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一项关于20毫克盐酸多西环素片与0.75%甲硝唑外用洗剂联合治疗酒渣鼻效果的随机、双盲、安慰剂对照试验。

A randomized, double-blind, placebo-controlled trial of the combined effect of doxycycline hyclate 20-mg tablets and metronidazole 0.75% topical lotion in the treatment of rosacea.

作者信息

Sanchez Jorge, Somolinos Aida Lugo, Almodóvar Pablo I, Webster Guy, Bradshaw Mark, Powala Christopher

机构信息

University of Puerto Rico, Rio Piedras, Puerto Rico.

出版信息

J Am Acad Dermatol. 2005 Nov;53(5):791-7. doi: 10.1016/j.jaad.2005.04.069. Epub 2005 Sep 15.

DOI:10.1016/j.jaad.2005.04.069
PMID:16243127
Abstract

BACKGROUND

Subantimicrobial doses of doxycycline may improve outcomes in rosacea when combined with topical metronidazole and used as maintenance monotherapy.

OBJECTIVE

The purpose of this study was to evaluate the safety and efficacy of doxycycline hyclate 20 mg (subantimicrobial dose doxycycline) administered twice daily as an adjunct to metronidazole 0.75% topical lotion in the treatment of rosacea.

METHODS

Patients received subantimicrobial doses of doxycycline twice daily plus metronidazole (n = 20) or placebo plus metronidazole (n = 20) for 12 weeks. Subantimicrobial-dose doxycycline or placebo monotherapy continued for 4 weeks. The primary efficacy measure was change from baseline in total inflammatory lesions at weeks 2 and 16.

RESULTS

Total inflammatory lesions were reduced significantly (P =.048) by week 4 and by all subsequent visits in the subantimicrobial-dose doxycycline/metronidazole group compared with placebo/metronidazole. Changes from baseline increased over time and were maintained during subantimicrobial-dose doxycycline monotherapy.

CONCLUSION

Adjunctive use of subantimicrobial dose doxycycline significantly reduced the clinical signs of rosacea compared with metronidazole alone and may be useful maintenance monotherapy.

摘要

背景

亚抗菌剂量的强力霉素与外用甲硝唑联合使用并用作维持单一疗法时,可能改善酒渣鼻的治疗效果。

目的

本研究旨在评估每日两次服用20毫克盐酸强力霉素(亚抗菌剂量强力霉素)作为0.75%甲硝唑外用洗剂辅助药物治疗酒渣鼻的安全性和有效性。

方法

患者每日两次接受亚抗菌剂量的强力霉素加甲硝唑(n = 20)或安慰剂加甲硝唑(n = 20)治疗,为期12周。亚抗菌剂量的强力霉素或安慰剂单一疗法持续4周。主要疗效指标是第2周和第16周时总炎性皮损相对于基线的变化。

结果

与安慰剂/甲硝唑组相比,亚抗菌剂量强力霉素/甲硝唑组在第4周时总炎性皮损显著减少(P = 0.048),且在随后的所有访视中均如此。相对于基线的变化随时间增加,并在亚抗菌剂量强力霉素单一疗法期间维持。

结论

与单独使用甲硝唑相比,亚抗菌剂量强力霉素的辅助使用显著减轻了酒渣鼻的临床症状,可能是一种有效的维持单一疗法。

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