厚朴排气合剂对妇科手术后胃肠功能恢复的影响

A multi-center prospective randomized controlled study on the effect of recovery of gastrointestinal function with Houpupaiqi mixture after the gynecological surgery

目的探讨中药厚朴排气合剂对妇科手术后胃肠功能恢复的影响,评价其有效性及安全性。方法 2010年5月至2011年7月在北京大学人民医院和中南大学湘雅二医院采用前瞻性、多中心、随机双盲对照的方法,将96例妇科入选患者依照试验编号,于手术后6h及10h给予厚朴排气合剂(试验组)或模拟剂(对照组),经过4d临床观察后,对数据进行统计学分析。结果试验组患者术后首次肛门排气、排便时间、出现规律肠鸣音及进食固体食物的时间显著早于对照组(P=0.000)。两组患者用药前后体温、呼吸、心率、收缩压、舒张压等生命体征的变化进行比较,差异均无统计学意义(P>0.05)。两组患者用药后血常规、肾功能、心电图异常变化的例数比较,差异均无统计学意义(P>0.05);而尿糖及天冬氨酸转氨酶异常变化的例数比较,试验组低于对照组(P=0.024,0.014)。结论厚朴排气合剂促进妇科手术后胃肠功能恢复,临床使用安全性较高。

Objective To observe the effect of recovery of gastrointestinal function with Houpupaiqi mixture after the gynecological surgery,and assess the efficacy and safety.Methods Through a prospective,multi-center,randomized,double blind,controlled trial,all 96 selected gynecological patients in Peking University People's Hospital and the Second Xiangya Hospital of Central South University between May 2010 and July 2011 were treated with Houpupaiqi mixture(test group),or the placebo(control group) according to the test number at 6 and 10 hours after surgery.The data got from the 4-days clinical observation was analyzed.Results Compared with the control group,the time of first exhaust,first defecation,recovery of regular bowel sounds,and eating solid diet were significantly earlier in the test group(P=0.000).There was no significant difference in the alteration of body temperature,respiration,heart rate and blood pressure before and after taking medicine between the two groups(P>0.05).There was no significant difference in the number of cases with the abnormal results of blood test,renal function,and ECG after taking medicine between the two groups(P>0.05);while compared with the control group,the number of cases with the abnormal results of urine glucose and aspartate aminotransferase were significantly less in the test group(P=0.024,0.014).Conclusion Taking houpupaiqi mixture can promote the recovery of gastrointestinal function after the gynecological surgery,and it's safe to clinical application.