Waksman R
Department of Medicine, Washington Hospital Center, Washington, DC 20010, USA.
Am J Cardiol. 1998 Apr 9;81(7A):21E-26E. doi: 10.1016/s0002-9149(98)00194-5.
Endovascular radiation therapy has proved to be safe and effective in preventing restenosis after coronary intervention both in animal studies and in pilot feasibility studies in humans. The rationale for such therapy is that radiation prevents neointimal proliferation and vessel constriction after vascular injury. Two forms of endovascular radiation therapy are available: catheter-based systems and radioactive stenting. However, several practical issues related to this technique still need to be addressed, such as questions about dosimetry, shielding, expense, handling and disposal of radioisotopes, certification for potential users, and-above all-safety and efficacy. In their pivotal studies, investigators and industry need to focus on prioritizing the clinical applications of this form of treatment. The clinical trials must attempt to determine the cost-effectiveness of this therapy as well as its risk versus benefit. For example, brachytherapy may prove to be of great benefit to patients with in-stent restenosis, and favorable results of studies examining this application should expedite the approval of endovascular radiation therapy for clinical use.
血管内放射治疗在动物研究和人体初步可行性研究中均已证明,在预防冠状动脉介入术后再狭窄方面是安全有效的。这种治疗方法的基本原理是,放射可防止血管损伤后新生内膜增生和血管收缩。血管内放射治疗有两种形式:基于导管的系统和放射性支架。然而,与该技术相关的几个实际问题仍有待解决,例如剂量测定、屏蔽、费用、放射性同位素的处理和处置、潜在使用者的认证,以及最重要的安全性和有效性问题。在关键研究中,研究人员和业界需要专注于优先考虑这种治疗形式的临床应用。临床试验必须尝试确定这种治疗方法的成本效益及其风险与益处。例如,近距离放射治疗可能被证明对支架内再狭窄患者非常有益,而研究该应用的良好结果应会加快血管内放射治疗临床应用的批准。