化湿消银方联合司库奇尤单抗治疗脾虚湿困型银屑病的临床研究

黄秋晨; 王磊; 蓝海冰; 李乃芳; 钱青; 苏婕; 周宇; 于鸿妲; 杨皓瑜; 白彦萍

doi:10.16025/j.1674-1307.2026.02.001

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化湿消银方联合司库奇尤单抗治疗脾虚湿困型银屑病的临床研究

临床研究 | 更新时间：2026-04-08

- 化湿消银方联合司库奇尤单抗治疗脾虚湿困型银屑病的临床研究
- Clinical efficacy of Huashi Xiaoyin Decoction combined with secukinumab in the treatment of psoriasis with spleen deficiency and dampness syndrome
- 北京中医药 2026年45卷第2期页码：149-154
- 作者机构：
  
  1.北京中医药大学研究生院，北京 100029
  2.中日友好医院皮肤科，北京 100029
  3.北京市鼓楼中医医院皮肤科，北京 100009
  4.北京市中西医结合医院皮肤科，北京 100039
  5.北京市和平里医院皮肤科，北京 100013
  6.首都医科大学附属北京中医医院皮肤科，北京 100010
  7.北京市昌平区中医医院皮肤科，北京 102200
- 作者简介：
  
  黄秋晨，女，26岁，博士研究生，住院医师。研究方向：中西医结合诊治皮肤病。
  白彦萍，E-mail：zhi@tsinghua.edu.cn
- 基金信息：
  
  国家自然科学基金资助项目(82074445);国家中医药管理局2021年岐黄学者支持项目(国中医药人教函〔2021〕203号);中日友好医院临床研究与转化跃升项目(2022-NHL-HCRF-LX-02-0122)
- DOI：10.16025/j.1674-1307.2026.02.001
  中图分类号：
- 收稿：2025-11-06，
  
  纸质出版：2026-02-25
- 稿件说明：
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黄秋晨，王磊，蓝海冰，等.化湿消银方联合司库奇尤单抗治疗脾虚湿困型银屑病的临床研究［J］.北京中医药，2026，45（2）：149-154.

HUANG Qiuchen,WANG Lei,LAN Haibing,et al.Clinical efficacy of Huashi Xiaoyin Decoction combined with secukinumab in the treatment of psoriasis with spleen deficiency and dampness syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(02):149-154.
黄秋晨，王磊，蓝海冰，等.化湿消银方联合司库奇尤单抗治疗脾虚湿困型银屑病的临床研究［J］.北京中医药，2026，45（2）：149-154. DOI： 10.16025/j.1674-1307.2026.02.001.

HUANG Qiuchen,WANG Lei,LAN Haibing,et al.Clinical efficacy of Huashi Xiaoyin Decoction combined with secukinumab in the treatment of psoriasis with spleen deficiency and dampness syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(02):149-154. DOI： 10.16025/j.1674-1307.2026.02.001.

摘要

目的

观察化湿消银方联合司库奇尤单抗治疗脾虚湿困型中重度斑块状银屑病的疗效与安全性。

方法

采用多中心、随机、双盲、安慰剂对照临床研究方法，选择2022年8月—2023年12月在中日友好医院、首都医科大学附属北京中医医院、北京市和平里医院、北京市鼓楼中医医院、北京市昌平区中医医院及北京市中西医结合医院皮肤科就诊的128例脾虚湿困型银屑病患者，使用区组随机法按照1∶1的比例将受试者分为观察组和对照组。2组患者均接受标准化的司库奇尤单抗皮下注射治疗24周，在治疗的前8周，观察组联合化湿消银方，对照组联合中药安慰剂干预。对比2组治疗前后银屑病皮损面积和严重程度指数（PASI）评分、PASI应答率、研究者整体评估（IGA）评分、皮肤病生活质量指数（DLQI）评分、受累的体表面积（BSA）。

结果

治疗后观察组BSA评分低于对照组（

0.05）。治疗第4、12、24周，2组PASI评分均较治疗前降低（

0.05）；治疗4、12周，2组PASI50、PASI75、PASI90应答率比较，差异无统计学意义（

0.05）；治疗24周，2组PASI50、PASI75应答率比较，差异无统计学意义（

0.05），观察组PASI90应答率高于对照组（

=0.015）。治疗后2组DLQI评分均较治疗前下降（

0.01）.治疗24周，观察组IGA0/1应答率高于对照组，差异有统计学意义（

0.01）；观察组复发率低于对照组，复发中位时间短于对照组（

0.05）。2组不良反应发生率比较差异无统计学意义（

0.05）。

结论

化湿消银方联合司库奇尤单抗治疗脾虚湿困型中重度斑块状银屑病，可显著改善患者临床症状、提高生活质量、降低复发率，且安全性良好。

Abstract

Objective

To observe the efficacy and safety of

Huashi Xiaoyin Decoction

combined with secukinumab in the treatment of moderate-to-severe plaque psoriasis with spleen deficiency and dampness syndrome.

Methods

This study was a multicenter， randomized， double-blind， placebo-controlled clinical trial. A total of 128 patients with psoriasis of the spleen deficiency and dampness syndrome treated i

n the dermatology departments of China-Japan Friendship Hospital， Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University， Beijing Hepingli Hospital， Beijing Gulou Hospital of Traditional Chinese Medicine， Changping District Hospital of Traditional Chinese Medicine， and Beijing Hospital of Integrated Traditional Chinese and Western Medicine between August 2022 and December 2023 were enrolled. Participants were randomly assigned in a 1∶1 ratio to the observation group or the control group using block randomization. Both groups received standardized subcutaneous secukinumab treatment for 24 weeks. During the first 8 weeks， the observation group received

Huashi Xiaoyin Decoction

， while the control group received a traditional Chinese medicine （TCM） placebo. Psoriasis Area and Severity Index （PASI） score， PASI response rates， Investigator's Global Assessment （IGA） score， Dermatology Life Quality Index （DLQI） score， and Body Surface Area （BSA） were assessed before and after treatment.

Results

After treatment， the BSA score in the observation group was lower than that in the control group （

0.05）. At weeks 4， 12， and 24， PASI scores in both groups were significantly reduced compared with baseline （

0.05）. At weeks 4 and 12， there were no statistically significant differences between the two groups in PASI50， PASI75， or PASI90 response rates （

0.05）. At week 24， the PASI90 response rate in the observation group was higher than that in the control group （

=0.015）， while no significant differences were observed in PASI50 or PASI75 response rates （

0.05）. After treatment， DLQI scores in both groups were significantly reduced compared with baseline （

0.05）. At week 24， the IGA 0/1 response rate in the observation group was higher than that in the control group （

0.01）. The recurrence rate in the observa

tion group was lower than that in the control group， and the median time to relapse was shorter than that in the control group （

0.05）. There was no statistically significant difference in the incidence of adverse events between the two groups （

0.05）.

Conclusion

Huashi Xiaoyin Decoction

combined with secukinumab can significantly improve clinical symptoms， enhance quality of life， and reduce recurrence in patients with moderate-to-severe psoriasis of the spleen deficiency and dampness syndrome. Its efficacy is superior to that of secukinumab combined with a TCM placebo， with a favorable safety profile.

关键词

Keywords

references

CAI Y , FLEMING C , YAN J . Dermal γδ T cells：a new player in the pathogenesis of psoriasis [J ] . Int Immunopharmacol , 2013 , 16 ( 3 ): 388 - 391 .

PARISI R , SYMMONS DP , GRIFFITHS CE , et al . Global epidemiology of psoriasis: a systematic review of incidence and prevalence [J ] . J Invest Dermatol , 2013 , 133 ( 2 ): 377 - 385 .

PARISI R , ISKANDAR I , KONTOPANTELIS E , et al . National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study [J ] . BMJ , 2020 , 369 : m1590 .

MENTER A , STROBERB E , KAPLAN DH , et al . Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics [J ] . J Am Acad Dermatol , 2019 , 80 ( 4 ): 1029 - 1072 .

MENTER A , KORMAN NJ , ELMETS CA , et al . Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents [J ] . J Am Acad Dermatol , 2009 , 61 ( 3 ): 451 - 485 .

HEGYI Z , ZWICKER S , BUREIK D , et al . Vitamin D analog calcipotriol suppresses the Th17 cytokine-induced proinflammatory S100 "alarmins" psoriasin (S100A7) and koebnerisin (S100A15) in psoriasis [J ] . J Invest Dermatol , 2012 , 132 ( 5 ): 1416 - 1424 .

ARMSTRONG AW , READ C . Pathophysiology, clinical presentation, and treatment of psoriasis: a review [J ] . JAMA , 2020 , 323 ( 19 ): 1945 - 1960 .

SMITH CH , JABBAR-LOPEZ ZK , YIU ZZ , et al . British association of dermatologists guidelines for biologic therapy for psoriasis 2017 [J ] . Br J Dermatol , 2017 , 177 ( 3 ): 628 - 636 .

DAI D , WU H , HE C , et al . Evidence and potential mechanisms of traditional Chinese medicine for the treatment of psoriasis vulgaris: a systematic review and meta-analysis [J ] . J Dermatolog Treat , 2022 , 33 ( 2 ): 671 - 681 .

ZENG M , GUO D , FERNÁNDEZ-VARO G , et al . The integration of nanomedicine with traditional chinese medicine: drug delivery of natural products and other opportunities [J ] . Mol Pharm , 2023 , 20 ( 2 ): 886 - 904 .

李宜乘 , 白彦萍 . 白彦萍中西协同治疗银屑病经验 [J ] . 北京中医药 , 2025 , 44 ( 10 ): 1298 - 1302 .

苏婕 , 杨皓瑜 , 白彦萍 . 白彦萍对燕京赵氏皮科流派学术思想的溯源与发扬 [J ] . 北京中医药 , 2023 , 42 ( 12 ): 1310 - 1312 .

徐景娜 , 白彦萍 . 论白彦萍教授“辨血为主,血分湿蕴”治疗银屑病的学术思想 [J ] . 中国中西医结合皮肤性病学杂志 , 2021 , 20 ( 2 ): 212 - 214 .

OKINAGA S , KAMATA M , SHIMIZU T , et al . Exploring mRNA expression in adipose tissue beneath the lesional skin of psoriasis patients [J ] . J Dermatol Sci , 2020 , 99 ( 2 ): 137 - 139 .

MA H , HUANG Q , QU W , et al . In vivo and in vitro anti-inflammatory effects of Sophora flavescens residues [J ] . J Ethnopharmacol , 2018 , 224 : 497 - 503 .

BAILLY C . Atractylenolides, essential components of Atractylodes-based traditional herbal medicines: Antioxidant, anti-inflammatory and anticancer properties [J ] . Eur J Pharmacol , 2021 , 891 : 173735 .

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 .

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 .

全国中医标准化技术委员会 . 中医临床诊疗术语第2部分证候： GB/T 16751.2-2021 [S ] . 北京 : 中国标准出版社 , 2021 : 192 .

LANGLEY RG , ELLIS CN . Evaluating psoriasis with psoriasis area and severity index, psoriasis global assessment, and lattice system physician's global assessment [J ] . J Am Acad Dermatol , 2004 , 51 ( 4 ): 563 - 569 .

LANGLEY RG , ELEWSKI BE , LEBWOHL M , et al . Secukinumab in plaque psoriasis:results of two phase 3 trials [J ] . N Engl J Med , 2014 , 371 ( 4 ): 326 - 338 .

LANGLEY RG , FELDMAN SR , NYIRADY J , et al . The 5-point Investigator's Global Assessment (IGA) scale: a modified tool for evaluating plaque psoriasis severity in clinical trials [J ] . J Dermatolog Treat , 2015 , 26 ( 1 ): 23 - 31 .

FREDRIKSSON T , PETTERSSON U . Severe psoriasis：oral therapy with a new retinoid [J ] . Dermatologica , 1978 , 157 ( 4 ): 238 - 344 .

CAREY W , GLAZER S , GOTTLIEB AB , et al . Relapse, rebound, and psoriasis adverse events: an advisory group report [J ] . J Am Acad Dermatol , 2006 , 54 ( 4 ): S171 - S181 .

HUEBER W , SANDS BE , LEWITZKY S , et al . Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial [J ] . Gut , 2012 , 61 ( 12 ): 1693 - 1700 .

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