Rauch A, Köhler N, Brehm T T, Zielinski N, Stoycheva K, Maier C, Böttcher L, Friesen I, Schaub D, Reimann M, Schmiedel S, Lange C, Kalsdorf B
Division of Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.
German Center for Infection Research (DZIF), Partner Site Borstel-Hamburg-Lübeck-Riems, Borstel, Germany.
Drugs. 2025 Jan;85(1):87-96. doi: 10.1007/s40265-024-02122-4. Epub 2024 Dec 29.
To investigate the safety profiles and clinical outcomes in a continuous cohort of tuberculosis (TB) patients from a clinical referral centre in Germany receiving self-administered outpatient parenteral antimicrobial therapy (sOPAT).
We conducted a retrospective observational cohort study of patients receiving sOPAT after discharge from the Research Center Borstel in Germany between January 2015 and December 2020. Data were extracted from medical records.
In the observation period, 150 patients received parenteral antibiotics at the Research Center Borstel. Of these, 89 received sOPAT via a port catheter and were further analysed. The majority were male (n = 59, 66.3%), with a median age of 33.6 years (interquartile range-IQR 26.2-42.8). Most patients had multidrug-resistant (MDR)-TB (n = 56, 62.9%) or pre-extensively drug resistant (pre-XDR)-TB (n = 21; 23.6%). Fifty-eight (65.2%) patients received one and 24 patients (27.0%) received two parenteral drugs, most commonly capreomycin (n = 53, 59.6%) and meropenem (n = 44, 49.4%). The median duration of sOPAT was 7.4 months (IQR 5.2-17.2). In total, 71,128 intravenous drug administrations were recorded. One patient died of TB while another patient was lost to follow-up. Sixty-two (69.7%) patients completed the sOPAT regimen, the most common reason for premature discontinuation was adverse drug events (n = 12, 13.5%). There were eight (9.0%) port-related complications requiring port explantation (bloodstream infections: n = 6, local infection: n = 1, port thrombosis: n = 1).
In selected patients requiring long-term intravenous anti-TB therapy, sOPAT is a feasible treatment option with a low risk of complications when adequate infrastructure and training are in place.
调查德国一家临床转诊中心接受自我给药门诊胃肠外抗菌治疗（sOPAT）的连续队列肺结核（TB）患者的安全性概况和临床结局。
我们对2015年1月至2020年12月间从德国博尔斯特研究中心出院后接受sOPAT的患者进行了一项回顾性观察队列研究。数据从医疗记录中提取。
在观察期内，150例患者在博尔斯特研究中心接受了胃肠外抗生素治疗。其中，89例通过端口导管接受sOPAT并进行进一步分析。大多数为男性（n = 59，66.3%），中位年龄为33.6岁（四分位间距-IQR 26.2-42.8）。大多数患者患有耐多药（MDR）-TB（n = 56，62.9%）或广泛耐药前（pre-XDR）-TB（n = 21；23.6%）。58例（65.2%）患者接受一种胃肠外药物，24例（27.0%）患者接受两种胃肠外药物，最常用的是卷曲霉素（n = 53，59.6%）和美罗培南（n = 44，49.4%）。sOPAT的中位持续时间为7.4个月（IQR 5.2-17.2）。总共记录了71128次静脉给药。1例患者死于结核病，另1例患者失访。62例（69.7%）患者完成了sOPAT方案，过早停药的最常见原因是药物不良事件（n = 12，13.5%）。有8例（9.0%）与端口相关的并发症需要取出端口（血流感染：n = 6，局部感染：n = 1，端口血栓形成：n = 1）。
对于需要长期静脉抗结核治疗的特定患者，当有适当的基础设施和培训时，sOPAT是一种可行的治疗选择，并发症风险较低。
