Background

Intake of potassium iodide (KI) reduces the accumulation of radioactive iodine in the thyroid gland in the event of possible contamination by radioactive iodine released from a nuclear facility. The World Health Organization (WHO) has stated the need for research for optimal timing, appropriate dosing regimen, and safety for repetitive iodine thyroid blocking (ITB). The French PRIODAC project, addressed all these issues, involving prolonged or repeated releases of radioactive iodine. Preclinical studies established an effective dose through pharmacokinetic modeling, demonstrating the safety of repetitive KI treatment without toxicity.

Summary

Recent preclinical studies have determined an optimal effective dose for repetitive administration, associated with pharmacokinetic modeling. The results show the safety and absence of toxicity of repetitive treatment with KI. Good laboratory practice level preclinical studies corresponding to individuals >12 years have shown a safety margin established between animal doses without toxic effect. After approval from the French health authorities, the market authorization of the two tablets of KI, 65 mg/day, was defined with a new dosing scheme of a daily repetitive intake of the treatment up to 7 days unless otherwise instructed by the competent authorities for all categories of population except pregnant women and children under the age of 12 years.

Conclusion

This new marketed authorization resulting from scientific-based evidence obtained as part of the PRIODAC project may serve as an example to further harmonize the application of KI for repetitive ITB in situations of prolonged radioactive release at the European and international levels, under the umbrella of the WHO.

中文翻译：

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PRIODAC 项目审查，该项目旨在通过 12 岁以上个体重复摄入碘来保护甲状腺免受放射性碘影响

背景：在可能受到核设施释放的放射性碘污染的情况下，摄入碘化钾（KI）可减少甲状腺中放射性碘的积累。世界卫生组织表示需要研究重复碘甲状腺阻断 (ITB) 的最佳时机、适当的给药方案和安全性。法国 PRIODAC 项目解决了所有这些问题，涉及放射性碘的长期或重复释放。临床前研究通过药代动力学模型确定了有效剂量，证明了重复 KI 治疗的安全性且无毒性。

摘要：最近的临床前研究已经确定了与药代动力学模型相关的重复给药的最佳有效剂量。结果表明 KI 重复治疗是安全的且无毒性。与超过 12 年的个体相对应的良好实验室实践水平临床前研究表明，动物剂量之间建立了安全裕度，没有毒性作用。经法国卫生当局批准后，2 片 KI-65mg/天的市场授权被定义为每天重复服用治疗长达 7 天的新剂量方案，除非主管当局对所有类别另有指示除孕妇和 12 岁以下儿童外的人口。

结论：这一新的上市授权源自作为 PRIODAC 项目一部分获得的科学证据，可以作为一个例子，在欧洲和国际层面，在长期放射性释放的情况下，进一步协调 KI 在重复性 ITB 中的应用。世界卫生组织。