目的 评价小儿化食口服液治疗小儿功能性便秘食积化热证的有效性和安全性。方法 采用随机、双盲、安慰剂对照、多中心临床试验的方法。治疗组和对照组分别服用小儿化食口服液或其模拟药，疗程1周。结果 共入选受试者238例，其中治疗组120例、对照组118例。治疗后，治疗组和对照组的自主排便（SBM）应答率分别为50%、36.52%，中医证候疗效总有效率分别为81.36%、67.83%，排便间隔有效率分别为68.64%、53.91%，排便困难有效率分别为65.52%、48.25%。两组比较，差异均有统计学意义（P<0.05）。试验中，未发现不良事件。结论 小儿化食口服液短期治疗小儿功能性便秘食积化热证有效，且安全性较好，值得临床推广应用。

Objective To evaluate the efficacy and safety of Xiao'er Huashi (XEHS) Oral Liquid in the treatment of functional constipation children (syndrome of internal heat stagnated from accumulated food). Methods A randomized, double-blind, placebocontrolled and multi-center clinical research method were adopted. Eligible subjects were randomly assigned to receive either XEHS or placebo for oneweek. Results A total of 238 subjects were enrolled in this study, of which 120 were in the XEHS group and 118 were in the placebo group. After treatment, in the XEHS group and the placebo group, the standardized rates of spontaneous bowel movements were 50% and 36.52%, the total effective rate of traditional Chinese medicine syndrome efficacy were 81.36% and 67.83%, the effective rate of long defecation interval timewere 68.64% and 53.91%, the effective rate of difficult defecation was 65.52% and 48.25%, respectively. There was statistical significance difference between the two groups (P<0.05). During the study, no adverse event was reported.Conclusion XEHS is effective forshort-term treatment of functional constipation children (syndrome of internal heat stagnated from accumulated food), which is safe and worthy of clinical application.