目的 评价九味熄风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、双盲、安慰剂平行对照、多中心临床研究、优效性检验的方法。将天津中医药大学第一附属医院等4家中心就诊的抽动障碍患儿144例，按照1∶1比例随机分配至治疗组和对照组，每组72例。治疗组服用九味熄风颗粒，对照组服用其安慰剂。疗程为6周。结果 治疗后，对照组和治疗组疾病疗效总有效率分别为25.00%、78.26%，中医征候疗效总有效率分别为67.65%、95.65%，两组比较差异有统计学意义（P < 0.05）。治疗后，两组运动积分、发声积分、总积分均显著降低，同组治疗前后差异有统计学意义（P < 0.05）；治疗后治疗组运动积分、发声积分、总积分低于对照组，治疗组YGTSS积分变化差值大于对照组，两组比较差异有统计学意义（P < 0.05）。治疗后，治疗组运动抽动评分、发声抽动评分中2分的患者例数明显多于对照组，4分的患者例数明显少于对照组；治疗组发声抽动评分中0分的患者例数明显多于对照组，两组比较差异有统计学意义（P < 0.05）。治疗组手足心热、潮热盗汗、急躁易怒的0分评分患者例数明显多于对照组，1分的患者例数少于对照组，两组比较差异有统计学意义（P < 0.05）。结论 九味熄风颗粒治疗小儿抽动障碍肾阴亏损、肝风内动证有效，优于安慰剂，且使用安全。

Objective To observe the efficacy and safety of Jiuwei Xifeng Granules in treatment of tic disorder in children with kidney-yin deficiency and liver-wind stirring Methods Randomized, doubled-blind, placebo parallel-controlled, multi-center trial, superiority test were designed for this study. Patients (144 cases) with tic disorder in First Teaching Hospital of Tianjin University of TCM etc. A total of 144 patients in four hospitals were randomly divided into treatment and control, and each group had 72 cases. Patients in the treatment group were po administered with Jiuwei Xifeng Granules, and patients in the control group were po administered with placebo. They were treated for six weeks. Results After treatment, disease curative efficacies in the control and treatment groups were 25.00% and 78.26%, respectively, and TCM symptoms efficacies in the control and treatment groups were 67.65%and 95.65%, and there was difference between two groups (P < 0.05). After treatment, movement integral, integral and total integral significantly decreased, and the difference was statistically significant in the same group (P < 0.05). After treatment, movement integral, integral and total integral in the treatment group were lower than those in the control group, and difference value of YGTSS integral was greater than that in the control group, and there was difference between two groups (P < 0.05). After treatment, the patients of 2 score of movement twitch score, voice twitch points in the treatment group were significantly more than those in the control group, and the patients of 4 score were less than those in the control group, and there was difference between two groups (P < 0.05). The patients of 0 score of feverishness in palms and soles, tidal fever and night sweating, and irascibility in the treatment group were significantly more than those in the control group, and the patients of 1 score were less than those in the control group, and there was difference between two groups (P < 0.05). Conclusion Jiuwei Xifeng Granules has clinical effective in treatment of tic disorder in children with kidney-yin deficiency and liver-wind stirring, and the effect is superior to placebo safely.