局部联合治疗痤疮的益处：使用需要治疗的人数分析效应大小。

Benefit of Topical Combination Therapy for Acne: Analyzing Effect Size Using Number Needed to Treat.

出版信息

J Drugs Dermatol. 2024 Feb 1;23(2):42-49. doi: 10.36849/JDD.7927.

Abstract

BACKGROUND

Topical acne trials often are confounded by high vehicle response rates and differing outcome measures, making it difficult to compare treatments. Number needed to treat (NNT) can be a simple, clinically meaningful way to indirectly compare treatment options without head-to-head data. NNT is the number of patients who need to be treated with an intervention to observe one additional patient successfully achieving a desired outcome versus vehicle/placebo. While treatment attributes such as adverse events may not be captured, lower NNT is a good indicator of a more effective treatment.

METHODS

Following a search of combination topical treatments for acne vulgaris, all treatments that reported pivotal trial efficacy data consistent with the 2018 FDA definition of success were included in NNT analyses. Results: Of 13 treatments, 7 reported 12-week treatment success rates in 11 phase 3 trials, with similar baseline demographics/disease severity. Treatment success ranged from 26.8% with tretinoin 0.1%/benzoyl peroxide (BPO) 3% cream to 50% with triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel. NNTs for the triple-combination gel were 4 and 5 (from 2 pivotal trials). Adapalene 0.3%/BPO 2.5% gel had an NNT of 5. Tretinoin/BPO had the largest range between trials, with NNTs of 4 and 9. The other 4 treatments had NNTs ranging from 6 to 8.

CONCLUSION

A comparison of combination topical acne treatment trial data, using the same treatment outcome and similar patient populations, resulted in triple-combination clindamycin phosphate/adapalene/BPO gel and adapalene/BPO gel having the most favorable NNTs.J Drugs Dermatol. 2024;23(2):42-49. doi:10.36849/JDD.7927.

摘要

背景

局部痤疮试验常常因高载体反应率和不同的结果测量而变得复杂，从而难以比较治疗方法。需要治疗的人数（NNT）可以是一种简单而具有临床意义的方法，可以在没有头对头数据的情况下间接比较治疗选择。NNT 是指需要用干预措施治疗的患者人数，以观察与载体/安慰剂相比，有多少额外的患者成功达到预期的结果。虽然可能无法捕获治疗属性（如不良反应），但较低的 NNT 是治疗效果更好的良好指标。

方法

在对治疗寻常痤疮的联合局部治疗进行搜索后，所有报告与 2018 年 FDA 成功定义一致的关键试验疗效数据的治疗方法均被纳入 NNT 分析。结果：在 13 种治疗方法中，有 7 种在 11 项 3 期试验中报告了 12 周的治疗成功率，这些试验具有相似的基线人口统计学/疾病严重程度。治疗成功率从使用维甲酸 0.1%/过氧化苯甲酰（BPO）3%乳膏的 26.8%到使用克林霉素磷酸酯 1.2%/阿达帕林 0.15%/BPO 3.1%凝胶的 50%不等。三组合凝胶的 NNT 分别为 4 和 5（来自 2 项关键试验）。阿达帕林 0.3%/BPO 2.5%凝胶的 NNT 为 5。维甲酸/BPO 的试验间差异最大，NNT 为 4 和 9。其他 4 种治疗方法的 NNT 范围为 6 至 8。