美国食品药品监督管理局不良事件报告系统中与普通坦索罗辛、左甲状腺素和苯丙胺相关的患者相关结局：一项试点研究。
Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study.
作者信息
Marimuthu Sathiya Priya, Iyer Geetha, Segal Jodi B, Singh Sonal
机构信息
Center for Drug Safety & Effectiveness, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA.
Division of Clinical Pharmacology, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
出版信息
J Comp Eff Res. 2017 Jul;6(5):437-447. doi: 10.2217/cer-2017-0006. Epub 2017 Jul 7.
AIM
Patient-reported outcomes associated with adverse events (AEs) reported with generics have not been evaluated. To map AEs associated with generics to the NIH Patient-reported Outcomes Measurement Information System.
METHODS
We mapped 381 AEs from 148 case reports of generic tamsulosin, levothyroxine and amphetamine/dextroamphetamine to the physical, mental and social domain of the NIH Patient-Reported Outcomes Measurement Information System after reviewing 1237 case reports in the US FDA's Adverse Event Reporting System (FAERS; 2011-2013).
RESULTS
75%, 76% and 71% reports were classified under the physical domain for tamsulosin, levothyroxine and amphetamine/dextroamphetamine, while 9%, 9% and 18% reports were classified under the mental domain, respectively.
CONCLUSION
FAERS reveals several domains of patient-relevant concerns associated with generic drugs.
目的
尚未对与仿制药报告的不良事件（AE）相关的患者报告结局进行评估。将与仿制药相关的不良事件映射到美国国立卫生研究院患者报告结局测量信息系统。
方法
在审查了美国食品药品监督管理局不良事件报告系统（FAERS；2011 - 2013年）中的1237份病例报告后，我们将来自148份关于坦索罗辛、左甲状腺素和苯丙胺/右旋苯丙胺仿制药病例报告中的381例不良事件映射到美国国立卫生研究院患者报告结局测量信息系统的身体、心理和社会领域。
结果
坦索罗辛、左甲状腺素和苯丙胺/右旋苯丙胺的报告分别有75%、76%和71%归类于身体领域，而分别有9%、9%和18%的报告归类于心理领域。
结论
FAERS揭示了与仿制药相关的几个患者相关关注领域。
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