国内沙利度胺治疗多发性骨髓瘤疗效与安全性的Meta分析

Effectiveness and Safety of Thalidomide for Treating Multiple Myeloma in China:A Meta-analysis

目的评价国内沙利度胺治疗多发性骨髓瘤的疗效与安全性。方法计算机检索中国期刊全文数据库(1979～2008),中国生物医学文献数据库(1979～2008)和中文科技期刊全文数据库(1989～2008),并手工检索所有纳入文献的参考文献,纳入沙利度胺治疗多发性骨髓瘤的随机对照试验(RCT)。评价纳入研究的方法学质量并进行资料提取后,采用RevMan4.3软件进行Meta分析。结果共纳入9个RCT,包括324例患者。Meta分析结果显示,沙利度胺+MP方案与单用MP方案比较,其总有效率[RR=1.34,95%C(I1.05,1.70)]和缓解率[RR=1.77,95%CI(1.26,2.49)]差异均有统计学意义;沙利度胺+VAD方案与单用VAD方案比较,其总有效率[RR=1.45,95%CI(1.20,1.75)]和缓解率[RR=1.73,95%CI(1.25,2.39)]差异也均有统计学意义。结论目前国内的有限证据表明,与未用沙利度胺相比,加用沙利度胺能增加多发性骨髓瘤治疗的总有效率和缓解率,但由于纳入研究样本量小且质量较低,上述结论尚需要高质量、大样本的随机双盲对照试验加以证实。

Objective To assess the effectiveness and safety of thalidomide for treating multiple myeloma in China. Methods Randomized controlled trials （RCTs） of thalidomide for multiple myeloma were collected from CNKI （1979 to 2008）, CBMdisc （1979 to 2008）, and VIP （1989 to 2008） databases. Other relevant journals were also handsearched. The methodological quality of the included studies was evaluated, and data analyses were performed using the Cochrane Collaboration＇s software RevMan 4.3. Results A total of 9 RCTs involving 324 patients were included. As for the total effective rate and complete remission rate, significant differences were found between thalidomide ＋ MP vs. MP alone （RR=1.34, 95%CI 1.05 to 1.70; RR=l.77, 95%CI 1.26 to 2.49） and thalidomide ＋ VAD vs. VAD alone （RR=1.45, 95%CI 1.20 to 1.75; RR=1.73, 95%CI 1.25 to 2.39）. Conclusion According to the domestic evidence, treatment for multiple myeloma with thalidomide can improve the total effective rate and the complete remission rate. However, more high-quality, large-sample, randomized, double-blind, controlled trials are required.