金花清感颗粒治疗流感样病例风热犯肺证的多中心随机双盲安慰剂对照试验  

Jinhua Qinggan Granule for influenza⁃like illness with wind⁃heat invading the lung:a multi⁃center,randomized,double⁃blind,placebo⁃controlled trial

作　　者：张家萌 金在艳[1] 边永君[1] 李国勤[1] 刘志国[1] 李磊[1] 赵婷[1] 夏宏盛 ZHANG Jiameng;JIN Zaiyan;BIAN Yongjun;LI Guoqin;LIU Zhiguo;LI Lei;ZHAO Ting;XIA Hongsheng(Department of Respiratory Medicine,Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053)

机构地区：[1]中国中医科学院广安门医院呼吸科,北京100053

出　　处：《现代中医临床》2023年第6期1-6,共6页Modern Chinese Clinical Medicine

基　　金：国家科技重大专项(No.2008ZX09312012)。

摘　　要：目的评价金花清感颗粒治疗流感样病例风热犯肺证的有效性及安全性。方法采用多中心、随机、双盲、安慰剂对照的设计方法,将480例流感样病例风热犯肺证患者分为治疗组360例、安慰剂组120例,分别给予金花清感颗粒5 g/次,3次/d;金花清感颗粒模拟剂5 g/次,3次/d。疗程均为连续服药3 d。观察2组退热时间及退热率、中医证候积分、中医证候疗效、流感主要症状/体征消失率及安全性指标。结果治疗组中位退热时间为25.7(24.0,28.0)h,安慰剂组中位退热时间为38.0(34.7,47.5)h。随时间增长,2组退热率均上升,治疗组总体退热情况较安慰剂组好,差异有统计学意义(log-rankχ^(2)=10.822,P=0.001)。中医证候积分2组治疗后较本组治疗前均下降,差异有统计学意义(P<0.05)。2组治疗前后差值比较,差异有统计学意义(P<0.05),治疗组在改善中医证候积分方面优于安慰剂组。治疗后,治疗组中医证候疗效总有效率为97.2%,安慰剂组总有效率为85.7%,治疗组疗效优于安慰剂组,差异有统计学意义(P<0.05)。除咽部充血、扁桃体肿大外,其他流感主要症状/体征包括发热、头痛、全身酸痛、咽痛、咳嗽等消失率,治疗组均优于安慰剂组,差异有统计学意义(P<0.05)。2组均未出现严重不良事件。结论金花清感颗粒治疗流感样病例(风热犯肺证)有较好的临床疗效和安全性。Objective To assess the effect and safety of Jinhua Qinggan Granule(JHG)on patients with influenza-like illness of the pattern of wind-heat invading the lung(WHIL).Methods In a multi-center,double-blind,randomized,controlled trial(RCT),patients with influenza-like illness of WHIL were randomized by stratification into the treatment group(n=360)and the placebo control group(n=120).Patients in the treatment group were given JHG,while those in the control group received placebo at a dosage of 5 g per time,3 times per day.All medications were administered three times daily for 3 days.The fever disappearance time,the fever disappearance rate,the total score and efficacy of TCM syndrome,the disappearance rate of main symptoms and physical signs of flu,and safety indicators were assessed.Results The median fever disappearance time was 25.7(24.0,28.0)h(n=357)in the treatment group,38.0(34.7,47.5)h(n=119)in the placebo control group.With the increase of time,the antipyretic rate of both groups increased,but the overall antipyretic condition of the treatment group was better than that of the control group,and the difference was statistically significant(log-rankχ^(2)=10.822,P=0.001).Compared with baseline in the same group,the total scores of TCM syndrome were decreased after treatment in both groups(P<0.05).There was significant difference between the two groups before and after treatment(P<0.05).The treatment group was superior to the placebo group in improving the score of TCM syndrome.Three days after treatment,the total effective rate of TCM syndrome in the treatment group was 97.2%,higher than that of the placebo control group(85.7%),with statistically significant differences between two groups(P<0.05).The disappearance rates of influenza symptoms/signs including fever,headache,general soreness,sore throat,cough in the treatment group were better than that of the placebo group(P<0.05),except for pharyngeal congestion and tonsil enlargement.There were no serious adverse events in either group.Conclusion JHG can play

关 键 词：金花清感颗粒 流感样病例 风热犯肺证 异病同治 

分 类 号：R254[医药卫生—中医内科学]