目的 确证评价菖麻熄风片治疗小儿多发性抽动症肝风内动挟痰证的有效性和安全性。方法 采用区组随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法。438例患者进入全分析数据集，治疗组328例，对照组110例。治疗组口服菖麻熄风片与硫必利片模拟药，3次/d，4～6岁，1片/次；7～11岁，2片/次，12～18岁，3片/次；对照组口服硫必利片与菖麻熄风片模拟药，2次/d，4～6岁，1/3片/次；7～11岁，1/2片/次；12～18岁，1片/次。两组均治疗4周。观察两组的YGTSS抽动积分、临床疗效、YGTSS社会功能损害、中医证候疗效和单项证候疗效，并对其依从性和安全性进行评价。结果 治疗组和对照组临床疗效的总有效率分别为86.59%、82.73%，且治疗组患儿抽动的疗效不劣于对照组。YGTSS抽动积分、社会功能损害、中医证候疗效和单项证候疗效的组间比较，差异均无统计学意义。PPS与FAS分析结论一致。试验中，未发现菖麻熄风片的不良反应，不良反应发生率低于硫必利片且有统计学意义。结论 菖麻熄风片对小儿多发性抽动症肝风内动挟痰证有效，疗效不劣于硫必利片，并且未提示更高的临床应用风险。

Objective To assess the efficacy and safety of Changma Xifeng Tablets in treating multiple tics with liver wind and sputum stirring internally. Methods The stratified random, double blind, double dummy, parallel control of positive drugs, and multi- center clinical method was applied to this study. Patients (438 cases) were included into the full analysis of the data set, and there were 328 and 110 cases in treatment and control group. Patients in the treatment group were po administered with Changma Xifeng Tablets and simulation of Tiapride Tablets, 3 times/d, 4 — 6 years old patients: 1 tablet/time; 7 — 11 years old patients: 2 tablets/time; 12 — 18 years old patients: 3 tablets/time. Patients in the control group were po administered with Tiapride Tablets and simulation of Changma Xifeng Tablets, twice per day, 4 — 6 years old patients: 1/3 tablet/time; 7 — 11 years old patients: 1/2 tablets/time; 12 — 18 years old patients: 1 tablet/time. The patients in two groups were treated for 4 weeks. YGTSS twitch integrals, clinical efficacy, YGTSS social function damage, traditional Chinese medicine syndrome, and single syndrome curative effect were observed. And the medication compliance and security were evaluated. The total effective rates of treatment and control groups were 86.59% and 82.73%, and the clinical efficacy of treatment group was not worse than that in the control group. There was no significant difference between the two groups in YGTSS twitch integrals, YGTSS social function damage, traditional Chinese medicine syndrome, and single syndrome curative effect. The conclusion of PPS and FAS analysis was consistent. In addition, there were no clinical adverse reactions in the treatment group. The incidence of adverse reactions of Changma Xifeng Tablets was obviously less than Tiapride Tablets with significant difference. Conclusion Changma Xifeng Tablet has high clinical efficacy in treating multiple tics with liver wind and sputum stirring internally. The clinical efficacy is not lower than that of Tiapride Tablets, and there is not higher risk of clinical application.