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Article(id=1203061228437483533, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1203061212524290053, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.2023.01.0091, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1644163200000, receivedDateStr=2022-02-07, revisedDate=null, revisedDateStr=null, acceptedDate=1656345600000, acceptedDateStr=2022-06-28, onlineDate=1764761748655, onlineDateStr=2025-12-03, pubDate=1674835200000, pubDateStr=2023-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1764761748655, onlineIssueDateStr=2025-12-03, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1764761748655, creator=13701087609, updateTime=1764761748655, updator=13701087609, issue=Issue{id=1203061212524290053, tenantId=1146029695717560320, journalId=1189873630562394117, year='2023', volume='48', issue='1', pageStart='1', pageEnd='120', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1764761744816, creator=13701087609, updateTime=1764763211166, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1203067362732913657, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1203061212524290053, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1203067362732913658, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1203061212524290053, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=91, endPage=96, ext={EN=ArticleExt(id=1203061229465088020, articleId=1203061228437483533, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Application of tofacitinib in treatment of seven patients with anti-MDA5 autoantibody-positive dermatomyositis-associated with interstitial lung disease and literature review, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective By literature review to retrospectively study the clinical characteristics, diagnosis and treatment process, and prognosis of anti-melanoma differentiation associated gene 5 (MDA5) autoantibody-positive dermatomyositis-associated with interstitial lung disease (ILD) treated with tofacitinib (TOF), so as to improve the understanding of the disease. Methods Retrospectively analyze the clinical and laboratory characteristics, imaging findings and adverse reactions before and after TOF treatment in seven patients who admitted to the First Medical Center of Chinese PLA General Hospital from January 2018 to October 2021. Thirty-six cases were found by searching databases to summarize the efficacy and safety of TOF in treating patients with anti-MDA5 autoantibody-positive dermatomyositis-associated ILD. Results Of the 7 patients, 5 were female and 2 were male with mean age of 50(30-64) years, the mean disease duration was 3(1-36) months, and the mean follow-up time was 12(1-35) months. Of them, 4 received previously the other immunosuppressive therapy, and 3 were newly treated. One patient died, and the remaining 6 patients were in relatively stable condition and maintenance treatment. One patient experienced fungal infection in the 18th month after TOF treatment. A total of 36 cases of anti-MDA5 autoantibody-positive dermatomyositis have been reported in databases. Clinical symptoms, laboratory tests and imaging findings were all improved after TOF therapy. Opportunistic infection occurred in 9(25%) cases after application of TOF. Conclusion Application of TOF is an effective and safe regimen in treatment of anti-MDA5 autoantibody-positive dermatomyositis-associated ILD, while attention should be paid for monitoring the opportunistic infection during treatment.

, correspAuthors=Jian Zhu, authorNote=null, correspAuthorsNote=
E-mail:
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目的 报道7例经托法替布治疗的抗黑色素瘤分化相关基因蛋白5(MDA5)抗体阳性皮肌炎合并间质性肺病(ILD)患者的临床特点、诊治经过及预后并进行文献复习，以提高对该病的认识。方法 收集解放军总医院第一医学中心风湿免疫科2018年1月-2021年10月收治的7例MDA5抗体阳性皮肌炎合并ILD患者，回顾性分析其应用托法替布治疗前后的临床症状、实验室检查指标、影像学表现变化及不良反应发生情况。检索相关数据库，结合文献报道的36例患者，总结托法替布治疗MDA5抗体阳性皮肌炎合并ILD的有效性及安全性。结果 7例患者中5例为女性，2例为男性；年龄50(30~64)岁，病程3(1~36)个月，随访时间12(1~35)个月。7例中有4例既往曾接受其他免疫抑制剂治疗，3例为初治患者。1例死亡，6例病情稳定，维持治疗。1例患者在使用托法替布后的第18个月出现真菌感染。国内外报道托法替布治疗MDA5抗体阳性皮肌炎合并ILD患者共36例，治疗后临床症状、实验室检查指标及影像学表现均有改善，应用托法替布后9例(25%)发生机会性感染。结论 托法替布治疗MDA5抗体阳性皮肌炎合并ILD的疗效显著，但在治疗期间应注意监测机会性感染。

, correspAuthors=朱剑, authorNote=null, correspAuthorsNote=
朱剑，E-mail：
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李华，医学硕士，主治医师，主要从事常见风湿病的临床研究

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李华，医学硕士，主治医师，主要从事常见风湿病的临床研究

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Rheumatology(Oxford), 2014, 53(12): 2196-2203., articleTitle=Cytokine profiles in polymyositis and dermatomyositis complicated by rapidly progressive or chronic interstitial lung disease, refAbstract=null), Reference(id=1203061251367744365, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, doi=null, pmid=null, pmcid=null, year=2016, volume=75, issue=10, pageStart=1843, pageEnd=1847, url=null, language=null, rfNumber=[24], rfOrder=25, authorNames=Curtis JR, Xie F, Yun H, journalName=Ann Rheum Dis, refType=null, unstructuredReference=Curtis JR, Xie F, Yun H, et al. Real-world comparative risks of Herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis[J]. Ann Rheum Dis, 2016, 75(10): 1843-1847., articleTitle=Real-world comparative risks of Herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis, refAbstract=null), Reference(id=1203061251623596918, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, doi=null, pmid=null, pmcid=null, year=2019, volume=71, issue=9, pageStart=1249, pageEnd=1254, url=null, language=null, rfNumber=[25], rfOrder=26, authorNames=Curtis JR, Xie FL, Yang S, journalName=Arthritis Care Res (Hoboken), refType=null, unstructuredReference=Curtis JR, Xie FL, Yang S, et al. Risk for Herpes zoster in tofacitinib-treated rheumatoid arthritis patients with and without concomitant methotrexate and glucocorticoids[J]. 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Chest, 2013, 144(6): 1934-1936., articleTitle=Successful polymyxin B hemoperfusion treatment associated with serial reduction of serum anti-CADM-140/MDA5 antibody levels in rapidly progressive interstitial lung disease with amyopathic dermatomyositis, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1203061236880617613, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, xref=1, ext=[AuthorCompanyExt(id=1203061236914172046, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, companyId=1203061236880617613, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1Department of Rheumatology and Immunology, the First Medical Center of Chinese PLA General Hospital, Beijing 100853, China), AuthorCompanyExt(id=1203061236964503695, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, companyId=1203061236880617613, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1解放军总医院第一医学中心风湿免疫科，北京 100853)]), AuthorCompany(id=1203061237954359450, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, xref=2, ext=[AuthorCompanyExt(id=1203061237975330973, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, companyId=1203061237954359450, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2Department of Rheumatology and Immunology, the First Hospital of Yulin, Yulin, Shaanxi 719000, China), AuthorCompanyExt(id=1203061238004691104, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, companyId=1203061237954359450, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2榆林市第一医院肾病风湿免疫科，陕西榆林 719000)]), AuthorCompany(id=1203061238231183525, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, xref=3, ext=[AuthorCompanyExt(id=1203061238268932262, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, companyId=1203061238231183525, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3Department of Rheumatology and Immunology, Hainan Hospital of Chinese PLA General Hospital, Sanya, Hainan 572013, China), AuthorCompanyExt(id=1203061238352818349, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, companyId=1203061238231183525, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3解放军总医院海南医院风湿免疫科，海南三亚 572013)])], figs=[ArticleFig(id=1203061245084676725, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=EN, label=Fig. 1, caption=Changes of laboratory indicators before and after TOF treatment for anti-MDA5 autoantiboby-positive dermatomgositis-associated with ILD, figureFileSmall=iFgOkMfRWztmLyEKhInRMQ==, figureFileBig=qq7fOW/9XzageV6M1skkgg==, tableContent=null), ArticleFig(id=1203061245181145726, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=CN, label=图1, caption=MDA5抗体阳性皮肌炎合并ILD 7例TOF治疗前后实验室指标变化

ILD. 间质性肺病；SpO2. 血氧分压；SpCO2. 二氧化碳分压；CK. 肌酸激酶；CRP. C反应蛋白；TOF. 托法替布

, figureFileSmall=iFgOkMfRWztmLyEKhInRMQ==, figureFileBig=qq7fOW/9XzageV6M1skkgg==, tableContent=null), ArticleFig(id=1203061245759959698, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=EN, label=Fig. 2, caption=Changes of rash and pulmonary CT before (A, B, C, D) and after (E, F, G, H) TOF treatment for anti-MDA5 autoantiboby-positive dermatomgositis-associated with ILD, figureFileSmall=QSSBEkQXhcw8SdcF7Ao1rw==, figureFileBig=m2B5eDXRb1QNMF+RJbKNWw==, tableContent=null), ArticleFig(id=1203061246863061660, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=CN, label=图2, caption=MDA5抗体阳性皮肌炎合并ILD托法替布治疗前(A、B、C、D)与治疗后(E、F、G、H)皮疹和肺CT变化

ILD. 间质性肺病；A、E为例4在加用TOF前及加用TOF 2周后的皮疹变化；B、F为例4在加用TOF前及加用TOF 3个月后肺间质病变的变化；C、G为例5加用TOF前及加用TOF 1个月后肺间质病变的变化；D、H为例2加用TOF前及加用TOF 2周后肺间质病变的变化

, figureFileSmall=QSSBEkQXhcw8SdcF7Ao1rw==, figureFileBig=m2B5eDXRb1QNMF+RJbKNWw==, tableContent=null), ArticleFig(id=1203061246997279396, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=EN, label=Tab. 1, caption=

Baseline data and clinical features of seven patients with anti-MDA5 autoantibody-positive dermatomyositis

, figureFileSmall=null, figureFileBig=null, tableContent=
患者编号年龄(岁)性别病程(月)随访(月)临床表现呼吸道表现胸部CT表现既往治疗目前治疗预后及不良反应
161女135乏力、发热、Gottron征、向阳性皮疹、吞咽困难、肌力减低病程第42天出现胸闷、气短双肺胸膜下斑片状、索条状高密度影激素+TAC激素4 mg/d+TOF 5 mg/d存活，病程18个月出现真菌感染
262男361乏力、Gottron征、向阳性皮疹、吞咽困难、肌力减低病程第35个月出现进行性胸闷、气短胸膜下区可见蜂窝及网格样改变激素+TAC死亡入院第39天自动出院，出院当天死亡
349女246发热、乏力、皮疹、肌无力病程第24个月出现活动后气短双肺胸膜下见多发斑片影及索条影激素+MMF激素10 mg/d+TOF 10 mg/d存活，临床症状缓解、ILD改善
450男96乏力、Gottron征、向阳性皮疹病程第7个月出现发热、咳嗽、咳痰双肺胸膜下片状、斑片状高密度影激素+CTX激素40 mg+TAC 0.2g/d+TOF 10 mg/d存活，临床症状缓解，ILD改善不明显
564女120乏力、发热、Gottron征、枪套征、向阳性皮疹、技工手、肌痛、吞咽困难病程第5天出现活动后气短明显双肺外周多发磨玻璃密度影无激素4 mg/d+TOF 5 mg/d存活，临床症状缓解、ILD改善
630女314乏力、Gottron征、技工手、关节痛无双肺下叶胸膜下斑片影无激素4 mg/d+TOF 5 mg/d存活，临床症状缓解、ILD改善
747女312乏力、Gottron征、枪套征、向阳性皮疹、技工手、脱发、关节痛、肌力减低无双肺下叶条片状高密度影，机化性肺炎可能无激素2 mg/d+TOF 5 mg/d存活，临床症状缓解、ILD改善
), ArticleFig(id=1203061247097942697, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=CN, label=表1, caption=

7例MDA5抗体阳性皮肌炎患者的一般资料

, figureFileSmall=null, figureFileBig=null, tableContent=
患者编号年龄(岁)性别病程(月)随访(月)临床表现呼吸道表现胸部CT表现既往治疗目前治疗预后及不良反应
161女135乏力、发热、Gottron征、向阳性皮疹、吞咽困难、肌力减低病程第42天出现胸闷、气短双肺胸膜下斑片状、索条状高密度影激素+TAC激素4 mg/d+TOF 5 mg/d存活，病程18个月出现真菌感染
262男361乏力、Gottron征、向阳性皮疹、吞咽困难、肌力减低病程第35个月出现进行性胸闷、气短胸膜下区可见蜂窝及网格样改变激素+TAC死亡入院第39天自动出院，出院当天死亡
349女246发热、乏力、皮疹、肌无力病程第24个月出现活动后气短双肺胸膜下见多发斑片影及索条影激素+MMF激素10 mg/d+TOF 10 mg/d存活，临床症状缓解、ILD改善
450男96乏力、Gottron征、向阳性皮疹病程第7个月出现发热、咳嗽、咳痰双肺胸膜下片状、斑片状高密度影激素+CTX激素40 mg+TAC 0.2g/d+TOF 10 mg/d存活，临床症状缓解，ILD改善不明显
564女120乏力、发热、Gottron征、枪套征、向阳性皮疹、技工手、肌痛、吞咽困难病程第5天出现活动后气短明显双肺外周多发磨玻璃密度影无激素4 mg/d+TOF 5 mg/d存活，临床症状缓解、ILD改善
630女314乏力、Gottron征、技工手、关节痛无双肺下叶胸膜下斑片影无激素4 mg/d+TOF 5 mg/d存活，临床症状缓解、ILD改善
747女312乏力、Gottron征、枪套征、向阳性皮疹、技工手、脱发、关节痛、肌力减低无双肺下叶条片状高密度影，机化性肺炎可能无激素2 mg/d+TOF 5 mg/d存活，临床症状缓解、ILD改善
), ArticleFig(id=1203061247202800302, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=EN, label=Tab. 2, caption=

Treatment of anti-MDA5 autoantibody-positive dermatomyositis-associated with interstitial lung disease (ILD) with TOF reported in previous literatur

, figureFileSmall=null, figureFileBig=null, tableContent=
文献例数男/女(例)平均年龄(岁)随访时间(月)临床表现既往治疗治疗加用TOF时间及剂量预后及不良反应
Hosokawa等[8]10/16612咳嗽、呼吸困难、皮疹、肌肉无力激素+TAC入院第66天加用TOF 10 mg存活1年
Ishikawa等[9]10/15712皮疹、皮肤、溃疡、关节痛激素+TAC入院第1天加用TOF 10 mg存活1年
Ohmura等[10]11/0556发烧、咳嗽、皮疹、肌痛激素+TAC入院第38天加用TOF 10 mg，第63天TOF加至20 mgCMV感染、存活6个月
Takatani等[11]10/15610皮疹、肌痛激素+CyA入院第170天加用TOF 10 mg存活10个月
Chen等[4]187/1147.618未提及初治入院第1天激素联合TOF 10 mg1例真菌感染、1例尿路感染，全部存活
Wendel等[7]10/155 7 皮疹、关节痛、呼吸困难、发热、浮肿、吞咽困难、肌痛、肌肉无力激素+TAC入院第1天加用TOF 10 mg存活7个月
Kato等[12]11/0448皮肤皮疹、呼吸困难激素+TAC入院第56天加用TOF 10 mg存活8个月
Kurasawa[6]52/360.611.3皮疹、肌肉无力、关节痛、发热激素+CyA分别于入院第5、7、10、13、15天加用TOF 10 mg5例均感染CMV，4例细菌性肺炎，3例带状疱疹，2例真菌感染，1例脓毒血症，最终2例死亡
唐宁等[13]11/0488咳嗽伴活动后气喘初治入院第4天激素加用TOF 10 mg存活
吴燕芳等[5]51/4446皮疹Gottorn征、溃疡性皮疹2例初诊，3例既往激素+免疫抑制入院后加用激素、环磷酰胺、TOF 10 mg1例死亡、1例带状疱疹
Takanashi等[14]11/0482.3皮疹、关节痛激素+MMF入院第27天加用TOF 10 mg细菌性肺炎、脓毒血症、真菌感染，69 d后死亡
), ArticleFig(id=1203061247307657911, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1203061228437483533, language=CN, label=表2, caption=

文献报道TOF治疗MDA5抗体阳性皮肌炎合并ILD患者的情况

, figureFileSmall=null, figureFileBig=null, tableContent=
文献例数男/女(例)平均年龄(岁)随访时间(月)临床表现既往治疗治疗加用TOF时间及剂量预后及不良反应
Hosokawa等[8]10/16612咳嗽、呼吸困难、皮疹、肌肉无力激素+TAC入院第66天加用TOF 10 mg存活1年
Ishikawa等[9]10/15712皮疹、皮肤、溃疡、关节痛激素+TAC入院第1天加用TOF 10 mg存活1年
Ohmura等[10]11/0556发烧、咳嗽、皮疹、肌痛激素+TAC入院第38天加用TOF 10 mg，第63天TOF加至20 mgCMV感染、存活6个月
Takatani等[11]10/15610皮疹、肌痛激素+CyA入院第170天加用TOF 10 mg存活10个月
Chen等[4]187/1147.618未提及初治入院第1天激素联合TOF 10 mg1例真菌感染、1例尿路感染，全部存活
Wendel等[7]10/155 7 皮疹、关节痛、呼吸困难、发热、浮肿、吞咽困难、肌痛、肌肉无力激素+TAC入院第1天加用TOF 10 mg存活7个月
Kato等[12]11/0448皮肤皮疹、呼吸困难激素+TAC入院第56天加用TOF 10 mg存活8个月
Kurasawa[6]52/360.611.3皮疹、肌肉无力、关节痛、发热激素+CyA分别于入院第5、7、10、13、15天加用TOF 10 mg5例均感染CMV，4例细菌性肺炎，3例带状疱疹，2例真菌感染，1例脓毒血症，最终2例死亡
唐宁等[13]11/0488咳嗽伴活动后气喘初治入院第4天激素加用TOF 10 mg存活
吴燕芳等[5]51/4446皮疹Gottorn征、溃疡性皮疹2例初诊，3例既往激素+免疫抑制入院后加用激素、环磷酰胺、TOF 10 mg1例死亡、1例带状疱疹
Takanashi等[14]11/0482.3皮疹、关节痛激素+MMF入院第27天加用TOF 10 mg细菌性肺炎、脓毒血症、真菌感染，69 d后死亡
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托法替布治疗MDA5抗体阳性皮肌炎合并间质性肺病7例并文献复习
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李华 1, 2 , 赵玉荣 1 , 刘晓飞 3 , 廖思敏 1 , 周博 1 , 杨春花 1 , 李坤鹏 1 , 邓小虎 1 , 张江林 1 , 黄烽 1 , 朱剑 1, *
解放军医学杂志 | 临床研究 2023,48(1): 91-96
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解放军医学杂志 | 临床研究 2023, 48(1): 91-96
托法替布治疗MDA5抗体阳性皮肌炎合并间质性肺病7例并文献复习
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李华1, 2, 赵玉荣1, 刘晓飞3, 廖思敏1, 周博1, 杨春花1, 李坤鹏1, 邓小虎1, 张江林1, 黄烽1, 朱剑1, *
作者信息
  • 1解放军总医院第一医学中心风湿免疫科，北京 100853
  • 2榆林市第一医院肾病风湿免疫科，陕西榆林 719000
  • 3解放军总医院海南医院风湿免疫科，海南三亚 572013

    • 李华，医学硕士，主治医师，主要从事常见风湿病的临床研究

通讯作者:

朱剑，E-mail：
Application of tofacitinib in treatment of seven patients with anti-MDA5 autoantibody-positive dermatomyositis-associated with interstitial lung disease and literature review
Hua Li1, 2, Yu-Rong Zhao1, Xiao-Fei Liu3, Si-Min Liao1, Bo Zhou1, Chun-Hua Yang1, Kun-Peng Li1, Xiao-Hu Deng1, Jiang-Lin Zhang1, Feng Huang1, Jian Zhu1, *
Affiliations
  • 1Department of Rheumatology and Immunology, the First Medical Center of Chinese PLA General Hospital, Beijing 100853, China
  • 2Department of Rheumatology and Immunology, the First Hospital of Yulin, Yulin, Shaanxi 719000, China
  • 3Department of Rheumatology and Immunology, Hainan Hospital of Chinese PLA General Hospital, Sanya, Hainan 572013, China
出版时间: 2023-01-28 doi: 10.11855/j.issn.0577-7402.2023.01.0091
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摘要
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目的 报道7例经托法替布治疗的抗黑色素瘤分化相关基因蛋白5(MDA5)抗体阳性皮肌炎合并间质性肺病(ILD)患者的临床特点、诊治经过及预后并进行文献复习，以提高对该病的认识。方法 收集解放军总医院第一医学中心风湿免疫科2018年1月-2021年10月收治的7例MDA5抗体阳性皮肌炎合并ILD患者，回顾性分析其应用托法替布治疗前后的临床症状、实验室检查指标、影像学表现变化及不良反应发生情况。检索相关数据库，结合文献报道的36例患者，总结托法替布治疗MDA5抗体阳性皮肌炎合并ILD的有效性及安全性。结果 7例患者中5例为女性，2例为男性；年龄50(30~64)岁，病程3(1~36)个月，随访时间12(1~35)个月。7例中有4例既往曾接受其他免疫抑制剂治疗，3例为初治患者。1例死亡，6例病情稳定，维持治疗。1例患者在使用托法替布后的第18个月出现真菌感染。国内外报道托法替布治疗MDA5抗体阳性皮肌炎合并ILD患者共36例，治疗后临床症状、实验室检查指标及影像学表现均有改善，应用托法替布后9例(25%)发生机会性感染。结论 托法替布治疗MDA5抗体阳性皮肌炎合并ILD的疗效显著，但在治疗期间应注意监测机会性感染。

皮肌炎  /  间质性肺病  /  抗黑色素瘤分化相关基因蛋白5  /  托法替布

Objective By literature review to retrospectively study the clinical characteristics, diagnosis and treatment process, and prognosis of anti-melanoma differentiation associated gene 5 (MDA5) autoantibody-positive dermatomyositis-associated with interstitial lung disease (ILD) treated with tofacitinib (TOF), so as to improve the understanding of the disease. Methods Retrospectively analyze the clinical and laboratory characteristics, imaging findings and adverse reactions before and after TOF treatment in seven patients who admitted to the First Medical Center of Chinese PLA General Hospital from January 2018 to October 2021. Thirty-six cases were found by searching databases to summarize the efficacy and safety of TOF in treating patients with anti-MDA5 autoantibody-positive dermatomyositis-associated ILD. Results Of the 7 patients, 5 were female and 2 were male with mean age of 50(30-64) years, the mean disease duration was 3(1-36) months, and the mean follow-up time was 12(1-35) months. Of them, 4 received previously the other immunosuppressive therapy, and 3 were newly treated. One patient died, and the remaining 6 patients were in relatively stable condition and maintenance treatment. One patient experienced fungal infection in the 18th month after TOF treatment. A total of 36 cases of anti-MDA5 autoantibody-positive dermatomyositis have been reported in databases. Clinical symptoms, laboratory tests and imaging findings were all improved after TOF therapy. Opportunistic infection occurred in 9(25%) cases after application of TOF. Conclusion Application of TOF is an effective and safe regimen in treatment of anti-MDA5 autoantibody-positive dermatomyositis-associated ILD, while attention should be paid for monitoring the opportunistic infection during treatment.

dermatomyositis  /  interstitial lung disease  /  melanoma differentiation associated gene 5  /  tofacitinib
李华, 赵玉荣, 刘晓飞, 廖思敏, 周博, 杨春花, 李坤鹏, 邓小虎, 张江林, 黄烽, 朱剑. 托法替布治疗MDA5抗体阳性皮肌炎合并间质性肺病7例并文献复习. 解放军医学杂志, 2023 , 48 (1) : 91 -96 . DOI: 10.11855/j.issn.0577-7402.2023.01.0091
Hua Li, Yu-Rong Zhao, Xiao-Fei Liu, Si-Min Liao, Bo Zhou, Chun-Hua Yang, Kun-Peng Li, Xiao-Hu Deng, Jiang-Lin Zhang, Feng Huang, Jian Zhu. Application of tofacitinib in treatment of seven patients with anti-MDA5 autoantibody-positive dermatomyositis-associated with interstitial lung disease and literature review[J]. Medical Journal of Chinese People’s Liberation Army, 2023 , 48 (1) : 91 -96 . DOI: 10.11855/j.issn.0577-7402.2023.01.0091
正文
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抗黑色素瘤分化相关基因蛋白5(MDA5)抗体阳性皮肌炎是一种罕见的炎症性肌病亚型，可见典型皮肌炎的皮肤表现，常快速进展，可发展为致死性的间质性肺病(ILD)，治疗成功率低[1]。该病的治疗以糖皮质激素和免疫抑制剂为主，托法替布(TOF)是目前尝试用于MDA5抗体阳性皮肌炎合并肺间质病变的治疗药物之一，但文献报道较少。本研究对TOF治疗的7例MDA5抗体阳性皮肌炎合并ILD患者的临床特点及疗效、安全性进行总结，并复习国内外关于TOF治疗MDA5抗体阳性皮肌炎合并ILD的文献，以提高临床医师对该病的认识。
1 病例资料
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1.1 一般资料
收集2018年11月-2021年10月解放军总医院第一医学中心风湿免疫科收治的7例应用TOF治疗的MDA5抗体阳性皮肌炎合并ILD患者的临床资料。皮肌炎的诊断基于2017年欧洲抗风湿病联盟/美国风湿病学会(EULAR/ACR)成人和青少年特发性炎症性肌病及其主要亚组的分类标准[2]，抗MDA5抗体阳性；ILD的诊断基于2013年美国胸科学会/欧洲呼吸病学会(ATS/ERS)标准[3]。本研究获解放军总医院第一医学中心伦理委员会审批(S2016-141-02)。
1.2 治疗
7例中有4例既往接受激素联合免疫抑制剂治疗，其中2例接受他克莫司(tacrolimus，TAC)、1例接受霉酚酸酯(mycophenolate mofetil，MMF)、1例接受环磷酰胺(cyclophosphamide，CTX)治疗。例1既往接受甲泼尼龙60 mg+TAC 1 mg 2次/d治疗，在病程的第42天，肺间质病变加重，加用TOF 5 mg(2次/d)，目前甲泼尼龙维持剂量4 mg/d、TOF 5 mg/d，于病程第18个月出现真菌感染。例2既往接受甲泼尼龙200 mg×3 d、80 mg×3 d静滴治疗后改为口服48 mg/d、TAC 2 mg/d，在治疗的第14天，双肺间质病变加重，加用TOF 5 mg 2次/d治疗后胸闷气短好转，第24天合并纵隔气肿及肠道感染，第38天出现大汗、血压下降、心率增快、血白蛋白降低，考虑毛细血管渗漏综合征可能，第39天死亡。例6既往接受甲泼尼龙40 mg/d口服，MMF 0.75 g 2次/d，在病程的第24个月出现气短，加用TOF 5 mg 2次/d，随访的第6个月甲泼尼龙减量至10 mg/d、TOF 5 mg 2次/d、硫酸羟氯喹0.2 g 2次/d维持；例7既往接受甲泼尼龙40 mg+CTX 0.8 g/2周，甲泼尼龙减量为8 mg/d，CTX累积剂量达6 g时，肺间质病变加重，调整甲泼尼龙为24 mg/d、加用TOF 5 mg 2次/d，甲泼尼龙减量为9 mg/d后疾病复发，目前服用甲泼尼龙36 mg/d、TAC 1 mg 2次/d、TOF 5 mg 2次/d治疗。另3例为初治患者，其中，例3确诊后在甲泼尼龙40 mg/d的基础上加用TOF 5 mg 2次/d、硫酸羟氯喹0.2 g 2次/d；例4入院第15天在甲泼尼龙24 mg/d基础上加用TOF 5 mg 2次/d、硫酸羟氯喹0.2 g 2次/d；例5入院第2天在甲泼尼龙40 mg/d基础上加用TOF 5 mg 2次/d、硫酸羟氯喹0.2 g 2次/d(表1)。
1.3 临床转归及不良反应
1.3.1 临床转归
7例在加用TOF前后血气分析：氧分压由66.9(52.4~84.7) mmHg升至82.1(70.2~93.3) mmHg，二氧化碳分压由39.1(29.9~46.3) mmHg至39.8(25.9~46.6) mmHg；肌酸激酶由69.9(17.4~971.2) U/L降至37.5(17.4~107.9) U/L；C反应蛋白由0.66(0.05~1.6) mg/dl降至0.1(0.05~22.37) mg/dl；铁蛋白由2328.5 (61~8227) ng/ml降至1957(142~3712) ng/ml(图1)。7例中例1死亡，其余6例病情平稳。最长随访时间35个月。患者经TOF治疗后，皮疹明显消退，且CT检查可见肺间质病变较治疗前明显减轻(图2)。
1.3.2 不良反应
7例中1例在治疗的第18个月时出现真菌感染，经伏立康唑抗感染治疗2周后好转。
2 文献检索与复习
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中文以“皮肌炎”“MDA5”“托法替布”“间质性肺病”，英文以“dermatomyositis”“MDA5”“tofacitinib”“interstital lung disease”为关键词，在中国知网、万方知识服务平台、PubMed等数据库中检索出中文文献2篇(1篇论著、1篇个案报道)、英文文献42篇。经获取全文，筛选出论著4篇[其中上海仁济医院团队开展的单中心、开放性临床试验纳入了18例[4]，中国福建医科大学报道5例[5]，日本报道5例[6]，德国报道1例[7]]，另有7篇个案报道(共7例)[8-14]。共纳入36例患者，其中男14例(38.9%)，女22例(61.1%)，中位年龄50.5(19~75)岁，随访时间7 d~24个月，中位时间18个月。36例中，21例为初治患者，15例既往曾接受激素及免疫抑制剂治疗[其中6例激素联合环孢素、5例激素联合TAC、3例激素联合免疫抑制剂(未注明)、1例激素联合MMF]。36例中位随访6个月的生存率为88.9%(32/36)，1例初治患者在病程的第7天合并纵隔气肿，因呼吸衰竭死亡，3例既往接受免疫抑制剂治疗的患者在病程第55、49、69天死亡。其中，Chen等[4]的队列研究纳入的18例初治患者的治疗方案为激素联合TOF 5 mg 2次/d，观察6个月后，患者不仅全部存活，而且铁蛋白水平较治疗前下降，肺功能及高分辨率CT影像表现较治疗前改善，与同期只接受激素组的34例患者比较生存率明显增高(100% vs. 78%，P=0.0363)。吴燕芳等[5]报道的5例均接受激素80 mg/d、CTX 0.8 g/月、TOF 5 mg 2次/d治疗，其中2例为初治患者，与同期只接受激素及CTX治疗的8例患者相比，接受TOF治疗的患者中仅1例死亡，而未接受TOF的8例患者中有6例死亡；该研究还发现，随访6个月后存活的4例患者的实验室指标、肺功能、氧合分数、影像学表现均有所改善。此外，36例中9例(25.0%)在TOF联合糖皮质激素和免疫抑制剂治疗过程中发生机会性感染，其中巨细胞病毒感染6例(16.7%)，细菌性肺炎5例(13.9%)，真菌感染4例(11.1%)，带状疱疹4例(11.1%)，脓毒血症2例(5.6%)。其他相关不良事件包括纵隔气肿2例(5.6%)、淋巴细胞减少1例(2.8%)(表2)。
3 讨论
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MDA5抗体最初发现于临床无肌病皮肌炎患者中，是一种由IFIH1基因编码、存在于细胞质中的RNA解旋酶[15-16]。此抗体与快速进展的ILD及无肌病肌炎相关，并与预后不良相关。研究发现，MDA5抗体阳性皮肌炎合并ILD的急性患者即使给予积极治疗，仍有高达72%的患者在1~2个月后死于呼吸衰竭[3]；慢性患者大多数经治疗后病情可稳定，少数病情仍迁延进展，预后极差，病死率可高达31.7%~45.0%[17-18]。本病目前尚无明确有效的治疗方案，且预后较差，是风湿科的一大难题。国内外各医疗机构一直在进行相关探索，目前已有多种治疗方案被报道，如糖皮质激素、钙调神经磷酸酶抑制剂和静脉CTX治疗[6]、利妥昔单抗[7]和血浆置换联合免疫抑制方案[12]，但效果均不理想。
越来越多的研究表明，Ⅰ型和Ⅱ型干扰素在青少年和成人型皮肌炎中具有重要作用，在肌肉、皮肤和血液中Ⅰ型干扰素基因表达上调[16,19]。α-干扰素的过度表达也可能导致MDA5抗体阳性的肺部疾病特征，且更易表现为弥漫性ILD，较其他类型的皮肌炎更严重[20]。MDA5是先天免疫反应的一部分，通过释放干扰素和肿瘤坏死因子-α引发Ⅰ型免疫反应，从而导致细胞因子风暴。TOF是一种蛋白酪氨酸激酶(JAK)抑制剂，通过抑制JAK1和JAK3来抑制多种细胞因子及分子，目前已尝试用于MDA5抗体阳性皮肌炎合并ILD的治疗[21-22]。MDA5抗体阳性皮肌炎合并ILD的发病机制尚未完全阐明，但已有研究发现，伴ILD的特发性炎性肌病患者的白细胞介素(IL)-4、IL-6和IL-10水平明显高于不伴ILD的患者，这些分子的信号传导是由JAK1和JAK3介导的，表明在理论上TOF可能对MDA5抗体阳性ILD有效[23]。最近一项队列研究通过18例MDA5抗体阳性皮肌炎合并ILD患者观察了TOF的疗效，结果显示，18例患者在TOF治疗6个月后全部存活，TOF组的6个月累积生存率(100%)明显高于基线条件匹配的历史对照组(78%)[4]。另有研究发现，接受激素、CTX联合TOF治疗的5例MDA5抗体阳性合并ILD患者中4例存活，而同期入院仅接受激素和CTX治疗的8例MDA5抗体阳性合并ILD患者，治疗6个月后仅2例存活[5]。本研究发现，7例MDA5抗体阳性皮肌炎患者中，4例病程<6个月者出现肺CT间质改变，其中2例出现了呼吸道症状，但在加用TOF后，无论是呼吸道症状还是肺CT间质改变均明显缓解；3例病程>6个月的患者在治疗中出现进行性的呼吸困难及肺CT间质病变较前加重，而加用TOF后呼吸道症状及肺间质性病变也得到缓解；此外，7例经TOF治疗后实验室检查指标(血气分析、C反应蛋白、铁蛋白、肌酸激酶)均较治疗前改善，仅1例死亡，其余6例均存活，存活率85.7%。上述结果表明，TOF对MDA5抗体阳性皮肌炎合并ILD患者具有较好的治疗效果，JAK通路有望成为MDA5抗体阳性皮肌炎合并ILD新的治疗靶点。
有研究显示，TOF使用期间带状疱疹的发生率会增高[24]，且当TOF联合糖皮质激素治疗时风险可增加1倍[25]。此外，有研究发现，当淋巴细胞绝对计数下降时，结核病、肺炎和尿路感染等的发生风险也会增加，尤其是当淋巴细胞计数<500个/mm3时[23,26]。本研究7例患者中1例发生真菌感染，1例在治疗过程中出现纵隔气肿，可能伴肠道感染。而文献报道的36例患者中，9例发生机会性感染，其中巨细胞病毒感染6例(16.7%)、带状疱疹4例(11.1%)。其他相关的不良事件有细菌性肺炎、真菌感染、脓毒血症、纵隔气肿、淋巴细胞减少等。因此，在TOF治疗期间应注意监测血细胞的动态变化，出现异常时须积极处理。对于机会性感染的常规预防用药是否能降低患者的死亡率及感染率仍有待进一步研究。
本研究为单中心回顾性研究，病例数仅7例，其中1例死亡，随访时间不等，最短仅6个月，最长35个月；部分患者在病情稳定后仅需小剂量激素及TOF 5 mg/d维持治疗，均表现出良好的疗效，但仍需进一步通过大样本前瞻性对照试验来证实TOF对MDA5抗体阳性皮肌炎合并ILD的疗效。此外，本研究中有1例合并真菌感染，因此在TOF治疗期间应密切监测机会性感染的发生情况。
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doi: 10.11855/j.issn.0577-7402.2023.01.0091
  • 接收时间：2022-02-07
  • 首发时间：2025-12-03
  • 出版时间：2023-01-28
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  • 收稿日期：2022-02-07
  • 录用日期：2022-06-28
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    1解放军总医院第一医学中心风湿免疫科，北京 100853
    2榆林市第一医院肾病风湿免疫科，陕西榆林 719000
    3解放军总医院海南医院风湿免疫科，海南三亚 572013

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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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