小儿脾胃乐颗粒(原小儿开胃增食颗粒)补充临床试验

目的:在Ⅱ、Ⅲ期临床试验的基础上,对小儿脾胃乐颗粒治疗小儿厌食脾失健运证的有效性做进一步评价并进行安全性观察。方法:采用安慰剂对照设计、分层区组随机、随机双盲试验、多中心临床研究、优效性检验的方法,入选144例患者,试验组72例,剔除2例,脱落7例,对照组72例,剔除5例,脱落3例。结果:小儿脾胃乐治疗小儿厌食脾失健运证食欲不振疗效的总有效率为92.86%,对照组为56.72%,两组比较,差异有统计学意义(P0.05)。两组食量减少疗效的总有效率,试验组为90.00%,对照组为67.16%,两组比较,差异有统计学意义(P0.05)。优效性检验结果显示,试验组疗效优于对照组。结论:小儿脾胃乐颗粒治疗小儿厌食脾失健运证有效并且安全。

Effect of Xiaoer Piweile Granule(Xiaoer Kaiwei Zengshi Granule)on Treating Infantile Anorexia with Dysfunction of Spleen in Transportation

Objective:The effect and safety of Piweile Granule on treating infantile anorexia with dysfunction of spleen in transportation were observed.Methods:Randomized,placebo-controlled,parallel-con-trolled,doubled-blind,double-dummy,multi-center trial methods were designed in clinical study.The test chose 144 children,72 cases were in test group,removed were 2,fall off were 7;72 cases were in control group,removed were 5,fall off were 3.Results:The efficacy on loss of appetite was 92.86% vs 56.72%.There was significant difference in marked effective rate between control and treatment group(P<0.05).The efficacy on food intake was 90.00% vs 67.16%.There was significant difference in marked effective rate between control and treatment group(P<0.05).The illness effectiveness of test drug was superior to the control one.Conclusion:Piweile Granule has an obvious curative effect on infantile anorexia with dysfunction of spleen in transportation and is safe in clinical study.