小儿化食口服液治疗小儿功能性便秘食积化热证的多中心临床研究被引量：9

A multi-center clinical trial: Evaluation of Xiao'er Huashi Oral Liquid in treatment of functional constipation children(syndrome of internal heat stagnated from accumulated food)

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摘要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.

作者胡思源钟成梁王映霞丁樱白晓红王建新洪丽君苏保玲颜云盈孙卫乾严明潘树强 HU Siyuan;ZHONG Chengliang;WANG Yingxia;DING Ying;BAI Xiaohong;WANG Jianxing;HONG Lijun;SU Baoling;YAN Yunying;SUN Weiqian;YAN Ming;PAN Shuqiang(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Ezhou Hospital of Traditional Chinese Medicine,Ezhou 436000,China;Qinzhou City Maternal and Child Health Hospital,Qinzhou 535000,China;Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 136300,China;The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,China;Harbin Children's Hospital,Haerbin 150010,China;Mudanjiang City Hospital of Traditional Chinese Medicine,Mudanjiang 157000,China;Heji Hospital Affiliated of Changzhi Medical College,Changzhi 04601I,China;Nanning Maternal and Child Health Hospital,Nannin 530011,China;Guangzhou Panyu Central Hospital,Guangzhou 511400,China)

机构地区天津中医药大学第一附属医院天津中医药大学河南中医药大学第一附属医院辽宁中医药大学附属医院哈尔滨市儿童医院牡丹江市中医医院长治医学院附属和济医院南宁市妇幼保健院广州市番禹区中心医院鄂州市中医医院钦州市妇幼保健院

出处《药物评价研究》 CAS 2018年第12期2155-2159,共5页 Drug Evaluation Research

关键词小儿功能性便秘食积化热证小儿化食口服液随机对照试验 children's functional constipation syndrome of internal heat stagnated from accumulated food Xiao'er Huashi Oral Liquid RCT

分类号 R969.4 [医药卫生—药理学]