目的： 藉由評估某醫學中心兒科藥物不良反應案例，供其他醫療院所參考。
方法： 收集本院6 年期間（2005 年1 月至2011 年12 月），通報至全國藥物不良反應通報中心之兒科藥物不良反應案例，以敘述統計分析方式呈現個案之相關資料。並利用獨立樣本t 檢定及單因子變異數分析，分別評估不同性別或年齡之條件，其藥物不良反應之嚴重度是否有差異。
結果： 2005 年1月至2011年12月本院兒科藥物不良反應通報案例共計105 件，佔全院總通報件數（共1,903 件）之5.5 %。個案基本資料以男性 (60%) 及11 ~ 15 歲 (24.8%) 居多，但不同性別、年齡之藥物不良反應嚴重度並無差異。藥物不良反應主要影響皮膚系統 (44.9%)。藥理分類中則以抗感染藥物 (52.8%) 最常見。被通報的前3 名懷疑藥物包括vancomycin、phenytoin、diclofenac。
結論： 通報及評估兒科上市後藥物不良反應，能加強醫療人員對兒科藥物性質之理解，提升兒童用藥安全。
Objectives: Assessing pediatric adverse drug reactions (ADRs) in a medical center to provide / ADRs information for other medical institutes.
Methods: Pediatric ADRs cases in our hospital which had ever reported to the National Reporting Center of Adverse Drug Reaction during January 2005 to December 2011 were collected, and analyzed by descriptive statistics. Another, independent samples t-test and one-way analysis of variance were used to evaluate differences in genders and age, respectively, between different severities of ADRs.
Results: Total 105 cases were collected in the study period. Male (60%) and patients between 11 to 15 years old (24.8%) were the major groups in this study, but there were no significant differences in gender and age between different severities of ADRs. Cutaneous ADRs were the most part (44.9%) in this study. The mainly pharmacological classification was antibiotics (52.8%). Top 3 items of suspected drugs included vancomycin, phenytoin and diclofenac.
Conclusions: Voluntarily reporting and assessment of pediatric ADRs can enhance medical staff to understand the nature of ADRs among children, and be beneficial to early detect ADRs for improving the drug safety in children.
