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健康志愿者进行实验性呼吸困难研究引发不良心理反应的非零风险:可能的伦理影响。

Non-zero risk of adverse psychological reactions induced by experimental dyspnoea studies in healthy volunteers: possible ethical implications.

作者信息

Lavault Sophie, Niérat Marie-Cécile, Nion Nathalie, Didier Caroline, Serresse Laure, Morélot-Panzini Capucine, Similowski Thomas

机构信息

Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.

AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, Hôpital Pitié-Salpêtrière, Service de Médecine de Réadaptation Respiratoire (Département R3S), Paris, France.

出版信息

ERJ Open Res. 2025 Sep 22;11(5). doi: 10.1183/23120541.01342-2024. eCollection 2025 Sep.

DOI:10.1183/23120541.01342-2024
PMID:40989788
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12451596/
Abstract

BACKGROUND

Experimentally inducing dyspnoea in healthy volunteers is a powerful research tool. Even though this approach is not considered to carry particular risks, dyspnoea occurs in a general context of stress. We hypothesised that experimental dyspnoea could be traumatic in some individuals, with immediate or delayed adverse psychological reactions.

METHODS

40 participants (median (interquartile range) age 38.7 (29.7-49.1) years; 20 women) were exposed, in random order, to inspiratory threshold loading (ITL; "excessive breathing effort"; unpleasantness rating 6 (4-7) on a 0-10 scale) and carbon dioxide stimulation with restricted ventilatory response (CO-rv; "air hunger"; unpleasantness rating 7 (7-8)). Participants were evaluated immediately after induced dyspnoea, at 7 days and after a further 3 months.

RESULTS

Peritraumatic Distress Inventory (PDI) scores were higher immediately after CO-rv than after ITL (3 (1-6.5) 2 (0-3); p<0.0001). After 7 days, six participants (15%) had an Impact of Event Scale-Revised (IES-R) score ≥12 (high risk of post-traumatic stress disorder (PTSD)). They had significantly higher baseline anxiety trait indicators than the participants with an IES-R score <12 (baseline Anxiety Sensitivity Index 27.5 (14.75-61.25) 10 (3-19); p=0.0087). At 3 months, no participant had a PTSD Checklist for DSM-5 (PCL-5) score suggestive of PTSD (1 (0-4), range 0-23, threshold 33) but the six participants with IES-R ≥12 on day 7 had significantly higher PCL-5 scores (13.5 (1-21.5) 0 (0-4); p=0.0014).

CONCLUSIONS

Although no severe situations were encountered, this study highlights the need for caution when designing experimental dyspnoea studies, particularly when involving individuals with high trait anxiety.

摘要

背景

在健康志愿者中通过实验诱导呼吸困难是一种强大的研究工具。尽管这种方法不被认为具有特殊风险,但呼吸困难是在压力的总体背景下发生的。我们假设实验性呼吸困难在某些个体中可能具有创伤性,会引发即时或延迟的不良心理反应。

方法

40名参与者(年龄中位数(四分位间距)为38.7(29.7 - 49.1)岁;20名女性)被随机依次暴露于吸气阈值负荷(ITL;“过度呼吸努力”;在0 - 10分制中的不愉快评分为6(4 - 7))和伴有受限通气反应的二氧化碳刺激(CO - rv;“空气饥饿”;不愉快评分为7(7 - 8))。在诱导呼吸困难后即刻、7天及再过3个月时对参与者进行评估。

结果

创伤期痛苦量表(PDI)得分在CO - rv后即刻高于ITL后(3(1 - 6.5)对2(0 - 3);p < 0.0001)。7天后,6名参与者(15%)事件影响量表修订版(IES - R)得分≥12(创伤后应激障碍(PTSD)高风险)。他们的基线焦虑特质指标显著高于IES - R得分<12的参与者(基线焦虑敏感性指数为27.5(14.75 - 61.25)对10(3 - 19);p = 0.0087)。3个月时,没有参与者的DSM - 5创伤后应激障碍检查表(PCL - 5)得分提示患有PTSD(1(0 - 4),范围0 - 23,阈值33),但7天时IES - R≥12的6名参与者的PCL - 5得分显著更高(13.5(1 - 21.5)对0(0 - 4);p = 0.0014)。

结论

尽管未遇到严重情况,但本研究强调在设计实验性呼吸困难研究时需要谨慎,特别是当涉及特质焦虑高的个体时。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81d2/12451596/b83529faaab6/01342-2024.02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81d2/12451596/26b1ce7c117a/01342-2024.01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81d2/12451596/b83529faaab6/01342-2024.02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81d2/12451596/26b1ce7c117a/01342-2024.01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81d2/12451596/b83529faaab6/01342-2024.02.jpg

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