清热祛湿颗粒治疗感冒（暑湿证）的多中心疗效观察

Multi-center clinical observation of Qingre Qushi Granules in treatment of colds with summer-heat and dampness syndrome

目的评价清热祛湿颗粒治疗感冒(暑湿证)的有效性、临床优势及安全性。方法采用分层区组随机、双盲、阳性药平行对照、多中心临床试验的方法,将239例受试者,随机分为试验组179例和对照组60例。对照组开水冲服广东凉茶颗粒,10 g/次,2次/d;试验组开水冲服清热祛湿颗粒,10 g/次,2次/d;两组均连续治疗3 d。比较两组的临床疗效。结果对照组、试验组愈显率分别是80.70%、85.39%,总有效率分别是92.98%、96.63%,两组愈显率和总有效率比较差异均无统计学意义;经PPS分析,对照组、试验组愈显率分别是80.00%、85.03%,总有效率分别是92.73%、97.01%,两组愈显率和总有效率比较差异均无统计学意义。经FAS分析,对照组和试验组上呼吸道感染的总有效率分别是81.67%、94.41%,两组总有效率比较差异有统计学意义(P<0.05)。经FAS分析,试验组单项症状喷嚏、恶寒发热、全身不适、四肢腰酸背痛的疗效显著高于对照组,两组比较差异有统计学意义(P<0.05)。结论清热祛湿颗粒治疗感冒(暑湿证)具有很好的临床疗效和安全性,尤其是暑湿感冒初期,疗效显著,具有一定的临床推广应用价值。

Objective To evaluate the clinical effectiveness, clinical advantages and safety of Qingre Qushi Granules in treatment of colds with summer-heat and dampness syndrome. Methods A stratified randomized, double-blind, parallel controlled, multi-center clinical trial was adopted. Patients(239 cases) were randomly divided into experimental group(179 cases) and control group(60 cases). Patients in the control group were po administered with Guangdong Liangcha Granules, 10 g/time, twice daily. Patients in the experimental group were po administered with Qingre Qushi Granules, 10 g/time, twice daily. Patients in two groups were treated for 3 d. After treatment, the clinical efficacy was evaluated. Results The markedly effective rate in the control and the experimental group were 80.70% and 85.39%, respectively, and the total effective rates were 92.73% and 97.01%, respectively, and there was no difference between two groups. According to FAS analysis, the total effective rates of the control and treatment group were 81.67% and 94.41%, respectively, and there were differences between two groups(P < 0.05). According to FAS analysis, the therapeutic effect of sneezing, cold and fever, general discomfort, limb pain and back pain in the experimental group was significantly higher than that in the control group, and there were differences between two groups(P < 0.05). Conclusion Qingre Qushi Granules has good clinical efficacy and safety in treatment of colds with summer-heat and dampness syndrome, especially in the early stage of heat dampness and cold, the curative effect was remarkable, which has a certain clinical application value.