Hamamoto Tomoyuki, Serizawa Ayaka, Ohtsuki Kaori, Kawakami Junko, Sato Kenichi
Educational and Research Center for Clinical Pharmacy, Showa Pharmaceutical University.
Yakugaku Zasshi. 2014;134(10):1069-80. doi: 10.1248/yakushi.14-00145.
Molecularly targeted anticancer agents cause a variety of adverse reactions compared with conventional anticancer agents because of their unique mechanisms of action. Sources of drug information such as package inserts (PIs) provide primarily document-based and numerical information. Therefore it is not easy to obtain a complete picture of drugs with similar effects, or to understand differences among drugs. In this study we used the self-organizing map (SOM) technique to visualize the adverse reactions indicated on PIs of 23 molecularly targeted anticancer agents as of March 2013. In both the presence/absence version and the frequency version, SOM was divided into domains according to mechanism of action, antibody drug or low-molecular weight drug, and molecular target. The component planes of the 753 adverse reaction items in the frequency version enabled us to grasp all available information and differences among the drugs. In some component planes in the presence/absence version, an adverse reaction that had not been reported for a drug but had already been reported for its proximally positioned drug(s) as of March 2013, was found to be reported thereafter by the Drug Safety Update (DSU) or the Adverse Event Report Search System "CzeekV," which is based on FDA Adverse Event Reporting System (FAERS). Our results suggest that visualization of the adverse reactions of molecularly targeted anticancer agents by the SOM technique is useful not only to acquire all available information and differences among drugs, but also to predict the appearance of adverse reactions.
与传统抗癌药物相比,分子靶向抗癌药物因其独特的作用机制会引发多种不良反应。诸如药品说明书(PI)等药物信息来源主要提供基于文档和数字的信息。因此,要全面了解具有相似效果的药物,或理解不同药物之间的差异并非易事。在本研究中,我们使用自组织映射(SOM)技术来可视化截至2013年3月的23种分子靶向抗癌药物的药品说明书中所指出的不良反应。在存在/不存在版本和频率版本中,SOM均根据作用机制、抗体药物或低分子量药物以及分子靶点进行了区域划分。频率版本中753项不良反应条目的成分平面使我们能够掌握所有可用信息以及药物之间的差异。在存在/不存在版本的某些成分平面中,我们发现一种药物在2013年3月时尚未报告但与其相邻药物已报告过的不良反应,此后在药物安全更新(DSU)或基于美国食品药品监督管理局不良事件报告系统(FAERS)的不良事件报告搜索系统“CzeekV”中被报告。我们的结果表明,通过SOM技术对分子靶向抗癌药物的不良反应进行可视化不仅有助于获取所有可用信息以及药物之间的差异,还能预测不良反应的出现。