Integrative Brain Imaging Center, National Center of Neurology and Psychiatry, 4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8551, Japan.
Graduate School of Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8675, Japan.
Ann Nucl Med. 2020 Apr;34(4):299-304. doi: 10.1007/s12149-020-01439-w. Epub 2020 Jan 27.
This pharmacovigilance-based survey was aimed at determining the prevalence of, and association between, radiopharmaceuticals and adverse reactions to radiopharmaceuticals from 1975 to 2017 in Japan.
The Subcommittee for Safety Issues of Radiopharmaceuticals of the Japan Radioisotope Association's Medical Science and Pharmaceutical Committee mailed a form for reporting adverse reactions to radiopharmaceuticals to all institutes performing nuclear medicine examinations in Japan. This investigation included adverse reactions to diagnostic radiopharmaceuticals labeled with both single-photon- and positron-emitting radionuclides and therapeutic sodium iodide labeled with I. Each institute returned the reporting form to the subcommittee each time an adverse reaction occurred.
Replies were obtained from 75% of the institutions. In total, 1099 adverse reactions were reported from 46,645,580 radiopharmaceutical administrations, giving a prevalence of 2.4 adverse reactions per 100,000 administrations (95% confidence interval 2.2-2.5). Adverse reactions were most frequently observed for I-iodomethylnorcholesterol (230.1/10 administrations), followed by I-HSA (76.3/10 administrations), I-sodium iodohippurate (31.2/10 administrations), and Tc-DTPA (12.0/10 administrations). Comparison of adverse reactions between before and after 1997 revealed that prevalence dropped from 3.7/10 administrations (95% confidence interval 3.5-4.1) to 1.5/10 administrations (95% confidence interval 1.4-1.6). During the study period, vasovagal reactions accounted for 50.3% of adverse reactions, fever for 7.5%, allergic reactions for 25.7%, and other for 16.5%; 3.7% of all adverse reactions were considered severe but none were lethal. A definite, probable, possible, less likely, and uncertain causal relationship with radiopharmaceuticals was observed in 13.1%, 33.7%, 39.9%, 6.2%, and 7.1% of adverse reactions, respectively.
These results suggest that nuclear medicine staff must be aware of the possibility of adverse reactions from radiopharmaceuticals, despite their rarity.
本基于药物警戒的调查旨在确定 1975 年至 2017 年日本放射性药物与放射性药物不良反应的发生率及其相关性。
日本放射性同位素协会医学科学与药物委员会放射性药物安全问题小组委员会向日本所有进行核医学检查的机构邮寄了一份放射性药物不良反应报告表。该调查包括单光子和正电子发射放射性核素标记的诊断放射性药物以及 I 标记的治疗性碘化钠的不良反应。每个机构在发生不良反应时都将报告表返回小组委员会。
该调查共收到 75%机构的回复。在总计 46645580 次放射性药物给药中，共报告了 1099 例不良反应，发生率为每 100000 次给药 2.4 例（95%置信区间 2.2-2.5）。I-碘甲基诺胆固醇的不良反应发生率最高（每 10 次给药 230.1 例），其次是 I-HSA（每 10 次给药 76.3 例）、I-碘酸钠尿酸（每 10 次给药 31.2 例）和 Tc-DTPA（每 10 次给药 12.0 例）。对 1997 年前后不良反应的比较显示，发生率从每 10 次给药 3.7 例（95%置信区间 3.5-4.1）降至每 10 次给药 1.5 例（95%置信区间 1.4-1.6）。在研究期间，血管迷走反应占不良反应的 50.3%，发热占 7.5%，过敏反应占 25.7%，其他占 16.5%；所有不良反应中有 3.7%被认为是严重的，但没有致命的。在 13.1%、33.7%、39.9%、6.2%和 7.1%的不良反应中，分别观察到与放射性药物的确定、可能、可能、不太可能和不确定因果关系。
这些结果表明，尽管放射性药物不良反应罕见，但核医学工作人员必须意识到其发生的可能性。
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