益母草注射液联合缩宫素防治剖宫产术中、术后出血有效性及安全性研究

Efficacy and Safety Analysis of Motherwort Injection Combined With Oxytocin on the Treatment of Hemorrhage During and After Caesarean Section

目的探讨益母草注射液(Motherwortinjection)联合缩宫素在防治剖宫产术中、术后出血的有效性和安全性。方法 选择2005年8月至2006年5月在崇州市妇幼保健院住院行剖宫产分娩孕妇143例为研究对象。根据其末次月经、超声检查结果等证实与孕周相符,将其随机分为益母草组(n=71)和缩宫素组(n=72)。纳入标准:单胎妊娠,孕龄>28孕周,因医学指征或社会因素行剖宫产。排除标准:术前48h内接受抑制宫缩药物治疗者,对益母草注射液或缩宫素有变态反应史或不能耐受者(本研究遵循的程序符合崇州市妇幼保健院人体试验委员会所制定的伦理学标准,得到该委员会批准,分组征得受试对象本人的知情同意,并与之签署临床研究知情同意书)。两组产妇年龄、孕次、产次、孕龄、高危妊娠率、手术持续时间和新生儿出生体重等比较,差异无显著意义(P>0.05)。两组分别在术中、术后采用益母草注射液联合缩宫素和单用缩宫素促进子宫收缩。比较两组术中出血量及术后多个时段内阴道出血量及药物不良反应。结果 益母草组除术中出血量多于缩宫素组(P<0.05)外,术后各时段阴道出血量两组比较,差异无显著意义(P>0.05)。同时,益母草组在术后(24~48)h、(48~72)h阴道出血量呈现接近或偏低趋势。两组均无明显药物不良反应发生。术后72h宫底高度比较,益母草组平均宫底高度低于缩宫素组,差异有显著意义(P<0.05)。结论 益母草注射液联合缩宫素可有效减少剖宫产术后出血量,尤其在减少产后(24~72)h阴道出血量方面效果优于单用缩宫素。

Objective To evaluate the efficacy and safety of Motherwort injection combined with oxytocin for preventing postpartum hemorrhage （PPH） during and after caesarean section. Methods From April 2005 to May 2006, a randomized, semi blind, active drug-controlled trial was conducted on 143 women who delivered by caesarean section. They were divided randomly into Motherwort group （n=71） and oxytocin group （n= 72）. Motherwort group was given both Motherwort injection and oxytocin during the caesarean section and intramuscularly administrated Motherwort injection till 72 hours after delivery; whereas oxytocin group had the same administration as Motherwort group but with oxytocin instead of Motherwort. The following items were recorded, volumes of intra-operative hemorrhage, postpartum vaginal bleeding at 2 h, 24 h, 48 h and 72 h after delivery, fundal heights after delivery and side-effects. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Chongzhou Women ＆- Children＇s Health Care Hospital. Informed consent was obtained from all participants. Results The intra-operative bleeding volume in Motherwort group was more than that of oxytocin group （P^0.05）. The volumes of vaginal bleeding was similar between two groups during all the postoperative study periods （P~ 0. 05）. Meanwhile, the vaginal bleeding volumes in Motherzvort group were similar or even less than those of oxytocin group during 24 48 hours and 48-72 hours after delivery. There were no side-effects in the two groups. Conclusion Mothervoort injection combined with oxytocin is safe and efficient for preventing postpartum hemorrhage after caesarean section. Motherwort injection combined with oxytocin is more efficient in decreasing the vaginal bleeding on postpartum days 2 and 3 as compared with oxytocin used only.