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Abiraterone

肿瘤

关键词肿瘤 药物 前列腺癌

词汇介绍

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解析

Abiraterone
释    义   阿比特龙
例    句   Phase III trial of abiraterone is planned for next year.   阿比特龙的III期试验计划在明年进行。

概述

阿比特龙是一种白色至淡白色的化学物质;化学名称叫做:17-(3-吡啶基)雄甾-5,16-二烯-3β-醇,分子式为:C24H31NO;其分子量为:349.51。阿比特龙是CYP17A1(17α-羟化酶/C17,20-裂解酶)的一种有效抑制剂,无细胞试验中IC50为2 nm,可用于治疗前列腺癌症,目前已有上市产品。阿比特龙专利药是由美国Couger Biotechnology(现已被强生收购)研发,于2011年由美国FDA批准上市,目前已进入中国市场,该药商品名为Zytiga

Olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: a randomised, double-blind, placebo-controlled, phase 2 trial复制标题

奥拉帕瑞联合阿比特龙治疗转移性去势抵抗性前列腺癌: 一项随机、双盲、安慰剂对照的2期临床试验

发表时间:2018-07-01

影响因子:35.4

作者: Noel Clarke

期刊:Lancet Oncol.

Between Nov 25, 2014, and July 14, 2015, 171 patients were assessed for eligibility. Of those, 142 patients were randomly assigned to receive olaparib and abiraterone (n=71) or placebo and abiraterone (n=71). The clinical cutoff date for the final analysis was Sept 22, 2017. Median rPFS was 13·8 months (95% CI 10·8–20·4) with olaparib and abiraterone and 8·2 months (5·5–9·7) with placebo and abiraterone (hazard ratio [HR] 0·65, 95% CI 0·44–0·97,p=0·034). The most common grade 1–2 adverse events were nausea (26 [37%] patients in the olaparib group vs 13 [18%] patients in the placebo group), constipation (18 [25%] vs eight [11%]), and back pain (17 [24%] vs 13 [18%]). 38 (54%) of 71 patients in the olaparib and abiraterone group and 20 (28%) of 71 patients in the placebo and abiraterone group had grade 3 or worse adverse events, including anaemia (in 15 [21%] of 71 patients vs none of 71), pneumonia (four [6%] vs three [4%]), and myocardial infarction (four [6%] vs none). Serious adverse events were reported by 24 (34%) of 71 patients receiving olaparib and abiraterone (seven of which were related to treatment) and 13 (18%) of 71 patients receiving placebo and abiraterone (one of which was related to treatment). One treatment-related death (pneumonitis) occurred in the olaparib and abiraterone group.

译文

2014年11月25日至2015年7月14日期间,对171名患者进行了资格评估。其中,142名患者被随机分配接受奥拉帕尼和阿比特龙(n = 71)或安慰剂和阿比特龙(n = 71)。最终分析的临床cuto ff日期为2017年9月22日。中位rPFS为13.8个月(95%CI 10·8-20·4),奥拉帕尼和阿比特龙为8·2个月(5·5-9·7) )用安慰剂和阿比特龙(风险比[HR] 0·65,95%CI 0·44-0·97,p = 0.034)。最常见的1-2级不良事件为恶心(奥拉帕尼组26例[37%]患者与安慰剂组13例[18%]),便秘(18例[25%] vs 8例[11%]),和背痛(17 [24%] vs 13 [18%])。奥拉帕尼和阿比特龙组71例患者中有38例(54%),安慰剂组和阿比特龙组71例患者中有20例(28%)有3级或更严重的不良事件,包括贫血(71例患者中15例[21%] vs没有71),肺炎(4 [6%]对3 [4%])和心肌梗死(4 [6%]与无)。接受奥拉帕尼和阿比特龙的71例患者中有24例(34%)报告了严重不良事件(其中7例与治疗有关),71例接受安慰剂和阿比特龙治疗的患者中有13例(18%)(其中一例与治疗有关)。奥拉帕尼和阿比特龙组发生一例与治疗相关的死亡(肺炎)。