Fleischer Russell, Boxwell Debra, Sherman Kenneth E
Division of Antiviral Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA.
Clin Infect Dis. 2004 Apr 15;38(8):e79-80. doi: 10.1086/383151. Epub 2004 Mar 26.
An evaluation of the US Food and Drug Administration's Adverse Event Reporting System identified that patients coinfected with human immunodeficiency virus and chronic hepatitis C virus who were treated with a regimen of ribavirin and didanosine, with or without stavudine, were at increased risk for events associated with mitochondrial toxicity, including fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis. In response, the US product labels for didanosine and ribavirin have been revised to caution clinicians against coadministration of these drugs.
一项对美国食品药品监督管理局不良事件报告系统的评估发现，感染人类免疫缺陷病毒和慢性丙型肝炎病毒且接受包含利巴韦林和去羟肌苷（无论是否联用司他夫定）治疗方案的患者，发生与线粒体毒性相关事件的风险增加，这些事件包括致命性肝衰竭、周围神经病变、胰腺炎以及有症状的高乳酸血症/乳酸性酸中毒。作为应对措施，美国去羟肌苷和利巴韦林的药品标签已修订，以提醒临床医生不要联用这些药物。
