十味蒂达胶囊治疗慢性胆囊炎的临床观察

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

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。

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.