小儿开胃增食颗粒治疗小儿厌食脾失健运证的临床观察

Effect of Xiaoer Kaiwei Zengshi Granule on treating infantile anorexia with dysfunction of the spleen in transportation

[目的]以健身消导颗粒为对照,初步评价小儿开胃增食颗粒治疗小儿厌食脾失健运证的有效性和安全性。[方法]采用分层区组随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法。[结果]疾病疗效的愈显率对照组为66.36%,试验组为67.59%,证候疗效的对照组为74.55%,试验组为75.93%,两组比较,差异均无显著性意义(P>0.05),非劣效检验成立。[结论]小儿开胃增食颗粒治疗小儿厌食脾失健运证临床有效,使用安全。

[Objective] Taking Jianshen Xiaodao Granule as the control drug,the effect and safety of Xiaoer Kaiwei Zengshi Granule in treating infantile anorexia with dysfunction of spleen in transportation was observed.[Methods] Randomized,positive-drug,parallel-con-trolled,doubled-blind,double-dummy,multi-center trial method were designed in clinical study.[Results] There was no significant dif-ference in marked effective rate between control and treatment group（P〈0.05）.The efficacy on diseases was 66.36% vs 67.57%,and the efficacy on syndrome 74.55% vs 75.93%.The illness effectiveness of test drug was not inferior to the control one.[Conclusion] Xiaoer kaiwei zengshi granule has a obvious curative effect on infantile anorexia with dysfunction of spleen in transportation and is safe in clini-cal study.