Koopmans A S, Smitt P A, Kalk W, de Graaff J
J Prosthet Dent. 1984 Apr;51(4):461-6. doi: 10.1016/0022-3913(84)90294-4.
This double-blind clinical trial was carried out in 38 patients to compare the efficacy of 2.5% Pimafucin suspension with a placebo in the treatment of denture stomatitis. The diagnosis of Candida infection was confirmed by the making of cultures and microscopic examination. Data were analyzed from 32 patients, of whom 18 received Pimafucin suspension and 14 a placebo suspension. Pimafucin suspension-treated patients showed a significant reduction of Candida infection in terms of culture, culture growth, and number of colonies within the first week of therapy. There was no statistical evidence of relapse during the 4-week period after therapy was stopped. The group receiving a placebo failed to show any statistically significant improvement with respect to the mentioned parameters. Erythema of oral mucosa showed significant improvement in both groups. No side effects were found.
这项双盲临床试验对38名患者进行，以比较2.5%匹美莫司混悬液与安慰剂治疗义齿性口炎的疗效。通过培养和显微镜检查确诊念珠菌感染。对32名患者的数据进行了分析，其中18名接受匹美莫司混悬液治疗，14名接受安慰剂混悬液治疗。接受匹美莫司混悬液治疗的患者在治疗的第一周，念珠菌感染在培养、培养生长和菌落数量方面均显著减少。治疗停止后的4周内没有复发的统计学证据。接受安慰剂的组在上述参数方面未显示出任何统计学上的显著改善。两组口腔黏膜红斑均有显著改善。未发现副作用。
