来那度胺治疗多发性骨髓瘤患者的疗效和相关严重感染:一项meta分析

国际输血及血液学杂志 Pub Date : 2020-01-20 DOI:10.3760/CMA.J.ISSN.1673-419X.2020.01.007

L. Fan, Yanping Ma, Meng Zhang, Xiaoyun Gao, Yao Chao

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引用次数: 0

摘要

目的系统评价来那度胺治疗多发性骨髓瘤（MM）的疗效及相关严重感染的风险。方法通过计算机检索PubMed、Embase和Cochrane文库对照试验，以确定来那度胺治疗MM疗效和相关严重感染风险的随机对照试验（RCT）的研究文献。研究组患者接受来那度胺或来那度酰胺和地塞米松的联合治疗，而对照组使用安慰剂、地塞米松或安慰剂和地塞米松的组合。两名研究人员根据本研究中的文献集独立筛选了文献，并排除了评估纳入文献质量和提取数据的标准。使用R3.3.1软件对MM的无病生存期（PFS）、总生存期（OS）、严重感染发生率、严重呼吸道感染发生率和严重感染RR进行Meta分析。采用改良的Jadad量表进行随机对照试验的质量评价。结果根据本研究的纳入标准，通过文献筛选，共纳入7篇随机对照试验文献。共有4 007例MM患者入选，其中2 117例为研究组，1 890例为对照组。7篇文献为高质量随机对照试验。Meta分析结果如下：①与对照组相比，研究组3年PFS明显延长（HR=0.54，95%CI:0.36-0.82，P=0.004），但3年OS无明显益处（HR=0.84，95%CI:0.62-1.14，P=0.262），总发病率为14.01%（95%CI:111.01%-17.02%），呼吸道严重感染的发病率为46%（95%CI:27%-65%）。与对照组相比，研究组相关严重感染的RR增加（RR=1.92，95%CI:1.59-2.33，P<0.0001）。结论来那度胺虽能改善MM患者的PFS，但对患者OS无明显改善。来那度胺引起相关严重感染的风险非常高，尤其是严重的呼吸道感染。关键词：多发性骨髓瘤；来那度胺；感染；呼吸道感染；Meta分析

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Efficacy and related severe infection of lenalidomide in treatment of patients with multiple myeloma: a Meta-analysis

Objective To systematically evaluate the efficacy of lenalidomide in the treatment of patients with multiple myeloma(MM) and the risk of related severe infection. Methods PubMed, Embase and Cochrane library controlled trials were searched by computer, to identify research literature of the randomized controlled trials (RCT) of the efficacy of lenalidomide in the treatment of MM and the risk of related severe infection. Patients in study group were treated with lenalidomide or a combination of lenalidomide and dexamethasone, while placebo, dexamethasone or a combination of placebo and dexamethasone were used in control group. Two researchers independently screened the literature according to the literature set in this study and excluded criteria to evaluate the quality of the included literature and extract the data. A Meta-analysis of disease-free survival (PFS), overall survival (OS), incidence of severe infection, incidence of severe respiratory tract infection, and RR of severe infection of MM were performed using R3.3.1 software. Modified Jadad scale was used for RCT quality evaluation. Results A total of 7 RCT literatures were included according to the inclusion criteria of this study through literature screening. A total of 4 007 MM patients were enrolled, of whom 2 117 cases were in study group, and 1 890 cases in control group. Seven literatures were high quality RCT. The results of Meta-analysis were as follows. ① Compared with the control group, the 3-years PFS of the study group was significantly prolonged (HR=0.54, 95% CI: 0.36-0.82, P=0.004), but the 3-years OS was not significantly beneficial (HR=0.84, 95% CI: 0.62-1.14, P=0.262). ②The incidence of severe infection in MM patients was 6.67%-21.47%, the overall incidence was 14.01%(95% CI: 11.01%-17.02%). The incidence of respiratory tract severe infection was 46%(95% CI: 27%-65%). Compared with the control group, the RR of related severe infection in study group was increased (RR=1.92, 95% CI: 1.59-2.33, P<0.000 1). Conclusions Although lenalidomide can benefit the PFS of MM patients, it has no significant improvement on the OS of patients.The risk of related severe infection caused by lenalidomide is very high, especially serious respiratory tract infection. Key words: Multiple myeloma; Lenalidomide; Infection; Respiratory tract infections; Meta-Analysis

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来源期刊

国际输血及血液学杂志

自引率

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发文量

10610

期刊介绍： The International Journal of Transfusion and Hematology was founded in September 1978. It is a comprehensive academic journal in the field of transfusion and hematology, supervised by the National Health Commission and co-sponsored by the Chinese Medical Association, West China Second Hospital of Sichuan University, and the Institute of Transfusion Medicine of the Chinese Academy of Medical Sciences. The journal is a comprehensive academic journal that combines the basic and clinical aspects of transfusion and hematology and is publicly distributed at home and abroad. The International Journal of Transfusion and Hematology mainly reports on the basic and clinical scientific research results and progress in the field of transfusion and hematology, new experiences, new methods, and new technologies in clinical diagnosis and treatment, introduces domestic and foreign research trends, conducts academic exchanges, and promotes the development of basic and clinical research in the field of transfusion and hematology.