与刺途径抑制剂相关的胃肠道不良事件:不成比例性分析
Anjana Shenoy1, Adithya Mysore Shivakumar2,3, Gouri Nair4
1Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India.
The International journal of pharmacy practice
|October 13, 2025
概括
刺途径抑制剂 (HPI) 可以导致胃肠道不良事件 (GIAE). 这项研究确定了用HPI治疗的患者中缩性眼球炎,老年症,腹痛症和潜在的肝损伤的安全信号.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
背景情况:
- 刺途径抑制剂 (HPI) 在治疗基底细胞癌 (BCC) 方面至关重要.
- 胃肠道不良事件 (GIAEs) 是已知的HPI的副作用.
- 早期发现GIAEs对于患者的安全至关重要.
研究的目的:
- 识别与HPI相关的GIAE的潜在安全信号.
- 为了分析vismodegib,sonidegib和glasdegib报告的GIAE的不成比例.
- 评估HPI关于胃肠道毒性的安全概况.
主要方法:
- 追溯案例/非案例不成比例性分析.
- 使用USFDA不良事件报告系统数据库通过OpenVigil 2.1.
- 对vismodegib,sonidegib和glasdegib报告的分析的GIAE,报告的几率比率 (ROR) 超过1个值.
主要成果:
- HPI与6781次不良事件有关,其中包括1196次GIAE.
- 维斯莫迪吉布显示了缩性眼球炎和老年的潜在安全信号.
- 索尼迪吉布表示对异质症的担忧,而格拉斯迪吉布则表示对肝毒性的担忧.
结论:
- 肝炎与一系列GIAE有关,包括美国FDA之前未列出的严重肝损伤.
- 这些发现强调了需要对HPI治疗患者进行警监测,以发现GIAE.
- 建议进行进一步的研究,以验证这些安全信号,并为临床实践提供信息.
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