Society of Junior Doctors, Athens, Greece.
First Department of Pediatrics, "Aghia Sophia" Children's Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Pediatr Allergy Immunol. 2021 Oct;32(7):1533-1558. doi: 10.1111/pai.13522. Epub 2021 May 20.
H1-antihistamines (AHs) are widely used for the treatment of allergic diseases, being one of the most commonly prescribed classes of medications in pediatrics. Newer-generation AHs are associated with fewer adverse effects compared with first-generation AHs. However, their relative harms in the pediatric population still need scrutiny.
We performed a systematic review of randomized controlled trials (RCTs), which included comparisons of safety parameters between an orally administered newer-generation AH and another AH (first- or second-generation), montelukast, or placebo in children aged ≤12 years. We searched MEDLINE and CENTRAL, independently extracted data on study population, interventions, adverse events (AEs), and treatment discontinuations, and assessed the methodologic quality of the included RCTs using the Cochrane's risk of bias tool.
Forty-five RCTs published between 1989 and 2017 met eligibility criteria. The majority of RCTs included school-aged children with allergic rhinitis and had a follow-up period of up to a month. Four RCTs reported serious AEs in patients receiving a newer-generation AH, but only two patients experienced a possibly drug-related serious AE. The occurrence of AEs, drug-related AEs, and treatment discontinuations due to AEs varied between RCTs. Most AEs reported were of mild intensity. Indirect evidence indicates that cetirizine is more sedating than the other newer-generation AHs.
Our findings confirm that newer-generation AHs have a favorable safety and tolerability profile. However, we could not draw firm conclusions regarding the comparative safety profile of the newer-generation AHs due to the paucity of head-to-head RCTs, variation in definitions and reporting of AEs, and short follow-up duration.
H1 抗组胺药（AHs）被广泛用于治疗过敏性疾病，是儿科最常开的药物之一。与第一代 AHs 相比，新一代 AHs 的不良反应较少。然而，它们在儿科人群中的相对危害仍需仔细审查。
我们对随机对照试验（RCTs）进行了系统评价，其中包括比较口服给予的新一代 AH 与第一代或第二代 AH、孟鲁司特或安慰剂在≤12 岁儿童中的安全性参数。我们检索了 MEDLINE 和 CENTRAL，独立提取了研究人群、干预措施、不良事件（AE）和治疗中断的数据，并使用 Cochrane 偏倚风险工具评估了纳入 RCTs 的方法学质量。
1989 年至 2017 年期间发表的 45 项 RCT 符合入选标准。大多数 RCT 纳入了患有过敏性鼻炎的学龄儿童，随访期长达一个月。四项 RCT 报告了接受新一代 AH 的患者发生严重 AE，但仅有两名患者发生了可能与药物相关的严重 AE。AE、药物相关 AE 和因 AE 而导致的治疗中断的发生在 RCT 之间存在差异。大多数报告的 AE 为轻度。间接证据表明，西替利嗪比其他新一代 AH 更具镇静作用。
我们的研究结果证实，新一代 AHs 具有良好的安全性和耐受性。然而，由于缺乏头对头 RCT、AE 的定义和报告存在差异以及随访时间短，我们无法对新一代 AHs 的比较安全性概况得出明确结论。
