Diabetic Foot Clinic Department, Ospedale Cannizzaro, Catania, Italy.
Medical Department, Cantabria Labs Difa Cooper, Caronno Pertusella, Italy.
Dermatol Ther. 2019 Sep;32(5):e13028. doi: 10.1111/dth.13028. Epub 2019 Jul 31.
We evaluated in a randomized, assessor-blinded, study the efficacy of a hydroxypropyl chitosan-based nail lacquer (HPC-NL) alone or in combination with oral biotin (HPC-NL + B) in the treatment of brittle nail syndrome (BNS). Fifty subjects (21 men; mean age 64 years) with BNS were enrolled. Twenty-six were randomly assigned to HPC-NL and 24 to the HPC-NL and biotin, 10 mg/daily (+B). Topical and oral treatments lasted for 4 consecutive months. The primary outcome was the evolution of the Onychodystrophy Global Severity Score (OGSS) assessing nail dystrophy, lamellar and longitudinal splitting, dyschromia, and pitting. At baseline, the OGSS, mean (SD), was 8.4 (2.1) in the HPC-NL group and 11.8 (2.3) in the HPC-NL + B group. The OGSS was significantly reduced during treatments in both groups. At Month 4, OGSS was reduced by 57% (HPC-NL) and 62% (HPC-NL + B). At the end of study period, the percentage of subjects with an OGSS reduction of ≥50% in comparison with baseline was 53% in the HPC-NL group and 80% in the HPC-NL + B group (p = .05). Both treatments were well tolerated. In subjects with BNS, HPC-NL alone is associated with a clinically relevant improvement of nail appearance. The combination of HPC-NL and oral biotin is associated with further clinical improvement.
我们在一项随机、评估者盲法、研究中评估了一种基于羟丙基壳聚糖的指甲漆（HPC-NL）单独使用或与口服生物素（HPC-NL+B）联合治疗脆性指甲综合征（BNS）的疗效。共有 50 名（21 名男性；平均年龄 64 岁）患有 BNS 的受试者入组。其中 26 名随机分配至 HPC-NL 组，24 名分配至 HPC-NL 和生物素组，每天 10mg（+B）。局部和口服治疗持续 4 个月。主要结局是评估指甲营养不良、层状和纵向分裂、变色和凹陷的指甲营养不良全球严重程度评分（OGSS）的变化。在基线时，HPC-NL 组的 OGSS 平均值（SD）为 8.4（2.1），HPC-NL+B 组为 11.8（2.3）。两组治疗期间 OGSS 均显著降低。在第 4 个月时，OGSS 在 HPC-NL 组降低了 57%，在 HPC-NL+B 组降低了 62%。在研究结束时，与基线相比，OGSS 降低≥50%的受试者百分比在 HPC-NL 组为 53%，在 HPC-NL+B 组为 80%（p=0.05）。两种治疗均耐受良好。在 BNS 患者中，HPC-NL 单独使用可使指甲外观得到显著改善。HPC-NL 联合口服生物素可进一步改善临床症状。
