克霉唑阴道膨胀栓治疗妊娠期合并霉菌性阴道炎的多中心、随机对照的开放性临床研究  

Open Multicenter,Randomized Controlled Clinical Trial of Clotrimazole Vaginal Expansion Suppository in the Treatment of Pregnant Women with Mycotic Vaginitis

作　　者：胡智敏 廖瑶 蒋思思 周成炎 Zhimin Hu;Yao Liao;Sisi Jiang;Chengyan Zhou(Shaw Hospital Affiliated to Zhejiang University,Hangzhou,Zhejiang,310002,China;Hangzhou First People,s Hospital,Hangzhou,Zhejiang,310003,China;Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University,Hangzhou,Zhejiang,310005,China;Second Affiliated Hospital of Zhejian University,Hangzhou,Zhejiang,310006,China)

机构地区：[1]浙江大学附属邵逸夫医院,中国浙江杭州310002 [2]杭州市第一人民医院,中国浙江杭州310003 [3]浙江中医药大学附属杭州市中医院,中国浙江杭州310005 [4]浙江大学附属第二医院,中国浙江杭州310006

出　　处：《实用医学研究》2019年第3期27-29,共3页Practical medical research

摘　　要：论文通过多中心、随机、开放性、平行对照的临床研究,进一步评价克霉唑阴道膨胀栓与其他抗真菌药物治疗妊娠期合并霉菌性阴道炎的临床疗效与安全性差异。入选4个中心,1200例经细菌性学检查确定为妊娠期合并霉菌性阴道炎患者,随机数字表分为组A300例克霉唑阴道膨胀栓(1粒/次),组B克霉唑阴道片(1片/次)、组C硝酸咪康唑(1粒/次)、组D制霉素栓组(1粒/次),每组治疗7天,评估转阴率等指标。结果显示,组A、B、C、D转阴率分别为95.0%,94.33%,85.33%,88.0%,4组比较差异具有统计学意义(P<0.05)。4组白日中重度瘙痒发生率分别为1.30%,9.33%,15.67%,12.0%,4组比较差异具有统计学意义(P<0.05),4组III+IV度阴道清洁度发生率分别为1.30%,8.67%,15.00%,11.3%,4组比较差异具有统计学意义(P<0.05),治疗过程中发现,克霉唑阴道膨胀栓、咪康唑、制霉素均无明显不良反应,而克霉唑阴道片11.3%的患者出现阴道灼热,红肿。由此得出,克霉唑阴道膨胀栓相比阴道片转阴率相似,但改善清洁度及安全性更优。相比制霉素、咪康唑,瘙痒控制更优、转阴率更高,清洁度及安全性更优。This paper evaluates the efficacy and safety of multiple-center,randomized,open-label,parallel-controlled clinical trials,to further evaluate the clinical efficacy and safety of clotrimazole vaginal expansion suppository compared with other Fungicide in the treatment of pregnant women with Mycotic vaginitis.1200 cases of pregnant women with Mycotic vaginitis were selected from 4 centers,and randomly divided into groups of A300 cases of clotrimazole vaginal swelling suppository(1 tablet per time),group B:CLOTRIMAZOLE vaginal tablet(1 tablet/TIME),Group C:miconazole nitrate(1 tablet/Time),and Group D:NYSTATIN suppository(1 tablet/time).The results show that the negative conversion rates of Group A,B,C and d were 95.0%,94.33%,85.33%and 88.0%respectively.The incidence of moderate and severe pruritus was 1.30%,9.33%,15.67%,12.0%in four groups,the incidence of III+IV vaginal cleanliness was 1.30%,8.67%,15.00%,11.3%,respectively,during the course of treatment,clotrimazole vaginal swelling suppository,miconazole and NYSTATIN had no obvious adverse reactions,but 11.3%of the patients with clotrimazole vaginal tablet had vaginal burning and redness.It is concluded that clotrimazole vaginal expansion suppository has similar negative conversion rate compared with vaginal tablets,but better cleanliness and safety.Compared with NYSTATIN and Miconazole,pruritus control is better,negative conversion rate is higher,cleanliness and safety are better.

关 键 词：克霉唑 妊娠期 膨胀栓 霉菌性阴道炎 

分 类 号：R71[医药卫生—妇产科学]