文献类型：期刊文献

中文题名：埃罗妥珠单抗治疗难治性/复发性多发性骨髓瘤临床试验效果的Meta分析（英文）

英文题名：A novel drug of elotuzumab for treatment of refractory/relapsed multiple myeloma: a meta-analysis of eight trials

作者：张林[1];丁洁卫[1];王阳[2];金晓宣[3];葛伟东[4];黄淑婷[3];李玉婷[3]

机构：[1]绍兴市人民医院浙江大学绍兴医院临床药学科;[2]Frontage Laboratories Inc;[3]绍兴文理学院化学化工学院药学系;[4]浙江省人民医院超声诊断科

年份：2017

卷号：26

期号：7

起止页码：528

中文期刊名：中国药学：英文版

收录：CSTPCD、、Scopus、CSCD2017_2018、CSCD

基金：Zhejiang Public Welfare Technology Application Research Project(Grant No.2015C33285);Zhejiang Provincial Natural Science Foundation Project(Grant No.LY14H300002);Shaoxing Science and Technology Bureau General Project(Grant No.2015B70070);Zhejiang Medical and Health General Research Program(Grant No.2013KYB030)

语种：中文

中文关键词：埃罗妥珠单抗;Meta分析;难治性/复发性多发性骨髓瘤

外文关键词：Elotuzumab;Meta-analysis;Refractory/Relapsed multiple myeloma

中文摘要：埃罗妥珠单抗在2015年被美国FDA批准成为治疗多发性骨髓瘤的新药后,即成为了多发性骨髓瘤患者的新选择,该药是治疗多发性骨髓瘤的首个免疫刺激疗法药物,用于与来那度胺、地塞米松联合治疗复发或难治性的多发性骨髓瘤。目前有8个临床试验是关于埃罗妥珠单抗在治疗多发性骨髓瘤的研究,因此我们收集现有的临床试验报告分析该药在临床应用上的效果,以更好地评价该药在难治性/复发性多发性骨髓瘤中的安全性与有效性。检索数据库包括Cochrane、EMBASE、PubMed、Medline;检索关键字为:"elotuzumab","Multiple myeloma"。最后应用R软件对收集到的数据进行Meta分析,根据文章间的异质性决定使用固定效应模型或者随机效应模型。根据收集到的文献,筛选并确认8篇总计608例多发性骨髓瘤患者参与的临床试验;结果应用联合埃罗妥珠单抗方案的608例多发性骨髓瘤患者中总缓解率达到63%,有162例(26.6%)达到非常满意的部分缓解,有34例(5.59%)达到了完全缓解。该药最常见的不良反应主要包括贫血、淋巴细胞减少、血小板减少症、中性粒细胞减少症和疲劳等。因此埃罗妥珠单抗联合方案在难治性/复发性多发性骨髓瘤患者中产生了满意的临床效果,可作为该类患者连续治疗的适宜选择。

外文摘要：Elotuzumab was approved by the US FDA in 2015 as a new drug for the treatment of multiple myeloma（MM）, and it became a new choice for MM patients. The drug is the first immunostimulatory drug to treat MM and used to treat recurrent/refractory multiple myeloma（R/RMM） in combination with lenalidomide and dexamethasone. Therefore, we collected the reports from existing clinical trials to analyze the efficacy of the drug in clinical applications to better evaluate the effects of the drug on R/RMM. The search strategy used ＂elotuzumab＂ and ＂multiple myeloma＂ as keywords to search from the database of Cochrane, Embase, Pub Med and Medline. The heterogeneity among the studies was assessed using the Cochrane χ~2 test, and its extent was evaluated using I^2 statistics. A P value of less than 0.05 was considered as statistically significant. All meta-analyses were conducted with R Software 3.3.2. We identified eight prospective studies consisting of 608 MM patients. The meta-analysis showed that the overall response rate（ORR） was 63%, 162 patients（26.6%） achieved a very good partial response rate（VGPR）, and 34 patients（5.59%） achieved complete response rate（CR）. The most common adverse effects of the drug included anemia, lymphopenia, thrombocytopenia, neutropenia and fatigue. Therefore, elotuzumab combination regimens offered clinical benefits to R/RMM patients, and such a combination therapy was a suitable option for continuous treatment for R/RMM patients.