社團法人臺灣臨床藥學會

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【綜合評述】某醫學中心藥品不良反應的案例分析
Analysis of Adverse Drug Reactions in a Hospital Center
藥物不良反應、Naranjo algorithm、adverse drug events
廖芬芬Fen-Fen Liao*1 、陳啟佑Chi-Yu Chen1 、黃耀斌Yaw-Bin Huang1,2 、楊紫麟Tzu-Lin Yang1
1高雄醫學大學附設醫院 藥劑部 、2高雄醫學大學 臨床藥學研究所
分析某醫學中心在2005年1月至2007年12月間,通報至全國藥物不良反應通報中心之藥品不良反應案例。3年內總共收到712件個案,經院內專家審議後的通報案例為600件。通報來源主要為醫師(52.7%)和藥師(36.7%),個案之平均年齡為55.3±20.9歲,大於50歲之病人佔64.0%。不良反應的嚴重度主要為輕度(49.0%)和中度(45.0%)。依Naranjo algorithm評分不良反應與藥物的相關性,結果「可能」和「極有可能」各約佔49.0%和47.3%。個案內容的通報品質大多為Fair data (68.5%),次之為Good data (25.2%)。最常被通報的前十名懷疑藥品依序為pyrazinamide、rifampin、vancomycin、rifater、metoclopramide、flunarizine、carbamazepine、phenytoin、diclofenac和ethambutol。藥理分類則以抗感染藥物最常見(40.5%),次之為中樞神經系統用藥(20.1%)和循環系統用藥(11.9%)。

Analyze the cases of adverse drug reactions (ADR) that had been reported to the national reporting center of adverse drug reactions between January 2005 and December 2007 in a medical center. A total of 712 ADR events were collected over a period of 3 years. The 600 ADR events, which were evaluated and confirmed by our specialists, were reported to the national ADR reporting center. Physician (52.7%) and pharmacist (36.7%) were principal providers. The average age of individuals was 55.3±20.9, about 64.0% of them were older than 50-yeara-old. The severity of ADR events was mainly mild (49.0%) and moderate (45.0%) based on a severity scale. Overall, possible ADR events and probable ADR events were approximately 49.0% and 47.3% respectively by Naranjo algorithm for estimating the probability of ADR. The quality of reporting contents was especially fair data (68.5%), following with good data (25.2%). The top ten suspicious medications, in turn, pyrazinamide, rifampin, vancomycin, rifater, metoclopramide, flunarizine, carbamazepine, phenytoin, diclofenac and ethambutol were the most commonly reported. According to pharmacological classification, antimicrobial agents (40.5%) were mainly contributing to ADR events, following with central nervous system drugs (20.1%) and circulatory system drugs (11.9%).
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