Efficacy and safety of traditional Chinese medicine injections in the treatment of chronic obstructive pulmonary disease A protocol for systematic review and network meta-Analysis

Abstract

Background: 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. Methods: 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. Results: This study will provide reliable evidence for the clinical selection of TCMI in the treatment of COPD. Conclusion: The results of this study will evaluate the efficacy and safety of TCMI in the treatment of COPD, and provide decisionmaking references for future clinical and scientific research. Abbreviations: COPD = chronic obstructive pulmonary disease, DHI = Danhong injection, FEV1 = forced expiratory volume in 1 second, FVC = forced vital capacity, HQI = Huangqi injection, IL-6 = interleukin-6, MVV = maximal voluntary ventilation, NMA = network meta-Analysis, PSRF= potential scale reduced factor, RCTs = randomized controlled trials, SMI = Shenmai injection, TCMI = traditional Chinese medicine injection, TNF-A = tumor necrosis factor-A, TRQI = Tanreqing injection, XBQI = Xuebiqing injection.