替吉奥与氟尿嘧啶治疗中晚期消化道肿瘤疗效的系统评价

摘要

目的 通过系统评价国内外有关替吉奥(S-1)与氟尿嘧啶治疗中晚期消化道肿瘤的随机对照试验,探讨二者的临床应用价值.方法检索Cochrane Library、MEDLINE、EMBase、Tompson SCI、VIP等数据库,采用循证医学中心提供的RevMan 5.1.2软件包完成整个研究的数据整合、Meta分析,采用GRADE 3.5.1软件包对主要测量指标进行证据等级的评估.结果 共纳入4项研究,其中低风险文献1篇,中等风险文献3篇.研究发现S-1可以提高患者24个月总生存率[RR=1.45,95%CI(1.05,2.00),I2=0,P=0.02],但并未能提高患者其他时间的总生存率和无病生存率;S-1对总体中性粒细胞的影响小于氟尿嘧啶[RR=0.75,95%CI(0.70,0.80),I2=0,P＜0.00001],对3～4级血小板减少影响较小[RR=0.60,95%CI(0.43,0.84),I2=0,P=0.003],对腹泻、恶心、内生肌酐清除率、血钾、血磷、血镁、骨髓的影响较轻,然而其对胆红素影响较重[RR=2.08,95%CI(1.49,2.91),I2=0,P＜0.0001].结论 对于中晚期消化道恶性肿瘤患者,服用S-1并不能延长患者的无病生存期和总的生存期,与氟尿嘧啶相比,S-1可降低药物对骨髓、血液系统尤其是中性粒细胞和血小板的影响,同时还能减少部分消化道症状如恶心、腹泻等,但其对胆红素的影响较重.%Objective To systematically evaluate the randomized controlled trials of S - 1 or fluorouracil for the treatment of advanced gastrointestinal cancer. Method Literature was retrieved from Cochrane Library, MEDLINE, EMBase, Tompson SCI, VIP and other databases, and the results were analyzed using RevMan 5. 1. 2 software package. Results Four studies were obtained for this analysis. It was found that S - 1 improved the overall survival up to 24 months [ RR = 1. 45 , 95% CI ( 1. 05 , 2. 00 ), I = 0, P = 0. 02 ] , but failed to improve the overall survival and the disease - free survival. The effect of S -1 over neutrophils was significantly less than that of flurouracil [ RR = 0. 75, 95% CI ( 0. 70, 0. 80 ), I2 = 0, P < 0. 00001 ]. S - 1 had little effect on grade 3-4 thrombocytopenia [ RR = 0. 60, 95% CI ( 0. 43, 0. 84 ), I2 = 0% , P = 0. 003 ]. The effects of S - 1 on diarrhea, nausea, creatinine clearance rate, bone marrow, and blood levels of potassium, phosphorus, and magnesium were low but had a high effect on bilirubin when compared with fluorouracil [ RR = 2. 08, 95% CI (1.49, 2. 91), I =0, P <0. 0001 ]. Conclusion S - 1 can not prolong disease - free survival and overall survival in patients with advanced gastrointestinal cancer. Compared with fluorouracil, S - 1 can lower the adverse effects of the drugs over bone marrow, blood cells ( especially neutrophils and platelets ), and gastrointestinal symptoms such as nausea and diarrhea, although with less effect on bilirubin.