超说明书应用洛匹那韦/利托那韦治疗新型冠状病毒肺炎的临床药学指引

自2019年12月以来,新型冠状病毒肺炎(COVID-19)疫情在全球多个国家和地区出现,目前还没有高质量临床实验证实任何药物可以有效治疗该疾病。洛匹那韦/利托那韦(LPV/r)是中国卫健委发布的试行诊疗方案中推荐试用的抗病毒药物之一。但因证据有限,临床工作者在实践中面临着许多问题,比如缺乏LPV/r在一般和特殊人群中的详细用药指导,诊疗方案中推荐方案的依据和理由不明确等。本文总结和分析了LPV/r在SARS和MERS患者中使用的临床证据,根据现有的安全性数据推荐了在成人和特殊人群中的用药方案,并讨论了治疗时长、注意事项和LPV/r的药学监护策略等。本文目的是解读在COVID-19的治疗中使用LPV/r的理论依据和潜在益处,并指导临床工作者在试用LPV/r治疗COVID-19时合理地使用LPV/r。

Pharmacological recommendations on the off-label use of lopinavir/ritonavir for treatment of coronavirus disease 2019

The epidemic situation of Coronavirus Disease 2019 (COVID-19) has emerged in many countries and regions around the world, and there is no high-quality clinical trial to confirm that any drug can effectively treat the disease. Lopinavir/ritonavir (LPV/r) is one of the recommended antivirals in the interim guideline issued by National Health Commission of China. However, due to limited evidence, clinicians face many problems in practice, such as the lack of detailed medication guidance for LPV/r in general and special populations, the undefined basis and reasons for the recommended regimen in the diagnosis and treatment plan. This article summarized and analyzed existing clinical evidences on the use of LPV/r in patients with SARS and MERS, extrapolated the dosing regimens for adults and pediatrics from referencing existing safety data, and discussed treatment duration, precautions, as well as therapeutic drug monitoring strategies of LPV/r. The purpose of this article is to demonstrate rationales and potential benefits of LPV/r against COVID-19, and to guide clinicians to use LPV/r appropriately in the treatment of COVID-19.