目的 系统评价艾迪注射液联合FOLFOX4化疗方案治疗中晚期结直肠癌疗效及安全性。方法 检索PubMed、Cochrane Library、Embase、Medline、中国期刊全文数据库（CNKI）、中国生物医学文献服务系统（SinoMed）、维普中文科技期刊数据库（VIP）、万方数据知识服务平台（Wanfang Data）中艾迪注射液联合FOLFOX4化疗方案治疗中晚期结直肠癌的临床随机对照试验（randomized controlled trial，RCT），检索时限为建库起至2022年4月1日，采用RevMan 5.3软件进行Meta分析。结果 共纳入18项RCTs，包括1 515例患者，其中试验组775例、对照组740例。汇总全部研究的Meta分析显示，试验组客观缓解率（objective response rate，ORR）［RR=1.22，95% CI（1.11，1.34）］及疾病控制率（diseasecontrol rate，DCR）［RR=1.10，95% CI（1.05，1.16）］均优于对照组（P<0.05）；试验组可改善患者生活质量［RR=1.30，95% CI（1.18，1.44），P<0.01］，降低白细胞减少发生率［RR=0.53，95% CI（0.41，0.70），P<0.01］，降低血小板减少发生率［RR=0.53，95% CI（0.28，0.98），P<0.05］，降低恶心呕吐发生率［RR=0.57，95% CI（0.47，0.70），P<0.01］，降低腹泻发生率［RR=0.30，95% CI（0.14，0.65），P<0.05］。敏感性分析显示ORR及DCR研究结果稳健，证据可靠。结论 艾迪注射液联合FOLFOX4方案治疗中晚期结直肠癌较单纯化疗可明显提高疗效，改善患者生活质量，降低相关不良反应发生率，具有良好的疗效和安全性。但鉴于本研究局限性，尚需要高质量、大样本的临床RCT对研究结果进一步验证。

Objective To systematically evaluate the efficacy and safety of Aidi Injection in combination with FOLFOX4 chemotherapy regimen for the treatment of intermediate to advanced colorectal cancer. Methods PubMed, Cochrane Library, Embase, Medline, CNKI, SinoMed, VIP, Wanfang were searched for RCTs of Aidi Injection combined with FOLFOX4 chemotherapy regimen for the treatment of intermediate to advanced colorectal cancer from the establisment of database to April 1, 2022, and Meta-analysis was performed using RevMan 5.3 software. Results A total of 18 RCTs with 1 515 patients were included, with 775 patients in the test group and 740 in the control group. A Meta-analysis after pooling all studies showed that the objective response rate (ORR)[RR=1.22, 95%CI (1.11, 1.34)] and disease control rate (DCR)[RR=1.10,95%CI (1.05, 1.16)] were better in the test group than in control group (P<0.05). The test group improved quality of life[RR=1.30, 95%CI (1.18, 1.44), P<0.01]. The test group reduced the incidence of leukopenia[RR=0.53, 95%CI (0.41, 0.70), P<0.01]; thrombocytopenia[RR=0.53, 95%CI (0.28, 0.98), P<0.05], nausea and vomiting[RR=0.57, 95%CI (0.47, 0.70), P<0.01], and diarrhea[RR=0.30, 95%CI (0.14, 0.65), P<0.05] than in control group. Sensitivity analysis showed that the ORR and DCR study results were robust and reliable. Conclusions Aidi Injection combined with FOLFOX4 regimen for the treatment of intermediate to advanced colorectal cancer can significantly improve the therapeutic effect, improve patients' quality of life and reduce the incidence of related adverse reactions than chemotherapy alone, with good efficacy and safety. However, in view of the limitations of the study, further validation of the study results by high-quality, large-sample RCTs is still needed.

R286.5;R979.1

国家自然科学基金资助项目（8207142125）；中国中医科学院科技创新工程重大攻关项目（CI2021A01801）