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克霉唑阴道片与口服氟康唑治疗重度外阴阴道念珠菌病的疗效与安全性比较

The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis.

作者信息

Zhou Xiaofang, Li Ting, Fan Shangrong, Zhu Yuxia, Liu Xiaoping, Guo Xuedong, Liang Yiheng

机构信息

Department of Obstetrics and Gynaecology, Peking University Shenzhen Hospital, Shenzhen, China.

Postgraduate College, Anhui Medical University, Hefei, Anhui, China.

出版信息

Mycoses. 2016 Jul;59(7):419-28. doi: 10.1111/myc.12485. Epub 2016 Apr 13.

Abstract

To compare the efficacy and safety of two doses of clotrimazole vaginal tablet 500 mg with two doses of oral fluconazole 150 mg in treating severe vulvovaginal candidiasis (SVVC), 240 consecutive patients with SVVC were studied at the Department of Obstetrics and Gynaecology of Peking University Shenzhen Hospital between June 2014, and September 2015. Patients were randomly assigned in a 1 : 1 ratio to receive treatment with either two doses of clotrimazole vaginal tablet or two doses of oral fluconazole. The clinical cure rates in the clotrimazole group and the fluconazole group at days 7-14 follow-up were 88.7% (102/115) and 89.1% (98/110) respectively; the clinical cure rates at days 30-35 in the two groups were 71.9% (82/114) and 78.0% (85/109) respectively. The mycological cure rates at days 7-14 follow-up in the two groups were 78.3% (90/115) and 73.6% (81/110) respectively. The mycological cure rates of the patients at days 30-35 in the two groups were 54.4% (62/114) and 56.0% (61/109) respectively (P > 0.05). The adverse events of clotrimazole were mainly local. This study demonstrated that two doses of clotrimazole vaginal tablet 500 mg were as effective as two doses of oral fluconazole 150 mg in the treatment of patients with SVVC and could be an appropriate treatment for this disorder.

摘要

为比较两剂500毫克克霉唑阴道片与两剂150毫克口服氟康唑治疗重度外阴阴道念珠菌病(SVVC)的疗效和安全性,2014年6月至2015年9月期间,北京大学深圳医院妇产科对240例连续的SVVC患者进行了研究。患者按1:1比例随机分配,接受两剂克霉唑阴道片或两剂口服氟康唑治疗。克霉唑组和氟康唑组在第7 - 14天随访时的临床治愈率分别为88.7%(102/115)和89.1%(98/110);两组在第30 - 35天的临床治愈率分别为71.9%(82/114)和78.0%(85/109)。两组在第7 - 14天随访时的真菌学治愈率分别为78.3%(90/115)和73.6%(81/110)。两组患者在第30 - 35天的真菌学治愈率分别为54.4%(62/114)和56.0%(61/109)(P>0.05)。克霉唑的不良事件主要为局部反应。本研究表明,两剂500毫克克霉唑阴道片在治疗SVVC患者方面与两剂150毫克口服氟康唑同样有效,可作为该疾病的一种合适治疗方法。

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