来那度胺治疗初诊多发性骨髓瘤疗效与安全性的meta分析

发布时间：2018-04-19 23:00

本文选题：来那度胺 + 初诊多发性骨髓瘤　；参考：《山西医科大学》2017年硕士论文

【摘要】：目的:系统评价公开发表的含来那度胺的联合化疗治疗初诊多发性骨髓瘤的疗效与安全性。方法:通过中国知网(CNKI)、中国生物医学文摘(CBM)、万方数据知识服务平台(Wanfang)、维普网(VIP)、Medline、Pub Med、Clinical Trials.gov等中英文数据库,检索限定的时限都从2005年截止至2017年1月,检索关键词:初诊多发性骨髓瘤或初治多发性骨髓瘤(the newly diagnosed multiple myeloma or the untreated multiple myeloma)、免疫调节剂(Immune modulators)、来那度胺(lenalidomide)等,检索已发表的关于来那度胺联合化疗方案治疗初治MM患者的临床试验文献,提取试验中缓解率、PFS、OS和药物的不良反应等数据。合并效应量后使用Rev Man5.3软件评价分析。结果:共纳入6篇文献,合计参与者1621人,来那度胺组848人,对照组773人,其中有4篇来那度胺与安慰剂的比较,2篇来那度胺与沙利度胺的比较。1、来那度胺组的CR/VGPR率、OR率高于对照组[OR=3.66,95%CI(2.87,4.66),P0.00001,P0.05;OR=2.47,95%CI(1.99,3.05),P0.00001,P0.05]。2、来那度胺治疗的初诊MM的1年和20个月PFS长于对照组[OR=2.25,95%CI(1.81,2.79),P0.00001,P0.05;OR=1.74,95%CI(1.40,1.2.16),P0.00001,P0.05]。3、来那度胺组在与对照组1年和20个月OS的比较中,结果相似[OR=1.28,95%CI(0.90,1.80),P=0.17,P0.05;OR=0.98,95%CI(0.75,1.28),P=0.90,P0.05]。4、就安全性而言,来那度胺组的不良反应主要表现在血液学毒性作用[OR=1.98,95%CI(1.77,2.21),P0.05],主要包括贫血、中性粒细胞减少、血小板减少等(P=0.0003,P0.00001,P0.0001,P值均小于0.05);非血液学毒性反应无统计学意义[OR=1.06,95%CI(0.91,1.23),P=0.44,P0.05],且来那度胺组神经系统症状明显发生率低(P=0.00001)。结论:1、含来那度胺的联合化疗能提高初诊MM患者的CR/VGPR率和OR率;2、含来那度胺的联合化疗能延长初诊MM的PFS(1年和20个月),但未表明能使其OS获益;3、含来那度胺的联合化疗安全性高,不良反应主要是血液学毒性方面,且神经系统病变风险低;4、含来那度胺的联合化疗是治疗初诊MM患者的理想用药。
[Abstract]:Objective: to evaluate the efficacy and safety of publicly published combined chemotherapy with renatamine in the treatment of newly diagnosed multiple myeloma. Methods: the Chinese and English databases such as CNKI, Chinese biomedical abstracts, Wanfangli, Wanfangli, Weipu.com were used to search the Chinese and English databases. The limited time limit for retrieval was from 2005 to January 2017. Search keywords: newly diagnosed multiple myeloma or the untreated multiple myeloma, newly diagnosed multiple myeloma or the untreated multiple myeloma, immunomodulator Immune modulator, and so on. To search the published literature on clinical trials of renalidomide combined with chemotherapy in the treatment of newly diagnosed MM patients, and to extract data on remission rate and adverse drug reactions. Rev Man5.3 software was used to evaluate and analyze the combined effect. Results: a total of 6 articles were included. 1621 participants were involved in the study, 848 in the Leridomide group and 773 in the control group. [ORA 2.25 ~ 95CIQ 1.81 ~ 2.79 ~ (1) P0.00001 / P0.05 ~ (1.744) ~ (95) CIQ 1.40 ~ 1.2.16 ~ + P0.00001p0.05] .3. in comparison with the control group for 1 and 20 months of OS, the control group was compared with the control group in terms of OS for one year and 20 months. Thrombocytopenia (P0. 0003), P0. 0001, P0. 0001, P < 0. 05, and non-hematological toxic reactions were not statistically significant [OR1. 06 + 95 + CI 0. 01 1 1. 23P0. 44P 0. 05], and the incidence of nervous system symptoms was significantly lower in the laminadine group (P 0. 00001) than that in the control group (P < 0. 05). ConclusionThe combination chemotherapy with genadamide can increase the CR/VGPR rate and OR rate of the newly diagnosed MM patients by 2%, and the combination chemotherapy with Lenadamide can prolong the PFSs of the newly diagnosed MM patients (1 year and 20 months), but it is not shown that the combination chemotherapy can benefit the OS of the patients with newly diagnosed MM. High safety in combination with chemotherapy, The adverse reactions were mainly hematological toxicity, and the risk of neuropathy was low. The combined chemotherapy containing renatamine was an ideal drug for the treatment of newly diagnosed MM patients.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R733.3

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