钆喷酸葡胺国产注射液与进口注射液安全性比较

目的：比较钆喷酸葡胺国产注射液与进口注射液的安全性。方法：22名健康男性志愿者，给予浓度为0.5mmol/L的钆喷酸葡胺国产注射液或进口注射液，单剂量0.2mmol/kg,iv，测定给药前后的血清铁、血清总胆红素、血清肌酐、血压、心率，并观察不良反应的发生率。结果：2组的血清铁值在给药后2，4，6h总体升高，8h后呈下降趋势，24h后恢复正常，血清总胆红素在给药后2，4h偶有升高，为一过性，其他未见异常。试验组有1例用药后15min自述头晕、目眩、平卧30min后恢复正常，未见其他不良反应。结论：钆喷酸葡胺国产注射液与进口注射液安全性相当，均为安全性较高的核磁共振造影剂。

Safety evaluation of gadopentetate dimeglumine in volunteers

AIM: To evaluate the clinical safety of gadopentetate dimeglumine. METHODS: Twenty- two healthy male volunteers were administered a single dose of 0.2 mmol/kg (0.5mol/L) gadopentetate dimeglumine and detected the serum iron, serum bilirubin, scrum creatinine, blood pressure, heart rate and the adverse reactions. RESULTS: The serum iron increased totally 2, 4, 6h after the administration of gadopentetate dimeglumine. It began to decrease 8h after the administration and recovered within 24h. The serum bilirubin increased occassionally 2 h and 4 h after the administration, and did not show any ab- normality There were no adverse events except one subject's feeling dizziness 14 min after the administra- tion, which recovered after 30 min. CONCLUSION: Gadopentetate dimeglumine is a safe magnetic reso- nance imaging contrast agent.