Kirkpatrick C H, Alling D W
N Engl J Med. 1978 Nov 30;299(22):1201-3. doi: 10.1056/NEJM197811302992201.
Twenty patients with chronic oral candidiasis were assigned by random allocation to a two-week course of either 10-mg clotrimazole buccal troches or placebo taken five times daily in a double-blind clinical trial. Each of the 10 recipients of clotrimazole had marked regression of symptoms and mucosal lesions, and in nine patients potassium hydroxide preparations and cultures of mucosal scrapings gave no evidence of candidiasis. In contrast, only one of the 10 patients receiving placebo showed any improvement. The clinical outcome in the clotrimazole-treated group was significantly more favorable (P less than 0.001) than in the group receiving placebo. No adverse reactions to the drug were observed. After the blind phase of their trial, 15 patients were treated with clotrimazole troches in an open trial. One to three troches per day were found adequate to sustain remissions. We conclude that clotrimazole is highly effective treatment for chronic oral candidiasis.
在一项双盲临床试验中,20例慢性口腔念珠菌病患者通过随机分配,接受为期两周的治疗,一组每天五次服用10毫克克霉唑口腔含片,另一组服用安慰剂。10名接受克霉唑治疗的患者症状和黏膜病变均显著消退,9名患者的氢氧化钾制剂及黏膜刮片培养未发现念珠菌病迹象。相比之下,10名接受安慰剂治疗的患者中只有1人有任何改善。克霉唑治疗组的临床结果明显优于接受安慰剂治疗的组(P小于0.001)。未观察到该药物的不良反应。在试验的盲法阶段结束后,15名患者在开放试验中接受克霉唑含片治疗。发现每天服用1至3片足以维持病情缓解。我们得出结论,克霉唑是治疗慢性口腔念珠菌病的高效药物。