达泊西汀凝胶治疗痤疮的疗效和安全性：系统评价和荟萃分析。

Efficacy and safety of dapsone gel for acne: a systematic review and meta-analysis.

机构信息

First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, China.

Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Veneorology, Jinan, China; Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, China.

出版信息

Ann Palliat Med. 2022 Feb;11(2):611-620. doi: 10.21037/apm-21-3935.

DOI:10.21037/apm-21-3935

PMID:35249339

Abstract

BACKGROUND

First-line medications for acne vulgaris include retinoids and antibiotics. Dapsone is a topical drug approved by the U.S. Food and Drug Administration for the treatment of acne. However, due to its side effects, the clinical application of dapsone has not been promoted, and the value of the medication is still unclear. The aim of this study is to determine the efficacy and safety of dapsone gel in patients with acne.

METHODS

Systematic searches were performed using the following databases on January 4, 2020: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Service System (SinoMed), China Science and Technology Journal Database (CQVIP), and Wanfang Data Knowledge Service Platform. A meta-analysis of randomized controlled trials was then conducted to analyze the efficacy and adverse events of dapsone gel treatment compared with excipient and other drug therapies. RevMan 5.3 software was used to calculate the odds ratio (OR), and the confidence interval (CI) was 95%.

RESULTS

Data of 11,424 participants across 7 trials which met the inclusion criteria were analyzed. Meta-analysis showed that dapsone gel alone or dapsone gel combined with isotretinoin was superior to excipient alone or oral isotretinoin alone in the treatment of acne (OR =1.51, 95% CI: 1.38-1.66, P<0.0001 random effects model, I2=0%). This indicates that dapsone gel is effective for the treatment of acne. We also found that dapsone gel is a more effective treatment for females (OR =1.80, 95% CI: 1.46-2.23). There was no significant difference in the incidence of adverse events between the dapsone group and the control group (OR =0.94, 95% CI: 0.82-1.14, P=0.24 random effects model; I2=29%). The common local adverse reactions in the dapsone group, such as dryness, heat, and eczema, were not statistically significant compared with those in the control group, and the side effects were transient.

DISCUSSION

Dapsone gel is effective in treating acne, and there is no significant difference in adverse events compared with other drugs.

摘要

背景

寻常痤疮的一线治疗药物包括维 A 酸类药物和抗生素。氨苯砜是一种美国食品和药物管理局批准的用于治疗痤疮的局部用药。然而，由于其副作用，氨苯砜的临床应用并未得到推广，其药物价值仍不明确。本研究旨在确定氨苯砜凝胶治疗痤疮的疗效和安全性。

方法

于 2020 年 1 月 4 日检索以下数据库：PubMed、EMBASE、Cochrane 中央对照试验注册库、中国知网（CNKI）、中国生物医学文献服务系统（SinoMed）、中国科技期刊数据库（CQVIP）和万方数据知识服务平台。然后对随机对照试验进行荟萃分析，以分析与赋形剂和其他药物治疗相比，氨苯砜凝胶治疗的疗效和不良事件。使用 RevMan 5.3 软件计算比值比（OR），置信区间（CI）为 95%。

结果

纳入的 7 项试验共 11424 名参与者的数据进行了分析。荟萃分析表明，与赋形剂或口服异维 A 酸相比，氨苯砜凝胶单独或与异维 A 酸联合使用在治疗痤疮方面更有效（OR=1.51，95%CI：1.38-1.66，P<0.0001 随机效应模型，I2=0%）。这表明氨苯砜凝胶对痤疮的治疗有效。我们还发现，氨苯砜凝胶对女性的治疗效果更显著（OR=1.80，95%CI：1.46-2.23）。氨苯砜组与对照组不良事件发生率无显著差异（OR=0.94，95%CI：0.82-1.14，P=0.24 随机效应模型；I2=29%）。与对照组相比，氨苯砜组常见的局部不良反应，如干燥、发热和湿疹，无统计学意义，且副作用是短暂的。