金童颗粒治疗小儿抽动障碍的临床研究

目的观察金童颗粒治疗小儿抽动障碍肾阴亏损、肝风内动证的有效性及临床应用的安全性。方法试验采用按分层区组随机、阳性药平行对照、双盲双模拟、多中心临床研究的方法,7家医疗机构计划观察小儿抽动障碍肾阴亏损、肝风内动证患者469例,按3:1比例分为试验组和对照组。两组分别用金童颗粒和泰必利片,疗程为6周。结果疾病疗效、证候疗效愈显率、总有效率的组间比较,差异均无显著性意义(P0.05);设α=0.05、β=0.2、δ=0.15,疾病疗效的非劣效性检验成立,试验组不低于对照组;YGTSS积分、运动性抽动积分、发声性抽动积分的疗前、疗后、治疗前后差值的组间比较,除疗后YGTSS积分、运动性抽动积分外,差异均无显著性意义(P0.05)。结论金童颗粒治疗小儿抽动障碍肾阴亏损、肝风内动证有效,疗效不劣于阳性对照药泰必利片,且临床使用安全。

Clinical observation of Jintong-Granules on treating tic disorder in children

Objective To observe the effectiveness and clinical safety of Jintong-Granules on trea- ting tic disorder in children with the syndrome of kidney-yin deficiency and liver-wind stirring internally. Methods Randomized, positive-drng, parallel-controlled, doubled-blind, double-dummy, multi-center trial were designed for clinical study. 469 subjects of tic disorder in children with kidney-yin deficiency and liver-wind stirring internally were randomly recruited into trial or control group （ 3 ： 1 ） by seven hospitals, who were treated by Jintong-granules and Tiapride respectively for six weeks continuously. Results There were no significant difference on markedly effective rate ,total effective rate of disease and syndrome efficacy between two groups （ P 〉 0.05 ） ; The illness effectiveness of Jintong granules was non-inferior to Tiapride＇ s. （ α =0.05,β =0.2,δ = 0.15 ） ; Amoung some therapeutic index such as scores of YGTSS,motor tics, phonic tics on every observating moments of time, except for the scores of YGTSS and motor tics after treating, the comparision between two groups were revealed as no significant difference in statistics （P 〉 0. 05）. Conclusions With safety , the therapeutic effectiveness of Jintong-Granules on tic disorder in children with kidney-yin deficiency and liver-wind stirring internally was non-inferior to Tiapride.