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中医补肾疗法治疗稳定期慢性阻塞性肺疾病:系统评价与Meta分析方案

Traditional Chinese medicine tonifying kidney therapy (Bu shen) for stable chronic obstructive pulmonary disease: Protocol for a systematic review and meta-analysis.

作者信息

Zhen Gao, Yingying Liu, Jingcheng Dong

机构信息

Institutes of Integrative Medicine, Fudan University, Shanghai, China.

出版信息

Medicine (Baltimore). 2018 Dec;97(52):e13701. doi: 10.1097/MD.0000000000013701.

Abstract

BACKGROUND

Traditional Chinese medicine (TCM) is commonly used to combine with pharmacotherapy for stable chronic obstructive pulmonary disease (COPD) in China and other Asian countries such as South Korea and Japan. The objective of this systematic review is to evaluate the efficacy and safety of tonifying kidney therapy (Bushen, TK) for stable COPD.

METHODS

Randomized controlled trials (RCTs) of TK for stable COPD were searched from 4 databases including Pubmed, the Cochrane library, CBM (China Biology Medicine disc, CBMdisc), CNKI (China National Knowledge Infrastructure) from inception to December 2017. Two reviewers independently screened the literature, extracted the data and assessed the risk of bias in included studies. RevMan 5.3 software was used for meta-analysis. The primary outcomes analyzed in this meta-analysis were effectiveness, TCM Syndrome Score, dyspnea (modified Medical Research Council questionnaire [mMRC]), COPD health status (COPD Assessment Test [CAT]), exercise capacity (6-min walk distance in meters [6mWD]), and respiratory-specific quality of life (St George's Respiratory Questionnaire [SGRQ]). Second outcomes analyzed for this meta-analysis were lung function (forced expiratory volume in 1 second [FEV1], FEV1%, forced vital capacity [FVC], FEV1/FVC), the frequency of acute exacerbation, T-lymphocyte subsets (CD4, CD8, CD4/CD8), and immunoglobulin (IgA, IgG, and IgM). The summary results will be pooled using the random-effects model or fixed-effects model according to the heterogeneity of the included studies.

RESULT

This systematic review will provide an evidence of TK for stable COPD, and will submit to a peer-reviewed journal for publication.

CONCLUSION

The conclusion of this systematic review will provide evidence to judge whether TK is an effective intervention for stable COPD patients.

PROSPERO REGISTRATION NUMBER

PROSPERO CRD 42018090328.

摘要

背景

在中国以及韩国、日本等其他亚洲国家,中医常与药物疗法联合用于稳定期慢性阻塞性肺疾病(COPD)的治疗。本系统评价的目的是评估补肾疗法(补肾,TK)治疗稳定期COPD的疗效和安全性。

方法

从4个数据库(包括PubMed、Cochrane图书馆、中国生物医学文献数据库(CBMdisc)、中国知网(CNKI))中检索从建库至2017年12月期间补肾疗法治疗稳定期COPD的随机对照试验(RCT)。两名评价员独立筛选文献、提取数据并评估纳入研究的偏倚风险。采用RevMan 5.3软件进行Meta分析。本Meta分析中分析的主要结局包括有效性、中医证候评分、呼吸困难(改良医学研究委员会问卷[mMRC])、COPD健康状况(COPD评估测试[CAT])、运动能力(6分钟步行距离,单位为米[6mWD])以及呼吸道特异性生活质量(圣乔治呼吸问卷[SGRQ])。本Meta分析中分析的次要结局包括肺功能(第1秒用力呼气容积[FEV1]、FEV1%、用力肺活量[FVC]、FEV1/FVC)、急性加重频率、T淋巴细胞亚群(CD4、CD8、CD4/CD8)以及免疫球蛋白(IgA、IgG和IgM)。将根据纳入研究的异质性,使用随机效应模型或固定效应模型汇总总结结果。

结果

本系统评价将提供补肾疗法治疗稳定期COPD的证据,并将提交给同行评审期刊发表。

结论

本系统评价的结论将为判断补肾疗法是否为稳定期COPD患者的有效干预措施提供证据。

国际前瞻性系统评价注册编号

PROSPERO CRD 42018090328。

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