法国放射性药物的不良反应：国家药物警戒数据库分析
Adverse reactions to radiopharmaceuticals in France: analysis of the national pharmacovigilance database.
作者信息
Laroche Marie-Laure, Quelven Isabelle, Mazère Joachim, Merle Louis
机构信息
Service de Pharmacologie, Toxicologie et Pharmacovigilance, CHU de Limoges, Limoges, France Faculté de Médecine, Université de Limoges, Limoges, France
Service de Pharmacologie, Toxicologie et Pharmacovigilance, CHU de Limoges, Limoges, France Service de Médecine Nucléaire, CHU de Limoges, Limoges, France.
出版信息
Ann Pharmacother. 2015 Jan;49(1):39-47. doi: 10.1177/1060028014558153. Epub 2014 Nov 3.
BACKGROUND
Radiopharmaceuticals are regarded as safe by the nuclear medicine community, but up to now, no survey has been conducted with from the perspective of pharmacovigilance.
OBJECTIVE
To describe the adverse reactions to radiopharmaceuticals (ARRPs) reported to the French Pharmacovigilance Database (FPVD).
METHODS
We selected and described all reports encompassing at least one radiopharmaceutical in the FPVD. The annual incidence of reported ARRPs used in diagnosis was also estimated.
RESULTS
From 1989 to 2013, 304 reports of ARRPs were identified (43.0% serious, 12 deaths) in 54.6% women and 45.4% men; the median age was 58 years. Five therapeutic radiopharmaceuticals ((131)I-sodium iodide, (131)I-lipiodol, (89)Sr-chloride, (153)Sm-lexidronam, and (90)Y-ibritumomab-tiuxetan) were involved in 48 reports (97 adverse reactions: 86.6% serious, 9 deaths). Pulmonary disorders represented 44.3% of ARRPs used for therapy, mainly related to (131)I-lipiodol. There were 34 diagnostic radiopharmaceuticals involved in 256 reports (451 adverse reactions: 38.1% serious, 3 deaths); 8 diagnostic products ((99m)Tc-oxidronate, (18)F-fluorodeoxyglucose, (99m)Tc-tin pyrophosphate, (99m)Tc-tetrofosmin, (99m)Tc-dimercaptosuccinic acid, (201)Tl-chloride, (99m)Tc-sestamibi, and (111)In-pentetate) accounted for two-thirds of ARRPs. The most frequent adverse reactions were skin (34.4%), general (18.2%), nervous (9.0%), and gastrointestinal disorders (7.0%). There were 25 cases of altered images and 10 medication errors. The annual incidence of reported adverse reactions ranged from 1.2 × 10(-5) to 3.4 × 10(-5) diagnostic administrations.
CONCLUSIONS
Reported ARRPs occurred rarely and were more serious in the therapeutic than in the diagnostic field. The notification of ARRPs was able to provide new guidance for safe use, as was the case for (131)I-lipiodol. Therefore, it is important to report ARRPs to a pharmacovigilance system.
背景
核医学界认为放射性药物是安全的，但截至目前，尚未从药物警戒的角度进行过调查。
目的
描述向法国药物警戒数据库（FPVD）报告的放射性药物不良反应（ARRPs）。
方法
我们挑选并描述了FPVD中所有包含至少一种放射性药物的报告。还估算了用于诊断的报告的ARRPs的年发病率。
结果
1989年至2013年，共识别出304例ARRPs报告（43.0%为严重不良反应，12例死亡），其中女性占54.6%，男性占45.4%；中位年龄为58岁。5种治疗用放射性药物（碘化钠（131）I、碘油（131）I、氯化锶（89）Sr、依替膦酸（153）Sm和替伊莫单抗（90）Y）涉及48份报告（97例不良反应：86.6%为严重不良反应，9例死亡）。肺部疾病占用于治疗的ARRPs的44.3%，主要与碘油（131）I有关。有34种诊断用放射性药物涉及256份报告（451例不良反应：38.1%为严重不良反应，3例死亡）；8种诊断产品（氧化膦酸盐（99m）Tc、氟脱氧葡萄糖（18）F、焦磷酸亚锡（99m）Tc、替曲膦（99m）Tc、二巯基丁二酸（99m）Tc、氯化铊（201）Tl、甲氧基异丁基异腈（99m）Tc和喷替酸铟（111）In）占ARRPs的三分之二。最常见的不良反应为皮肤（34.4%）、全身（18.2%）、神经（9.0%）和胃肠道疾病（7.0%）。有25例图像改变和10例用药错误。报告的不良反应的年发病率范围为每诊断给药1.2×10⁻⁵至3.4×10⁻⁵。
结论
报告的ARRPs很少发生，且治疗领域的比诊断领域的更严重。ARRPs的通报能够为安全使用提供新的指导，碘油（131）I的情况就是如此。因此，向药物警戒系统报告ARRPs很重要。
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