【摘要】 目的　观察金叶败毒颗粒治疗风温肺热病 (热在肺卫证 )的疗效 ,并对其安全性作出客观评价。方法　采用多中心双盲双模拟随机对照试验 ,选择风温肺热病 (热在肺卫证 )患者 2 0 0例 ,随机分为金叶败毒颗粒组 (治疗组 ) 10 0例 ,双黄连颗粒组 (对照组 ) 10 0例。治疗组给予金叶败毒颗粒每日 3次 ,每次 10 g ,对照组给予双黄连颗粒每日 3次 ,每次5 g ,疗程均为 5天。 结果　临床综合疗效 :意向性分析 (intention -to -treat,ITT)显示 :治疗组总显效率 72 6 4 % ,总有效率 94 0 0 % ;对照组总显效率 6 8 6 3% ,总有效率 90 2 0 %。符合方案数据分析 (per -protocolpopulation ,PP)疗效 :治疗组总显效率 75 0 0 % ,总有效率 96 0 0 % ;对照组总显效率 6 8 0 0 % ,总有效率 90 0 0 %。两组临床综合疗效比较差异无显著性 (P >0 0 5 )。中医证候疗效 :ITT分析显示 :治疗组总显效率 71 70 % ,总有效率 93 4 5 % ;对照组总显效率6 6 6 7% ,总有效率 89 2 2 %。PP疗效 :治疗组总显效率 74 0 0 % ,总有效率 96 0 0 % ;对照组总显效率 6 8 0 0 % ,总有效率 90 0 0 %。两组中医证候疗效比较差异亦无显著性 (P >0 0 5 )。ITT疗效与PP疗效具有一致性。临床观察中 ,未发现明显不良反应。结论　金叶败毒颗粒临?更多还原

【Abstract】 Background To prove the effect of Jinyebaidu Granule (JYBDG) in treating the Disease of Wind-heat Attacking the Lung (type of heat pathogen invading the defensive Qi of the lung) and objectively evaluate its safety.Methods The muti-center ,double-blinded, double-dummy and randomized controlled method was adopted to observe 200 patients who were divided into the treatment group (n=100,treated with JYBDG 10g, three times a day) and the control group (n=100,treated with Shuanghuanglian Granule 5g, three times a day). The therapeutic course for both groups was 5 days. Results According to ITT(intention-to-treat) and PP(per-protocol population),In the treatment group, the markedly effective rate was 72 64% and 75 00% respectively, and effective rate was 94 00% and 96 00% respectively, while in the control group the markedly effective rate was 68 63% and 68 00% respectively, and effective rate was 90 20% and 90 00% respectively, no significant difference was found between the two groups ( P >0 05). For therapeutic effects on TCM syndromes,In the treatment group, the markedly effective rate was 71 70% and 74 00% respectively, and effective rate was 93 45% and 96 00% respectively, while in the control group the markedly effective rate was 66 67% and 68 00% respectively, and effective rate was 89 22% and 90 00% respectively, also showed insignificantly difference ( P >0 05). No adverse effect was found in the observation.Conclusion?JYBDG shows a definite clinical effect with no obvious toxic-adverse effects.更多还原