2nd Dermatology Department, Attikon Hospital, University of Athens Medical School, Athens, Greece.
Dermatology. 2011;223(4):325-9. doi: 10.1159/000334482. Epub 2011 Nov 30.
The objective of this open-label prospective unblinded study was to evaluate the efficacy of ustekinumab in nail psoriasis and the improvement of patient quality of life (QoL).
Twenty-seven patients with plaque psoriasis and fingernail involvement were treated with the standard ustekinumab regimen. Outcome measures were assessed at baseline and at weeks 4, 16, 28 and 40 using the nail psoriasis severity index (NAPSI). QoL was evaluated before and after treatment using the international onychomycosis-specific questionnaire.
The pairwise comparisons showed statistically significant NAPSI reduction in 4, 16, 28 and 40 weeks compared to the baseline score. The mean NAPSI at week 40 was 2.00 ± 2.337. The international onychomycosis QoL scores were significantly improved at all time points (p < 0.001). No patient reported any adverse events.
Even though no control group was used in this study, ustekinumab was effective and safe in the treatment of nail psoriasis.
本开放性、前瞻性、非盲研究旨在评估乌司奴单抗治疗甲银屑病的疗效及改善患者生活质量(QoL)。
27 例斑块型银屑病伴甲损害患者接受标准乌司奴单抗治疗方案。采用甲银屑病严重程度指数(NAPSI)于基线和治疗第 4、16、28、40 周评估疗效。采用国际甲真菌病特异性问卷(iQoL)于治疗前后评估 QoL。
与基线评分相比,治疗第 4、16、28、40 周 NAPSI 评分均有统计学显著降低。第 40 周时 NAPSI 平均评分为 2.00±2.337。所有时间点的 iQoL 评分均显著改善(p<0.001)。无患者报告任何不良事件。
尽管本研究未设对照组,但乌司奴单抗治疗甲银屑病安全且有效。