Streinu-Cercel Anca, Miron Victor Daniel, Oană Alina Alexandra, Irimia Mădălina, Popescu Ramona Ștefania, Dărămuș Ioana Andreea, Moțoi Maria Magdalena, Ceapraga Gabriela Jana, Săndulescu Oana
Carol Davila University of Medicine and Pharmacy, 050474 Bucharest, Romania.
National Institute for Infectious Diseases "Prof. Dr. Matei Balș", 021105 Bucharest, Romania.
Pharmaceuticals (Basel). 2022 Aug 27;15(9):1065. doi: 10.3390/ph15091065.
During the current pandemic, the gap between fundamental research and clinical practice has been narrowing at a faster pace than ever before. While clinical trials play the main role of confirming the safety and efficacy of new drugs, a drug's introduction into clinical practice creates the need for further research in order to best position the use of the novel drug in terms of when, to whom, and how it would be best administered to achieve the best possible outcome under feasible clinical circumstances. We briefly present the results of a retrospective analysis of the characteristics of outpatients treated with molnupiravir in a tertiary care infectious disease hospital in Bucharest, Romania, between February and March 2022, when Romania was experiencing its fifth wave of COVID-19. A total of 46 outpatients received molnupiravir treatment and had complete clinical data available; of them, 56.5% ( = 20) were males and the median age was 48.5 years (IQR: 37.8, 67.0 years). A total of 54.2% ( = 26) of patients had at least one chronic condition. Of the 45 patients who underwent lung CT imaging evaluation, 13 (28.9%) showed changes suggestive of COVID-19 pneumonia. COVID-19 vaccination status was strongly protective for pneumonia ( = 0.002). All patients were symptomatic, and molnupiravir was initiated at a mean time from onset of symptoms of 3.5 (±1.5) days. At phone follow-up 5 days after the initial evaluation and initiation of molnupiravir treatment, all patients, except for one, confirmed a favorable course under treatment, with no worsening of COVID-19 severity and improvement in symptoms; none of them progressed to respiratory failure or required hospitalization. In conclusion, treatment was well tolerated and associated a favorable outcome of COVID-19 in routine practice in a clinical population that was slightly older and had a smaller burden of comorbidities and a higher rate of COVID-19 vaccination compared to that from the pivotal trial.
在当前的大流行期间，基础研究与临床实践之间的差距正在以前所未有的速度迅速缩小。虽然临床试验在确认新药的安全性和有效性方面发挥着主要作用，但一种药物引入临床实践后仍需要进一步研究，以便在何时、对何人以及如何以最佳方式给药以在可行的临床情况下实现最佳可能结果方面，为新药的使用找到最佳定位。我们简要介绍了2022年2月至3月期间在罗马尼亚布加勒斯特一家三级医疗传染病医院对接受莫努匹拉韦治疗的门诊患者特征进行回顾性分析的结果，当时罗马尼亚正在经历第五波新冠疫情。共有46名门诊患者接受了莫努匹拉韦治疗且有完整的临床数据；其中，56.5%（n = 20）为男性，中位年龄为48.5岁（四分位间距：37.8，67.0岁）。共有54.2%（n = 26）的患者至少有一种慢性病。在接受肺部CT成像评估的45名患者中，13名（28.9%）显示出提示新冠肺炎的变化。新冠疫苗接种状况对肺炎有很强的保护作用（p = 0.002）。所有患者均有症状，莫努匹拉韦在症状出现后的平均3.5（±1.5）天开始使用。在初次评估和开始莫努匹拉韦治疗5天后的电话随访中，除一名患者外，所有患者均确认治疗过程良好，新冠病情没有恶化且症状有所改善；他们中没有人进展为呼吸衰竭或需要住院治疗。总之，在一个年龄稍大、合并症负担较小且新冠疫苗接种率高于关键试验人群的临床人群中，莫努匹拉韦治疗耐受性良好且与新冠的良好转归相关。
