金童颗粒治疗肾阴亏损、肝风内动证小儿抽动障碍患者随机双盲对照试验  

Jintong Keli (金童颗粒) for treatment of Children Tic Disorder with Deficiency of Kidney Yin and Liver Wind Stirring up Internally Syndrome: A Randomized Double-blind Controlled Trial

作　　者：李金惠[1] 马融[2] 胡思源[2] 魏小维[2] 王雪峰[3] 丁樱[4] 张雅凤[5] 黄文玉[6] 

机构地区：[1]天津中医药大学研究生院,天津市南开区双峰道9号300193 [2]天津中医药大学第一附属医院 [3]辽宁中医学院附属医院 [4]河南中医学院第一附属医院 [5]辽宁中医学院第二附属医院 [6]天津市儿童医院

出　　处：《中医杂志》2016年第10期860-863,共4页Journal of Traditional Chinese Medicine

摘　　要：目的评价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和安全性。方法采用随机对照、双盲双模拟的试验方法,将2004年11月至2005年8月于天津中医药大学等5个中心诊断的抽动障碍肾阴亏损、肝风内动证患儿随机分为试验组和对照组,每组120例。试验组口服金童颗粒,同时服用盐酸硫必利片模拟药;对照组口服盐酸硫必利片,同时服用金童颗粒模拟药。两组均治疗6周。治疗前及治疗2、4、6周采用耶鲁综合抽动严重程度量表(YGTSS)进行评分,治疗后评价疾病疗效、证候疗效及安全性。结果治疗组与对照组的疾病疗效总有效率分别为78.8%和72.7%,证候疗效总有效率分别为93.8%和97.3%,两组比较差异均无统计学意义(P>0.05)。两组治疗2、4、6周时与本组治疗前YGTSS评分比较均明显降低(P<0.05),而两组间各时间点比较差异无统计学意义(P>0.05)。试验组无与试验用药相关的异常改变。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,疗效不劣于盐酸硫必利片,且安全性好。Objective To evaluate the effect and safety of Jintong Keli（ 金童颗粒） in treating Tic disorder（ TD）in children with syndrome of deficiency of kidney Yin and liver wind stirring up internally. Methods The trial method of randomized,controlled,double-blind and double simulation was adopted. TD children patients with the syndrome of deficiency of kidney Yin and liver wind stirring up internally,diagnosed by Tianjin University of Traditional Chinese Medicine and other 4 centers from November,2004 to August,2005,were randomized into a trial group and a control group,with 120 cases in each group. The trial group was given Jintong Keli orally and simulated drug of tiapride hydrochloride tablets. The control group was given tiapride hydrochloride tablets orally and simulated drug of Jintong Keli. Both groups were treated for 6 weeks. The scores of Yale Global Tic Severity Scale（ YGTSS）were compared before treatment,and in the 2nd,4th and 6th week after starting treatment. Therapeutic effects for disease or syndrome,as well as safety were evaluated after treatment. Results The total effective rate for disease in the treating group and the control group were 78. 8% and 72. 7%,respectively,and the total effective rate for syndrome were 93. 8% and 97. 3%,respectively,both with no significant difference between the two groups（ P 〉0. 05）. The scores of YGTSS in both groups in the 2nd,4th and 6th weeks after starting treatment were lower than those in the same group before treatment（ P 〈 0. 05）. There were no significant differences in scores of YGTSS between the two groups at the same time-point（ P 〉 0. 05）. Conclusion Jintong Keli is effective and safe in treating TD in children with syndrome of deficiency of kidney Yin and liver wind stirring up internally,with the effect not worse than that of tiapride hydrochloride tablets.

关 键 词：抽动障碍 肾阴亏损 肝风内动 金童颗粒 

分 类 号：R277.7[医药卫生—中医学]