<International Circulation>: The main cost of the procedure that makes it so expensive is what exactly?
《国际循环》：导致研究的成本如此昂贵的主要费用是什么？
Prof. Oparil: The hospital stay is the most costly component. Other than that it should not be particularly expensive. I am not sure how much they charge for the patented radio frequency ablation catheter that they use in the renal vessels and the impulse generator. I don’t know how expensive the catheters are. What will matter most is just how they decide to price them. They do do a renal angiogram， to inject a dye， and take images and the radiologist’s interpretation. All of these things are considered costs of the procedure. It is necessary to have normal renal arteries to qualify for the procedure. Stents， short renal vessels， history of stroke within the past 6 months， valvular heart disease， atherosclerosis in the renal artery， or existence of multiple renal vessels all are， at least in these first studies， criteria for exclusion. Since they don’t have the history to troubleshoot these variations and haven’t established how they may influence the outcome. Conceivably it would work as well but would require more manipulation of the vessels. Although currently those with poor renal function are not include， they would be benefitted because they have increased sympathetic activity. If you are trying to get a procedure approved by the FDA then you don’t want to possibly do harm and there is motivation， at least at this early stage， to exclude subsets at higher risk of complication. Any condition where a sudden decrease in blood pressure could put a patient at risk are not included in the study. Investigational drugs or procedures are not given to anyone who is unstable.
Oparil教授：住院是最昂贵的成本。除此之外，并无特殊的昂贵的费用。我不知道医院如何收取肾血管手术和脉冲发生器中使用的特殊射频消融导管的费用。我并不知道这些导管有多昂贵。关键在于他们是如何定价？进行肾血管造影，注入一种染料，摄影并经放射科医生阅片，所有这些工作都认定为试验成本。这是确保获得正常肾动脉所必须的。支架植入、肾血管短缺、过去6个月内有过卒中史、心脏瓣膜病、肾动脉粥样硬化、肾血管多发症，至少在这些初次研究中，均是剔除标准。因为他们的继往史存在问题，这些变异可能会影响到试验结果。我们都期望研究能顺利进行，但这需要更多的血管可以用来研究。虽然本研究并未包括肾功能不良的患者，但将来他们将会受益，因为他们的交感神经兴奋性得到提高。如果你试图让FDA批准该治疗策略，那你要确保成功。至少在早期阶段，必须排除并发症高风险的亚组人群。任何条件下，可能危及患者生命的血压突然下降均不得纳入本研究。研究药物或手术治疗并不意味可以适用于任何不稳定的个体。
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