目的 觀(guān)察復(fù)方五指柑膠囊治療急性胃腸炎的療效及安全性.方法 采用多中心、隨機(jī)、雙盲、陽(yáng)性平行對(duì)照試驗(yàn)方法,治療組120例口服復(fù)方五指柑膠囊,2粒/次,3次/d.對(duì)照組120例口服復(fù)方五指柑片,4片/次,3次/d.兩組患者均治療3 d.觀(guān)察兩組的臨床綜合療效、中醫(yī)證候療效、單個(gè)中醫(yī)證候療效.結(jié)果 治療后,治療組和對(duì)照組臨床綜合療效總有效率分別為98.32%、98.31%,兩組比較差異無(wú)統(tǒng)計(jì)學(xué)意義.治療組和對(duì)照組中醫(yī)證候療效總有效率分別為98.32%、98.31%,兩組比較差異無(wú)統(tǒng)計(jì)學(xué)意義.兩組均可顯著改善便次改變、便質(zhì)改變、排便異常、脘腹脹痛、惡心嘔吐等主癥,兩組的主癥療效差異均無(wú)統(tǒng)計(jì)學(xué)意義.結(jié)論 復(fù)方五指柑膠囊治療急性胃腸炎療效確切,安全性良好.

Objective To observe the curative effect and safety of Compound Wuzhigan Capsule in treatment of acute gastroenteritis. Methods A multi-center randomized double-blind positive parallel controlled trial method was adopted. The patients (120 cases) in the treatment group were po administered with Compound Wuzhigan Capsule, 2 grains/time, three times daily. The patients (120 cases) in the control group were po administered with Compound Wuzhigan Tablet, 4 tablets/time, three times daily. The clinical comprehensive efficacy, efficacy of TCM syndrome, and efficacy of single syndromes in two groups were observed. Results After treatment, the clinical comprehensive efficacies in the treatment and control groups were 98.32% and 98.31%, respectively, with no difference between the two groups. The efficacies of TCM syndrome in two groups were 98.32% and 98.31%, respectively, with no difference between the two groups. Two groups could significantly improve the change of defecate frequency and nature, abnormal defecate, abdominal distension painful, nausea, and vomiting, with no difference between the two groups. Conclusion Compound Wuzhigan Capsule has good clinical effect in treatment of acute gastroenteritis with good security.

廣東省經(jīng)貿(mào)委省級(jí)挖潛改造資金重點(diǎn)產(chǎn)業(yè)技術(shù)創(chuàng)新項(xiàng)目(2006855007)