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卡泊芬净与两性霉素治疗念珠菌性食管炎的随机双盲研究。

A randomized double-blind study of caspofungin versus amphotericin for the treatment of candidal esophagitis.

作者信息

Villanueva A, Arathoon E G, Gotuzzo E, Berman R S, DiNubile M J, Sable C A

机构信息

Universidad de Antioquia, Medellin, Colombia.

出版信息

Clin Infect Dis. 2001 Nov 1;33(9):1529-35. doi: 10.1086/323401. Epub 2001 Oct 4.

DOI:10.1086/323401
PMID:11588698
Abstract

Caspofungin is a new broad-spectrum antifungal drug. A multicenter, double-blind, randomized trial was conducted to assess the efficacy, safety, and tolerability of caspofungin relative to amphotericin B in adults with endoscopically documented symptomatic Candida esophagitis. By use of a modified intent-to-treat analysis, endoscopically verified clinical success was achieved in 74% (95% confidence interval [CI], 59%-86%) and 89% (95% CI, 72%-98%) of patients receiving caspofungin at 50 and 70 mg/day, respectively, and in 63% (95% CI, 49%-76%) of patients given amphotericin B at 0.5 mg/kg/day. Therapy was stopped because of drug-related adverse events in 24% of patients in the amphotericin B group and 4% and 7%, respectively, for the caspofungin groups. This report provides the first demonstration of clinical utility for an echinocandin compound. Caspofungin appeared in this study to be as effective as and better tolerated than amphotericin B for the treatment of esophageal candidiasis.

摘要

卡泊芬净是一种新型广谱抗真菌药物。开展了一项多中心、双盲、随机试验,以评估卡泊芬净相对于两性霉素B治疗经内镜检查确诊为有症状念珠菌食管炎的成年患者的疗效、安全性和耐受性。采用改良的意向性分析,接受50mg/天和70mg/天卡泊芬净治疗的患者中,分别有74%(95%置信区间[CI],59%-86%)和89%(95%CI,72%-98%)经内镜证实临床治愈,而接受0.5mg/kg/天两性霉素B治疗的患者中这一比例为63%(95%CI,49%-76%)。两性霉素B组24%的患者因药物相关不良事件停药,卡泊芬净组分别为4%和7%。本报告首次证明了棘白菌素类化合物的临床应用价值。在本研究中,卡泊芬净治疗食管念珠菌病的疗效与两性霉素B相当且耐受性更好。

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