目的 系統(tǒng)分析康艾注射液治療晚期大腸癌臨床療效及不良反應(yīng)發(fā)生情況。方法 檢索中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM）、維普生物醫(yī)學(xué)數(shù)據(jù)庫（VIP）、Cochrane Library、PubMed、Embase等中英文數(shù)據(jù)庫中關(guān)于康艾注射液治療晚期大腸癌化療患者的臨床隨機(jī)對(duì)照試驗(yàn)（RCT），檢索時(shí)限均為建庫至2023年4月，采用RevMan 5.3軟件進(jìn)行Meta分析。結(jié)果 共納入20項(xiàng)RCTs，Meta分析結(jié)果顯示：與對(duì)照組比較，康艾注射液治療組可提高患者臨床總緩解率［RR＝1.34，95% CI（1.23，1.45），P<0.01］，降低肝損傷發(fā)生率［RR＝0.38，95% CI（0.29，0.49），P<0.01］、腎損傷發(fā)生率［RR＝0.43，95% CI（0.24，0.78），P=0.08］；白細(xì)胞下降發(fā)生率［RR＝0.67，95% CI（0.57，0.79），P<0.01］、血小板下降發(fā)生率［RR＝0.73，95% CI（0.53，1.00），P=0.05］、惡心嘔吐發(fā)生率［RR＝0.46，95% CI（0.37，0.57），P<0.01］、腹瀉發(fā)生率［RR＝0.55，95% CI（0.36，0.85），P=0.007］、神經(jīng)毒性發(fā)生率［RR＝0.54，95% CI（0.38，0.77），P=0.000 6］、卡氏功能狀態(tài)（KPS）評(píng)分上升率［RR＝1.56，95% CI（1.30，1.87），P<0.01］。結(jié)論 康艾注射液對(duì)腸癌晚期化療患者可以起到增效減毒的作用，可以有效降低化療所致的不良反應(yīng)，降低肝腎損傷及其他不良反應(yīng)的發(fā)生率，提升治療效果，提高患者生存質(zhì)量，但不能有效提升血小板水平，未來仍需進(jìn)一步評(píng)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

國家自然科學(xué)基金青年基金資助項(xiàng)目（81803951）；陜西省科技廳資助項(xiàng)目（2022JM-506）；陜西省第二屆名中醫(yī)劉力工作傳承工作室建設(shè)項(xiàng)目；陜西省第3屆名中醫(yī)杜曉泉工作傳承工作室建設(shè)項(xiàng)目（2019021）