Faculty of Pharmacy, Université de Montréal, Montréal, Quebec, Canada.
Drug Saf. 2010 Dec 1;33(12):1081-8. doi: 10.2165/11539300-000000000-00000.
Case series and case reports are a cornerstone of drug safety research; however, the characteristics of case series published in the literature remain poorly examined. A narrative review of case series addressing drug safety, published in the literature between 1 January 2003 and 15 July 2009, and identified through a PubMed search, was conducted in order to determine their characteristics and quality according to the criteria found in the US FDA Pharmacovigilance Guidance 2005. Of 130 publications that met the search criteria, 11.5% included an analytical component and 88.5% were descriptive. The median number of cases included in a given case series was 7 (range 2-2195) and the median time period for recruitment of the cases was 23 months (range 0.5-96). Overall, 43.1% of case series consisted of individual case reports, while 24.6% originated from cohorts and 21% from pharmacovigilance databases. Of the case series, 65.1% concerned adults (age ≥18 years), 11.6% elderly (age ≥65 years) and 8.5% youth (<18 years). Adverse effects involved mainly the skin (18.5%) and the circulatory system (13.8%). The main suspected drug classes (Anatomical Therapeutic Chemical classification) were nervous system drugs (23.1%) and antineoplastic and immunomodulating agents (20.0%). On average, six out of the possible nine US FDA Pharmacovigilance Guidance Criteria were fulfilled, with 27% of publications fulfilling at least seven criteria. Only 10% reported data on co-morbidity. In conclusion, this review highlights the reporting gaps and heterogeneity in published case series with respect to size, recruitment period and quality.
病例系列和病例报告是药物安全性研究的基石；然而，文献中发表的病例系列的特征仍未得到充分研究。本研究对 2003 年 1 月 1 日至 2009 年 7 月 15 日期间发表的、通过 PubMed 检索发现的、涉及药物安全性的病例系列文献进行了叙述性综述，旨在根据美国 FDA 药物警戒指南 2005 中的标准，确定其特征和质量。在符合检索标准的 130 篇文献中，11.5%包含分析部分，88.5%为描述性。特定病例系列中纳入的病例中位数为 7 例（范围 2-2195 例），病例招募的中位时间为 23 个月（范围 0.5-96 个月）。总体而言，43.1%的病例系列由单个病例报告组成，24.6%源于队列研究，21%源于药物警戒数据库。在病例系列中，65.1%的病例涉及成年人（年龄≥18 岁），11.6%的病例涉及老年人（年龄≥65 岁），8.5%的病例涉及青少年（年龄<18 岁）。不良反应主要涉及皮肤（18.5%）和循环系统（13.8%）。主要的可疑药物类别（解剖治疗化学分类）为神经系统药物（23.1%）和抗肿瘤和免疫调节药物（20.0%）。平均而言，9 项美国 FDA 药物警戒指南标准中有 6 项得到满足，27%的文献至少满足 7 项标准。只有 10%的文献报告了合并症的数据。总之，本综述强调了发表的病例系列在大小、招募期和质量方面存在的报告差距和异质性。
