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药物不良反应的DOTs分类法是一种对住院患者不良反应进行分类的有用方法:一项初步研究

The DoTS classification is a useful way to classify adverse drug reactions: a preliminary study in hospitalized patients.

作者信息

Calderón-Ospina Carlos, Bustamante-Rojas Carlos

机构信息

Pharmacology Unit, Department of Basic Sciences, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia.

出版信息

Int J Pharm Pract. 2010 Aug;18(4):230-5. doi: 10.1111/j.2042-7174.2010.00039.x.

Abstract

OBJECTIVE

The aim was to determine the prevalence of adverse drug reactions (ADRs) in hospitalized patients in a university hospital.

METHODS

ADRs were identified by two evaluators, who reviewed the clinical histories of all patients admitted between 24 April and 24 May 2006. Patients with suspected ADRs were contacted. Three different investigators evaluated causality, the degree of preventability, and the mechanism producing the ADR. Causality was assessed using the scale proposed by the World Health Organization (WHO), and preventability was assessed using the modified Schumock and Thornton criteria.

KEY FINDINGS

There were 32 ADRs in 104 hospitalized patients. Effects on the autonomic nervous system were the most common (13%) and the drugs most frequently implicated were systemic antimicrobial drugs (19%). Fifty-four per cent of the ADRs were classified as possible. Using the Dose, Time and Susceptibility (DoTS) classification, 77% of the ADRs were classified as being of collateral dose-responsiveness (i.e. they occurred within the range of therapeutic doses), and 65% were classified as intermediate reactions. The susceptibility factors associated most frequently with ADRs were comorbidities (i.e. the presence of diseases that were considered as risk factors to developing an ADR; 36%), age (26%) and exogenous factors (i.e. the presence of drug interactions that were involved in the occurrence of ADRs; 17%). Fifty per cent of the ADRs could have been prevented.

CONCLUSIONS

ADRs are very frequent in hospitalized patients and a significant proportion of them is preventable. The DoTS classification allowed complete evaluation of the types of ADR encountered. We are currently carrying out a much larger prospective study.

摘要

目的

旨在确定某大学医院住院患者中药物不良反应(ADR)的发生率。

方法

由两名评估人员识别ADR,他们查阅了2006年4月24日至5月24日期间所有入院患者的临床病史。与疑似发生ADR的患者进行了联系。三名不同的研究人员评估了因果关系、可预防性程度以及产生ADR的机制。使用世界卫生组织(WHO)提出的量表评估因果关系,使用改良的舒莫克和桑顿标准评估可预防性。

主要发现

104名住院患者中发生了32例ADR。对自主神经系统的影响最为常见(13%),最常涉及的药物是全身用抗菌药物(19%)。54%的ADR被归类为“可能”。使用剂量、时间和易感性(DoTS)分类,77%的ADR被归类为附带剂量反应性(即它们发生在治疗剂量范围内),65%被归类为中度反应。与ADR最常相关的易感性因素是合并症(即被视为发生ADR风险因素的疾病的存在;36%)、年龄(26%)和外源性因素(即参与ADR发生的药物相互作用的存在;17%)。50%的ADR本可预防。

结论

ADR在住院患者中非常常见,其中很大一部分是可预防的。DoTS分类能够对所遇到的ADR类型进行全面评估。我们目前正在开展一项规模大得多的前瞻性研究。

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