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Caspofungin for post solid organ transplant invasive fungal disease: results of a retrospective observational study
Authors:M. Winkler  J. Pratschke  U. Schulz  S. Zheng  M. Zhang  W. Li  M. Lu  D. Sgarabotto  G. Sganga  P. Kaskel  S. Chandwani  L. Ma  J. Petrovic  M. Shivaprakash
Affiliation:1. Medizinische Hochschule Hannover, Klinik für Allgemein‐, Viszeral‐ und Transplanationschirurgie, Hannover, Germany;2. Charité– Universit?tsmedizin Berlin, Klinik für Viszeral‐ und Transplantationsmedizin, Berlin, Germany;3. Herz‐ und Diabeteszentrum Nordrhein‐Westfalen, Ruhr‐Universit?t Bochum, Klinik für Thorax‐ und Kardiovaskularchirurgie, Bad Oeynhausen, Germany;4. Zhejiang University, Zhejiang, China;5. Beijing Chao‐Yang Hospital, Beijing, China;6. Hospital of Sun‐Yat Sen University, Guangzhou, China;7. Ospedale Civile di Padova, Padova, Italy;8. Department of Surgery, Division of General Surgery and Organ Transplantation, Catholic University, Rome, Italy;9. Department of Outcomes Research, MSD Sharp & Dohme GmbH, Haar, Germany;10. University of Medicine and Dentistry of New Jersey, Somerset, New Jersey, USA;11. Outcomes Research, Merck & Co. Inc., Whitehouse Station, New Jersey, USA;12. Merck Sharp & Dohme Italia S.p.A., Rome, Italy
Abstract:M. Winkler, J. Pratschke, U. Schulz, S. Zheng, M. Zhang, W. Li, M. Lu, D. Sgarabotto, G. Sganga, P. Kaskel, S. Chandwani, L. Ma, J. Petrovic, M. Shivaprakash. Caspofungin for post solid organ transplant invasive fungal disease: results of a retrospective observational study.
Transpl Infect Dis 2010: 12: 230–237. All rights reserved 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 ≥5 doses of caspofungin (modified all‐patients‐treated population). Safety was assessed for patients who received ≥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.
Keywords:aspergillosis  candidiasis  caspofungin  solid organ transplant  invasive fungal disease
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