塞克硝唑片治疗滴虫阴道炎的随机对照多中心临床研究  

Secnidazole Tablet in Treatment of Trichomonal Vaginitis:A Multi-center,Randomized,Controlled Clinical Trial

作　　者：沈慧敏[1] 杨越波[1] 李小毛[1] 伍招娣[2] 丁依玲[3] 张鹤鸣 方莉[1] 万璟[1] 黄敏[1] 

机构地区：[1]中山大学附属第三医院妇产科,广东广州510630 [2]中南大学湘雅医院妇产科,湖南长沙410008 [3]中南大学湘雅二医院妇产科,湖南长沙410011 [4]广东太阳神集团有限公司,广东广州510620

出　　处：《中山大学学报（医学科学版）》2007年第4期447-451,共5页Journal of Sun Yat-Sen University:Medical Sciences

基　　金：广东省科技计划项目(2005B34201006)

摘　　要：【目的】评价口服塞克硝唑片治疗滴虫阴道炎的有效性和安全性。【方法】采用多中心、随机双盲、平行对照设计,入选滴虫阴道炎患者144例,塞克硝唑片组与替硝唑片组各72例,对其临床疗效和滴虫清除率进行比较,并观察用药后不良事件和实验室检查异常的发生情况。【结果】用药后塞克硝唑片组痊愈率和有效率分别为61%和94%;替硝唑片组痊愈率和有效率分别为51%和94%,两组之间比较差异无统计学意义(P>0.05)。塞克硝唑片组滴虫清除率为96%;替硝唑片组滴虫清除率为97%,两组比较差异无统计学意义(P>0.05)。144例病例中无不良事件与严重不良事件发生;塞克硝唑片组实验室检查异常发生率为0,替硝唑片组实验室检查异常发生率为4%,两组之间比较差异无统计学意义(P>0.05)。【结论】口服塞克硝唑片治疗滴虫阴道炎安全、有效。[Objective] To evaluate the efficacy and safety of secnidazole tablet in treatment of trichomonal vaginitis. [Methods]A multi-center, randomized, double-blinding, parallel-controlled clinical trial including 144 cases suffered trichomonal vaginitis was conducted, 72 cases in trial group were given secnidazole tablets and 72 cases in control group were given tinidazole tablets. The clinical efficacy and the eradicated rates of trichomonad between trial group and control group were compared. The adverse events and abnormal results of laboratory tests were observed. [Results] After treatment, the cure rates were 61% in trial group and 51% in control group, the efficacy rates were 94% in trial group and 94% in control group. There were no significant difference between the two groups （P 〉0.05）. The eradicated rates of trichomonad were 96% in trial group and 97% in control group. There were no significant differences between the two groups in eradicated rates of trichomonad （P 〉0.05）. There were no adverse events and severe adverse events happened in these 144 cases. The rate of abnormal results of laboratory test were 0 in trial group and 4% in control group. There were no significant difference between the two groups in safety （P 〉0.05）. [Conclusion] Secnidazole tablet is effect and safe in the treatment of trichomonal vaginitis.

关 键 词：塞克硝唑 替硝唑 滴虫阴道炎 

分 类 号：R711.3[医药卫生—妇产科学]