Oshikoya Kazeem Adeola, Ogunyinka Ibrahim Abayomi, Ogar Comfort Kunak, Abiola Abiodun, Ibrahim Ali, Oreagba Ibrahim Adekunle
Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine, 1-5, Oba Akinjobi Street, Ikeja, Lagos 234, Nigeria.
Department of Clinical Pharmacy and Pharmacy Practice, Usmanu Danfodiyo University, Sokoto, Nigeria.
Ther Adv Drug Saf. 2020 Feb 12;11:2042098620905998. doi: 10.1177/2042098620905998. eCollection 2020.
BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions (SCARs). There is scant literature on the characteristics and causes of these conditions among the Nigerian population. Here, we describe the epidemiology, associated morbidity and mortality, and culpable drugs in SJS and TEN cases using the National Pharmacovigilance (NPC) database in Nigeria. METHODS: A retrospective review of the NPC database was done to analyze SJS and TEN cases reported over a period of 14 years. Annual reports, age and sex of patients, type of reporter, suspects and concomitant drugs, time to onset (TTO) of the reactions, and outcome of SJS and TEN were evaluated. RESULTS: The NPC received a total of 24,015 adverse drug reaction (ADR) reports. SJS and TEN accounted for 284 (0.1%) of the total reports, of which 254 (89.4%) were SJS and the remainder were TEN. Females ( = 184, 64.8%) and individuals aged 19-40 years ( = 181, 63.7%) were the most affected by SJS and TEN. Antiretrovirals, followed by antibiotics, were the most common drug classes reported to cause SJS and TEN, with nevirapine ( = 174, 40.7%) and co-trimoxazole ( = 143, 33.5%) being the most widely implicated drugs. Among patients with reported outcomes, 73 (28.7%) SJS and 3 (10.0%) TEN cases recovered without sequelae, at the time of reporting. Severity of the SCAR was reported for only 171 (69.0%) cases, of which 12 (4.7%) and 8 (26.7%) resulted in death (Grade 5) among SJS and TEN cases, respectively. CONCLUSIONS: Antiretroviral and antibiotics were the commonly reported offending group of drugs for SJS and TEN cases. Nevirapine and co-trimoxazole were the commonly reported suspect drugs. SJS and TEN were reported most frequently in females and in patients aged 19-40 years, indicating that drug surveillance and counseling in these groups of patients may be beneficial.
背景:史蒂文斯 - 约翰逊综合征(SJS)和中毒性表皮坏死松解症(TEN)是严重的皮肤不良反应(SCARs)。关于尼日利亚人群中这些病症的特征和病因的文献很少。在此,我们使用尼日利亚国家药物警戒中心(NPC)数据库描述SJS和TEN病例的流行病学、相关的发病率和死亡率以及致病药物。 方法:对NPC数据库进行回顾性分析,以分析14年间报告的SJS和TEN病例。评估年度报告、患者的年龄和性别、报告者类型、可疑药物和伴随用药、反应的发病时间(TTO)以及SJS和TEN的结局。 结果:NPC共收到24,015份药物不良反应(ADR)报告。SJS和TEN占总报告数的284份(0.1%),其中254份(89.4%)为SJS,其余为TEN。女性(n = 184,64.8%)和19 - 40岁的个体(n = 181,63.7%)受SJS和TEN影响最大。抗逆转录病毒药物,其次是抗生素,是报告导致SJS和TEN最常见的药物类别,奈韦拉平(n = 174,40.7%)和复方新诺明(n = 143,33.5%)是牵连最广泛的药物。在报告结局的患者中,73例(28.7%)SJS和3例(10.0%)TEN病例在报告时康复且无后遗症。仅171例(69.0%)病例报告了SCAR严重程度,其中SJS和TEN病例分别有12例(4.7%)和8例(26.7%)导致死亡(5级)。 结论:抗逆转录病毒药物和抗生素是SJS和TEN病例中常见的致病变药物组。奈韦拉平和复方新诺明是常见的可疑药物。SJS和TEN在女性和19 - 40岁患者中报告最为频繁,表明对这些患者群体进行药物监测和咨询可能有益。
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