Hoppe J E
University Children's Hospital, Tübingen, Germany.
Pediatr Infect Dis J. 1997 Mar;16(3):288-93. doi: 10.1097/00006454-199703000-00007.
Miconazole gel has previously been shown to be an effective treatment for oropharyngeal candidiasis (thrush) in immunocompetent infants. This study compares miconazole gel with the standard therapeutic agent, nystatin suspension, with regard to efficacy, optimal duration of therapy and safety.
Prospective multicenter, randomized, office-based open trial.
Twenty-six pediatricians enrolled 227 immunocompetent infants with signs of oropharyngeal thrush. Subjects were randomly assigned to receive 25 mg of miconazole as oral gel four times daily or 100,000 IU of nystatin as suspension four times daily after meals. All subjects were evaluated for safety. Fifteen patients whose thrush was not confirmed by culture were excluded from further analysis. The remaining 212 subjects were entered into an intention-to-treat analysis. Another 29 patients violated the study protocol; the remaining 183 subjects were evaluated for efficacy (per protocol analysis).
Clinical cure by Day 5 of treatment was demonstrated in 84.7% of the 98 subjects in the miconazole group and 21.2% of the 85 subjects in the nystatin group (P < 0.0001). By Day 8, the cumulative clinical cure rates were 96.9% (miconazole) and 37.6% (nystatin), respectively (P < 0.0001). By Day 12.99.0% of subjects in the miconazole group and 54.1% of subjects in the nystatin group were clinically cured (P < 0.0001). Premature cessation of treatment at parents' request because of lack of clinical efficacy occurred in none of the infants treated with miconazole and in 6 infants treated with nystatin (P = 0.029). The oral yeast eradication rate on Day 5 was 54.1% with miconazole and 8.2% with nystatin (P < 0.0001). Clinical relapses of oropharyngeal thrush and side effects of the study drugs were observed with similar frequency in both study arms.
Miconazole gel was significantly superior to nystatin suspension with regard to efficacy, rapidity of achieving cure and oropharyngeal yeast eradication. Relapses and side effects did not occur more frequently with miconazole than with nystatin. The results of this study indicate that miconazole gel is superior to nystatin suspension as the treatment for oropharyngeal candidiasis in immunocompetent infants.
先前已证明咪康唑凝胶对免疫功能正常的婴儿的口腔念珠菌病（鹅口疮）是一种有效的治疗方法。本研究比较了咪康唑凝胶与标准治疗药物制霉菌素混悬液在疗效、最佳治疗持续时间和安全性方面的差异。
前瞻性多中心、随机、基于门诊的开放试验。
26名儿科医生招募了227名有口腔鹅口疮体征的免疫功能正常的婴儿。受试者被随机分配接受每日4次、每次25mg的咪康唑口腔凝胶，或每日4次、每次100,000IU的制霉菌素混悬液，餐后服用。对所有受试者进行安全性评估。15名鹅口疮未通过培养确诊的患者被排除在进一步分析之外。其余212名受试者进入意向性分析。另外29名患者违反了研究方案；其余183名受试者进行疗效评估（符合方案分析）。
咪康唑组98名受试者中有84.7%在治疗第5天临床治愈，制霉菌素组85名受试者中有21.2%临床治愈（P<0.0001）。到第8天，累积临床治愈率分别为96.9%（咪康唑）和37.6%（制霉菌素）（P<0.0001）。到第12天，咪康唑组99.0%的受试者和制霉菌素组54.1%的受试者临床治愈（P<0.0001）。因缺乏临床疗效而应家长要求提前停止治疗的情况在接受咪康唑治疗的婴儿中未发生，但在接受制霉菌素治疗的6名婴儿中发生（P=0.029）。第5天咪康唑的口腔酵母菌清除率为54.1%，制霉菌素为8.2%（P<0.0001）。在两个研究组中观察到口腔鹅口疮的临床复发和研究药物的副作用的频率相似。
在疗效、治愈速度和口腔酵母菌清除方面，咪康唑凝胶明显优于制霉菌素混悬液。咪康唑引起的复发和副作用并不比制霉菌素更频繁。本研究结果表明，在治疗免疫功能正常的婴儿的口腔念珠菌病方面，咪康唑凝胶优于制霉菌素混悬液。
