ULTRASOUND INDUCED LUNG DAMAGE ASSESSMENT

描述（改编自申请人的摘要）： 研究计划是一项基础科学（非临床）评估， 显著的超声诱导生物效应，其旨在 确定诊断超声技术的当前和未来的作用。 如果能证明诊断性的 超声波对患者来说是一个重大的医疗风险， 临床医生对这种风险，并建议如何（通过可能修改的 机械指数），临床医生可以监测风险程度。 同样地， 医学界受益，如果它是显示，诊断超声是不是 通过消除这一临床风险， 关心 无论哪种情况，都有明显的医学意义。 数据 目前没有必要决定这个问题，但目前 实验动物超声肺损伤研究现状 支持诊断超声设备可能损害人体的观点 肺 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可能 与物种之间存在的结构差异有关。 关键 肺的结构特征，可用于将物种分为 不同的组是胸膜厚度（薄与厚），胸膜血 供应（肺动脉与支气管动脉），间隔或小叶间 结缔组织（少与丰富），和相对厚度的 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（“厚”组）分组，因此，猪将代表 超声致肺损伤的动物模型 伤害和出血。 此外，当这些相同的 在包含人类的“厚”组之间进行了比较， 和猪，和“瘦”组，这是清楚地表明，大鼠和 兔子属于“瘦”组。 后一组作为关键的 结构生物学对照组，以检验结构生物学 差异确实是为人类提供 充分保护免受与超声波相关的任何有害生物效应。 实验（基于动物的）研究计划有四个具体目标， 即 (1)以评估最小可检测肺的超声水平 出血的发生是物种的函数，（2）和年龄，（3）评估 超声诱发肺出血的功能改变. 超阈值条件下，（4）评估损伤机制， 超声波引起的肺出血

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.