Siegel J A
Nuclear Physics Enterprises, Voorhees, New Jersey 08043, USA.
J Nucl Med. 1998 Aug;39(8 Suppl):28S-33S.
The Nuclear Regulatory Commission regulations for the release of patients administered radioactive material have been revised to include dose-based or activity-based criteria.
The revised 10 CFR 35.75 regulations and the formula that can be used to determine when an individual patient administered radioactivity is releasable are reviewed. The implications of these new regulations on patient release after 131I anti-B1 therapy for the treatment of non-Hodgkin's lymphoma are also discussed.
A licensee may now release patients if the total effective dose equivalent to another individual from exposure to a released patient is <500 mrem. Compliance with this dose limit is demonstrated by licensees either by using a default table for activity or dose rate provided in Regulatory Guide 8.39 or by performing a patient-specific dose calculation. Licensees may also demonstrate compliance by basing patient release on the patient-specific measured dose rate at 1 m instead of administered activity. Data on more than 50 patients receiving 131I anti-B1 therapy, an investigational therapy for non-Hodgkin's lymphoma, indicate that all patients would have been releasable under the new regulations.
The new regulations will permit 131I anti-B1 therapy to be conducted on an outpatient basis.
美国核管理委员会关于接受放射性物质治疗患者出院的规定已修订，纳入了基于剂量或基于活度的标准。
对修订后的10 CFR 35.75规定以及可用于确定接受放射性治疗的个体患者何时可出院的公式进行了审查。还讨论了这些新规定对131I抗B1疗法治疗非霍奇金淋巴瘤后患者出院的影响。
如果释放患者对另一个人的总有效剂量当量小于500毫雷姆，持照人现在可以让患者出院。持照人可通过使用监管指南8.39中提供的活度或剂量率默认表，或通过进行患者特定剂量计算来证明符合此剂量限制。持照人也可以根据患者在1米处特定测量的剂量率而非给药活度来证明符合规定，从而让患者出院。对50多名接受131I抗B1疗法（一种用于非霍奇金淋巴瘤的试验性疗法）患者的数据表明，根据新规定，所有患者都可以出院。
新规定将允许131I抗B1疗法在门诊进行。
