沙利度胺联合CAG方案治疗老年急性髓系白血病患者有效性与安全性的Meta分析  

Meta-analysis on efficacy and safety of thalidomide combined with CAG regimen in the treatment of elderly patients with acute myeloid leukemia

作　　者：李晓靖 胡琦[1] 陆嘉惠[1] 刘敏[1] 邓剑青[1] 江雯雯[1] 鲍计章[1] LI Xiaojing;HU Qi;LU Jiahui;LIU Min;DENG Jianqing;JIANG Wenwen;BAO Jizhang(Dept.of Hematology,Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200040,China)

机构地区：[1]上海中医药大学附属市中医医院血液病科,上海200040

出　　处：《中国药房》2024年第9期1139-1144,共6页China Pharmacy

基　　金：国家自然科学基金项目(No.81774258);上海市科技计划项目(No.23Y11921300,No.22Y11921100);上海市中医医院中医药传承人才培育项目(No.WLJH2021ZY-MZY033);上海市中医医院中医药科技发展项目(No.WL-XJRY-2021004K);中国民族医药学会科研项目(No.2020ZY366-440401)。

摘　　要：目的系统评价沙利度胺联合阿克拉霉素、粒细胞集落刺激因子与阿糖胞苷(CAG)方案治疗老年急性髓系白血病(AML)患者的疗效与安全性。方法检索中国知网、万方数据、维普网、Sino Med、PubMed、Embase、the Cochrane Library、Web of Science,检索时限为数据库建库至2023年8月27日。收集沙利度胺联合CAG方案(试验组)对比CAG方案(对照组)治疗老年AML患者的临床随机对照试验,对纳入的研究采用RevMan 5.3软件进行Meta分析。结果最终纳入7项临床随机对照试验,共计601例患者,其中试验组307例、对照组294例。Meta分析结果显示,试验组在提升总有效率[Z=4.75,P<0.00001,OR=2.80,95%CI(1.83,4.28)]、完全缓解率[Z=2.82,P=0.005,OR=1.61,95%CI(1.16,2.25)],改善血小板计数[Z=2.70,P=0.007,MD=64.02,95%CI(17.53,110.51)]、血管内皮生长因子水平[Z=13.63,P<0.00001,MD=-65.17,95%CI(-74.54,-55.80)]、血管内皮生长因子受体水平[Z=12.03,P<0.00001,MD=-499.01,95%CI(-580.31,-417.71)]、碱性成纤维细胞生长因子水平[Z=4.17,P<0.0001,MD=-0.23,95%CI(-0.35,-0.12)]等方面均显著优于对照组,不良反应发生率[Z=0.99,P=0.32,OR=0.52,95%CI(0.14,1.89)]以及恶心呕吐[Z=1.06,P=0.29,OR=0.66,95%CI(0.30,1.43)]、便秘或腹泻[Z=0.92,P=0.36,OR=0.65,95%CI(0.26,1.63)]、嗜睡[Z=1.38,P=0.17,OR=0.57,95%CI(0.26,1.27)]、骨髓抑制[Z=0.88,P=0.38,OR=0.68,95%CI(0.28,1.62)]的发生率与对照组比较,差异均无统计学意义。结论沙利度胺联合CAG方案治疗老年AML患者能显著增加疗效,且安全性较好。OBJECTIVE To systematically evaluate the efficacy and safety of thalidomide combined with aclacinomycin,granulocyte colony-stimulating factor and cytarabine(CAG)regimen in the treatment of elderly patients with acute myeloid leukemia(AML).METHODS CNKI,Wanfang data,VIP,Sino Med,PubMed,Embase,the Cochrane Library and Web of Science were searched comprehensively from the inception to Aug.27th,2023.Randomized controlled trials(RCTs)about thalidomide combined with CAG regimen(trial group)versus CAG regimen(control group)in the treatment of elderly AML patients were collected,and RevMan 5.3 software was used for meta-analysis of included studies.RESULTS Finally,7 RCTs were included,with a total of 601 patients,including 307 patients in the trial group and 294 patients in the control group.Meta-analysis results showed that the trial group was superior to the control group in enhancing the overall response rate[Z=4.75,P<0.00001,OR=2.80,95%CI(1.83,4.28)],complete remission rate[Z=2.82,P=0.005,OR=1.61,95%CI(1.16,2.25)],and improving platelet count[Z=2.70,P=0.007,MD=64.02,95%CI(17.53,110.51)],vascular endothelial growth factor[Z=13.63,P<0.00001,MD=-65.17,95%CI(-74.54,-55.80)],vascular endothelial growth factor receptor[Z=12.03,P<0.00001,MD=-499.01,95%CI(-580.31,-417.71)]and basic fibroblast growth factor[Z=4.17,P<0.0001,MD=-0.23,95%CI(-0.35,-0.12)].And there was no statistical difference between the trial group and the control group in the incidence of adverse drug reaction[Z=0.99,P=0.32,OR=0.52,95%CI(0.14,1.89)],nausea and vomiting[Z=1.06,P=0.29,OR=0.66,95%CI(0.30,1.43)],constipation or diarrhea[Z=0.92,P=0.36,OR=0.65,95%CI(0.26,1.63)],drowsiness[Z=1.38,P=0.17,OR=0.57,95%CI(0.26,1.27)]or myelosuppression[Z=0.88,P=0.38,OR=0.68,95%CI(0.28,1.62)].CONCLUSIONS The combination of thalidomide and CAG regimen in the treatment of elderly AML patients can significantly improve clinical efficacy and has high safety.

关 键 词：沙利度胺 阿克拉霉素 粒细胞集落刺激因子 阿糖胞苷 急性髓系白血病 老年患者 META分析 

分 类 号：R979.1[医药卫生—药品]