摘要
目的系统评价达沙替尼140 mg,qd和70 mg,bid治疗慢性髓细胞白血病(chronic myeloidleukemia,CML)的疗效。方法计算机检索EMbase(1974～2011.11)、PubMed(1966～2011.11)、CochraneLibrary(2011年第11期)、CBM(1979～2011.11)、VIP(1989～2011.11)、CNKI(1994～2011.11)和WanFangData(1997～2011.11)等数据库并手工检索相关领域的杂志,查找比较达沙替尼140 mg,qd和70 mg,bid治疗CML的随机对照试验。对符合纳入标准的RCT,由两位评价员按Cochrane系统评价的方法,独立进行资料提取、质量评价并交叉核对后,采用RevMan 5.1软件进行Meta分析。结果共纳入4个研究(2个随机对照试验,不同随访时间),862例患者。Meta分析结果显示,达沙替尼140 mg,qd和70 mg,bid长期治疗CML时,两者完全血液学反应[RR=0.97,95%CI(0.88,1.07),P=0.58]、完全细胞遗传学反应[RR=0.94,95%CI(0.80,1.11),P=0.47]及主要细胞遗传学反应[RR=0.99,95%CI(0.86,1.13),P=0.86]差异均无统计学意义;短期治疗CML慢性期(CP-CML)时,完全血液学反应[RR=0.99,95%CI(0.90,1.07),P=0.73]、完全细胞遗传学反应[RR=0.99,95%CI(0.78,1.26),P=0.95]及主要细胞遗传学反应[RR=1.01,95%CI(0.83,1.22),P=0.95]的差异也均无统计学意义;对长期治疗CML慢性期及进展期进行亚组分析,结果显示其完全血液学反应、完全细胞遗传学反应及主要细胞遗传学反应的差异均无统计学意义。结论达沙替尼140 mg单次和70 mg双次用药治疗CML的疗效相似。但鉴于纳入研究的方法学质量存在中度选择性偏倚的可能性,可能影响结果真实性,因此上述结论还有待开展更多高质量大样本的随机双盲临床对照试验来验证。
Objective To systematically evaluate the effectiveness of dasatinib in doses of 140 mg once daily and 70 mg twice daily for chronic myeloid leukemia （CML）. Methods The randomized controlled trials （RCTs） were retrieved from Embase （1974 to November 2011）, Pubmed （1966 to November 2011）, The Cochrane Library （Issue 11, 2011）, CBM （1979 to November 2011）, VIP （1989 to November 2011）, CNKI （1994 to November 2011）, Wanfang Data （1997 to November 2011） and references listed in all articles. RCTs meeting inclusive criteria were included, the data were extracted, the quality was evaluated and cross-checked by two reviewers independently according to Cochrane Handbook for Systematic Reviews of Interventions, and then meta-analyses were conducted using RevMan 5.1 software. Results A total of four studies involving two RCTs and 862 patients were included. Results of meta-analyses showed that when dasatinib was used in the long-term treatment of CML, no significant difference was found between 140 mg once daily and 70 mg twice daily in the complete hematologic response （RR=0.97, 95%CI 0.88 to 1.07, P=0.58）, complete cytogenetic response （RR=0.94, 95%CI 0.80 to 1.11, P=0.47） and major cytogenetic response （RR=0.99, 95%CI 0.86 to 1.13, P=0.86）. In the short-term treatment of CML, there were no significant differences in the complete hematologic response （RR=0.99, 95%CI 0.90 to 1.07, P=0.73）, complete cytogenetic response （RR=0.99, 95%CI 0.78 to 1.26, P=0.95） and major cytogenetic response （RR=I.01, 95%CI 0.83 to 1.22, P=0.95）. The subgroup analyses on the long-term treatment of CML in both chronic phase and advanced phase showed that there were no significant differences in the complete hematologic response, major cytogenetic response and complete cytogenetic response. Conclusion In the effectiveness of dasatinib for CML, the dose of 140 mg once daily is similar to the dose of 70 mg twice daily. Considering possible moderate selec-tion bias existing in the methodological quality of the included studies which may affect the authenticity of outcomes, this conclusion should be further proved by conducting more high-quality, large-scale and doubleblinded RCTs.
出处
《中国循证医学杂志》
CSCD
2012年第7期785-790,共6页
Chinese Journal of Evidence-based Medicine
