Zhou Pengxiang, Jia Qiong, Wang Zhenhuan, Zhao Rongsheng, Zhou Wei
Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
Front Pediatr. 2022 Aug 25;10:940213. doi: 10.3389/fped.2022.940213. eCollection 2022.
The global prevalence of allergic diseases has led to a negative and extensive impact on the health and lives of a large population of children. This study investigates the efficacy, acceptability, and safety of cetirizine (CTZ) for treating allergic diseases in children and provides evidence-based assertions for decision-making.
PubMed, Embase, the Cochrane Library, World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov, and the European Union Clinical Trials Register were systematically searched from inception to April 21, 2022. Randomized controlled trials (RCTs) or quasi-RCTs of children with allergic diseases receiving CTZ compared with those receiving placebo or other drugs were included without language limitations. Two investigators independently identified articles, extracted data, conducted meta-analyses, assessed the Cochrane risk of bias of individual studies, and evaluated the evidence certainty using the Grading of Recommendations Assessment, Development, and Evaluation approach; any discrepancies were resolved by consulting with a third investigator. Primary outcomes included scales that evaluated the recovery of allergic conditions in AR, such as the total symptom score (TSS). Secondary outcomes included laboratory test changes, safety (adverse events, AEs), and quality of life (QOL). Data were pooled using the Cochrane Review Manager 5.4, and a fixed-effects model was used if heterogeneity was evaluated as low ( < 50%); otherwise, a random-effects model was adopted.
A total of 22 studies (5,867 patients) were ultimately included [eight with perennial AR, six with seasonal AR, four with atopic dermatitis (AD), and four with other allergic diseases], most of which had a low or unclear risk of bias. Moderate certainty evidence showed that CTZ was found to benefit allergic symptom control [mean difference (MD) of TSS at 1 week: MD, -0.32 (-0.52, -0.12); at 2 weeks: MD, -0.25 (-0.35, -0.14); at 4 weeks: MD, -4.07 (-4.71, -3.43); at 8 weeks: MD, -4.22 (-4.73, -3.72); at 12 weeks: MD, -5.63 (-6.14, -5.13); all -values were less than 0.05] and QOL [at 12 weeks: MD, -23.16 (-26.92, -19.39); < 0.00001] in children with AR. It had similar efficacy compared with other antihistamines (AHs) or montelukast, without showing better control of AD severity in children. Moderate-to-low certainty evidence demonstrated that CTZ was well tolerated and did not increase the risk of severe and overall AEs, cardiotoxicity, damage to the central nervous and digestive systems, or other systems in children, except for the risk of somnolence [risk ratio, 1.62 (1.02, 2.57); = 0.04, compared with placebo].
Moderate-to-low certainty evidence revealed that CTZ could improve clinical improvement and QOL in children with AR and have comparable efficacy with other AHs. CTZ is well tolerated in the pediatric population, except for an increased risk of somnolence.
[https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42021262767].
过敏性疾病的全球流行对大量儿童的健康和生活产生了负面且广泛的影响。本研究调查西替利嗪(CTZ)治疗儿童过敏性疾病的疗效、可接受性和安全性,并为决策提供循证依据。
系统检索了从创刊至2022年4月21日的PubMed、Embase、Cochrane图书馆、世界卫生组织国际临床试验注册平台、ClinicalTrials.gov和欧盟临床试验注册库。纳入了比较接受CTZ治疗的过敏性疾病儿童与接受安慰剂或其他药物治疗的儿童的随机对照试验(RCT)或半随机对照试验,无语言限制。两名研究者独立识别文章、提取数据、进行荟萃分析、评估单个研究的Cochrane偏倚风险,并使用推荐分级评估、制定和评价方法评估证据确定性;如有分歧,通过与第三名研究者协商解决。主要结局包括评估AR中过敏状况恢复情况的量表,如总症状评分(TSS)。次要结局包括实验室检查变化、安全性(不良事件,AE)和生活质量(QOL)。使用Cochrane系统评价软件5.4进行数据合并,如果异质性评估为低(<50%),则使用固定效应模型;否则,采用随机效应模型。
最终纳入22项研究(5867例患者)[8项为常年性AR,6项为季节性AR,4项为特应性皮炎(AD),4项为其他过敏性疾病],其中大多数研究的偏倚风险低或不明确。中等确定性证据表明,CTZ有助于控制过敏症状[TSS在1周时的平均差值(MD):MD,-0.32(-0.52,-0.12);2周时:MD,-0.25(-0.35,-0.14);4周时:MD,-4.07(-4.71,-3.43);8周时:MD=-4.22(-4.73,-3.72);12周时:MD=-5.63(-6.14,-5.13);所有P值均<0.05],并改善AR儿童的生活质量(12周时:MD=-23.16(-26.92,-19.39);P<0.00001)。与其他抗组胺药(AHs)或孟鲁司特相比,其疗效相似,但在控制儿童AD严重程度方面未显示出更好的效果。中等至低确定性证据表明,CTZ耐受性良好,除嗜睡风险外,不会增加儿童严重和总体AE、心脏毒性、中枢神经和消化系统或其他系统损害的风险[风险比,1.62(1.02,2.57);P=0.04,与安慰剂相比]。
中等至低确定性证据表明,CTZ可改善AR儿童的临床症状和生活质量,且与其他AHs疗效相当。CTZ在儿科人群中耐受性良好,但嗜睡风险增加。