含有神经酰胺的医学护肤品辅助治疗慢性湿疹的临床效果观察

Observation of the Clinical Effect of Medical Skin Care Products Containing Ceramides in the treatment of Chronic Eczema

目的:评价含有神经酰胺的医学护肤品(简称保湿霜)辅助治疗慢性湿疹的临床疗效和安全性。方法:由3个中心根据标准纳入87例符合研究的慢性湿疹患者,所有患者均于皮损处使用保湿霜2周,并自身前后对照试验。于使用前及使用后第7、14天,通过皮肤油脂含量、皮肤pH值、角质层含水量、经表皮水分丢失量(TEWL)来评估皮肤屏障功能,并由各中心同一医生及患者对临床症状(红斑、干燥、瘙痒)进行评分,于第14天评估疗效及患者满意度。结果:除1例外其余患者皆完成随访,治疗前及治疗后第7天、14天,患者皮肤角质层含水量较治疗前升高、TEWL值较治疗前降低,差异有统计学意义(P<0.01),随着治疗时间的延长,皮肤油脂含量也逐渐增加,pH值基本稳定(P>0.05)。治疗前及治疗后第7天、14天,医生临床症状评分随着时间推移呈下降趋势(P<0.01),患者临床症状评分(干燥、瘙痒)也随时间推移呈下降趋势(P<0.01);临床有效率73.3%;满意65例(75.5%),较满意19例(22.1%);整个研究过程所有患者未发生与该试验产品相关的不良反应。结论:该保湿霜可以缓解皮肤干燥,帮助皮肤屏障功能恢复,具有辅助治疗慢性湿疹的临床疗效,且安全性好。

Objective To investigate the clinical efficacy and safety of a ceramide-containing skin care products in patients with chronic eczema.Methods 87 patients with chronic eczema who met the criteria were included by 3 centers,all of whom were treated with moisturizers at the lesions for 2 weeks and conducted their own before-and-after controlled trials.Before use and on the 7th and 14th days after use,the skin barrier function was assessed by skin oil content,skin pH,stratum corneum moisture content,transepidermal water loss(TEWL),and the clinical symptoms(erythema,dryness,itching)were scored by the same doctor and patient in each center,and efficacy and patient satisfaction were assessed on day 14.Results With the exception of 1 exception,the rest of the patients completed follow-up,before treatment and on the 7th and 14th days after treatment,the water content of the cuticle of the skin was higher than before treatment,the TEWL value was lower than before treatment,the difference was statistically significant(P<0.01),and the skin oil content gradually increased with the prolongation of treatment time,the pH was basically stable(P>0.05).On the 7th and 14th days before treatment and after treatment,the doctor’s clinical symptom score showed a downward trend over time(P<0.01),and the patient’s clinical symptom score(dryness,itching)also showed a downward trend over time(P<0.01),the clinical effective rate was 73.3%,65 cases(75.5%)were satisfied,compared with 19 cases(22.1%),and all patients in the whole study process did not have adverse reactions related to the experimental product.Conclusion Winona gentle moisturizing cream can effectively restore skin barrier function and relieve the skin dryness,with a clinical effect in the adjuvant treatment of chronic eczema with a high safty.