氟达拉滨与环磷酰胺治疗慢性淋巴细胞白血病的系统评价

Fludarabine plus cyclophosphamide versus fludarabine for chronic lymphocytic leukemia :A systematic review

目的:系统评价氟达拉滨与环磷酰胺联合用药与氟达拉滨相比治疗慢性淋巴细胞白血病的有效性及安全性。方法:按Cochrane系统评价方法,检索Cochrane图书馆(2012年第3期)、计算机检索CNKI(1994～2012.3)、CBM(1978～2012.3)、VIP(1989～2012.3)、PubMed(1966～2012.3)、EMBASE(1974～2012.3),同时手工检索相关杂志和参考文献,选择符合纳入标准的随机对照试验和半随机对照试验,按Cochrane协作网提供的方法对纳入文献进行质量评价和结果分析。结果:共纳入3个随机对照试验,1043例患者。Meta分析结果显示氟达拉滨与环磷酰胺(FC)联合用药与氟达拉滨(F)单一用药相比①完全应答率(CR)差异有统计学意义[OR4.65,95%CI(2.57,8.39)];②部分应答率(PR)差异无统计学意义[OR0.91,95%CI(0.64,1.30)];③完全缓解率(CR)差异有统计学意义[OR3.77,95%CI(2.50,5.69)];④无疾病进展生存时间(PFS)差异有统计学意义[OR2.26,95%CI(1.74,2.92)];⑤3个研究均报道了不良反应,从总体看来FC组不良反应明显多于F组。⑥生存时间差异无统计学意义。结论:FC组在完全应答率、完全缓解率、无疾病进展生存时间、不良反应方面明显高于F组;但部分应答率,生存时间两组化疗方案相比没有明显差别。而且限于纳入研究方法学方面的局限性,其确切的疗效和安全性还不能肯定,需要大样本、高质量的随机对照试验加以证实。

Objective： To review the effectiveness and safety of fludarabine plus cyclophosphamide versus fludarabine for chronic lymphocytic leukemia. Methods：We searched the specialized trials register of the Cochrane Collaboration＇s Bone,the cochrane library （Issue 3,2012）, CNKI（ 1994 to January 2012）,CBM（ 1978 to January 2012）、VIP（ 1989 to January 2012）,PubMed（ 1966 to January 2012）,EMBASE （1974 to January 2012）.We also handedsearched some chinese orthopedic journals. Randomized controlled trials （RCTs） and quai-randomized tlials （quai-RCTs）.The quality evaluation of studies and data analysis followed the methods of the Cochrane Collaboration. Results ：Three studies including , 1043 patients met the inclusion criteria, the following data were the results of metaanalysis;①complete response rate ,with a statistically difference OR 4.65,95%CI 2.57 to 8.39;②partial response rate, no statistical difference OR 0.91,95% CI 0.64 to 1.30; ③complete remission rate, with a statistically difference OR 3.77,95 % CI2.50 to 5.69 ; ④ progression-free survival time, with a statistically difference OR2.26,95%CI1.74 to 2.92; ⑤The three studies all reported adverse reactions.Generally speaking, the adverse reactions of FC group was much higher than F group; ⑥survival time with no statistical difference. Conclusions：Fludarabine plus eyclophosphamide were statistical by higher than that of F group in complete response rate, complete remission rate, progression-fi＇ee survival time and adverse reactions. But there were no evidence of difference in partial response rate and survival time. Because the limitation of the methodology research of the including studies,that the efficacy and safety cannot be affirmed, so big sample and high quality of randomized controlled trial should be conducted.