活血止痛软胶囊治疗急性软组织损伤临床研究

Randomized,double-blind and double-dummy,multi-center clinical study of Huoxue Zhitong soft capsule for patients with acute soft tissue injury

目的评价活血止痛软胶囊治疗急性软组织损伤的临床有效性和安全性。方法采用随机、双盲双模拟、阳性药平行对照的多中心临床研究方法。入选有效病例276例,其中试验组207例,口服活血止痛软胶囊及愈伤灵胶囊模拟剂;对照组69例,口服愈伤灵胶囊及活血止痛软胶囊模拟剂。两组疗程皆为7d,分别观察治疗前及治疗后中医证候疗效、单项症状疗效和安全性指标的变化。结果 (1)试验组和对照组中医证候疗效差异有统计学意义(P<0.05)。(2)试验组和对照组疼痛、肿胀、功能障碍三项单项症状疗效差异有统计学意义(P<0.05)。(3)试验组和对照组均无不良事件发生。结论活血止痛软胶囊治疗急性软组织损伤疗效确切,无明显不良反应。

Objective This study was to evaluate the efficacy and safety of Huoxue Zhitong Soft Capsule in the treatment of acute soft tissue injury. Methods The trial was a randomized, double-blind, double-dummy,controlled and multicenter design. 276 patients were randomly divided into two groups： experiment group（ 207 cases） and control group（ 69 cases）. The experiment group were given Huoxue Zhitong soft capsule and placebo（ Yushangling capsule）,and the control group were given Yushangling capsule and placebo（ Huoxue Zhitong soft capsule）. After 7 days treatment, the score of traditional Chinese medicine syndrome and the safety index were recorded. Results（1） The difference of curative effect of traditional Chinese medicine syndrome between two groups showed statistical significance（P〈0.05）.（2） The difference of curative effect of pain, swelling and dysfunction between two groups showed statistical significance（P〈0.05）.（3） There was no adverse event in two groups during the clinical study. Conclusion Huoxue Zhitong soft capsule was proved to be safe and effective in the treatment of acute soft tissue injury.