PDF(Pubmed)
Abstract：
UNASSIGNED: The purpose of the study is to analyze FAERS data to identify drugs associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), determine demographics, drug classes involved, most likely resulted in death, and highlight emerging trends in SJS/TEN reactions.
UNASSIGNED: We reviewed the publicly available FAERS database from 2004-2021. Using search terms \"Stevens-Johnson syndrome\" or \"Toxic epidermal necrolysis\", we identified the reports of SJS/TEN or SJS/TEN followed by death that might associated with specific drugs. Then the amounts and trends were counted analyzed.
UNASSIGNED: During the study period of 2004-2021, the Food and Drug Administration (FDA) received a total of 14,363,139 reports of adverse reactions, among which 24,976 were linked to SJS or TEN. After excluding the cases with incomplete or insufficient information on age, gender, or country of origin, the median median age of patients was 53.82 (IQR = 57.52), the females accounted for 56.59% (12,827 cases) and 8,507 (38.34%) originated in the United States. The top 50 drugs were associated with 15,149 cases (60.65%). The subsequent fatal outcome occurring in 4878 out of 24,976 cases (19.53%). Top 3 drug classes associated with SJS/TEN in FAERS were antiepileptics, non-steroidal anti-inflammatory drugs (NSAIDs) and others. Top drug classes associated with SJS/TEN deaths were antineoplastic agents and cephalosporins. Linear regression showed that the annual percentage of monoclonal antibody-related SJS/TEN reactions increased at an average rate of 0.25% (95% confidence interval: 0.18, 0.32) from 0.00% in 2004 to 4.79% in 2021, faster than any other drug class except antigout drug (allopurinol).
UNASSIGNED: By using the publicly available FAERS data, we have identified some important themes and trends in drug-related SJS/TEN reactions. Monoclonal antibodies and proton pump inhibitors are drugs with emerging trends causing SJS/TEN. Additionally, cephalosporin antibiotics have a higher mortality rate following SJS/TEN.
UNASSIGNED: We reviewed the publicly available FAERS database from 2004-2021. Using search terms \"Stevens-Johnson syndrome\" or \"Toxic epidermal necrolysis\", we identified the reports of SJS/TEN or SJS/TEN followed by death that might associated with specific drugs. Then the amounts and trends were counted analyzed.
UNASSIGNED: During the study period of 2004-2021, the Food and Drug Administration (FDA) received a total of 14,363,139 reports of adverse reactions, among which 24,976 were linked to SJS or TEN. After excluding the cases with incomplete or insufficient information on age, gender, or country of origin, the median median age of patients was 53.82 (IQR = 57.52), the females accounted for 56.59% (12,827 cases) and 8,507 (38.34%) originated in the United States. The top 50 drugs were associated with 15,149 cases (60.65%). The subsequent fatal outcome occurring in 4878 out of 24,976 cases (19.53%). Top 3 drug classes associated with SJS/TEN in FAERS were antiepileptics, non-steroidal anti-inflammatory drugs (NSAIDs) and others. Top drug classes associated with SJS/TEN deaths were antineoplastic agents and cephalosporins. Linear regression showed that the annual percentage of monoclonal antibody-related SJS/TEN reactions increased at an average rate of 0.25% (95% confidence interval: 0.18, 0.32) from 0.00% in 2004 to 4.79% in 2021, faster than any other drug class except antigout drug (allopurinol).
UNASSIGNED: By using the publicly available FAERS data, we have identified some important themes and trends in drug-related SJS/TEN reactions. Monoclonal antibodies and proton pump inhibitors are drugs with emerging trends causing SJS/TEN. Additionally, cephalosporin antibiotics have a higher mortality rate following SJS/TEN.
摘要：
■研究的目的是分析FAERS数据，以确定与史蒂文斯-约翰逊综合征（SJS）和中毒性表皮坏死松解症（TEN）相关的药物，确定人口统计，涉及毒品类别，最有可能导致死亡，并强调SJS/TEN反应的新兴趋势。
■我们回顾了2004-2021年公开的FAERS数据库。使用搜索词\"Stevens-Johnson综合征\"或\"中毒性表皮坏死松解症\",我们确定了可能与特定药物相关的SJS/TEN或SJS/TEN的死亡报告.然后对数量和趋势进行计数分析。
■在2004-2021年的研究期间，美国食品和药物管理局（FDA）共收到14,363,139份不良反应报告，其中24,976人与SJS或TEN相关。在排除年龄信息不完整或不充分的情况后，性别,或原产国，患者的中位年龄为53.82（IQR=57.52），女性占56.59%(12,827例)，8,507例(38.34%)起源于美国。前50名药物与15,149例（60.65%）相关。随后的致命结局发生在24976例中的4878例（19.53％）。FAERS中与SJS/TEN相关的前3类药物是抗癫痫药，非甾体抗炎药（NSAIDs）等。与SJS/TEN死亡相关的顶级药物是抗肿瘤药和头孢菌素。线性回归显示，单克隆抗体相关的SJS/TEN反应的年百分比以平均0.25％（95％置信区间：0.18，0.32）的速率从2004年的0.00％增加到2021年的4.79％，比其他任何药物类别都快。
■通过使用公开的FAERS数据，我们已经确定了药物相关SJS/TEN反应的一些重要主题和趋势。单克隆抗体和质子泵抑制剂是具有引起SJS/TEN的新兴趋势的药物。此外,SJS/TEN后，头孢菌素类抗生素的死亡率更高。
■我们回顾了2004-2021年公开的FAERS数据库。使用搜索词\"Stevens-Johnson综合征\"或\"中毒性表皮坏死松解症\",我们确定了可能与特定药物相关的SJS/TEN或SJS/TEN的死亡报告.然后对数量和趋势进行计数分析。
■在2004-2021年的研究期间，美国食品和药物管理局（FDA）共收到14,363,139份不良反应报告，其中24,976人与SJS或TEN相关。在排除年龄信息不完整或不充分的情况后，性别,或原产国，患者的中位年龄为53.82（IQR=57.52），女性占56.59%(12,827例)，8,507例(38.34%)起源于美国。前50名药物与15,149例（60.65%）相关。随后的致命结局发生在24976例中的4878例（19.53％）。FAERS中与SJS/TEN相关的前3类药物是抗癫痫药，非甾体抗炎药（NSAIDs）等。与SJS/TEN死亡相关的顶级药物是抗肿瘤药和头孢菌素。线性回归显示，单克隆抗体相关的SJS/TEN反应的年百分比以平均0.25％（95％置信区间：0.18，0.32）的速率从2004年的0.00％增加到2021年的4.79％，比其他任何药物类别都快。
■通过使用公开的FAERS数据，我们已经确定了药物相关SJS/TEN反应的一些重要主题和趋势。单克隆抗体和质子泵抑制剂是具有引起SJS/TEN的新兴趋势的药物。此外,SJS/TEN后，头孢菌素类抗生素的死亡率更高。
