半枝莲总黄酮胶囊治疗急性咽炎肺胃实热证的Ⅱ期临床研究

Phase Ⅱ clinical research of Banzhilian Zonghuangtong Capsules in treatment of acute pharyngitis with lung-stomach excess-heat syndrome

目的评价半枝莲总黄酮胶囊治疗急性咽炎肺胃实热证的有效性和安全性。方法采用分层区组随机双盲、平行对照、剂量探索、多中心临床研究的方法。238例进入全分析数据集(FAS),随机分为对照组(79例)、低剂量组(80例)和高剂量组(79例)。对照组口服半枝莲总黄酮胶囊模拟剂,3粒/次,3次/d。低剂量组口服半枝莲总黄酮胶囊,2粒/次,3次/d,同时口服半枝莲总黄酮胶囊模拟剂,1粒/次,3次/d。高剂量组口服半枝莲总黄酮胶囊,3粒/次,3次/d。3组患者均治疗5 d。评价治疗前后3组患者临床疗效、中医证候疗效、主症及检查单项疗效。结果治疗后,对照组临床疗效临床痊愈率和显效率分别为7.6%、34.2%,低剂量组临床痊愈率和显效率分别为10.0%、48.8%,高剂量组临床痊愈率和显效率分别为26.6%、65.8%,高剂量组临床痊愈率和显效率均显著高于对照组和低剂量组,3组临床痊愈率、显效率比较差异具有统计学意义(P<0.05、0.01)。治疗后,对照组中医证候临床痊愈率和显效率分别为7.6%、32.9%,低剂量组临床痊愈率和显效率分别为8.8%、47.5%,高剂量组临床痊愈率和显效率分别为24.1%、64.6%;高剂量组临床痊愈率及显效率均优于对照组和低剂量组,3组临床痊愈率、显效率比较差异具有统计学意义(P<0.05、0.01)。对照组主症及检查单项临床痊愈率和显效率分别为7.6%、41.8%;低剂量临床痊愈率和显效率分别为15.0%、68.8%,高剂量组临床痊愈率和显效率分别为31.6%、78.5%,高剂量组临床痊愈率优于对照组和低剂量组,3组临床痊愈率、显效率比较差异具有统计学意义(P<0.05、0.01)。结论半枝莲总黄酮胶囊对急性咽炎肺胃实热证有较好的临床疗效,明显优于安慰剂,且安全性较好,有进一步开展Ⅲ期临床试验进行疗效确证的价值。

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.