1200毫克硝酸咪康唑治疗外阴阴道念珠菌病的临床疗效与安全性

[Clinical effect and safety of miconazole nitrate 1200 mg in treating vulvovaginal candidiasis].

作者信息

DI Wen, Duan Tao, Shen Li-Hua, Zhou Wen-Xiang, Niu Jin-Ling, Luo Xin, Liu Xiao-Chun, Zhang Zhi-Fen, Rong Feng-Hua, Li Wen-Ling

机构信息

Department of Obstetrics and Gynecology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200001, China.

出版信息

Zhonghua Fu Chan Ke Za Zhi. 2008 Oct;43(10):757-9.

PMID:19087543

Abstract

OBJECTIVE

To investigate the clinical effect and safety of miconazole nitrate 1200 mg in treating vulvovaginal candidiasis (VVC).

METHODS

An open, multicentre, non case control clinical trial was conducted in 568 patients suffering from VVC from Jul 1, 2006 to Nov 30, 2006. Routine examination, score of clinical symptoms and physical signs, mycetology test and safety evaluation were done in all patients before treatment, 7 - 14 days after treatment and 30 days after treatment.

RESULTS

Seven to fourteen days after treatment, 563 patients could be followed and 323 patients (57.3%) were cured. The overall effective rate was 90.2%. The mycologic cure rate was 91.3% (514). Thirty days after treatment, 480 patients could be followed and 411 patients (85.6%) were cured. The total effective rate was 96.0%. Mycologic cure rate was 92.3% (443/480). Adverse effect rate was 2.7% (15/563) and they were relieved without any treatment in one or two days.

CONCLUSIONS

Miconazole nitrate 1200 mg is effective in the treatment of VVC, with good compliance and few adverse effects. Moreover, it can be accepted easily.

摘要

目的

探讨1200mg硝酸咪康唑治疗外阴阴道假丝酵母菌病（VVC）的临床疗效及安全性。

方法

于2006年7月1日至2006年11月30日对568例VVC患者进行了一项开放、多中心、非病例对照的临床试验。所有患者在治疗前、治疗后7 - 14天及治疗后30天进行常规检查、临床症状和体征评分、真菌学检查及安全性评估。

结果

治疗后7 - 14天，可随访563例患者，323例（57.3%）治愈。总有效率为90.2%。真菌学治愈率为91.3%（514例）。治疗后30天，可随访480例患者，411例（85.6%）治愈。总有效率为96.0%。真菌学治愈率为92.3%（443/480）。不良反应发生率为2.7%（15/563），1 - 2天内未经任何治疗即缓解。