基于自身前后对照试验的透明质酸钠医用敷料对敏感性皮肤的疗效与安全性研究

Efficacy and safety of sodium hyaluronate medical dressing for sensitive skin based on a self-controlled before-and-after trial

  • 摘要:
    目的 评估透明质酸钠医用敷料对敏感性皮肤的临床疗效与安全性。
    方法 采用自身前后对照试验设计,选取30例敏感性皮肤受试者作为研究对象,均接受透明质酸钠医用敷料干预。比较干预前后皮肤屏障功能、受试者自我评估结果、研究者评估结果,并观察不良反应发生情况。
    结果 30例受试者均严格按照方案完成4周干预及随访; 使用敷料第2周和第4周时,皮肤含水量、经皮水分丢失量(TEWL)与使用敷料前比较,差异无统计学意义(P>0.05)。受试者面部不适症状自我评估结果显示,与使用前相比,使用敷料第2周和第4周时紧绷感、干燥、脱屑、灼热感、刺痛感、瘙痒、发红、红斑、毛细血管扩张症状评分均降低,差异有统计学意义(P < 0.05)。研究者评估结果显示,受试者使用敷料第2周和第4周时面部红斑严重程度评分低于使用前,差异有统计学意义(P < 0.05)。研究过程中,受试者均未出现相关不良反应。
    结论 透明质酸钠医用敷料可有效缓解敏感性皮肤患者的主观症状,且具有良好的安全性和耐受性,尤其适用于轻中度敏感性皮肤人群。

     

    Abstract:
    Objective To evaluate the clinical efficacy and safety of sodium hyaluronate medical dressing for sensitive skin.
    Methods A self-controlled before-and-after trial design was adopted. Thirty subjects with sensitive skin were selected as the study cohort, and received intervention with sodium hyaluronate medical dressing. Skin barrier function, self-assessment results of the subjects, and researcher assessment results were compared before and after intervention. Additionally, the occurrence of adverse reactions was observed.
    Results All 30 subjects completed the 4-week intervention and follow-up strictly according to the protocol. When comparing the skin water content and transepidermal water loss (TEWL) at the 2nd and 4th weeks of dressing use with those before dressing use, there was no statistically significant difference (P>0.05). The self-assessment results of facial discomfort symptoms in the subjects showed that, compared with before use, the scores for tightness, dryness, desquamation, burning sensation, prickling sensation, itching, redness, erythema, and telangiectasia at the 2nd and 4th weeks of dressing use were all reduced, with statistically significant differences (P < 0.05). The researcher assessment results indicated that the scores for facial erythema severity in the subjects at the 2nd and 4th weeks of dressing use were lower than those before use, with statistically significant differences (P < 0.05). During the study, no relevant adverse reactions occurred.
    Conclusion Sodium hyaluronate medical dressing can effectively alleviate the subjective symptoms of patients with sensitive skin and has good safety and tolerability, especially suitable for individuals with mild-to-moderate sensitive skin.

     

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