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1%奥昔沙星乳膏治疗脓疱病:一项多中心、随机、安慰剂和瑞他帕林对照的临床试验。

Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial.

作者信息

Gropper Savion, Albareda Nuria, Chelius Klaus, Kruger Dawie, Mitha Ismail, Vahed Yacoob, Gani Mashra, García-Alonso Fernando

机构信息

Ferrer Internacional SA, Barcelona, Spain.

出版信息

Future Microbiol. 2014;9(9):1013-23. doi: 10.2217/fmb.14.78.

Abstract

AIM

We compared the efficacy and safety of ozenoxacin (a new nonfluorinated quinolone) 1% cream with placebo in the treatment of impetigo.

PATIENTS & METHODS: In a randomized, double-blind, multicenter study, patients received ozenoxacin cream or placebo cream twice daily for 5 days (a third group received retapamulin 1% ointment as a control). Clinical, microbiological and laboratory evaluations were performed during follow-up (over 2 weeks).

RESULTS

Ozenoxacin was superior to placebo (success rate 34.8 vs 19.2%; p = 0.003). Microbiological success was 70.8% for ozenoxacin and 38.2% for placebo after 3-4 days and 79.2% versus 56.6% after 6-7 days. Ozenoxacin produced more rapid microbiological clearance than retapamulin. All treatments were well tolerated.

CONCLUSION

Ozenoxacin 1% cream was effective and safe in the treatment of impetigo.

摘要

目的

我们比较了1%奥扎沙星乳膏(一种新型非氟喹诺酮类药物)与安慰剂治疗脓疱病的疗效和安全性。

患者与方法

在一项随机、双盲、多中心研究中,患者每日两次外用奥扎沙星乳膏或安慰剂乳膏,持续5天(第三组外用1%瑞他帕林软膏作为对照)。在随访期间(超过2周)进行临床、微生物学和实验室评估。

结果

奥扎沙星优于安慰剂(成功率分别为34.8%和19.2%;p = 0.003)。3 - 4天后,奥扎沙星的微生物学清除成功率为70.8%,安慰剂为38.2%;6 - 7天后,分别为79.2%和56.6%。奥扎沙星比瑞他帕林产生更快的微生物学清除效果。所有治疗耐受性良好。

结论

1%奥扎沙星乳膏治疗脓疱病有效且安全。

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