Martins A C M, Giordani F, Rozenfeld S
National Regulatory Agency for Private Health Insurance/Agência Nacional de Saúde Suplementar, Rio de Janeiro, RJ, Brasil; National School of Public Health/Escola Nacional de Saúde Pública Sérgio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brasil.
J Clin Pharm Ther. 2014 Dec;39(6):609-20. doi: 10.1111/jcpt.12204. Epub 2014 Sep 15.
Studies in a number of countries have shown that adverse drug events (ADE) occur frequently among hospital inpatients. The objective of this study was to conduct a systematic review of observational studies of the frequency of ADE in adult inpatients and to examine factors associated with observed heterogeneity in the reported results.
The systematic review included observational studies, which identified and analysed ADE during hospitalization of adult inpatients. The literature search was conducted on MEDLINE, Embase, Lilacs and Google Scholar (January of 2000 to June of 2013). Article selection, quality assessment and information extraction were performed by two of the authors, working independently. Using the random-effects model, the proportion of patients with adverse events was used as an outcome measure. Proportion was estimated for subgroups based on event identification method: stimulated reporting (SR), retrospective monitoring (RM) and prospective monitoring (PM). For the latter group, meta-regression was used to identify sources of heterogeneity in the estimates.
Twenty-eight articles from the 7550 identified met our inclusion criteria. The articles were heterogeneous in terms of quality, outcome definition and event identification method and in the corresponding descriptions. Of the 28 articles selected, 25 were included in the corresponding quantitative summary: four used SR, six RM and 15 PM, returning incidences of 2·3% (CI 95%: 1·6-4·5), 8·7% (CI 95%: 4·8-15·3) and 21·3% (CI 95%: 15·7-28·3), respectively, and I(2) greater than 95%. There were other sources of heterogeneity, including the use of combined strategies within each subgroup. In the PM subgroup, using multivariate meta-regression model, no variables were found to associate with proportion.
Event frequency seems to associate with the event identification method. PM returned the highest estimates. This subgroup used a greater diversity of approaches for event identification and more diverse data sources. Improved recording of information on the event identification method, the characteristics of the events and the conduct of the study would enable more reliable and precise estimates of the frequency of ADE among hospital inpatients.
多个国家的研究表明，住院患者中药物不良事件（ADE）频繁发生。本研究的目的是对关于成年住院患者ADE发生频率的观察性研究进行系统评价，并探讨报告结果中观察到的异质性相关因素。
该系统评价纳入了观察性研究，这些研究对成年住院患者住院期间的ADE进行识别和分析。文献检索在MEDLINE、Embase、Lilacs和谷歌学术（2000年1月至2013年6月）上进行。文章筛选、质量评估和信息提取由两位作者独立完成。使用随机效应模型，将发生不良事件的患者比例作为结局指标。根据事件识别方法对亚组进行比例估计：激发报告（SR）、回顾性监测（RM）和前瞻性监测（PM）。对于后一组，使用元回归来识别估计值中的异质性来源。
从7550篇文献中筛选出的28篇文章符合纳入标准。这些文章在质量、结局定义、事件识别方法及相应描述方面存在异质性。在入选的28篇文章中，25篇被纳入相应的定量汇总：4篇使用SR，6篇使用RM，15篇使用PM，发生率分别为2.3%（95%CI：1.6 - 4.5）、8.7%（95%CI：4.8 - 15.3）和21.3%（95%CI：15.7 - 28.3），I²大于95%。还存在其他异质性来源，包括每个亚组内联合策略的使用。在PM亚组中，使用多变量元回归模型，未发现与比例相关的变量。
事件频率似乎与事件识别方法有关。PM得出的估计值最高。该亚组在事件识别方法上使用了更多样化的方法和更广泛的数据来源。改进事件识别方法、事件特征及研究开展方面信息的记录，将能更可靠、精确地估计住院患者中ADE的发生频率。
