目的 評價九味熄風顆粒治療小兒抽動障礙腎陰虧損、肝風內(nèi)動證的有效性和安全性。方法 采用隨機、雙盲、安慰劑平行對照、多中心臨床研究、優(yōu)效性檢驗的方法。將天津中醫(yī)藥大學第一附屬醫(yī)院等4家中心就診的抽動障礙患兒144例，按照1∶1比例隨機分配至治療組和對照組，每組72例。治療組服用九味熄風顆粒，對照組服用其安慰劑。療程為6周。結果 治療后，對照組和治療組疾病療效總有效率分別為25.00%、78.26%，中醫(yī)征候療效總有效率分別為67.65%、95.65%，兩組比較差異有統(tǒng)計學意義（P < 0.05）。治療后，兩組運動積分、發(fā)聲積分、總積分均顯著降低，同組治療前后差異有統(tǒng)計學意義（P < 0.05）；治療后治療組運動積分、發(fā)聲積分、總積分低于對照組，治療組YGTSS積分變化差值大于對照組，兩組比較差異有統(tǒng)計學意義（P < 0.05）。治療后，治療組運動抽動評分、發(fā)聲抽動評分中2分的患者例數(shù)明顯多于對照組，4分的患者例數(shù)明顯少于對照組；治療組發(fā)聲抽動評分中0分的患者例數(shù)明顯多于對照組，兩組比較差異有統(tǒng)計學意義（P < 0.05）。治療組手足心熱、潮熱盜汗、急躁易怒的0分評分患者例數(shù)明顯多于對照組，1分的患者例數(shù)少于對照組，兩組比較差異有統(tǒng)計學意義（P < 0.05）。結論 九味熄風顆粒治療小兒抽動障礙腎陰虧損、肝風內(nèi)動證有效，優(yōu)于安慰劑，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.