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应用映射函数估计豚草过敏免疫治疗试验的效用值。

Application of a Mapping Function to Estimate Utilities for Ragweed Allergy Immunotherapy Trials.

作者信息

Dick Katherine, Briggs Andrew, Brandi Henrik

机构信息

Health Economist, Avalon Health Economics, 26 Washington Street, Floor 2, Morristown, NJ, 07960, USA.

London School of Hygiene and Tropical Medicine, London, UK.

出版信息

Pharmacoecon Open. 2020 Dec;4(4):649-655. doi: 10.1007/s41669-020-00205-y.

Abstract

BACKGROUND

Ragweed pollen sensitivity is a common cause of allergic rhinitis (AR) worldwide. AR symptoms include itchy and runny eyes, sneezing, blocked nose, impaired sleep and social and emotional problems, which can have a significant impact on quality of life.

OBJECTIVE

The objective of this analysis was to estimate utilities for two pooled standardised quality (SQ) ragweed sublingual immunotherapy (SLIT) tablet trials by applying a previously developed mapping algorithm. This study validated the algorithm and extended its application to ragweed seasonal allergy trials. The mapping algorithm relates disease-specific quality-of-life scores to preference-based utilities that may be used to calculate quality-adjusted life-years (QALYs) in cost-effectiveness studies.

METHODS

A mapping algorithm based on a grass pollen allergy immunotherapy trial, GT-08 (EudraCT no. 2004-000083-27) was applied to pooled data from two ragweed pollen immunotherapy trials, P05233 (EudraCT 2008-003863-38) and P05234 (EudraCT 2008-003864-20) to generate EuroQoL 5-Dimensions, 3-Levels (EQ-5D-3L) utilities from Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) data.

RESULTS

The mean utility difference between the SQ ragweed SLIT tablet and placebo was 0.025 [95% confidence interval (CI) 0.011-0.038]. The SQ ragweed SLIT tablet showed an incremental quality-adjusted life-days (QALDs) benefit of 1.900 (95% CI 0.835-2.916) over 75 days.

CONCLUSIONS

Application of a previously developed mapping function allowed for the calculation of QALDs associated with the SQ ragweed SLIT tablet. The results showed a QALD benefit of the SQ ragweed SLIT tablet in P05233 and P05234 trials in the treatment of ragweed pollen-induced AR.

摘要

背景

在全球范围内,豚草花粉过敏是过敏性鼻炎(AR)的常见病因。AR症状包括眼睛瘙痒、流泪、打喷嚏、鼻塞、睡眠障碍以及社交和情绪问题,这些会对生活质量产生重大影响。

目的

本分析的目的是通过应用先前开发的映射算法,估算两项合并的标准化质量(SQ)豚草舌下免疫疗法(SLIT)片剂试验的效用值。本研究验证了该算法,并将其应用扩展至豚草季节性过敏试验。该映射算法将特定疾病的生活质量评分与基于偏好的效用值相关联,后者可用于成本效益研究中计算质量调整生命年(QALY)。

方法

将基于一项草花粉过敏免疫疗法试验GT - 08(欧盟临床试验注册号2004 - 000083 - 27)的映射算法应用于两项豚草花粉免疫疗法试验P05233(欧盟临床试验注册号2008 - 003863 - 38)和P05234(欧盟临床试验注册号2008 - 003864 - 20)的汇总数据,以从变应性鼻结膜炎生活质量问卷(RQLQ)数据生成欧洲五维健康量表3级(EQ - 5D - 3L)效用值。

结果

SQ豚草SLIT片剂与安慰剂之间的平均效用差值为0.025[95%置信区间(CI)0.011 - 0.038]。在75天内,SQ豚草SLIT片剂显示出质量调整生命天数(QALD)增加了1.900(95%CI 0.835 - 2.916)。

结论

应用先前开发的映射函数能够计算与SQ豚草SLIT片剂相关的QALD。结果表明,在P05233和P05234试验中,SQ豚草SLIT片剂在治疗豚草花粉诱导的AR方面具有QALD益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c33/7688878/3d851c17e58c/41669_2020_205_Fig1_HTML.jpg

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