司库奇尤单抗联合卡泊三醇治疗中重度斑块型银屑病患者的临床研究  

Clinical trial of skuchizumab combined with calcipotriol in the treatment of patients with moderate to severe plaque psoriasis

作　　者：高蕾[1] 周爱妍 GAO Lei;ZHOU Ai-yan(Department of Dermatology,Jinan Children's Hospital,Jinan 250022,Shandong Province,China)

机构地区：[1]济南市儿童医院皮肤科,山东济南250022

出　　处：《中国临床药理学杂志》2024年第20期2973-2977,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察司库奇尤单抗联合卡泊三醇治疗中重度斑块型银屑病患者的临床疗效。方法将中重度斑块型银屑病患者按队列法分为试验组和对照组。对照组给予卡泊三醇软膏,于患处均匀涂抹适量软膏,每天2次;试验组在对照组治疗的基础上给予司库奇尤单抗注射液,每次300 mg,每周1次,注射4周后调整为每4周注射1次,皮下注射。2组患者均治疗12周。比较2组患者治疗后的临床疗效、银屑病面积及严重程度指数(PASI)评分、生活质量[皮肤生命质量指数(DLQI)评分]、皮肤屏障功能指标[角质层油脂含量、角质层含水量]、血清血管内皮生长因子(VEGF)、白细胞介素-22(IL-22)、IL-17,并进行安全性评价。结果对照组入组42例,试验组入组48例。治疗后,试验组和对照组总有效率分别为93.75%(45例/48例)和78.57%(33例/42例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的PASI评分分别为(6.57±1.52)和(10.68±2.13)分,DLQI评分分别为(5.36±1.29)和(9.85±1.67)分,角质层油脂含量分别为(49.73±6.16)和(42.81±5.97)μg·cm^(-2),角质层含水量分别为(36.84±4.59)%和(29.53±4.06)%,血清VEGF含量分别为(136.43±25.05)和(183.52±29.56)pg·mL^(-1),血清IL-22含量分别为(5.27±1.15)和(7.93±1.43)pg·mL^(-1),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有腹泻、呼吸道感染、鼻炎,对照组的药物不良反应主要有皮肤刺激、皮肤干燥。试验组和对照组的总药物不良反应发生率分别为8.33%(4例/48例)和7.14%(3例/42例),在统计学上差异无统计学意义(P>0.05)。结论司库奇尤单抗联合卡泊三醇能降低中重度斑块型银屑病患者PASI评分,提高生活质量,改善皮肤屏障功能,减少血清VEGF及IL-22含量。Objective To observe the curative effect of skuchizumab combined with calcipotriol in patients with moderate to severe plaque psoriasis.Methods Patients with moderate and severe plaque psoriasis were divided into treatment group and control group by cohort method.The control group was given calcipotriol ointment,and an appropriate amount of ointment was evenly applied to the affected area,twice a day,while treatment group was given subcutaneous injection of skuchizumab injection(300 mg/once,once/week;once/4 weeks after 4 weeks of injection)on basis of control group.All patients were treated for 12 weeks.The clinical curative effect,score of psoriasis area and severity index(PASI),quality of life[score of dermatology life quality index(DLQI)],skin barrier function indexes(content of fat and water in stratum corneum),serum vascular endothelial growth factor(VEGF),interleukin-22(IL-22),IL-17 and safety were compared between the two groups after treatment.Results There were 42 cases in control group and 48 cases in treatment group.After treatment,total response rates of treatment group and control group were 93.75%(45 cases/48 cases)and 78.57%(33 cases/42 cases),the difference was statistically significant(P<0.05).After treatment,PASI score in treatment group and control group were(6.57±1.52)and(10.68±2.13)points;DLQI score were(5.36±1.29)and(9.85±1.67)points;content of stratum corneum fat were(49.73±6.16)and(42.81±5.97)μg·cm~(-2);content of stratum corneum water were(36.84±4.59)%and(29.53±4.06)%;levels of serum VEGF were(136.43±25.05)and(183.52±29.56)pg·mL^(-1);levels of serum IL-22 were(5.27±1.15)and(7.93±1.43)pg·mL^(-1),and the differences were statistically significant(all P<0.05).The adverse drug reactions were mainly on diarrhea,respiratory tract infection and rhinitis in treatment group,while which were mainly on skin irritation and dry skin in control group.There was no significant difference in total incidence of adverse drug reactions between treatment group and control group[8.33%(4 cases/4

关 键 词：司库奇尤单抗注射液 卡泊三醇软膏 斑块型银屑病 临床疗效 安全性评价 

分 类 号：R976[医药卫生—药品]