van Zuuren E J, Graber M A, Hollis S, Chaudhry M, Gupta A K
Medicines Evaluation Board, Kalvermarkt 53, 2500 BE The Hague, the Netherlands.
Cochrane Database Syst Rev. 2004(1):CD003262. doi: 10.1002/14651858.CD003262.pub2.
Rosacea is a common skin condition affecting the face, characterised by flushing, redness, pimples, pustules and dilated blood vessels. The eyes are often also involved. The cause of rosacea is unclear. It is a chronic disease, which can be controlled in most cases with appropriate treatment. Numerous treatments are in use although it is unclear which are best, and which are most appropriate for the different types of rosacea.
To assess and summarise current evidence for the efficacy and safety of treatments for rosacea.
We searched the Skin Group Specialised Trials Register (March 2002), Cochrane Central Register of Controlled Trials (CENTRAL, March 2002), MEDLINE (from 1966 to March 2002), EMBASE (from 1980 to March 2002), Biosis (from 1970 to March 2002) and the Science Citation Index (from 1988 to March 2002). Reference lists of trials and key review articles were also searched. Relevant manufacturers and experts were contacted.
Randomised controlled trials in people with moderate to severe rosacea were included. Studies judged by the reviewers to have seriously flawed methodology were excluded.
Study selection, assessment of methodological quality, data extraction and analysis were carried out by two independent reviewers.
The evidence provided by twenty-two included studies was generally weak because of poor methodology and reporting. One of our primary outcome measures, 'quality of life', was not assessed in any of the studies. Only two studies of ocular rosacea could be included. Pooled data from two trials involving 174 participants indicated that topical metronidazole is more effective than placebo (odds ratio 5.96, 95% confidence interval 2.95 to 12.06). Data from a between-patient trial (114 patients) and a within-patient trial (33 patients) of azelaic cream versus placebo were not pooled, but both showed good evidence of efficacy. Data pooled from three studies of oral tetracycline versus placebo involving 152 participants showed that, according to physicians' ratings, tetracycline was effective (odds ratio 6.06, 95% confidence interval 2.96 to 12.42). Some evidence of efficacy of oral metronidazole was provided by one small study.
REVIEWER'S CONCLUSIONS: The quality of studies evaluating rosacea treatments was generally poor. There is evidence that topical metronidazole and azelaic acid cream have a therapeutic effect. There is some evidence that oral metronidazole and tetracycline are effective. There is insufficient evidence concerning the effectiveness of other treatments. As many of these treatments are used for rosacea, good RCTs are urgently needed.
酒渣鼻是一种常见的影响面部的皮肤疾病,其特征为潮红、发红、丘疹、脓疱和血管扩张。眼睛也常受累。酒渣鼻的病因尚不清楚。它是一种慢性疾病,在大多数情况下通过适当治疗可以得到控制。虽然不清楚哪些治疗方法是最佳的,以及哪些最适合不同类型的酒渣鼻,但目前有多种治疗方法在使用。
评估并总结目前关于酒渣鼻治疗方法的疗效和安全性的证据。
我们检索了皮肤组专业试验注册库(2002年3月)、Cochrane对照试验中心注册库(CENTRAL,2002年3月)、MEDLINE(1966年至2002年3月)、EMBASE(1980年至2002年3月)、Biosis(1970年至2002年3月)以及科学引文索引(1988年至2002年3月)。还检索了试验的参考文献列表和关键综述文章。并联系了相关制造商和专家。
纳入中度至重度酒渣鼻患者的随机对照试验。被评审者判定方法学存在严重缺陷的研究被排除。
由两名独立评审者进行研究选择、方法学质量评估、数据提取和分析。
由于方法学和报告不佳,22项纳入研究提供的证据总体较弱。我们的主要结局指标之一“生活质量”在任何研究中均未评估。仅能纳入两项眼部酒渣鼻研究。两项涉及174名参与者的试验的汇总数据表明,局部用甲硝唑比安慰剂更有效(优势比5.96,95%置信区间2.95至12.06)。壬二酸乳膏与安慰剂的一项患者间试验(114例患者)和一项患者内试验(33例患者)的数据未进行汇总,但两者均显示出良好的疗效证据。三项口服四环素与安慰剂的研究(涉及152名参与者)的汇总数据表明,根据医生的评分,四环素是有效的(优势比6.06,95%置信区间2.96至12.42)。一项小型研究提供了口服甲硝唑有效性的一些证据。
评估酒渣鼻治疗方法的研究质量总体较差。有证据表明局部用甲硝唑和壬二酸乳膏有治疗效果。有一些证据表明口服甲硝唑和四环素有效。关于其他治疗方法的有效性证据不足。由于这些治疗方法中有许多用于酒渣鼻,因此迫切需要高质量的随机对照试验。