细菌性阴道病的治疗：一项比较塞克硝唑和甲硝唑的多中心、双盲、双模拟、随机III期研究。
Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomised phase III study comparing secnidazole and metronidazole.
作者信息
Bohbot Jean-Marc, Vicaut Eric, Fagnen Didier, Brauman Michel
机构信息
Institut Alfred Fournier, 25 Boulevard Saint-Jacques, 75014 Paris, France.
出版信息
Infect Dis Obstet Gynecol. 2010;2010. doi: 10.1155/2010/705692. Epub 2010 Sep 15.
OBJECTIVE
Multiple-dose metronidazole oral therapy is currently the reference treatment for bacterial vaginosis (BV). This double-blind, double-dummy, noninferiority study compared the efficacy of secnidazole, another nitroimidazole with pharmacokinetics allowing a single dose regimen, to this standard treatment.
METHODS
A total of 577 patients were randomized to receive metronidazole (500 mg, b.i.d for seven days) or secnidazole (2 g, once). Therapeutic cure at D28 was defined as the resolution of vaginal discharge, positive KOH whiff test, vaginal pH >4.5 and Nugent score >7 on Gram-stained vaginal fluid.
RESULTS
According to this primary endpoint, the single-dose secnidazole regimen was shown to be at least as effective as the multiple-dose metronidazole regimen (60.1 % cured women vs 59.5% , 95% confidence interval with a noninferiority margin of 10%: [-0.082; 0.0094]). Safety profiles were comparable in both groups.
CONCLUSION
The secnidazole regimen studied represents an effective, convenient therapeutic alternative that clinicians should consider in routine practice.
目的
多剂量口服甲硝唑目前是细菌性阴道病（BV）的参考治疗方法。这项双盲、双模拟、非劣效性研究将另一种硝基咪唑类药物塞克硝唑（其药代动力学允许单剂量给药方案）与这种标准治疗方法的疗效进行了比较。
方法
总共577名患者被随机分配接受甲硝唑（500毫克，每日两次，共七天）或塞克硝唑（2克，单次给药）。第28天的治疗痊愈定义为阴道分泌物消失、KOH嗅味试验呈阳性、阴道pH值>4.5以及革兰氏染色阴道分泌物的 Nugent评分>7。
结果
根据这一主要终点，单剂量塞克硝唑方案显示出至少与多剂量甲硝唑方案一样有效（治愈的女性比例分别为60.1%和59.5%，95%置信区间，非劣效性界限为10%：[-0.082；0.0094]）。两组的安全性概况相当。
结论
所研究的塞克硝唑方案是一种有效、便捷的治疗选择，临床医生在常规实践中应予以考虑。
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