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.