氟康唑与两性霉素B治疗血源性念珠菌病的配对队列研究。

Fluconazole versus amphotericin B in the treatment of hematogenous candidiasis: a matched cohort study.

作者信息

Anaissie E J, Vartivarian S E, Abi-Said D, Uzun O, Pinczowski H, Kontoyiannis D P, Khoury P, Papadakis K, Gardner A, Raad I I, Gilbreath J, Bodey G P

机构信息

Department of Medical Specialties, University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.

出版信息

Am J Med. 1996 Aug;101(2):170-6. doi: 10.1016/s0002-9343(96)80072-6.

DOI:10.1016/s0002-9343(96)80072-6

PMID:8757357

Abstract

PURPOSE

To compare the efficacy and toxicity of fluconazole and amphotericin B in the treatment of hematogenous candidiasis in cancer patients.

PATIENTS AND METHODS

A matched cohort study of cancer patients with hematogenous candidiasis was conducted. Forty-five patients with hematogenous candidiasis who received fluconazole (200 to 600 mg/day) in an open-label trial at the University of Texas M. D. Anderson Cancer Center, Houston, Texas, between February 1990 and June 1992 were matched to 45 patients treated with amphotericin B (0.3 to 1.2 mg/kg/day) for the same diagnosis. Criteria for matching included the following prognostic variables at the initiation of therapy: pneumonia, neutropenia (< 1,000 cells/mm3), number of positive blood cultures before therapy, infecting Candida species, underlying disease, and the simplified acute physiology score. Response and survival at 48 hours, after 5 days of therapy, and at the end of therapy, as well as toxicity rates were obtained. Other post hoc analyses were performed. Differences in outcomes were assessed by the McNemar, the sign, and the log rank tests.

RESULTS

Patients were similar with respect to the matching criteria, age, sex, status of underlying disease, use of antibiotics and growth factors, duration of treatment, presence and removal of central venous catheters, disseminated disease, and concomitant infections. Response rates at 48 hours and 5 days were similar between the two study groups. Overall response rates at the end of therapy were 73% for patients treated with fluconazole and 71% for patients treated with amphotericin B (P = 0.78). There were no differences in survival rates or causes of death. Toxicity was observed in 9% of patients treated with fluconazole and in 67% of patients treated with amphotericin B (P < 0.0001). Toxic effects of amphotericin B included nephrotoxicity, hypokaliemia, and fever and chills.

CONCLUSION

Fluconazole is effective and better tolerated than amphotericin B for the treatment of hematogenous candidiasis in cancer patients.

摘要

目的

比较氟康唑和两性霉素B治疗癌症患者血源性念珠菌病的疗效和毒性。

患者与方法

对患有血源性念珠菌病的癌症患者进行了一项匹配队列研究。1990年2月至1992年6月期间，在德克萨斯州休斯顿的德克萨斯大学MD安德森癌症中心进行的一项开放标签试验中，45例接受氟康唑（200至600mg/天）治疗的血源性念珠菌病患者与45例因相同诊断接受两性霉素B（0.3至1.2mg/kg/天）治疗的患者进行匹配。匹配标准包括治疗开始时的以下预后变量：肺炎、中性粒细胞减少（<1000个细胞/mm³）、治疗前血培养阳性次数、感染念珠菌种类、基础疾病以及简化急性生理学评分。获取了治疗48小时、治疗5天后、治疗结束时的反应和生存率以及毒性率。进行了其他事后分析。通过McNemar检验、符号检验和对数秩检验评估结果差异。

结果

患者在匹配标准、年龄、性别、基础疾病状况、抗生素和生长因子的使用、治疗持续时间、中心静脉导管的存在和拔除、播散性疾病以及合并感染方面相似。两个研究组在48小时和5天的反应率相似。治疗结束时，氟康唑治疗患者的总体反应率为73%，两性霉素B治疗患者的总体反应率为71%（P = 0.78）。生存率或死亡原因无差异。氟康唑治疗的患者中有9%出现毒性反应，两性霉素B治疗的患者中有67%出现毒性反应（P < 0.0001）。两性霉素B的毒性作用包括肾毒性、低钾血症以及发热和寒战。