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天冬酰胺酶治疗急性淋巴细胞白血病和自然杀伤/T细胞淋巴瘤相关毒性的发生率及管理:一项观察性研究

Incidence and Management of Toxicity Associated with LAsparaginase in the Treatment of ALL and NK/TCell Lymphoma: an Observational Study.

作者信息

Yeang Shu Hui, Chan Alexandre, Tan Chuen Wen, Lim Soon Thye, Ng Heng Joo

机构信息

Clinical Pharmacist, Department of Pharmacy, Singapore General Hospital, Singapore Email :

出版信息

Asian Pac J Cancer Prev. 2016;17(7):3155-60.

PMID:27509944
Abstract

BACKGROUND

Lasparaginase (ASNase) is commonly used in the treatment of acute lymphoblastic leukemia (ALL) and natural killer (NK)/Tcell lymphoma. This study was designed to describe the incidence of toxicity associated with ASNase in Asian adults. Secondary objectives were to investigate the management and impact of toxicity on subsequent ASNase use, and to compare the actual management against current recommendations.

MATERIALS AND METHODS

In this retrospective, multicenter, observational study, Asian patients ≥ 18 years old who received ≥ 1 dose of the native E. coli ASNase from 2008 to 2013 were included. Patients were excluded if they did not receive ASNase. Endpoints of this study were development of specific toxicities, whether ASNase was discontinued or rechallenged, and developmentg of recurrent toxicity. All data analyses were performed using SPSS version 20.0.

RESULTS

A total of 56 patients were analyzed. Mean (±SD) age was 36.2 (±15.2) years old, with 62.5% being males, 55.4% with ALL and 28.6% with NK/Tcell lymphoma. Hypersensitivity (12.5%) was associated with the highest incidence of toxicity (6 out of 7 patients had Grade 3 and 4 toxicity), followed by 10.7% for hepatic transaminitis, 3.6% for nonCNS thrombosis and 1.8% each for hyperbilirubinemia and pancreatitis. Hypersensitivity recurred in the 3 patients who were rechallenged with E. coli ASNase.

CONCLUSIONS

ASNase is associated with a wide range of toxicities, with hypersensitivity being the most commonly observed among Asian adult patients.

摘要

背景

天冬酰胺酶(ASNase)常用于治疗急性淋巴细胞白血病(ALL)和自然杀伤(NK)/T细胞淋巴瘤。本研究旨在描述亚洲成年人中与ASNase相关的毒性发生率。次要目标是调查毒性的管理及其对后续ASNase使用的影响,并将实际管理与当前建议进行比较。

材料与方法

在这项回顾性、多中心、观察性研究中,纳入了2008年至2013年期间接受≥1剂天然大肠杆菌ASNase的≥18岁亚洲患者。未接受ASNase的患者被排除。本研究的终点是特定毒性的发生、ASNase是否停药或再次使用以及复发性毒性的发生。所有数据分析均使用SPSS 20.0版进行。

结果

共分析了56例患者。平均(±标准差)年龄为36.2(±15.2)岁,男性占62.5%,ALL患者占55.4%,NK/T细胞淋巴瘤患者占28.6%。超敏反应(12.5%)的毒性发生率最高(7例患者中有6例为3级和4级毒性),其次是肝转氨酶升高,发生率为10.7%,非中枢神经系统血栓形成发生率为3.6%,高胆红素血症和胰腺炎发生率均为1.8%。3例接受大肠杆菌ASNase再次治疗的患者出现了超敏反应复发。

结论

ASNase与多种毒性相关,超敏反应是亚洲成年患者中最常见的毒性反应。

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