当前位置: X-MOL 学术N. Engl. J. Med. › 论文详情
Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis
The New England Journal of Medicine ( IF 70.670 ) Pub Date : 2020-02-13 , DOI: 10.1056/nejmoa1803537
Michael Walsh; Peter A. Merkel; Chen-Au Peh; Wladimir M. Szpirt; Xavier Puéchal; Shouichi Fujimoto; Carmel M. Hawley; Nader Khalidi; Oliver Floßmann; Ron Wald; Louis P. Girard; Adeera Levin; Gina Gregorini; Lorraine Harper; William F. Clark; Christian Pagnoux; Ulrich Specks; Lucy Smyth; Vladimir Tesar; Toshiko Ito-Ihara; Janak Rashme de Zoysa; Wojciech Szczeklik; Luis Felipe Flores-Suárez; Simon Carette; Loïc Guillevin; Charles D. Pusey; Alina L. Casian; Biljana Brezina; Andrea Mazzetti; Carol A. McAlear; Elizabeth Broadhurst; Donna Reidlinger; Samir Mehta; Natalie Ives; David R.W. Jayne

Background More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis. Methods We conducted a randomized trial with a 2-by-2 factorial design to evaluate the use of plasma exchange and two regimens of oral glucocorticoids in patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m2 of body-surface area or diffuse pulmonary hemorrhage). Patients were randomly assigned to undergo plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group). Patients were also randomly assigned to follow either a standard-dose regimen or a reduced-dose regimen of oral glucocorticoids. Patients were followed for up to 7 years for the primary composite outcome of death from any cause or end-stage kidney disease (ESKD). Results Death from any cause or ESKD occurred in 100 of 352 patients (28.4%) in the plasma-exchange group and in 109 of 352 patients (31.0%) in the control group (hazard ratio, 0.86; 95% confidence interval [CI], 0.65 to 1.13; P=0.27). The results were similar in subgroup analyses and in analyses of secondary outcomes. We also assessed the noninferiority of a reduced-dose regimen of glucocorticoids to a standard-dose regimen, using a noninferiority margin of 11 percentage points. Death from any cause or ESKD occurred in 92 of 330 patients (27.9%) in the reduced-dose group and in 83 of 325 patients (25.5%) in the standard-dose group (absolute risk difference, 2.3 percentage points; 90% CI, −3.4 to 8.0), which met the criterion for noninferiority. Serious infections at 1 year were less common in the reduced-dose group than in the standard-dose group (incidence rate ratio, 0.69; 95% CI, 0.52 to 0.93), but other secondary outcomes were similar in the two groups. Conclusions Among patients with severe ANCA-associated vasculitis, the use of plasma exchange did not reduce the incidence of death or ESKD. A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD. (Funded by the U.K. National Institute for Health Research and others; PEXIVAS Current Controlled Trials number, ISRCTN07757494; ClinicalTrials.gov number, NCT00987389.) VISUAL ABSTRACT Plasma Exchange and Glucocorticoids for ANCA-Associated Vasculitis
更新日期:2020-02-13

 

全部期刊列表>>
Springer Nature 2019高下载量文章和章节
化学/材料学中国作者研究精选
《科学报告》最新环境科学研究
ACS材料视界
自然科研论文编辑服务
中南大学国家杰青杨华明
南开大学陈弓课题组招聘启事
中南大学
材料化学和生物传感方向博士后招聘
课题组网站
X-MOL
北京大学分子工程苏南研究院
华东师范大学分子机器及功能材料
中山大学化学工程与技术学院
试剂库存
天合科研
down
wechat
bug