目的 評價小兒化食口服液治療小兒功能性便秘食積化熱證的有效性和安全性。方法 采用隨機(jī)、雙盲、安慰劑對照、多中心臨床試驗的方法。治療組和對照組分別服用小兒化食口服液或其模擬藥，療程1周。結(jié)果 共入選受試者238例，其中治療組120例、對照組118例。治療后，治療組和對照組的自主排便（SBM）應(yīng)答率分別為50%、36.52%，中醫(yī)證候療效總有效率分別為81.36%、67.83%，排便間隔有效率分別為68.64%、53.91%，排便困難有效率分別為65.52%、48.25%。兩組比較，差異均有統(tǒng)計學(xué)意義（P<0.05）。試驗中，未發(fā)現(xiàn)不良事件。結(jié)論 小兒化食口服液短期治療小兒功能性便秘食積化熱證有效，且安全性較好，值得臨床推廣應(yīng)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.