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在一家三级护理医院的传染病科进行的一项前瞻性药物警戒研究。

A prospective pharmacovigilance study in the infectious diseases unit of a tertiary care hospital.

作者信息

Karaismailoglu Berna, Saltoglu Nese, Balkan Ilker Inanc, Mete Bilgul, Tabak Fehmi, Ozturk Recep

机构信息

Infectious Diseases and Clinical Microbiology Department, Istanbul University - Cerrahpasa, Cerrahpasa Medical Faculty, Istanbul, Turkey.

Infectious Diseases and Clinical Microbiology Department, Istanbul Medipol University Medical Faculty, Istanbul, Turkey.

出版信息

J Infect Dev Ctries. 2019 Jul 31;13(7):649-655. doi: 10.3855/jidc.11503.

DOI:10.3855/jidc.11503
PMID:32065823
Abstract

INTRODUCTION

The frequency, causality, severity, preventability and risk factors of ADRs (adverse drug reactions) in infectious disease units are not well defined in the literature. Thus, the aim of this study was to determine the characteristics of the ADRs encountered in an infectious disease unit of a tertiary teaching hospital.

METHODOLOGY

The patients who were admitted to the infectious disease unit of a tertiary teaching hospital longer than 24 hours between January and December of 2016 were followed prospectively. Patients were observed and questioned for any sign of ADRs. The proportion of ADRs and patient characteristics were investigated. Causality was evaluated by the Naranjo algorithm, severity was determined using the Hartwig classification, and preventability was assessed using the Schumock and Thornton scale.

RESULTS

210 patients were admitted to the unit during the study period, of whom 44 patients (20.9%) experienced 51 ADRs. 5.9% of ADRs were found to be serious according to the Hartwig severity classification. In addition, 88.1% of ADRs were not preventable. The most frequently detected ADR was skin and subcutaneous tissue reactions (33.3%), and systemic antimicrobials were the most common type of drugs that caused an ADR. Prolonged hospitalization (p < 0.001) and usage of an increased number of drugs (p < 0.001) were found to be significant risk factors for ADR development.

CONCLUSIONS

Prolonged hospital stay and polypharmacy are significant risk factors that increase the incidence of ADRs in infectious disease units. The likelihood of unavoidable ADRs should arouse the attention of clinicians when prescribing antimicrobials.

摘要

引言

传染病科中药物不良反应(ADR)的发生率、因果关系、严重程度、可预防性及风险因素在文献中尚无明确界定。因此,本研究旨在确定一家三级教学医院传染病科中所遇到的ADR的特征。

方法

对2016年1月至12月期间入住一家三级教学医院传染病科超过24小时的患者进行前瞻性随访。观察患者并询问其是否有任何ADR迹象。调查ADR的比例及患者特征。采用Naranjo算法评估因果关系,使用Hartwig分类法确定严重程度,并用Schumock和Thornton量表评估可预防性。

结果

研究期间该科室收治了210例患者,其中44例患者(20.9%)出现了51例ADR。根据Hartwig严重程度分类,5.9%的ADR被判定为严重。此外,88.1%的ADR不可预防。最常检测到的ADR是皮肤和皮下组织反应(33.3%),全身性抗菌药物是引起ADR最常见的药物类型。发现住院时间延长(p<0.001)和用药数量增加(p<0.001)是ADR发生的显著风险因素。

结论

住院时间延长和联合用药是增加传染病科ADR发生率的重要风险因素。开具抗菌药物时,不可避免的ADR的可能性应引起临床医生的注意。

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