【摘要】 目的:观察痰热清胶囊与双黄连胶囊对照治疗急性气管-支气管炎(风热袭肺证),评价痰热清胶囊有效性和安全性。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264例,按照3∶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。疗程两组均为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)的总有效率试验组为84.62%,对照组为72.31%,治疗组疗效显著优于对照组,中医证候的有效率试验组为83.08%,对照组为72.30%,治疗组证候总有效率显著优于对照组,咳嗽、咳痰等单项症状试验组的改善明显优于对照组。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 treatment with Tanreqing capsules and Shuanghuanglian capsules for acute broncho-bronchitis(Fengrexifei syndrome),and to evaluate the efficacy and safety of Tanreqing capsules.Methods:A multi-center,randomized, double-blinded, single-dummy and positive drug parallel controlled trial was adopted. 264 cases of patients with TCM Fengrexifei syndrome were selected and divided into the treatment and the control groups, with 3∶1 ratio. The Patients in the treatment group were treated with Tanreqing capsules and simulated capsules,those in the control group were treated with Shuanghuanglian capsule, for 7 days in both groups. Results:FAS analysis showed,the total effective rates inTanreqing capsules and control groups on acute broncho-bronchitis(Fengrexifei Syndrome) were 84.62% and 72.31%, respectively, the effect of Tanreqing showed significant. The total effective rates in TCM syndrome group and control group were 83.08% and 72.30%, respectively, the TCM syndrome group showed significant difference in total effective rate. Also, the improvement in single symptom group such as cough, spitting sputum was significantly better than that in the control group.Conclusion:Tanreqing capsules has a good clinical effect on acute broncho-bronchitis(cough of wind-heat invading the lung), and shows no toxic and side effects.更多还原