Vecchio Gisela, Zapico Valeria, Catanzariti Alejandro, Carboni Bisso Indalecio, Las Heras Marcos
Farmacia, Hospital Italiano de Buenos Aires, Argentina. E-mail:
Terapia Intensiva de Adultos, Hospital Italiano de Buenos Aires, Argentina.
Medicina (B Aires). 2020;80(5):439-441.
During the SARSCoV-2 pandemic many drugs have been used as potential treatments in order to improve the clinical outcome and reduce the mortality. But since it is a currently unknown disease, the evidence about efficacy and safety is built as the drugs are prescribed. In this context, intensive pharmacovigilance allows early detection of adverse events, and thereby infer the safety profile of the indication. We conducted an observational, retrospective, single-center study involving adult patients with severe SARS-CoV-2 infection. All adverse events detected in 23 patients in the Intensive Care Unit between March 15 and June 15, 2020 were registered. We describe type and severity of the adverse events and if treatment suspension was needed. The results show a high rate of adverse events (10/23, 43%) in treatment with lopinavir/ritonavir. In most cases early treatment suspension was required. Even though the limitations of our study derived from the small sample size, these results could help in building evidence about the safety of using lopinavir/ritonavir for severe SARS-CoV-2 infection.
在新型冠状病毒肺炎大流行期间，许多药物被用作潜在治疗手段，以改善临床结局并降低死亡率。但由于这是一种目前尚不明确的疾病，随着药物的使用，关于其疗效和安全性的证据也在不断积累。在此背景下，强化药物警戒可早期发现不良事件，从而推断该适应症的安全性概况。我们开展了一项观察性、回顾性、单中心研究，纳入了患有严重新型冠状病毒肺炎感染的成年患者。记录了2020年3月15日至6月15日期间在重症监护病房的23例患者中检测到的所有不良事件。我们描述了不良事件的类型和严重程度，以及是否需要暂停治疗。结果显示，洛匹那韦/利托那韦治疗的不良事件发生率较高（10/23，43%）。在大多数情况下，需要尽早暂停治疗。尽管我们的研究存在样本量小的局限性，但这些结果有助于积累关于使用洛匹那韦/利托那韦治疗严重新型冠状病毒肺炎感染安全性的证据。
