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Allergy:中度至重度过敏成人中,草树过敏免疫疗法与安慰剂RQLQ评分的最小重要差异

2022-01-21 AlexYang MedSci原创

调查了中度至重度过敏成人中,草树过敏免疫疗法与安慰剂RQLQ评分的最小重要差异情况。

草树的花粉可引发过敏性鼻炎(AR),其症状和相关后果可对生活质量(QoL)产生负面影响。鼻结膜炎生活质量问卷(RQLQ)经常用于AR临床试验来评估QoL。为了帮助解释RQLQ数据,最小重要差异(MID)可用于评估治疗组之间QoL的平均差异是否具有临床意义。在季节性过敏中,MID因过敏原、花粉暴露、症状严重程度、患者年龄和治疗而不同;另外,相同的MID也不能适用于所有情况。

近期,来自美国的研究人员在《Allergy》上发表文章,调查了中度至重度过敏成人中,草树过敏免疫疗法与安慰剂RQLQ评分的最小重要差异情况

研究人员使用了SQ舌下免疫治疗药片在中、重度过敏成人中的四项III期、随机、双盲和安慰剂对照临床试验的数据,在分布方法的支持下,使用了anchor-based方法学,得出了草花粉过敏(在花粉高峰期[n=501]和整个花粉季节[n=514])和树花粉过敏(在桦树[n=516]和树花粉季节[n=518])的组间MID。

研究结果发现,对于草花粉过敏,anchor-based的组间MIDs在整个花粉季节(n=343)为0.22,在花粉高峰季节(n=335)为0.10。对于树花粉过敏,anchor-based的组间MIDs在树花粉季节(n=306)为0.26,在桦树花粉季节(n=305)为0.16(代表高峰季节)。另外,基于分布的MIDs支持了anchor-based的数值。

使用anchor-based方法获得的草和树花粉过敏RQLQ的最小重要差异情况

综上所述,该分析得出了针对所评估试验人群在一定条件下的组间MID,强调了需要一系列的MID来反映季节过敏性疾病的独特性质

原始出处:

Michael S Blaiss , Ruta Gronskyte Juhl , Leonard Q C Siew et al. Determining the minimal important differences in the RQLQ score with grass and tree allergy immunotherapy versus placebo in adults with moderate-to-severe allergy. Allergy. Jan 2022

 

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