Wohlreich Madelaine M, Acharya Nayan, Strombom Indiana, Kuritzky Louis, Robinson Michael, Heinloth Alexandra N, Regev Arie, Wernicke Joachim F
Eli Lilly and Company, Indianapolis, IN 46285, USA.
Postgrad Med. 2008 Jul;120(2):111-8. doi: 10.3810/pgm.2008.07.1803.
Since its first FDA approval in 2004, duloxetine has been taken by more than 5 million patients. A small fraction of patients treated with duloxetine develop elevations in liver enzymes, which generally resolve spontaneously without any change in treatment. Very rare cases (estimated 1-2 per 100,000 exposures) of idiosyncratic hepatic toxicity have been reported in patients taking duloxetine, particularly in those with substantial alcohol use and/or preexisting liver disease. In the context of more than 23,000 patients exposed during clinical trials, and more than 1.5 million patient years of exposure subsequent to product launch, the hepatic risk after exposure to duloxetine appears to be within the range identified for other therapeutic agents. Therefore, it does not warrant hepatic enzyme monitoring. As with any medication, physicians should follow prescribing guidelines and educate patients on the risks and benefits of duloxetine.
自2004年首次获得美国食品药品监督管理局（FDA）批准以来，已有超过500万患者服用度洛西汀。接受度洛西汀治疗的患者中有一小部分会出现肝酶升高的情况，这种情况通常会自行缓解，治疗无需改变。据报道，服用度洛西汀的患者中出现过非常罕见的特异质性肝毒性病例（估计每10万次用药中有1 - 2例），尤其是那些大量饮酒和/或已有肝病的患者。在临床试验期间有超过23000名患者用药，产品上市后又有超过150万患者年的用药暴露量的情况下，度洛西汀用药后的肝脏风险似乎在其他治疗药物所确定的范围内。因此，无需进行肝酶监测。与任何药物一样，医生应遵循处方指南，并就度洛西汀的风险和益处对患者进行教育。
