Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study.
Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study.
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DOI：
10.1097/lgt.0000000000000062
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发表时间：
2015-04
影响因子：
3.7
通讯作者：
Nyirjesy P
中科院分区：
文献类型：
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作者：
Chavoustie SE;Jacobs M;Reisman HA;Waldbaum AS;Levy SF;Hillier SL;Nyirjesy P
1.3%甲硝唑阴道凝胶每日一次，持续1、3或5天，与0.75%甲硝唑阴道凝胶每日一次，持续5天提供相似的疗效、安全性和耐受性。甲硝唑阴道凝胶（MVG）0.75%是美国食品和药物管理局批准的，5天治疗细菌性阴道病（BV）。本研究检验了以下假设：较高剂量（MVG 1.3%）下较短疗程将产生与5天MVG 0.75%相似的疗效。这项II期、多中心、随机、对照、药物设盲、剂量范围探索研究招募了临床诊断为BV的女性患者。患者被分配至MVG 1.3%每日一次，持续1、3或5天，或MVG 0.75%每日一次，持续5天。在研究结束访视时确定符合方案人群的治疗治愈率（需要临床和细菌学治愈）。Kaplan-Meier分析用于估计至症状缓解的中位时间。共入组255名女性（平均年龄= 35岁）。符合方案人群包括189例患者。MVG 1.3%组1天（13/43，30.2%）、3天（12/48，25.0%）和5天（16/49，32.7%）的治疗治愈率高于MVG 0.75%组（10/49，20.4%）。与MVG 0.75%组相比，3个MVG 1.3%组中鱼腥味消退的中位时间更短。5天MVG 1.3%组的症状复发率最低。各治疗组间不良事件未观察到具有临床意义的差异;大多数事件的严重程度为轻度或中度，认为与治疗无关。在改良的意向治疗人群中发现了类似的结果。甲硝唑阴道凝胶1.3%，每日一次，持续1、3或5天，与MVG 0.75%，每日一次，持续5天显示出相似的疗效、安全性和耐受性。
Metronidazole vaginal gel 1.3% once daily for 1, 3, or 5 days provides similar efficacy, safety, and tolerability as metronidazole vaginal gel 0.75% once daily for 5 days. Metronidazole vaginal gel (MVG) 0.75% is a US Food and Drug Administration–approved, 5-day treatment for bacterial vaginosis (BV). This study tested the hypothesis that a shorter treatment course at a higher dose (MVG 1.3%) would yield similar efficacy to 5 days of MVG 0.75%. This phase 2, multicenter, randomized, controlled, investigator-blinded, dose-ranging study enrolled women with a clinical diagnosis of BV. Patients were assigned to MVG 1.3% once daily for 1, 3, or 5 days or MVG 0.75% once daily for 5 days. The therapeutic cure rate, requiring clinical and bacteriological cure, at the end-of-study visit was determined for the per-protocol population. A Kaplan-Meier analysis was used to estimate median time-to-symptom resolution. In total, 255 women (mean age = 35 y) were enrolled. The per-protocol population included 189 patients. The therapeutic cure rate was higher in the 1-day (13/43, 30.2%), 3-day (12/48, 25.0%), and 5-day (16/49, 32.7%) MVG 1.3% groups versus the MVG 0.75% group (10/49, 20.4%). Median time-to-resolution of fishy odor was shorter in the 3 MVG 1.3% groups versus the MVG 0.75% group. The 5-day MVG 1.3% group had the lowest rate of symptom return. No clinically important differences were observed in adverse events across treatment groups; most events were mild or moderate in intensity and considered unrelated to treatment. Similar results were found in the modified intent-to-treat population. Metronidazole vaginal gel 1.3% applied once daily for 1, 3, or 5 days showed similar efficacy, safety, and tolerability as MVG 0.75% once daily for 5 days.