The efficacy of QingfengGanke granule in treating postinfectious cough in pathogenic wind invading lungs syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.
The efficacy of QingfengGanke granule in treating postinfectious cough in pathogenic wind invading lungs syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.
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DOI：
10.1186/s13020-015-0049-6
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发表时间：
2015
期刊：
影响因子：
4.9
通讯作者：
Liu Q
中科院分区：
文献类型：
--
作者：
Jiang H;Mao B;Wang L;Zhang R;She B;Jin F;Xu Y;Ma J;Liu Q
感染后咳嗽（PIC）显著影响咳嗽相关的生活质量，但仍然缺乏有效的治疗。观察清风感咳颗粒治疗风邪犯肺型PIC的临床疗效。进行了多中心、随机、双盲、安慰剂对照临床试验。共180例合格受试者随机（1：1：1）分配至A组（QFGKG 6 g + QFGKG匹配安慰剂6 g）、B组（QFGKG 12 g）和C组（QFGKG匹配安慰剂12 g）。所有草药口服给药，每天两次，连续10天。主要结局为咳嗽缓解时间，次要结局包括咳嗽缓解时间、咳嗽症状评分（CSS）、视觉模拟量表（VAS）评分、咳嗽特异性生活质量问卷（CQLQ）评分和中医（TCM）综合征评分从基线至第10天的平均变化以及不良事件。共有173名参与者被纳入疗效和安全性分析（A组，n = 57; B组，n = 57; C组，n = 59）。A、B和C组咳嗽缓解的中位时间分别为10天以上、8天和10天以上（P < 0.0001），咳嗽缓解的中位时间分别为4天、4天和6天（P < 0.0001）。与安慰剂组相比，A组和B组的CSS改善显著（分别为P = 0.0005，P < 0.0001），VAS（P = 0.0002，P < 0.0001）、CQLQ（P = 0.0258，P = 0.0003）、中医证候（P = 0.0031，P < 0.0001）。与A组相比，B组的咳嗽缓解时间更快（P = 0.0091）。三组之间的不良事件特征相当。清风感咳颗粒治疗风邪犯肺证型PIC有效。本文的在线版本（doi：10.1186/s13020-015-0049-6）包含补充材料，可供授权用户使用。
Postinfectious cough (PIC) significantly affects cough-related quality of life but still lacks effective treatments. This study aims to investigate the efficacy of QingfengGanke granule (QFGKG) in treating PIC induced by pathogenic wind invading lungs syndrome. A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 180 eligible participants were randomly (1:1:1) assigned to group A (QFGKG 6 g plus QFGKG-matched placebo 6 g), group B (QFGKG 12 g), and group C (QFGKG-matched placebo 12 g). All herbal medications were orally administered twice daily for 10 consecutive days. The primary outcome was time to cough resolution, and secondary outcomes included time to cough alleviation, mean changes in cough symptom score (CSS), visual analogue scale (VAS) score, cough-specific quality of life questionnaire (CQLQ) score, and traditional Chinese medicine (TCM) syndrome score from baseline to Day 10, as well as adverse events. A total of 173 participants were included in the efficacy and safety analyses (group A, n = 57; group B, n = 57; group C, n = 59). The median time to cough resolution in groups A, B, and C was more than 10 days, 8 days, and more than 10 days, respectively (P < 0.0001), and the median time to cough alleviation was 4, 4, and 6 days, respectively (P < 0.0001). Compared with the placebo condition, groups A and B showed significantly greater improvements in CSS (P = 0.0005, P < 0.0001, respectively), VAS (P = 0.0002, P < 0.0001, respectively), CQLQ (P = 0.0258, P = 0.0003, respectively), and TCM syndrome (P = 0.0031, P < 0.0001, respectively). The time to cough resolution was faster in group B compared with group A (P = 0.0091). The adverse event profiles were comparable among the three groups. QingfengGanke granule is efficacious in the treatment of PIC induced by pathogenic wind invading lungs syndrome. The online version of this article (doi:10.1186/s13020-015-0049-6) contains supplementary material, which is available to authorized users.