卡泊芬净用于实体器官移植后侵袭性真菌病：一项回顾性观察性研究的结果
Caspofungin for post solid organ transplant invasive fungal disease: results of a retrospective observational study.
作者信息
Winkler M, Pratschke J, Schulz U, Zheng S, Zhang M, Li W, Lu M, Sgarabotto D, Sganga G, Kaskel P, Chandwani S, Ma L, Petrovic J, Shivaprakash M
机构信息
Medizinische Hochschule Hannover, Klinik für Allgemein-, Viszeral- und Transplanationschirurgie, Hannover, Germany.
出版信息
Transpl Infect Dis. 2010 Jun;12(3):230-7. doi: 10.1111/j.1399-3062.2009.00490.x. Epub 2010 Jan 11.
OBJECTIVE
This study was designed to determine clinical outcomes with caspofungin in patients with proven or probable invasive fungal infection (IFI) after a solid organ transplant (SOT) procedure.
METHODS
In this retrospective observational study, data were collected for a single episode of IFI in patients with an SOT between January 2004 and June 2007. Response was determined by the investigator as favorable (complete or partial) or unfavorable (stable disease or failure) at the end of caspofungin therapy (EOCT). The primary effectiveness population was the proportion of patients who received >or=5 doses of caspofungin (modified all-patients-treated population). Safety was assessed for patients who received >or=1 dose of caspofungin.
RESULTS
A total 81 of patients from 13 sites in China, Germany, Italy, and the United Kingdom were enrolled, including 49 (60%) liver, 22 (27%) heart, 5 (6%) lung, 2 (2%) kidney, 2 (2%) liver and kidney, and 1 (1%) pancreas and kidney recipients. Candidiasis was diagnosed in 64/81 patients (79%) and aspergillosis in 22/81 patients (27%). Most patients received caspofungin monotherapy (75%). Caspofungin was given as first-line therapy to 59 (73%) patients. The overall favorable response at EOCT was 87% (58/67; 95% confidence interval [CI]: 76%, 94%), with favorable responses in 88% (43/49; 95% CI: 75%, 95%) of patients receiving caspofungin monotherapy and 83% (15/18; 95% CI: 59%, 96%) of patients receiving combination therapy with caspofungin (modified all-patients-treated population). Response by type of SOT was as follows: liver 87% (39/45), heart 93% (14/15), kidney 100% (5/5), and lung 50% (2/4). An overall survival rate (all-patients-treated) of 69% (56/81; 95% CI: 59%, 79%) was observed at 7 days post EOCT. No serious drug-related adverse events were reported.
CONCLUSION
In this study, caspofungin was effective and well tolerated in the treatment of IFIs involving SOT recipients.
目的
本研究旨在确定卡泊芬净用于实体器官移植（SOT）术后确诊或疑似侵袭性真菌感染（IFI）患者的临床疗效。
方法
在这项回顾性观察研究中，收集了2004年1月至2007年6月期间SOT患者单次IFI发作的数据。研究者在卡泊芬净治疗结束时（EOCT）将反应判定为良好（完全或部分缓解）或不良（病情稳定或失败）。主要疗效人群为接受≥5剂卡泊芬净的患者比例（改良的所有接受治疗患者人群）。对接受≥1剂卡泊芬净的患者进行安全性评估。
结果
来自中国、德国、意大利和英国13个地点的共81例患者入组，包括49例（60%）肝移植、22例（27%）心脏移植、5例（6%）肺移植、2例（2%）肾移植、2例（2%）肝肾联合移植和1例（1%）胰肾联合移植受者。64/81例患者（79%）诊断为念珠菌病，22/81例患者（27%）诊断为曲霉病。大多数患者接受卡泊芬净单药治疗（75%）。59例（73%）患者将卡泊芬净作为一线治疗。EOCT时的总体良好反应率为87%（58/67；95%置信区间[CI]：76%，94%），接受卡泊芬净单药治疗的患者中良好反应率为88%（43/49；95%CI：75%，95%），接受卡泊芬净联合治疗的患者中良好反应率为83%（15/18；CI：59%，96%）（改良的所有接受治疗患者人群）。按SOT类型划分的反应如下：肝移植87%（39/45），心脏移植93%（14/15），肾移植100%（5/5），肺移植50%（2/4）。EOCT后7天观察到总体生存率（所有接受治疗患者）为69%（56/81；95%CI：59%，79%）。未报告严重的药物相关不良事件。
结论
在本研究中，卡泊芬净治疗涉及SOT受者的IFI有效且耐受性良好。
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