疾病修饰疗法的对多发性硬化症疲劳的影响
Samantha Cruz Rivera1, Olalekan Lee Aiyegbusi2, Daniela Piani Meier3
1Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
Multiple sclerosis and related disorders
|October 15, 2023
概括
疲劳是多发性硬化症 (MS) 患者的主要关注点,但目前的疾病修饰疗法 (DMT) 试验很少将其作为结果. 需要更多的研究来理解DMT.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 疲劳是患有多发性硬化症 (PwMS) 的人的普遍和衰弱症状.
- 疾病修饰疗法 (DMT) 是MS的标准治疗方法,但它们对疲劳的影响尚未得到充分证实.
- 现有的MS治疗的随机临床试验 (RCT) 对疲劳结果的数据有限.
研究的目的:
- 为了确定疲劳是否被评估为MS DMT试验的结果.
- 在PwMS中评估DMTs对疲劳的影响.
- 评估MS试验的方法质量,包括疲劳作为结果.
主要方法:
- 从1993年到2023年对MEDLINE,EMBASE和ClinicalTrials.gov进行测量疲劳的RCT的系统搜索.
- 通过使用CONSORT-Patient-Reported Outcomes (PRO) 声明评估报告质量.
- 使用Cochrane手册的RoB 2工具对偏见风险的评估.
主要成果:
- 在130个确定的RCT中,只有7个 (5%) 将疲劳作为结果.
- 在这7项试验中,只有两项报告了疲劳的统计学上显著的结果.
- 报告疲劳结果的情况不够理想 (36%的人遵守CONSORT-PRO),四项试验存在高偏差风险.
结论:
- 疲劳在MS DMT临床试验中的结果不足.
- 在MS试验中,患者报告的疲劳结果的报告质量是不理想的.
- 对于专门包括并严格评估疲劳的RCT非常需要,以指导PwMS的治疗决策.
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