目的 初步評價熄風(fēng)止動片治療小兒多發(fā)性抽動癥肝風(fēng)內(nèi)動挾痰證得有效性和安全性。方法 采用去組隨機、雙盲、平行對照試驗方法。將入選216例患兒分成2組，試驗組108例，2組剔除或脫落病例各2、3例。結(jié)果 熄風(fēng)止動片與對照藥硫必利片對小兒多發(fā)性抽動癥的總有效率分別為81.48%、83.81%。對于中醫(yī)證狀綜合療效，熄風(fēng)止動片與硫必利片的總有效率分別為83.02%、83.81%，組間差異均無統(tǒng)計學(xué)意義。非劣效檢驗結(jié)果顯示，試驗組療效不劣于對照組。兩組的中醫(yī)單項證候及舌脈治療前后組內(nèi)比較，差異均有統(tǒng)計學(xué)意義。試驗組與對照組分別有2、4例不良反應(yīng)，不良反應(yīng)發(fā)生率分別為1.85%、3.70%。結(jié)論 熄風(fēng)止動片對小兒多發(fā)性抽動癥肝風(fēng)內(nèi)動挾痰證得療效不劣于對照藥硫必利片，并具有良好安全性。

Objective To evaluate the efficacy and safety of Xifeng Zhidong Tablet in the treatment of Multiple tics with syndrome of Liver Wind and sputum stirring internally. Methods The random, double blind, parallel controlled method was applied to this study. Results The total effective rate of Multiple tics treatment in treatment group and control group was 81.48% and 83.81% respectively. To total effective rate of improving TCM symptoms was 83.02% and 83.81% respectively. There was no significant difference between the two groups (P＞0.05). The results of non-inferiority test indicated that the efficiency of treatment group was no worse than that of control group. In this clinical research, 6 subjects showed adverse reactions (2 from treat group, 4 from control group). The incidence rate of adverse reaction in the two groups was 1.85% and 3.7% respectively. Conclusion Xifeng Zhidong Tablet has high safety and good therapeutic effects for the treatment of Muliple tics with syndrome of Liver Wind and sputum stirring internally.