Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Sex Transm Dis. 2013 Sep;40(9):710-4. doi: 10.1097/01.olq.0000431069.38601.d5.
Trichomonas vaginalis is the causative agent of the most common curable sexually transmitted disease in the world. The infection is treated with a single oral dose of metronidazole or tinidazole, currently the only licensed class of drugs available for this indication; however, both of these antimicrobials are associated with significant gastrointestinal adverse effects, and some individuals are unable to tolerate them because of these adverse effects.
Randomized, dose-ranging pilot study conducted in 2 phases consisting of 20 participants in each phase. In the first phase, participants were randomized to the vaginal suppository (metronidazole 750 mg/miconazole nitrate 200 mg) twice a day for 7 days versus oral metronidazole 2 g single dose. In the second phase, participants randomized to suppository used it once a day for 7 days. Women were reevaluated on days 12 to 15 and 30 to 35. Treatment failures were defined as persistence of trichomonas by wet prep and/or culture.
There were no significant differences in cure rates between the vaginal suppositories and oral metronidazole in either phase. The overall efficacy across both follow-up visits was 80% versus 90% for the suppository (2×/d) versus oral medication arms in phase 1 (P = 1.00) and 78% versus 70% for the suppository (1×/d) versus oral medication arms in phase 2 (P = 1.00). The results were also nonsignificant when combining results across arm (P = 1.00).
High-dose intravaginal metronidazole combined with miconazole offers the possibility of a well-tolerated treatment that avoids the systemic adverse effects of nitroimidazoles for the treatment of trichomoniasis.
阴道毛滴虫是世界上最常见的可治愈性传播疾病的病原体。该感染采用单剂量口服甲硝唑或替硝唑治疗，目前这是该适应证下唯一获得许可的药物类别；然而，这两种抗生素都与明显的胃肠道不良反应相关，一些人由于这些不良反应而无法耐受它们。
这是一项在两个阶段进行的、包含 20 名参与者的随机、剂量范围的试点研究。在第一阶段，参与者被随机分配至阴道栓剂（甲硝唑 750mg/硝酸咪康唑 200mg，每日两次，连用 7 天）与口服甲硝唑 2g 单剂量治疗。在第二阶段，随机分配至栓剂的参与者每天使用一次，连用 7 天。女性在第 12-15 天和第 30-35 天接受重新评估。治疗失败定义为湿片检查和/或培养仍存在滴虫。
在两个阶段中，阴道栓剂与口服甲硝唑的治愈率均无显著差异。在两次随访中，阴道栓剂（2×/d）与口服药物组的总体疗效为 80%，而阴道栓剂（1×/d）与口服药物组的总体疗效为 78%，在第一阶段（P=1.00）；在第二阶段，阴道栓剂（2×/d）与口服药物组的总体疗效为 80%，而阴道栓剂（1×/d）与口服药物组的总体疗效为 70%（P=1.00）。当组合臂的结果时，结果也无统计学意义（P=1.00）。
高剂量阴道甲硝唑联合咪康唑可能为治疗滴虫病提供一种耐受良好的治疗方法，避免了硝基咪唑类药物的全身不良反应。
