天津中医药2012，Vol.29Issue(1)：28-30,3.
小儿开胃增食颗粒治疗小儿厌食脾失健运证的Ⅲ期临床试验
Clinical research of Xiaoer Kaiwei Zengshi granula on anorexia with dysfunction of spleen transportation in infantile
摘要
Abstract
[Objective] To study the effect and safety of Xiaoer Kaiwei Zengshi granule in treating infantile anorexia with dysfunction of spleen transportation taking Jianshen Xiaodao granule as the control drug. [Methods] Randomized, positive-drug, parallel-controlled, doubled-blind, double-dummy, multi-center trial methods were designed in the clinical study. The test choose 451 children. 338 cases were in treatment group, among them 16 removed,4 excluded; 113 cases in control group, 2 removed, 1 excluded. [Results] The total effective rate of treatment group was 95.28% and that of the control group was 92.73%. There weren't obviously different in treatment group and control group (P>0.05). The test showed that the drug in trial group was not inferior than that of the control group. The syndrome total effective rate of treatment group was 98.43% and that of control group was 97.27% without significant difference between the control and the treatment group (P>0.05). [Conclusion] Xiaoer Kaiwei Zengshi granule is safe and effective on infantile anorexia with dysfunction of spleen transportation.关键词
小儿开胃增食颗粒/健身消导颗粒/小儿厌食症Key words
Xiaoer Kaiwei Zengshi granule/Jianshen Xiaodao granule/infantile anorexia分类
医药卫生引用本文复制引用
赵越郡,马融,胡思源,魏小维,吕玉霞,丁樱,周盈,何平..小儿开胃增食颗粒治疗小儿厌食脾失健运证的Ⅲ期临床试验[J].天津中医药,2012,29(1):28-30,3.基金项目
国家十二五重大新药创制一儿科中药新药临床评价研究技术平台规范化建设(2011ZX09302-00603). （2011ZX09302-00603）
