^(131)I-间碘苄胍注射液在临床怀疑嗜铬细胞瘤单次给药的安全性和药动学临床试验体外辐射剂量变化研究

Safety of a single dose of ^(131) I-MIBG injection in a clinical trial with suspected pheochromocytoma and pharmacokinetic changes of radiation dose in vitro

目的 探讨应用^(131)I-间碘苄胍(^(131)I-MIBG)注射肾上腺髓质显像对临床怀疑嗜铬细胞瘤单次给药的安全性和药动学临床试验受试者周围剂量当量率的动态变化。方法 前瞻性选取2021年4~6月在首都医科大学附属北京友谊医院研究型病房参加^(131)I-MIBG注射液在临床怀疑嗜铬细胞瘤单次给药的安全性和药动学临床试验项目受试者10名,其中男性6名,女性4名,年龄(56.4±12.5)岁。所有受试者均空腹肘静脉注射11.1 MBq(0.3 m Ci)/m^(2) ^(131)I-MIBG注射液,分别应用多功能数字核辐射仪实时测定给药后2、4、8、24、48 h时距体部分别20、50、100、150、200 cm处情况下每组的辐射剂量率。每个点有两个测量值,分别是无铅防护,有铅防护。对两组辐射剂量率数据进行配对t检验分析。结果 20、50、100 cm距离时,给药后2、4、8、24 h无防护组辐射剂量当量率均高于有铅防护组,差异均有统计学意义(P <0.05);20、50、100 cm距离时,给药后48 h无防护组与有铅防护组的辐射剂量当量率比较,差异无统计学意义(P> 0.05)。200 cm距离时,给药后2、4、8、24、48 h无防护组与有铅防护组的辐射剂量当量率比较,差异无统计学意义(P>0.05)。结论 应用^(131)I-MIBG注射液在嗜铬细胞瘤诊断时,在给药24 h后及100 cm以上距离可以无需做放射防护。

Objective To investigate the safety of a single dose of ^(131) I-MIBG injection adrenal medulla imaging for suspected pheochromocytoma and the dynamic change of dose equivalent rate in pharmacokinetic clinical trial subjects.Methods From April 2021 to June 2021,10 subjects,6 males and 4 females,aged(56.4±12.5)years,were prospectively enrolled in the safety and pharmacokinetic clinical trial of single dose of ^(131) I-MIBG injection in clinical suspected pheochromocytoma in the research ward of Beijing Friendship Hospital,Capital Medical University.All subjects received 11.1 MBq(0.3 mCi)/m^(2) ^(131) I-MIBG injection intravenously in fasting elbow,Multifunctional digital radiometer was used to measure the radiation dose rate of each group at 20 cm,50 cm,100 cm,150 cm and 200 cm respectively at 2 h,4 h,8 h,24 h and 48 h after administration.Each point has two measured values,respectively lead free protection and lead protection.The radiation dose rate data of the two groups were analyzed by paired T test.Results At distances of 20 cm,50 cm,and 100 cm,the radiation dose equivalent rate in the unprotected group was higher than that in the lead-protected group at 2 h,4 h,8 h,and 24 h after administration,and the differences were statistically significant(P<0.05).At distances of 20 cm,50 cm,and 100 cm,there was no significant difference in the radiation dose equivalent rate between the unprotected group and the lead-protected group at 48 h after administration(P>0.05).At a distance of 200 cm,there was no significant difference in the radiation dose equivalent rate between the unprotected group and the lead-protected group at 2 h,4 h,8 h,24 h,and 48 h after administration(P>0.05).Conclusion In the diagnosis of pheochromocytoma,it is unnecessary to use ^(131) I-MIBG injection in 24h after administration and at a distance of more than 100 cm.