Article(id=1291704917132079961, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.19.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1747152000000, receivedDateStr=2025-05-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896050961, onlineDateStr=2026-08-05, pubDate=1760630400000, pubDateStr=2025-10-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896050961, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896050961, creator=13701087609, updateTime=1785896050961, updator=13701087609, issue=Issue{id=1291704892859638107, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='19', pageStart='2701', pageEnd='2850', issueExtLink='null', onlineDate='null', pubDate='1760630400000', pubDateStr='2025-10-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896045171, creator='13701087609', updateTime=1785896787712, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708007352656266, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708007352656267, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704892859638107, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2717, endPage=2722, ext={EN=ArticleExt(id=1291704917320823642, articleId=1291704917132079961, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical study of dupilumab in treating adult atopic dermatitis, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of tacrolimus ointment combined with dupilumab injection in treatment of adult atopic dermatitis (AD).

Methods

Adult patients with AD in the Affiliated Hospital of Xuzhou Medical University were enrolled as study subjects. The control group was treated with tacrolimus ointment (external use, twice a day) + ebastine tablets (oral administration, 10 mg·times-1·d-1), and the observation group received tacrolimus ointment + ebastine tablets + dupilumab injection (subcutaneous injection, initial dose of 600 mg, followed by 300 mg·times-1, once every two weeks). The clinical efficacy, skin barrier indicators, serum thymic stromal lymphopoietin (TSLP) and interleukin-31 (IL-31) were compared between the two groups, and the safety was assessed.

Results

A total of 140 cases (80 cases in control group and 60 cases in observation group) were screened in this study. 48 pairs were successfully matched by the propensity matching score method according to the ratio of 1∶1. Finally, 48 cases in control group and 48 cases in observation group were included. After 4 weeks of treatment, the effective rate in observation group was 93.75% (45 cases/48 cases), which was significantly higher than 79.17% (38 cases /48 cases) in control group (P<0.05). the scoring atopic dermatitis (SCORAD) scores in observation and control groups were (15.56±3.33) and (21.50±3.51) points, and the investigator global assessment (IGA) scores were (1.98±0.57) and (2.25±0.44) points, and pruritus index (NRS) scores were (2.85±0.58) and (3.19±0.49) points, and dermatological life quality index (DLQI) scores were (10.04±1.03) and (10.88±1.16) points, and AD disease control (ADCT) scores were (7.00±0.29) and (7.17±0.43) points, respectively. The transdermal water loss (TEWL) values in observation group and control group were (13.17±2.37) g·m-2·h-1 and (15.35±3.21) g·m-2·h-1, and skin moisture contents were (26.46±4.68)% and (22.23±5.10)%, and sebum contents were (89.79±3.44) μg·cm-2 and (80.31±3.73) μg·cm-2, respectively. Serum TSLP levels in observation group and control group were (138.81±14.79) pg·mL-1 and (148.30±16.23) pg·mL-1, and serum IL-31 levels were (74.63±9.42) pg·mL-1 and (85.34±10.18) pg·mL-1, respectively, and the above indicators in observation group were statistically significantly different compared with those in control group (all P<0.05). During treatment, the adverse drug reactions in observation group were conjunctivitis, edema, diarrhea, swelling and pain at the injection site, and the adverse drug reactions in control group were nausea and edema, and there was no statistical significantly differences in the total incidence rate of adverse drug reactions between groups (P>0.05).

Conclusion

Combination of dupilumab injection on the basis of tacrolimus ointment and ebastine tablets has a significant clinical effect in the treatment of AD, and it can statically significantly improve the symptoms and skin barrier, and reduce the levels of serum TSLP and IL-31.

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目的

观察他克莫司软骨联合度普利尤单抗注射液治疗成人特应性皮炎(AD)的临床疗效和安全性。

方法

以徐州医科大学附属医院收治的成人AD患者纳入为研究对象,对照组用他克莫司软膏(外用,每日2次)+依巴斯汀片(口服,10 mg·time-1·d-1)治疗,观察组用他克莫司软膏+依巴斯汀片+度普利尤单抗注射液(皮下注射,初始剂量600 mg,后续300 mg·time-1,2周1次)治疗。比较2组患者的临床疗效、皮肤屏障指标、血清胸腺基质淋巴细胞生成素(TSLP)和白细胞介素-31(IL-31)水平,并进行安全性评价。

结果

本研究共筛选140例(对照组80例,观察组60例),用倾向性匹配评分法按1∶1比例匹配成功48对,最终对照组48例、观察组48例。治疗4周后,观察组的有效率为93.75%(45例/48例),显著高于对照组的79.17%(38例/48例)(P<0.05)。治疗4周后,观察组和对照组的特应性皮炎积分指数(SCORAD)分别为(15.56±3.33)和(21.50±3.51)分,研究者整体评估(IGA)评分分别为(1.98±0.57)和(2.25±0.44)分,瘙痒指数(NRS)分别为(2.85±0.58)和(3.19±0.49)分,皮肤病生活质量指数(DLQI)分别为(10.04±1.03)和(10.88±1.16)、AD病情控制(ADCT)评分分别为(7.00±0.29)和(7.17±0.43)分;观察组和对照组组的经皮水分丢失量(TEWL)分别为(13.17±2.37)和(15.35±3.21)g·m-2·h-1,皮肤水分含量分别为(26.46±4.68)%和(22.23±5.10)%、皮脂含量分别为(89.79±3.44)和(80.31±3.73)μg·cm-2;观察组和对照组的血清TSLP水平分别为(138.81±14.79)和(148.30±16.23)pg·mL-1,血清IL-31水平分别为(74.63±9.42)和(85.34±10.18)pg·mL-1,观察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)。治疗期间,观察组的药物不良反应有结膜炎、浮肿、腹泻、注射部位红肿疼痛,对照组有恶心、浮肿,2组的药物不良反应总发生率比较,在统计学上差异无统计学意义(P>0.05)。

结论

在他克莫司、依巴斯汀片基础上联合度普利尤单抗治疗AD的临床效果显著,可明显改善患者症状及皮肤屏障,降低血清TSLP和IL-31水平。

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刘庆娜(1997-),女,在读硕士研究生,主要从事医学影像诊断、中枢神经诊断方面的工作与研究

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魏志平,主任医师,硕士生导师 MP: 18052268255 E-mail:
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度普利尤单抗治疗成人特应性皮炎的临床研究
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刘庆娜 1, 2 , 魏志平 2
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(19): 2717-2722
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (19) : 2717 -2722
度普利尤单抗治疗成人特应性皮炎的临床研究
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刘庆娜(1997-),女,在读硕士研究生,主要从事医学影像诊断、中枢神经诊断方面的工作与研究

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刘庆娜1, 2, 魏志平2
作者信息
  • 1.徐州医科大学 第一临床医学院,江苏 徐州 221000
  • 2.徐州医科大学 附属医院 皮肤科,江苏 徐州 221000
通讯作者:
魏志平,主任医师,硕士生导师 MP: 18052268255 E-mail:
作者简介:

刘庆娜(1997-),女,在读硕士研究生,主要从事医学影像诊断、中枢神经诊断方面的工作与研究

Clinical study of dupilumab in treating adult atopic dermatitis
Qing-na LIU1, 2, Zhi-ping WEI2
Affiliations
  • 1.The First Clinical College of Xuzhou Medical University, Xuzhou 221000, Jiangsu Province, China
  • 2.Department of Dermatology, Affiliated Hospital of Xuzhou Medical University, Xuzhou 221000, Jiangsu Province, China
出版时间: 2025-10-17 doi: 10.13699/j.cnki.1001-6821.2025.19.004
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目的

观察他克莫司软骨联合度普利尤单抗注射液治疗成人特应性皮炎(AD)的临床疗效和安全性。

方法

以徐州医科大学附属医院收治的成人AD患者纳入为研究对象,对照组用他克莫司软膏(外用,每日2次)+依巴斯汀片(口服,10 mg·time-1·d-1)治疗,观察组用他克莫司软膏+依巴斯汀片+度普利尤单抗注射液(皮下注射,初始剂量600 mg,后续300 mg·time-1,2周1次)治疗。比较2组患者的临床疗效、皮肤屏障指标、血清胸腺基质淋巴细胞生成素(TSLP)和白细胞介素-31(IL-31)水平,并进行安全性评价。

结果

本研究共筛选140例(对照组80例,观察组60例),用倾向性匹配评分法按1∶1比例匹配成功48对,最终对照组48例、观察组48例。治疗4周后,观察组的有效率为93.75%(45例/48例),显著高于对照组的79.17%(38例/48例)(P<0.05)。治疗4周后,观察组和对照组的特应性皮炎积分指数(SCORAD)分别为(15.56±3.33)和(21.50±3.51)分,研究者整体评估(IGA)评分分别为(1.98±0.57)和(2.25±0.44)分,瘙痒指数(NRS)分别为(2.85±0.58)和(3.19±0.49)分,皮肤病生活质量指数(DLQI)分别为(10.04±1.03)和(10.88±1.16)、AD病情控制(ADCT)评分分别为(7.00±0.29)和(7.17±0.43)分;观察组和对照组组的经皮水分丢失量(TEWL)分别为(13.17±2.37)和(15.35±3.21)g·m-2·h-1,皮肤水分含量分别为(26.46±4.68)%和(22.23±5.10)%、皮脂含量分别为(89.79±3.44)和(80.31±3.73)μg·cm-2;观察组和对照组的血清TSLP水平分别为(138.81±14.79)和(148.30±16.23)pg·mL-1,血清IL-31水平分别为(74.63±9.42)和(85.34±10.18)pg·mL-1,观察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)。治疗期间,观察组的药物不良反应有结膜炎、浮肿、腹泻、注射部位红肿疼痛,对照组有恶心、浮肿,2组的药物不良反应总发生率比较,在统计学上差异无统计学意义(P>0.05)。

结论

在他克莫司、依巴斯汀片基础上联合度普利尤单抗治疗AD的临床效果显著,可明显改善患者症状及皮肤屏障,降低血清TSLP和IL-31水平。

度普利尤单抗注射液  /  他克莫司软膏  /  成人特应性皮炎  /  皮肤屏障  /  胸腺基质淋巴细胞生成素  /  白细胞介素-31
Objective

To observe the clinical efficacy and safety of tacrolimus ointment combined with dupilumab injection in treatment of adult atopic dermatitis (AD).

Methods

Adult patients with AD in the Affiliated Hospital of Xuzhou Medical University were enrolled as study subjects. The control group was treated with tacrolimus ointment (external use, twice a day) + ebastine tablets (oral administration, 10 mg·times-1·d-1), and the observation group received tacrolimus ointment + ebastine tablets + dupilumab injection (subcutaneous injection, initial dose of 600 mg, followed by 300 mg·times-1, once every two weeks). The clinical efficacy, skin barrier indicators, serum thymic stromal lymphopoietin (TSLP) and interleukin-31 (IL-31) were compared between the two groups, and the safety was assessed.

Results

A total of 140 cases (80 cases in control group and 60 cases in observation group) were screened in this study. 48 pairs were successfully matched by the propensity matching score method according to the ratio of 1∶1. Finally, 48 cases in control group and 48 cases in observation group were included. After 4 weeks of treatment, the effective rate in observation group was 93.75% (45 cases/48 cases), which was significantly higher than 79.17% (38 cases /48 cases) in control group (P<0.05). the scoring atopic dermatitis (SCORAD) scores in observation and control groups were (15.56±3.33) and (21.50±3.51) points, and the investigator global assessment (IGA) scores were (1.98±0.57) and (2.25±0.44) points, and pruritus index (NRS) scores were (2.85±0.58) and (3.19±0.49) points, and dermatological life quality index (DLQI) scores were (10.04±1.03) and (10.88±1.16) points, and AD disease control (ADCT) scores were (7.00±0.29) and (7.17±0.43) points, respectively. The transdermal water loss (TEWL) values in observation group and control group were (13.17±2.37) g·m-2·h-1 and (15.35±3.21) g·m-2·h-1, and skin moisture contents were (26.46±4.68)% and (22.23±5.10)%, and sebum contents were (89.79±3.44) μg·cm-2 and (80.31±3.73) μg·cm-2, respectively. Serum TSLP levels in observation group and control group were (138.81±14.79) pg·mL-1 and (148.30±16.23) pg·mL-1, and serum IL-31 levels were (74.63±9.42) pg·mL-1 and (85.34±10.18) pg·mL-1, respectively, and the above indicators in observation group were statistically significantly different compared with those in control group (all P<0.05). During treatment, the adverse drug reactions in observation group were conjunctivitis, edema, diarrhea, swelling and pain at the injection site, and the adverse drug reactions in control group were nausea and edema, and there was no statistical significantly differences in the total incidence rate of adverse drug reactions between groups (P>0.05).

Conclusion

Combination of dupilumab injection on the basis of tacrolimus ointment and ebastine tablets has a significant clinical effect in the treatment of AD, and it can statically significantly improve the symptoms and skin barrier, and reduce the levels of serum TSLP and IL-31.

dupilumab injection  /  tacrolimus ointment  /  adult atopic dermatitis  /  skin barrier  /  thymic stromal lymphopoietin  /  interleukin-31
刘庆娜, 魏志平. 度普利尤单抗治疗成人特应性皮炎的临床研究. 中国临床药理学杂志, 2025 , 41 (19) : 2717 -2722 . DOI: 10.13699/j.cnki.1001-6821.2025.19.004
Qing-na LIU, Zhi-ping WEI. Clinical study of dupilumab in treating adult atopic dermatitis[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (19) : 2717 -2722 . DOI: 10.13699/j.cnki.1001-6821.2025.19.004

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doi: 10.13699/j.cnki.1001-6821.2025.19.004
  • 接收时间:2025-05-14
  • 首发时间:2026-08-05
  • 出版时间:2025-10-17
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  • 收稿日期:2025-05-14
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    1.徐州医科大学 第一临床医学院,江苏 徐州 221000
    2.徐州医科大学 附属医院 皮肤科,江苏 徐州 221000

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魏志平,主任医师,硕士生导师 MP: 18052268255 E-mail:
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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