两种中药配方治疗中度至重度稳定期慢性阻塞性肺疾病的疗效：一项多中心、双盲、随机对照试验
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.
作者信息
Wang Genfa, Liu Baojun, Cao Yuxue, Du Yijie, Zhang Hongying, Luo Qingli, Li Bei, Wu Jinfeng, Lv Yubao, Sun Jing, Jin Hualiang, Wei Kai, Zhao Zhengxiao, Kong Lingwen, Zhou Xianmei, Miao Qing, Wang Gang, Zhou Qingwei, Dong Jingcheng
机构信息
Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
Respiratory Department, Jiangsu Province Hospital of TCM, Nanjing University of TCM, Nanjing, PR China.
出版信息
PLoS One. 2014 Aug 13;9(8):e103168. doi: 10.1371/journal.pone.0103168. eCollection 2014.
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.
目的
本研究旨在评估两种中药配方治疗稳定期慢性阻塞性肺疾病（COPD）的疗效和安全性。
方法
进行了一项多中心、双盲、双模拟和随机对照试验（RCT）。所有组均加用常规药物治疗。进行为期6个月的治疗和为期12个月的随访，共5次。主要结局包括肺功能测试、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。
结果
共331例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）片剂组，n = 109）和一个安慰剂组（n = 113）。最终262例患者完成研究。与安慰剂相比，BY颗粒和BF片剂增加了肺活量（VC）、第1秒用力呼气容积（FEV1）（%）和FEV1/用力肺活量（FVC）（%）的值。BY颗粒改善了呼气峰流速（PEF）。两种治疗均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评分的下降幅度而言，两种治疗均有增加（P = 0.01）。两种治疗均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（P = 0.0219）。与安慰剂相比，BY颗粒显著降低了IL-17（P<0.05）、IL-1β（P = 0.05）、IL-6。它们提高了IL-10和皮质醇水平。BY颗粒提高了皮质醇（P = 0.07）并降低了肿瘤坏死因子-α（TNF-α）。两种治疗均轻微降低了转化生长因子-β1（TGF-β1）。在安全性、受试者依从性和药物联合使用方面，三组之间无差异（P>0.05）。
结论
BY颗粒和BF片剂对COPD治疗有积极效果，且前者总体表现更佳。
试验注册
中国临床试验注册中心ChiCTR-TRC-09000530。
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