在参与一项临床试验的儿童中，用腰果进行食物激发试验后，与健康相关的生活质量没有差异。
No difference in health-related quality of life, after a food challenge with cashew nut in children participating in a clinical trial.
作者信息
van der Valk J P M, Gerth van Wijk R, Flokstra-de Blok B M J, van der Velde J L, de Groot H, Wichers H J, Dubois A E J, de Jong N W
机构信息
Department Of Internal Medicine, Allergology, Erasmus MC, Rotterdam, The Netherlands.
Department of General Practice, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
出版信息
Pediatr Allergy Immunol. 2016 Dec;27(8):812-817. doi: 10.1111/pai.12621. Epub 2016 Sep 16.
BACKGROUND
Previous studies showed that health-related quality of life (HRQL) significantly improved after the food challenge, with greater improvements in HRQL after a negative outcome than after a positive outcome. It is currently unknown whether this also occurs in patients undergoing DBPCFCs with cashew nut in the context of a clinical trial.
METHODS
Quality of life was studied in children enrolled in a cashew nut study using Food Allergy Quality of Life Questionnaires (FAQLQs). Children, teenagers and parents of the children completed the questionnaires before the challenge test and 6 months after the DBPCFC with cashew nut. The difference in the change in HRQL between the children with a positive and negative DBPCFC outcome was studied by Mann-Whitney U-test.
RESULTS
In total, 112 children (67 boys, median age of 9 years) were included. The children, teenagers and parents of the children completed 143 sets of questionnaires in total. There were no significant differences in baseline total and domain scores compared to the follow-up scores in the FAQLQ-CF, FAQLQ-TF and FAQLQ-PF. In children, the delta FAIM score in the negative DBPCFC tested group was significantly better than the delta FAIM score in the positive challenged group (p = 0.026). There were no significant differences in the changes in the scores of the FAQLQ-CF and FAQLQ-PF in the children with a positive challenge outcome, compared to the children with a negative challenge result. However, there was a significant difference in the change in score between the latter groups in the domain 'accidental exposure' of the FAQLQ-TF (p = 0.049).
CONCLUSION
This study showed no difference in the change in HRQL scores after a DBPCFC with cashew nut in children participating in a clinical trial. The utility of HRQL as an outcome for clinical trials in food allergy may be limited if participant baseline HRQL is relatively unimpaired.
背景
先前的研究表明，食物激发试验后健康相关生活质量（HRQL）显著改善，阴性结果后的HRQL改善程度大于阳性结果。目前尚不清楚在临床试验背景下接受腰果双盲安慰剂对照食物激发试验（DBPCFC）的患者中是否也会出现这种情况。
方法
使用食物过敏生活质量问卷（FAQLQs）对参加腰果研究的儿童的生活质量进行研究。儿童、青少年及其父母在激发试验前以及腰果DBPCFC后6个月完成问卷。通过曼-惠特尼U检验研究DBPCFC结果为阳性和阴性的儿童之间HRQL变化的差异。
结果
总共纳入了112名儿童（67名男孩，中位年龄9岁）。儿童、青少年及其父母总共完成了143套问卷。与FAQLQ-CF、FAQLQ-TF和FAQLQ-PF中的随访分数相比，基线总分和领域分数没有显著差异。在儿童中，阴性DBPCFC测试组的FAIM得分变化显著优于阳性激发组（p = 0.026）。与激发结果为阴性的儿童相比，激发结果为阳性的儿童在FAQLQ-CF和FAQLQ-PF得分变化方面没有显著差异。然而，在FAQLQ-TF的“意外暴露”领域中，后一组之间的得分变化存在显著差异（p = 0.049）。
结论
本研究表明，参与临床试验的儿童在进行腰果DBPCFC后，HRQL得分变化没有差异。如果参与者的基线HRQL相对未受损害，HRQL作为食物过敏临床试验结果的效用可能有限。
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