■最近,抗生素耐药性的上升促使人们重新考虑四环素类药物。然而,现有研究不足以评估此类抗生素的儿科安全性.为了弥补差距,我们的研究旨在全面评估儿童四环素类药物的安全性.
■2005年1月至2023年9月的不良事件(AE)报告来自美国食品和药物管理局(FDA)不良事件报告系统(FAERS)数据库,和报告比值比(ROR)进行,以确定18岁以下儿童的潜在风险信号,这些儿童接受了三种四环素:强力霉素,米诺环素,还有替加环素.
■我们的研究共纳入1903例AE病例:多西环素782例,981用于米诺环素,替加环素140.多西环素和替加环素主要与“一般疾病和给药部位条件”和“胃肠道疾病”相关,米诺环素更经常与“皮肤和皮下组织疾病”和“胃肠道疾病”有关。“精神病风险主要包括抑郁症,自杀意念,和自杀企图。在皮肤和皮下组织类别中,有嗜酸性粒细胞增多和全身症状(DRESS)的米诺环素诱导的药物反应的30.88%导致死亡。伴随着并发AE的高发生率,如多器官功能障碍综合征,1型糖尿病(T1DM),和自身免疫性甲状腺炎.至于内分泌系统,研究发现,多西环素和米诺环素均可能增加甲状腺功能异常的风险.对于8岁以下的儿童,多西环素与牙齿变色有关(N=7,ROR=20.11%,95%CI:9.48-42.67),尽管目前尚不清楚变色是否是永久性的。
■我们的研究结果表明,对于儿科患者,大多数结果与处方信息和以前的研究一致,与多西环素相比,米诺环素往往会引起更频繁和更严重的AE。然而,值得注意的是,发现与多西环素相关的精神疾病和甲状腺功能异常,在其FDA处方信息中没有提到。此外,对于儿童,替加环素的安全性仍需进一步研究.给儿科患者开四环素类药物时,仔细的风险收益评估至关重要。
UNASSIGNED: Recently, the rise of antibiotic resistance has prompted a reconsideration of tetracyclines. However, existing studies are inadequate in assessing the pediatric safety of this class of antibiotics. To address the gap, our study aims to comprehensively assess the safety of tetracyclines in children.
UNASSIGNED: Adverse event (AE) reports from January 2005 to September 2023 were obtained from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, and reporting odds ratio (ROR) was performed to identify potential risk signals in children under 18 years old who were administered any of the three tetracyclines: doxycycline, minocycline, and tigecycline.
UNASSIGNED: A total of 1903 AE cases were included in our study: 782 for doxycycline, 981 for minocycline, and 140 for tigecycline. Doxycycline and tigecycline were predominantly associated with \"general disorders and administration site conditions\" and \"gastrointestinal disorders,\" while minocycline was more frequently linked to \"skin and subcutaneous tissue disorders\" and \"gastrointestinal disorders.\" Psychiatric risks predominantly included depression, suicidal ideation, and suicide attempt. In the category of skin and subcutaneous tissues, 30.88% of the minocycline-induced drug reaction with eosinophilia and systemic symptoms (DRESS) cases resulted in death, alongside a high occurrence of co-occurring AEs such as multiple organ dysfunction syndrome, Type 1 Diabetes Mellitus (T1DM), and autoimmune thyroiditis. As for the endocrine system, both doxycycline and minocycline were found to potentially increase the risk of thyroid dysfunction. For children under the age of 8, doxycycline was associated with tooth discoloration (N = 7, ROR = 20.11%, 95% CI: 9.48-42.67), although it remained unclear whether the discoloration was permanent.
UNASSIGNED: Our findings indicated that for pediatric patients, the majority of results were in line with the prescribing information and previous studies, and minocycline tended to cause more frequent and severe AEs than doxycycline. However, it is noteworthy that exceptions were found for psychiatric disorders and thyroid dysfunction associated with doxycycline, which are not mentioned in its FDA prescribing information. Additionally, further safety studies on tigecycline are still needed for children. When prescribing tetracyclines to pediatric patients, a careful risk-benefit assessment is crucial.