發(fā)布時(shí)間：2018-06-02 16:49

  本文選題：銀屑病 + 烏司奴單抗��； 參考：《臨床皮膚科雜志》2014年09期

【摘要】：目的:評(píng)估烏司奴單抗對(duì)中國(guó)3期、雙盲、安慰劑對(duì)照臨床(LOTUS)研究患者健康相關(guān)生活質(zhì)量(HRQoL)的影響。方法:共322例患者,在第0周和第4周隨機(jī)接受烏司奴單抗45mg(n=160)或安慰劑(n=162);第12周和第16周安慰劑組交叉使用烏司奴單抗,而烏司奴單抗組則在第16周繼續(xù)使用烏司奴單抗。第12周HRQoL終點(diǎn)包括皮膚病生活質(zhì)量指數(shù)(DLQI)評(píng)分較基線的變化、單個(gè)DLQI域的變化、DLQI評(píng)分為0分或1分的患者比例以及獲得有臨床意義DLQI改善(評(píng)分降低≥5分)的患者比例。結(jié)果:烏司奴單抗治療患者12周時(shí)DLQI評(píng)分較基線的改善(-9.3分)顯著優(yōu)于安慰劑組(-1.9分)(P0.001)。同樣,烏司奴單抗治療后DLQI≤1分的患者比例顯著高于安慰劑組(42.6%vs 10.7%,P0.001),烏司奴單抗組和安慰劑組治療后分別有71.5%和29.6%的患者DLQI降低≥5分(P均0.001)。烏司奴單抗治療患者12周時(shí)單個(gè)DLQI域與安慰劑相比顯著改善(P0.001)。烏司奴單抗組DLQI的改善在治療28周內(nèi)持續(xù)存在。交叉接受烏司奴單抗的安慰劑組患者,與最初隨機(jī)接受烏司奴單抗治療的患者相比,HRQoL改善程度類(lèi)似。結(jié)論:烏司奴單抗顯著改善了中國(guó)中至重度斑塊狀銀屑病患者的HRQoL。
[Abstract]:Aim: to evaluate the effects of Ulinumab on health related quality of life (HRQoL) in Chinese phase 3, double blind, placebo controlled clinical trials. Methods: a total of 322 patients were randomly assigned to Ulinumab 45mgnn160) or placebo 162g at week 0 and week 4, and Ulinumab was cross-used in the 12th and 16th week placebo group, while Ulinumab was continued in the Ulinumab group at the 16th week. The end point of HRQoL at the 12th week included the change of the quality of life index (DLQI) score of dermatology compared with the baseline, the proportion of patients with a single DLQI domain with a DLQI score of 0 or 1, and the proportion of patients with clinically significant DLQI improvement (score reduction 鈮，

本文編號(hào)：1969480