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阿奇霉素治疗玫瑰糠疹的疗效:一项随机、双盲、安慰剂对照试验。

The efficacy of azithromycin in pityriasis rosea: a randomized, double-blind, placebo-controlled trial.

作者信息

Pandhi Deepika, Singal Archana, Verma Prashant, Sharma Reena

机构信息

Department of Dermatology and STD, University College of Medical Sciences and Guru Teg Bahadur Hospital, University of Delhi, New Delhi, India.

出版信息

Indian J Dermatol Venereol Leprol. 2014 Jan-Feb;80(1):36-40. doi: 10.4103/0378-6323.125484.

Abstract

BACKGROUND

Macrolides are prescribed in the treatment of pityriasis rosea despite conflicting results of the limited number of studies evaluating their role in its treatment.

AIM

A randomized double-blind placebo-controlled trial was conducted to evaluate the effect of azithromycin on the clinical course of pityriasis rosea.

METHODS

Seventy patients of pityriasis rosea were given either azithromycin (n=35) or placebo (n=35) and were followed-up at 2, 4 and 6 weeks. Pruritus was assessed in both groups using the visual analogue scale (VAS) . Change in the pityriasis rosea severity score (PRSS) and in the VAS were recorded as outcome measures and were compared statistically.

RESULTS

The decrease in PRSS from baseline through 2, 4 and 6 weeks within both treatment (P<0.001) and placebo (P<0.001) arms was found to be statistically significant; however, this change was not significantly different in the two groups (P=0.179). Similarly, the decrease in VAS was found to be statistically significant within both groups (P<0.001); however, the change was comparable between the two groups (P<0.937). Analysis by Fisher's exact test did not find a significant difference between the two groups for PRSS and VAS.

CONCLUSION

Azithromycin is not effective in pityriasis rosea and the use of macrolides for this disease should not be encouraged in clinical practice.

摘要

背景

尽管评估大环内酯类药物在玫瑰糠疹治疗中作用的研究数量有限且结果相互矛盾,但仍将其用于玫瑰糠疹的治疗。

目的

进行一项随机双盲安慰剂对照试验,以评估阿奇霉素对玫瑰糠疹临床病程的影响。

方法

70例玫瑰糠疹患者分别给予阿奇霉素(n = 35)或安慰剂(n = 35),并在2周、4周和6周进行随访。两组均使用视觉模拟量表(VAS)评估瘙痒情况。记录玫瑰糠疹严重程度评分(PRSS)和VAS的变化作为结局指标,并进行统计学比较。

结果

发现治疗组(P < 0.001)和安慰剂组(P < 0.001)从基线到2周、4周和6周PRSS的降低均具有统计学意义;然而,两组间的这种变化无显著差异(P = 0.179)。同样,两组内VAS的降低均具有统计学意义(P < 0.001);然而,两组间的变化相当(P < 0.937)。通过Fisher精确检验分析,两组在PRSS和VAS方面未发现显著差异。

结论

阿奇霉素对玫瑰糠疹无效,临床实践中不应鼓励将大环内酯类药物用于该疾病的治疗。

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