参黄散贴剂对腹部术后胃肠功能不全患者的促康复作用——110例前瞻性多中心随机对照临床研究

Shenhuang Powder(参黄散)Paste for 110 Patients With Gastrointestinal Dysfunction After Abdominal Surgery: A Prospective Multi-Center Randomized Controlled Clinical Study

目的观察参黄散贴剂敷神阙穴对腹部术后胃肠功能不全气滞血瘀型患者的临床疗效及安全性。方法将220例胃肠道肿瘤术后胃肠功能不全气滞血瘀型患者随机分为参黄散组和安慰剂组各110例。参黄散组在基础治疗同时给予参黄散贴剂,以肚脐(神厥穴)为中心贴于腹部,每日1次,共治疗7日;安慰剂组在基础治疗同时给予安慰剂贴剂,给药方法同参黄散组。记录两组患者术后首次排气时间、首次排便时间、肠蠕动恢复情况及肠鸣音恢复时间,并进行中医证候评分判定中医证候疗效,测定术前及术后1、5天时血清胃动素(MOT)、生长抑素(SS)水平,记录不良反应。结果参黄散组中医证候疗效总有效率为96.4%,安慰剂组为89.1%,参黄散组总有效率明显高于安慰剂组(P<0.05)。参黄散组肠鸣音恢复时间、首次排气时间及首次排便时间均较安慰剂组提前(P<0.01)。参黄散组术后第2、3、4天首次排气例数明显多于安慰剂组(P<0.05或P<0.01)。参黄散组术后第3、4、5天首次排便例数明显多于安慰剂组(P<0.05或P<0.01)。参黄散组术后第3天出现有效肠蠕动患者比例明显高于安慰剂组(P<0.01)。两组患者术后第2、3、4、5天中医证候积分均明显低于术后第1天(P<0.05);参黄散组患者术后第2、3、4天中医证候积分明显低于同时间点的安慰剂组(P<0.05或P<0.01)。两组患者术后第1天血清SS和MOT较术前比较差异有统计学意义(P<0.05),两组均无严重不良事件发生。结论参黄散贴剂可使胃肠肿瘤术后气滞血瘀型患者首次排气、排便时间提前,促术后肠蠕动及胃肠功能早期康复,改善患者临床症状,耐受性良好。

Objective To observe the efficacy and safety of the external application of Shenhuang Powder（参黄散） Paste on acupoint Shenque （CV8） for gastrointestinal dysfunction patients with qi stagnation and blood stasis pattern after abdominal surgery. Methods Totally 220 gastrointestinal dysfunction patients with qi stagnation and blood stasis pattern were randomized into the Shenhuang Powder group and placebo group, with 110 in each. Both groups were given basic treatment. The Shenhuang Powder group was added with external application of Shenhuang Powder （~i~） Paste on Shenque （CV8） once daily for 7 days. The placebo group was added with placebo. The first exhaust time, first defecation time, bowel recovery, TCM patterns, recovery time of bowel sounds and adverse re- actions were recorded after surgery. The levels of serum motilin （MOT） and somatostatin （SS） were measured before and after surgery. Results The total pattern efficacy in the Shenhuang Powder group and placebo group was 96.4% and 89. 1% respectively, with a significant difference between groups （P 〈 0.05）. Comparing with the place- bo group, the recovery time of bowel sounds, first exhaust time and first defecation time in the Shenhuang Powder group was obviously earlier （P 〈 0. 01 ）. The case numbers of first exhaust in the Shenhuang Powder group were sig- nificantly more than those in the placebo group on the 2rid, 3rd and 4th day after surgery （ P 〈 0.05 or P 〈 0. 01 ）. The case numbers of first defecation in the Shenhuang Powder group were significantly more than those in the placebo group on the 3rd, 4th and 5th day after surgery （P 〈 0. 05 or P 〈 0. 01 ）. The proportion of patients with effective in- testinal peristalsis in the Shenhuang Powder group was significantly higher than that in the placebo group on the 3rd day after surgery （P 〈0. 01 ）. The TCM pattern score on the 2nd, 3rd, 4th and 5th day was significantly lower than that on the 1st day after surgery in both groups （P 〈0.05）, especially on the 2nd, 3rd and 4th day in the Shenhuang Powder group as compared with the same time point in the placebo group （P 〈 0. 05 or P 〈 0. 01 ）. There were signifi- cant differences between before surgery and the 1 st day after surgery in the levels of SS and MOT in both groups （P 〈 0. 05 ）. There was no severe adverse reaction in both groups. Conclusion Shenhuang Powder （参黄散） Paste can shorten the first exhaust and defecation time, promote early rehabilitation of gastrointestinal function and intestinal peristalsis and relieve symptoms of gastrointestinal dysfunction patients with qi stagnation and blood stasis pattern after abdominal surgery.