摘要
目的观察芪黄通秘软胶囊(润肠通便中成药)治疗功能性便秘的临床疗效和安全性。方法用随机双盲双模拟阳性药平行对照的多中心研究,入选223例病例,随机分配到芪黄通秘软胶囊试验组(3粒/次,每日2次,n=110)和麻仁软胶囊对照组(1粒/次,每日2次,n=113),疗程3周,从功能性便秘和中医证候两方面进行疗效评定,并观察临床安全性。结果治疗3周后,试验组和对照组对功能性便秘、中医虚秘证候有效率均超过80%,2组比较差异有统计学意义。治疗期间未发生不良事件。结论芪黄通秘软胶囊治疗功能性便秘安全有效。
Objective To evaluate the efficacy and safety of the Qihuang Tongmi soft capsule in the treatment of functional constipation（weak constipation）.Methods A randomized,double-blind,double-dummy,positive-controlled and multi-center clinical trial was conducted for treatment of 223 patients with functional constipation（weak constipation）.Patients were randomized into two groups,trial group to receive Qihuang Tongmi soft capsules（every 3 capsules,2 times a day;n=110） or control group to receive Maren soft-capsules（every 1 capsules,2 times a day;n=113） for 3 weeks.The efficacy and safety of the functional constipation in two groups（weak constipation） were evaluated.Results More than 80% of patients with functional constipation（weak constipation） was evaluated effective in each group after 3 weeks treatment.There were no drug-related adverse drug reaction found during the study in two groups.Conclusion The Qihuang Tongmi soft capsules had been proved safe and effective in the treatment of function constipation（weak constipation）.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2011年第2期100-103,共4页
The Chinese Journal of Clinical Pharmacology
关键词
芪黄通秘软胶囊
功能性便秘
麻仁软胶囊
Qihuang Tongmi soft capsule
function constipation
Maren soft-capsule
