目的 评价肠炎宁颗粒治疗小儿急性水样便腹泻（湿热证）的有效性和安全性。方法 采用分层随机、双盲、阳性药对照、多中心临床研究的方法。从7个研究中心共入选急性水样便腹泻患儿168例，随机分为对照组和治疗组，每组各84例。两组均治疗5 d。观察两组的临床疗效、中医证候疗效、单项症状消失率、止泻时间和安全性。结果 治疗后，对照组和治疗组的总有效率分别为69.33%、74.36%，两组比较差异无统计学意义。轮状病毒性肠炎对照组和治疗组的总有效率分别为66.67%、64.29%，两组比较差异无统计学意义。非轮状病毒性肠炎对照组和治疗组的总有效率分别为70.83%、80.00%，两组比较差异无统计学意义。两组急性腹泻止泻时间的中位时间均为4 d，两组比较差异均无统计学意义。对照组和治疗组的中医证候疗效的总有效率均为100.0%，两组比较差异均无统计学意义。治疗3 d，治疗组大便性状、食欲不振、神疲乏力、发热、口渴喜饮的消失率均略高于对照组，两组比较差异均无统计学意义。治疗5 d，治疗组大便次数、大便性状、食欲不振、神疲乏力、口渴喜饮、小便短黄的消失率均略高于对照组，两组比较差异均无统计学意义。两组不良事件/不良反应发生率比较差异均无统计学意义。结论 肠炎宁颗粒治疗急性水样便腹泻（湿热证）具有较好疗效，可有效改善患儿的急性腹泻的症状体征、缩短病程、改善中医证候，与对照药蒙脱石散作用相当，且安全性好，有较好的临床应用价值。

Objective To evaluate the clinical efficacy and safety of Changyanning Granules in the treatment of pediatric acute watery diarrhea (damp-heat syndrome). Methods A stratified-random, double-blind and double-dummy, positive-drug parallel control, and multi-centered observational clinical approach were used. A total of 168 patients from 7 centers were randomly divided into control group and treatmnet group, each group had 84 cases. Patients in the control group were po administered with Montmorillonite Powder and simulation of Changyanning Granules, while patients in the treatment group were po administered with Changyanning Granules and simulation of Montmorillonite Powder. The patients in two groups were treated for 5 d. Clinical efficacy, traditional Chinese medicine syndrome, single syndrome disappearance rate, antidiarrheal time, and security were observed. Results After treatment, the total effective rate in control and treatment groups were 69.33% and 74.36%, respectively, there was no significant different between two groups. The total effective rate in control and treatment groups with rotavirus enteritis were 66.67% and 64.29%, respectively, there was no significant different between two groups. The total effective rate in control and treatment groups with non-rotavirus enteritis were 70.83% and 80.00%, respectively, there was no significant different between two groups. The clinical curative rates of both groups in traditional Chinese medicine syndrome effect in two groups were both 100.00%, there was no significant different between two groups. The median time of antidiarrheal time in two groups were both 4 d, there was no significant different between two groups. After treatment for 3 d, the disappearance rate of stool characters, anorexia, weak, fever, and thirst in the treatment group were higher than those in the control group, and there was no significant different between two groups. After treatment for 5 d, the disappearance rate of stool frequency and characters, anorexia, weak, fever, thirst, and short yellow urine were higher than those in the control group, and there was no significant different between two groups. And there was no significant difference in adverse event/reaction rate between two groups. Conclusion Changyanning Granules has good effect pediatric acute watery diarrhea (damp-heat syndrome),and can improve the diarrhea symptoms, shorten the diarrhea time, and improve the TCM syndrome, and has the same efficacy as Montmorillonite Powder, with good safety, which has a certain clinical application value.