xin Hong;Zhou Wei;Cao Yinli;He Xiaochun;Yan Li;You Yiping;Cui Hongyan;Fang Fang;Liang Xuxia;Cai Qinghua;Chen Meng;Li Tao;Wu Lin(Department of Obstetrics and Gynecology,Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Department of Obstetrics,Women′s Hospital,Zhejiang University School of Medicine,Hangzhou 310006,China;Department of Obstetrics,Sir Run Run Shaw Hospital,Zhejiang University School of Medicine,Hangzhou 310016,China;Department of Obstetrics,Tongji Hospital,Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030,China;Department of Obstetrics,Xiangya Hospital,Central South University,Changsha 410008,China;Department of Obstetrics,Bethune First Hospital of Jilin University,Changchun 130041,China;Department of Obstetrics,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China;Department of Obstetrics,Chongqing Health Center for Women and Children,Chongqing 400013,China;Department of Obstetrics,Northwest Women′s and Children′s Hospital,Xi′an 710003,China;Department of Obstetrics,Gansu Provincial Maternity and Child Care Hospital,Lanzhou 730050,China;Department of Obstetrics,Maternal and Child Health Hospital,Xinjiang Uygur Autonomous Region,Urumqi 830004,China;Department of Obstetrics,Hunan Provincial Maternal and Child Health Care Hospital,Changsha 410008,China;Department of Obstetrics,Tianjin Central Hospital of Gynecology Obstetrics,Tianjin 300052,China;Department of Obstetrics,the Fourth Hospital of Shijiazhuang,Shijiazhuang 050011,China;Department of Obstetrics and Gynecology,the People′s Hospital of Guangxi Zhuang Autonomous Region,Nanning 530021,China;Department of Obstetrics,Jiangxi Maternal and Child Health Hospital,Nanchang 330006,China)

机构地区：[1]四川大学华西第二医院妇产科出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [2]浙江大学医学院附属妇产科医院产科,杭州310006 [3]浙江大学医学院附属邵逸夫医院产科,杭州310016 [4]华中科技大学同济医学院附属同济医院产科,武汉430030 [5]中南大学湘雅医院产科,长沙410008 [6]吉林大学第一医院产科,长春130041 [7]河北医科大学第二医院产科,石家庄050000 [8]重庆市妇幼保健院产科,重庆400013 [9]西北妇女儿童医院产科,西安710003 [10]甘肃省妇幼保健院产科,兰州730050 [11]新疆维吾尔自治区妇幼保健院产科,乌鲁木齐830004 [12]湖南省妇幼保健院产科,长沙410008 [13]天津市中心妇产科医院产科,天津300052 [14]石家庄市第四医院产科,石家庄050011 [15]广西壮族自治区人民医院妇产科,南宁530021 [16]江西省妇幼保健院产科,南昌330006

出　　处：《中华妇产科杂志》2022年第11期836-842,共7页Chinese Journal of Obstetrics and Gynecology

基　　金：国家重点研发计划(2016YFC1000406)。

摘　　要：目的评价马来酸麦角新碱用于预防剖宫产术产妇产后出血的有效性和安全性。方法本研究采用多中心、随机、双盲、对照的临床研究设计,于2018年12月至2019年11月在全国16家医院开展,共纳入298例产妇,按1∶1比例随机分配分为试验组(马来酸麦角新碱注射液+缩宫素注射液)148例,对照组(缩宫素注射液)150例。比较两组产妇下列指标的差异:(1)主要指标:产后2 h总出血量;(2)次要指标:产后6、24 h出血量,胎盘滞留时间,产后出血的发生率,产后2、24 h额外使用促宫缩药物、止血药物或其他止血措施的比例,需要输血比例,因子宫复旧不良导致住院时间延长的比例;(3)安全性指标:恶心、呕吐、头晕等副反应,各给药时间点的血压。结果(1)试验组产妇产后2 h总出血量[(402±18)ml]少于对照组[(505±18)ml],两组比较,差异有统计学意义(P<0.05)。(2)试验组产后6、24 h出血量少于对照组,分别比较,差异均有统计学意义(P均<0.05)。两组产后出血的发生率,产后2、24 h额外使用促宫缩药物、止血药物或其他止血措施的比例,需要输血比例,因子宫复旧不良导致住院时间延长的比例分别比较,差异均无统计学意义(P均>0.05)。(3)试验组2例(1.4%,2/148)产妇出现副反应,对照组有1例(0.7%,1/150)出现副反应,两组比较,差异无统计学意义(P>0.05)。试验组产妇给药2.0 h及以内的收缩压高于对照组,给药1.5 h及以内的舒张压高于对照组,分别比较,差异均有统计学意义(P均<0.05);但两组血压均在正常范围。结论剖宫产术中使用马来酸麦角新碱注射液可减少产后出血量,安全可行。Objective To compare oxytocin combined with ergometrine with oxytocin alone in terms of primary prophylaxis for postpartum hemorrhage(PPH)at the time of cesarean section(CS).Methods This was a multicenter double-blind randomized controlled interventional study comparing ergometrine combined with oxytocin and oxytocin alone administered at CS.From December 2018 to November 2019,a total of 298 parturients were enrolled in 16 hospitals nationwide.They were randomly divided into experimental group(ergometrine intra-myometrial injection following oxytocin intravenously;148 cases)and control group(oxytocin intra-myometrial injection following oxytocin intravenously;150 cases)according to 1∶1 random allocation.The following indexes were compared between the two groups:(1)main index:blood loss 2 hours(h)after delivery;(2)secondary indicators:postpartum blood loss at 6 h and 24 h,placental retention time,incidence of PPH,the proportion of additional use of uterine contraction drugs,hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery,the proportion requiring blood transfusion,and the proportion of prolonged hospital stay due to poor uterine involution;(3)safety indicators:nausea,vomiting,dizziness and other adverse reactions,and blood pressure at each time point of administration.Results(1)The blood loss at 2 h after delivery in the experimental group[(402±18)ml]was less than that in the control group[(505±18)ml],and the difference was statistically significant(P<0.05).(2)The blood loss at 6 h and 24 h after delivery in the experimental group were less than those in the control group,and the differences were statistically significant(all P<0.05).There were no significant differences between the two groups in the incidence of PPH,the proportion of additional use of uterine contraction drugs,hemostatic drugs or other hemostatic measures at 2 h and 24 h after delivery,the proportion requiring blood transfusion,and the proportion of prolonged hospital stay due to poor uterine involution(all P>0.05)

关 键 词：剖宫产术 产后出血 麦角新碱 催产素 多中心研究 随机对照试验 

分 类 号：R714.461[医药卫生—妇产科学]