Beltran Gonzalez Jose Lenin, González Gámez Mario, Mendoza Enciso Emanuel Antonio, Esparza Maldonado Ramiro Josue, Hernández Palacios Daniel, Dueñas Campos Samuel, Robles Itzel Ovalle, Macías Guzmán Mariana Jocelyn, García Díaz Andrea Lucia, Gutiérrez Peña César Mauricio, Martinez Medina Lucila, Monroy Colin Victor Antonio, Arreola Guerra Jose Manuel
Internal Medicine Department Centenario Hospital Miguel Hidalgo, Aguascalientes 20259, Mexico.
Pediatrics Department Centenario Hospital Miguel Hidalgo, Aguascalientes 20259, Mexico.
Infect Dis Rep. 2022 Mar 3;14(2):160-168. doi: 10.3390/idr14020020.
During the first year of the COVID-19 pandemic, unauthorized drugs were widely used. Ivermectin and hydroxychloroquine are drugs that inhibit viral replication in vitro and that have been used in several medical centers. This clinical trial analyzes their efficacy in hospitalized patients with moderate COVID-19. This a controlled, clinical, randomized, double-blind trial that included hospitalized patients with COVID-19-induced pneumonia, without severe respiratory failure. Patients were randomized to one of three groups: Group 1-hydroxychloroquine, 400 mg every 12 h on the first day and, subsequently, 200 mg every 12 h for 4 days; Group 2-ivermectin, 12 mg or 18 mg, according to patient weight; and Group 3-placebo. At inclusion, blood samples for arterial blood gases and biochemical markers were obtained. The primary outcome was established as the length of stay due to patient improvement and the rate of respiratory deterioration or death. During the month of August 2020, the admission of patients requiring hospitalization mostly encompassed cases with severe respiratory failure, so we ended the recruitment process and analyzed the data that was available at the time. One hundred and six (106) patients with an average age of 53 yrs (±16.9) were included, with a greater proportion of males (n = 66, 62.2%). Seventy-two percent (72%) (n = 76) had an associated comorbidity. Ninety percent (90%) of patients were discharged due to improvement (n = 96). The average duration of hospitalization was 6 days (IQR, 3-10). No difference in hospitalization duration was found between the treatment groups (Group1: 7 vs. Group 2: 6 vs. Group 3: 5, = 0.43) nor in respiratory deterioration or death (Group 1: 18% vs. Group 2: 22.2% vs. Group 3: 24.3%, = 0.83). In non-critical hospitalized patients with COVID-19 pneumonia, neither ivermectin nor hydroxychloroquine decreases the number of in-hospital days, respiratory deterioration, or deaths.
在新冠疫情的第一年，未经批准的药物被广泛使用。伊维菌素和羟氯喹是在体外能抑制病毒复制且已在多家医疗中心使用的药物。这项临床试验分析了它们对中度新冠肺炎住院患者的疗效。这是一项对照、临床、随机、双盲试验，纳入了患有新冠病毒引起的肺炎但无严重呼吸衰竭的住院患者。患者被随机分为三组：第一组——羟氯喹，首日每12小时服用400毫克，随后4天每12小时服用200毫克；第二组——伊维菌素，根据患者体重服用12毫克或18毫克；第三组——安慰剂。入组时，采集动脉血气和生化标志物的血样。主要结局确定为因患者病情改善的住院时长以及呼吸恶化或死亡的发生率。在2020年8月期间，需要住院治疗的患者大多是患有严重呼吸衰竭的病例，所以我们结束了招募过程并分析了当时可用的数据。纳入了106名平均年龄为53岁（±16.9）的患者，男性比例更高（n = 66，62.2%）。72%（n = 76）的患者有合并症。90%（n = 96）的患者因病情改善而出院。平均住院时长为6天（四分位距，3 - 10天）。治疗组之间在住院时长上未发现差异（第一组：7天 vs. 第二组：6天 vs. 第三组：5天，P = 0.43），在呼吸恶化或死亡方面也无差异（第一组：18% vs. 第二组：22.2% vs. 第三组：24.3%，P = 0.83）。在非重症新冠肺炎肺炎住院患者中，伊维菌素和羟氯喹均未减少住院天数、呼吸恶化或死亡人数。
