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《Arch Dermatol Res》关于过氧化苯甲酰(BPO)治疗痤疮的疗效研究

更新日期:2018年01月19日

1. 过氧化苯甲酰治疗寻常痤疮的临床疗效和安全性:日本和西方患者的比较


  摘要:过氧化苯甲酰(BPO)作为一种常用药物,已经被广泛用于寻常痤疮的治疗,许多国家(例如欧洲和美国)已经积累了很多临床数据。日本在2014年批准使用BPO治疗痤疮,其患者的临床试验结果最近已经被报道出来。这篇综述比较了日本和西方患者的临床研究结果。根据BPO单一疗法的双盲研究和与媒介物组比较研究的标准,检索得到西方国家的临床研究结果。日本研究的两个报告也是用相同的标准筛选出来的。通过比较BPO组和载体组之间的平均差异来评估疗效,从基线的病灶数目减少率来看,日本病人与西方病人之间没有差异。安全性评估也显示,日本患者的不良事件发生率高于西方患者,但不良事件的特征并无不同。因此,我们得出结论,这些患者使用BPO的有效性和安全性方面没有显着差异。预计日本患者长期使用BPO的有效性和安全性也适用于西方患者。

  关键词:寻常痤疮;过氧化苯甲酰;临床疗效;种族;安全

(英文原文)Clinical efficacy and safety of benzoyl peroxide for acne vulgaris: Comparison between Japanese and Western patients


  Abstract Benzoyl peroxide (BPO) has been well established as a common medication for acne vulgaris in many countries (e.g. in Europe and the USA), where clinical data have been accumulated over a long time. In Japan, the use of BPO for acne treatment was approved in 2014, and the results of clinical trials in Japanese patients have recently been reported. This review compares clinical study results between Japanese and Western patients. Clinical studies that had been performed in Western countries were searched on the basis of the criteria, double-blind studies of BPO monotherapy and comparison with a vehicle group. Two reports of Japanese studies were also selected by using the same criteria. Efficacy was assessed by comparing the mean difference between the BPO and the vehicle groups for reduction rate in the number of lesions from baseline, and there were no differences between Japanese and Western patients. Safety assessment also showed that the incidence of adverse events was higher in Japanese patients than in Western patients, but the characteristics of the adverse events were not different.Therefore, we conclude that there are no significant differences in the efficacy and safety of BPO between these patient populations. The efficacy and safety of long-term use in Japanese patients are also expected to be applicable to those in Western patients.

  Key words acne vulgaris; benzoyl peroxide; clinical efficacy; ethnicity; safety




 2.临床评估试验设计:根据随机对照试验的系统评价,确定过氧化苯甲酰局部治疗痤疮的效果


  摘要:过氧化苯甲酰治疗痤疮的功效可能受到研究设计,实施和载体效应的影响。我们计划在随机对照试验中研究活性治疗和载体治疗的反应率,通过这种研究来确定准确的治疗效果,以评估局部使用过氧化苯甲酰治疗痤疮的疗效。我们对随机对照试验进行了系统评价,评估了过氧化苯甲酰治疗痤疮的功效。并比较了对照治疗组的反应率与过氧化苯甲酰组的反应率。有12项试验符合纳入标准,其中2818名患者接受了过氧化苯甲酰单药治疗,2004名接受载体治疗。痤疮病灶总数的平均减少率分别为44.3(SD = 9.2)和27.8(SD = 21.0)。活性治疗组中非炎性病灶平均减少41.5%(SD = 9.4),载体组平均减少27.0%(SD = 20.9)。过氧化苯甲酰组炎症损害平均减少率为52.1(SD = 10.4),载体组为34.7(SD = 22.7)。研究中,参加者的平均试验成功率分别为28.6(SD = 17.3)和15.2(SD = 9.5)。随机对照试验中,在评估局部痤疮治疗的患者反应时,可能会受到临床试验设计、实施、载体效应和自然疾病进展的影响。因此,加入“没有治疗”组可能更有助于确定准确的治疗效果。

  关键词:随机对照试验;研究设计;安慰剂效应;安慰剂反应;痤疮;局部给药;载体传送;过氧化苯甲酰



(英文原文)Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne


  Abstract Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehiclecontrolled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 %(SD = 9.4) in the active treatment group and 27.0 %(SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2(SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. ‘‘No treatment’’ groups may facilitate determination of accurate treatment efficacies.

  Keywords Randomized controlled trial; Study design; Placebo effect; Placebo response; Acne; Topical administration; Vehicle delivery; Benzoyl peroxide



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