Livengood C H, Soper D E, Sheehan K L, Fenner D E, Martens M G, Nelson A L, Ismail M, Thorp J M, Lappin M, Long B J, Blackwelder T, Sweet R L, Sagov S
Duke University Medical Center, Durham, North Carolina 27710, USA.
Sex Transm Dis. 1999 Mar;26(3):137-42. doi: 10.1097/00007435-199903000-00003.
Bacterial vaginosis is the most common cause of vaginal symptoms in women and has potential complications. Efforts to improve treatment of this disease process are warranted.
The goal of this study was to compare the safety and efficacy of once-daily intravaginal administration of 0.75% metronidazole gel for 5 days to the established twice-daily regimen in the treatment of bacterial vaginosis.
Nonpregnant women with bacterial vaginosis diagnosed by accepted clinical criteria at 14 geographically diverse general gynecology clinics were enrolled in this prospective, randomized, investigator-blind, parallel study. They were treated with either once-daily or twice-daily 0.75% metronidazole gel 5 g intravaginally for 5 days and were reevaluated at 7 to 12 days and 28 to 35 days after completing treatment. Efficacy was determined by clinical criteria. Adverse drug reactions were monitored.
Of the 514 evaluable women enrolled, bacterial vaginosis was cured at the first return visit among evaluable patients in 153 of 199 (77%) of those who received the once-daily and in 157 of 196 (80%) of those who received the twice-daily administration. Bacterial vaginosis was cured among evaluable patients at the final visit in 104 of 180 (58%) of those who received once-daily and 109 of 178 (61%) of those who received the twice-daily regimen. Intent-to-treat analysis showed cure at 1 month in 118 of 207 (57%) of those treated once daily and 129 of 209 (62%) of those treated twice daily. Side effects were mild, and none caused treatment discontinuation.
Once-daily dosing of 0.75% metronidazole gel 5 g for 5 days yields efficacy, safety, and tolerance equivalent to the currently used twice-daily dosing in the treatment of bacterial vaginosis, adding another competitive choice to the available therapeutic options for this condition.
细菌性阴道病是女性阴道症状最常见的病因，且存在潜在并发症。有必要努力改进对这一疾病进程的治疗。
本研究的目标是比较每日一次阴道内给予0.75%甲硝唑凝胶，持续5天与既定的每日两次给药方案在治疗细菌性阴道病方面的安全性和有效性。
在14个地理位置不同的普通妇科诊所，根据公认的临床标准诊断为细菌性阴道病的非妊娠女性被纳入这项前瞻性、随机、研究者盲法、平行研究。她们接受每日一次或每日两次阴道内给予5 g 0.75%甲硝唑凝胶，持续5天，并在完成治疗后7至12天以及28至35天进行重新评估。疗效根据临床标准确定。监测药物不良反应。
在纳入的514例可评估女性中，接受每日一次给药的199例可评估患者中有153例（77%）在首次复诊时细菌性阴道病得到治愈，接受每日两次给药的196例中有157例（80%）。在最终复诊时，接受每日一次给药的180例可评估患者中有104例（58%）细菌性阴道病得到治愈，接受每日两次给药方案的178例中有109例（61%）。意向性分析显示，每日治疗一次的207例中有118例（57%）在1个月时治愈，每日治疗两次的209例中有129例（62%）治愈。副作用轻微，无一例导致治疗中断。
每日一次给予5 g 0.75%甲硝唑凝胶，持续5天，在治疗细菌性阴道病方面产生的疗效、安全性和耐受性与目前使用的每日两次给药相当，为这种情况的现有治疗选择增加了另一种有竞争力的选择。
