目的研究小儿腹泻贴在治疗儿童急性腹泻中的疗效及安全性。方法采用多中心、随机、开放、阳性药物对照等效性试验。收集2011年3月至2012年11月上海、北京、广州3所医院儿科急性腹泻患儿。随机分成试验组和对照组，分别采用小儿腹泻贴、蒙脱石散剂治疗，同时均给予口服补液盐治疗。观察治疗前后患者腹泻次数、大便性状以及相关的临床症状及体征，比较治疗第3天以及第5天的疗效，并记录药物相关不良反应。结果共有197例符合入选条件的患儿完成研究，其中试验组100例，对照组97例。两组患儿的年龄、体质量、性别、治疗前腹泻时间、治疗前大便性状和次数、治疗期呕吐次数以及脱水、发热、哭闹、食欲不振、腹胀、腹痛等情况的差异均无统计学意义（P均>0.05）；试验组第3天和第5天的治疗有效率达97%和100%，与对照组差异无统计学意义（P均>0.05）；试验组呕吐的恢复情况要优于对照组，且差异有统计学意义（P<0.05）。治疗期间未发现与药物有关的不良反应。结论小儿腹泻贴治疗儿童急性腹泻的疗效与蒙脱石散剂相同，对呕吐的疗效更优，且无不良反应。%Objectives To evaluate the effect and safety of Xiao Er Fu Xie Tie in children with acute diarrhea. Methods A multicenter, randomized, open-label, active-controlled clinical trial was carried out in three hospitals from March 2011 to December 2012. Children with acute diarrhea were enrolled and divided randomly into two groups, the observation group (treated with Xiao Er Fu Xie Tie) and the control group (treated with smectite powder). Boths groups received oral rehydration salts treatment. Symptoms and signs were recorded before and after therapy. The therapeutic effect was evaluated at 3 and 5 days after therapy. All of the adverse drug reactions were recorded during the study. Results In 197 children who completed the study, 100 children received Xiao Er Fu Xie Tie and 97 received smectite powder. Both groups were similar in age and gender distribution, weight, duration and frequency of diarrhea, times of vomiting, degree of dehydration and so on (P>0.05). After therapy, effective rates of the observation group at 3 days (97%) and 5 days (100%) were similar to those of control group (P>0.05). The effective rate for relieving vomiting in the observation group was higher than that in control group (P<0.05). No obvious adverse drug reactions were found during the study. Conclusions Xiao Er Fu Xie Tie has the same effect as smectite powder for treatment of acute diarrhea in children and is more effective in vomiting. Furthermore, no obvious adverse drug re-actions were found.
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