为了系统评价参芪扶正注射液联合常规治疗作为干预措施对慢性阻塞性肺疾病（chronic obstructive pulmonary disease, COPD）患者的临床疗效和安全性。检索中国国家知识基础设施（China national knowledge infrastructure, CNKI）、PubMed、万方数据知识服务平台（Wanfang Data）、维普中文科技期刊数据库（Weipu China science and technology journal database, VIP）等数据库，筛选并纳入2023年6月18日以前发表的参芪扶正注射液联合常规疗法治疗COPD患者的随机对照试验（randomized controlled trials, RCT），采用Cochrane风险评价工具及评估、发展和评价建议分级（grading of recommendations assessment, development and evaluation, GRADE）系统进行文献证据质量评价，用RevMan 5.4软件对临床疗效及安全性指标进行Meta分析。结果表明，共纳入16项RCTs，1 486例患者。Meta分析结果显示，参芪扶正注射液辅助治疗可提高患者总有效率和第1秒用力呼气容积/用力肺活量比值（forced expiratory volume in one second/forced vital capacity, FEV1/FVC）指标，与对照组相比具有优势（P < 0.000 01、P < 0.000 1）；不良反应少，无严重不良反应（adverse drug reactions, ADR），两组对比无统计学差异（P = 0.32）；GRADE评价结果显示，有效率及不良反应指标的证据质量均为中等级，肺功能为低等级。可见参芪扶正注射辅助治疗COPD可以提高患者临床疗效，改善肺功能，且具有良好的安全性。但所纳入研究具有局限性，证据质量不高，仍需结合中药辨证使用特点，规范实验方案，开展更多的高质量RCT研究。

In order to systematically evaluate the clinical efficacy and safety of Shenqi Fuzheng Injection combined with conventional treatment as an intervention measure for patients with chronic obstructive pulmonary disease (COPD). CNKI, PubMed, Wanfang Data, VIP and other databases were searched. Randomized controlled trials (RCTs) of Shenqi Fuzheng Injection combined with conventional therapy in the treatment of COPD patients published before June 18, 2023 were screened and included. Cochrane risk assessment tool and GRADE system were used to evaluate the quality of literature evidence. RevMan 5.4 software was used for Meta-analysis of clinical efficacy and safety indicators. The results show that a total of 16 RCTs involving 1 486 patients were included. The results of meta-analysis show that Shenqi Fuzheng Injection adjuvant therapy could improve the total effective rate and forced expiratory volume in one second/forced vital capacity (FEV1/FVC) index of patients, which is superior to the control group (P < 0.000 01, P < 0.000 1). There are few adverse reactions and no serious adverse drug reactions(ADR). There is no significant difference between the two groups (P = 0.32). The results of grading of recommendations assessment, development and evaluation(GRADE) evaluation show that the quality of evidence for effective rate and adverse reaction indexes is medium grade, and lung function is low grade. It can be seen that Shenqi Fuzheng Injection adjuvant treatment of COPD can improve the clinical efficacy of patients, improve lung function, and has good safety. However, the included studies have limitations and the quality of evidence is not high. It is still necessary to standardize the experimental program and carry out more high-quality RCT studies in combination with the characteristics of TCM syndrome differentiation.