一项关于过氧化苯甲酰/克林霉素复方外用凝胶治疗轻至中度痤疮后患者满意度的非随机、多中心、开放标签研究的初步结果。

Preliminary results of a nonrandomized, multicenter, open-label study of patient satisfaction after treatment with combination benzoyl peroxide/clindamycin topical gel for mild to moderate acne.

作者信息

Weiss Jonathan W, Shavin Joel, Davis Matthew

机构信息

Gwinnett Clinical Research Center, Sneliville, Georgia, USA.

出版信息

Clin Ther. 2002 Oct;24(10):1706-17. doi: 10.1016/s0149-2918(02)80073-x.

DOI:10.1016/s0149-2918(02)80073-x

PMID:12462298

Abstract

BACKGROUND

Assessments of patient satisfaction are needed to determine treatment-related improvement in acne from the patient's perspective.

OBJECTIVES

The aims of this study were to assess patient satisfaction, drug efficacy, and the social aspects of quality of life after treatment with benzoyl peroxide/clindamycin topical gel in patients who were dissatisfied with their previous acne treatment regimens.

METHODS

This nonrandomized, open-label, multicenter study was open to patients aged > or = 12 years who were dissatisfied with their previous acne treatments. Patients applied topical benzoyl peroxide/clindamycin gel twice daily for 8 weeks. Patient satisfaction was assessed on an 11-point analog scale (0 = not satisfied; 10 = very satisfied). The social effects of acne were assessed using a 9-question acne quality of life (AQOL) scale, and treatment efficacy was assessed using the global acne grading system (GAGS). Safety and tolerability were monitored continuously through self-reporting and patient questioning.

RESULTS

Preliminary results were gathered for 257 patients. Relative to baseline, patients were significantly more satisfied after 8 weeks of treatment with benzoyl peroxide/ clindamycin gel (P < 0.001). The mean overall cumulative AQOL score improved significantly among 249 patients aged > or = 12 years (P < 0.001), but the clinical relevance of this finding is unknown. The mean GAGS score decreased from 15.9 (SD = 6.0) at baseline to 8.2 (SD = 5.7) at week 8 (P < 0.001). The most common adverse events were dry skin and skin irritation.

CONCLUSIONS

These preliminary results suggest that patients who are dissatisfied with their current acne regimen may be more satisfied after treatment with benzoyl peroxide/clindamycin gel. However, more definitive conclusions can be drawn only following the completion of the study.

摘要

背景

需要从患者角度评估患者满意度，以确定痤疮治疗相关的改善情况。

目的

本研究旨在评估对既往痤疮治疗方案不满意的患者使用过氧化苯甲酰/克林霉素外用凝胶治疗后的患者满意度、药物疗效及生活质量的社会方面。

方法

这项非随机、开放标签、多中心研究对年龄≥12岁且对既往痤疮治疗不满意的患者开放。患者每天外用过氧化苯甲酰/克林霉素凝胶两次，持续8周。使用11点模拟量表评估患者满意度（0=不满意；10=非常满意）。使用9个问题的痤疮生活质量（AQOL）量表评估痤疮的社会影响，使用全球痤疮分级系统（GAGS）评估治疗疗效。通过自我报告和询问患者持续监测安全性和耐受性。

结果

收集了257例患者的初步结果。与基线相比，患者在使用过氧化苯甲酰/克林霉素凝胶治疗8周后满意度显著提高（P<0.001）。在249例年龄≥12岁的患者中，平均总体累积AQOL评分显著改善（P<0.001），但这一发现的临床相关性尚不清楚。平均GAGS评分从基线时的15.9（标准差=6.0）降至第8周时的8.2（标准差=5.7）（P<0.001）。最常见的不良事件是皮肤干燥和皮肤刺激。