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加拿大国立癌症研究所临床试验组的一项II期研究:Didemnin B用于组织学类型良好的非霍奇金淋巴瘤。

Didemnin B in favourable histology non-Hodgkin's lymphoma. A phase II study of the National Cancer Institute of Canada Clinical Trials Group.

作者信息

Goss G, Muldal A, Lohmann R, Taylor M, Lopez P, Armitage G, Steward W P

机构信息

Ottawa General Hospital, Canada.

出版信息

Invest New Drugs. 1995;13(3):257-60. doi: 10.1007/BF00873810.

Abstract

Ten patients with previously untreated stage III/IV low grade histology non-Hodgkin's lymphoma received a 1-hour intravenous infusion of Didemnin B 2.3 mg/m2 weekly for 4 weeks repeated every 6 weeks. 40% of patients experienced significant hypersensitivity reactions, one of which was life-threatening, despite premedication with diphenhydramine and cimetidine. Other toxicities included nausea, vomiting, fatigue, diarrhea and skin rashes. No objective responses were seen. Given the serious toxicity and lack of activity in a non-pretreated group of patients, the study was closed early. Further investigation of Didemnin B at this dose and schedule is not recommended.

摘要

10例先前未经治疗的Ⅲ/Ⅳ期低级别组织学非霍奇金淋巴瘤患者接受了每周一次、每次2.3mg/m²的Didemnin B静脉输注,持续1小时,共4周,每6周重复一次。尽管预先使用了苯海拉明和西咪替丁进行预处理,但40%的患者出现了严重的过敏反应,其中1例危及生命。其他毒性反应包括恶心、呕吐、疲劳、腹泻和皮疹。未观察到客观缓解。鉴于在未经预处理的患者组中存在严重毒性且缺乏活性,该研究提前终止。不建议按此剂量和方案对Didemnin B进行进一步研究。

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