甘桔冰梅片治疗风热犯肺型急性咽炎多中心随机对照研究

Multicenter Randomized-Controlled Trial for Ganjie Bingmei Tablet(甘桔冰梅) in Treating Acute Pharyngitis with Wind Heat Invading Lung Syndrome

目的评价甘桔冰梅片治疗风热犯肺型急性咽炎的临床疗效和安全性。方法采用多中心、随机、双盲、安慰剂平行对照临床试验设计,共纳入240例患者,完成235例,其中治疗组119例、对照组116例。治疗组和对照组分别给予甘桔冰梅片和安慰剂治疗,均每次0.4 g,每日4次,疗程5天。疗程结束后观察两组疾病综合疗效及中医症状(包括咽痛、咽干灼热、咽黏膜充血、吞咽不利)疗效,观察并记录患者不良反应。结果治疗组临床痊愈率13.5%,总有效率87.4%,对照组临床痊愈率7.8%,总有效率54.3%,两组比较差异有统计学意义(P<0.05),治疗组优于对照组。治疗组咽痛改善率为89.9%,对照组为61.2%;治疗组咽干灼热改善率为70.6%,对照组为52.6%;治疗组咽黏膜充血改善率为73.9%,对照组为48.3%;治疗组吞咽不利消失率为88.7%,对照组为76.6%,治疗组各症状改善率均优于对照组(P<0.05或P<0.01)。甘桔冰梅片未见明显毒副作用和不良反应。结论甘桔冰梅片治疗风热犯肺型急性咽炎疗效确切,安全性好。

Objective To evaluate the clinical curative effect and safety of Ganjie Bingmei tablet（ 甘桔冰梅片）in treating acute pharyngitis with wind heat invading lung syndrome. Methods Using multi-center,randomized,double-blind,placebo parallel controlled clinical trial design,240 patients were included in which 235 cases completed,with 119 cases in the treatment group and 116 cases in the control group. The treatment group and the control group were treated by the Ganjie Bingmei tablet and placebo respectively,with 0. 4 g each time,4 times per day,totally for 5 days. Observed the comprehensive curative effect of the two groups and the curative effect of Chinese medicine symptoms（ including sore throat,dry pharynx and burning sensation,pharyngeal mucosal hyperemia,dysphagia）,and recorded the adverse reactions. Results In the treatment group,the clinical curative rate was13. 5%,and the total effective was 87. 4%; in the control group,the clinical curative rate was 7. 8%,and the total effective was 54. 3%. There were statistical differences in curative effect between the the two groups（ P〈0. 05）,and the curative effect in the treatment group was better than that in the control group. The improvement rate of pharyngalgia in the treatment group was 89. 9%,and that in the control group was 61. 2%. The improvement rate of dry pharynx and burning sensation in the treatment group was 88. 7%,and that in the control group was 52. 6%. The improvement rate of pharyngeal mucosal congestion in the treatment group was 73. 9%,and that in the control group was 48. 3%. The disappearance rate of dysphagia in the treatment group was 88. 7%,and that in the control group was 76. 6%,thus,the improvement rate of the symptoms were better than those in the control group（ P〈0. 05 or P〈 0. 01）. Ganjie Bingmei tablet had no obvious toxic side effects and adverse reactions. Conclusion Ganjie Bingmei tablet in treating acute pharyngitis with wind heat invading lung syndrome seems to have definite curative effect,and the safety appears good.