't Jong G W, Eland I A, Sturkenboom M C J M, van den Anker J N, Strickerf B H C
Dept of Paediatrics, Sophia Children's Hospital, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Eur Respir J. 2004 Feb;23(2):310-3. doi: 10.1183/09031936.04.00015404.
Many respiratory drugs are not available in formulations suitable for infants and toddlers. Efficacy and safety research is mostly restricted to older children. However, respiratory drugs are frequently used in children for common diseases like asthma, upper and lower respiratory tract infections, rhinitis and sinusitis. The unlicensed and off-label use of respiratory drugs in children were studied. A population-based cohort study was conducted by using the computerised medical records in the Integrated Primary Care Information project. The study population comprised a random sample from all children aged 0-16 yrs who were registered with a general practitioner in 1998. All prescriptions for respiratory drugs during the study period were classified according to their licensing and off-label status. The study population comprised 13,426 patients (51.7% male, median age 8.7 yrs), of whom 2,502 (19%) received 5,253 prescriptions for respiratory drugs in 1998. A total of 3,306 (62.9%) prescriptions concerned licensed drugs. Of the remaining 1,947 prescriptions (37.1%), 882 (16.8%) were unlicensed for use in children, and 1,065 (20.3%) were prescribed off-label. The 1-yr cumulative risk of receiving an unlicensed or off-label prescription was 45% among children with at least one prescription for a respiratory drug. This population-based study showed that a large proportion of respiratory drugs prescribed by the general practitioner are unlicensed for use in children, or licensed but prescribed in an off-label manner. Results have to be interpreted with caution because they may unjustly suggest inaccurate prescribing, whereas it may be difficult to treat children with respiratory symptoms and diseases, because for many respiratory drugs paediatric data on safety and efficacy are insufficient. These findings underline the importance of research on suitable formulations, dosages and efficacy of respiratory drugs in children.
许多呼吸药物没有适合婴幼儿的剂型。疗效和安全性研究大多局限于年龄较大的儿童。然而，呼吸药物常用于儿童的常见疾病，如哮喘、上呼吸道和下呼吸道感染、鼻炎和鼻窦炎。对儿童呼吸药物的无许可证和超说明书使用情况进行了研究。利用综合初级保健信息项目中的计算机化医疗记录进行了一项基于人群的队列研究。研究人群包括1998年在全科医生处登记的所有0至16岁儿童的随机样本。研究期间所有呼吸药物处方均根据其许可和超说明书状态进行分类。研究人群包括13426名患者（男性占51.7%，中位年龄8.7岁），其中2502名（19%）在1998年接受了5253张呼吸药物处方。共有3306张（62.9%）处方涉及有许可证的药物。在其余1947张处方（37.1%）中，882张（16.8%）未获儿童使用许可，1065张（20.3%）为超说明书处方。在至少有一张呼吸药物处方的儿童中，接受无许可证或超说明书处方的1年累积风险为45%。这项基于人群的研究表明，全科医生开出的很大一部分呼吸药物未获儿童使用许可，或虽有许可证但属超说明书用药。对结果的解释必须谨慎，因为它们可能会不公正地暗示处方不准确，而治疗有呼吸道症状和疾病的儿童可能很困难，因为许多呼吸药物的儿科安全性和疗效数据不足。这些发现强调了研究儿童呼吸药物合适剂型、剂量和疗效的重要性。
