抑肽酶和氨甲环酸在儿科先心手术中应用的疗效与安全性比较

The Comparison of Efficacy and Safety between Aprotinin and Tranexamic in Pediatric Cardiac Surgery

目的：评价抗纤溶药物抑肽酶和氨甲环酸在儿科先心手术中应用的安全性和有效性。方法：回顾分析557例实施先心体外循环（cardiopulmonarybypass,CPB）术患儿抗纤溶药物的应用情况。其中2007年7~12月间为抑肽酶（aprotinin）治疗组（AP组n=265）;2008年2~7月为氨甲环酸（tranexamic acid）治疗组（TA组n=292）。全部患儿按手术复杂程度分为：复杂先心手术组（n=156,其中AP组n=79,TA组n=77）;简单先心手术组（n=401,其中AP组n=186,TA组n=215）。简单先心手术组按体质量又分为〈10kg组（其中AP组n=129,TA组n=134）和〉10kg组（其中AP组n=57,TA组n=81）。抗纤溶药物有效性评价指标包括：术后24h胸腔引流量、输血例数比例、血制品用量;安全性评价指标包括：术后肾功能不全发生率、神经系统并发症发生率和住院病死率。结果：抑肽酶的止血效果在复杂先心手术组中表现较显著,术后24h胸腔引流量比氨甲环酸组减少21%[分别为9.6（7.5~17.5）mL/kg和12.1（6.2~17）mL/kg]（P〈0.05）。而在简单先心手术组中,体质量〈10kg组术后出血量较体质量〉10kg组明显增多,但2种药物止血效果并无显著差异。在各手术组内,抑肽酶治疗组和氨甲环酸治疗组间在输血例数比例、输血量方面均无显著差异。各手术组内,抑肽酶治疗组和氨甲环酸治疗组间在术后气管拔管时间、肾功能障碍、神经系统并发症I、CU滞留时间及住院病死率方面均无显著差异。在简单先心手术组中,体质量〉10kg患儿在术后24h胸腔引流量、输血例数比例、输血量方面均较其余各组显著减少。结论：抑肽酶在减少小儿复杂先心术后出血方面优于氨甲环酸。术后并发症,尤其是术后肾功能障碍发生率,抑肽酶和氨甲环酸相比无显著差异。

Objective：To examine the benefits,risk of aprotinin compared to tranexamic acid in pediatrics cardiac surgery with cardiopulmonary bypass（CPB）.Methods： Perioperative data of 557 patients undergoing open-heart cardiac surgery with CPB were collected between July 2007 and July 2008.During the first 6 months,265 patients received aprotinin;in the next 6 months,292 patients were treated with tranexamic acid.We divided all 557 patients into two groups,the complexity procedure group（n=156） and the low complexity procedure group（n=401）.In low complexity procedure,two subgroups were set by patients 10kg and patients 10kg.Aprotinin and tranexamic acid were compared in each procedure group and subgroup.Demographics and baseline laboratory findings,total blood loss and transfusion requirements during the period from protamine administration until 24h after admission to intensive care unit（ICU） and relevant laboratory findings were recorded.Postoperative complications and in-hospital mortality were also considered as outcome parameters.Results：Children who were treated with aprotinin had 21% less 24h blood loss compared with children who received tranexamic acid in complexity procedure group[9.6（7.5-17.5）ml/kg vs 12.1（6.2-17）ml/kg]（P0.05）.No significant difference was found in low complexity procedure group.Also,no significant differences were observed in the postoperative transfusion requirements and rates,as well as the incidence of the postoperative complications and in-hospital mortality between the two treatment groups within each procedure group.Conclusions： Aprotinin was more effective than tranexamic acid in reducing 24h blood lose during complexity congenital heart defects procedure.There were no significant differences in risks of renal dysfunction,CNS complication or in-hospital mortality between aprotinin and tranexamic acid.