厚朴排气合剂对开腹胃肠道手术后胃肠功能恢复影响的随机对照研究

目的 观察中药厚朴排气合剂对开腹胃肠道手术后患者胃肠功能恢复的影响,评价其有效性及安全性.方法 2010年10月至2011年9月,我院开腹胃肠道手术患者66例.采用前瞻性、随机、双盲、对照研究方法,以2∶1的比例将患者随机分为2组(试验组44例,对照组22例),于手术后16 h及20h分别给予厚朴排气合剂50 ml(试验组)或厚朴排气合剂模拟剂(对照组)50 ml,术后进行常规外科治疗,分别记录患者规律出现肠鸣音时间,首次肛门排气、排便时间和首次进食固体食物时间,术后第6天进行血尿常规、肝肾功能、心电图检查,并记录药物不良事件.结果 试验组患者术后出现规律肠鸣音时间和首次肛门排气时间均早于对照组中位术后出现规律肠鸣音时间分别为32.0(23.5,42.5)h和65.0(49.5,67.8)h,中位首次肛门排气时间分别为67.2(59.5,76.0)h和92.7(87.0,96.0)h],差异有统计学意义(Log-rank值分别为5.42和22.07,P＜0.05).试验组患者术后首次肛门排便时间和进食固体食物时间早于对照组中位术后排便时间分别为96.2(89.0,113.0)h和112.8(92.5,138.5)h,中位首次进食固体食物时间分别为119.3(114.7,139.7)h和136.5(117.0,141.0)h],但差异无统计学意义(Log-rank值分别为1.88和0.36,P＞0.05).2组患者用药前后的生命体征的变化,用药后血尿常规、肝肾功能、心电图异常的比例,差异均无统计学意义(P＞0.05).2组患者均无严重不良事件发生.结论 厚朴排气合剂可促进开腹胃肠道手术后患者胃肠功能恢复,临床使用安全有效.

A prospective randomized controlled study on the effect of Houpupaiqi mixture on recovery of gastrointestinal function after the open gastrointestinal surgery

Objective To observe the recovery of gastrointestinal function with Houpupaiqi mixture after the open gastroenterological surgery. Methods Sixty-six patients who underwent open gastreenterological surgery were enrolled into this prospective, randomized, double blind, placebo-controlled clinical trial from October 2010 to September 2011. The patients were treated according to routine postoperative protocol and received the Houpupaiqi mixture （experimental group）, or the placebo （control group） according to the random number at 16 and 20 hours after surgery. Results Compared with the control group, the time of the recovery of regular bowel sounds and the first exhaust was significantly earlier in the experimental group 32.0 （ 23.5,42.5 ） hours vs 65.0 （49.5,67.8） hours, Log-rank value = 5.42, P 〈 0.05, and 67.2 （59.5,76.0） hours vs 92.7 （87.0,96.0） hours, Log-rank value = 22.07, P 〈 0.05 ]. The time of first defecation and toleration of solid food was earlier in the experimental group, but the difference was not significant 96.2 （89.0,113.0） hours vs 112.8 （92.5,138.5） hours, Log-rank value = 1.88, P〉0.05, and 119.3（114.7,139.7）hours vs 136.5（117.0,141.0）hours, Log-rank value =0.36, P〉0.05]. 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, liver function, renal function and ECG after taking medicine between the two groups （P 〉 0. 05 ）. There were no serious adverse events observed in this clinical trial. Conclusion Houpupaiqi mixture significantly promotes the recovery of gastrointestinal function of the patients undergoing the open gastroenterelogical surgery with relatively low adverse events.