心肌显像剂^(99)Tc^mN-NOET在健康人体中的安全性、生物学分布及内照射辐射吸收剂量

Safety,Biodistribution,and Dosimetry of Myocardial Imaging Agent ^(99)Tc^mN-NOET in Healthy Volunteers

目的研究心肌显像剂99TcmN-NOET在健康人体中的安全性、生物学分布及内照射辐射吸收剂量。方法10名正常志愿者静脉注射99TcmN-NOET744～792MBq后,观察受试者24h内的生命体征变化及有无不良反应,于给药后1、30min,1、2、4、8和24h进行全身显像以测定生物分布,用感兴趣区技术对重要器官进行放射性计数,用MIR-DOSE3.0剂量估算软件,估算各主要受照器官的内照射辐射吸收剂量。于给药后1和4h进行心肌断层显像。结果试验后24h内受试者的生命体征如心率、血压和心电图无明显变化,无任何不良反应。所有受试者的血清学和生化指标均无改变。心肌对99TcmN-NOET的摄取较高,2h时达2.68%;给药后30min心/肺比值大于1,2h达最大,为1.91±0.53。有效剂量当量为1.28×10-5Sv/MBq,按一次给药740MBq计算,各主要器官的内照射辐射吸收剂量均低于50mGy。结论心肌对99TcmN-NOET的摄取率高,断层图像清晰,99TcmN-NOET的内照射辐射吸收剂量低,安全性好,符合临床用放射性显像剂的要求。

Objective To study the safety, biodistribution, and dosimetry of myocardial perfusion imaging agent ^（99）Tc^mN-NOET in 10 healthy volunteers. Methods 744-792 MBq of ^（99）Tc^mN-NOET was injected to each volunteer. Safety parameters and adverse event was measured in 24 hours of injection. Biodistribution was studied by whole-body imaging 1, 30 minutes, 1, 2, 4, 8, and 24 hours after the injection of ^（99）Tc^mN-NOET. The estimation of dosimetry was based on the standard medical internal radiation dose method using MIRDOSE 3.0 analysis program. Myocardial single photon emission computed tomography （SPECT） imaging was performed at 1 and 4 hours after injection. Results No undesirable effects were reported by the subject during 24 hours after injection of ^（99）Tc^mN-NOET . No clinically significant changes were found in vital signs （heart rate, blood pressure, and electrocardiogram）. No biochemical aspects and serology changes were measured. The myocardial SPECT imaging was clear. Cardiac uptake of ^（99）Tc^mN-NOET was as high as 2.68% at 2 hours after injection. The heart to lung ratio was more than 1 from 30 minutes after injection, reaching a maxi- mum of 1.91 ± 0.53 at 2 hours after injection. Radiation dosimetry calculations indicated an effective absorbed dose of 1.28 ×10^-5 Sv/MBq. The dosimetry in each main organ is lower then 50mGy given 740 MBq of ^（99）Tc^mN-NOET in once imaging. Conclusions effective absorbed dose. It＇s a safe myocardial ^（99）Tc^mN-NOET exhibits high cardiac uptake and low estimated perfusion imaging agent.