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  

Sucrose gel for treatment of bacterial vaginosis: a randomized,double-blind,multi-center,parallel-group,phase Ⅲ clinical trial

作　　者：肖冰冰[1] 张岱[1] 陈锐[1,2] 史惠蓉[3] 辛晓燕[4] 王惠兰[5] 庞义存[6] 朱赛楠[7] 姚晨[7] 廖秦平[1,2] 

机构地区：[1]北京大学第一医院妇产科,北京100034 [2]北京清华长庚医院,北京100044 [3]郑州大学第一附属医院妇产科,郑州450052 [4]第四军医大学西京医院妇产科,西安710032 [5]河北医科大学第二医院妇产科,石家庄050000 [6]河北医科大学第三医院妇产科,石家庄050051 [7]北京大学第一医院医学统计室,北京100034

出　　处：《北京大学学报（医学版）》2015年第6期925-932,共8页Journal of Peking University:Health Sciences

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（P〈0.05）。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（P〉0.05）。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。Objective： To evaluate the cure effectiveness and safety of sucrose gel in the treatment of bacterial vaginosis through a multi-center,randomized,double-blind,parallel controlled clinical study.Methods： A clinical research method of multi-center,randomly double-blind,and dose group parallel comparison was adopted. In the study,533 patients with bacterial vaginosis were randomly divided into two groups,which included 214 cases in the control group（ 5. 0 g metronidazole gel） and 319 cases in the trial group（ 5. 0 g sucrose gel）. The patients were treated with different medication according to the group where they were. All the cases in these two groups were treated with drugs vaginally twice in a day,morning and evening separately,for 5 days. The curative effect and safety evaluation were assessed from7 to 10 days and 21 to 30 days after treatment respectively. Results： The efficacy of the comprehensive clinical treatment showed that the cure rate of metronidazole gel group and sucrose gel group were70. 53% and 80. 83% respectively 7 to 10 days after treatment. The recovery rate of Nugent score for vaginal smear were 71. 50% and 81. 15% respectively. The differences in the efficacy between these two groups were significant statistically（ P〈0. 05）. However,the cure rates of metronidazole gel group and sucrose gel group were 63. 29% and 61. 98% respectively 21 to 30 days after treatment. No statistically significant difference（ P〈0. 05） could be found in the cure rates of the two groups. Conclusion： The clinical comprehensive efficacy and recovery of vaginal bacteria of sucrose gel group in the treatment of bacterial vaginosis were obviously superior to those of metronidazole gel 7 to 10 days after treatment. The susucrose gel could improve the clinical efficacy index and laboratory index of bacterial vaginosis. Other effects included the release of clinical symptoms,and the recovery of the normal micro-environment in the vagina according to the Nugent score. The curative efficacy of sucro

关 键 词：阴道病 细菌性 投药 阴道内 蔗糖 临床试验 Ⅲ期 

分 类 号：R711.73[医药卫生—妇产科学]