复方五指柑胶囊治疗急性胃肠炎的多中心临床研究

Multi-center clinical study of Compound Wuzhigan Capsule in treatment of acute gastroenteritis

目的观察复方五指柑胶囊治疗急性胃肠炎的疗效及安全性。方法采用多中心、随机、双盲、阳性平行对照试验方法,治疗组120例口服复方五指柑胶囊,2粒/次,3次/d。对照组120例口服复方五指柑片,4片/次,3次/d。两组患者均治疗3 d。观察两组的临床综合疗效、中医证候疗效、单个中医证候疗效。结果治疗后,治疗组和对照组临床综合疗效总有效率分别为98.32%、98.31%,两组比较差异无统计学意义。治疗组和对照组中医证候疗效总有效率分别为98.32%、98.31%,两组比较差异无统计学意义。两组均可显著改善便次改变、便质改变、排便异常、脘腹胀痛、恶心呕吐等主症,两组的主症疗效差异均无统计学意义。结论复方五指柑胶囊治疗急性胃肠炎疗效确切,安全性良好。

Objective To observe the curative effect and safety of Compound Wuzhigan Capsule in treatment of acute gastroenteritis. Methods A multi-center randomized double-blind positive parallel controlled trial method was adopted. The patients（120 cases） in the treatment group were po administered with Compound Wuzhigan Capsule, 2 grains/time, three times daily. The patients（120 cases） in the control group were po administered with Compound Wuzhigan Tablet, 4 tablets/time, three times daily. The clinical comprehensive efficacy, efficacy of TCM syndrome, and efficacy of single syndromes in two groups were observed. Results After treatment, the clinical comprehensive efficacies in the treatment and control groups were 98.32% and 98.31%, respectively, with no difference between the two groups. The efficacies of TCM syndrome in two groups were 98.32% and 98.31%, respectively, with no difference between the two groups. Two groups could significantly improve the change of defecate frequency and nature, abnormal defecate, abdominal distension painful, nausea, and vomiting, with no difference between the two groups. Conclusion Compound Wuzhigan Capsule has good clinical effect in treatment of acute gastroenteritis with good security.