Vazquez José A, Schranz Jennifer A, Clark Kay, Goldstein Beth P, Reboli Annette, Fichtenbaum Carl
Division of Infectious Diseases, Henry Ford Hospital and Wayne State University School of Medicine, Detroit, MI 48202, USA.
J Acquir Immune Defic Syndr. 2008 Jul 1;48(3):304-9. doi: 10.1097/QAI.0b013e31817af47a.
Azole-refractory mucosal candidiasis is a debilitating disease frequently seen in patients who are immunosuppressed as a result of HIV, malignancy, posttransplant immunosuppressive therapy, persistent neutropenia, steroid use, or diabetes. Anidulafungin has potent activity against a broad spectrum of Candida species, including strains resistant to azoles and amphotericin B. We performed an open-label, noncomparative study to examine efficacy and safety of anidulafungin in patients with azole-refractory oropharyngeal and esophageal candidiasis.
Patients enrolled met diagnostic criteria for azole-refractory mucosal candidiasis. They received intravenous anidulafungin 100 mg on day 1 followed by daily 50-mg doses on day 2 through day 14 or for a maximum of 21 days. Primary efficacy variables were clinical response (for oropharyngeal candidiasis) and endoscopic and clinical response (for esophageal candidiasis) at the end of therapy.
Nineteen patients were enrolled; 89% had advanced HIV infection. Clinical success was observed in 95% of patients at end of therapy, and endoscopic success was observed in 92% of patients with esophageal candidiasis. At follow-up, clinical success was maintained in 47% of patients. The most common adverse event, experienced by 4 patients, was nausea and/or vomiting.
Anidulafungin was well tolerated and efficacious in the treatment of patients with azole-refractory esophageal and oropharyngeal candidiasis.
唑类难治性黏膜念珠菌病是一种使人衰弱的疾病，常见于因人类免疫缺陷病毒（HIV）、恶性肿瘤、移植后免疫抑制治疗、持续性中性粒细胞减少、使用类固醇或糖尿病而免疫抑制的患者。阿尼芬净对多种念珠菌具有强大活性，包括对唑类和两性霉素B耐药的菌株。我们进行了一项开放标签、非对照研究，以检验阿尼芬净治疗唑类难治性口咽和食管念珠菌病患者的疗效和安全性。
入组患者符合唑类难治性黏膜念珠菌病的诊断标准。他们在第1天接受静脉注射阿尼芬净100mg，随后在第2天至第14天每天给予50mg剂量，最多使用21天。主要疗效变量为治疗结束时的临床反应（用于口咽念珠菌病）以及内镜和临床反应（用于食管念珠菌病）。
共入组19例患者；89%患有晚期HIV感染。治疗结束时，95%的患者观察到临床成功，食管念珠菌病患者中92%观察到内镜成功。在随访时，47%的患者维持临床成功。4例患者出现的最常见不良事件是恶心和/或呕吐。
阿尼芬净在治疗唑类难治性食管和口咽念珠菌病患者时耐受性良好且有效。
