活血通腑方防治术后腹腔粘连多中心随机双盲对照临床研究

目的 观察活血通腑方防治术后腹腔粘连（PPA）的临床疗效，探讨其可能作用机制。方法 采用多中心随机双盲对照的研究方法，将119例粘连性肠梗阻手术患者分为对照组(58例)和治疗组（61例）。对照组常规治疗，治疗组在对照组基础上予活血通腑方治疗，干预4周，观察2组患者术后第1次排气时间、第1次排便时间；术后腹痛VAS评分；术后血清转化生长因子-β（TGF-β），纤连蛋白（FN）水平；术后B超粘连评价；术后1年随访观察粘连性肠梗阻复发率及复发手术率。结果 治疗后与对照组比，治疗组能减少术后第1次排气及第1次排便时间（P<0.01），降低术后7 d及14 d 的VAS疼痛评分（P<0.01），减少术后腹腔粘连形成（P＜0.05），减少术后粘连性肠梗阻复发及复发手术率（P＜0.05）。组内比较VAS 疼痛评分，对照组术后7、14 d与术后3 d比较差异有统计学意义（P＜0.05~0.01）；治疗组术后7、14 d与术后3 d比较有显著性差异（P<0.01）。2组术后血清TGF-β、FN含量3 d显著升高（P<0.01），治疗组14 d无显著差异（P>0.05），2组比较，术后7、14 d，治疗组明显修复（P<0.01）。结论 活血通腑方对术后腹腔粘连疗效显著，值得临床推广运用。 

A Multicenter， Randomized， Double-Blind Clinical Study of Huoxue Tongfu Formula in Postoperative Peritoneal Adhesions

OBJECTIVE To observe the clinical effect of Huoxue Tongfu formula on prevention and treatment of postoperative peritoneal adhesions (PPA) and to explore its possible mechanism. METHODS 119 patients with adhesive intestinal obstruction were divided into two groups: control group (n=58) and treatment group (n=61). The control group was treated with routine therapy and the treatment group was treated with Huoxue Tongfu formula on the basis of the control group. After 4 weeks of intervention， the first time of exhaust and defecation were observed in the two groups， and the VAS score of postoperative abdominal pain was also observed. Serum transforming growth factor -β (TGF-β)， the level of fibronectin (FN) and the B-ultrasound adhesion after operation were evaluated， and the recurrence rate of the adhesive ileus and rate of its recurrent operation were observed at 1-year follow-up. RESULTS Compared with the control group， the treatment group reduced the first time of exhaust and defecation after operation (P<0.01)， lower the VAS pain score of 7 d and 14 d (P<0.01)， reduce the postoperative peritoneal adhesion formation (P<0.05)， and reduce recurrence rate of postoperative adhesive intestinal obstruction and the rate of its recurrent operation (P<0.05). Comparing with postoperative 3th day， there was statistically significant on postoperative 7th day and 14th day(P<0.05， P<0.01) in control group， and there was significant difference on postoperative 7th day and 14th day(P<0.01) in treatment group. The serum level of TGF-β and FN were significantly increased on postoperative 3th day(P<0.01) both in treatment group and control group. And there was no significant difference on postoperative 14th day(P>0.05) in treatment group. Comparing the two groups， there was a significant reduction in treatment group on postoperative 7th and 14th day(P<0.01). CONCLUSION The effect of Huoxue Tongfu formula on postoperative peritoneal adhesion is significant， and it is worthy of clinical popularization and application.