金花清感颗粒治疗流行性感冒风热犯肺证双盲随机对照研究  

Treating Influenza Patients of Wind-Heat Affecting Fei Syndrome by Jinhua Qinggan Granule:a Double-blinded Randomized Control Trial

作　　者：李国勤[1] 赵静[2] 屠志涛[2] 厉将斌[2] 刘清泉[2] 史利卿[3] 苗青[4] 苑惠清[5] 刘新桥[6] 龙友余[7] 刘志国[1] 赵婷[1] 李磊[1] 唐全红[8] 何迎春[9] 边永君[1] 胡镜清[1] 

机构地区：[1]中国中医科学院广安门医院呼吸科,北京100053 [2]北京中医药大学东直门医院急诊科,北京100700 [3]北京中医药大学东方医院呼吸科,北京100078 [4]中国中医科学院西苑医院呼吸科,北京100091 [5]首都医科大学附属北京中医医院呼吸科,北京100010 [6]天津中医药大学第一附属医院呼吸科,天津300193 [7]天津中医药大学第二附属医院呼吸科,天津300151 [8]北京创立科创医药技术开发有限公司,北京100029 [9]上海中医药大学药物临床研究中心,上海201203

出　　处：《中国中西医结合杂志》2013年第12期1631-1635,共5页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家科技重大专项项目(No.2008ZX09312012)

摘　　要：目的 评价金花清感颗粒治疗流行性感冒风热犯肺证的有效性及安全性。方法 选择136例流行性感冒风热犯肺证患者，按各试验中心进行分层区组随机化，将患者分为金花清感颗粒高（44例）、低剂量组（45例）及对照组（47例），分别给予金花清感颗粒10 g/次， 3次/天；金花清感颗粒5 g/次加金花清感颗粒模拟剂5 g/次， 3次/天；金花清感颗粒模拟剂10 g/次， 3次/天。疗程均为5天。评价三组间退热时间及退热率、中医证候疗效、流感主要症状/体征消失率、单项症状疗效、咽分泌物病毒核酸检测转阴率及安全性指标。结果 高剂量组中位退热时间为32.8 h（95%CI：22.5～41.0 h），低剂量组为26.0 h（95 %CI：14.5～36.5 h），对照组为39.5 h（95%CI：29.0～46.0 h），低剂量组中位退热时间短于对照组（P=0.011）。低剂量组治疗3天后中医证候疗效显效率（66.7%）高于对照组（38.3%），有效率优于高剂量组（P=0.043）。低剂量组治疗5天后痊愈率（42.2%）高于高剂量组（25.0%，P=0.026）及对照组（14.9%，P=0.002）；低剂量组显效率（86.7%）高于对照组（55.3%，P=0.001）。高剂量组疗效与低剂量组疗效近似，在部分疗效指标方面略差。三组间不良反应比较，差异无统计学意义（P〉0.05）。结论 金花清感颗粒治疗流行性感冒风热犯肺证安全、有效，临床常规剂量为其适合剂量。Objective To assess the effect and safety of Jinhua Qinggan Granule （JHG） in treating influenza patients of wind-heat affecting Fei syndrome （WHAFS）. Methods Totally 136 influenza pa- tients of WHAFS were randomized by stratification into 3 groups, the high dose JHG group （44 cases, 10 g each time）, the low dose JHG group （45 cases, 5 g JHG ＋5 g placebo each time）, and the placebo control group （47 cases, 10 g placebo each time）. All medication was administered three times daily for 5 days. The fever disappearance time, the fever disappearance rate, efficacy of TCM syndrome, the disappearance rate of main symptoms and physical signs of flu, the negative rate of virus nucleic acid in the pharyngeal secretion, and safety indicators were assessed. Results The median fever disappearance time was 32.8 h（95%C1：22.5-41.0 h） in the high dose JHG group, 26.0 h（95 %CI：14.5- 36.5 h） in the low dose JHG group, 39.5 h （95%CI： 29.0 -46.0 h） in the placebo control group. There was statistical difference in the median fever disappearance time between the low dose JHG group and the placebo control group （P = 0.011）. Three days after treatment, the markedly effective rate of TCM symptoms in the low dose JHG group was 66.7%, higher than that of the placebo control group （38.3%）, and its effective rate was superior to that of the high dose JHG group （P =0.043）. Five days after treatment, the recovery rate of the low dose JHG group （42.2%） was higher than that of the high dose JHG group （25.0%,P =0.026） and that of the placebo control group （14.9%,P =0.002）. The markedly effective rate of the low dose JHG group （86.7%） was higher than that of the placebo control group （55.3%,P =0.001 ）. Similar effects were ob- tained in the low dose JHG group and the high dose JHG group, but slightly poor in partial indicators of the high dose JHG group. There was no statistical difference in adverse reaction among these three groups （P 〉0.05）. Conclusions JHG was effectiv

关 键 词：金花清感颗粒 流行性感冒 风热犯肺证 随机对照研究 

分 类 号：R254.9[医药卫生—中医内科学]