DRUG-INDUCED CUTANEOUS REACTIONS: A PHARMACOVIGILANCE STUDY

Mitali Dua, Arvind Narwat, Abhinav Goyal
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Abstract

Objective: Drug-induced cutaneous reactions are common problem in our country and can range from simple rash to severe reactions. Early recognition of these reactions enables early identification and withdrawal of offending drugs, thereby reducing morbidity and mortality. So present study aimed to assess clinical pattern of drug-induced cutaneous reactions in Dermatology OPD. Methods: This study was an open, non-comparative, non-interventional, observational study conducted on patients visiting dermatology department to see the clinical pattern of drug-induced cutaneous reactions. A total of 60 patients with suspected cutaneous adverse drug reactions were recruited. A detailed physical examination was done by a physician, including drug intake during 3 w preceding reactions and type of drug reactions. Results: Most frequently reported cutaneous drug reactions were Stevens-Johnson Syndrome (23%), Maculopapular rash (18%) Toxic Epidermal Necrolysis (15%) and were caused by antiepileptic drugs in 21(35%) patients, followed by antibiotics in 17(28.33%) cases, NSAID’s in 7(11.6%) cases, antitubercular drugs in 3(5%) and antiretroviral drugs in 3(5%) cases. A high proportioned of these reactions (50%) were moderate (31%) of these were severe because they require hospitalisation or increased the duration of stay in hospital or were life-threatening in (1%). Principal offending drug was phenytoin. Conclusion: A good knowledge of ADRs, a careful history taking and watchful approach while prescribing of drugs can prevent many of adverse drug reactions. These facts justify the development of an intensive programme of pharmacovigilance.
药物引起的皮肤反应:药物警戒研究
目的:药物引起的皮肤反应是我国常见的问题,从简单的皮疹到严重的反应都有。及早识别这些反应可以及早发现并停用违规药物,从而降低发病率和死亡率。因此,本研究旨在评估皮肤科门诊中由药物引起的皮肤反应的临床模式:本研究是一项开放性、非比较性、非干预性、观察性研究,研究对象为皮肤科就诊患者,旨在了解药物诱发皮肤反应的临床模式。共招募了 60 名疑似皮肤药物不良反应患者。医生对患者进行了详细的体格检查,包括反应发生前 3 天的药物摄入量和药物反应类型:最常报告的皮肤药物不良反应是史蒂文斯-约翰逊综合征(23%)、斑丘疹(18%)和中毒性表皮坏死(15%),21(35%)例患者由抗癫痫药物引起,其次是抗生素(17(28.33%)例、非甾体抗炎药(7(11.6%)例、抗结核药物(3(5%)例和抗逆转录病毒药物(3(5%)例)。在这些反应中,中度反应所占比例较高(50%)(31%),其中有 1%为严重反应,需要住院治疗或延长住院时间,或危及生命。主要的不良反应药物是苯妥英:结论:充分了解药物不良反应、仔细询问病史并在开药时多加留意,可以避免许多药物不良反应的发生。这些事实证明,有必要制定一项强化的药物警戒计划。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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