目的 確證評價(jià)菖麻熄風(fēng)片治療小兒多發(fā)性抽動(dòng)癥肝風(fēng)內(nèi)動(dòng)挾痰證的有效性和安全性。方法 采用區(qū)組隨機(jī)、雙盲雙模擬、陽性藥平行對照、多中心臨床研究的方法。438例患者進(jìn)入全分析數(shù)據(jù)集，治療組328例，對照組110例。治療組口服菖麻熄風(fēng)片與硫必利片模擬藥，3次/d，4～6歲，1片/次；7～11歲，2片/次，12～18歲，3片/次；對照組口服硫必利片與菖麻熄風(fēng)片模擬藥，2次/d，4～6歲，1/3片/次；7～11歲，1/2片/次；12～18歲，1片/次。兩組均治療4周。觀察兩組的YGTSS抽動(dòng)積分、臨床療效、YGTSS社會(huì)功能損害、中醫(yī)證候療效和單項(xiàng)證候療效，并對其依從性和安全性進(jìn)行評價(jià)。結(jié)果 治療組和對照組臨床療效的總有效率分別為86.59%、82.73%，且治療組患兒抽動(dòng)的療效不劣于對照組。YGTSS抽動(dòng)積分、社會(huì)功能損害、中醫(yī)證候療效和單項(xiàng)證候療效的組間比較，差異均無統(tǒng)計(jì)學(xué)意義。PPS與FAS分析結(jié)論一致。試驗(yàn)中，未發(fā)現(xiàn)菖麻熄風(fēng)片的不良反應(yīng)，不良反應(yīng)發(fā)生率低于硫必利片且有統(tǒng)計(jì)學(xué)意義。結(jié)論 菖麻熄風(fēng)片對小兒多發(fā)性抽動(dòng)癥肝風(fēng)內(nèi)動(dòng)挾痰證有效，療效不劣于硫必利片，并且未提示更高的臨床應(yīng)用風(fēng)險(xiǎn)。

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.