Núñez J T, Gómez G
Faculty of Medicine, University of Zulia, Hospital Manuel Noruega Trigo, Maracaibo, Venezuela.
Int J Gynaecol Obstet. 2005 Mar;88(3):281-5. doi: 10.1016/j.ijgo.2004.11.028. Epub 2005 Jan 20.
To determine whether bacterial vaginosis could be cured with a single 1-g oral dose of secnidazole.
A total of 80 women were recruited at the outpatient gynecologic clinic of Manuel Noriega Hospital, Maracaibo, Venezuela. Diagnosis and patient enrollment were based on the Amsel criteria. The participants were randomized to 2 groups. In group 1 (n=44) participants received a single 1-g oral dose and in group 2 (n=32) participants received a single 2-g oral dose of secnidazole. Clinical cure was defined as the absence of the characteristic symptoms (a bad odor and a grossly abnormal discharge) and at least 2 of the following: vaginal pH less than 4.5, no fish odor on addition of KOH, and no Gardnerella vaginalis or clue cells on wet-mount examination. Cytologic cure was defined as an absence of G. vaginalis on a Papanicolaou (Pap) smear.
Clinical cure was experienced by 95.5% of the women who received the 1-g oral dose and by 97.4% of the women who received the 2-g oral dose of secnidazole. There was no significant difference between the groups in the clinical resolution of bacterial vaginosis. Following treatment, results were negative for G. vaginalis in 94.7% of the women. In group 1, 41 women (93.2%), and in group 2, 31 women (96.9%) had cytologic cure. The Pap smear revealed G. vaginalis in 3 of the women in group 1 and 1 of the women in group 2 (P=0.47). Twenty-seven women (35.5%) reported mild side effects. More women had adverse effects in group 1 (n=16) than in group 2 (n=11) but this difference was not statistically significant.
This clinical study showed that a single 1-g oral dose of secnidazole is effective to cure bacterial vaginosis associated with G. vaginalis.
确定单次口服1克塞克硝唑是否能治愈细菌性阴道病。
在委内瑞拉马拉开波的曼努埃尔·诺列加医院妇科门诊招募了80名女性。诊断和患者入选基于阿姆斯勒标准。参与者被随机分为两组。第1组（n = 44）的参与者接受单次口服1克剂量，第2组（n = 32）的参与者接受单次口服2克剂量的塞克硝唑。临床治愈定义为无特征性症状（异味和大量异常分泌物），且具备以下至少两项：阴道pH值小于4.5、加入氢氧化钾后无鱼腥臭味、湿片检查无阴道加德纳菌或线索细胞。细胞学治愈定义为巴氏涂片上无阴道加德纳菌。
接受1克口服剂量的女性中有95.5%实现临床治愈，接受2克口服剂量的女性中有97.4%实现临床治愈。两组在细菌性阴道病的临床缓解方面无显著差异。治疗后，94.7%的女性阴道加德纳菌检测结果为阴性。第1组中41名女性（93.2%）、第2组中31名女性（96.9%）实现细胞学治愈。第1组有3名女性、第2组有1名女性的巴氏涂片显示有阴道加德纳菌（P = 0.47）。27名女性（35.5%）报告有轻微副作用。第1组（n = 16）出现不良反应的女性比第2组（n = 11）多，但这种差异无统计学意义。
这项临床研究表明，单次口服1克塞克硝唑可有效治愈与阴道加德纳菌相关的细菌性阴道病。
