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多种中医干预措施治疗特发性肺纤维化:一项系统评价和概述性荟萃分析方案

Multiple Traditional Chinese Medicine interventions for idiopathic pulmonary fibrosis: A protocol for systematic review and meta-analysis of overview.

作者信息

Zhang Hao-Yang, Pang Li-Jian, Lv Xiao-Dong, Liu Chuang, Nan Ming-Hua

机构信息

Graduate School, Liaoning University of Traditional Chinese Medicine.

Respiratory department, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine.

出版信息

Medicine (Baltimore). 2020 Sep 25;99(39):e22396. doi: 10.1097/MD.0000000000022396.

Abstract

BACKGROUND

The therapeutic strategies of idiopathic pulmonary fibrosis (IPF) tend to be comprehensive. Improving the major symptoms and quality of life (QoL) is as important as postponing the process of fibrosis. However, only pirfenidone and nintedanib conditionally recommended by guidelines and no definite proof indicate that they can significantly ameliorate the main symptoms and QoL of IPF sufferers. At present, multiple types of Traditional Chinese Medicine (TCM) interventions alone or in combination with conventional western medicine managements are widespreadly applied in IPF treatment, which seemingly have a promising clinical effect, especially in ameliorating the main symptoms and improving QoL. Subsequently, the number of relevant studies in systematic reviews(SRs) and meta-analyses of randomized controlled trials(RCTs) increased significantly. Hence, we plan to implement an overview to collect, evaluate, and summarize the results of these SRs.

METHODS

An all-round literature retrieval will be conducted in 9 electronic databases, including PubMed, EMBASE, CINAHL, Cochrane Library, Epistemonikos, CNKI, CBM, Wanfang, and VIP. We will focus on the systematic review and meta-analysis of RCTs for multiple TCM interventions alone or in combination with routine western medicine measures in IPF treatment. The main outcomes we follow with interest include the improvement of major symptoms (cough, dyspnea) and QoL. Secondary outcomes will consist of minor symptoms improvement, clinical total effective rate, lung function, blood gas analysis, 6-minute walk text, adverse events, acute exacerbation, all-cause mortality, and IPF-related mortality. Two reviewers will independently select the SRs satisfactory with the enrolling criteria, extract key characteristics, and datas on predefined form, evaluate methodological quality by AMSTAR-2, ROBIS and PRISMA tools, and the quality of evidences adopting GRADE method. In case of any divergence will be reached an agreement by discussion or adjudicated by a third senior reviewer. We will perform a narrative synthesis of the proofs from SRs included.

RESULTS

The findings of this overvew will be presented at relevant conferences and submitted for peer-review publication.

CONCLUSIONS

We expect to obtain comprehensive and reliable evidence of IPF treated by diversified TCM interventions from the potential standard SRs, which may provide suggestions for future RCTs and SRs.

REGISTRATION NUMBER

INPLASY 202080110.

摘要

背景

特发性肺纤维化(IPF)的治疗策略倾向于综合性。改善主要症状和生活质量(QoL)与延缓纤维化进程同样重要。然而,仅有吡非尼酮和尼达尼布获得指南有条件推荐,且尚无确切证据表明它们能显著改善IPF患者的主要症状和生活质量。目前,多种中医(TCM)干预措施单独或与西医常规治疗联合广泛应用于IPF治疗,似乎具有良好的临床效果,尤其是在改善主要症状和提高生活质量方面。随后,系统评价(SRs)和随机对照试验(RCTs)的荟萃分析中的相关研究数量显著增加。因此,我们计划进行一项概述,以收集、评估和总结这些SRs的结果。

方法

将在9个电子数据库中进行全面的文献检索,包括PubMed、EMBASE、CINAHL、Cochrane图书馆、Epistemonikos、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方和维普。我们将重点关注RCTs的系统评价和荟萃分析,这些RCTs涉及多种中医干预措施单独或与西医常规措施联合用于IPF治疗。我们感兴趣的主要结局包括主要症状(咳嗽、呼吸困难)的改善和生活质量。次要结局将包括次要症状的改善、临床总有效率、肺功能、血气分析、6分钟步行试验、不良事件、急性加重、全因死亡率和IPF相关死亡率。两名研究者将独立选择符合纳入标准的SRs,提取关键特征,并按照预定义表格填写数据,使用AMSTAR-2、ROBIS和PRISMA工具评估方法学质量,并采用GRADE方法评估证据质量。如有分歧,将通过讨论达成一致或由第三位资深研究者裁决。我们将对纳入的SRs的证据进行叙述性综合。

结果

本概述的结果将在相关会议上展示,并提交同行评审发表。

结论

我们期望从潜在的标准SRs中获得关于多种中医干预措施治疗IPF的全面且可靠的证据,这可能为未来的RCTs和SRs提供建议。

注册号

INPLASY 202080110。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4480/7523800/b1c1cf4a8f62/medi-99-e22396-g001.jpg

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