ULTRASOUND INDUCED LUNG DAMAGE ASSESSMENT

说明(改编自申请人摘要)：经修订、建议 研究计划是对基础科学(非临床)的评估 显著的超声波诱导的生物效应，旨在 确定诊断超声技术当前和未来的作用。 如果能够证明诊断结果，医疗行业将会受益 超声波对患者来说是一个重大的医疗风险，因为它建议 临床医生对这种风险的看法，并建议如何(通过可能经过修改的 机械指数)，临床医生可以监测风险的程度。同样， 如果有证据表明，诊断超声不能 通过将其作为临床应用来消除对患者的重大医疗风险 担忧。无论是哪种情况，都有明显的医学意义。数据 决定此问题当前不可用所必需的，但当前 超声致实验动物肺损伤的研究现状 支持诊断超声设备会对人体造成伤害的观点 肺部。大多数哺乳动物的肺在功能上非常相似，因此， 与超声相关的肺损伤和出血很可能是 与物种之间存在的结构差异有关。批判性 肺的结构特征，可用来将物种分离成 不同的组别是胸膜厚度(薄与厚)、胸膜血 供血(肺动脉与支气管动脉)，间隔或小叶间 结缔组织(稀少与丰富)，以及 胸壁(薄或厚[皮肤、肌肉、脂肪、结缔组织的相对量 组织])。在这些比较的基础上，人类可以清楚地 与猪(“粗”组)分在一起，因此，猪将代表 了解超声致肺损伤发病机制的动物模型 人体内的损伤和出血。此外，当这些相同的 比较了包括人类在内的“胖”群体 和猪，以及“瘦”组，这清楚地表明，老鼠和 兔子属于“瘦”组。这后一组人充当一个关键的 结构生物对照组检验结构假说 差异确实是为人类提供 充分保护您免受任何与超声波相关的有害生物影响。 实验(基于动物的)研究计划有四个具体目标， 也就是。(1)评估最低可检测到的肺的超声水平 出血作为物种的函数发生，(2)和年龄，(3)评估 超声诱发肺出血后的功能改变 超阈值条件下，以及(4)评估损伤机制 超声致肺出血。

DESCRIPTION (Adapted from Applicant's Abstract): The amended, proposed research program is a basic science (non-clinical) evaluation of a significant ultrasound-induced biological effect which is intended to determine the current and future role of diagnostic ultrasound technology. The medical profession benefits if it can be shown that diagnostic ultrasound is a significant medical risk to the patient by advising clinicians about this risk, and suggesting how (through a possibly modified Mechanical Index) the clinician can monitor the degree of risk. Likewise, medical profession benefits if it is show that diagnostic ultrasound is not a significant medical risk to the patient by eliminating this as a clinical concern. In either case, there is clear medical significance. The data necessary to decide this issue is not currently available, but the current status regarding ultrasound-induced lung damage in experimental animals supports the view that diagnostic ultrasound equipment can damage human lungs. Most mammalian lungs, functionally are very similar and therefore, it is likely that lung damage and hemorrhage associated with ultrasound is related to structural differences that exists between species. Critical structural features of the lung that can be used to separate species into distinct groups are pleural thickness (thin verses thick), pleural blood supply (pulmonary artery verses bronchial artery), septal or interlobular connective tissue (scant verses abundant), and relative thickness of the chest wall (thin or thick [relative amounts of skin, muscle, fat, connective tissue]). On the basis of these comparisons, human beings can be clearly grouped with pigs (the "thick" group) and therefore, pigs will represent the animal model for understanding the pathogenesis of ultrasound-induced lung damage and hemorrhage in human beings. In addition, when these same comparisons are made between the "thick" group which contains human beings and pigs, and the "thin" group, it is clearly demonstrated that rats and rabbits are in the "thin" group. This latter group serves as a critical structural biologic control group to test the hypothesis that structural differences are truly the critical components that provide human beings with ample protection from any harmful bioeffects associated with ultrasound. The experimental (animal-based) research program has the four specific aims, viz. (1) to evaluate ultrasound levels at which minimum detectable lung hemorrhage occurs as a function of species, (2) and of age, (3) to evaluate functional alterations from ultrasound induced-lung hemorrhage at superthreshold conditions, and (4) to evaluate the damage mechanism of ultrasound-induced lung hemorrhage.