Jane M. Hanson, James A. McGregor, Sharon L. Hillier, D. Eschenbach, A. Karen Kreutner, Rudolph P. Galask, Mark Martens
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引用次数: 78
摘要
目的比较0.75%甲硝唑阴道凝胶与口服甲硝唑治疗细菌性阴道病(BV)的疗效和安全性。研究设计:未怀孕的BV患者被纳入一项多中心、随机、研究者盲治疗试验。患者被随机分配使用0.75%甲硝唑阴道凝胶(5 g,每天2次,连续5天)或口服甲硝唑(500 mg,每天2次,连续7天)。随访在治疗开始后约2周和5周进行。结果阴道内组和口服组分别有83.7% (36/43,95% CI 72.3 ~ 95.1%)和85.1% (40/47,95% CI 74.6 ~ 95.6%)的患者在第一次随访时临床消除bv。在最后一次就诊时,阴道内组70.7% (29/41,95% CI 56.3-85.1%)和口服组71.1% (32/45,95% CI 56.4 -84.8%)的BV被消除。与阴道内治疗组(32.7%,P = 0.04)相比,口服治疗组(51.8%)有更多的患者报告了胃肠道不适。结论0.75%甲硝唑阴道凝胶治疗细菌性阴道炎的疗效与标准口服甲硝唑治疗相似,且伴有较少的胃肠道不适。
Metronidazole for bacterial vaginosis. A comparison of vaginal gel vs. oral therapy.
OBJECTIVE
To compare the efficacy and safety of 0.75% metronidazole vaginal gel with oral metronidazole for the treatment of bacterial vaginosis (BV).
STUDY DESIGN
Nonpregnant women with BV were enrolled in a multicenter, randomized, investigator-blind treatment trial. Patients were randomly assigned to either 0.75% metronidazole vaginal gel (5 g twice daily for five days) or oral metronidazole (500 mg twice daily for seven days). Follow-up visits occurred approximately two and five weeks after initiation of therapy.
RESULTS
BV was clinically eliminated at the first follow-up visit in 83.7% (36/43, 95% CI 72.3-95.1%) of the intravaginal group and 85.1% (40/47, 95% CI 74.6-95.6%) of the oral group. At the final visit, BV was eliminated in 70.7% (29/41, 95% CI 56.3-85.1%) of the intravaginal group and 71.1% (32/45, 95% CI 57.4-84.8%) of the oral group. Significantly more patients in the oral treatment group (51.8%) reported gastrointestinal complaints as compared to the intravaginal treatment group (32.7%, P = .04).
CONCLUSION
The efficacy of 0.75% metronidazole vaginal gel twice daily for five days in treating BV was similar to that of standard oral metronidazole treatment and was associated with fewer gastrointestinal complaints.