Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.
Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA.
Lancet Infect Dis. 2018 Nov;18(11):1251-1259. doi: 10.1016/S1473-3099(18)30423-7. Epub 2018 Oct 5.
Among women, trichomoniasis is the most common non-viral sexually transmitted infection worldwide, and is associated with serious reproductive morbidity, poor birth outcomes, and amplified HIV transmission. Single-dose metronidazole is the first-line treatment for trichomoniasis. However, bacterial vaginosis can alter treatment efficacy in HIV-infected women, and single-dose metronidazole treatment might not always clear infection. We compared single-dose metronidazole with a 7-day dose for the treatment of trichomoniasis among HIV-uninfected, non-pregnant women and tested whether efficacy was modified by bacterial vaginosis.
In this multicentre, open-label, randomised controlled trial, participants were recruited at three sexual health clinics in the USA. We included women positive for Trichomonas vaginalis infection according to clinical screening. Participants were randomly assigned (1:1) to receive either a single dose of 2 g of metronidazole (single-dose group) or 500 mg of metronidazole twice daily for 7 days (7-day-dose group). The randomisation was done by blocks of four or six for each site. Patients and investigators were aware of treatment assignment. The primary outcome was T vaginalis infection by intention to treat, at test-of-cure 4 weeks after completion of treatment. The analysis of the primary outcome per nucleic acid amplification test or culture was also stratified by bacterial vaginosis status. This trial is registered with ClinicalTrials.gov, number NCT01018095, and with the US Food and Drug Administration, number IND118276, and is closed to accrual.
Participants were recruited from Oct 6, 2014, to April 26, 2017. Of the 1028 patients assessed for eligibility, 623 women were randomly assigned to treatment groups (311 women in the single-dose group and 312 women in the 7-day-dose group; intention-to-treat population). Although planned enrolment had been 1664 women, the study was stopped early because of funding limitations. Patients in the 7-day-dose group were less likely to be T vaginalis positive at test-of-cure than those in the single-dose group (34 [11%] of 312 vs 58 [19%] of 311, relative risk 0·55, 95% CI 0·34-0·70; p<0·0001). Bacterial vaginosis status had no significant effect on relative risk (p=0·17). Self-reported adherence was 96% in the 7-day-dose group and 99% in the single-dose group. Side-effects were similar by group; the most common side-effect was nausea (124 [23%]), followed by headache (38 [7%]) and vomiting (19 [4%]).
The 7-day-dose metronidazole should be the preferred treatment for trichomoniasis among women.
National Institutes of Health.
在女性中，滴虫病是全球最常见的非病毒性性传播感染，与严重的生殖系统疾病、不良的生育结局和 HIV 传播加剧有关。单剂量甲硝唑是治疗滴虫病的一线药物。然而，细菌性阴道病会改变 HIV 感染女性的治疗效果，而且单剂量甲硝唑治疗可能并不总能清除感染。我们比较了单剂量甲硝唑和 7 天剂量甲硝唑治疗 HIV 阴性、非孕妇女性的滴虫病，并检测了细菌性阴道病是否会影响疗效。
这是一项多中心、开放性、随机对照试验，参与者是在美国的三个性健康诊所招募的。我们根据临床筛查招募了阴道毛滴虫感染阳性的女性。参与者被随机（1:1）分为单剂量 2 g 甲硝唑（单剂量组）或 7 天 500 mg 甲硝唑（2 次/天）。每个地点的随机分组为 4 或 6 个块。患者和研究人员均知晓治疗分组。主要结局是根据治疗后 4 周的治愈性检测，按意向治疗分析的阴道毛滴虫感染情况。对核酸扩增试验或培养的主要结局进行了分析，同时还分层分析了细菌性阴道病的状态。该试验在 ClinicalTrials.gov 注册，编号为 NCT01018095，在美国食品和药物管理局注册，编号为 IND118276，目前已停止入组。
参与者于 2014 年 10 月 6 日至 2017 年 4 月 26 日被评估是否符合纳入标准。在 1028 名符合条件的患者中，有 623 名女性被随机分配到治疗组（单剂量组 311 名，7 天剂量组 312 名；意向治疗人群）。尽管计划招募 1664 名女性，但由于资金限制，该研究提前停止。与单剂量组相比，7 天剂量组在治愈性检测时阴道毛滴虫阳性的患者较少（312 名患者中 34 名[11%]，311 名患者中 58 名[19%]，相对风险 0.55，95%CI 0.34-0.70；p<0·0001）。细菌性阴道病状态对相对风险无显著影响（p=0·17）。7 天剂量组的自我报告依从性为 96%，单剂量组为 99%。组间不良反应相似；最常见的不良反应是恶心（124 例[23%]），其次是头痛（38 例[7%]）和呕吐（19 例[4%]）。
7 天剂量甲硝唑应该是治疗女性滴虫病的首选药物。
美国国立卫生研究院。
