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一项评估外用四环素和口服四环素治疗轻至中度痤疮疗效的安慰剂对照研究。皮肤病研究小组。

A placebo-controlled study to evaluate the efficacy of topical tetracycline and oral tetracycline in the treatment of mild to moderate acne. Dermatology Research Group.

作者信息

Burton J

机构信息

Department of Dermatology, Bristol Royal Infirmary, UK.

出版信息

J Int Med Res. 1990 Mar-Apr;18(2):94-103. doi: 10.1177/030006059001800204.

Abstract

This double-blind, parallel group multicentre study in 85 hospital out-patients with mild to moderate acne evaluated the efficacy of 2.2 mg/ml topical tetracycline or placebo applied twice daily for 16 weeks together with an initial course of oral tetracycline, at doses of 1000 mg/day during weeks 1-4 and 500 mg/day during weeks 5-8. Acne severity improved significantly (P less than 0.01) with both treatments after 8 and 16 weeks. After 4 weeks, 78% of patients using topical tetracycline showed reduced acne severity compared with 50% using placebo and, by week 16, improvements were 94% and 57%, respectively (P = 0.035). Global evaluations of patients and of investigators showed most improvement to occur within the first 8 weeks of treatment. Tingling and stinging were the most frequently reported adverse effects, occurring in similar frequencies in both treatment groups. Skin discoloration was more frequent in patients given topical tetracycline. Overall, 90% of patients rated topical tetracycline as 'cosmetically acceptable'. In conclusion, topical tetracycline is useful in treatment of mild to moderate acne when given with an initial course of oral tetracycline and may enhance efficacy without unacceptable side-effects.

摘要

这项双盲、平行组多中心研究纳入了85名轻至中度痤疮门诊患者,评估了2.2毫克/毫升外用四环素或安慰剂每日两次、共应用16周,并联合初始疗程口服四环素(第1 - 4周剂量为1000毫克/天,第5 - 8周剂量为500毫克/天)的疗效。8周和16周后,两种治疗方法均使痤疮严重程度显著改善(P < 0.01)。4周后,使用外用四环素的患者中78%的痤疮严重程度减轻,而使用安慰剂的患者为50%;到第16周时,改善率分别为94%和57%(P = 0.035)。患者和研究者的整体评估显示,治疗的前8周内改善最为明显。刺痛是最常报告的不良反应,两个治疗组的发生率相似。外用四环素的患者皮肤变色更为常见。总体而言,90%的患者认为外用四环素“在美容方面可接受”。总之,外用四环素与初始疗程口服四环素联合使用时,对轻至中度痤疮的治疗有效,且可能提高疗效而无不可接受的副作用。

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