Villanueva Alvaro, Gotuzzo Eduardo, Arathoon Eduardo G, Noriega L Miguel, Kartsonis Nicholas A, Lupinacci Robert J, Smietana Juanita M, DiNubile Mark J, Sable Carole A
Preventio, Barranquilla, Colombia.
Am J Med. 2002 Sep;113(4):294-9. doi: 10.1016/s0002-9343(02)01191-9.
Candida esophagitis remains an important cause of morbidity in patients with advanced human immunodeficiency virus (HIV) infection. Fluconazole is widely regarded as the treatment of choice for this condition.
The efficacy and safety of caspofungin were compared with fluconazole in adult patients with Candida esophagitis in a double-blind randomized trial. Eligible patients had symptoms compatible with esophagitis, endoscopic demonstration of mucosal plaques, and microscopic demonstration of Candida from the esophageal lesions. Patients were randomly assigned to receive caspofungin (50 mg) or fluconazole (200 mg) intravenously once daily for 7 to 21 days. The primary endpoint was the combined response of symptom resolution and significant endoscopic improvement 5 to 7 days after discontinuation of treatment. Data were analyzed with a modified intention-to-treat analysis, which excluded 2 ineligible patients.
Most patients (154/177; 87%) had HIV infection, with a median CD4 count of 30 cells/mm(3). Candida albicans was the predominant isolate. Favorable response rates were achieved in 66 (81%) of the 81 patients in the caspofungin arm and in 80 (85%) of the 94 patients in the fluconazole arm (difference = -4%; 95% confidence interval: -15% to +8%). Symptoms had resolved in >50% of patients in both groups by the fifth day of treatment. No patient in the caspofungin group developed a serious drug-related adverse event; therapy was only discontinued in 1 patient (receiving fluconazole) due to a drug-related adverse experience. Four weeks after stopping study drug, symptoms had recurred in 18 (28%) of 64 patients given caspofungin and in 12 (17%) of 72 patients given fluconazole (P = 0.19).
In this study, caspofungin appeared to be as efficacious and generally as well tolerated as fluconazole in patients with advanced HIV infection and documented Candida esophagitis.
念珠菌食管炎仍是晚期人类免疫缺陷病毒（HIV）感染患者发病的重要原因。氟康唑被广泛认为是治疗该病的首选药物。
在一项双盲随机试验中，比较了卡泊芬净与氟康唑对成年念珠菌食管炎患者的疗效和安全性。符合条件的患者有与食管炎相符的症状、内镜显示黏膜斑块以及食管病变处念珠菌的显微镜检查结果。患者被随机分配接受卡泊芬净（50毫克）或氟康唑（200毫克）静脉注射，每日一次，持续7至21天。主要终点是治疗停药后5至7天症状缓解和内镜显著改善的综合反应。数据采用改良意向性分析进行分析，排除了2例不符合条件的患者。
大多数患者（154/177；87%）感染了HIV，CD4细胞计数中位数为30个/立方毫米。白色念珠菌是主要分离株。卡泊芬净组81例患者中有66例（81%）取得了良好反应率，氟康唑组94例患者中有80例（85%）取得了良好反应率（差异=-4%；95%置信区间：-15%至+8%）。治疗第5天时，两组中超过50%的患者症状已缓解。卡泊芬净组没有患者发生严重的药物相关不良事件；只有1例接受氟康唑治疗的患者因药物相关不良经历而停药。停止研究药物四周后，接受卡泊芬净治疗的64例患者中有18例（28%）症状复发，接受氟康唑治疗的72例患者中有12例（17%）症状复发（P=0.19）。
在本研究中，对于晚期HIV感染且确诊为念珠菌食管炎的患者，卡泊芬净似乎与氟康唑疗效相当，且总体耐受性良好。
