Chongqing Three Gorges Medical College, Chongqing, China.
Xindu Hospital of Traditional Chinese Medicine Affiliated to Chengdu Medical College, Sichuan, China.
Medicine (Baltimore). 2021 Sep 24;100(38):e27324. doi: 10.1097/MD.0000000000027324.
Chronic obstructive pulmonary disease (COPD) is a widespread, heterogeneous disease characterized by chronic inflammation of the airway and the gradual blockage of air flow due to bronchial obstruction. At present, a large number of traditional Chinese medicine injections (TCMIs) has been applied in the clinical treatment of COPD. However, there is insufficient evidence of evidence-based medicine of the interaction between them. Therefore, the purpose of this study is through the network meta-analysis to evaluate the efficacy and safety of the different TCMIs treatment of COPD, offering reference and evidence for clinical application.
We will search 7 databases for randomized controlled trials of TCMI for the COPD, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chinese Scientific Journals Database, and Wan-fang databases, from the date of the establishment of each database to October 31, 2021. The network meta-analysis will be implemented through Aggregate Data Drug Information System 1.16.8 and Stata 13.0 software. Pulmonary function included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and FEV1/FVC will be the primary outcomes, FEV1 as a percentage of the estimated value (FEV1%pred), maximal voluntary ventilation (MVV), MVV as a percentage of the estimated value (MVV%pred), 6 minutes walking distance, The St. George's Respiratory Questionnaire score, and safety/adverse event will be evaluated as secondary outcomes. Mean differences or odds ratios will be used for statistical analysis. We will ensure the reliability of the results through node-split model and heterogeneity analysis. In addition, methodological quality will be evaluated based on the Cochrane Collaboration's tool, and the quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation system.
This study will provide reliable evidence for the clinical selection of TCMI in the treatment of COPD.
The results of this study will evaluate the efficacy and safety of TCMI in the treatment of COPD, and provide decision-making references for future clinical and scientific research.
慢性阻塞性肺疾病（COPD）是一种广泛存在且异质性的疾病，其特征为气道慢性炎症和支气管阻塞导致的气流逐渐受限。目前，大量中药注射剂（TCMI）已应用于 COPD 的临床治疗，但它们之间相互作用的循证医学证据不足。因此，本研究旨在通过网络荟萃分析评价不同 TCMI 治疗 COPD 的疗效和安全性，为临床应用提供参考和证据。
我们将检索 7 个数据库中关于 TCMI 治疗 COPD 的随机对照试验，包括 PubMed、Cochrane 图书馆、EMbase、中国知网、中国生物医学文献数据库、中国科学引文数据库和万方数据库，时间从各数据库建立起至 2021 年 10 月 31 日。通过 Aggregate Data Drug Information System 1.16.8 和 Stata 13.0 软件进行网络荟萃分析。肺功能包括 1 秒用力呼气量（FEV1）、用力肺活量（FVC）和 FEV1/FVC 将作为主要结局，FEV1 预计值的百分比（FEV1%pred）、最大自主通气量（MVV）、MVV 预计值的百分比（MVV%pred）、6 分钟步行距离、圣乔治呼吸问卷评分和安全性/不良事件将作为次要结局进行评估。统计分析采用均数差或比值比。我们将通过节点分裂模型和异质性分析确保结果的可靠性。此外，还将根据 Cochrane 协作工具评估方法学质量，并根据推荐评估、制定与评价系统对证据质量进行评估。
本研究将为 TCMI 治疗 COPD 的临床选择提供可靠的证据。
本研究结果将评价 TCMI 治疗 COPD 的疗效和安全性，为未来的临床和科学研究提供决策参考。
