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目的采用Meta分析法系统评价含西地尼布方案治疗晚期实体瘤的疗效及安全性。方法检索Pub Med、Cochrane Library、EMBase、ASCO Abstract、万方、知网、维普等数据库,收集有关含西地尼布方案治疗晚期实体瘤的随机对照试验(RCT),按纳入、排除标准进行筛选、资料提取及方法学质量评价,采用Revman 5.3软件进行Meta分析,结局指标为无进展生存期(PFS)、总生存期(OS)、客观缓解率(ORR)及≥3级不良反应。结果共纳入9项RCT,包括6种实体瘤和2 345例患者。Meta分析结果显示,与不含西地尼布方案组相比,含西地尼布方案组在PFS(HR=0.78,95%CI:0.71~0.85,P<0.000 01)方面差异有显著意义,效果更优;但在OS(HR=0.91,95%CI:0.81~1.02,P=0.12)及ORR(RR=1.21,95%CI:0.97~1.51,P=0.09)方面,两组无显著差异。在≥3级不良反应方面,含西地尼布方案组增加了腹泻(RR=4.06,95%CI:2.97~5.54,P<0.000 01)、疲乏(RR=1.91,95%CI:1.49~2.54,P<0.000 01)、高血压(RR=3.55,95%CI:2.54~4.96,P<0.00 001)、食欲不振(RR=4.05,95%CI:2.31~7.07,P<0.000 01)、中性粒细胞减少(RR=1.31,95%CI:1.14~1.50,P=0.000 2)、白细胞减少(RR=1.63,95%CI:1.09~2.43,P=0.02)和血小板减少(RR=1.68,95%CI:1.31~2.14,P<0.000 1)事件的发生率。外周感觉神经障碍(RR=1.42,95%CI:0.91~2.23,P=0.12)、贫血(RR=1.13,95%CI:0.51~2.47,P=0.77)和恶心(RR=1.46,95%CI:0.56~3.77,P=0.44)事件的发生率无显著差异。结论含西地尼布方案能够延长晚期实体瘤患者的PFS,但对OS及ORR并无明显改善,同时含西地尼布方案增加了不良反应的发生。
Objective To evaluate the efficacy and safety of metformin-containing regimen in the treatment of advanced solid tumors by Meta-analysis. Methods The databases of Pub Med, Cochrane Library, EMBase, ASCO Abstract, Wanfang, Zhidu and Vipu were searched and randomized controlled trials (RCTs) on advanced solid tumors with cedilanib were collected and screened by inclusion and exclusion criteria , Data extraction and methodological quality evaluation. Meta-analysis was performed using Revman 5.3 software. The outcome measures were progression-free survival (PFS), overall survival (OS), objective response rate (RRR) and grade 3 adverse reactions. Results A total of 9 RCTs were included, including 6 solid tumors and 2 345 patients. Meta-analysis showed significant differences in PFS (HR = 0.78, 95% CI: 0.71-0.85, P <0.000 01) compared with the cediranib-containing regimen group, But there was no significant difference between OS (HR = 0.91,95% CI: 0.81-1.02, P = 0.12) and ORR (RR = 1.21,95% CI: 0.97-1.51, P = 0.09) . In ≥3 adverse reactions, the cediranib-containing regimen increased diarrhea (RR = 4.06, 95% CI: 2.97-5.54, P <0.000 01), and fatigue (RR = 1.91, 95% CI: 1.49-2.54 , P <0.000 01), high blood pressure (RR 3.55, 95% CI 2.54-4.96, P 0.00 0.00), loss of appetite (RR 4.05, 95% CI 2.31-7.07, P 0.0001) (RR = 1.31, 95% CI: 1.14-1.50, P = 0.0002), leukopenia (RR = 1.63, 95% CI: 1.09-2.43, P = 0.02) and thrombocytopenia (RR = 95% CI: 1.31-2.14, P <0.000 1) Incidence of events. (RR = 1.42, 95% CI: 0.91-2.23, P = 0.12), anemia (RR = 1.13, 95% CI: 0.51-2.47, P = 0.77) and nausea (RR = 1.46, 95% CI : 0.56 ~ 3.77, P = 0.44) no significant difference in the incidence of events. CONCLUSIONS: Cilnidipine-containing regimen prolongs PFS in patients with advanced solid tumors, but has no significant improvement in both OS and ORR. Meanwhile, the cediranib-containing regimen increased the incidence of adverse reactions.