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目的:评价来那度胺单药治疗难治复发慢性淋巴细胞白血病(CLL)的疗效。方法:计算机检索PubMed/Medline,Embase,中国期刊网数据库,万方数据库,维普网,中国生物医学文献数据库,以及ClinicalTrials.gov,美国食品药品监督管理局和欧洲药品管理局网站,对纳入的文献进行治疗评价并提取相关数据。采用R软件和Cochrane协作网提供的RevMan5.3对提取数据进行Meta分析,计算有效率、相对风险率、相对危险度(RR)和95%置信区间(95%CI)。结果:共纳入8个队列研究进行后续分析。结果显示,来那度胺单药治疗难治复发CLL的总有效率为24%(95%CI 16%~35%,I2=66.6%),来那度胺单药最大耐受剂量对难治复发CLL的有效率为27%(95%CI19%~36%,I2=52.1%)。28d为1个周期,用药28d,休息0d(28/28)的给药方案最好,有效率为36%(95%CI30%~43%,I2=40);28d为1个周期,用药21d,休息7d(21/28)方案次之,有效率为18%(95%CI10%~31%,I2=0)。二者相比,相对风险率为2.00(95%CI 1.05~3.62)。对遗传学高危[17p和(或)11q]患者疗效的比较可见,来那度胺单药治疗后,与其他患者相比,二者有效率差异无统计学意义(RR=0.56,95%CI0.25~1.28)。结论:对于不适用于其他治疗或遗传学高危的难治复发CLL患者,来那度胺单药是一个可供选择的治疗方案。
Objective: To evaluate the efficacy of lenalidomide monotherapy in refractory recurrent chronic lymphocytic leukemia (CLL). METHODS: We searched PubMed / Medline, Embase, China Journal Net Database, Wanfang Database, VEP, China Biomedical Literature Database, and ClinicalTrials.gov, the US Food and Drug Administration and the European Medicines Agency website for computerized literature Therapeutic evaluation and extraction of relevant data. The extracted data were analyzed by Meta-analysis using R software and RevMan5.3 provided by the Cochrane Collaboration to calculate the efficiency, relative risk, relative risk (RR) and 95% confidence interval (95% CI). Results: A total of 8 cohort studies were included for follow-up analysis. The results showed that lenalidomide monotherapy for the treatment of refractory relapsed CLL total effective rate was 24% (95% CI 16% to 35%, I2 = 66.6%), lenalidomide single drug maximum tolerated dose of refractory The effective rate of recurrent CLL was 27% (95% CI 19% -36%, I2 = 52.1%). 28d for one cycle, medication for 28d, rest 0d (28/28) dosing regimen the best, the effective rate was 36% (95% CI30% ~ 43%, I2 = 40); 28d for a cycle of medication 21d , Followed by the rest 7d (21/28), the effective rate was 18% (95% CI10% ~ 31%, I2 = 0). The relative risk ratio was 2.00 (95% CI 1.05 ~ 3.62). Comparison of the efficacy of genetically high risk patients with 17p and / or 11q showed no statistically significant difference in efficacy after lenalidomide monotherapy (RR = 0.56, 95% CI0 .25 ~ 1.28). Conclusions: Lenalidomide monotherapy is an option for refractory relapsed CLL patients who are not eligible for other therapies or genetics.