目的 評(píng)價(jià)半枝蓮總黃酮膠囊治療急性咽炎肺胃實(shí)熱證的有效性和安全性。方法 采用分層區(qū)組隨機(jī)雙盲、平行對(duì)照、劑量探索、多中心臨床研究的方法。238例進(jìn)入全分析數(shù)據(jù)集（FAS），隨機(jī)分為對(duì)照組（79例）、低劑量組（80例）和高劑量組（79例）。對(duì)照組口服半枝蓮總黃酮膠囊模擬劑，3粒/次，3次/d。低劑量組口服半枝蓮總黃酮膠囊，2粒/次，3次/d，同時(shí)口服半枝蓮總黃酮膠囊模擬劑，1粒/次，3次/d。高劑量組口服半枝蓮總黃酮膠囊，3粒/次，3次/d。3組患者均治療5 d。評(píng)價(jià)治療前后3組患者臨床療效、中醫(yī)證候療效、主癥及檢查單項(xiàng)療效。結(jié)果 治療后，對(duì)照組臨床療效臨床痊愈率和顯效率分別為7.6%、34.2%，低劑量組臨床痊愈率和顯效率分別為10.0%、48.8%，高劑量組臨床痊愈率和顯效率分別為26.6%、65.8%，高劑量組臨床痊愈率和顯效率均顯著高于對(duì)照組和低劑量組，3組臨床痊愈率、顯效率比較差異具有統(tǒng)計(jì)學(xué)意義（P< 0.05、0.01）。治療后，對(duì)照組中醫(yī)證候臨床痊愈率和顯效率分別為7.6%、32.9%，低劑量組臨床痊愈率和顯效率分別為8.8%、47.5%，高劑量組臨床痊愈率和顯效率分別為24.1%、64.6%；高劑量組臨床痊愈率及顯效率均優(yōu)于對(duì)照組和低劑量組，3組臨床痊愈率、顯效率比較差異具有統(tǒng)計(jì)學(xué)意義（P< 0.05、0.01）。對(duì)照組主癥及檢查單項(xiàng)臨床痊愈率和顯效率分別為7.6%、41.8%；低劑量臨床痊愈率和顯效率分別為15.0%、68.8%，高劑量組臨床痊愈率和顯效率分別為31.6%、78.5%，高劑量組臨床痊愈率優(yōu)于對(duì)照組和低劑量組，3組臨床痊愈率、顯效率比較差異具有統(tǒng)計(jì)學(xué)意義（P< 0.05、0.01）。結(jié)論 半枝蓮總黃酮膠囊對(duì)急性咽炎肺胃實(shí)熱證有較好的臨床療效，明顯優(yōu)于安慰劑，且安全性較好，有進(jìn)一步開展Ⅲ期臨床試驗(yàn)進(jìn)行療效確證的價(jià)值。

Objective To evaluate the clinical efficacy and safety of Banzhilian Zonghuangtong Capsules in treatment of acute pharyngitis with lung-stomach excess-heat syndrome. Methods The stratified random, double blind, parallel control, and dose-finding, and multi-center was applied to this study. Patients (238 cases) included into full analysis data set (FAS) were randomly divided into placebo group (79 cases), low-dose group (80 cases), and high-dose group (79 cases). Patients in the placebo group were po administered with simulation of Banzhilian Zonghuangtong Capsules, 3 grains/time, three times daily. Patients in the low-dose group were po administered with Banzhilian Zonghuangtong Capsules, 2 grains/time, three times daily, and at the same time they were po administered with simulation of Banzhilian Zonghuangtong Capsules, 1 grain/time, three times daily. Patients in the high-dose group were po administered with Banzhilian Zonghuangtong Capsules, 3 grains/time, three times daily. Patients in three groups were treated for 5 d. After treatment, clinical efficacy, TCM syndrome, main symptoms, and single examination in three groups before and after treatment were compared. Results After treatment, clinical cure rate and significant efficiency of clinical efficacy in the placebo group were 7.6% and 34.2%, clinical cure rate and significant efficiency in the low-dose group were 10.0% and 48.8%, which were significantly lower than 26.6% and 65.8% in the high-dose group, respectively, and there were differences among three groups (P < 0.05, 0.01). After treatment, clinical cure rate and significant efficiency of TCM syndrome efficacy in the placebo group were 7.6% and 32.9%, clinical cure rate and significant efficiency in the low-dose group were 8.8% and 47.5%, which were significantly lower than 24.1% and 64.6% in the high-dose group, respectively, and there were differences among three groups (P < 0.05, 0.01). After treatment, clinical cure rate and significant efficiency of main symptoms and single examination efficacy in the placebo group was 7.6% and 41.8%, clinical cure rate and significant efficiency in the low-dose group were 15.0% and 68.8%, which were significantly lower than 31.6% and 78.5% in the high-dose group, respectively, and there were differences among three groups (P < 0.05, 0.01). Conclusion Banzhilian Zonghuangtong Capsules has good curative effect in treatment of acute pharyngitis with lung-stomach excess-heat syndrome, and the clinical efficacy is significantly better than that in the placebo group with high security, which has value to carry out Phase III clinical research to corroborate the curative effect.