Fast-Track Drugs & Biologics, North Potomac, MD, 20878, USA.
Clinical Network Services Pty Ltd, 88/4 Jephson Road, Toowong, 4066, Queensland, Australia.
Malar J. 2018 Nov 6;17(1):407. doi: 10.1186/s12936-018-2555-3.
Tafenoquine was recently approved for Plasmodium vivax radical cure (KRINTAFEL™) and malaria prevention (ARAKODA™).
A review of the non-clinical and clinical literature was conducted to assess whether tafenoquine (and primaquine) exhibit the same neurologic lesions and associated clinical signs as earlier 8-aminoquinolines, as has been alleged in recent opinion pieces.
Plasmocid, pamaquine and pentaquine damage specific neuro-anatomical structures in Rhesus monkeys and humans leading to corresponding deficits in neurologic function. Neurologic therapeutic indices for these 3 drugs calculated based on monkey data were well correlated with human data. Despite 60 years of use, there is no evidence that primaquine exhibits similar neurotoxicity in humans.
DISCUSSION/CONCLUSIONS: Extrapolation of data from Rhesus monkeys to humans, and the available clinical data, suggest that tafenoquine also does not exhibit pamaquine, pentaquine or plasmocid-like clinical neurologic signs in humans.
他非诺喹啉最近被批准用于根治间日疟原虫（KRINTAFEL™）和预防疟疾（ARAKODA™）。
对非临床和临床文献进行了回顾，以评估他非诺喹啉（和伯氨喹啉）是否与早期的 8-氨基喹啉一样，引起相同的神经病变和相关的临床体征，正如最近的一些观点文章所声称的那样。
疟立康、扑疟喹啉和戊奎宁会损害恒河猴和人类特定的神经解剖结构，导致相应的神经功能缺陷。基于猴子数据计算的这 3 种药物的神经治疗指数与人类数据相关性良好。尽管使用了 60 年，但没有证据表明伯氨喹啉在人类中表现出类似的神经毒性。
讨论/结论：从恒河猴到人类的数据推断，以及现有的临床数据表明，他非诺喹啉在人类中也没有表现出与扑疟喹啉、戊奎宁或疟立康类似的临床神经体征。
