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首页> 外文期刊>Journal of Clinical and Diagnostic Research >The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study
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The Profile of Voluntary Reported Adverse Drug Reactions at a Tertiary Care Hospital: A Fifteen Month Prospective Study

机译：三级护理医院自愿报告的药物不良反应概况：十五个月的前瞻性研究

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Objectives: The present study was undertaken to provide the health professionals who were working at a tertiary care hospital, with a simple method to report Adverse Drug Reactions (ADRs) and to monitor, document and to evaluate them according to the set criteria. Method and Materials: This study was conducted over a period of 15 months from 1st Jan? 2008 to 31st March 2009 at Goa Medical College and Hospital (Goa, India). The evaluation of the data was done for various parameters, which included patient demographics and drug and reaction characteristics. An assessment was also done for the outcome, causality and the severity of the drug reactions. Results: A total of 265 ADRs were reported. Among the drugs, the ?-lactam antibiotics were implicated the maximum number of times (54, 20.37%), followed by fluoroquinolones (35, 13.20%), antiretrovirals (33, 12.45%) and antiepileptics (31, 11.69%). Females showed more ADRs (142, 54%) than males (123, 46%). The skin was involved in about 57.73% (153) of the ADRs, while the CNS and the vascular system were involved in 8.67% (23) and 8.30% (22) of the ADRs. Most of the ADRs were categorized as ?Type II? (203, 77%) against ?Type I? (62, 23%) by Rawlins and Thompson?s classification. The causality assessment was done by the Naranjo Algorithm and 62.26% (165) were seen to fall in the ?probable category? as compared to 29.05% (77) in the ?highly probable? one. Out of all the ADRs which were reported, 34.71% (148) were ?severe?, in accordance with the Modified Hartwig and Siegel?s scale. Conclusion: The present work was a humble attempt to set up a well organized ADR reporting system at our government hospital. The systematic tracking and monitoring of ADRs can shed light on their extensiveness and their patterns of occurrence.
机译：目的：进行本研究旨在为在三级医院工作的卫生专业人员提供一种简单的方法来报告不良药物反应（ADR）并根据设定的标准进行监测，记录和评估。方法和材料：本研究从1月1日开始进行了15个月。 2008年至2009年3月31日在印度果阿医学院和医院。对各种参数进行了数据评估，其中包括患者的人口统计资料以及药物和反应特征。还对药物反应的结果，因果关系和严重性进行了评估。结果：总共报告了265种ADR。在这些药物中，涉及β-内酰胺类抗生素的次数最多（54次，占20.37％），其次是氟喹诺酮类（35次，占13.20％），抗逆转录病毒药（33次，占12.45％）和抗癫痫药（31次，占11.69％）。女性的ADR（142，54％）比男性（123，46％）多。皮肤约占ADR的57.73％（153），而中枢神经系统和血管系统约占ADR的8.67％（23）和8.30％（22）。大多数ADR被归类为“ II类”。 （203，77％）对？类型I？ （62，23％）按罗林斯和汤普森的分类。因果关系评估由Naranjo算法完成，并且发现62.26％（165）属于“可能类别”。相比“高可能性”中的29.05％（77）一。根据改良的Hartwig和Siegel量表，在所有已报告的ADR中，有34.71％（148）是“严重”的。结论：目前的工作是在我们的政府医院建立一个组织良好的ADR报告系统的拙劣尝试。对ADR进行系统的跟踪和监视可以阐明其广泛性和发生方式。

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