甘桔冰梅片治疗急性咽炎风热犯肺证多中心、双盲双模拟随机对照临床观察

Ganjiebingmei Tablet (甘桔冰梅片) in Treating Acute Pharyngitis with Wind-Heat Invading the Lung Syndrome:A Multicenter,Randomized,Double-blind Double-dummy Clinical Observation

目的 观察甘桔冰梅片治疗急性咽炎风热犯肺证的临床疗效和安全性。方法 采用随机、双盲双模拟、阳性药平行对照、多中心临床试验设计,纳入2022年10月8日至2023年3月31日就诊于6家医院的急性咽炎风热犯肺证患者144例,随机分为治疗组和对照组各72例。治疗组给予甘桔冰梅片(每次0.4 g,每日4次)+甘桔清咽颗粒模拟剂(每次10 g,每日3次),对照组给予甘桔清咽颗粒(每次10 g,每日3次)+甘桔冰梅片模拟剂(每次0.4 g,每日4次),两组疗程均为5天。治疗后比较两组患者咽痛消失率、中医证候疗效,治疗前后进行咽痛视觉模拟评分法(VAS)评分,观察并记录治疗期间的不良反应。结果 治疗组治疗后咽痛消失率(98.61%,71/72)高于对照组(80.56%,58/72)(P<0.01)。两组患者治疗后咽痛VAS评分均较治疗前明显降低(P<0.05),且治疗后治疗组患者咽痛VAS评分明显低于对照组(P<0.05);两组中医证候疗效总有效率均为100%,但治疗组痊愈率(73.61%,53/72)高于对照组(62.50%,45/72)(P<0.05)。治疗期间两组患者均未见明显不良反应。结论 甘桔冰梅片治疗急性咽炎风热犯肺证疗效确切,安全性好。

Objective To evaluate the clinical efficacy and safety of Ganjie Bingmei Tablet (甘桔冰梅片,GBT) in treating acute pharyngitis with wind-heat invading the lung syndrome.Methods Using multi-center,randomized,double-blind,double-dummy,positive and parallel controlled clinical trial design,144 acute pharyngitis patients with wind-heat invading the lung syndrome from October 8th,2022 to March 31st,2023 were collected and randomly assigned to the treatment group and the control group,with 72 cases in each group.The treatment group was treated by GBT(0.4 g each time,4 times a day) combined with Ganjie Qingyan Granules (甘桔清咽颗粒,GQG) placebo(10 g each time,3 times a day),while the control group was treated by GQG(10 g each time,3 times a day) combined with GBT placebo(0.4 g each time,4 times a day),both for 5 days.The clinical efficacy of the two groups was observed,and the disappearance rate of pharyngalgia and the efficacy regarding TCM syndromes were compared between groups after treatment.The visual analog scale(VAS) score before and after treatment was assessed,and the safety was evaluated.Results The disappearance rate of pharyngalgia in the treatment group was 98.61%(71/72),significantly higher than 80.56%(58/72) in the control group(P<0.01).The VAS scores in both groups significantly decreased after treatment(P<0.05),and lower score was found in the treatment group than the control group(P<0.05).The total effective rate regarding TCM syndromes was 100% in both groups,but the curative rate was significantly higher in the treatment group(73.61%,53/72) than the control group(62.50%,45/72,P<0.05).There were no obvious adverse reactions in the both groups.Conclusion GBT is effective and safe in treating acute pharyngitis with wind-heat affecting the lung syndrome.