开发和初步的临床经验,用帕克利塔塞尔涂层气球治疗良性难食管狭窄的治疗
Kenneth K Wang1, Ian Schorn2, Carlos Adorno3
1Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota, USA.
一种新型的药物涂层气球 (DCB) 安全地扩大食道狭窄,输送帕克利塔塞尔以防止复发. 人类试验显示持续的光线改善和减少食障碍,长达两年.
科学领域:
- 胃肠病学 胃肠病学
- 干预性内镜检查是干预性的内镜检查.
- 药物输送系统 药物输送系统
背景情况:
- 良性食道狭窄会导致食欲障碍并降低生活质量.
- 一个新的药物涂层气球 (DCB) 在扩张期间提供帕克利塔塞尔,以最大限度地减少狭窄的复发.
研究的目的:
- 评估巴克利塔克塞尔排泄的DCB在良性食道狭窄的安全性和有效性.
- 评估临床前组织学和药物动力学概况以及最初的人类安全性和结果.
主要方法:
- 临床前研究涉及39只用DCB或裸体气球治疗的猪,评估了帕克利塔塞尔的药理动力学和组织反应.
- 九名患有食道狭窄的人接受了DCB治疗,并被跟踪长达2年.
主要成果:
- 帕克利塔塞尔在猪组织中存在长达28天的时间,血水平最低,无毒性.
- 人体受试者没有出现重大不良事件,在2年内重复治疗率为11%,食障碍得分有所改善.
- 在人体中,食道光线直径在1年内显著增加.
结论:
- 对于食道粘膜来说,DCB治疗似乎是安全的,持续的局部帕克利塔克塞尔存在和最小的全身吸收.
- 最初的人类数据表明,DCB在治疗食道狭窄时是安全有效的,改善了光线直径和症状.
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