Opri Francesca, Opri Roberta, Zaffanello Marco, Rigotti Erika
Pediatric Clinic, Magalini Hospital, I-37069 Villafranca di Verona, Italy.
Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, Pediatric Clinic, University of Verona, I-37129 Verona, Italy.
Children (Basel). 2024 Sep 4;11(9):1086. doi: 10.3390/children11091086.
Infantile haemangiomas (IHs) sometimes require treatment with propranolol. Sleep disturbances are the most frequently reported side effects. Monitoring adverse drug events necessitates repeated hospital visits, which can be challenging during a pandemic.
To explore the effectiveness of a new electronic questionnaire in identifying sleep disturbances related to treatment with propranolol and potential confounding factors. To evaluate the response rate to the questionnaire. To report the proportion of patients on propranolol with sleep disturbances.
In an observational, prospective cohort study, caregivers provided clinical information during ambulatory visits and via an electronic questionnaire after an 8-week treatment course with propranolol and at the time of treatment interruption. Adverse drug reaction reporting forms were assessed for causality.
The questionnaire response rate was 91%, and the completion rate was 100%. A total of 59% of patients experienced sleep disturbances during propranolol treatment, which were considered adverse reactions. Sleep disorders were frequent during sleep regression phases and in subjects who fell asleep during physical contact with caregivers or bed-sharing with parents.
The application of this questionnaire allows for identifying adverse sleep events associated with propranolol in IHs and potential confounders. Counselling on sleep hygiene is recommended before treatment onset.
婴儿血管瘤（IHs）有时需要使用普萘洛尔进行治疗。睡眠障碍是最常报告的副作用。监测药物不良事件需要多次住院就诊，在大流行期间这可能具有挑战性。
探讨一种新的电子问卷在识别与普萘洛尔治疗相关的睡眠障碍及潜在混杂因素方面的有效性。评估问卷的回复率。报告使用普萘洛尔且有睡眠障碍的患者比例。
在一项观察性前瞻性队列研究中，照料者在门诊就诊期间以及在普萘洛尔治疗8周疗程后和治疗中断时通过电子问卷提供临床信息。对药物不良反应报告表进行因果关系评估。
问卷回复率为91%，完成率为100%。共有59%的患者在普萘洛尔治疗期间出现睡眠障碍，这些被视为不良反应。在睡眠倒退阶段以及在与照料者身体接触或与父母同床共枕时入睡的受试者中，睡眠障碍很常见。
应用该问卷可以识别婴儿血管瘤患者中与普萘洛尔相关的不良睡眠事件及潜在混杂因素。建议在治疗开始前进行睡眠卫生咨询。
