Rosli Rosliana, Dali Ahmad Fauzi, Aziz Noorizan Abd, Ming Long Chiau, Manan Mohamed Mansor
Faculty of Pharmacy, Universiti Teknologi MARA Puncak Alam, Malaysia.
Faculty of Pharmacy, Universiti Teknologi MARAPuncak Alam, Malaysia; Unit for Medication Outcomes Research and Education, Pharmacy, School of Medicine, University of TasmaniaHobart, TAS, Australia.
Front Pharmacol. 2017 Feb 10;8:30. doi: 10.3389/fphar.2017.00030. eCollection 2017.
Spontaneous adverse drug reactions (ADRs) reporting is a useful source of drug safety information in infants as only adult patients are routinely tested in clinical trials. This study was aimed to evaluate the spontaneously reported ADRs using WHO Adverse Reaction Terminology and to identify the common drugs associated with ADRs in children under 2 years of age. A retrospective analysis of ADR data for children below 2 years old from 2000 to 2013 was conducted using the data extracted from Malaysia's national pharmacovigilance database, QUEST2 System. From 2000 to 2013, Malaysia's National Pharmaceutical Control Bureau received a total of 11,932 reports for children from various healthcare facilities in Malaysia. 14.0% ( = 1667) of the ADRs reported for those children were related to children under 2 years old. The data retrieved was analyzed in terms of age, gender, source of reporting, type of reporters, suspected medicines and characteristics of ADRs (category, onset, severity, and outcomes). A total of 1312 ADRs reported in 907 ADR reports were analyzed. The most common ADRs reported were skin appendage disorders (60.1%), and the most frequently reported symptoms were rash ( = 215), maculopapular rash ( = 206), urticaria ( = 169), erythematous rash ( = 76), and pruritus ( = 58). In general, drugs from antibacterials for systemic use (58.8%) appeared to be the most common contributors to ADRs in children below 2 years old. Penicillins and other β-Lactam Antibacterials accounted for more than 40% of all drugs implicated in ADRs. The majority of ADRs were subacute reactions that occurred within 24 h of exposure to the drug. A high proportion of ADRs was classified as mild, and most victims had no sequela. Only one fatality was seen. There were 10 cases for each symptom, namely erythema multiforme and Stevens-Johnson Syndrome, observed in this study. A large proportion of ADRs in children under 2 years old were mainly caused by drugs from antibacterial for systemic use, with most of the ADRs manifesting in skin reactions. This study also reveals rare cutaneous ADRs experienced by Malaysian children under the age of 2, which constitutes a crucial cause of harm among children.
由于在临床试验中通常仅对成年患者进行测试，因此自发药物不良反应（ADR）报告是获取婴儿药物安全信息的有用来源。本研究旨在使用世界卫生组织不良反应术语来评估自发报告的ADR，并确定2岁以下儿童中与ADR相关的常见药物。利用从马来西亚国家药物警戒数据库QUEST2系统中提取的数据，对2000年至2013年2岁以下儿童的ADR数据进行了回顾性分析。2000年至2013年，马来西亚国家药品监管局共收到来自马来西亚各医疗机构的11932份儿童报告。这些报告中14.0%（=1667）的ADR与2岁以下儿童有关。对检索到的数据从年龄、性别、报告来源、报告者类型、可疑药物以及ADR的特征（类别、发作、严重程度和结果）等方面进行了分析。对907份ADR报告中报告的1312例ADR进行了分析。报告的最常见ADR是皮肤附属器疾病（60.1%），最常报告的症状是皮疹（=215）、斑丘疹（=206）、荨麻疹（=169）、红斑疹（=76）和瘙痒（=58）。一般来说，全身用抗菌药物（58.8%）似乎是2岁以下儿童ADR最常见的原因。青霉素和其他β-内酰胺类抗菌药物占所有导致ADR药物的40%以上。大多数ADR是在接触药物后24小时内发生的亚急性反应。高比例的ADR被归类为轻度，大多数受害者没有后遗症。仅观察到1例死亡。本研究中观察到每种症状各有10例，即多形红斑和史蒂文斯-约翰逊综合征。2岁以下儿童的ADR很大一部分主要由全身用抗菌药物引起，大多数ADR表现为皮肤反应。本研究还揭示了马来西亚2岁以下儿童经历的罕见皮肤ADR，这是儿童伤害的一个关键原因。
