Spence M R, Harwell T S, Davies M C, Smith J L
Department of Community and Preventive Medicine, Allegheny University of the Health Sciences, Philadelphia, Pennsylvania, USA.
Obstet Gynecol. 1997 May;89(5 Pt 1):699-703. doi: 10.1016/s0029-7844(97)81437-8.
To identify the minimum effective single oral dose of metronidazole for trichomoniasis.
Women attending an inner-city sexually transmitted disease clinic who had Trichomonas vaginalis vaginitis diagnosed by microscopy were recruited for this randomized, double-blind study. Subjects were given a 0.5-, 1-, 1.5-, or 2-g single oral dose of metronidazole, taken under direct observation. Demographic information, symptoms, and clinical findings were collected from patient interviews, and physical examinations were conducted at the time of enrollment and at the follow-up visit. The primary outcome measure was treatment success at the follow-up visit, established by negative culture and microscopy.
Three (1.8%) of the 167 women enrolled were excluded because of vomiting after taking metronidazole, and 66 (40%) of the 164 remaining subjects did not return for the follow-up visit. No associations were found between the proportion of subjects lost to follow-up and the characteristics of these subjects across assignment groups. The treatment success ratio was highest in subjects who received the 1.5-g dose (23, 85%), followed by the 2-g (16, 84%), 1-g (18, 62%), and the 0.5-g dose (8, 35%).
A single 1.5-g dose of metronidazole has efficacy equivalent to a single 2-g dose for the treatment of T vaginalis vaginitis.
确定治疗滴虫病的甲硝唑单次口服最小有效剂量。
招募到一家市中心性传播疾病诊所就诊、经显微镜检查诊断为阴道毛滴虫性阴道炎的女性参与这项随机双盲研究。受试者在直接观察下接受0.5克、1克、1.5克或2克的甲硝唑单次口服剂量。通过患者访谈收集人口统计学信息、症状和临床检查结果,并在入组时和随访时进行体格检查。主要结局指标是随访时的治疗成功情况,通过培养和显微镜检查结果为阴性来确定。
167名入组女性中有3名(1.8%)因服用甲硝唑后呕吐被排除,其余164名受试者中有66名(40%)未返回进行随访。在失访受试者比例与各分配组这些受试者的特征之间未发现关联。接受1.5克剂量的受试者治疗成功率最高(23例,85%),其次是2克剂量组(16例,84%)、1克剂量组(18例,62%)和0.5克剂量组(8例,35%)。
单次1.5克剂量的甲硝唑治疗阴道毛滴虫性阴道炎的疗效与单次2克剂量相当。