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Article(id=1241768177961603678, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241768176522957402, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.05.11, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1700409600000, receivedDateStr=2023-11-20, revisedDate=null, revisedDateStr=null, acceptedDate=1713801600000, acceptedDateStr=2024-04-23, onlineDate=1773990204563, onlineDateStr=2026-03-20, pubDate=1716566400000, pubDateStr=2024-05-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773990204563, onlineIssueDateStr=2026-03-20, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773990204562, creator=13701087609, updateTime=1773990204562, updator=13701087609, issue=Issue{id=1241768176522957402, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='5', pageStart='321', pageEnd='400', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773990204220, creator=13701087609, updateTime=1773992176593, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241776449330414547, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241768176522957402, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241776449330414548, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241768176522957402, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=374, endPage=379, ext={EN=ArticleExt(id=1241768178246816356, articleId=1241768177961603678, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Quantitative evaluation of selective Janus kinase inhibitors for atopic dermatitis, columnId=1207314218647392369, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Original Article, runingTitle=null, highlight=null, articleAbstract=
AIM

To quantitative evaluate of selective Janus kinase inhibitors in treatment of atopic dermatitis, and provide scientific basis for drug selection and clinical rational drug use.

METHODS

According to the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions （the Second Edition）, a comprehensive evaluation of upadacitinib and abrocitinib was conducted from five aspects of pharmaceutical characteristics, efficacy, safety, economy,and other attributes, and scores were assigned.

RESULTS

The total scores of upadacitinib and abrocitinib were 80.5 and 80.2 respectively. Upadacitinib and abrocitinib had definite therapeutic effects in terms of itching relief, and skin lesion clearance. But when combined with topical corticosteroids and other drugs, the improvement in efficacy of abrocitinib was better than that of upadacitinib. Upadacitinib had a wider range of applicability compared to abrocitinib, but the incidence of adverse reactions in the blood system of abrocitinib was lower than that of upadacitinib. Upadacitinib and abrocitinib were recommended for admission.

CONCLUSION

Abrocitinib is suitable for patients who seek quick results and build confidence, as well as those who need to flexibly adjust treatment plans based on their condition. Upadacitinib is preferred for adolescents over 12 years old, patients with severe renal insufficiency, or concomitant diseases such as rheumatoid arthritis and ulcerative colitis.

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目的

对治疗特应性皮炎的选择性Janus激酶抑制剂进行量化评估，为临床合理用药方案决策提供科学的依据。

方法

根据《中国医疗机构药品评价与遴选快速指南（第二版）》，从药学特性、有效性、安全性、经济性与其他属性五个方面对乌帕替尼和阿布昔替尼进行综合评价并量化评估。

结果

乌帕替尼与阿布昔替尼的总分分别为80.5分和80.2分。乌帕替尼与阿布昔替尼在瘙痒缓解及皮损清除方面疗效确切，但在联合外用糖皮质激素等药物时，阿布昔替尼疗效提高幅度优于乌帕替尼。乌帕替尼在适用人群方面较阿布昔替尼范围更广，而阿布昔替尼血液系统不良反应发生率低于乌帕替尼。对于医疗机构药品遴选，两者均可推荐入选。

结论

阿布昔替尼适用于追求迅速见效、建立信心的患者，以及需要根据病情灵活调整治疗方案的患者。对于12岁以上青少年、严重肾功能不全或合并类风湿关节炎、溃疡性结肠炎等疾病的患者优选乌帕替尼。

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董占军
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赵越，男，主管药师，硕士，主要从事药品循证评价的研究, E-mail: 。

董占军，男，主任药师，硕士，主要从事医院药事管理的研究，E-mail:

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赵越，男，主管药师，硕士，主要从事药品循证评价的研究, E-mail: 。

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赵越，男，主管药师，硕士，主要从事药品循证评价的研究, E-mail: 。

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董占军，男，主任药师，硕士，主要从事医院药事管理的研究，E-mail:

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董占军，男，主任药师，硕士，主要从事医院药事管理的研究，E-mail:

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Lancet, 2022, 400（10348）: 273-282., articleTitle=Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial, refAbstract=null), Reference(id=1241768194722041873, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, doi=null, pmid=null, pmcid=null, year=2022, volume=11, issue=11, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[18], rfOrder=25, authorNames=KELLEHER MM, PHILLIPS R, BROWN SJ, journalName=Cochrane Database Syst Rev, refType=null, unstructuredReference=KELLEHER MM, PHILLIPS R, BROWN SJ, et al. Skin care interventions in infants for preventing eczema and food allergy[J].Cochrane Database Syst Rev, 2022, 11（11）: CD013534., articleTitle=Skin care interventions in infants for preventing eczema and food allergy, refAbstract=null), Reference(id=1241768194831093780, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, doi=null, pmid=null, pmcid=null, year=2023, volume=52, issue=10, pageStart=1545, pageEnd=1550, url=null, language=null, rfNumber=[19], rfOrder=26, authorNames=刘水清, 宋 雪, 陆东亚, journalName=重庆医学, refType=null, unstructuredReference=刘水清, 宋 雪, 陆东亚, 等. 阿布昔替尼治疗中重度特应性皮炎疗效与安全性的系统评价与meta分析[J]. 重庆医学,2023, 52（10）: 1545-1550., articleTitle=阿布昔替尼治疗中重度特应性皮炎疗效与安全性的系统评价与meta分析, refAbstract=null), Reference(id=1241768194977894425, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, doi=null, pmid=null, pmcid=null, year=2023, volume=52, issue=10, pageStart=1545, pageEnd=1550, url=null, language=null, rfNumber=[19], rfOrder=27, authorNames=LIU SQ, SONG X, LU DY, journalName=Chongqing Med J, refType=null, unstructuredReference=LIU SQ, SONG X, LU DY, et al.Efficacy and safety of abrocitinib for the treatment of moderate-to-severe atopic dermatitis: a systematic review and meta-analysis[J].Chongqing Med J, 2023, 52（10）: 1545-1550., articleTitle=Efficacy and safety of abrocitinib for the treatment of moderate-to-severe atopic dermatitis: a systematic review and meta-analysis, refAbstract=null), Reference(id=1241768195112112153, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, doi=null, pmid=null, pmcid=null, year=2020, volume=396, issue=10246, pageStart=255, pageEnd=266, url=null, language=null, rfNumber=[20], rfOrder=28, authorNames=SIMPSON EL, SINCLAIR R, FORMAN S, journalName=Lancet, refType=null, unstructuredReference=SIMPSON EL, SINCLAIR R, FORMAN S, et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis （JADE MONO-1）: a multicentre, double-blind,randomised, placebo-controlled, phase 3 trial [J]. Lancet, 2020,396（10246）: 255-266., articleTitle=Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis （JADE MONO-1）: a multicentre, double-blind,randomised, placebo-controlled, phase 3 trial, refAbstract=null), Reference(id=1241768195200192540, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, doi=null, pmid=null, pmcid=null, year=2021, volume=397, issue=10290, pageStart=2151, pageEnd=2168, url=null, language=null, rfNumber=[21], rfOrder=29, authorNames=GUTTMAN YE, TEIXEIRA HD, SIMPSON EL, journalName=Lancet, refType=null, unstructuredReference=GUTTMAN YE, TEIXEIRA HD, SIMPSON EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderateto-severe atopic dermatitis （Measure Up 1 and Measure Up 2）: results from two replicate double-blind, randomised controlled phase 3 trials [J]. Lancet, 2021, 397（10290）:2151-2168., articleTitle=Once-daily upadacitinib versus placebo in adolescents and adults with moderateto-severe atopic dermatitis （Measure Up 1 and Measure Up 2）: results from two replicate double-blind, randomised controlled phase 3 trials, refAbstract=null)], funds=[Fund(id=1241768189684683696, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, awardId=H2020307043, language=CN, fundingSource=河北省自然科学基金(H2020307043), fundOrder=null, country=null), Fund(id=1241768189810512820, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, awardId=20240488, language=CN, fundingSource=河北省医学科学研究课题(20240488), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241768180234916478, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, xref=1., ext=[AuthorCompanyExt(id=1241768180243305086, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, companyId=1241768180234916478, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Department of Pharmacy, Hebei General Hospital, Shijiazhuang HEBEI 050057, China), AuthorCompanyExt(id=1241768180255887999, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, companyId=1241768180234916478, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.河北省人民医院　药学部，河北　石家庄　050057)]), AuthorCompany(id=1241768180352356997, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, xref=2., ext=[AuthorCompanyExt(id=1241768180356551302, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, companyId=1241768180352356997, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.Department of Pharmacy, Hebei Provincial Hospital of Chinese Medicine, Shijiazhuang HEBEI 050011, China), AuthorCompanyExt(id=1241768180364939911, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, companyId=1241768180352356997, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.河北省中医院　药学部，河北　石家庄　050011)]), AuthorCompany(id=1241768180461408905, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, xref=3., ext=[AuthorCompanyExt(id=1241768180469797515, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, companyId=1241768180461408905, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Hebei Key Laboratory of Clinical Pharmacy,Shijiazhuang HEBEI 050051, China), AuthorCompanyExt(id=1241768180494963340, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, companyId=1241768180461408905, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.河北省临床药学重点实验室，河北　石家庄　050051)])], figs=[ArticleFig(id=1241768186585092979, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
项目乌帕替尼阿布昔替尼
抑制靶点JAKJAK1
tmax/h2~41
t1/2/h8~145
每日1次给药达稳4 d内48 h
血浆浓度时间
生物利用度/%7960
血浆蛋白结合率/%52-
分布容积/L294约100
代谢产物主要代谢产物为单氧化之后的葡萄糖醛酸化产物，无
活性		代谢产物为M1（3-羟丙基）、M2（2-羟丙基）和M4（吡咯
烷酮嘧啶）。M1和M2的JAK抑制特征与阿布昔替尼相似，
而M4无药理学活性
消除途径/方式绝大部分以母体分子原型形式消除，小部分以代谢产
物的形式消除。经肾脏消除24%，经肝脏消除38%		不到1%的剂量以原型药形式随尿液排出，代谢产物M1、
M2和M4主要通过尿液排泄
), ArticleFig(id=1241768186668979064, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=CN, label=表1, caption=

选择性Janus激酶（JAK）抑制剂药动学参数

, figureFileSmall=null, figureFileBig=null, tableContent=
项目乌帕替尼阿布昔替尼
抑制靶点JAKJAK1
tmax/h2~41
t1/2/h8~145
每日1次给药达稳4 d内48 h
血浆浓度时间
生物利用度/%7960
血浆蛋白结合率/%52-
分布容积/L294约100
代谢产物主要代谢产物为单氧化之后的葡萄糖醛酸化产物，无
活性		代谢产物为M1（3-羟丙基）、M2（2-羟丙基）和M4（吡咯
烷酮嘧啶）。M1和M2的JAK抑制特征与阿布昔替尼相似，
而M4无药理学活性
消除途径/方式绝大部分以母体分子原型形式消除，小部分以代谢产
物的形式消除。经肾脏消除24%，经肝脏消除38%		不到1%的剂量以原型药形式随尿液排出，代谢产物M1、
M2和M4主要通过尿液排泄
), ArticleFig(id=1241768186761253756, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
项目乌帕替尼阿布昔替尼
主要成分与辅料主要成分为乌帕替尼，辅料包括微晶纤维素、羟丙甲
纤维素、甘露醇、酒石酸、胶态二氧化硅、硬脂酸
镁（2）		主要成分为阿布昔替尼（1）
规格与包装15 mg，每盒28片（2）100 mg，每盒14片（2）
用量起始剂量为15 mg每日1次。如果应答不佳，考虑将
剂量增加至30 mg每日1次；如果仍未达到充分应
答，则停用本品。应使用所需的最低有效剂量以维
持应答（1.5）		初始剂量为100 mg每日1次。如果初始剂量未实现充分应
答，考虑将剂量增加至200 mg每日1次（可短期使用，
≤12周）；如果仍未达到充分应答，则停用本品。应使
用所需的最低有效剂量以维持应答（1.5）
有效期24个月（1）36个月（1.5）
), ArticleFig(id=1241768186882888579, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=CN, label=表2, caption=

选择性Janus激酶（JAK）抑制剂药剂学和有效期区别点与评价结果（分）

, figureFileSmall=null, figureFileBig=null, tableContent=
项目乌帕替尼阿布昔替尼
主要成分与辅料主要成分为乌帕替尼，辅料包括微晶纤维素、羟丙甲
纤维素、甘露醇、酒石酸、胶态二氧化硅、硬脂酸
镁（2）		主要成分为阿布昔替尼（1）
规格与包装15 mg，每盒28片（2）100 mg，每盒14片（2）
用量起始剂量为15 mg每日1次。如果应答不佳，考虑将
剂量增加至30 mg每日1次；如果仍未达到充分应
答，则停用本品。应使用所需的最低有效剂量以维
持应答（1.5）		初始剂量为100 mg每日1次。如果初始剂量未实现充分应
答，考虑将剂量增加至200 mg每日1次（可短期使用，
≤12周）；如果仍未达到充分应答，则停用本品。应使
用所需的最低有效剂量以维持应答（1.5）
有效期24个月（1）36个月（1.5）
), ArticleFig(id=1241768187008717701, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指南推荐内容
中国特应性皮炎诊疗指南（2020
版）［1］		JAK抑制剂可以阻断多种参与免疫应答和炎症因子信号传递，口服和局部外用JAK抑制剂均显示了良
好的疗效，乌帕替尼对成人中重度特应性皮炎（AD）也显示出较好疗效
特应性皮炎的全程管理共识［2］对于中度AD患者采取外用糖皮质激素或外用磷酸二酯酶4抑制剂治疗效果不佳或患者治疗不耐受时，
应考虑系统抗炎治疗，如生物制剂、JAK抑制剂或传统免疫治疗。对于重度AD患者应尽早启动系统
抗炎治疗，并联合局部外用药、光疗等。系统抗炎药物主要为生物制剂度普利尤单抗、JAK抑制剂（乌
帕替尼和阿布昔替尼）、传统免疫抑制剂和糖皮质激素，目前JAK抑制剂推荐用于系统性治疗或生
物制剂治疗失效之后
中重度特应性皮炎系统药物达标
治疗专家指导建议［3］
系统Janus激酶抑制剂治疗特应
性皮炎专家共识［5］		目前可用于中重度AD系统治疗的药物包括传统免疫抑制剂、生物制剂和JAK抑制剂（选择性JAK1抑
制剂阿布昔替尼和选择性JAK抑制剂乌帕替尼），以及糖皮质激素和抗组胺药物等
阿布昔替尼兼具快速起效、较强改善瘙痒和皮损及较好安全性的特点，并且在合并外用药物、剂量调整
等方面表现出比较明显的量-效相关性，便于临床上根据病情需要灵活调整治疗方案。乌帕替尼可以
快速缓解瘙痒，清除皮损，但其部分不良反应的发生率相对较高，如痤疮和对血液系统的影响
ETFAD/EADV湿疹特别工作组
2020年成人和儿童特应性皮炎
的诊断和治疗立场文件［12］		JAK抑制剂是一种快速作用药物，JAK1抑制剂的优势之一是可影响AD相关的多种细胞因子，包括
IL-4、IL-13、IL-31、TSLP和IL-22。选择性JAK1抑制仅抑制JAK1，减少了抑制其他JAKs可能带来
的潜在风险
2022年欧洲特应性湿疹指南［13］对于成人及青少年重度AD患者推荐使用乌帕替尼
2021年葡萄牙生物制剂和JAK
抑制剂治疗特应性皮炎专家共
识［14］		JAK1抑制剂乌帕替尼为成人及12岁以上中重度AD患者提供了绝佳的治疗机会，JAK1抑制剂阿布昔
替尼也即将获批AD适应证
), ArticleFig(id=1241768187121963916, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=CN, label=表3, caption=

选择性Janus激酶（JAK）抑制剂诊疗规范、指南、专家共识推荐

, figureFileSmall=null, figureFileBig=null, tableContent=
指南推荐内容
中国特应性皮炎诊疗指南（2020
版）［1］		JAK抑制剂可以阻断多种参与免疫应答和炎症因子信号传递，口服和局部外用JAK抑制剂均显示了良
好的疗效，乌帕替尼对成人中重度特应性皮炎（AD）也显示出较好疗效
特应性皮炎的全程管理共识［2］对于中度AD患者采取外用糖皮质激素或外用磷酸二酯酶4抑制剂治疗效果不佳或患者治疗不耐受时，
应考虑系统抗炎治疗，如生物制剂、JAK抑制剂或传统免疫治疗。对于重度AD患者应尽早启动系统
抗炎治疗，并联合局部外用药、光疗等。系统抗炎药物主要为生物制剂度普利尤单抗、JAK抑制剂（乌
帕替尼和阿布昔替尼）、传统免疫抑制剂和糖皮质激素，目前JAK抑制剂推荐用于系统性治疗或生
物制剂治疗失效之后
中重度特应性皮炎系统药物达标
治疗专家指导建议［3］
系统Janus激酶抑制剂治疗特应
性皮炎专家共识［5］		目前可用于中重度AD系统治疗的药物包括传统免疫抑制剂、生物制剂和JAK抑制剂（选择性JAK1抑
制剂阿布昔替尼和选择性JAK抑制剂乌帕替尼），以及糖皮质激素和抗组胺药物等
阿布昔替尼兼具快速起效、较强改善瘙痒和皮损及较好安全性的特点，并且在合并外用药物、剂量调整
等方面表现出比较明显的量-效相关性，便于临床上根据病情需要灵活调整治疗方案。乌帕替尼可以
快速缓解瘙痒，清除皮损，但其部分不良反应的发生率相对较高，如痤疮和对血液系统的影响
ETFAD/EADV湿疹特别工作组
2020年成人和儿童特应性皮炎
的诊断和治疗立场文件［12］		JAK抑制剂是一种快速作用药物，JAK1抑制剂的优势之一是可影响AD相关的多种细胞因子，包括
IL-4、IL-13、IL-31、TSLP和IL-22。选择性JAK1抑制仅抑制JAK1，减少了抑制其他JAKs可能带来
的潜在风险
2022年欧洲特应性湿疹指南［13］对于成人及青少年重度AD患者推荐使用乌帕替尼
2021年葡萄牙生物制剂和JAK
抑制剂治疗特应性皮炎专家共
识［14］		JAK1抑制剂乌帕替尼为成人及12岁以上中重度AD患者提供了绝佳的治疗机会，JAK1抑制剂阿布昔
替尼也即将获批AD适应证
), ArticleFig(id=1241768187197461393, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
常见不良反应乌帕替尼阿布昔替尼
恶心-9~20
痤疮7~17-
上呼吸道感染7~167
鼻咽炎6~1212~15
头痛5~78~10
外周血肌酸磷酸激酶升高3~6-
带状疱疹1~21
贫血<1~2-
中性粒细胞减少1~5-
), ArticleFig(id=1241768187277153170, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=CN, label=表4, caption=

选择性Janus激酶（JAK）抑制剂常见不良反应的发生率［20, 21］

, figureFileSmall=null, figureFileBig=null, tableContent=
常见不良反应乌帕替尼阿布昔替尼
恶心-9~20
痤疮7~17-
上呼吸道感染7~167
鼻咽炎6~1212~15
头痛5~78~10
外周血肌酸磷酸激酶升高3~6-
带状疱疹1~21
贫血<1~2-
中性粒细胞减少1~5-
), ArticleFig(id=1241768187352650645, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药品乌帕替尼阿布昔替尼
儿童适用于12岁及以上且体重≥40 kg的儿童（0.5）国内未获批（0）
老年65岁及以上的成人推荐的剂量为15 mg，每日1次。
≥75岁患者的数据有限（1）		≥75岁患者的数据有限（1）
肝功能不全轻中度肝功能不全无需调整剂量，严重肝功能不全
禁用（2）		轻中度肝功能不全无需调整剂量，严重肝功能不全禁用（2）
肾功能不全肌酐清除率>30 mL·min-1者无需调整剂量；肌酐清
除率<30 mL·min-1者推荐剂量为15 mg，每日1
次（3）		估计肾小球滤过率（eGFR）为60~89 mL·min-1，推荐阿布昔替尼片
100 mg，每日1次；eGFR为30~59 mL·min-1，推荐阿布昔替尼片
50 mg，每日1次；eGFR<30 mL·min-1不推荐使用（2）
), ArticleFig(id=1241768187449119641, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=CN, label=表5, caption=

选择性Janus激酶（JAK）抑制剂特殊人群评价结果（分）

, figureFileSmall=null, figureFileBig=null, tableContent=
药品乌帕替尼阿布昔替尼
儿童适用于12岁及以上且体重≥40 kg的儿童（0.5）国内未获批（0）
老年65岁及以上的成人推荐的剂量为15 mg，每日1次。
≥75岁患者的数据有限（1）		≥75岁患者的数据有限（1）
肝功能不全轻中度肝功能不全无需调整剂量，严重肝功能不全
禁用（2）		轻中度肝功能不全无需调整剂量，严重肝功能不全禁用（2）
肾功能不全肌酐清除率>30 mL·min-1者无需调整剂量；肌酐清
除率<30 mL·min-1者推荐剂量为15 mg，每日1
次（3）		估计肾小球滤过率（eGFR）为60~89 mL·min-1，推荐阿布昔替尼片
100 mg，每日1次；eGFR为30~59 mL·min-1，推荐阿布昔替尼片
50 mg，每日1次；eGFR<30 mL·min-1不推荐使用（2）
), ArticleFig(id=1241768187574948766, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药品包装生产厂家包装价格/元*日均治疗费用/元同通用名药品评分主要适应证可替代药品评分经济性得分
乌帕替尼15 mg×28片艾伯维医药2 08674.537.010.0
阿布昔替尼100 mg×14
片		辉瑞制药1 09278.036.79.7
度普利尤单抗300 mg赛诺菲2 780.8198.632.65.6
), ArticleFig(id=1241768189172978594, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=CN, label=表6, caption=

生物制剂及选择性Janus激酶（JAK）抑制剂经济性评价结果

, figureFileSmall=null, figureFileBig=null, tableContent=
药品包装生产厂家包装价格/元*日均治疗费用/元同通用名药品评分主要适应证可替代药品评分经济性得分
乌帕替尼15 mg×28片艾伯维医药2 08674.537.010.0
阿布昔替尼100 mg×14
片		辉瑞制药1 09278.036.79.7
度普利尤单抗300 mg赛诺菲2 780.8198.632.65.6
), ArticleFig(id=1241768189344945064, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
药品药学特性有效性安全性经济性其他属性总分
乌帕替尼25.526.013.5105.580.5
阿布昔替尼25.526.513.09.75.580.2
), ArticleFig(id=1241768189483357099, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241768177961603678, language=CN, label=表7, caption=

选择性Janus激酶（JAK）抑制剂遴选评价得分

, figureFileSmall=null, figureFileBig=null, tableContent=
药品药学特性有效性安全性经济性其他属性总分
乌帕替尼25.526.013.5105.580.5
阿布昔替尼25.526.513.09.75.580.2
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治疗特应性皮炎的选择性Janus激酶抑制剂的量化评估
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赵越 1 , 杨浩天 1 , 薛朝军 1 , 李宵 1 , 鞠晓宇 2 , 赵倩 2 , 董占军 1, 3
中国新药与临床杂志 | 论著 2024,43(5): 374-379
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中国新药与临床杂志 | 论著 2024, 43(5): 374-379
治疗特应性皮炎的选择性Janus激酶抑制剂的量化评估
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赵越1 , 杨浩天1, 薛朝军1, 李宵1, 鞠晓宇2, 赵倩2, 董占军1, 3
作者信息
  • 1.河北省人民医院　药学部，河北　石家庄　050057
  • 2.河北省中医院　药学部，河北　石家庄　050011
  • 3.河北省临床药学重点实验室，河北　石家庄　050051

    • 赵越，男，主管药师，硕士，主要从事药品循证评价的研究, E-mail: 。

    董占军，男，主任药师，硕士，主要从事医院药事管理的研究，E-mail:

通讯作者:

董占军
Quantitative evaluation of selective Janus kinase inhibitors for atopic dermatitis
Yue ZHAO1 , Hao-tian YANG1, Chao-jun XUE1, Xiao LI1, Xiao-yu JU2, Qian ZHAO2, Zhan-jun DONG1, 3
Affiliations
  • 1.Department of Pharmacy, Hebei General Hospital, Shijiazhuang HEBEI 050057, China
  • 2.Department of Pharmacy, Hebei Provincial Hospital of Chinese Medicine, Shijiazhuang HEBEI 050011, China
  • 3.Hebei Key Laboratory of Clinical Pharmacy,Shijiazhuang HEBEI 050051, China
出版时间: 2024-05-25 doi: 10.14109/j.cnki.xyylc.2024.05.11
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摘要
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目的

对治疗特应性皮炎的选择性Janus激酶抑制剂进行量化评估，为临床合理用药方案决策提供科学的依据。

方法

根据《中国医疗机构药品评价与遴选快速指南（第二版）》，从药学特性、有效性、安全性、经济性与其他属性五个方面对乌帕替尼和阿布昔替尼进行综合评价并量化评估。

结果

乌帕替尼与阿布昔替尼的总分分别为80.5分和80.2分。乌帕替尼与阿布昔替尼在瘙痒缓解及皮损清除方面疗效确切，但在联合外用糖皮质激素等药物时，阿布昔替尼疗效提高幅度优于乌帕替尼。乌帕替尼在适用人群方面较阿布昔替尼范围更广，而阿布昔替尼血液系统不良反应发生率低于乌帕替尼。对于医疗机构药品遴选，两者均可推荐入选。

结论

阿布昔替尼适用于追求迅速见效、建立信心的患者，以及需要根据病情灵活调整治疗方案的患者。对于12岁以上青少年、严重肾功能不全或合并类风湿关节炎、溃疡性结肠炎等疾病的患者优选乌帕替尼。

乌帕替尼  /  阿布昔替尼  /  Janus激酶抑制剂  /  皮炎，特应性  /  药物评价
AIM

To quantitative evaluate of selective Janus kinase inhibitors in treatment of atopic dermatitis, and provide scientific basis for drug selection and clinical rational drug use.

METHODS

According to the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions （the Second Edition）, a comprehensive evaluation of upadacitinib and abrocitinib was conducted from five aspects of pharmaceutical characteristics, efficacy, safety, economy,and other attributes, and scores were assigned.

RESULTS

The total scores of upadacitinib and abrocitinib were 80.5 and 80.2 respectively. Upadacitinib and abrocitinib had definite therapeutic effects in terms of itching relief, and skin lesion clearance. But when combined with topical corticosteroids and other drugs, the improvement in efficacy of abrocitinib was better than that of upadacitinib. Upadacitinib had a wider range of applicability compared to abrocitinib, but the incidence of adverse reactions in the blood system of abrocitinib was lower than that of upadacitinib. Upadacitinib and abrocitinib were recommended for admission.

CONCLUSION

Abrocitinib is suitable for patients who seek quick results and build confidence, as well as those who need to flexibly adjust treatment plans based on their condition. Upadacitinib is preferred for adolescents over 12 years old, patients with severe renal insufficiency, or concomitant diseases such as rheumatoid arthritis and ulcerative colitis.

upadacitinib  /  abrocitinib  /  Janus kinase inhibitors  /  dermatitis, atopic  /  drug evaluation
赵越, 杨浩天, 薛朝军, 李宵, 鞠晓宇, 赵倩, 董占军. 治疗特应性皮炎的选择性Janus激酶抑制剂的量化评估. 中国新药与临床杂志, 2024 , 43 (5) : 374 -379 . DOI: 10.14109/j.cnki.xyylc.2024.05.11
Yue ZHAO, Hao-tian YANG, Chao-jun XUE, Xiao LI, Xiao-yu JU, Qian ZHAO, Zhan-jun DONG. Quantitative evaluation of selective Janus kinase inhibitors for atopic dermatitis[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (5) : 374 -379 . DOI: 10.14109/j.cnki.xyylc.2024.05.11
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特应性皮炎（atopic dermatitis，AD）是一种伴有剧烈瘙痒的慢性、复发性、炎症性皮肤病［1］，以慢性反复发作的瘙痒和多形性炎症性皮损为特征，给患者及其家庭带来巨大的经济和精神负担，已成为非致命性皮肤病负担排名第一的疾病［2］。全球AD患者达2.3亿［3］，2019 年我国 AD 患者约为3 558万［2］。AD的发病机制尚未明确，但研究发现在皮肤炎症启动、进展和慢性化过程中，T辅助细胞（Th）是重要驱动因素，Th1、Th2、Th17和Th22细胞均被不同程度地激活，过度释放与AD 症状相关的细胞因子，如白细胞介素（IL）-4、IL-13、IL-22、IL-31、γ干扰素、胸腺基质淋巴细胞生成素（TSLP）等［4-6］。
Janus激酶（JAK） 是一类非受体酪氨酸激酶，与底物信号转导与转录激活因子（STAT）构成 JAK-STAT 信号通路，参与细胞转录与基因表达［7］。JAK广泛分布于机体各组织和细胞中，包括 JAK1、JAK2、JAK3 和酪氨酸激酶 2（TYK2）4个成员［8］，其中，JAK1在AD 症状相关细胞因子的信号转导中发挥重要作用［5］。JAK 抑制剂与传统免疫抑制剂相比，靶向性更强；与注射给药的生物制剂相比，患者接受度及依从性更高，同时还可避免因免疫原性导致反应缺失的风险，打破了生物制剂的困境［9］。因此对于迫切要求迅速缓解瘙痒症状的患者、不愿意注射治疗但能够按时口服药物的患者、合并口服 JAK 抑制剂治疗有效疾病（如类风湿关节炎、银屑病关节炎、溃疡性结肠炎等）的患者、合并生物制剂并发症或不能耐受不良反应的患者，选择性 JAK 抑制剂是一个很好的选择［5］。为帮助医疗机构科学遴选治疗药物，为临床医师、药师全面认识和正确合理选用药物提供参考，本研究根据《中国医疗机构药品评价与遴选快速指南（第二版）》［10］（下称《指南》）对国内上市的选择性JAK抑制剂乌帕替尼和阿布昔替尼进行量化评价。
资料与方法
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评价对象
国内上市的选择性JAK抑制剂为艾伯维医药公司生产的乌帕替尼缓释片（15 mg×28片、30 mg×28片）、辉瑞制药公司生产的阿布昔替尼片（100 mg×14片、200 mg×14片）。由于两药大剂量均为应答不佳的短期补救初始剂量，为非常规用量，故本研究仅对比常规初始剂量两种规格，即乌帕替尼缓释片（15 mg×28片）与阿布昔替尼片（100 mg×14片）。
评价依据与方法
《指南》从药学特性、有效性、安全性、经济性与其他属性五个方面对医疗机构涉及的所有药品种类（化学药品、生物制剂以及中成药）进行量化打分。为保证评价结果客观、准确，本研究由2名临床药师独立评价，评价分数差异较大（大于3分）时，由本院临床药师团队共同商讨确定。评价结果用于指导医疗机构药品遴选与临床用药方案决策。
检索策略
查阅药品说明书获取药品主要成分、用法用量、药品有效期、贮存条件等基础信息；检索PubMed、Embase英文数据库及中国知网、维普网、万方数据中文数据库获取有效性、安全性相关信息；检索国家药品监督管理局（NMPA）、美康MCDEX、医脉通、UpToDate查阅相关诊疗规范、临床路径、指南或专家共识；检索河北省医疗机构药品集中采购平台查询药品挂网价格；检索NMPA药品审评中心网站获取药品一致性评价情况；检索《国家基本药物目录（2018版）》《国家基本医疗保险、工伤保险和生育保险药品目录（2022版）》确定药品政策准入相关信息；检索药智数据、参比购、药融云网查阅药品全球销售情况；查阅美国《制药经理人》公布的全球制药企业50强目录、工信部医药工业百强榜等评估生产企业信誉。
结 果
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药学特性
1　药理作用
乌帕替尼和阿布昔替尼均为选择性JAK抑制剂，通过在细胞内选择性结合JAK1分子，抑制JAK1活性和关键细胞因子信号通路，进而调节促炎级联放大反应，有效调节AD发病机制相关的细胞因子［7］。在不含细胞的分离酶活性测定中，乌帕替尼对JAK1和JAK2的抑制作用高于对JAK3和TYK2的抑制作用；阿布昔替尼对JAK1有高度选择性，高于其他3种JAK同工酶［11］。故乌帕替尼得4.0分，阿布昔替尼得5.0分。
2　体内过程
阿布昔替尼给药1 h即可达血药峰浓度，每日1次给药后48 h内即可达稳态血浆浓度。乌帕替尼绝大部分以母体分子原型形式消除，而阿布昔替尼以代谢物形式通过尿液排泄。两者体内过程明确，乌帕替尼药动学参数完整，得5.0分，阿布昔替尼血浆蛋白结合率不清晰，得4.5分，药动学参数见表1。
3　药剂学、
贮藏条件与有效期 乌帕替尼说明书中辅料成分明确，阿布昔替尼有效期长于乌帕替尼，评分见表2。两者均每日口服1次（均2分），空腹或随餐均可，但应在每日大致相同的时间口服（均2分）；若漏服，应尽快补服该剂量，若与下次服药时间间隔<12 h，则按常规时间继续下次服药即可（均2分）。两者密封，不超过30 ℃保存（均4分）。乌帕替尼本项得16.5分，阿布昔替尼得16分。
有效性
1　适应证
选择性JAK抑制剂已被明确为重度AD患者的首选治疗方案，阿布昔替尼国内仅获批用于18岁以上中重度AD患者，乌帕替尼除此之外还可用于12岁以上青少年，故乌帕替尼得5.0分，阿布昔替尼得4.5分。
2　指南推荐情况
乌帕替尼与阿布昔替尼均被多项国内外指南、专家共识推荐，故得分均为12.0分，
推荐内容见表3［1-3, 5, 12-14］。
3　临床疗效
在临床实际应用中，一般选定度普利尤单抗作为临床疗效评估的标准药物。乌帕替尼与度普利尤单抗头对头研究［15］显示，乌帕替尼组湿疹面积和严重程度指数（EASI）改善75%（EASI 75）、EASI 90或EASI 100应答率均优于度普利尤单抗。阿布昔替尼与度普利尤单抗头对头研究显示，阿布昔替尼200 mg每日1次治疗2周后，初始峰值瘙痒数值评定量表评分改善≥4分（PP-NRS4）应答率接近度普利尤单抗的2倍［16］，联合局部药物时瘙痒缓解作用显著优于度普利尤单抗［17］。此外，一项评价不同剂量靶向药物疗效及安全性的网状Meta分析显示，乌帕替尼30 mg·d-1皮损清除、瘙痒改善效果与阿布昔替尼200 mg·d-1相当，均优于其他靶向治疗［18］。对于重度AD患者，以局部药物（外用糖皮质激素或外用磷酸二酯酶4抑制剂等）作为背景治疗有利于更快应答，并延长缓解时间、降低复发风险［3］，研究显示阿布昔替尼联合局部治疗药物可明显提高疗效，而乌帕替尼增效不明显［5］。因此，乌帕替尼本项得9.0分，阿布昔替尼得10.0分。
安全性
1　不良反应
阿布昔替尼常见的不良事件包括恶心、鼻咽炎、头痛、上呼吸道感染和带状疱疹等（表4），多数为轻、中度，随餐服用可在一定程度上缓解恶心的发生，安全性总体可控。Meta分析显示，阿布昔替尼治疗期间不良反应发生率显著高于安慰剂组（RR=1.16,95%CI：1.10~1.37, P<0.001），但严重不良反应发生率与安慰剂组无明显差异（RR=1.08, 95%CI：0.97~1.21,P=0.170）［19］。
痤疮是乌帕替尼最常见的治疗紧急不良事件之一，主要包括炎性丘疹、脓疱和粉刺，试验数据提示发病率与乌帕替尼的剂量相关。此外，由于乌帕替尼在一定程度上影响JAK2通路，故中性粒细胞减少、贫血等血液系统不良反应需引起临床关注［11］。在严重不良反应方面，现有研究中心血管事件、癌症、血栓栓塞发生率较低，无死亡事件的相关报道［11］。故乌帕替尼本项得6分，阿布昔替尼得7分。
2　特殊人群
乌帕替尼与阿布昔替尼在妊娠期与哺乳期均禁用，乌帕替尼适用于12岁及以上且体重≥40 kg的青少年，对于肌酐清除率<30 mL·min-1的患者也可正常使用，优于阿布昔替尼，见表5。乌帕替尼本项得6.5分，阿布昔替尼得5分。
3　药物相互作用所致不良反应
乌帕替尼主要由细胞色素P450（CYP）3A4介导，因此联合强效CYP3A4抑制剂治疗时，乌帕替尼的推荐剂量为15 mg·d-1；不推荐与强 CYP3A4 诱导剂联合治疗。阿布昔替尼由多种CYP酶介导，其中主要是CYP2C19（约53%）、CYP2C9（约30%），因此对于正在服用强效CYP2C19抑制剂的患者，建议减量50%；不建议与强效CYP2C19或CYP2C9诱导剂联合使用，故两者得分均为1.0分。
4　其他
使用乌帕替尼和阿布昔替尼治疗的患者中均观察到淋巴瘤和其他恶性肿瘤，因此两者说明书黑框警示提示相关风险，故两者本项均不得分。
经济性
选择度普利尤单抗作为乌帕替尼和阿布昔替尼经济性评价的对照药，乌帕替尼与阿布昔替尼两者经济性显著优于度普利尤单抗，且两者间日均费用差别不大，见表6。
其他属性
乌帕替尼与阿布昔替尼均为国家谈判品种，按照医保乙类有支付条件限制，非基本药物与国家集中采购药品。乌帕替尼为艾伯维医药公司（全球制药50强第8名）生产的原研产品，在全球上市使用；阿布昔替尼为辉瑞制药公司（全球制药50强第1名）生产的原研产品，同样在全球上市使用。根据 《指南》，乌帕替尼和阿布昔替尼其他属性得分均为5.5分。
总分
综上，乌帕替尼和阿布昔替尼得分分别为80.5分和80.2分，乌帕替尼安全性得分高于阿布昔替尼，但有效性得分略低，见表7。
讨 论
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经量化评价发现，虽然乌帕替尼与阿布昔替尼均为选择性JAK抑制剂，但阿布昔替尼对于JAK1的选择性更好，由于对JAK2几乎无影响，故其血液系统不良反应发生率低于乌帕替尼。阿布昔替尼起效迅速，适用于追求迅速见效、建立信心的患者；临床试验中表现出明显的量-效相关性，便于临床上灵活调整方案；在联合外用糖皮质激素等药物时，阿布昔替尼疗效提高幅度优于乌帕替尼。然而，乌帕替尼适用人群范围更广，可用于12岁以上青少年、严重肾功能不全的患者。2 种选择性JAK 抑制剂在起效时间、瘙痒缓解及皮损清除方面均显著优于生物制剂，在经济方面的优势较为突出，但两者日均费用差别不大。综上，对于医疗机构药品遴选，两者均可“推荐”入选，但由于乌帕替尼除AD适应证外，还可用于治疗类风湿关节炎、银屑病关节炎、溃疡性结肠炎等疾病，受医院目录品种数限制，乌帕替尼在一定程度上更有优势。临床上合理选药，应根据患者年龄、自身肝肾功能、合并疾病，结合药物有效性及安全性等方面综合考虑。
基金
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  • 河北省自然科学基金(H2020307043)
  • 河北省医学科学研究课题(20240488)
文献
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doi: 10.14109/j.cnki.xyylc.2024.05.11
  • 接收时间：2023-11-20
  • 首发时间：2026-03-20
  • 出版时间：2024-05-25
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  • 收稿日期：2023-11-20
  • 录用日期：2024-04-23
基金
河北省自然科学基金(H2020307043)
河北省医学科学研究课题(20240488)
作者信息
    1.河北省人民医院　药学部，河北　石家庄　050057
    2.河北省中医院　药学部，河北　石家庄　050011
    3.河北省临床药学重点实验室，河北　石家庄　050051

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董占军
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https://castjournals.cast.org.cn/joweb/zgxyylczz/CN/10.14109/j.cnki.xyylc.2024.05.11
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
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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