蔗糖凝胶治疗细菌性阴道病的多中心、随机、双盲、平行对照Ⅲ期临床试验

发布时间：2018-07-27 09:25

【摘要】：目的:通过多中心、随机、双盲、平行对照的临床研究,进一步评价蔗糖凝胶治疗细菌性阴道病的有效性及安全性。方法:选择5个研究中心的533例细菌性阴道病患者作为研究对象,依据随机表按对照组与试验组为2∶3比例随机入组,甲硝唑凝胶5.0 g组(对照组)214例,蔗糖凝胶5.0 g组(实验组)319例,两组均采取每日早晚各一次阴道上药,连用5 d的疗程进行治疗。分别于治疗第7~10天、第21~30天进行疗效观察及安全性评价。结果:治疗第7~10天,甲硝唑凝胶组和蔗糖凝胶组的临床综合疗效治愈率分别为70.53%和80.83%,阴道分泌物涂片Nugent积分痊愈率分别为71.50%和81.15%,差异均有统计学意义(P0.05)。治疗第21~30天,甲硝唑凝胶组和蔗糖凝胶组的临床综合疗效治愈率分别为63.29%和61.98%,差异无统计学意义(P0.05)。结论:蔗糖凝胶治疗细菌性阴道病的临床综合疗效近期(治疗第7~10天)及恢复阴道菌群方面明显优于甲硝唑凝胶,远期治愈率(治疗第21~30天)与甲硝唑凝胶相当,可成为治疗细菌性阴道病的新策略。
[Abstract]:Objective: to evaluate the efficacy and safety of sucrose gel in the treatment of bacterial vaginosis. Methods: 533 patients with bacterial vaginosis were selected from 5 research centers. According to the random table, the patients were randomly assigned to the control group at 2:3, and the metronidazole gel 5.0 g group (control group) to 214 cases. There were 319 cases in sucrose gel 5.0 g group (experimental group). The two groups were treated with vaginal administration once a day and every day for 5 days. The curative effect and safety were observed on the 7th day and the 21st day. Results: the cure rates of metronidazole gel group and sucrose gel group were 70.53% and 80.833% respectively, and the cure rate of vaginal secretion smear Nugent integral were 71.50% and 81.15% respectively (P0.05). The curative rates of metronidazole gel group and sucrose gel group were 63.29% and 61.98 respectively on the 21st day (P0.05). Conclusion: sucrose gel is superior to metronidazole gel in the treatment of bacterial vaginosis in the short term (710 days) and the recovery of vaginal flora. The long-term cure rate (2130 days of treatment) is similar to that of metronidazole gel. It may become a new strategy for the treatment of bacterial vaginosis.
【作者单位】：北京大学第一医院妇产科;北京清华长庚医院;郑州大学第一附属医院妇产科;第四军医大学西京医院妇产科;河北医科大学第二医院妇产科;河北医科大学第三医院妇产科;北京大学第一医院医学统计室;
【分类号】：R711.73

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