Effects of two Chinese herbal formulae for the treatment of moderate to severe stable chronic obstructive pulmonary disease: a multicenter, double-blind, randomized controlled trial.
Effects of two Chinese herbal formulae for the treatment of moderate to severe stable chronic obstructive pulmonary disease: a multicenter, double-blind, randomized controlled trial.
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两种中药方治疗中重度稳定型慢性阻塞性肺疾病的疗效：一项多中心、双盲、随机对照试验
DOI：
10.1371/journal.pone.0103168
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Dong J
中科院分区：
文献类型：
--
作者：
Wang G;Liu B;Cao Y;Du Y;Zhang H;Luo Q;Li B;Wu J;Lv Y;Sun J;Jin H;Wei K;Zhao Z;Kong L;Zhou X;Miao Q;Wang G;Zhou Q;Dong J
本研究旨在评估两种中药方剂治疗稳定期慢性阻塞性肺疾病（COPD）的有效性和安全性。
开展了一项多中心、双盲、双模拟、随机对照试验（RCT）。所有组均额外使用常规药物治疗。进行了6个月的治疗以及为期12个月、共5次的随访。主要结局指标包括肺功能测试、急性加重频率、圣乔治呼吸问卷（SGRQ）评分。次要结局指标包括6分钟步行距离（6MWD）、BODE指数、心理领域评分、炎症因子和皮质醇。
共有331名患者被随机分为两个积极治疗组（补肾益气（BY）颗粒组，n = 109；补肾防喘（BF）片组，n = 109）和一个安慰剂组（n = 113）。最终有262名患者完成了研究。与安慰剂相比，BY颗粒和BF片提高了肺活量（VC）、第一秒用力呼气容积占预计值百分比（FEV1%）以及第一秒用力呼气容积与用力肺活量比值（FEV1/FVC%）。BY颗粒改善了呼气峰流速（PEF）。两种治疗都降低了急性加重频率（P = 0.067）、BODE指数和心理领域评分，同时提高了6MWD。就SGRQ评分下降幅度而言，两种治疗都有所增加（P = 0.01）。两种治疗都降低了炎症细胞因子，如白细胞介素 - 8（IL - 8）和白细胞介素 - 17（IL - 17）（P = 0.0219）。与安慰剂相比，BY颗粒明显降低了白细胞介素 - 17（P < 0.05）、白细胞介素 - 1β（P = 0.05）、白细胞介素 - 6。它们提高了白细胞介素 - 10水平和皮质醇水平。BY颗粒提高了皮质醇水平（P = 0.07）并降低了肿瘤坏死因子 - α。两种治疗都略微降低了转化生长因子 - β1。在安全性、受试者依从性和药物联用方面，三组之间没有差异（P > 0.05）。
BY颗粒和BF片对COPD的治疗有积极效果，且前者总体表现更佳。
中国临床试验注册中心ChiCTR - TRC - 09000530
Objective The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD. Methods A multicenter, double-blind, double-dummy, and randomized controlled trial (RCT) was conducted. All groups were treated with additional conventional medicines. There were a 6-month treatment and a 12-month follow-up for 5 times. Primary outcomes included lung function test, exacerbation frequency, score of SGRQ. Second outcomes consisted of 6MWD, BODE index, psychological field score, inflammatory factors and cortisol. Results A total of 331 patients were randomly divided into two active treatment groups (Bushen Yiqi (BY) granule group, n = 109; Bushen Fangchuan (BF) tablet group, n = 109) and a placebo group (n = 113). Finally 262 patients completed the study. BY granule & BF tablet increased the values of VC, FEV1 (%) and FEV1/FVC (%), compared with placebo. BY granule improved PEF. Both treatments reduced acute exacerbation frequency (P = 0.067), BODE index and psychological field score, while improved 6MWD. In terms of descent rang of SGRQ score, both treatments increased (P = 0.01). Both treatments decreased inflammatory cytokines, such as IL-8, and IL-17(P = 0.0219). BY granule obviously descended IL-17(P<0.05), IL-1β (P = 0.05), IL-6, compared with placebo. They improved the level of IL-10 and cortisol. BY granule raised cortisol (P = 0.07) and decreased TNF-α. Both treatments slightly descended TGF-β1. In terms of safety, subject compliance and drug combination, there were no differences (P>0.05) among three groups. Conclusions BY granule and BF tablet were positively effective for the treatment of COPD, and the former performed better in general. Trial Registration Chinese Clinical Trial Register center ChiCTR-TRC-09000530
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中医辨证综合疗法治疗稳定期慢性阻塞性肺疾病的四中心、开放、随机、对照研究
影响因子：
--
作者：
Li SY;Li JS;Wang MH;Xie Y;Yu XQ;Sun ZK;Ma LJ;Zhang W;Zhang HL;Cao F;Pan YC
通讯作者：
Pan YC
影响因子：
9.6
作者：
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Wedzicha, Jadwiga A.
影响因子：
5.4
作者：
Li, Jian-Sheng;Li, Su-Yun;Wang, Yan-Fang
通讯作者：
Wang, Yan-Fang
影响因子：
3.4
作者：
Gao, Jixu;Zhan, Bingyan
通讯作者：
Zhan, Bingyan
DOI：
10.1165/ajrcmb.26.2.4666
发表时间：
2002-02-01
影响因子：
6.4
作者：
Kucich, U;Rosenbloom, JC;Rosenbloom, J
通讯作者：
Rosenbloom, J