■膀胱内化疗和免疫治疗是非肌层浸润性膀胱癌术后常见的辅助治疗方法。分析与这些治疗相关的不良事件,可以协助临床决策和风险评估。
■进行了不相称性分析,以分析2004年第一季度至2024年第一季度食品和药物管理局不良事件报告系统数据库中的数据,探索了卡介苗之间的潜在正信号-Guérin,丝裂霉素C,表柔比星,吉西他滨,和不良事件。
■数据库检索了与卡介苗相关的2018、140、31和85份不良事件报告,丝裂霉素C,表柔比星,和吉西他滨,分别。标签中未提及的不良反应,如主动脉瘤和眼部充血,在与卡介苗相关的首选术语水平上观察到。丝裂霉素-C在包装说明书中未反映的皮肤和皮下组织疾病中表现出特异性。吉西他滨引起的药物不良反应在血管和淋巴疾病中的信号符合所有4项指标的筛选标准。毛细血管渗漏综合征是信号强度最高的首选术语。
■本研究观察到新的不良事件信号,为非肌层浸润性膀胱癌术后辅助治疗的药物选择提供重要帮助。
UNASSIGNED: Intravesical chemotherapy and immunotherapy are common adjuvant treatments for non-muscle invasive bladder cancer post-surgery. Analyzing adverse events linked to these therapies, can assist in clinical decision-making and risk assessment.
UNASSIGNED: Disproportionality analysis was conducted to analyze data from the Food and Drug Administration Adverse Event Reporting System database from the first quarter of 2004 to the first quarter of 2024, exploring potential positive signals between Bacillus Calmette-Guérin, mitomycin-C, epirubicin,
gemcitabine, and adverse events.
UNASSIGNED: The database retrieved 2018, 140, 31, and 85 adverse event reports associated with Bacillus Calmette-Guérin, mitomycin-C, epirubicin, and
gemcitabine, respectively. Adverse reactions not mentioned in the label, such as aortic aneurysm and ocular congestion, were observed in preferred term level related to Bacillus Calmette-Guérin. Mitomycin-C exhibited specificity in skin and subcutaneous tissue diseases not reflected in the package insert.
Gemcitabine-induced adverse drug reactions showed signals in vascular and lymphatic diseases meeting the screening criteria of all 4 indicators, with capillary leakage syndrome being the preferred term with the highest signal intensity.
UNASSIGNED: This study observed new adverse event signals, providing important assistance for drug selection in adjuvant therapy for non-muscle invasive bladder cancer postoperatively.