目的 系统分析康艾注射液治疗晚期大肠癌临床疗效及不良反应发生情况。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等中英文数据库中关于康艾注射液治疗晚期大肠癌化疗患者的临床随机对照试验（RCT），检索时限均为建库至2023年4月，采用RevMan 5.3软件进行Meta分析。结果 共纳入20项RCTs，Meta分析结果显示：与对照组比较，康艾注射液治疗组可提高患者临床总缓解率［RR＝1.34，95% CI（1.23，1.45），P<0.01］，降低肝损伤发生率［RR＝0.38，95% CI（0.29，0.49），P<0.01］、肾损伤发生率［RR＝0.43，95% CI（0.24，0.78），P=0.08］；白细胞下降发生率［RR＝0.67，95% CI（0.57，0.79），P<0.01］、血小板下降发生率［RR＝0.73，95% CI（0.53，1.00），P=0.05］、恶心呕吐发生率［RR＝0.46，95% CI（0.37，0.57），P<0.01］、腹泻发生率［RR＝0.55，95% CI（0.36，0.85），P=0.007］、神经毒性发生率［RR＝0.54，95% CI（0.38，0.77），P=0.000 6］、卡氏功能状态（KPS）评分上升率［RR＝1.56，95% CI（1.30，1.87），P<0.01］。结论 康艾注射液对肠癌晚期化疗患者可以起到增效减毒的作用，可以有效降低化疗所致的不良反应，降低肝肾损伤及其他不良反应的发生率，提升治疗效果，提高患者生存质量，但不能有效提升血小板水平，未来仍需进一步评估。

Objective To systematically analyze the clinical efficacy and adverse reactions of Kang'ai Injection in the treatment of advanced colorectal cancer. Methods The databases CNKI, Wanfang Data, CBM, VIP, Cochrane Library, PubMed and Embase were searched for randomized controlled trials (RCT) of Kang'ai Injection in the treatment of advanced colorectal cancer in chemotherapy patients. The search deadline is from database establishment to April 1, 2023, and RevMan 5.3 software was used to analyze the data. Results A total of 20 RCTs were included. The results of Meta-analysis showed that, compared with the control group, the treatment group (use Kang'ai Injection) could improve the overall clinical response rate [RR = 1.34, 95%CI (1.23, 1.45), P< 0.01]; incidence of liver injury [RR = 0.38, 95%CI (0.29, 0.49), P< 0.01], kidney injury [RR = 0.43, 95%CI (0.24, 0.78), P= 0.08], leukopenia [RR = 0.67, 95%CI (0.57, 0.79), P< 0.01], thrombocytopenia [RR = 0.73, 95%CI (0.53, 1.00), P= 0.05], nausea and vomiting [RR = 0.46, 95%CI (0.37, 0.57), P< 0.01], diarrhea [RR = 0.55, 95%CI (0.36, 0.85), P= 0.007], neurotoxicity [RR = 0.54, 95%CI (0.38, 0.77), P= 0.000 6], and KPS score increase rate [RR = 1.56, 95%CI (1.30, 1.87, P< 0.01]. Conclusion Kang'ai Injection can play a synergistic and attenuated role in patients with advanced colorectal cancer undergoing chemotherapy, which can effectively reduce the adverse reactions caused by chemotherapy, reduce the incidence of liver and kidney damage and other adverse reactions, improve the therapeutic effect and improve the quality of life of patients, but it can not effectively improve the platelet level, which needs further evaluation in the future.

R965.3

国家自然科学基金青年基金资助项目（81803951）；陕西省科技厅资助项目（2022JM-506）；陕西省第二届名中医刘力工作传承工作室建设项目；陕西省第3届名中医杜晓泉工作传承工作室建设项目（2019021）