司库奇尤单抗联合中药熏洗治疗中重度斑块状银屑病临床疗效及不良反应观察

摘要/Abstract

摘要： 目的观察司库奇尤单抗联合中药熏洗治疗中重度斑块状银屑病的临床疗效及不良反应。方法本研究共纳入68例中重度斑块状银屑病患者,使用随机数表法划分成两组, 各34例,对照组予以自拟养血润燥祛风汤熏洗及他克莫司软膏治疗;治疗组患者在对照组基础上接受司库奇尤单抗300 mg治疗。两组患者均需持续按疗程完成≥24周的临床观察,并于治疗前及治疗后第4、12、24周时分析银屑病皮损面积及严重程度指数（PASI）、体表受累面积（BSA）、皮肤病生活质量指数（DLQI）的变化来评估临床疗效,并对其药物不良反应进行分析。结果两组患者均完成了24周临床观察,无患者因药物不耐受或药物不良反应而退出研究。在治疗第4周、12周、24周后,治疗组较对照组PASI评分、BSA评分、DLQI评分前后差值的差异均有统计学意义（P<0.05）;除第4周时PASI 100应答率差异无统计学意义外（P=0.063）,PASI 75/90/100应答率差异均有统计学意义（P<0.05）;DLQI 0/1应答率差异均有统计学意义（P<0.001）。结论司库奇尤单抗联合中药熏洗治疗中重度斑块状银屑病,可获得较高的PASI 75/90/100及DLQI 0/1应答率,并具有较高的安全性。

关键词: 中重度斑块状银屑病, 司库奇尤单抗, 中药熏洗, 不良反应

Abstract: Objective To observe the clinical efficacy and adverse reaction of secukinumab with herbal fumigation in the treatment of patients with moderate to severe plaque psoriasis. Methods A total of 68 patients with moderate to severe plaque psoriasis were randomly divided into two groups by digital table method, with 34 cases in each group.The control group was treated with self-made traditional Chinese medicine Yangxue Runzao Qufeng soup and tacrolimus ointment, and the treatment group was received treatment with 300 mg of Sikuximab on the basis of the control group. Both groups will require continuous observation for at least 24 weeks. The efficacy was assessed by the changes of Psoriasis Area and Severity Index （PASI) , Body Surface Area (BSA),and Dermatology Life Quality Index(DLQI) before treatment and at weeks 4, 12, and 24. The adverse drug reaction was also analyzed. Results After 24 weeks of treatment, no patient exit from the study due to drug intolerance or adverse drug reactions. After weeks 4, 12 and 24, there were significant differences in PASI score, BSA score and DLQI score in the treatment group compared with the control group （P <0.05); Except that there were no significant difference in PASI 100 response rate at week 4 （P =0.063), PASI 75/90/100 response rates were all statistically significant （P<0.05); and DLQI 0/1 response rates were also significant differences （P<0.001). Conclusion Secukinumab with herbal fumigation in the treatment of patients with moderate to severe plaque psoriasis can obtain high PASI 75/90/100 and DLQI 0/1 response rates and has a relatively high safety profile.

Key words: moderate to severe plaque psoriasis, secukinumab, herbal fumigation, adverse reaction

中图分类号:

R275.9

李玉锋, 李树香, 刘美娟. 司库奇尤单抗联合中药熏洗治疗中重度斑块状银屑病临床疗效及不良反应观察[J]. 中华养生保健, 2025, 43(4): 9-13.

LI Yu-feng, LI Shu-xiang, LIU Mei-juan. Clinical Efficacy and Adverse Reaction of Secukinumab Combined with Herbal Fumigation in the Treatment of Moderate to Severe Plaque Psoriasis[J]. ZHONGHUA YANGSHENG BAOJIAN, 2025, 43(4): 9-13.

参考文献

[1] 中华医学会皮肤性病学分会银屑病专业委员会.中国银屑病诊疗指南(2023版)[J]. 中华皮肤科杂志,2023,56(7):573-625.
[2] CHEN K, Wang G, Jin H, et al.Clinic characteristics of psoriasis in China: a nationwide survey in over 12000 patients[J].Oncotarget,2017,8(28):46381-46389.
[3] 寻常型银屑病中西医结合诊疗指南[J].世界中医药,2024,19(17):2535-2544.
[4] 寻常型银屑病(白疕)中医药循证临床实践指南(2013版)[J].中医杂志,2014,55(1):76-82.
[5] 赵煜,方萧辉,王龙君,等.中医外治法治疗斑块型银屑病的研究进展[J].医学综述,2020,26(12):2406-2410.
[6] 蔡旭阳,金朝辉,吴斌,等.他克莫司软膏治疗银屑病疗效及安全性的系统评价[J].医药导报,2018,37(12):1466-1472.
[7] FRIEDER J, KIVELEVITCH D, MENTER A.Secukinumab: a review of the anti-IL-17A biologic for the treatment of psoriasis[J].Ther Adv Chronic Dis.,2018,9(1):5-21.
[8] AUGUSTIN M, SATOR P G, von Kiedrowski R, et al.Secukinumab demonstrated sustained retention, effectiveness and safety in a real-world setting in patients with moderate‐to‐severe plaque psoriasis: long-term results from an interim analysis of the SERENA study[J].J Eur Acad Dermatol Venereol,2022,36(10):1796-1804.
[9] YIU Z Z, BECHER G, KIRBY B, et al.Drug survival associated with effectiveness and safety of treatment with guselkumab, ixekizumab, secukinumab, ustekinumab, and adalimumab in patients with psoriasis[J].JAMA Dermatology,2022,158(10):1131-1141.
[10] BLAUVELT A, CHIRICOZZI A.The Immunologic Role of IL-17 in Psoriasis and Psoriatic Arthritis Pathogenesis[J].Clin Rev Allergy Immunol,2018,55(3):379-390.
[11] LY K, SMITH M P, THIBODEAUX Q, et al.Anti IL-17 in psoriasis[J].Expert Rev Clin Immunol, 2019,15(11):1185-1194.
[12] ZHANG J, JI C, CHENG B, et al.Real-world clinical experience of secukinumab in Chinese patients with psoriasis in real-world practice: a 36-week single-center study of 24 patients[J].Chin Med J (Engl),2020,133(24):3020-3022.
[13] DING Y, LI W, GUAN X, et al.Treatment outcomes of secukinumab in adult patients with moderate-to-severe plaque psoriasis in China: A real-world multicenter retrospective study[J].Clin Transl Sci.,2023,16(10):1803-1814.
[14] MURPHY M J, COHEN J M, VESE M D, et al.Paradoxical eruptions to targeted therapies in dermatology: A systematic review and analysis[J].J Am Acad Dermatol,2022,86(5):1080-1091.
[15] YOUSIF J, AL-DEHNEEM R, KASKAS N, et al.A Case Series of Patients With Eczematous Eruptions Following IL-17 Inhibitor Treatment for Psoriasis Vulgaris[J].J Drugs Dermatol,2023,22(12):1225-1227.
[16] MA X, LI T, HAN G.Two Cases of Immune Drift Phenomena Caused by Biologic Agents for Treating Psoriasis and Atopic Dermatitis[J].Clin Cosmet Investig Dermatol,2023,16:3521-3525.
[17] AL-JANABI A, FOULKES A C, MASON K, et al.Phenotypic switch to eczema in patients receiving biologics for plaque psoriasis: a systematic review[J].J Eur Acad Dermatol Venereol,2020,34(7):1440-1448.
[18] LI Y, LIU H, ZHANG F.Biologics-Induced Immunophenotypic Cross-Switching in Patients with Psoriasis and Atopic Dermatitis[J].Indian J Dermatol,2023,68(2):186-191.
[19] EYERICH S, ONKEN A T, WEIDINGER S, et al.Mutual antagonism of T cells causing psoriasis and atopic eczema[J].N Engl J Med.,2011,365(3):231-8.
[20] NAPOLITANO M, MEGNA M, FABBROCINI G, et al.Eczematous eruption during anti-interleukin 17 treatment of psoriasis: an emerging condition[J].Br J Dermatol,2019,181(3):604-606.
[21] CALDAROLA G, PIRRO F, DI STEFANI A, et al.Clinical and histopathological characterization of eczematous eruptions occurring in course of anti IL-17 treatment: a case series and review of the literature[J].Expert Opin Biol Ther.,2020,20(6):665-672.
[22] 李妍,李明,李邻峰.湿疹样损害与银屑病样损害的免疫漂移[J].皮肤科学通报,2023,40(1):37-43.