Department of Dermatology, Venereology and Leprology, Smt. N.H.L. Municipal Medical College, Ahmedabad, Gujarat, India.
Pharmacoepidemiol Drug Saf. 2012 Apr;21(4):384-95. doi: 10.1002/pds.3212. Epub 2012 Feb 28.
The aims of the present article were to study clinical features and to analyse them in different drug class associated with Stevens-Johnson syndrome (SJS) in a tertiary care hospital in Gujarat, India.
A prospective hospital-based study was carried out over a period of 3 years (June 2007 to September 2009) at Sheth Vadilal Hospital, Ahmedabad, India. The diagnosis of SJS was made mainly on the basis of the clinical findings, which included extensive erythema multiforme, purpuric lesions with bullae and detachment of skin involving at least two mucous membranes. Further, in each patient suspected with SJS, various laboratory tests such as complete blood count, liver function tests, metabolic panel, chest X-ray and other serological test were carried out. SJS was confirmed on the basis of most widely accepted Bastuji-Garin definition. Causality assessment was performed using the Naranjo scale. Only 'probable' and 'definite' reactions were included.
Antibacterials for systemic use, anti-inflammatory and antirheumatic products and antiepileptics were the drug classes most commonly associated (8 of 29 cases, each) with SJS. Individually, ibuprofen was involved in the highest number of cases (five cases, 17.2%), followed by carbamazepine (four cases, 13.8%) . The mean duration of developing SJS symptoms was 15.9 days (SD = 8.7 days) and improvement after treatment was 14.2 days (SD = 4.6 days). The duration of appearing SJS symptoms varied significantly between different classes of drugs (p < 0.001). The appearance of SJS symptom started within 10 days for anti-inflammatory and antibacterial compared with 24 days of antiepileptic agents. All the patients with antiepileptic agent-induced SJS had 7% to 9% of detached body surface area. In two patients, SJS progressed to toxic epidermal necrolysis and of which one led to death and the other developed long-term complication of conjunctival xerosis. A total of six patients developed long-term complications: four patients had conjunctival synechia, one patient had conjunctival xerosis and one patient had urethral stricture.
More than 80% of the SJS events were induced by antibacterial, anti-inflammatory and antiepileptic agents with same frequency. The duration of the appearance of SJS symptoms significantly varied between different drug classes and started within 10 days for anti-inflammatory and antibacterial compared with 24 days of antiepileptic agents.
本研究旨在分析印度古吉拉特邦一家三级护理医院中与 Stevens-Johnson 综合征（SJS）相关的不同药物类别中的临床特征。
本前瞻性医院研究于 2007 年 6 月至 2009 年 9 月在印度艾哈迈达巴德的谢思瓦迪拉尔医院进行。SJS 的诊断主要基于临床发现，包括广泛的多形性红斑、瘀斑伴水疱和皮肤脱落，至少涉及两个粘膜。此外，对每一位疑似 SJS 的患者进行了各种实验室检查，如全血细胞计数、肝功能检查、代谢组学、胸部 X 射线和其他血清学检查。SJS 是根据最广泛接受的 Bastuji-Garin 定义确认的。使用 Naranjo 量表进行因果关系评估。仅包括“可能”和“确定”反应。
全身性抗菌药物、抗炎和抗风湿产品以及抗癫痫药是与 SJS 最相关的药物类别（29 例中的 8 例，各 8 例）。布洛芬单独涉及的病例最多（5 例，17.2%），其次是卡马西平（4 例，13.8%）。SJS 症状出现的平均时间为 15.9 天（SD=8.7 天），治疗后改善时间为 14.2 天（SD=4.6 天）。不同药物类别的 SJS 症状出现时间差异显著（p<0.001）。与抗癫痫药相比，抗炎和抗菌药的 SJS 症状出现时间在 10 天内，而抗癫痫药的 SJS 症状出现时间为 24 天。所有因抗癫痫药引起的 SJS 患者的体表面积脱落率为 7%至 9%。在 2 例患者中，SJS 进展为中毒性表皮坏死松解症，其中 1 例死亡，另 1 例发生结膜干燥长期并发症。共有 6 例患者发生长期并发症：4 例患者出现结膜粘连，1 例患者出现结膜干燥，1 例患者出现尿道狭窄。
超过 80%的 SJS 事件是由抗菌药、抗炎药和抗癫痫药引起的，其频率相同。SJS 症状出现的时间在不同药物类别之间有显著差异，与抗癫痫药相比，抗炎药和抗菌药的 SJS 症状出现时间在 10 天内，而抗癫痫药的 SJS 症状出现时间为 24 天。
