十味蒂达胶囊治疗慢性胆囊炎的临床观察

目的:观察十味蒂达胶囊治疗慢性胆囊炎的有效性及安全性。方法:用随机、双盲、单模拟阳性药平行对照的多中心研究,将受试者随机分为2组:十味蒂达胶囊试验组和胆康胶囊对照组,疗程为1个月。结果:治疗后,主要疗效(疾病综合疗效、影像学疗效、中医证候疗效)方面,试验组和对照组比较,差异有统计学意义(P<0.05);次要疗效(单项症状)方面,试验组和对照组比较,差异也有统计学意义(P<0.05)。治疗期间2组未发生不良事件。结论:十味蒂达胶囊治疗慢性胆囊炎安全、有效。

Efficacy and Safety of Shiweidida Capsule in The Treatment of Chronic Cholecystitis

OBJECTIVE:To evaluate the efficacy and safety of Shiweidida capsule in the treatment of chronic cholecystitis.METHODS: In a randomized,double blind,single-dummy,multicenter clinical trial,the enrolled subjects were randomly assigned to receive either Shiweidida capsule(treatment group) or Dankang capsule(control group) for one month.RESULTS: After treatment,statistically significant differences were noted between the treatment group and the control group in primary curative efficacy including comprehensive efficacy,imaging efficacy,traditional Chinese medical syndrome(P<0.05) and secondary curative efficacy(P<0.05).There was no occurrence of adverse drug reactions during the study in two groups.CONCLUSION: Shiweidida capsule had been proved to be safe and effective for chronic cholecystitis.