清风感咳颗粒治疗感染后咳嗽的随机对照临床试验  

Qingfeng Gan ke Granule in the Treatment of Post-Infectious Cough:A Randomized,Double-Blinded and Placebo-Controlled Clinical Trial

作　　者：蒋红丽[1] 蔡林莉[1] 毛兵[1] 王蕾[1] 张瑞明[1] 

机构地区：[1]四川大学华西医院中西医结合科,成都610041

出　　处：《成都医学院学报》2015年第2期182-185,共4页Journal of Chengdu Medical College

基　　金：四川省中医药管理局应用研究项目(No:2012-B-081)

摘　　要：目的评价清风感咳颗粒治疗感染后咳嗽(风邪恋肺证)的有效性和安全性。方法采用多中心、随机、双盲以及安慰剂对照临床试验的方法。纳入符合标准的180例感染后咳嗽(风邪恋肺证)患者,随机分为A组(清风感咳颗粒6g+安慰剂6g)、B组(清风感咳颗粒12g)、C组(清风感咳颗粒安慰剂12g),均2次/d,连续10d。观察治疗前后咳嗽评分、中医证候疗效、中医证候积分及不良反应。结果共173例纳入疗效及安全性分析。1)咳嗽改善程度:A组为(-4.2±2.1)分,B组为(-4.8±2.0)分,C组为(-2.6±2.3)分;2)中医证候总有效率:A组89.5%,B组96.5%,C组71.2%;3)中医证候积分:A组(-8.5±3.7)分,B组(-9.5±3.0)分,C组(-5.8±4.5)分;以上组间差异均具有统计学意义(P<0.01,P=0.004 6,P<0.01),A、B组均优于C组;3组均无严重不良事件发生,不良事件发生率A组4/57(7.0%),B组4/57(7.0%),C组1/59(1.7%),组间差异无统计学意义(P=0.331 3)。结论清风感咳颗粒治疗感染后咳嗽(风邪恋肺证),能有效改善患者咳嗽症状,不良反应少。Objective To assess the efficacy and safety of Qingfeng Ganke granule （QFGKG） in the treatment of post-infectious cough （wind-evil invading lung syndrome）. Methods A multicenter, randomized, double-blind, placebo-controlled,clinical trial was conducted. A total of 180 eligible patients were randomly assigned into group A,group B and group C. Patients in group A received 6 g of QFGKG plus 6 g of matched placebo; patients in group B received 12 g of QFGKG; and patients in group C received 12 g of matched placebo. All the medications were orally administered twice daily and the treatment duration was 10 days. Cough score, effect rate in traditional Chinese medicine （TCM） syndrome, TCM syndrome score, and side effects were evaluated at baseline. Results A total of 173 patients were included in final efficacy and safety analyses （group A,57; group B,57; group C,59）. After treatment,cough improvement Egroup A, （-4.2±2.1） ; group B, （-4.8±2.0） ; group C, （-2.6±2.3） ], effective rate of TCM syndrome （group A, 89.5 % ; group B, 96.5 % ; group C, 71.2 % ）, and changes of TCM syndrome score [group A,（-8. 5±3.7）; group B,（-9. 5±3. 0）; group C： （-5. 8±4. 5）] were statistically significant （P〈0.01 ,P= 0. 004 6, P〈0. 01）. Compared with group C, group A and group B showed significantly greater improvements in cough scores, effective rate of TCM syndrome, and TCM syndrome score. The adverse event profiles were comparable among the three groups （7.0 %, 7.0 %, and 1.7 % ）. Conclusion QFGKG is well-tolerated, and can improve cough in patients with post-infectious cough （wind-evil invading lung syndrome）.

关 键 词：感染后咳嗽 清风感咳颗粒 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]