雷替曲塞联合伊立替康二线治疗晚期结直肠癌疗效与安全性的Meta分析  

Meta-Analysis on Efficacy and Safety of Raltitrexed Combined with Irinotecan in the Second-Line Treatment of Advanced Colorectal Cancer

作　　者：马中骏 孙颢琳 王婧[1] 苏强[2] 曹邦伟[1] MA Zhongjun;SUN Haolin;WANG Jing;SU Qiang;CAO Bangwei(Cancer Center,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Dept.of Radiotherapy of Cancer Center,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院肿瘤中心,北京100050 [2]首都医科大学附属北京友谊医院肿瘤中心放疗科,北京100050

出　　处：《中国医院用药评价与分析》2024年第2期218-221,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家自然科学基金资助项目(No.82173056);北京市消化内科学科协同发展中心特色项目(No.XXT01)。

摘　　要：目的:评价雷替曲塞联合伊立替康方案对比5-氟尿嘧啶+亚叶酸钙+伊立替康(FOLFIRI)方案二线治疗晚期结直肠癌的疗效及安全性。方法:计算机检索建库至2023年7月的PubMed、Embase、the Cochrane Library、中国知网、中国生物医学文献服务系统、万方数据库、维普数据库,查找雷替曲塞联合伊立替康方案对比FOLFIRI方案二线治疗晚期结直肠癌的临床随机对照试验,按纳入与排除标准筛选文献、评价文献质量、提取数据,应用RevMan 5.4软件进行Meta分析,应用Stata 13.1 MP软件分析发表偏倚。结果:共纳入7篇文献,涉及449例患者。在客观缓解率(OR=3.06,95%CI=1.96~4.80,P<0.000 01)和疾病控制率(OR=2.19,95%CI=1.42~3.38,P=0.000 4)方面,雷替曲塞联合伊立替康组均高于FOLFIRI组,差异均有统计学意义。Ⅰ—Ⅳ级不良反应中,在中性粒细胞减少发生率(OR=0.22,95%CI=0.05~0.89,P=0.03)及黏膜炎发生率(OR=0.30,95%CI=0.17~0.54,P<0.000 1)方面,雷替曲塞联合伊立替康组均低于FOLFIRI组,而在肝功能损伤发生率(OR=2.81,95%CI=1.45~5.43,P=0.002)方面,雷替曲塞联合伊立替康组高于FOLFIRI组,上述差异均有统计学意义。在其余Ⅰ—Ⅳ级不良反应发生率及Ⅲ/Ⅳ级不良反应发生率方面,两组的差异均无统计学意义(P>0.05)。结论:雷替曲塞联合伊立替康方案在二线治疗晚期结直肠癌的应用中,客观缓解率、疾病控制率均优于FOLFIRI方案,不良反应方面仅肝功能异常发生率高于FOLFIRI方案,雷替曲塞联合伊立替康方案有望成为晚期结直肠癌二线治疗的理想方案。OBJECTIVE:To evaluate the efficacy and safety of raltitrexed combined with irinotecan regimen compared with 5-fluorouracil+calcium folinate+irinotecan(FOLFIRI)regimen in the second-line treatment of advanced colorectal cancer.METHODS:Clinical randomized controlled trials on raltitrexed combined with irinotecan regimen compared with FOLFIRI regimen in the second-line treatment of advanced colorectal cancer were collected by retrieving PubMed,Embase,the Cochrane Library,CNKI,SinoMed,Wanfang Data and VIP database from base-building to Jul.2023,literature screening,quality evaluation and data extraction were conducted according to the inclusion and exclusion criteria,Meta-analysis was performed by using RevMan 5.4 software and publication bias was analyzed by adopting Stata 13.1 MP software.RESULTS:A total of 7 studies were enrolled,including 449 patients.The raltitrexed combined with irinotecan group was higher than the FOLFIRI group in terms of objective remission rate(OR=3.06,95%CI=1.96-4.80,P<0.00001)and disease control rate(OR=2.19,95%CI=1.42-3.38,P=0.0004),both with statistically significant differences.Among the gradeⅠtoⅣadverse drug reactions,the raltitrexed combined with irinotecan group was lower than the FOLFIRI group in terms of the incidence of neutropenia(OR=0.22,95%CI=0.05-0.89,P=0.03)and the incidence of mucositis(OR=0.30,95%CI=0.17-0.54,P<0.0001),while the raltitrexed combined with irinotecan group was higher than the FOLFIRI group in terms of the incidence of liver function injury(OR=2.81,95%CI=1.45-5.43,P=0.002),with statistically significant differences.In terms of the incidences of the rest gradeⅠtoⅣadverse drug reactions and gradeⅢ/Ⅳadverse drug reactions,the differences were not statistically significant between two groups(P>0.05).CONCLUSIONS:The application of raltitrexed combined with irinotecan regimen in the second-line treatment of advanced colorectal cancer is higher than the FOLFIRI regimen in terms of objective remission rate and disease control rate,and is only higher than

关 键 词：雷替曲塞 伊立替康 FOLFIRI方案 结直肠癌 化疗 META分析 

分 类 号：R979.1[医药卫生—药品]