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

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。

Clinical research of Xiaoer Kaiwei Zengshi granula on anorexia with dysfunction of spleen transportation in infanti

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.