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克林霉素磷酸酯栓治疗细菌性阴道病多中心随机双盲对照临床试验

Clindamycin phosphate suppository in treatment of bacterial vaginosis:a multicenter,randomized,and double-blind clinical trail

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【作者】 董晓静胡丽娜王芳吴艺佳常青蔡丽萍谭布珍

【Author】 DONG Xiao-jing,HU Li-na,WANG Fang,WU Yi-jia,CHANG Qing,CAI Li-ping,TAN Bu-zhen (Department of Gynecology and Obstetrics,No.2 Hospital of Chongqing Medical University,CHONGQING 400010,China; Department of Gynecology and Obstetrics,West China Second University Hospital,Chengdu SICHUAN 610041,China;Department of Gynecology and Obstetrics,South-west Hospital of No.3 Military Medical College of PLA,CHONGQING 400040,China;Department of Gynecology and Obstetrics,the First Affiliated Hospital of Jiangxi Medical University,Nanchang JIANGXI 330000,China;Department of Gynecology and Obstetrics,the Second Affiliated Hospital of Jiangxi Medical University,Nanchang JIANGXI 330000,China)

【机构】 重庆医科大学附属第二医院妇产科四川大学华西第二医院妇产科中国人民解放军第三军医大学西南医院妇产科江西医学院第一附属医院妇产科江西医学院第二附属医院妇产科 重庆 400010四川成都 610041重庆 400010重庆 400040江西南昌 330000

【摘要】 目的:评价克林霉素磷酸酯栓治疗细菌性阴道病的疗效和安全性。方法:本研究采用多中心随机双盲对照试验。试验组109例,对照组110例,分别阴道置入克林霉素磷酸酯栓100 mg·d-1和甲硝唑栓500 mg·d-1治疗,疗程均为7 d。分别于停药后3~5 d和停药后月经来潮干净3—7 d观察疗效和安全性。结果:停药后3-5 d,试验组和对照组有效率分别为92.7%和82.7%,试验组高于对照组(P<0.05),2组间疗效比较差异无显著意义(P>0.05);停药后月经来潮干净后3~7 d,试验组和对照组有效率分别为82.6%和75.4%,2组疗效无显著差异(P>0.05)。不良反应发生率试验组和对照组分别为6.7%和8.3%(P>0.05)。结论:克林霉素磷酸酯栓治疗细菌性阴道病安全、有效。

【Abstract】 AIM:To evaluate the efficacy and safety of clindamycin phosphate suppository in the treatment of bacterial vaginosis. METHODS; A multicenter randomized and double-blind controlled clinical trail was conducted. One hundred and nine patients in trial group were treated with clindamycin phosphate suppository via vagina 100 mg·d-1 and 110 patients in control group were given metronidazole suppository 500 mg·d-1. Seven successive days were taken as a course for both groups. The efficacy and safety were observed respectively 3 - 5 d after end of treatment and 3 - 7 d after menorrhea. RESULTS: The efficacy rates were 92.7 % in trial group, higher than that in control group (82.7 %, P < 0.05) 3 - 5 d after end of treatment. But there was no significant difference in clinical efficacy between two groups (P > 0.05). The efficacy rates were 82.6 % in trial group and 75.4 % in control group respectively 3 - 7 d after menorrhea, with no significant difference in clinical efficacy between these two groups (P > 0.05). The rate of adverse reactions in trial group was 6.7 % and in control group was 8.3 % respectively (P > 0.05). CONCLUSION; Clindamycin phosphate suppository is an effective and safe preparation in the treatment of bacterial vaginosis.

  • 【文献出处】 中国新药与临床杂志 ,Chinese Journal of New Drugs and Clinical Remedies , 编辑部邮箱 ,2007年02期
  • 【分类号】R711.3
  • 【被引频次】4
  • 【下载频次】212
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