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0.75%甲硝唑凝胶治疗脂溢性皮炎是否有效?一项双盲、安慰剂对照研究。

Is metronidazole 0.75% gel effective in the treatment of seborrhoeic dermatitis? A double-blind, placebo controlled study.

作者信息

Ozcan Hamdi, Seyhan Muammer, Yologlu Saim

机构信息

Inonu University, Medical Faculty, Department of Dermatology 44280 Malatya, Turkey.

出版信息

Eur J Dermatol. 2007 Jul-Aug;17(4):313-6. doi: 10.1684/ejd.2007.0206. Epub 2007 Jun 1.

DOI:10.1684/ejd.2007.0206
PMID:17540638
Abstract

The study aimed to evaluate the effectiveness of metronidazole 0.75% gel in patients with mild and moderate seborrhoeic dermatitis. Sixty-seven patients with seborrhoeic dermatitis were enrolled. Cases were randomly treated with metronidazole 0.75% gel or placebo for four weeks and were additionally followed up for another four weeks. Patients were evaluated by scoring before the treatment, once a week during the treatment and twice after the cessation of the treatment within a 15-day interval. Furthermore, patient satisfaction and doctor global evaluation were done at the end of the treatment and of the study as well. In the metronidazole group 33 patients (median age: 26, total severity score: 15.0 +/- 11.0 (median +/- interquartile range) and in the placebo group 34 patients (median age: 26, total severity score: 13.0 +/- 7.5) were enrolled in the study. Three patients from the metronidazole group and four patients from the placebo group did not attend to follow-up visits. Erythema, scales, papule, pruritus and the total severity scores in both group decreased significantly during the treatment when compared with the basal levels (p < 0.05). There was no difference between the two groups in terms of efficacy (p > 0.05). Total severity scores were found as 7.33 +/- 1.08 and 6.43 +/- 0.93 in the metronidazole and placebo groups at the end of the treatment, respectively. After the cessation of the treatment, all scores had increased rapidly. Total severity scores were 10.40 +/- 1.54 and 11.20 +/- 1.53 in the metronidazole and placebo groups one month after the cessation of the treatment, respectively. Both metronidazole 0.75% gel and the placebo were well tolerated by the patients. In conclusion, in the treatment of seborrhoeic dermatitis, administration of metronidazole 0.75% gel is well tolerated but it is only as effective as placebo and the disease severity quickly returns to the basal levels after the cessation of treatment.

摘要

该研究旨在评估0.75%甲硝唑凝胶对轻、中度脂溢性皮炎患者的疗效。招募了67例脂溢性皮炎患者。病例被随机分为两组,分别使用0.75%甲硝唑凝胶或安慰剂治疗四周,并额外随访四周。在治疗前、治疗期间每周一次以及治疗停止后15天内分两次进行评分评估患者。此外,在治疗结束时和研究结束时还进行了患者满意度和医生整体评估。甲硝唑组纳入33例患者(中位年龄:26岁,总严重程度评分:15.0 +/- 11.0(中位数 +/- 四分位间距)),安慰剂组纳入34例患者(中位年龄:26岁,总严重程度评分:13.0 +/- 7.5)。甲硝唑组有3例患者和安慰剂组有4例患者未参加随访。与基线水平相比,两组在治疗期间红斑、鳞屑、丘疹、瘙痒及总严重程度评分均显著降低(p < 0.05)。两组在疗效方面无差异(p > 0.05)。治疗结束时,甲硝唑组和安慰剂组的总严重程度评分分别为7.33 +/- 1.08和6.43 +/- 0.93。治疗停止后,所有评分迅速升高。治疗停止后一个月,甲硝唑组和安慰剂组的总严重程度评分分别为10.40 +/- 1.54和11.20 +/- 1.53。患者对0.75%甲硝唑凝胶和安慰剂的耐受性均良好。总之,在脂溢性皮炎的治疗中,0.75%甲硝唑凝胶耐受性良好,但疗效仅与安慰剂相当,且治疗停止后疾病严重程度迅速恢复至基线水平。

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