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生物制剂治疗老年中重度银屑病124例的临床疗效和安全性回顾分析

Clinical efficacy and safety of biological agents in the treatment of moderate-to-severe psoriasis in 124 elderly patients: a retrospective analysis

摘要目的:回顾性分析生物制剂治疗老年银屑病的临床疗效及安全性。方法:本研究为回顾性研究,收集2020年6月至2023年12月在新疆维吾尔自治区人民医院皮肤性病科就诊、使用生物制剂治疗、年龄≥ 65岁、银屑病面积和严重程度指数(PASI)评分≥ 3分或银屑病皮损面积(BSA) ≥ 3%的中重度银屑病患者124例,记录第0(治疗前)、4、12、24周PASI、BSA和皮肤病生活质量指数(DLQI)评分以评估疗效,统计PASI评分改善超过75%(PASI75)和90%(PASI90)的患者比例,记录不良反应。使用SPSS 29.0、GraphPad Prism10.0软件处理数据,符合正态分布的计量资料用 ± s表示,非正态分布的计量资料用 M( Q1, Q3)表示。非正态分布的计量资料组间比较采用Wilcoxon符号秩检验,计数资料率的比较采用卡方检验和Fisher精确概率法。 结果:124例患者中,男72例(58.1%),女52例(41.9%),年龄65 ~ 87岁。使用司库奇尤单抗治疗86例(69.4%),乌司奴单抗15例(12.1%),依奇珠单抗14例(11.3%),古塞奇尤单抗5例(4.0%),阿达木单抗4例(3.2%)。治疗前,124例患者PASI、BSA、DLQI评分[ M( Q1, Q3)]分别为12.2(7.8,19.6)、16.0%(10.2%,25.0%)、16(11,20),治疗后第24周分别显著下降至0.8(0,1.2)、1.0%(0,2.0%)、0(0,3),治疗前后比较差异均有统计学意义( Z值分别为9.66、9.66、9.63,均 P<0.01);第4、12、24周达PASI75的患者比例分别为42.7%(53/124)、80.6%(100/124)、93.5%(116/124),达PASI90的比例分别为13.7%(17/124)、48.4%(60/124)、85.5%(106/124)。分别比较有合并症组(93例)和无合并症组(31例)、早发型组(41例)和晚发型组(83例)患者在治疗第4、12、24周时PASI75和PASI90的达标率,结果显示差异均无统计学意义(均 P>0.05)。124例患者中42例随访超过2年,2年时达到PASI75和PASI90的患者比例分别为71.4%(30例)和54.8%(23例)。有13例出现不良反应,分别为上呼吸道感染4例(3.2%)、肝酶升高3例(2.4%)、湿疹样皮炎2例(1.6%)、瘙痒2例(1.6%)、结节性痒疹1例(0.1%)和白癜风1例(0.1%)。 结论:生物制剂治疗老年中重度银屑病起效迅速,不良反应少且轻微,安全性较高,总体疗效显著。

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abstractsObjective:To retrospectively analyze the clinical efficacy and safety of biological agents in the treatment of psoriasis in the elderly.Methods:A retrospective study was conducted. A total of 124 patients aged ≥ 65 years with moderate-to-severe psoriasis (psoriasis area and severity index [PASI] score ≥ 3 points or body surface area [BSA] ≥ 3%), who were treated with biological agents at the Department of Dermatology and Venereology, People's Hospital of Xinjiang Uygur Autonomous Region, from June 2020 to December 2023, were collected. PASI, BSA, and dermatology life quality index (DLQI) scores were recorded at weeks 0 (pre-treatment), 4, 12, and 24 after the beginning of treatment to evaluate the efficacy. The proportions of patients achieving ≥ 75% and 90% improvements in PASI scores (PASI75 and PASI90, respectively) were calculated, and adverse reactions were recorded. Data were processed using SPSS 29.0 and GraphPad Prism 10.0 software. Normally distributed continuous variables were presented as mean ± standard deviation, while non-normally distributed continuous variables were presented as median with upper and lower quartiles ( Q1, Q3). Wilcoxon signed-rank test was used for comparisons of non-normally distributed data between groups, and chi-square test and Fisher's exact test were used for comparing categorical data. Results:Among the 124 patients, there were 72 males (58.1%) and 52 females (41.9%), and their ages ranged from 65 to 87 years. Treatment regimens included secukinumab for 86 patients (69.4%), ustekinumab for 15 (12.1%), ixekizumab for 14 (11.3%), guselkumab for 5 (4.0%), and adalimumab for 4 patients (3.2%). The pre-treatment PASI, BSA, and DLQI scores [ M ( Q1, Q3) ] were 12.2 (7.8, 19.6) points, 16.0% (10.2%, 25.0%), and 16 (11, 20) points respectively, which significantly decreased to 0.8 (0, 1.2) points, 1.0% (0, 2.0%), and 0 (0, 3) points respectively at week 24 after the start of treatment ( Z = 9.66, 9.66, 9.63, respectively, all P < 0.01). The proportions of patients achieving PASI75 at weeks 4, 12, and 24 were 42.7% (53/124), 80.6% (100/124), and 93.5% (116/124) respectively, and those achieving PASI90 were 13.7% (17/124), 48.4% (60/124), and 85.5% (106/124) respectively. There were no significant differences in the proportions of patients achieving PASI75 and PASI90 between the subgroups with and without comorbidities, as well as between the early-onset psoriasis subgroup and late-onset psoriasis subgroup at weeks 4, 12, and 24 (all P > 0.05). Among the 124 patients, 42 were followed up for over 2 years, and the proportions of patients achieving PASI75 and PASI90 after 2 years of treatment were 71.4% (30 cases) and 54.8% (23 cases), respectively. Adverse reactions occurred in 13 patients, including upper respiratory infections in 4 patients (3.2%), elevated aminotransferase levels in 3 patients (2.4%), eczematoid dermatitis in 2 patients (1.6%), pruritus in 2 patients (1.6%), nodular prurigo in 1 patient (0.1%), and vitiligo in 1 patient (0.1%) . Conclusion:Biological agents showed rapid and marked efficacy in the treatment of moderate-to-severe psoriasis in the elderly, with few and mild adverse reactions, suggesting high safety and overall marked efficacy.

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