【摘要】 目的:观察痰热清胶囊治疗急性气管-支气管炎(风热袭肺证)的临床疗效及安全性。方法:选用随机、双盲单模拟、阳性平行对照、多中心的临床研究方法。中医辨证为风热袭肺证患者240例,按照1∶1的比例分为试验组和对照组两组。试验组给予痰热清胶囊及模拟剂胶囊,对照组给予双黄连胶囊。两组治疗疗程均为7 d。结果:FAS分析人群,痰热清胶囊治疗急性气管-支气管炎(风热袭肺证)的显愈率试验组为79.31%,对照组为66.39%,两组显愈率比较有显著差异(P<0.05或P<0.01),中医证候的显愈率试验组为78.44%,对照组为70.58%,两组显愈率比较有显著差异,咳嗽、身楚、口渴等单项症状试验组的改善明显优于对照组(P<0.05或P<0.01)。结论:痰热清胶囊治疗急性气管-支气管炎(风热袭肺证),具有良好的临床疗效,且无毒副作用。更多还原

【Abstract】 Objective: To observe the efficacy and safety of Tanreqing capsules on acute broncho-bronchitis(Fengrexifei). Methods:A multi-center,randomized, double-blinded, single-dummy and positive drug parallel controlled trial was adopted. 240 cases of patients were selected by TCM Fengrexifei syndrome, then they were divided into the treatment group and the control group with the ratio 1: 1. Patients in the treatment group were treated with Tanreqing capsules and simulated capsules,patients in the control group were treated with Shuanghuanglian capsule,for seven days. Results:FAS analysis showed, the effective rate of Tanreqing capsules in acute broncho-bronchitis(Fengrexifei) was 79.31 % and 66.39% in the treatment group and the control group respectively, which had significant difference. The effective rates of TCM syndrome in the treatment group and the control group were 78.44% and 70.58%, respectively, which also had significant difference. The improvement in the single symptom group such as cough, body, thirst was obviously better than that in the control group.Conclusion:Tanreqing capsule has a good clinical effect on acute broncho-bronchitis(Fengrexifei), and has no toxic and side effects.更多还原