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目的系统评价来那度胺联合地塞米松治疗复发难治性多发性骨髓瘤的疗效和安全性。方法计算机检索Cochrane图书馆(CENTRAL,2010年第3期)、MEDLINE(PubMed,1966～2010.11)、EMbas(e1984～2010.11)、中国生物医学文献光盘数据库(1978～2010.11)、中文期刊全文数据库(1979～2010.11)、临床试验注册网站,并手工检索纳入文献的参考文献及相关文献。按照纳入与排除标准选择文献、评价质量和提取数据后,采用RevMan 5.0软件Meta分析。结果共纳入2个随机对照试验,合计704例患者。其中1个为高质量研究,另一个研究的随机和隐蔽分组方法不清楚。Meta分析结果显示:来那度胺联合地塞米松(LD)组病死率[RR=0.78,95%CI(0.62,0.97),P=0.03]和疾病进展发生率[RR=0.16,95%CI(0.08,0.34),P<0.00001]均低于安慰剂联合地塞米松(PD)组;LD组的缓解率[RR=2.75,95%CI(2.22,3.41),P<0.00001]优于PD组。LD组血栓发生率[RR=3.20,95%CI(1.78,5.73),P<0.0001]、3级和4级中性粒细胞减少发生率[RR=10.20,95%CI(5.76,18.08),P<0.00001]、3级和4级血小板减少发生率[RR=2.08,95%CI(1.28,3.38),P=0.003]、不良反应导致减量或停药事件发生率[RR=1.34,95%CI(1.21,1.49),P<0.00001]均高于PD组。结论对于复发难治性多发性骨髓瘤,LD治疗疗效优于PD,但药物不良事件(如血栓发生、3级和4级中性粒细胞减少、血小板减少)发生率也高于PD组,应予积极预防。
Objective To evaluate the efficacy and safety of lenalidomide and dexamethasone in the treatment of relapsed and refractory multiple myeloma. Methods The Cochrane Library (CENTRAL, 2010), MEDLINE (PubMed, 1966 ~ 2010.11), EMbas (e1984 ~ 2010.11), Chinese Biomedical Literature Disc Database (1978 ~ 2010.11), Chinese Journal Full-text Database ~ 2010.11), clinical trial registration website, and manual retrieval of references and related literature. After selecting the literature according to the inclusion and exclusion criteria, evaluating the quality and extracting the data, RevMan 5.0 software Meta analysis was used. Results A total of 2 randomized controlled trials were included, totaling 704 patients. One of them is a high-quality study and the other is not clear about the random and covert grouping methods. Meta-analysis showed that the mortality of lenalidomide combined with dexamethasone (LD) group [RR = 0.78,95% CI (0.62,0.97), P = 0.03] and incidence of disease progression [RR = 0.16,95% CI (0.08,0.34), P <0.00001] were lower than placebo plus dexamethasone (PD) group. The response rate of LD group was significantly higher than that of PD group [RR = 2.75,95% CI 2.22,3.41, P <0.00001] group. The incidence of thrombosis in the LD group [RR = 3.20, 95% CI (1.78, 5.73), P <0.0001], grade 3 and 4 neutropenia incidences [RR = 10.20,95% CI P <0.00001], Grade 3 and 4 thrombocytopenia [RR = 2.08,95% CI (1.28,3.38), P = 0.003]. Adverse reactions led to reduction or withdrawal events [RR = 1.34, 95 % CI (1.21,1.49), P <0.00001] were higher than the PD group. Conclusions The efficacy of LD is better than that of PD in refractory relapsed multiple myeloma, but the incidence of adverse drug events such as thrombosis, grade 3 and 4 neutropenia and thrombocytopenia is also higher than that in PD group To actively prevent.