Könsberg R, Axéll T
Dental Hospital Clinic, Värnhem's Hospital, Malmö, Sweden.
Oral Surg Oral Med Oral Pathol. 1994 Sep;78(3):306-11. doi: 10.1016/0030-4220(94)90059-0.
The efficacy of a topically administered miconazole denture lacquer was compared with that of a placebo lacquer in the treatment of Candida-infected denture stomatitis. The study was a double-blind, randomized, controlled clinical trial with two parallel treatment groups. The lacquer was applied once on the fitting denture surface. Follow-up examinations took place on days 3, 7, 14, 21, 28, and 35. On day 14 the effect of the treatment was assessed. Thirty-six patients were included in the statistical analysis. Eighteen received miconazole and 18 received placebo lacquer. Primary efficacy endpoints were the number of colonies cultured from the palatal mucosa and denture surface on day 14. Thirteen of 16 patients in the miconazole group A showed < 10 colonies on culture medium on day 14 in the specimens from the palatal mucosa as did 5 of 18 patients in the placebo group B (p < 0.05). Corresponding results for the denture surface were 6 of 17 and 3 of 18, respectively (p < 0.05). Reapplication of lacquer was considered necessary (> 100 colonies in at least one sampling site within 14 days) in 35% of the patients from group A and in 83% of the patients from group B. The results indicate that a single application of a miconazole denture lacquer considerably reduces the number of Candida yeasts for a substantial period of time.
将局部应用的咪康唑义齿漆与安慰剂漆在治疗念珠菌感染性义齿性口炎中的疗效进行了比较。该研究是一项双盲、随机、对照临床试验，有两个平行治疗组。将漆剂在合适的义齿表面涂抹一次。在第3、7、14、21、28和35天进行随访检查。在第14天评估治疗效果。36名患者纳入统计分析。18名患者接受咪康唑治疗，18名患者接受安慰剂漆治疗。主要疗效终点是在第14天从腭黏膜和义齿表面培养的菌落数。咪康唑组A的16名患者中有13名在第14天腭黏膜标本的培养基上菌落数<10个，安慰剂组B的18名患者中有5名也是如此（p<0.05）。义齿表面的相应结果分别为17名中的6名和18名中的3名（p<0.05）。A组35%的患者和B组83%的患者被认为有必要重新涂抹漆剂（14天内至少一个采样部位菌落数>100个）。结果表明，单次应用咪康唑义齿漆可在相当长一段时间内显著减少念珠菌酵母的数量。
