目的 评价康艾注射液辅助治疗中晚期胃癌的疗效、对免疫功能的影响及安全性。方法 检索中国学术期刊全文数据库（CNKI）、万方数据库、中国生物医学文献数据库（CBM）、维普生物医学数据库（VIP）、Cochrane Library、PubMed、Embase中关于康艾注射液辅助化疗治疗中晚期胃癌的随机对照试验（RCT），检索时间为建库至2022年6月，采用RevMan 5.3软件进行Meta分析。结果 共纳入13项RCTs，1 205例患者。Meta分析结果显示，相较于对照组，康艾注射液辅助化疗可以提高临床总缓解率［RR=1.58，95% CI=（1.39，1.79）］，提高CD3⁺水平［SMD=3.39，95% CI=（2.09，4.69）］、CD4⁺水平［SMD=2.19，95% CI=（1.10，3.27）］、CD4⁺/CD8⁺［MD=0.34，95% CI=（0.23，0.45）］，差异均有统计学意义（P<0.01）；可减少白细胞降低发生率［RR=0.55，95% CI=（0.46，0.65），P<0.01］、肝功能损伤发生率［RR=0.36，95% CI（0.19，0.69），P<0.01］。结论 对比单用化疗的晚期胃癌患者，加用康艾注射液可有效提高患者的临床疗效、改善免疫功能，缓解因化疗导致的白细胞降低、肝功能损害等不良反应。

Objective To evaluate the clinical efficacy, immune function and safety of Kang'ai Injection as adjuvant therapy for advanced gastric. Methods Data were electronically searched from CNKI, Wanfang Data, CBM, VIP, Cochrane Library, PubMed, and Embase from the establishment of the database to June 2022 for randomized controlled trials (RCT) of Kang'ai Injection in the treatment of advanced gastric cancer. Meta-analysis was performed by RevMan 5.3 software. Results A total of 13 RCTs involving 1 205 patients were included. Meta-analysis results showed that compared with control group, Kang'ai Injection adjuvant chemotherapy could improve the clinical total remission rate[RR=1.58, 95%CI (1.39, 1.79)], increased CD3⁺ level[SMD=3.39, 95%CI (2.09, 4.69)], CD4⁺ level[SMD=2.19, 95%CI (1.10, 3.27)], CD4⁺/CD8⁺[MD=0.34, 95%CI (0.23, 0.45)], and the differences were statistically significant (P<0.01). It can reduce the incidence of leukopenia[RR=0.55, 95%CI (0.46, 0.65), P<0.01] and liver function injury[RR=0.36, 95%CI (0.19, 0.69), P<0.01]. Conclusion Compared with patients with advanced gastric cancer treated with chemotherapy alone, Kang'ai Injection can effectively improve clinical efficacy, improve immune function, alleviate the adverse reactions caused by chemotherapy, such as leukopenia and liver function damage.

R969.3;R286.5

国家自然科学基金资助项目（81803951）