摘要
目的探讨注射用尖吻蝮蛇血凝酶对于治疗特殊妇产科手术创面出血的疗效和安全性。方法采用随机、双盲、安慰剂对照、多中心的方法研究2010年6月至2011年6月,上海地区4家医院中宫颈锥切和阴道分娩病人共269例,其中研究组134例(宫颈LEEP锥切术68例,阴道分娩66例),安慰剂对照组135例(宫颈LEEP锥切术69例,阴道分娩66例),分别研究尖吻蝮蛇血凝酶(又称苏灵)对其创面止血的疗效和安全性。结果研究组和对照组宫颈锥切出血时间为(71.57±46.84)s和(153.04±125.59)s,P<0.0001;出血量分别为(16.30±9.75)g和(34.70±17.24)g,P<0.0001。研究组和对照组的阴道分娩2 h内出血量为(49.12±22.28)g和(93.10±54.25)g,出血量减少了47.23%,P<0.0001。在血常规、凝血功能、肝肾功能和心电图方面,研究组和对照组均未发生药物不良反应事件。结论苏灵对妇产科局部创面的止血作用安全有效。
Objective To detect the curative effect and safety of Heamocoagulase Agkistrodon for Obstetric and Gyneco- logical special wound bleeding hemostasis. Methods 269 patients receiving cervical loop eelectrosurgical excision proce- dure or vaginal delivery were studied prospectively by randomized, double blind controlled and multicenter design between June 2010 and June 2011. They were divided into the study groups （134 patients） and the placebo groups （135 pa- tients）. They were observed in terms of the effects on hemostatic time, hemorrhagic volume and the side effects. Results In the cervical Loop Eelectrosurgical excision procedure aspect, the hemostatic time of study group and control group were （71.57 ± 46.84）s, （ 153.04± 125.59） s （P 〈 0.0001 ）, and the hemorrhagic volume of them were （ 16.30 ± 9.75 ） g, （34.70 ± 17.24）g （P 〈0.0001 ）, respectively. On the other hand, the hemorrhagic volume of vaginal delivery were （49.12±22.28） g, （93.10 ± 54.25 ） g （ P 〈 0. 0001 ）. However, based on the blood routine examination, coagulation function, hepatic and renal function and electrocardiogram, there were none adverse drug event. Conclusion Heamo- coagulase Agkistrodon may play an important role of hemostasis effect on Obstetric and Gynecological special wound. Therefore, it has developed the new clinical practice field.
出处
《中国实用妇科与产科杂志》
CAS
CSCD
北大核心
2014年第1期64-66,共3页
Chinese Journal of Practical Gynecology and Obstetrics
关键词
尖吻蝮蛇血凝酶
妇产科创面出血
止血
heamocoagulase agkistrodon
obstetric and gynecological wound bleeding
hemostasis
