伊沙佐米治疗多发性骨髓瘤的疗效性与安全性的Meta分析*

doi:10.3969/j.issn.1671-2587.2023.02.017

临床输血与检验 ›› 2023, Vol. 25 ›› Issue (2): 243-249.DOI: 10.3969/j.issn.1671-2587.2023.02.017

伊沙佐米治疗多发性骨髓瘤的疗效性与安全性的Meta分析^*

向倩, 任诗慧, 李晓明

646000 西南医科大学附属医院血液内科

收稿日期:2022-10-26 发布日期:2023-04-25
通讯作者: 李晓明,主任医师,硕士生导师,主要从事血液系统恶性疾病的研究,（E-mail）lxm6358@21.cn。
作者简介:向倩,主要从事血液系统恶性疾病的研究,（E-mail）xiangq5365@163.com。
基金资助:
*本项目受泸州市人民政府-西南医科大学科技战略合作项目（No. 2019LZXNYDJ54）资助

Efficacy and Safety of Therapy with Ixazomib in Patients with Multiple Myeloma: A Meta Analysis

XIANG Qian, REN Shi-hui, LI Xiao-ming

Department of Hematology, the Affiliated Hospital of Southwest Medical University, Luzhou 646000

Received:2022-10-26 Published:2023-04-25

摘要/Abstract

摘要： 目的系统评价伊沙佐米治疗多发性骨髓瘤（MM）的疗效性与安全性。方法计算机检索Web of science 、PubMed、Embase、The Cochrane Library、美国临床试验注册中心数据库,检索时限为从建库至2022年6月,手工检索查询到的所有文献。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RevMan5.4软件进行Meta分析。结果共纳入7项随机对照试验（RCT）,共计3 094例患者。Meta分析结果显示,伊沙佐米可降低MM患者疾病进展风险（HR=0.75,95%CI：0.68~0.83,P<0.000 01）,并可降低高危细胞遗传学患者疾病进展风险（HR=0.73,95%CI：0.57~0.94,P=0.01）,但对患者的死亡风险无明显改善（HR=0.94,95%CI：0.82~1.08,P=0.37）。伊沙佐米组发生任何≥3级不良事件风险增加（RR=1.18,95%CI：1.11~1.25,P<0.000 01）,主要增加的不良事件为血小板减少、腹泻、皮疹、周围神经病变。结论伊沙佐米治疗MM对延长无进展生存期（PFS）有明显益处,可明显降低高危细胞遗传学患者的疾病进展风险,且毒性有限,口服疗法更加方便,因此是MM患者的重要治疗选择。

关键词: 多发性骨髓瘤, 伊沙佐米, 疗效性, 安全性, Meta分析

Abstract: Objective To systematically evaluate the efficacy and safety of Ixazomib in the treatment of multiple myeloma (MM). Methods Web of science, PubMed, Embase, The Cochrane Library, ClinicalTrials.gov were searched. Data was extracted between their inception and June 2022 and all the documents were manually retrieved. After literature selection, evaluation quality and data extraction according to inclusion and exclusion criteria, meta-analysis was performed using RevMan5.4 software. Results Seven RCTs involving a total of 3 094 patients were included. Meta-analysis showed that Ixazomib reduced the risk of disease progression in MM patients (HR=0.75, 95%CI：0.68~0.83, P<0.00001) and reduced the risk of disease progression in high-risk cytogenetic patients (HR=0.73,95%CI：0.57~0.94, P=0.01), but did not significantly reduce the risk of death (HR=0.94, 95%CI：0.82~1.08, P=0.37). Ixazomib had an increased risk of any grade ≥ 3 adverse events (RR=1.18, 95%CI：1.11~1.25, P<0.000 01). The main increased adverse events were thrombocytopenia, diarrhea, rash and peripheral neuropathy. Conclusion Ixazomib has significant progression-free survival (PFS) benefit in patients with MM, and can significantly reduce the risk of disease progression in high-risk cytogenetic patients. With limited toxicity and convenient oral therapy, it is an important treatment choice for patients with multiple myeloma.

Key words: Multiple myeloma, Ixazomib, Efficacy, Safety, Meta-analysis

中图分类号:

R733.3

向倩, 任诗慧, 李晓明. 伊沙佐米治疗多发性骨髓瘤的疗效性与安全性的Meta分析^*[J]. 临床输血与检验, 2023, 25(2): 243-249.

XIANG Qian, REN Shi-hui, LI Xiao-ming. Efficacy and Safety of Therapy with Ixazomib in Patients with Multiple Myeloma: A Meta Analysis[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2023, 25(2): 243-249.

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伊沙佐米治疗多发性骨髓瘤的疗效性与安全性的Meta分析^*

Efficacy and Safety of Therapy with Ixazomib in Patients with Multiple Myeloma: A Meta Analysis

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