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題 名 | A Pharmacoepidemiological Study on the Weber Curve Phenomena=韋伯現象之藥物流行病學研究 |
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作 者 | 蕭正光; 尤瑞鴻; 張慈桂; | 書刊名 | 慈濟醫學 |
卷 期 | 7:1 1995.03[民84.03] |
頁 次 | 頁1-9 |
分類號 | 418.1 |
關鍵詞 | 韋伯現象; 藥物副作用; Weber curve; Adverse drug experience; |
語 文 | 英文(English) |
中文摘要 | 韋伯現象是描述NSAID類藥物之副作用報告常在上市後第二年達到最 高點,並隨即逐年下降。藥物安全人員常以韋伯現象來解釋藥物之副作用報告異 常增加,但是韋伯現象是否適用於其他藥物則尚無定論。本研究檢測美國食品藥 物安局(FDA1所收集之18種藥物副作用報告,共計23,461例,分析其報告趨勢。 由於叮片A於1985年改變副作用報告規定,為減少其干擾作用,本研究選擇9種藥 上市於1985年之前,9種在1985年之後。這18種藥物均無重大副作用報告記錄, 藥物之使用量是以處方量估計。結果顯示18種藥物中,僅1種藥品之副作用報告 符合韋伯現象,然而所有之藥品副作用報告均在上市之早期達到頂點隨即有下降 之趨勢。本研究結果和韋伯現象之巨觀描述相似,但是韋伯現象之變異,限制了 推廣應用於其它藥物之可能性。(慈濟醫學 1995;7:1-9) |
英文摘要 | In 1984, Weber noted that adverse drug experience (ADE) reports to regulatory agencies inthe United Kingdom peaked in the second year after seven NSAIDs were introduced to the market and declined in subsequent years, regardless of sales volume. Drug safety researchers haveoften cited Weber's data without demonstrating the replicability of the phenomenon to other classesof drugs. We analyzed ADE data filed with the US FDA on 18 prescription medications and total of 23,461 ADE reports to test if reporting patterns followed the "Weber curve". The drugchosen consisted of pairs of market share leaders in 9 distinct classes of pharmaceutical agents.To avoid confounding by changes in FDA reporting regulations, which were revised in 1985, eachpair consisted of 1 drug introduced to market before 1985 and the other after. Drugs which hadbeen the subject of "Dear Doctor" letters were excluded. Reports were adjusted by unit sales datafrom IMS America. Of the 18 drugs examined, only 1 demonstrated an annual ADE report distribution similar to Weber's. All of the products studied showed a peak in ADE report relativelyearly in marketing history, and followed by a subsequent decline. Drugs launched in the early1980s tended to peak in year three or later, while those marketed after 1985 tend to peaked inyear one. Weber's observations and our findings are concordant in a gross descriptive manner,but the variation of the Weber curve may limit the generalization by drug safety researchers. (TZUChi Med J 1995; 7: 1-9) |
本系統中英文摘要資訊取自各篇刊載內容。