芪黄通秘软胶囊治疗功能性便秘的安全性及有效性研究  

Study on the Safety and Efficacy of the Treatment of Functional Constipation with Qi Huang Tong Mi Soft Capsule

作　　者：徐国防[1] 赵岳[1] 冯军安[1] 牛志强[2] 

机构地区：[1]郑州人民医院,河南郑州450000 [2]安阳市肿瘤医院,河南安阳455000

出　　处：《亚太传统医药》2016年第11期112-114,共3页Asia-Pacific Traditional Medicine

摘　　要：目的：评价芪黄通秘软胶囊治疗功能性便秘（虚秘证）的有效性和安全性。方法：采用开放临床试验设计,随机选择30例功能性便秘（虚秘证）患者接受芪黄通秘软胶囊治疗,观察和评价五项便秘症状指标和八项中医证候指标,评价其疗效。结果：治疗21天后,便秘症状综合疗效总有效率为83.3%（n=30）,双侧95%可信区间为82.1%-84.5%。中医证候疗效痊愈率为26.9%,总有效率为92.3%。研究期间出现3例不良事件,均为轻度胃肠道反应,没有严重不良反应发生。结论：芪黄通秘软胶囊治疗功能性便秘（虚秘证）有效性较高,对功能性便秘的各项症状均有较好的疗效,值得临床推广应用。Objective：To investigate the clinical efficacy and safety of Qihuang Tongmi Soft Capsules in treatment of functional constipation.Methods：The open clinical trial design,randomly selected 30 cases of functional constipation（virtual constipation syndrome）in patients undergoing Qihuang Secret Soft Capsule in the treatment,observation and five constipation symptom index and eight TCM syndrome index evaluation,and evaluate its clinical efficacy.Results：After treatment for 21 d,the efficacy was 83.3%.TCM syndrome curative effect of recovery rate was 26.9%,total effective rate was 92.3%.During the study period,3cases of adverse events were occured,were all mild gastrointestinal reaction,no serious adverse reactions.Conclusion：Qihuang Tongmi Soft Capsules has good clinical effect in treatment of functional constipation,and no adverse reaction occurred,which is worth clinical promotion.

关 键 词：功能性便秘 芪黄通秘软胶囊 安全性 

分 类 号：R256.35[医药卫生—中医内科学]