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.