Lichtenstern C, Pratschke J, Schulz U, Schmoeckel M, Knitsch W, Kaskel P, Krobot K J, Weigand M A, Winkler M
Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Giessen und Marburg, Standort Giessen, Rudolf-Buchheim Str. 7, 35385, Giessen, Deutschland.
Anaesthesist. 2010 Dec;59(12):1083-90. doi: 10.1007/s00101-010-1795-6. Epub 2010 Nov 12.
This study was a pre-planned country-specific secondary analysis of results in Germany from a multinational multicenter observational study to retrospectively evaluate clinical outcomes with caspofungin in patients with probable and proven invasive fungal infection following solid organ transplantation (SOT).
Data were retrospectively collected on a single episode of invasive fungal infection (IFI) in patients who had a SOT between January 2004 and June 2007. Effectiveness was reported as the proportion of patients who received at least five doses of caspofungin with a favorable (complete or partial) response. Safety was assessed for patients who received at least one dose of caspofungin. Descriptive statistics were employed for all evaluations.
A total of 41 SOT patients (27 male, 14 female; median age 56 years, median APACHE II score at start of caspofungin therapy 23) were enrolled from 5 sites in Germany. Organs transplanted were mainly heart (51%) and liver (46%). Prevalent risk factors for IFI at baseline were use of central venous catheter (37 out of 41 patients, 90%), steroid use (37 out of 41 patients, 90%), recent stay in intensive care (36 out of 41 patients, 88%),and duration of SOT procedure >5 hours (21 out of 41 patients, 51%). Candidiasis was diagnosed in 34 patients (83%) and aspergillosis in 10 patients (24%). The lungs were the most common site of IFI (21 out of 41, 51%). Caspofungin as monotherapy was received by 28 patients (68%); 6 patients (15%) received caspofungin as salvage therapy for IFI, in most cases because they were refractory to prior antifungal drugs. Immunosuppressants were administered with caspofungin in 39 out of 41 patients (95%). In subjects with at least 5 doses of caspofungin (modified intention to treat population) the favorable response rate at the end of caspofungin therapy was 88% overall, 29 out of 33 patients; 95% confidence interval (95%-CI) 72-97%), 86% (19 out of 22 patients) with monotherapy and 91% (10 out of 11 patients) with combination therapy. No (serious) adverse events or drug interactions related to treatment with caspofungin were reported. The overall survival rate was 79% (26 out of 33 patients; 95%-CI 61-91%) at 7 days after completion of caspofungin treatment.
Caspofungin was found to be an effective treatment of probable and proven invasive fungal infections in patients following SOT in Germany.
本研究是一项针对德国地区的预先计划的国别特异性二次分析，该分析基于一项跨国多中心观察性研究的结果，旨在回顾性评估卡泊芬净对实体器官移植（SOT）后可能患有及已确诊侵袭性真菌感染患者的临床疗效。
回顾性收集2004年1月至2007年6月期间接受SOT且发生过单次侵袭性真菌感染（IFI）患者的数据。疗效以接受至少五剂卡泊芬净且有良好（完全或部分）反应的患者比例表示。对接受至少一剂卡泊芬净的患者进行安全性评估。所有评估均采用描述性统计方法。
从德国的5个地点招募了41例SOT患者（男性27例，女性14例；中位年龄56岁，卡泊芬净治疗开始时的中位急性生理与慢性健康状况评分系统II评分为23）。移植的器官主要是心脏（51%）和肝脏（46%）。基线时IFI的常见危险因素包括使用中心静脉导管（41例患者中的37例，90%）、使用类固醇（41例患者中的37例，90%）、近期入住重症监护病房（41例患者中的36例，88%）以及SOT手术持续时间>5小时（41例患者中的21例，51%）。34例患者（83%）诊断为念珠菌病，10例患者（24%）诊断为曲霉病。肺部是IFI最常见的部位（41例中的21例，51%）。28例患者（68%）接受卡泊芬净单药治疗；6例患者（15%）接受卡泊芬净作为IFI的挽救治疗，大多数情况下是因为他们对先前的抗真菌药物耐药。41例患者中有39例（95%）在使用卡泊芬净时同时使用免疫抑制剂。在接受至少5剂卡泊芬净的受试者（改良意向性治疗人群）中，卡泊芬净治疗结束时的总体良好反应率为88%，33例患者中有29例；95%置信区间（95%-CI）为72-97%），单药治疗组为86%（22例患者中的19例），联合治疗组为91%（11例患者中的10例）。未报告与卡泊芬净治疗相关的（严重）不良事件或药物相互作用。卡泊芬净治疗完成后7天的总体生存率为79%（33例患者中的26例；95%-CI 61-91%）。
在德国，发现卡泊芬净是治疗SOT后患者可能患有及已确诊侵袭性真菌感染的有效药物。
