目的 評價康艾注射液輔助治療中晚期胃癌的療效、對免疫功能的影響及安全性。方法 檢索中國學術期刊全文數據庫（CNKI）、萬方數據庫、中國生物醫(yī)學文獻數據庫（CBM）、維普生物醫(yī)學數據庫（VIP）、Cochrane Library、PubMed、Embase中關于康艾注射液輔助化療治療中晚期胃癌的隨機對照試驗（RCT），檢索時間為建庫至2022年6月，采用RevMan 5.3軟件進行Meta分析。結果 共納入13項RCTs，1 205例患者。Meta分析結果顯示，相較于對照組，康艾注射液輔助化療可以提高臨床總緩解率［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）］，差異均有統(tǒng)計學意義（P<0.01）；可減少白細胞降低發(fā)生率［RR=0.55，95% CI=（0.46，0.65），P<0.01］、肝功能損傷發(fā)生率［RR=0.36，95% CI（0.19，0.69），P<0.01］。結論 對比單用化療的晚期胃癌患者，加用康艾注射液可有效提高患者的臨床療效、改善免疫功能，緩解因化療導致的白細胞降低、肝功能損害等不良反應。

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

國家自然科學基金資助項目（81803951）