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.