Aronson Jeffrey K, Derry Sheena, Loke Yoon K
University Department of Clinical Pharmacology, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, UK.
Fundam Clin Pharmacol. 2002 Feb;16(1):49-56. doi: 10.1046/j.1472-8206.2002.00066.x.
The amount of published literature on adverse drug reactions is overwhelming; for example, the serial publication Side Effects of Drugs Annual lists and critically discusses over 3000 references each year. As a group, pharmacotherapeutics journals publish more papers on adverse drug reactions than journals that cover other fields, but even so they publish a minority of the total number of papers, and no single journal or group of journals can be highlighted as being a frequent source of primary information. Non-specialists must therefore rely on secondary literature (reviews) and tertiary literature (critical summaries) for information. Most of the primary published literature is in the form of anecdotal reports (30%) and formal studies or randomized controlled trials (35%). The anecdotal reports vary in quality; a new serial publication devoted to this type of article would bring some of the literature together and would improve the quality of reporting. Although many of the randomized controlled trials are of good quality and large enough to reveal benefit, most are too small to provide robust information about adverse drug reactions. Systematic reviews are too few in number (only 1.25% of publications on adverse drug reactions cited in Side Effects of Drugs Annual); more are needed.
关于药物不良反应的已发表文献数量众多；例如，连续出版的《药物副作用年鉴》每年列出并批判性地讨论3000多篇参考文献。作为一个整体，药物治疗学期刊发表的关于药物不良反应的论文比涵盖其他领域的期刊更多，但即便如此，它们发表的论文数量也仅占总数的一小部分，而且没有哪一本或哪一组期刊能被特别指出是主要信息的常见来源。因此，非专业人士必须依靠二次文献（综述）和三次文献（批判性总结）来获取信息。大多数已发表的原始文献形式为轶事报告（30%）和正式研究或随机对照试验（35%）。轶事报告的质量参差不齐；一本专门针对此类文章的新连续出版物将把一些文献汇集起来，并提高报告质量。尽管许多随机对照试验质量良好且规模足以揭示益处，但大多数规模太小，无法提供关于药物不良反应的可靠信息。系统综述的数量太少（仅占《药物副作用年鉴》中引用的药物不良反应出版物的1.25%）；需要更多。
