Department of Pharmacology, All India Institute of Medical Sciences, Gorakhpur Gorakhpur, Uttar Pradesh 273008, India.
Department of Pharmacology, GMERS Medical College, Gotri, Vadodara, Gujarat 390021, India.
J Infect Public Health. 2021 Jun;14(6):740-748. doi: 10.1016/j.jiph.2021.03.015. Epub 2021 Apr 20.
Lopinavir-ritonavir is a repurposed drug for coronavirus disease-2019 (COVID-19). In this study, a pooled effect of lopinavir-ritonavir on mortality, virological cure, radiological improvement and safety profile in COVID-19 patients has been evaluated.
The databases were searched for comparative randomized controlled studies evaluating the efficacy and/or safety of lopinavir-ritonavir in COVID-19 patients. The mortality outcome was pooled as a risk difference (RD) with 95% CI. The virological cure, radiological improvement and adverse events were pooled as risk ratio (RR) with 95% CI. All outcomes were pooled using the Mantle-Hanzle method random effect model. The heterogeneity was assessed using the I test.
Out of 82 full text assessed, seven studies were included in the analysis. The included studies had five different control interventions: supportive care (n=4), umifenovir (arbidol) (n=2), navaferon (recombinant anti-tumour and anti-virus protein) (n=1), lopinavir-ritonavir+novaferon (n=1) and lopinavir-ritonavir+interferon beta 1b+ribavirin (n=1). Lopinavir-ritonavir group did not show significant difference in mortality [RD: 0.00 (95% CI: -0.01, 0.02), I=0], virological cure [RR: 1.06 (95% CI: 0.85, 1.31), I=0%], radiological improvement [RR: 0.81 (95% CI: 0.62, 1.05)] and adverse events [RR: 2.59 (95% CI: 0.17, 38.90), I=75%] than supportive care. Similarly, no difference was observed for any efficacy outcomes between lopinavir-ritonavir and other control interventions. We observed significantly high risk of adverse events with lopinavir-ritonavir as compared to umifenovir [RR: 2.96 (95% CI: 1.42-6.18); I=0%].
There is no benefit of the addition of lopinavir-ritonavir to the standard care in COVID-19 patients.
洛匹那韦利托那韦是一种用于治疗 2019 年冠状病毒病（COVID-19）的药物。本研究评估了洛匹那韦利托那韦在 COVID-19 患者中的死亡率、病毒学治愈率、影像学改善和安全性的综合效果。
本研究检索了比较洛匹那韦利托那韦治疗 COVID-19 患者疗效和/或安全性的随机对照研究。使用风险差异（RD）表示死亡率的结果，并采用 95%置信区间（CI）进行评估。病毒学治愈率、影像学改善和不良事件的结果采用风险比（RR）表示，并采用 95%CI 进行评估。所有结果均采用 Mantel-Hanzle 法随机效应模型进行汇总。采用 I 检验评估异质性。
在评估的 82 篇全文中，有 7 篇研究纳入分析。纳入的研究有 5 种不同的对照干预措施：支持性护理（n=4）、阿比多尔（n=2）、纳法雷隆（重组抗肿瘤和抗病毒蛋白）（n=1）、洛匹那韦利托那韦+纳法雷隆（n=1）和洛匹那韦利托那韦+干扰素β 1b+利巴韦林（n=1）。洛匹那韦利托那韦组在死亡率[RD：0.00（95%CI：-0.01，0.02），I=0]、病毒学治愈率[RR：1.06（95%CI：0.85，1.31），I=0%]、影像学改善[RR：0.81（95%CI：0.62，1.05）]和不良事件[RR：2.59（95%CI：0.17，38.90），I=75%]方面与支持性护理相比无显著差异。同样，洛匹那韦利托那韦与其他对照干预措施在任何疗效结局方面均无差异。与阿比多尔相比，洛匹那韦利托那韦发生不良事件的风险显著增加[RR：2.96（95%CI：1.42-6.18）；I=0%]。
在 COVID-19 患者中，加用洛匹那韦利托那韦不能提高标准治疗的疗效。
