依鲁替尼单药治疗难治/复发的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤的疗效和不良反应的Meta分析

Efficacy and Adverse Effect of Ibrutinib on the Treatment of Refractory/Relapse Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Meta-Analysis

目的评价依鲁替尼单药治疗难治/复发的慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)的疗效和不良反应。方法计算机检索PubMed/Medline,Embase,The Cochrane Library及中国期刊网数据库(CNKI)、万方数据库、维普网数据库等,对纳入的文献进行质量评价并提取相关数据。采用Stata15软件对提取数据进行Meta分析,计算有效率(ORR)、不良反应发生率和95%置信区间(95%CI)。结果共纳入10篇文献、6个地区的研究进行后续分析。Meta分析显示:鲁替尼单药治疗的总有效率(完全缓解+部分缓解+伴有淋巴细胞增高的部分缓解)为0.80(95%CI:0.68~0.92,I^2=0%),完全缓解率为0.04(95%CI:0.03~0.05),伴染色17p缺失[del(17p)]的难治/复发CLL的总有效率为0.81(95%CI:0.76~0.86)。等级≥3级的血液学毒性不良反应中,中性粒细胞减少最常见,发生率为0.10(95%CI:0.07~0.12);血小板减少和血红蛋白降低的发生率分别为0.08(95%CI:0.05~0.11)和0.04(95%CI:0.02~0.06)。等级≥3级的非血液学毒性不良反应中,出血发生率为0.02(95%CI:0.01~0.03),心房颤动的发生率为0.05(95%CI:0.04~0.07)。结论对于难治/复发的CLL/SLL,甚至伴del(17p)的患者,依鲁替尼单药治疗也可以提供良好的疗效。

Objective To evaluate the efficacy and adverse effect of ibrutinib on the treatment of refractory/relapse chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL).Methods We conducted a literature searching in PubMed/Medline,Embase,The Cochrane Library,China Journal Network Database(CNKI),Wanfang database,and Weipu database and analyzed the extracted data meta and calculated the effective rate(ORR),the incidence rate of adverse effect,and the 95%confidence interval(95%CI)by Stata15 software.Results Ten papers were enrolled in study.Meta-analysis results showed that the pooled ORR(CR+PR+PR-L)of ibrutinib therapy was 0.80(95%CI:0.68-0.92,I^2=0%),the pooled CR rate was 0.04(95%CI:0.03-0.05),and the pooled ORR of del(17p)was 0.81(95%CI:0.76-0.86).Neutropenia was the most frequent grade 3 or 4 adverse effect,with cumulative prevalence of 0.10(95%CI:0.07-0.12).But the cumulative prevalence of thrombocytopenia and anemia were 0.08(95%CI:0.05-0.11)and 0.04(95%CI:0.02-0.06),respectively.The cumulative prevalence of bleeding was 0.02(95%CI:0.01-0.03),and the cumulative prevalence of atrial fibrillation was 0.05(95%CI:0.04-0.07).Conclusion Our finding demonstrated that ibrutinib monotherapy may provide good efficacy for the refractory/relapse chronic lymphocytic leukemia/small lymphocytic lymphoma,even in patients with del(17p).