已入深夜,您辛苦了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!祝你早点完成任务,早点休息,好梦!

Efficacy and Tolerability of Pegloticase for the Treatment of Chronic Gout in Patients Refractory to Conventional Treatment

医学 痛风 内科学 耐受性 耐火材料(行星科学) 不利影响 物理 天体生物学
作者
John S. Sundy,Herbert S. B. Baraf,Robert A. Yood,N. Lawrence Edwards,Sergio Gutiérrez‐Ureña,Edward L. Treadwell,Janitzia Vázquez-Mellado,William B. White,Peter E. Lipsky,Zeb Horowitz,William J. Huang,Allan N. Maroli,Royce W. Waltrip,Steven A. Hamburger,Michael A. Becker
出处
期刊:JAMA [American Medical Association]
卷期号:306 (7): 711-711 被引量:483
标识
DOI:10.1001/jama.2011.1169
摘要

Patients with chronic disabling gout refractory to conventional urate-lowering therapy need timely treatment to control disease manifestations related to tissue urate crystal deposition. Pegloticase, monomethoxypoly(ethylene glycol)-conjugated mammalian recombinant uricase, was developed to fulfill this need.To assess the efficacy and tolerability of pegloticase in managing refractory chronic gout.Two replicate, randomized, double-blind, placebo-controlled trials (C0405 and C0406) were conducted between June 2006 and October 2007 at 56 rheumatology practices in the United States, Canada, and Mexico in patients with severe gout, allopurinol intolerance or refractoriness, and serum uric acid concentration of 8.0 mg/dL or greater. A total of 225 patients participated: 109 in trial C0405 and 116 in trial C0406.Twelve biweekly intravenous infusions containing either pegloticase 8 mg at each infusion (biweekly treatment group), pegloticase alternating with placebo at successive infusions (monthly treatment group), or placebo (placebo group).Primary end point was plasma uric acid levels of less than 6.0 mg/dL in months 3 and 6.In trial C0405 the primary end point was reached in 20 of 43 patients in the biweekly group (47%; 95% CI, 31%-62%), 8 of 41 patients in the monthly group (20%; 95% CI, 9%-35%), and in 0 patients treated with placebo (0/20; 95% CI, 0%-17%; P < .001 and <.04 for comparisons between biweekly and monthly groups vs placebo, respectively). Among patients treated with pegloticase in trial C0406, 16 of 42 in the biweekly group (38%; 95% CI, 24%-54%) and 21 of 43 in the monthly group (49%; 95% CI, 33%-65%) achieved the primary end point; no placebo-treated patients reached the primary end point (0/23; 95% CI, 0%-15%; P = .001 and < .001, respectively). When data in the 2 trials were pooled, the primary end point was achieved in 36 of 85 patients in the biweekly group (42%; 95% CI, 32%-54%), 29 of 84 patients in the monthly group (35%; 95% CI, 24%-46%), and 0 of 43 patients in the placebo group (0%; 95% CI, 0%-8%; P < .001 for each comparison). Seven deaths (4 in patients receiving pegloticase and 3 in the placebo group) occurred between randomization and closure of the study database (February 15, 2008).Among patients with chronic gout, elevated serum uric acid level, and allopurinol intolerance or refractoriness, the use of pegloticase 8 mg either every 2 weeks or every 4 weeks for 6 months resulted in lower uric acid levels compared with placebo.clinicaltrials.gov Identifier: NCT00325195.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刘宇萌完成签到 ,获得积分10
刚刚
1秒前
lvsehx发布了新的文献求助10
1秒前
YOLO完成签到 ,获得积分10
5秒前
Legend_完成签到 ,获得积分10
5秒前
6秒前
6秒前
kelien1205完成签到 ,获得积分10
7秒前
多年以后发布了新的文献求助20
8秒前
左肩微笑发布了新的文献求助10
8秒前
锅包肉爱吃肉完成签到 ,获得积分10
9秒前
顺顺科研完成签到 ,获得积分10
9秒前
牛蛙丶丶完成签到,获得积分10
10秒前
Grandir发布了新的文献求助20
10秒前
hjy完成签到,获得积分10
10秒前
11秒前
meimei完成签到 ,获得积分10
12秒前
12秒前
wenhao完成签到 ,获得积分10
12秒前
刺闰土的猹完成签到,获得积分10
12秒前
99668完成签到,获得积分10
13秒前
可爱的函函应助直觉采纳,获得10
14秒前
麦子发布了新的文献求助10
15秒前
左肩微笑完成签到,获得积分20
16秒前
在水一方应助笔墨留香采纳,获得10
16秒前
璨澄完成签到 ,获得积分10
17秒前
天天快乐应助Li采纳,获得10
17秒前
桀桀桀完成签到,获得积分10
18秒前
简单白风完成签到 ,获得积分10
20秒前
20秒前
青糯完成签到 ,获得积分10
20秒前
清爽的火车完成签到 ,获得积分10
20秒前
ganson完成签到 ,获得积分10
22秒前
22秒前
23秒前
Bismarck完成签到,获得积分20
24秒前
25秒前
25秒前
楚楚完成签到 ,获得积分10
25秒前
wippe完成签到,获得积分10
26秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
Aktuelle Entwicklungen in der linguistischen Forschung 300
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989957
求助须知:如何正确求助?哪些是违规求助? 3532034
关于积分的说明 11255966
捐赠科研通 3270856
什么是DOI,文献DOI怎么找? 1805053
邀请新用户注册赠送积分活动 882252
科研通“疑难数据库(出版商)”最低求助积分说明 809216