Vieira Jean Mendes de Lucena, de Matos Guacira Corrêa, da Silva Fabrício Alves Barbosa, Bracken Louise E, Peak Matthew, Lima Elisangela da Costa
Pharmacy School, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
Scientific Computing Program, Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil.
Front Pharmacol. 2020 Aug 6;11:964. doi: 10.3389/fphar.2020.00964. eCollection 2020.
Children are more exposed to inappropriate medicine use and its consequent harms. Spontaneous reporting of suspected Serious Adverse Drug Reactions (SADR) increases knowledge and prevention of pharmacotherapy risk. Disproportionality measures are useful to quantify unexpected safety issues associated with a given drug-event pair (signals of disproportionality). This cross-sectional study aimed to assess SADR reporting and safety signals for Brazilian children from 0-12 years old, notified between January 2008 and December 2013 from the Brazilian Surveillance Agency (Notivisa). Information from serious reports (gender and age of the patient, event description, suspected drug) was included. Disproportionality analysis based on Reporting Odds Ratios with a confidence interval of 95% was conducted to identify possible signals of disproportionate reporting (SDR). Almost 30% of 1,977 suspected SADR was related to babies (0-1-year-old). 69% of reports happened with intravenous dosage forms, and 35% of suspected SADR involved off label use according to age. Laronidase, miglustat, imipenem/cilastatin, and clofarabine were involved in six or more suspected deaths among 75 deaths reported. There were 107 SDRs, of which 16 events (15%) were not described in the product labels. There was a relatively higher number of SADRs in Brazilian children compared with studies from other countries. SDRs found, (especially drug-event pairs 'imipenen/cilastatin-pneumonia' and 'laronidase-respiratory insufficiency') should be investigated more. The reports of SADR with IV dosage forms and OL drug use suggest the need for drug research and the use of better dosage forms for children in Brazil.
儿童更容易接触到不当用药及其带来的危害。对疑似严重药物不良反应（SADR）进行自发报告可增加对药物治疗风险的认识并预防此类风险。不成比例性衡量方法有助于量化与特定药物 - 事件对相关的意外安全问题（不成比例信号）。这项横断面研究旨在评估2008年1月至2013年12月期间巴西监测机构（Notivisa）通报的0至12岁巴西儿童的SADR报告及安全信号。纳入了严重报告中的信息（患者性别和年龄、事件描述、疑似药物）。基于报告比值比并采用95%置信区间进行不成比例性分析，以识别不成比例报告（SDR）的可能信号。在1977例疑似SADR中，近30%与婴儿（0至1岁）有关。69%的报告发生在静脉剂型用药时，35%的疑似SADR涉及根据年龄的超说明书用药。在报告的75例死亡中，拉罗尼酶、米格鲁司他、亚胺培南/西司他丁和氯法拉滨涉及6例或更多疑似死亡。有107个SDR，其中16个事件（15%）在产品标签中未描述。与其他国家的研究相比，巴西儿童中的SADR数量相对较多。发现的SDR（特别是药物 - 事件对“亚胺培南/西司他丁 - 肺炎”和“拉罗尼酶 - 呼吸功能不全”）应进一步调查。SADR与静脉剂型用药和超说明书用药的报告表明，巴西需要开展药物研究并为儿童使用更好的剂型。
