Scientific Consultant, Hunstanton, Norfolk, United Kingdom.
J Aerosol Med Pulm Drug Deliv. 2012 Dec;25 Suppl 1:S10-28. doi: 10.1089/jamp.2012.1Su4.
Two-dimensional (2D or planar) imaging with (99m)Tc radiolabels enables quantification of whole-lung and regional lung depositions for orally inhaled drug products. This article recommends standardized methodology for 2D imaging studies. Simultaneous anterior and posterior imaging with a dual-headed gamma camera is preferred, but imaging with a single-headed gamma camera is also acceptable. Correction of raw data for the effects of gamma ray attenuation is considered essential for accurate quantification, for instance, using transmission scanning with a flood-field source of (99m)Tc or (57)Co. Evidence should be provided of the accuracy of the quantification method, for instance, by determining "mass balance." Lung deposition may be expressed as a percentage of ex-valve or ex-device dose, but should also be given as mass of drug when possible. Assessment of regional lung deposition requires delineation of the lung borders, using X-ray computed tomography, radioactive gas scans ((133)Xe or (81m)Kr), or transmission scans. When quantifying regional lung deposition, the lung should be divided into outer (O) and inner (I) zones. A penetration index should be calculated, as the O/I ratio for aerosol, normalized to that for a radioactive gas or transmission scan. A variety of methods can be used to assess lung deposition and distribution. Methodology and results should be documented in detail, so that data from different centers may be compared. The use of appropriate methodology will provide greater confidence in the results of 2D imaging studies, and should allay concerns that such studies are qualitative or semiquantitative in nature.
二维(2D 或平面)成像与(99m)Tc 放射性标记可实现定量评估经口吸入药物产品的全肺和区域性肺沉积。本文推荐了 2D 成像研究的标准化方法。优先采用双探头伽马相机进行前、后同时成像,但单探头伽马相机成像也是可以接受的。为了进行准确的定量分析,需要对原始数据进行伽马射线衰减效应的校正,例如,使用(99m)Tc 或(57)Co 源的透射扫描。应提供定量方法的准确性的证据,例如,通过确定“质量平衡”来实现。肺沉积可以表示为阀后或装置后剂量的百分比,但在可能的情况下,也应表示为药物的质量。评估区域性肺沉积需要使用 X 射线计算机断层扫描、放射性气体扫描((133)Xe 或(81m)Kr)或透射扫描来描绘肺边界。在定量区域性肺沉积时,应将肺分为外区(O)和内区(I)。应计算穿透指数,即将气溶胶的 O/I 比归一化为放射性气体或透射扫描的 O/I 比。可以使用多种方法来评估肺沉积和分布。应详细记录方法和结果,以便可以比较不同中心的数据。使用适当的方法将提高对 2D 成像研究结果的信心,并减轻对这些研究定性或半定量性质的担忧。