Barbaro G, Barbarini G, Di Lorenzo G
Department of Emergency Medicine, La Sapienza University of Rome, Italy.
Endoscopy. 1995 Jun;27(5):377-83. doi: 10.1055/s-2007-1005717.
Contrasting opinions exist as to the pharmacological treatment of esophageal candidiasis in human immunodeficiency virus (HIV)-positive patients. The aim of this study has been to evaluate the role, therapeutic efficacy, and the cost-benefit ratio of two antifungal drugs, fluconazole and flucytosine, compared with a placebo, in the treatment of endoscopically-diagnosed esophageal candidiasis in patients with acquired immune deficiency syndrome (AIDS).
The study included 60 HIV-positive patients (38 males and 22 females, mean age 27 +/- 2) with a first episode of esophageal candidiasis diagnosed by endoscopy (grades I-II of Kodsi's endoscopic classification, and grades I-IIa of Barbaro's clinical classification). No other opportunistic infection of the esophagus was detected. In a double-blind procedure, patients were randomized into three groups of 20 patients each, receiving either fluconazole (3 mg/kg/daily per os), flucytosine (100 mg/kg/daily per os) or placebo. After two weeks of treatment, the patients previously assigned to receive the placebo were double-blindly randomized to receive fluconazole (eight patients) or flucytosine (nine patients). In order to evaluate the efficacy of pharmacological therapy, clinical examination was performed at weeks 2 and 5, and then every week up to the end of follow-up (three months); endoscopic examination was performed at weeks 2 and 5, and at the end of follow-up.
At week 2, endoscopic cure (grade 0) was observed in 13 patients (65%) of the fluconazole group and in three patients (15%) in the flucytosine group (relative risk ratio: 0.23; 95% C.I.: 0.10-0.48; p < 0.05), and a partial endoscopic response (grade I) was observed in two patients (10%) in the placebo group. Complete clinical remission (grade 0) was observed in 16 patients (80%) in the fluconazole group and 12 patients (60%) in the flucytosine group (relative risk ratio: 0.75; 95% C.I.: 0.42-0.89; p = n.s.), while six patients (30%) in the placebo group presented partial clinical remission (grade I). At the end of follow-up, endoscopic cure was observed in 19 patients (70%) in the fluconazole group and in nine patients (33%) in the flucytosine group (relative risk ratio: 0.47; 95% C.I.: 0.19-0.65; p < 0.05). Complete clinical remission was observed in 21 patients (77.7%) in the fluconazole group and in 17 patients (63%) in the flucytosine group (relative risk ratio: 0.81; 95% C.I.: 0.53-0.92; p = n.s.). No noticeable side-effects were observed in the patients in either treatment group, without a statistically significant difference in comparison with the placebo.
The results of this study have demonstrated that both fluconazole and flucytosine are safe and well tolerated in the treatment of esophageal candidiasis in AIDS patients. Fluconazole showed greater therapeutic efficacy than flucytosine, with a difference that was statistically significant in terms of the rate of endoscopic cure.
对于人类免疫缺陷病毒（HIV）阳性患者食管念珠菌病的药物治疗存在不同观点。本研究旨在评估两种抗真菌药物氟康唑和氟胞嘧啶与安慰剂相比，在获得性免疫缺陷综合征（AIDS）患者内镜诊断的食管念珠菌病治疗中的作用、治疗效果及成本效益比。
本研究纳入60例HIV阳性患者（38例男性和22例女性，平均年龄27±2岁），均经内镜诊断为首次发作的食管念珠菌病（科兹内镜分类的I-II级，以及巴巴罗临床分类的I-IIa级）。未检测到食管的其他机会性感染。采用双盲程序，将患者随机分为三组，每组20例，分别接受氟康唑（3mg/kg/日口服）、氟胞嘧啶（100mg/kg/日口服）或安慰剂。治疗两周后，先前分配接受安慰剂的患者再次双盲随机分为接受氟康唑（8例患者）或氟胞嘧啶（9例患者）。为评估药物治疗效果，在第2周和第5周进行临床检查，然后直至随访结束（三个月）每周进行一次；在第2周、第5周及随访结束时进行内镜检查。
在第2周时，氟康唑组13例患者（65%）内镜治愈（0级），氟胞嘧啶组3例患者（15%）内镜治愈（相对风险比：0.23；95%置信区间：0.10 - 0.48；p<0.05），安慰剂组2例患者（10%）出现部分内镜反应（I级）。氟康唑组16例患者（80%）完全临床缓解（0级），氟胞嘧啶组12例患者（60%）完全临床缓解（相对风险比：0.75；95%置信区间：0.42 - 0.89；p = 无统计学意义），安慰剂组6例患者（30%）出现部分临床缓解（I级）。随访结束时，氟康唑组19例患者（70%）内镜治愈，氟胞嘧啶组9例患者（33%）内镜治愈（相对风险比：0.47；95%置信区间：0.19 - 0.65；p<0.05）。氟康唑组21例患者（77.7%）完全临床缓解，氟胞嘧啶组17例患者（63%）完全临床缓解（相对风险比：0.81；95%置信区间：0.53 - p = 无统计学意义）。在两个治疗组的患者中均未观察到明显的副作用，与安慰剂相比无统计学显著差异。
本研究结果表明，氟康唑和氟胞嘧啶在治疗AIDS患者食管念珠菌病时均安全且耐受性良好。氟康唑的治疗效果优于氟胞嘧啶，在内镜治愈率方面差异具有统计学意义。
