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

[目的]以健身消导颗粒为对照,进一步验证小儿开胃增食颗粒治疗小儿厌食脾失健运证的有效性。[方法]分层区组随机、双盲双模拟、阳性药平行对照、多中心的临床研究的方法,将入选451例患者分为2组,试验组338例,脱落16例,剔除4例;对照组113例,脱落2例,剔除1例。两组分别应用小儿开胃增食颗粒和健身消导颗粒,疗程均为14 d。[结果]小儿开胃增食颗粒治疗小儿厌食脾失健运证疾病疗效的总有效率为95.28%,对照组为92.73%,两组比较,差异无统计学意义(P>0.05)。非劣效检验结果显示,试验组疗效非劣于对照组。两组证候疗效的总有效率,试验组为98.43%,对照组为97.27%,两组比较,差异无统计学意义(P>0.05)。[结论]小儿开胃增食颗粒治疗小儿厌食脾失健运证安全、有效。

[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.