Marx Kathrin, Kalbitz Sven, Kellner Nils, Fedders Maike, Lübbert Christoph
Hospital Pharmacy, St. Georg Hospital, Leipzig, Germany.
Department of Infectious Diseases and Tropical Medicine, St. Georg Hospital, Leipzig, Germany.
GMS Infect Dis. 2023 Sep 28;11:Doc03. doi: 10.3205/id000083. eCollection 2023.
To ensure the fastest and earliest possible treatment, the German Federal Ministry of Health (BMG) initiated central procurement and nationwide distribution of new drugs against COVID-19. A single centre was used for a retrospective temporal analysis of this procedure.
A descriptive analysis of hospitalization and treatment of COVID-19 patients with drugs centrally procured by the BMG at St. Georg Hospital, Leipzig, Germany, for the period from 1 March 2020 to 28 February 2023 was employed considering the approval status, evolving guidelines and recommendations of medical societies.
In total, 3,412 patients ≥18 years (54.9% men) with PCR-confirmed SARS-CoV-2 infection were admitted. The mean age was 64 years during the reporting period and 66.1/70.6 years during the first and second COVID-19 waves, respectively. 964 patients (28.2%) received COVID-19 therapy with drugs procured centrally by the BMG. Remdesivir was the most commonly used (63%). SARS-CoV-2 neutralizing monoclonal antibodies represented 23% of the therapies. Peroral antivirals (nirmatrelvir/ritonavir and molnupiravir) were used in 14% of COVID-19 patients, with molnupiravir being insignificant (five prescriptions).
Specific therapeutic approaches were mainly based on antiviral therapy in the early phase of COVID-19 to prevent severe disease progression in vulnerable patient groups. Most drugs had not been approved at the time of central procurement; therefore, prescriptions were given on a case-by-case basis after careful risk-benefit assessments. All available neutralizing monoclonal SARS-CoV-2 antibodies lost efficacy during the pandemic due to different circulating immune escape variants. Remdesivir and nirmatrelvir/ritonavir remained effective therapies in the early phase of COVID-19.
为确保尽可能快速且早期的治疗，德国联邦卫生部（BMG）启动了针对新型冠状病毒肺炎（COVID-19）新药的集中采购和全国配送。本研究使用了一个单一中心对该程序进行回顾性时间分析。
对2020年3月1日至2023年2月28日期间在德国莱比锡圣乔治医院接受BMG集中采购药物治疗的COVID-19患者的住院和治疗情况进行描述性分析，同时考虑医学协会的批准状态、不断演变的指南和建议。
共收治了3412例年龄≥18岁（男性占54.9%）且经聚合酶链反应（PCR）确诊的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染患者。报告期内患者的平均年龄为64岁，在第一波和第二波COVID-19疫情期间分别为66.1岁和70.6岁。964例患者（28.2%）接受了BMG集中采购药物的COVID-19治疗。瑞德西韦是最常用的药物（63%）。SARS-CoV-2中和单克隆抗体占治疗药物的23%。口服抗病毒药物（奈玛特韦/利托那韦和莫努匹拉韦）用于14%的COVID-19患者，其中莫努匹拉韦使用量极少（仅5例处方）。
在COVID-19早期，特定的治疗方法主要基于抗病毒治疗，以防止脆弱患者群体病情严重进展。大多数药物在集中采购时尚未获批；因此，在仔细评估风险效益后逐案开具处方。由于不同的循环免疫逃逸变异株，在疫情期间所有可用的中和SARS-CoV-2单克隆抗体均失去了疗效。瑞德西韦和奈玛特韦/利托那韦在COVID-19早期仍然是有效的治疗药物。
