Hecht F M, Wheat J, Korzun A H, Hafner R, Skahan K J, Larsen R, Limjoco M T, Simpson M, Schneider D, Keefer M C, Clark R, Lai K K, Jacobson J M, Squires K, Bartlett J A, Powderly W
Albert Einstein College, Bronx, New York, U.S.A.
J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Oct 1;16(2):100-7. doi: 10.1097/00042560-199710010-00005.
To study the efficacy and safety of maintenance treatment with itraconazole for disseminated histoplasmosis in patients with AIDS.
This was a prospective, multicenter, open-label study conducted at university-based hospitals participating in the AIDS Clinical Trial Group (ACTG). Forty-six AIDS patients with mild to moderate disseminated histoplasmosis who had successfully completed 12 weeks of induction treatment with itraconazole were treated with itraconazole, 200 mg once daily (42 patients) or 400 mg once daily (4 patients). Patients were followed at monthly intervals with clinical and laboratory assessment for relapse or toxicity. Primary outcome measures were relapse of histoplasmosis and survival. Secondary outcome measures included drug-limiting toxicity and changes in serum and urine Histoplasma polysaccharide antigen (HPA) levels.
Two patients relapsed during a median follow-up period of 87 weeks. The 1-year relapse-free rate was estimated to be 95.3% (95% CI, 85.3%-99.7%). One relapse may have been related to poor adherence to treatment and the second to concurrent administration of rifampin. From the start of maintenance treatment, the estimated 1-year survival rate was 73.0% (95% CI, 67.5%-77.9%). Five patients discontinued treatment because of suspected drug toxicity, three of whom had possible or probable hepatotoxicity. Median serum and urine HPA levels declined significantly during treatment. The only patient in whom antigen levels rose >2 U developed clinical relapse 1 week later; antigen levels were unavailable in the other relapsing patient.
Itraconazole, 200 mg daily, is effective in preventing relapse of disseminated histoplasmosis in patients with AIDS. It is generally well tolerated, but clinicians should be alert for drug interactions and possible hepatotoxicity.
研究伊曲康唑维持治疗艾滋病患者播散性组织胞浆菌病的疗效和安全性。
这是一项在参与艾滋病临床试验组（ACTG）的大学附属医院进行的前瞻性、多中心、开放标签研究。46例轻度至中度播散性组织胞浆菌病的艾滋病患者成功完成了12周的伊曲康唑诱导治疗，随后接受伊曲康唑治疗，200mg每日1次（42例患者）或400mg每日1次（4例患者）。每月对患者进行随访，进行临床和实验室评估以检测复发或毒性。主要结局指标为组织胞浆菌病复发和生存情况。次要结局指标包括药物限制毒性以及血清和尿液中组织胞浆菌多糖抗原（HPA）水平的变化。
在中位随访期87周期间，有2例患者复发。1年无复发率估计为95.3%（95%CI，85.3%-99.7%）。1例复发可能与治疗依从性差有关，另1例与同时使用利福平有关。从维持治疗开始，估计1年生存率为73.0%（95%CI，67.5%-77.9%）。5例患者因疑似药物毒性而停药，其中3例可能或很可能出现肝毒性。治疗期间血清和尿液HPA水平中位数显著下降。抗原水平升高>2U的唯一1例患者在1周后出现临床复发；另一例复发患者的抗原水平数据未提供。
每日200mg伊曲康唑可有效预防艾滋病患者播散性组织胞浆菌病的复发。其耐受性一般良好，但临床医生应警惕药物相互作用和可能的肝毒性。
