含马齿苋及牛油果树提取物的医学护肤品辅助治疗特应性皮炎的临床观察

The adjuvant treatment of atopic dermatitis with medical skin preparation containing extracts from Portulaca oleracea and avocado

目的:评价含马齿苋及牛油果树提取物的医学护肤品(简称保湿霜)辅助治疗特应性皮炎的临床疗效和安全性。方法:采用多中心临床研究,所有90例受试者在使用保湿霜前后对靶皮损作两侧对照观察的方法进行效果评价,靶皮损侧外用保湿霜,为期2周,并在用药的第0、3、7、14 d进行随访。采用皮肤干燥程度评分、研究者总体评估(IGA)评分、IGA等级评分及总体效果前后比较,以观察患者皮损改善情况。结果:除1例外其余受试者皆能完成随访;治疗第3、7、14 d IGA评分、IGA等级评分、受试者皮肤干燥程度评分均较治疗前明显下降,且随使用时间延长效果更好,差异有统计学意义(P<0.01)。研究结束时明显改善率67.42%(60/89);改善率93.26%(83/89);治疗成功率74.16%(66/89)。研究过程中不良反应的发生率低(<10%)。结论:该保湿霜具有辅助治疗特应性皮炎的临床疗效,且安全性好。

Objective： To investigate the clinical efficacy and safety of Winona gentle moisturizing cream in the adjuvant treatment of atopic dermatitis. Methods： Ninety patients from 6 centers were involved in the random and open clinical study. All the selected patients used medical preparation （Winona gentle moisturizing cream） unilaterally for 2 weeks and carried out follow-ups on day 0, 3, 7 and 14. Results were compared before and after use, as well as the test side and the control side. Skin lesions were assessed by investigator to obtain skin dryness score, investigator＇s global assessment （IGA） score and overall evaluation. Results： All but one loss of follow up completed this study. IGA score and skin dryness score on day 3, 7 and 14 decreased in comparison with that before use （P〈0.01）. The efficacy increased with time. And the test side was better than the control side （P〈0.01） at each time point. The marked response rate, response rate and cure rate were 67.42%（60/89）, 93.26%（83/89） and 74.16%（66/89）respectively. The incidence of adverse reactions was low （〈10%）. Conclusion： Winona gentle moisturizing cream has a clinical effect in the adjuvant treatment of atopic dermatitis with high safety.