泰戈普拉赞对移植患者的塔克罗利和酸水平的影响:使用智能试验平台的随机对照研究
Seong-Wook Lee1, You Hyun Jeon1, Jeong-Hoon Lim1
1Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University Hospital, Kyungpook National University, Daegu 41944, Republic of Korea.
Pharmaceuticals (Basel, Switzerland)
|June 27, 2025
概括
泰戈普拉桑是一种与竞争的酸阻断剂,在移植接受者中与免疫抑制剂塔克罗利和酸没有相互作用. 这项研究还强调了临床试验中远程监测的有效性.
科学领域:
- 药理学和药物相互作用
- 腎科和移植醫學 腎科和移植醫學
- 临床试验技术临床试验技术
背景情况:
- 竞争性酸阻断剂 (P-CAB) 为质子抑制剂 (PPI) 提供了替代品,具有快速胃酸抑制和降低毒性的潜力.
- 调查P-CABs和必需的免疫抑制剂 (如塔克罗利和酸) 之间的药物相互作用对于脏移植接受者 (KTRs) 来说至关重要.
研究的目的:
- 在KTRs中评估P-CABtegoprazan和免疫抑制剂塔克罗利和菌酸盐之间的潜在药物相互作用.
- 在KTR中评估泰戈普拉桑与潘托普拉的安全性和有效性,重点关注免疫抑制药物水平和胃肠道症状.
主要方法:
- 一项涉及62名KTRs的随机试验,将泰戈普拉桑 (50 mg) 与潘托普拉 (20 mg) 进行比较.
- 利用智能临床试验平台通过移动应用程序远程监测药物坚持,生命体征和患者报告的症状.
- 在12周内,每4周测量一次塔克罗利斯和酸的最低水平.
主要成果:
- 在两个治疗组中都观察到100%的药物坚持.
- 在12周后,在泰戈普拉桑和潘托普拉组之间,没有发现塔克罗利斯和甲酸平均最低水平的显著差异.
- 胃肠道症状得分,生命体征和全移植功能保持稳定,在不同组之间可比.
结论:
- 泰戈普拉桑在12周的时间内不会改变KTRs中塔克罗利斯和酸的血谷水平.
- 与 pantoprazole 相比,Tegoprazan 在胃肠道症状方面表现出类似的安全性.
- 该研究成功验证了在随机试验中使用智能临床试验系统与远程监控的可行性和安全性.
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