中药外敷促术后胃肠功能不全早期康复的临床观察

Clinical observation of external application of Chinese herbal medicine on promoting recovery of gastrointestinal function after abdominal surgery

目的:观察中药复方参黄贴敷神阙穴治疗促术后胃肠功能不全早期康复的疗效及安全性。方法:采用前瞻性、多中心、随机、双盲、安慰剂平行对照实验设计方案,400例腹部术后存在胃肠功能不全患者,按中央数字随机法随机分成参黄贴剂组(200例)及安慰剂组(200例),术后开始敷神阙穴治疗5d,观察肛门排气、排便时间,肠蠕动恢复时间,中医症状评分,血清胃动素、生长抑素等疗效指标及不良反应等指标。结果:与安慰剂组比较,参黄贴剂组肛门排气、排便时间、肠蠕动恢复时间、中医症状显著改善(P<0.05),术后第5天血清胃动素参黄贴剂组高与宽慰补组(P<0.05),而生长抑素参黄贴剂组低于安慰剂组(P<0.05),基线各指标比较及安全性指标差异无统计学意义。结论:中药复方参黄贴可使腹部术后患者肛门排气排便时间提前,促术后胃肠功能早期康复,改善患者临床症状,耐受性良好。

Objective： To observe the effect and safety of Chinese compound Shenhuang Patch （SP） on promoting recovery of gastrointestinal function after abdominal surgery. Methods： A prospective, multi-centered, randomized, doubl-blinded, controlled trial was conducted in 400 postoperative gastrointestinal dysfunction patients after abdominal surgery, who were randomly assigned to two groups treated with SP and placebo for 5 days after operation. The time of exhaust, defecate, recovery of intestinal peristalsis, the change of TCM syndrome score, the serum levels of motilin （MOT） and somatostatin （SS） and the adverse reaction were observed. Results： Compared with group of placebO, the time of exhaust, defecate, recovery of intestinal peristalsis were shift to an earlier date, the TCM syndrome scores decreased significantly in SP treated group （P〈0.05）. The level of MOT was raised and SS was decreased significantly in the fifth day after operation in SP treated group （P〈0.05）, there was no significant difference in all the above parameters between the two groups. In addition, no severe adver＇se event was found. Conclusion： SP treatment shows effects in recovery of postoperative gastrointestinal dysfunction and increaseing patient＇s degree of comfort, and could be well tolerated by patients.