柴葛清热颗粒治疗急性上呼吸道感染风热证的双盲随机对照临床试验

A double-blind,randomized controlled trial of Chaige Qingre Granule in treating acute upper respiratory tract infection of wind heat syndrome

目的:评价柴葛清热颗粒治疗急性上呼吸道感染风热证的安全性及有效性。方法:采用随机双盲多中心阳性药平行对照试验设计。本中心Ⅱ期纳入60例,随机分为试验组(n=30)和对照组(n=30);Ⅲ期纳入112例,随机分为试验组(n=84)和对照组(n=28)。试验组给予柴葛清热颗粒,每次1包(6g),4次/d;对照组给予复方双花颗粒,每次1包(6g),4次/d。疗程均为3d。观察治疗前后症状、体征变化和有无不良反应,并进行血、尿、大便常规,肝肾功能及心电图检查。结果:试验组和对照组经治疗后的Ⅱ期总显效率分别为78.57%、82.14%(符合方案分析)和75.86%、79.31%(意向性治疗分析),总有效率分别为96.43%、100%(符合方案分析)和93.10%、96.55%(意向性治疗分析),两组比较差异无统计学意义(P>0.05);试验组和对照组经治疗后的Ⅲ期总显效率分别为90.54%、73.08%(符合方案分析)和88.16%、70.37%(意向性治疗分析),总有效率分别为94.59%、96.15%(符合方案分析)和92.11%、92.59%(意向性治疗分析),两组比较差异亦无统计学意义(P>0.05)。在用药过程中,未发现柴葛清热颗粒的明显不良反应。结论:柴葛清热颗粒是治疗急性上呼吸道感染风热证安全有效的药物。

Objective： To evaluate the safety and efficacy of Chaige Qingre Granule, a traditional Chinese compound herbal medicine, in treating acute upper respiratory tract infection of wind heat syndrome. Methods： A multi-center, double-blinded, randomized controlled trial was conducted. In the phase Ⅱ, 60 patients with acute upper respiratory tract infection were randomly divided into the trial group （n=30） and the control group （n=30）. In the phase Ⅲ, 112 patients were randomly divided into the trial group （n=84） and the control group （n=28）. The trial group received 6 g Chaige Qingre Granule, and the control group received 6 g Fufang Shuanghua Granule （another traditional Chinese compound herbal medicine）. The two groups were all treated for 3 days and four times daily. Clinical symptoms, syndromes, adverse effect, blood, urine and stool test, hepatorenal function and electrocardiogram were examined before and after the treatment.Results： After treatment, the overall obvious response rates of the trial group and the control group were 78.57%, 82.14% （by per-protocol analysis） and 75.86%, 79.31% （by intention-to-treat analysis） respectively, and the overall response rates of the two groups were 96.43%, 100% （by per-protocol analysis） and 93.10%, 96.55% （by intention-to-treat analysis） respectively in phaseⅡ. There were no significant differences between the two groups （P〉0.05）. In the phase Ⅲ, the overall obvious response rates of the trial group and the control group were 90.54%, 73.08% （by per-protocol analysis） and 88.16%, 70.37% （by intention-to-treat analysis） respectively, and the overall response rates of the two groups were 94.59%, 96.15% （by per-protocol analysis） and 92.11%, 92.59% （by intention-to-treat analysis） respectively. There were no statistical differences between the two groups （P〉0.05） too. No adverse effects were found in the trial.Conclusion： Chaige Qingre Granule is effective and safe in treating acute upper respiratory tract infection of wind heat syndrome.