Leśniak Małgorzata, Woron Jarosław, Czarnobilska Ewa
Przegl Lek. 2013;70(12):1003-7.
Adverse drug reactions in children are serious public health problem. The overall incidence of ADRs is estimated at about 9.5% in hospitalized children and about 1.5% for outpatient children. ADRs have very diverse manifestations from minor skin rashes to potentially life-threatening severe skin reactions such as: acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylactic reactions. The aim of the study was to analyze the results of ADRs monitoring with particular regard to life-threatening reactions in the pediatric population in Poland. We analyzed spontaneous reports of ADRs in Poland in patients aged 0-18 years in the period 01.01.2004-31.03.2013. Each reported case was evaluated and classified by a clinical pharmacologist and an allergologist. Analysis of the data showed the occurrence of ADR in 846 pediatric patients including one case of Stevens-Johnson syndrome, and 90 (10.6% ADR) drug reactions classified as anaphylactic reactions (44 responses (5.2% ADR)) and non-immune anaphylaxis (46 responses (5.4% ADR)). Classes of drugs most frequently causing anaphylactic reactions were: anti-inflammatory and antipyretic (31%), antibiotics (19%) and drugs used in anesthesia (16%). The substances most commonly causing anaphylactic reactions/non-immune anaphylaxis were: paracetamol and lidocaine (with 8 responses). The most common clinical manifestations of ADRs are skin reactions (402 responses, 47.5%). Acute drug reactions in the pediatric population may have life-threatening clinical manifestations. Drugs that most commonly cause anaphylaxis are: anti-inflammatory/ antipyretic drugs (acetaminophen, aspirin, ibuprofen), antibiotics (cephalosporins, amoxicillin, sulfonamides), local anesthetics (lidocaine). Early diagnosis of allergy and choice of safe product can prevent life-threatening drug reactions.
儿童药物不良反应是严重的公共卫生问题。住院儿童药物不良反应的总体发生率估计约为9.5%,门诊儿童约为1.5%。药物不良反应的表现形式多种多样,从轻微的皮疹到可能危及生命的严重皮肤反应,如:急性全身性发疹性脓疱病、史蒂文斯-约翰逊综合征、中毒性表皮坏死松解症和过敏反应。本研究的目的是分析药物不良反应监测结果,特别关注波兰儿科人群中危及生命的反应。我们分析了2004年1月1日至2013年3月31日期间波兰0至18岁患者的药物不良反应自发报告。每例报告病例均由临床药理学家和过敏症专科医生进行评估和分类。数据分析显示,846例儿科患者出现了药物不良反应,其中包括1例史蒂文斯-约翰逊综合征,90例(10.6%的药物不良反应)药物反应被归类为过敏反应(44例反应(5.2%的药物不良反应))和非免疫性过敏反应(46例反应(5.4%的药物不良反应))。最常引起过敏反应的药物类别为:抗炎和解热药(31%)、抗生素(19%)和麻醉用药(16%)。最常引起过敏反应/非免疫性过敏反应的物质为:对乙酰氨基酚和利多卡因(各有8例反应)。药物不良反应最常见的临床表现是皮肤反应(402例反应,47.5%)。儿科人群中的急性药物反应可能具有危及生命的临床表现。最常引起过敏反应的药物有:抗炎/解热药(对乙酰氨基酚、阿司匹林、布洛芬)、抗生素(头孢菌素、阿莫西林、磺胺类药物)、局部麻醉药(利多卡因)。过敏的早期诊断和安全产品的选择可以预防危及生命的药物反应。