塞克硝唑治疗滴虫阴道炎84例疗效观察

Clinical effect of secnidazole tablet in the treatment of 84 cases suffered trichomonal vaginitis

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 采用随机双盲、平行对照设计、入选滴虫阴道炎患者84例．塞克硝唑片组与替硝唑片组各42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35．0％和92．5％；替硝唑片组痊愈率和有效率分别为19．5％和92．7％．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95．2％；替硝唑片组滴虫清除率为97．6％．两组之间比较差异无统计学意义（P〉0．05）。84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0．00％、替硝唑片组实验室检查异常发生率为7．14％．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 the treatment of trichomonal vaginitis. Methods A randomized,double-blinding,parallel-controlled clinical trial including 84 cases suffered trichomonal vaginitis was conducted. 42 cases in trial group were given secnidazole tablets and 42 cases in control group were given tinidazole tablets. The clinical efficacy and the eradicated rates of trichomonad were compared between trial group and control group. The adverse events and abnormal results of laboratory test were observed. Results After treatment, the cure rates were 35.0 % in trial group and 19.5 % in control group, the efficacy rates were 92.5 % in trial group and 92.7 % in control group. There were no significant differences between two groups（ P 〉 0.05 ）. The eradicated rates of trichomonad were 95.2 % in trial group and 97.6 % in control group. There were no significant differences between two groups in eradicated rates of trichomonad （P 〉 0.05 ）. There were no adverse events and severe adverse.events happened in all these 84 cases. The rates of abnormal results of laboratory test were 0.00 % in trial group and 7.14 % in control group. There were no significant differences between two groups in safety（P 〉 0.05）. Conclusion Secnidazole tablet is effect and safe in the treatment of trichomonal vaginitis.