Jurairattanaporn Nathachat, Chalermchai Thep, Ophaswongse Suwirakorn, Udompataikul Montree
J Med Assoc Thai. 2017 Jan;100(1):78-85.
Treatments of acne vulgaris commonly use antimicrobials and comedolytic agents. Considering bacterial resistance to topical antibiotics, the alternative treatment such as silver manufactured into nanoparticle receives an attention. Silver nanoparticle has an antibacterial effect against Propionibacterium acnes and anti-inflammation. Clinical study of silver nanoparticle gel for the treatment of acne vulgaris is limited.
To compare the efficacy and safety between silver nanoparticle gel and 1% clindamycin gel both combine with 2.5% benzoyl peroxide for the treatment of moderate severity of acne vulgaris.
This was an experimental, double-blinded, randomized-controlled study. Sixty-four moderately severe acne patients were enrolled. They were randomized to receive either silver nanoparticle gel with 2.5% benzoyl peroxide or clindamycin gel with 2.5% benzoyl peroxide (32 patients each). The clinical outcomes were evaluated for inflammatory and non-inflammatory acne count, acne redness, the patients’ satisfaction and patients’ Dermatology Life Quality Index (DLQI) at the baseline, 2, 4, 6 and 8-week visit.
After 8 weeks of follow-up period, the average mean percent change from the baseline of non-inflammatory and inflammatory acne counts were gradually declined in both silver nanoparticle and clindamycin group. At the study endpoint (8-week visit), average mean percent change from the baseline of inflammatory acne count was slightly better reduction in silver nanoparticle group (79.7%) than clindamycin group (72.6%) with no significant difference (p = 0.18). The average mean percent change from the baseline of non-inflammatory acne count reduction was also no difference from silver nanoparticle and clindamycin group (61.1% and 66.8% respectively, p = 0.22). For clinical erythema score and Mexameter erythema index to evaluate acne redness were no statistical difference between the 2 groups. Moreover, the patients’ satisfaction to study medication and their quality of life of patients (DLQI score) were reported with better improvement from the baseline in both groups but there was no statistical significant difference. Except for average mean, patients’ satisfaction to acne severity at 6-week visit showed that silver nanoparticle group had better satisfaction score than clindamycin group (4.6±0.6 vs. 4.2±0.6) with statistical significance (p = 0.01). Common adverse effects were skin dryness (28.1%) and skin irritation (4.7%) which might be caused by 2.5% benzoyl peroxide. There was no adverse effect for silver nanoparticle gel from the present study.
Silver nanoparticle gel is effective with good safety profile for the treatment of acne vulgaris. The present study demonstrated that there were no clinical significant differences between silver nanoparticle gel and clindamycin gel for the treatment of moderate severity of acne vulgaris when use in combination with 2.5% benzoyl peroxide. The clinical application as alternative treatment for acne is advised.
寻常痤疮的治疗通常使用抗菌药物和角质溶解剂。考虑到细菌对局部抗生素的耐药性，诸如制成纳米颗粒的银等替代治疗方法受到关注。银纳米颗粒对痤疮丙酸杆菌具有抗菌作用且有抗炎作用。银纳米颗粒凝胶治疗寻常痤疮的临床研究有限。
比较银纳米颗粒凝胶与1%克林霉素凝胶联合2.5%过氧化苯甲酰治疗中度寻常痤疮的疗效和安全性。
这是一项实验性、双盲、随机对照研究。纳入64例中度严重痤疮患者。他们被随机分为接受含2.5%过氧化苯甲酰的银纳米颗粒凝胶或含2.5%过氧化苯甲酰的克林霉素凝胶治疗（每组32例患者）。在基线、第2、4、6和8周就诊时评估临床结局，包括炎性和非炎性痤疮计数、痤疮发红情况、患者满意度以及患者的皮肤病生活质量指数（DLQI）。
在8周的随访期后，银纳米颗粒组和克林霉素组的非炎性和炎性痤疮计数从基线的平均变化百分比均逐渐下降。在研究终点（第8周就诊时），银纳米颗粒组炎性痤疮计数从基线的平均变化百分比略高于克林霉素组（79.7%比72.6%），但无显著差异（p = 0.18）。非炎性痤疮计数减少从基线的平均变化百分比在银纳米颗粒组和克林霉素组之间也无差异（分别为61.1%和66.8%，p = 0.22）。对于评估痤疮发红的临床红斑评分和Mexameter红斑指数，两组之间无统计学差异。此外，两组患者对研究药物的满意度及其生活质量（DLQI评分）较基线均有更好改善，但无统计学显著差异。除平均值外，在第6周就诊时患者对痤疮严重程度的满意度显示银纳米颗粒组的满意度评分高于克林霉素组（4.6±（此处原文似乎有误，推测为4.6±0.6）对4.2±（此处原文似乎有误，推测为4.2±0.6）），具有统计学意义（p = 0.01）。常见不良反应为皮肤干燥（28.1%）和皮肤刺激（4.7%），可能由2.5%过氧化苯甲酰引起。本研究中银纳米颗粒凝胶未出现不良反应。
银纳米颗粒凝胶治疗寻常痤疮有效且安全性良好。本研究表明，银纳米颗粒凝胶与克林霉素凝胶联合2.5%过氧化苯甲酰治疗中度寻常痤疮时，在临床疗效上无显著差异。建议将其作为痤疮的替代治疗方法进行临床应用。
