摘要
目的评价奥硝唑栓(第3代硝基咪唑类抗滴虫药)治疗滴虫性阴道炎的临床疗效和安全性。方法用随机、双盲、平行对照、多中心临床试验,试验组113例,对照组112例,分别给予奥硝唑栓或甲硝唑栓,每日1枚(500mg)置入阴道,共5天。于停药3～5天、月经净后3～7天随访,观察症状、体征并进行阴道分泌物病原学检查。结果停药3-5天随访,2组的症状、体征和病原学指标均有明显改善,试验组、对照组的有效率(滴虫阴性率)分别为95.58%、97.32%,差异无统计学意义。月经后随访,试验组、对照组的有效率分别为89.38%、79.46%,2组比较有非常显著性差异(P<0.001)。试验组、对照组的药物不良反应发生率分别为9.57%、9.48%,差异无统计学意义。结论奥硝唑栓治疗滴虫性阴道炎安全、有效。
Objective To evaluate the efficacy and safey of ornidazole suppositories in the treatment of trichomonal vaginitis. Methods Double -blind randomized controlled muhicenter clinical trial was conducted. The trial group of 113 cases were given ornidazole suppositories and the control group of 112 cases were given metronidazole suppositories. The suppositories were inserted into vagina once a day for five days, respectively. The clinical symptoms, signs as well as pathogens were observed 3 ～5 days after end of treatment and 3 ～ 7days after menorrhea. Results After treatment , the effifiency（eradicated rates of pathogen） of the trial group was 95.58% and which of the control group was 97.32% ,respectively. There were no significant statistic difference between two groups. Three to 7days after menorrhea, the effifiency（ eradicated rates of pathogen） of the trial group was 89.38% and which of the control group was 79.46% ,respectively（P 〈 0.001 ）. The total rate of adverse reaction of trial and control groups were 9.58%, 9.48% respectively. There were no significant statistic difference between two groups. Conclusion It is suggested that ornidazole suppositories was safe and efficient in the treatment of trichomonal vaginitis.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2008年第3期195-198,共4页
The Chinese Journal of Clinical Pharmacology
关键词
奥硝唑栓
甲硝唑栓
滴虫性阴道炎
ornidazole suppositories
metronidazole suppositories
trichomonal vaginitis
