【摘要】 目的 :观察枳术宽中胶囊治疗功能性消化不良 (FD )的疗效及安全性。方法 :采用双盲双模拟对照方法 ,将 4 0 3例FD病人随机分为治疗组(196例 ) ,给枳术宽中胶囊 3粒 ,po ,tid ,同时给西沙必利模拟片B ;对照组 (10 5例 ) ,给西沙必利 5mg ,po ,tid ,同时给枳术宽中模拟胶囊A ;开放组 (10 2例 ) ,给枳术宽中胶囊 3粒 ,po ,tid。 2wk为一个疗程。结果 :治疗组、对照组对中医证候的总有效率分别为 86 .7% ,77.1% (P >0 .0 5 )。开放组对中医证候的总有效率为 89.2 %。服药后治疗组与对照组胃排空的比较 ,差异无显著性 ,未发现治疗组有明显不良反应。结论 :枳术宽中胶囊治疗功能性消化不良安全有效。更多还原

【Abstract】 AIM: To observe the effects and safety of Zhizhukuanzhong capsule on functional dyspepsia(FD). METHODS: Four hundred and three patients with functional dyspepsia were randomly divided into three groups .One hundred and ninety-six patients in double-blind treatment group were treated with Zhizhukuanzhong capsule 1.29 g,po ,tid,and cisapride-simulated tablet B. One hundred and five patients in double-blind control group were treated with cisapride 5 mg, po , tid, and zhizhukuanzhong-simulated capsule A. One hundred and two patients in open treatment group were treated with Zhizhukuanzhong capsule 1.29 g,po ,tid .The course of treatment was 2 wk. The changes of symptom and gastric emptying (sixty patients in double-blind treatment group,thirty patients in double-blind control group )before and after oral administration of drugs were observed. Safety was evaluated by laboratory and physical examination. RESULTS: All the treatment and control groups had significantly improved the symptoms of FD. The effective rates of the drugs in double-blind treatment group,double-blind control group and open treatment group on the traditional Chinese medicine syndromes were 86.7 %,77.1 %,89.2 %,respectively. There were no statistical differences in the effective rate and the change of gastric emptying between double-blind treatment and control groups( P >0.05).No obvious adverse reactions were observed. CONCLUSION: Zhizhukuanzhong capsule is effective and safe in the treatment of functional dyspepsia.更多还原