塞克硝唑治疗滴虫阴道炎的随机双盲、平行对照研究  

A randomized,double-blinding,parallel-controlled clinical trial of secnidazole tablet in the treatment of trichomonal vaginitis.

作　　者：沈慧敏[1] 杨越波[1] 方莉[1] 万璟[1] 李小毛[1] 黄敏[1] 

机构地区：[1]中山大学附属第三医院妇产科,广州510630

出　　处：《中国医药》2007年第7期439-441,共3页China Medicine

摘　　要：目的评价口服塞克硝唑治疗滴虫阴道炎的有效性和安全性。方法采用随机双盲、平行对照设计,入选滴虫阴道炎患者36例,塞克硝唑组与替硝唑组各18倒,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相关指标检查异常的发生情况。结果用药后塞克硝唑组痊愈率和有效率分别为56.3%和87.6%,替硝唑组分别为35.3%和94.1%,2组比较差异无统计学意义(P>0.05)。塞克硝唑组滴虫清除率为88.9%,替硝唑组为94.4%,2组比较差异无统计学意义(P>0.05)。塞克硝唑组实验室检查相关指标异常发生率为0,替硝唑组为5.56%,2组之间比较差异无统计学意义(P>0.05)。结论口服塞克硝唑治疗滴虫性阴道炎安全、有效。Objective To evaluate the efficacy and safety of secnidazole tablet in the treatment of trichomonal vaginitis. Methods A randomized, double-blinding, parallel-controlled clinical trial including 36 cases suffering trichomonal vaginitis was conducted. 18 cases in trial group were given secnidazole tablets and 18 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 test were observed. Results After treatment, the cure rates were 56.3% in trial group and 35.3% in control group, and the efficacy rates were 87.6% in trial group and 94.1% in control group. There were no significant differences between the two groups （ P 〉 0.05 ）. The eradication rates of trichomonad were 88.9% in trial group and 94.4% in control group （ P 〉 0.05 ）. There were no adverse events and severe adverse events in these 36 cases. The rates of abnormal results of laboratory test were 0.00% in trial group and 5.56% in control group （ P 〉 0.05）. Conclusion Secnidazole tablet is effective and safe in the treatment of trichomonal vaginitis.

关 键 词：滴虫阴道炎 塞克硝唑 替硝唑 

分 类 号：R711.31[医药卫生—妇产科学]