Prevalence of Adverse Reactions in Nuclear Medicine
Prevalence of Adverse Reactions in Nuclear Medicine
复制标题
核医学不良反应的发生率
DOI：
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复制
发表时间：
1996
期刊：
影响因子：
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通讯作者：
J. Ryan
中科院分区：
文献类型：
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作者：
E. Silberstein;J. Ryan
本研究旨在确定介入核医学中使用的放射性药物和非放射性药物的不良反应发生率。我们还将报告给美国市售放射性药物制造商的所有不良反应制成表格。方法：对18个合作机构进行了一项为期5年的前瞻性研究，使用问卷调查，每月列举使用的程序和不良反应的数量。开发了一种用于确定放射性药物不良反应病因概率水平的算法。我们回顾了所有关于核医学不良反应的文献。在此期间，分析了783，525例放射性药物和67，835例非放射性药物给药。18例放射性药物不良反应中有10例为皮疹。没有患者对放射性药物发生不良反应，需要住院治疗或有严重后遗症。通过对来自美国药典-核医学会不良反应报告系统的30份不良反应报告进行独立评价，验证了不良反应算法的重现性。对49种市售放射性药物的所有不良反应进行制表和参考。结论放射性药物具有良好的安全记录。评估推定的放射性药物反应的算法是高度可重复的。
UNLABELLED This investigation sought to determine the prevalence of adverse reactions to radiopharmaceuticals and to nonradioactive drugs used in interventional nuclear medicine. We also tabulated all adverse reactions reported to manufacturers of radiopharmaceuticals commercially available in the United States. METHODS A prospective 5-yr study was performed of 18 collaborating institutions using a questionnaire which enumerated monthly the number of procedures used and adverse reactions noted. An algorithm to determine the level of etiologic probability of an adverse reaction from an administered radiopharmaceutical was developed. We reviewed all available literature on adverse reactions in nuclear medicine. RESULTS During this period, 783,525 radiopharmaceutical and 67,835 nonradioactive drug administrations were analyzed. Ten of the 18 adverse reactions to radiopharmaceuticals were rashes. No patient experiencing an adverse reaction to a radiopharmaceutical required hospitalization or had significant sequelae. Reproducibility of the adverse reactions algorithm was validated by independent evaluation of 30 adverse reaction reports from the U.S. Pharmacopeia-Society of Nuclear Medicine adverse reaction reporting system. All adverse reactions to 49 commercially available radiopharmaceuticals were tabulated and referenced. CONCLUSION Radiopharmaceuticals have an excellent safety record. An algorithm to evaluate putative radiopharmaceutical reactions is highly reproducible.