蔗糖凝胶治疗细菌性阴道病Ⅱ期临床试验研究

Sucrose Gel for the treatment of bacterial vaginosis:a phase Ⅱ clinical trial

目的:评价蔗糖凝胶治疗细菌性阴道病的有效剂量及其安全性。方法:采用多中心、随机双盲、剂量组平行对照的临床实验研究方法,对96例细菌性阴道病患者随机分为蔗糖凝胶5.0g组(A组)32例、蔗糖凝胶7.5g组(B组)32例、安慰剂组(C组)32例,按照不同治疗方法进行治疗,并于用药开始第3～4天、用药开始第8天进行疗效观察及安全性评价。结果:临床综合疗效分析显示用药第8天A组治愈率84.38%,B组治愈率86.67%,C组治愈率3.13%。A组和B组治愈率相比,差异无统计学意义,A组和C组治愈率、B组和C组治愈率相比,差异均有统计学意义(P<0.001)。结论:蔗糖凝胶7.5g组与5.0g组患者早晚各一次用药,与安慰剂组凝胶基质相比,可显著改善细菌性阴道病临床疗效指标和实验室指标,具有缓解临床症状、恢复阴道正常微生态环境的作用,而两剂量组治愈率无明显差别。

Objective：To evaluate the effective dose and safety of S-Gel in the treatment of bacterial vaginosis. Methods： Clinical research method of multi-center,randomly double-blind,and dose group parallel comparison was adopted. In the study,96 bacterial vaginosis patients were randomized into three groups： Group A,S-Gel 5.0 g,32 patients; Group B,S-Gel 7.5 g,32 patients; Group C,placebo,32 patients. The patients were treated with different methods. Safety and efficacy were analyzed 3 to 4 days and 8 days after the treatment,respectively. Results： The efficacy of comprehensive clinical treatment showed that： 8 days after the treatment,the cure rates of group A （5.0 g）,group B （7.5 g）,and group C （placebo） were 84.38%,86.67%,and 3.13% respectively. No difference of statistic significance was found in groups A and B,difference of statistical significance was found in group A and group C,group B and group C respectively （P〈0.001）. Conclusion： As compared with placebo,S-Gel 7.5 g and 5.0 g bid （in the morning and evening） could obviously 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. No significant difference was found in the cure rates of the two dose groups.