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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96例,塞克硝唑片组与替硝唑片组各48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82.6%和93.5%;替硝唑片组痊愈率和有效率分别为72.3%和95.7%,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93.8%;替硝唑片组滴虫清除率为95.8%,两组之间比较差异无统计学意义(P>0.05)。96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2.08%,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 oral Secnidazole tablets in the treatment of Trichomonas vaginitis. Methods A randomized, double-blind, parallel-controlled design was enrolled in this study. Ninety-six patients with Trichomonas vaginitis, forty-eight patients with secundazole and tinidazole were enrolled in this study. The clinical efficacy and trichomonad clearance were compared. Post Adverse Events and Laboratory Abnormalities. Results The cure rate and effective rate of Secnidazole tablets group were 82.6% and 93.5%, respectively. The cure rate and effective rate of tinidazole tablets group were 72.3% and 95.7%, respectively. There was no significant difference between the two groups (P> 0.05). Trimethoprim tablets group trichomonad clearance rate was 93.8%; tinidazole tablets group trichomonad clearance rate was 95.8%, the difference between the two groups was not statistically significant (P> 0.05). There were no adverse events and serious adverse events in 96 cases. The incidence of laboratory abnormalities in Secnidazole tablets group was 0.00%, and the incidence of laboratory abnormalities in tinidazole tablets group was 2.08%. There were significant differences between the two groups No statistical significance (P> 0.05). Conclusion oral Secnidazole tablets trichomonas vaginitis safe and effective.