Sushma M, Noel M V, Ritika M C, James J, Guido S
Department of Pharmacology, St. John's Medical College, Bangalore, India.
Pharmacoepidemiol Drug Saf. 2005 Aug;14(8):567-70. doi: 10.1002/pds.1105.
To study the clinical spectrum of cutaneous adverse drug reactions (ADRs) in hospitalized patients retrospectively for 9 years and to establish a causal link between the drug and the reaction by using World Health Organization (WHO) causality definitions.
A retrospective hospital-based study over a period of 9 years (January 1994 to December 2002) was carried out in the Department of Dermatology of St. John's Medical College Hospital to record various cutaneous ADRs of the hospitalized patients. Based on WHO causality definitions, ADRs were categorized into certain, probable, possible, and unlikely. The data was subjected to descriptive analysis.
Of the total 3541 patients, 404 (11.4%) were diagnosed as cutaneous ADRs, of which 52% were males and 48% females. A majority of the patients were in the age group of 21-40 years. Only drugs having certain and probable causal association to the reaction were considered for analysis (384). The most common type of ADR was maculopapular rash (42.7%), followed by Stevens-Johnson syndrome (SJS) (19.5%) and fixed drug eruption (11.4%). The drug class implicated was antibiotics (45%), followed by antiepileptics (19%), NSAIDs (19%). The reaction time (RT) recorded was in accordance with the previous reports.
A wide clinical spectrum of cutaneous ADRs ranging from mild maculopapular rash to serious toxic epidermal necrolysis (TEN) were observed. The incidence of life threatening cutaneous ADRs like SJS and TEN were found to be higher compared to studies published abroad. Antibiotics were the most commonly implicated drugs. A higher number of cutaneous ADRs were found to newer drugs like cephalosporins and fluroquinolones compared to previous studies.
回顾性研究住院患者皮肤药物不良反应（ADR）的临床谱，并根据世界卫生组织（WHO）因果关系定义确定药物与反应之间的因果联系。
在圣约翰医学院医院皮肤科进行了一项为期9年（1994年1月至2002年12月）的回顾性医院研究，以记录住院患者的各种皮肤ADR。根据WHO因果关系定义，ADR被分为肯定、很可能、可能和不太可能。对数据进行描述性分析。
在总共3541例患者中，404例（11.4%）被诊断为皮肤ADR，其中男性占52%，女性占48%。大多数患者年龄在21 - 40岁之间。仅对与反应有肯定和很可能因果关联的药物进行分析（384例）。最常见的ADR类型是斑丘疹（42.7%），其次是史蒂文斯 - 约翰逊综合征（SJS）（19.5%）和固定性药疹（11.4%）。涉及的药物类别是抗生素（45%），其次是抗癫痫药（19%）、非甾体抗炎药（19%）。记录的反应时间（RT）与先前报道一致。
观察到皮肤ADR的临床谱广泛，从轻度斑丘疹到严重的中毒性表皮坏死松解症（TEN）。与国外发表的研究相比，发现像SJS和TEN这样危及生命的皮肤ADR的发生率更高。抗生素是最常涉及的药物。与先前研究相比，发现头孢菌素和氟喹诺酮等新药引起的皮肤ADR数量更多。
