Wynzora乳膏有哪些不良反应?
Almirall is a Spanish-based global pharmaceutical company focused on skin health.近日,该公司宣布,在首批欧洲国家(西班牙、德国、英国)推出(钙泊三醇和二丙酸倍他米松,CAL/BDP,w/w,0.005%/0.064%):该药作为每日一次的外用疗法,用于≥18岁成人治疗轻度至中度斑块型银屑病,包括头皮部位,那么,Wynzora乳膏有哪些不良反应?
Wynzora cream adverse reactions
Wynzora乳膏局部的上市后报告包括:萎缩、条纹、毛细血管扩张、瘙痒、干燥、色素沉着不足、口周皮炎、继发性感染和痱子。
Ophthalmic adverse reactions such as cataracts, glaucoma, and increased intraocular pressure have been reported during use of Wynzora cream.
Clinical adverse reactions of Wynzora cream
在一项针对成年斑块型银屑病受试者的随机、多中心、前瞻性、载体和活性对照临床试验中,报告了以下不良反应发生率。受试者使用WYNZORA乳膏、钙泊三烯/二丙酸倍他米松局部混悬液(0.005%/0.064%或赋形剂,每日一次,持续8周。WYNZORA乳膏的平均周剂量为33.8 g。总计342名受试者接受了WYNZORA乳膏治疗,337名接受了钙泊三烯/二丙酸倍他米松局部混悬液治疗,0.005%/0.064%和115名接受了赋形剂治疗。大多数受试者为白人(87%)和男性(62%)。约72%的人是非西班牙裔/拉丁裔。平均年龄52岁,年龄18 ~ 89岁。
The most common adverse reactions reported in ≥1% of subjects treated with WYNZORA Cream and more frequently than vehicle are given in Table 1 below.
Table 1: Adverse reactions through week 8
|
Preemption Terms |
WYNZORA Cream(N=342) |
Excipient cream (N=115) |
|
Upper respiratory tract infection (URI)a |
7% |
5% |
|
headache |
2% |
0% |
|
Application site stimulation |
1% |
0% |
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