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在系统性红斑狼的药物试验中选择报告响应率的指标:偏好和相对敏感度

Jingru Tian^1,2, Shuntong Kang³, Dingyao Zhang^4,5

¹Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, Jiangsu, China qianlu5860@pumcderm.cams.cn jingru.tian@pumcderm.cams.cn zhaoming301@pumcderm.cams.cn.

Lupus science & medicine

|October 5, 2023

概括

这项研究比较了系统性红斑狼 (SLE) 临床试验的疗效指标. 建议使用SLE疾病活动指数4 (SLEDAI-4) 和SLE响应指数4来评估治疗响应率.

科学领域:

风湿病学和免疫学
临床试验方法论临床试验方法论
药理疗效评价药理疗效评价

背景情况:

系统性红斑狼 (SLE) 是一种慢性自身免疫性疾病,需要对有效治疗进行评估.
对于SLE临床试验,有许多有效性指标存在,但它们的可比性尚不清楚.
选择适当的初级结果对于准确评估SLE药物治疗至关重要.

结论:

在SLE试验中选择主要结果需要灵活性和全面性.
建议仔细解释SLEDAI-4结果,以防止对治疗疗效的高估.
由于包含的RCT的数量,在子组分析中发现了局限性.

关键词:

临床试验临床试验结果评估,医疗保健系统性红斑性狼红斑性狼系统性狼

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