Bigby M
Department of Dermatology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA 02215,
Arch Dermatol. 2001 Jun;137(6):765-70.
To determine the validity, magnitude, precision, and applicability of data on the rates at which drugs cause adverse cutaneous reactions.
Systematic review of the medical literature.
The MEDLINE database was searched (1966-August 2000) for studies that contain information on the rates of cutaneous reactions to drugs. The bibliographies of retrieved articles and review articles were also examined to find relevant studies.
Studies that included primary data on cutaneous reaction rates to drugs were evaluated for their validity, magnitude, precision, and applicability, using guidelines derived from existing guidelines for the evaluation of articles about harm and prognosis.
Nine studies met the study criteria. Five of the studies were based on prospectively collected data on medical inpatients, 2 were retrospective studies based on chart or computerized medical record review, and 2 were based on spontaneous reports and consumption data. The morbilliform drug exanthem and urticaria were the most common cutaneous reactions to drugs. Reaction rates varied from 0% to 8% and were highest for antibiotics (in the range of 1% to 8% for several classes of antibiotics).
Despite differences in the methods of the studies reviewed and their time of execution, there is remarkable agreement in the results. Reaction rates (and 95% confidence intervals) are available for many commonly used drugs.
确定关于药物引起皮肤不良反应发生率数据的有效性、大小、精确性和适用性。
对医学文献进行系统评价。
检索MEDLINE数据库(1966年至2000年8月),查找包含药物皮肤反应发生率信息的研究。还查阅了检索到的文章和综述文章的参考文献,以寻找相关研究。
使用从现有关于危害和预后评估文章的指南中得出的指南,对包含药物皮肤反应发生率原始数据的研究进行有效性、大小、精确性和适用性评估。
9项研究符合研究标准。其中5项研究基于前瞻性收集的住院患者数据,2项是基于病历或计算机化医疗记录回顾的回顾性研究,2项基于自发报告和消费数据。麻疹样药疹和荨麻疹是药物最常见的皮肤反应。反应发生率从0%到8%不等,抗生素的反应发生率最高(几类抗生素的反应发生率在1%到8%之间)。
尽管所综述研究的方法及其实施时间存在差异,但结果仍有显著一致性。许多常用药物的反应发生率(及95%置信区间)是可得的。