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普乐沙福用于非霍奇金淋巴瘤和多发性骨髓瘤患者自体移植造血干细胞动员的疗效与安全性:一项系统评价和荟萃分析。

Efficacy and safety of plerixafor for hematopoietic stem cell mobilization for autologous transplantation in patients with non-Hodgkin lymphoma and multiple myeloma: A systematic review and meta-analysis.

作者信息

Yang Xiaoyang, Wan Mengjie, Yu Feng, Wang Zhidong

机构信息

Department of Hematology, Affiliated Haikou Hospital of Xiangya Medical College, Central South University and Haikou Municipal People's Hospital, Haikou, Hainan 570208, P.R. China.

Department of Hematology, People's Hospital of Peking University, Beijing 100044, P.R. China.

出版信息

Exp Ther Med. 2019 Aug;18(2):1141-1148. doi: 10.3892/etm.2019.7691. Epub 2019 Jun 19.

DOI:10.3892/etm.2019.7691
PMID:31363366
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6614714/
Abstract

Plerixafor in combination granulocyte-colony stimulating factor (G-CSF) has been used for the mobilization of hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The aim of this study was to systematically search the published literature and analyze evidence on the efficacy of additional plerixafor for successful HSC mobilization in patients with NHL and MM, and to evaluate the safety of the drug. The PubMed, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) and Google scholar databases were searched electronically for studies published in the English language up to March, 2019. Five studies (3 on NHL and 2 on MM) were included in this review article. The meta-analysis of data of 364 patients in the treatment group and 368 patients in the control group, indicated that the mobilization of ≥5/6×10 CD34 cells/kg in 4 or less apheresis days was superior with plerixafor + G-CSF than with G-CSF alone (RR=2.59, 95% CI: 1.40 to 4.81; P<0.0001). Similarly, a greater proportion of patients in the treatment group exhibited the mobilization of ≥2×10 CD34 cells/kg in 4 or less apheresis days (RR=1.46, 95% CI: 1.01 to 2.12; P=0.04). The addition of plerixafor significantly increased the total collection of CD34 cells (random: MD=4.21; 95% CI: 2.85 to 5.57; P<0.00001). Meta-analysis indicated no significant increase in adverse events with the addition of plerixafor for HSC mobilization (RR=1.03, 95% CI: 0.99 to 1.06; P=0.16). On the whole, the findings of this study indicate that the addition of plerixafor to G-CSF leads to an increased HSC collection in a shorter period of time with no concomitant increase in adverse events. Further randomized controlled trials with a larger sample size evaluating short term efficacy, as well as long term survival would help to further strengthen the evidence on this subject.

摘要

普乐沙福联合粒细胞集落刺激因子(G-CSF)已被用于将造血干细胞(HSCs)动员至外周血,以便采集并随后用于非霍奇金淋巴瘤(NHL)和多发性骨髓瘤(MM)患者的自体移植。本研究的目的是系统检索已发表的文献,分析关于额外使用普乐沙福对NHL和MM患者成功进行造血干细胞动员的疗效证据,并评估该药物的安全性。通过电子检索PubMed、Scopus、Cochrane对照试验中心注册库(CENTRAL)和谷歌学术数据库,查找截至2019年3月发表的英文研究。本综述文章纳入了五项研究(三项关于NHL,两项关于MM)。对治疗组364例患者和对照组368例患者的数据进行的荟萃分析表明,在4个或更少的单采天数内动员≥5/6×10 CD34细胞/kg,普乐沙福 + G-CSF组优于单独使用G-CSF组(RR = 2.59,95% CI:1.40至4.81;P < 0.0001)。同样,治疗组中更大比例的患者在4个或更少的单采天数内表现出动员≥2×10 CD34细胞/kg(RR = 1.46,95% CI:1.01至2.12;P = 0.04)。添加普乐沙福显著增加了CD34细胞的总采集量(随机效应模型:MD = 4.21;95% CI:2.85至5.57;P < 0.00001)。荟萃分析表明,添加普乐沙福进行造血干细胞动员时不良事件没有显著增加(RR = 1.03,95% CI:0.99至1.06;P = 0.16)。总体而言,本研究结果表明,在G-CSF基础上加用普乐沙福可在更短时间内增加造血干细胞采集量,且不良事件没有随之增加。进一步开展更大样本量的随机对照试验,评估短期疗效以及长期生存率,将有助于进一步加强关于该主题的证据。

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Mozobil® (Plerixafor, AMD3100), 10 years after its approval by the US Food and Drug Administration.莫泽比利(普乐沙福,AMD3100),在美国食品药品监督管理局批准其上市十年后。
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Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study.普乐沙福用于动员和采集日本非霍奇金淋巴瘤患者自体移植的造血干细胞:一项随机2期研究。
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