[Safety and Effectiveness of NEPTIS Plug-01 and Florbetapir (18F) in Daily Clinical Setting: Based on the Post-Marketing Surveillance Study].

Kaku igaku. The Japanese journal of nuclear medicine Pub Date : 2019-01-01 DOI:10.18893/kakuigaku.oa.1802

Tomomi Nakamura, Taka Matsumura, Y. Yamamoto, M. Senda

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Abstract

OBJECTIVE Obtaining the information on safety and effectiveness of radiopharmaceutical synthesizer NEPTIS plug - 01 and florbetapir (18F) injection solution synthesized by NEPTIS plug - 01 from the post marketing surveillance study. METHODS Regarding the safety evaluation, failure of device and adverse events were recorded. Regarding the effectiveness evaluation, we assessed the quality of PET images and the impact on the clinical diagnosis. RESULT During the study period, 12 patients were enrolled. No adverse event was reported from those 12 patients. Two events in 2 patients were reported as a failure of device (In a subsequent investigation, those failures were thought to be caused by inadequacy of procedure manual, which has been revised now). For the quality of PET images, all 12 cases were "good" or "excellent", regardless of the positive or negative of amyloid plaque. The attending physician's diagnosis was changed in 9 patients following the PET imaging. CONCLUSION NEPTIS plug-01 and florbetapir (18F) were safe and has a favorable effectiveness profile in 12 patients under daily clinical setting.

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[NEPTIS Plug-01和Florbetapir (18F)在日常临床环境中的安全性和有效性:基于上市后监测研究]。

目的通过对放射性药物合成剂NEPTIS plug - 01和其合成的氟倍他吡(18F)注射液的上市后监测研究，了解其安全性和有效性。方法在安全性评价方面，记录器械失效和不良事件。在疗效评估方面，我们评估了PET图像的质量和对临床诊断的影响。结果在研究期间，12例患者入组。12例患者无不良事件报告。2例患者中2例事件报告为器械失效(在随后的调查中，这些失效被认为是由于操作手册的不充分引起的，现已修订)。无论淀粉样斑块阳性或阴性，12例PET图像质量均为“良”或“优”。9例患者PET显像后主治医师的诊断发生改变。结论在12例患者的日常临床环境中，neptis - plu01和florbetapir (18F)是安全且有效的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Kaku igaku. The Japanese journal of nuclear medicine Medicine-Medicine (all)

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期刊介绍： The main scope of JSNM is the appropriate development of the application of radioactive substances and stable nuclides in medicine. Towards this scope, JSNM promotes the exchange of idea and information, and researches in nuclear medicine. JSNM are interested in the international collaboration for the development of nuclear medicine. Through the activities, JSNM contributes to the medicine, as well as humanity, not only in Japan but also in any countries over the world.