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Article(id=1190310109550056229, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1190243275249390089, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.0911.2025.0219, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1719158400000, receivedDateStr=2024-06-24, revisedDate=null, revisedDateStr=null, acceptedDate=1722787200000, acceptedDateStr=2024-08-05, onlineDate=1761721645009, onlineDateStr=2025-10-29, pubDate=1748361600000, pubDateStr=2025-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1761721645009, onlineIssueDateStr=2025-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1761721645009, creator=13701087609, updateTime=1761721645009, updator=13701087609, issue=Issue{id=1190243275249390089, tenantId=1146029695717560320, journalId=1189873630562394117, year='2025', volume='50', issue='5', pageStart='505', pageEnd='640', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1761705710470, creator=13701087609, updateTime=1765784077922, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1207349188233372409, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1190243275249390089, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1207349188233372410, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1190243275249390089, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=545, endPage=552, ext={EN=ArticleExt(id=1190310109847851815, articleId=1190310109550056229, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Systematic review of biologic therapy safety in pregnant and breastfeeding psoriasis patients, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective To systematically review and quantitatively analyze the safety of biologic agents for the clinical treatment of psoriasis during pregnancy and lactation. Methods The literature from start of database to June 27, 2023, was searched in MEDLINE (PubMed), Embase, Cochrane Library, and Web of Science by two researcher. Quality of included studies was assessed by the quality evaluation tool of case series from Australian JBI Evidence Based Healthcare Centre. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), a systematic review and was conducted to assess pregnancy or breastfeeding outcomes in psoriasis patients exposed to biologics within 3 months prior to pregnancy, during pregnancy or breastfeeding. Data on pregnancy and exposure characteristics were pooled, and the prevalence of adverse pregnancy outcome was summarized using a random effects model. Results A total of 54 studies involving 1206 pregnancies in 1177 female patients with psoriasis exposed to biologic agents were included in the analysis. Systematic review results demonstrated that the majority of the exposures were limited to early pregnancy, with pooled spontaneous abortion rates, elective abortion rates, overall mortality, preterm birth rates, incidence of low birth weights, and congenital anomalies similar to those of general population (P>0.05). Furthermore, no serious adverse reactions were reported during lactation. Conclusions The use of biologic agents in pregnant and breastfeeding women with psoriasis does not significantly increase the risk of adverse pregnancy outcomes and does not affect neonatal health or growth. However, the limited available safety data underscores the necessity of further studies to establish the relationship between psoriasis, biologic agents, and pregnancy/lactation outcomes, thereby providing comprehensive guidance for clinical practice.

, correspAuthors=Xiao-Yan Zhang, authorNote=null, correspAuthorsNote=
E-mail:
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目的 基于既往文献报道的系统回顾及定量分析，评估生物制剂用于妊娠期及哺乳期银屑病临床治疗的安全性。方法 由两名研究人员独立检索文献数据库MEDLINE(PubMed)、Embase、Cochrane Library和Web of Science建库以来至2023年6月27日收录的相关文献，采用澳大利亚JBI循证卫生保健中心病例系列的质量评价工具评估纳入文献的质量；遵循系统评价和Meta分析的优先报告条目(PRISMA)指南，选取妊娠前3个月内、妊娠期或哺乳期暴露于生物制剂的银屑病患者的妊娠或哺乳结局的研究报告进行系统评价。汇总分析其妊娠及暴露特征，并使用随机效应模型汇总各不良妊娠结局的发生率。结果 共纳入54项研究，包括1177例女性患者1206次暴露于生物制剂的妊娠。系统评价结果显示，多数暴露仅限于妊娠早期，汇总自然流产率、选择性流产率、总死亡率、早产率、低出生体重发生率、先天异常发生率均与一般人群相近(P>0.05)，哺乳期用药未报告严重的不良反应。结论 妊娠及哺乳期女性银屑病患者使用生物制剂导致的不良妊娠结局未见明显增加，对新生儿健康及生长发育未见明显影响。但目前相关安全性数据有限，仍需要更多研究来确定银屑病、生物制剂以及妊娠/哺乳结局之间的关系，以指导临床诊疗。

, correspAuthors=张晓艳, authorNote=null, correspAuthorsNote=
张晓艳，E-mail：
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李宗阳，博士研究生，主要从事银屑病发病机制及治疗方面的研究

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李宗阳，博士研究生，主要从事银屑病发病机制及治疗方面的研究

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李宗阳，博士研究生，主要从事银屑病发病机制及治疗方面的研究

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Birth Defects Res A Clin Mol Teratol, 2012, 94(8): 607-611., articleTitle=Emerging data on the use of anti‐tumor necrosis factor‐alpha medications in pregnancy, refAbstract=null), Reference(id=1190330587689882046, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, doi=null, pmid=null, pmcid=null, year=2017, volume=3, issue=1, pageStart=21, pageEnd=25, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=Porter ML, Lockwood SJ, Kimball AB, journalName=Int J Womens Dermatol, refType=null, unstructuredReference=Porter ML, Lockwood SJ, Kimball AB. Update on biologic safety for patients with psoriasis during pregnancy[J]. Int J Womens Dermatol, 2017, 3(1): 21-25., articleTitle=Update on biologic safety for patients with psoriasis during pregnancy, refAbstract=null), Reference(id=1190330587756990911, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, doi=null, pmid=null, pmcid=null, year=2020, volume=183, issue=4, pageStart=628, pageEnd=637, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=Smith CH, Yiu ZZN, Bale T, journalName=Br J Dermatol, refType=null, unstructuredReference=Smith CH, Yiu ZZN, Bale T, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update[J]. Br J Dermatol, 2020, 183(4): 628-637., articleTitle=British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update, refAbstract=null), Reference(id=1190330587891208640, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, doi=null, pmid=null, pmcid=null, year=2020, volume=43, issue=null, pageStart=147, pageEnd=161, url=null, language=null, rfNumber=[27], rfOrder=26, authorNames=Geldhof A, Slater J, Clark M, journalName=Drug Saf, refType=null, unstructuredReference=Geldhof A, Slater J, Clark M, et al. Exposure to infliximab during pregnancy: post-marketing experience[J]. Drug Saf, 2020, 43: 147-161., articleTitle=Exposure to infliximab during pregnancy: post-marketing experience, refAbstract=null), Reference(id=1190330587983483329, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, doi=null, pmid=null, pmcid=null, year=2010, volume=4, issue=5, pageStart=603, pageEnd=605, url=null, language=null, rfNumber=[28], rfOrder=27, authorNames=Cheent K, Nolan J, Shariq S, journalName=J Crohns Colitis, refType=null, unstructuredReference=Cheent K, Nolan J, Shariq S, et al. Case report: fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease[J]. J Crohns Colitis, 2010, 4(5): 603-605., articleTitle=Case report: fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's disease, refAbstract=null), Reference(id=1190330588046397890, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, doi=null, pmid=null, pmcid=null, year=2019, volume=30, issue=7, pageStart=668, pageEnd=673, url=null, language=null, rfNumber=[29], rfOrder=28, authorNames=Plachouri KM, Georgiou S, journalName=J Dermatol Treat, refType=null, unstructuredReference=Plachouri KM, Georgiou S. Special aspects of biologics treatment in psoriasis: management in pregnancy, lactation, surgery, renal impairment, hepatitis and tuberculosis[J]. J Dermatol Treat, 2019, 30(7): 668-673., articleTitle=Special aspects of biologics treatment in psoriasis: management in pregnancy, lactation, surgery, renal impairment, hepatitis and tuberculosis, refAbstract=null), Reference(id=1190330588197392835, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, doi=null, pmid=null, pmcid=null, year=2011, volume=5, issue=6, pageStart=555, pageEnd=558, url=null, language=null, rfNumber=[30], rfOrder=29, authorNames=Ben-Horin S, Yavzori M, Kopylov U, journalName=J Crohns Colitis, refType=null, unstructuredReference=Ben-Horin S, Yavzori M, Kopylov U, et al. Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease[J]. J Crohns Colitis, 2011, 5(6): 555-558., articleTitle=Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1190330582350532969, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, xref=1, ext=[AuthorCompanyExt(id=1190330582358921578, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, companyId=1190330582350532969, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China), AuthorCompanyExt(id=1190330582371504491, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, companyId=1190330582350532969, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1北京中医药大学研究生院，北京 100029)]), AuthorCompany(id=1190330582467973484, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, xref=2, ext=[AuthorCompanyExt(id=1190330582493139309, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, companyId=1190330582467973484, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2Department of Dermatology, China-Japan Friendship Hospital, Beijing 100029, China), AuthorCompanyExt(id=1190330582505722222, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, companyId=1190330582467973484, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2中日友好医院皮肤科，北京 100029)])], figs=[ArticleFig(id=1190330585110385052, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=EN, label=Fig.1, caption=The process and result of literature screening, figureFileSmall=5PiLlqkjLVSgTRjc0KT1gg==, figureFileBig=rSEbwPBwzu5wZlmpYqZtNg==, tableContent=null), ArticleFig(id=1190330585194271133, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=CN, label=图1, caption=文献筛选流程及结果

*所检索的数据库及检出文献数：MEDLINE(PubMed)(n=259)、Embase(n=310)、The Cochrane Library(n=10)、Web of Science(n=188)

, figureFileSmall=5PiLlqkjLVSgTRjc0KT1gg==, figureFileBig=rSEbwPBwzu5wZlmpYqZtNg==, tableContent=null), ArticleFig(id=1190330585286545822, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=EN, label=Tab.1, caption=

The pregnancies exposed to biologic agents for psoriasis

, figureFileSmall=null, figureFileBig=null, tableContent=
指标频率[例(%)]
暴露于生物制剂的总妊娠次数1206(100.0)
妊娠期使用的生物制剂(n=1208)*
乌司奴单抗(UST)502(41.6)
培塞利珠单抗(CZP)182(15.1)
依那西普(ETA)138(11.4)
英夫利昔单抗(IFX)121(10.0)
依奇珠单抗(IXE)51(4.2)
古塞奇尤单抗(GUS)25(2.1)
阿达木单抗(ADA)24(2.0)
司库奇尤单抗(SEC)15(1.2)
替瑞奇珠单抗(TIL)12(1.0)
未明确134(11.1)
暴露期(n=288)
<妊娠前3个月2(0.7)
妊娠早期166(57.6)
妊娠中期4(1.4)
妊娠晚期6(2.1)
妊娠早期+中期5(1.7)
妊娠中期+晚期4(1.4)
持续全程101(35.1)

妊娠期所采用的其他银屑病治疗

(10篇研究，n=190)

非甾体抗炎药31(16.3)
类固醇外用药23(12.1)
系统性类固醇8(4.2)
环孢素4(2.1)
甲氨蝶呤4(2.1)
柳氮磺吡啶4(2.1)
光疗3(1.6)
阿片类镇痛药2(1.1)
粒细胞和单核细胞吸附单采(GMA)1(0.5)
系统性抗生素1(0.5)
), ArticleFig(id=1190330585353654687, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=CN, label=表1, caption=

暴露于银屑病生物制剂的妊娠特征

, figureFileSmall=null, figureFileBig=null, tableContent=
指标频率[例(%)]
暴露于生物制剂的总妊娠次数1206(100.0)
妊娠期使用的生物制剂(n=1208)*
乌司奴单抗(UST)502(41.6)
培塞利珠单抗(CZP)182(15.1)
依那西普(ETA)138(11.4)
英夫利昔单抗(IFX)121(10.0)
依奇珠单抗(IXE)51(4.2)
古塞奇尤单抗(GUS)25(2.1)
阿达木单抗(ADA)24(2.0)
司库奇尤单抗(SEC)15(1.2)
替瑞奇珠单抗(TIL)12(1.0)
未明确134(11.1)
暴露期(n=288)
<妊娠前3个月2(0.7)
妊娠早期166(57.6)
妊娠中期4(1.4)
妊娠晚期6(2.1)
妊娠早期+中期5(1.7)
妊娠中期+晚期4(1.4)
持续全程101(35.1)

妊娠期所采用的其他银屑病治疗

(10篇研究，n=190)

非甾体抗炎药31(16.3)
类固醇外用药23(12.1)
系统性类固醇8(4.2)
环孢素4(2.1)
甲氨蝶呤4(2.1)
柳氮磺吡啶4(2.1)
光疗3(1.6)
阿片类镇痛药2(1.1)
粒细胞和单核细胞吸附单采(GMA)1(0.5)
系统性抗生素1(0.5)
), ArticleFig(id=1190330585424957856, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=EN, label=Tab.2, caption=

The pregnancies and live birth outcomes with biological agents for psoriasis

, figureFileSmall=null, figureFileBig=null, tableContent=
项目ETAIFXUSTADASECCZPIXETILGUS未明确总计Pb
基线母体特征
总妊娠次数(次)13712043022141845112252131208-
年龄(岁, x±s)31.7±6.530.5±7.130.9±6.931.1±4.032.9±9.332.0±4.7-27.2±6.0--31.4±6.10.090
年龄范围(岁)22~4218~4419~4426~3826~45--21~37--18~45-
暴露时间(例)
<孕前3个月001001000-2
孕早期419861166147821-326
孕中期115227464120-113
孕晚期114199264000-108
妊娠全程1/411/7618/877/151/1461/1780/470/120/220/999/4040.002
妊娠/活产结局(例)
已知结局的胎儿总数137c12242223141844512132141186
活产65/8694/122325/42220/2310/14159/18425/457/128/13173/214886/1135<0.001
自然流产/死胎14/869/12258/4222/234/1420/1849/452/122/1331/214151/11350.155
选择性流产7/8619/12236/4221/230/143/18411/453/122/1310/21492/11350.001
未指明的流产0/860/1220/422000001/1301/1135-
死产0/860/1223/422002/18400005/1135-
早产17/1154/5123/2681/171/815/1554/251/120/89/4274/6870.479
低出生体重12/1142/4910/1971/160/1010/158-1/120/71/4227/5880.403
先天异常d3/1164/949/3240/200/104/1580/10/120/84/17324/9110.791
), ArticleFig(id=1190330585521426849, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=CN, label=表2, caption=

按生物制剂分组的银屑病妊娠及活产结局a

, figureFileSmall=null, figureFileBig=null, tableContent=
项目ETAIFXUSTADASECCZPIXETILGUS未明确总计Pb
基线母体特征
总妊娠次数(次)13712043022141845112252131208-
年龄(岁, x±s)31.7±6.530.5±7.130.9±6.931.1±4.032.9±9.332.0±4.7-27.2±6.0--31.4±6.10.090
年龄范围(岁)22~4218~4419~4426~3826~45--21~37--18~45-
暴露时间(例)
<孕前3个月001001000-2
孕早期419861166147821-326
孕中期115227464120-113
孕晚期114199264000-108
妊娠全程1/411/7618/877/151/1461/1780/470/120/220/999/4040.002
妊娠/活产结局(例)
已知结局的胎儿总数137c12242223141844512132141186
活产65/8694/122325/42220/2310/14159/18425/457/128/13173/214886/1135<0.001
自然流产/死胎14/869/12258/4222/234/1420/1849/452/122/1331/214151/11350.155
选择性流产7/8619/12236/4221/230/143/18411/453/122/1310/21492/11350.001
未指明的流产0/860/1220/422000001/1301/1135-
死产0/860/1223/422002/18400005/1135-
早产17/1154/5123/2681/171/815/1554/251/120/89/4274/6870.479
低出生体重12/1142/4910/1971/160/1010/158-1/120/71/4227/5880.403
先天异常d3/1164/949/3240/200/104/1580/10/120/84/17324/9110.791
), ArticleFig(id=1190330585601118626, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=EN, label=Tab.3, caption=

The incidence rates of pregnancies and live birth outcomes exposed to biological agents for psoriasis

, figureFileSmall=null, figureFileBig=null, tableContent=
结局指标加权发生率*(95%CI)异质性检验结果偏倚风险检测
I2(95%CI)PEgger's检验(P)
自然流产/死胎12.04(9.88~14.19)16.4(0~41.1)0.1570.932
选择性流产6.72(3.57~9.87)32.1(4.5~51.7)0.0150.113
总死亡率18.73(13.48~23.99)57.8(42.7~68.9)<0.0010.987
早产14.19(7.06~21.32)60.8(44.2~72.5)<0.0010.070
低出生体重4.59(2.28~6.90)26.3(0~54.6)0.1100.200
先天异常1.85(0.79~2.92)0.0(0~33.5)0.9990.632
), ArticleFig(id=1190330585672421795, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=CN, label=表3, caption=

暴露于银屑病相关生物制剂的妊娠/活产结局的合并发生率(%)

, figureFileSmall=null, figureFileBig=null, tableContent=
结局指标加权发生率*(95%CI)异质性检验结果偏倚风险检测
I2(95%CI)PEgger's检验(P)
自然流产/死胎12.04(9.88~14.19)16.4(0~41.1)0.1570.932
选择性流产6.72(3.57~9.87)32.1(4.5~51.7)0.0150.113
总死亡率18.73(13.48~23.99)57.8(42.7~68.9)<0.0010.987
早产14.19(7.06~21.32)60.8(44.2~72.5)<0.0010.070
低出生体重4.59(2.28~6.90)26.3(0~54.6)0.1100.200
先天异常1.85(0.79~2.92)0.0(0~33.5)0.9990.632
), ArticleFig(id=1190330585752113572, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=EN, label=Tab.4, caption=

The final outcomes of pregnancies and lactation exposed to biological agents for psoriasis

, figureFileSmall=null, figureFileBig=null, tableContent=
研究

妊娠数

(次)

生物制剂用药情况哺乳结局
母乳喂养，同时哺乳期继续用药
Gao等[10]1IFX哺乳期持续用药婴儿随访5年，身体健康
Ishikawa等[7]1IFX产后5周恢复治疗，哺乳期持续用药24日龄时婴儿血清中IFX浓度为4.46 μg/ml；155日龄时为0.19 µg/ml；278日龄时低于检测水平限值
Puig等[11]1IFX哺乳期(1个月)持续用药婴儿发育正常
Lund等[8]4*IFX哺乳期持续用药婴儿无不良反应
1UST
Mugheddu等[12]1UST哺乳期持续用药分娩后银屑病加重，婴儿无并发症
Odorici等[13]1CZP哺乳期持续用药婴儿健康，生长发育良好
Huang等[6]1IXE哺乳期持续用药/
母乳喂养，但未在哺乳期用药
Rocha等[14]1UST末次暴露为妊娠早期后续随访婴儿生长发育正常
Lund等[8]2UST末次暴露<妊娠前3个月1例、妊娠早期1例婴儿无不良反应
Odorici等[13]3UST末次暴露均在妊娠早期，哺乳期未用药后续随访婴儿健康，生长发育正常
2IFX
2SEC
1ETA
2ADA
Mugheddu等[12]1ADA末次暴露均在妊娠早期，结束哺乳后恢复用药哺乳期银屑病加重，婴儿情况不详
1UST
未行母乳喂养
Lund等[8]2ADA妊娠期、产后持续用药婴儿无不良反应
Watson等[9]8UST

末次暴露妊娠早期7次、中期

1次，8次妊娠中7次在产后恢复用药

/
), ArticleFig(id=1190330585852776869, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1190310109550056229, language=CN, label=表4, caption=

暴露于银屑病相关生物制剂的妊娠哺乳特征及结局

, figureFileSmall=null, figureFileBig=null, tableContent=
研究

妊娠数

(次)

生物制剂用药情况哺乳结局
母乳喂养，同时哺乳期继续用药
Gao等[10]1IFX哺乳期持续用药婴儿随访5年，身体健康
Ishikawa等[7]1IFX产后5周恢复治疗，哺乳期持续用药24日龄时婴儿血清中IFX浓度为4.46 μg/ml；155日龄时为0.19 µg/ml；278日龄时低于检测水平限值
Puig等[11]1IFX哺乳期(1个月)持续用药婴儿发育正常
Lund等[8]4*IFX哺乳期持续用药婴儿无不良反应
1UST
Mugheddu等[12]1UST哺乳期持续用药分娩后银屑病加重，婴儿无并发症
Odorici等[13]1CZP哺乳期持续用药婴儿健康，生长发育良好
Huang等[6]1IXE哺乳期持续用药/
母乳喂养，但未在哺乳期用药
Rocha等[14]1UST末次暴露为妊娠早期后续随访婴儿生长发育正常
Lund等[8]2UST末次暴露<妊娠前3个月1例、妊娠早期1例婴儿无不良反应
Odorici等[13]3UST末次暴露均在妊娠早期，哺乳期未用药后续随访婴儿健康，生长发育正常
2IFX
2SEC
1ETA
2ADA
Mugheddu等[12]1ADA末次暴露均在妊娠早期，结束哺乳后恢复用药哺乳期银屑病加重，婴儿情况不详
1UST
未行母乳喂养
Lund等[8]2ADA妊娠期、产后持续用药婴儿无不良反应
Watson等[9]8UST

末次暴露妊娠早期7次、中期

1次，8次妊娠中7次在产后恢复用药

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妊娠及哺乳期银屑病患者生物制剂治疗安全性的系统评价
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李宗阳 1, 2 , 谷峥 1, 2 , 王慧静 1, 2 , 方雨诗 1, 2 , 李姿 1, 2 , 张晓艳 2, *
解放军医学杂志 | 临床研究 2025,50(5): 545-552
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解放军医学杂志 | 临床研究 2025, 50(5): 545-552
妊娠及哺乳期银屑病患者生物制剂治疗安全性的系统评价
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李宗阳1, 2, 谷峥1, 2, 王慧静1, 2, 方雨诗1, 2, 李姿1, 2, 张晓艳2, *
作者信息
  • 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

    • 李宗阳，博士研究生，主要从事银屑病发病机制及治疗方面的研究

通讯作者:

张晓艳，E-mail：
Systematic review of biologic therapy safety in pregnant and breastfeeding psoriasis patients
Zong-Yang Li1, 2, Zheng Gu1, 2, Hui-Jing Wang1, 2, Yu-Shi Fang1, 2, Zi Li1, 2, Xiao-Yan Zhang2, *
Affiliations
  • 1Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China
  • 2Department of Dermatology, China-Japan Friendship Hospital, Beijing 100029, China
出版时间: 2025-05-28 doi: 10.11855/j.issn.0577-7402.0911.2025.0219
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摘要
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目的 基于既往文献报道的系统回顾及定量分析，评估生物制剂用于妊娠期及哺乳期银屑病临床治疗的安全性。方法 由两名研究人员独立检索文献数据库MEDLINE(PubMed)、Embase、Cochrane Library和Web of Science建库以来至2023年6月27日收录的相关文献，采用澳大利亚JBI循证卫生保健中心病例系列的质量评价工具评估纳入文献的质量；遵循系统评价和Meta分析的优先报告条目(PRISMA)指南，选取妊娠前3个月内、妊娠期或哺乳期暴露于生物制剂的银屑病患者的妊娠或哺乳结局的研究报告进行系统评价。汇总分析其妊娠及暴露特征，并使用随机效应模型汇总各不良妊娠结局的发生率。结果 共纳入54项研究，包括1177例女性患者1206次暴露于生物制剂的妊娠。系统评价结果显示，多数暴露仅限于妊娠早期，汇总自然流产率、选择性流产率、总死亡率、早产率、低出生体重发生率、先天异常发生率均与一般人群相近(P>0.05)，哺乳期用药未报告严重的不良反应。结论 妊娠及哺乳期女性银屑病患者使用生物制剂导致的不良妊娠结局未见明显增加，对新生儿健康及生长发育未见明显影响。但目前相关安全性数据有限，仍需要更多研究来确定银屑病、生物制剂以及妊娠/哺乳结局之间的关系，以指导临床诊疗。

银屑病  /  妊娠期  /  哺乳期  /  生物制剂  /  安全性

Objective To systematically review and quantitatively analyze the safety of biologic agents for the clinical treatment of psoriasis during pregnancy and lactation. Methods The literature from start of database to June 27, 2023, was searched in MEDLINE (PubMed), Embase, Cochrane Library, and Web of Science by two researcher. Quality of included studies was assessed by the quality evaluation tool of case series from Australian JBI Evidence Based Healthcare Centre. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), a systematic review and was conducted to assess pregnancy or breastfeeding outcomes in psoriasis patients exposed to biologics within 3 months prior to pregnancy, during pregnancy or breastfeeding. Data on pregnancy and exposure characteristics were pooled, and the prevalence of adverse pregnancy outcome was summarized using a random effects model. Results A total of 54 studies involving 1206 pregnancies in 1177 female patients with psoriasis exposed to biologic agents were included in the analysis. Systematic review results demonstrated that the majority of the exposures were limited to early pregnancy, with pooled spontaneous abortion rates, elective abortion rates, overall mortality, preterm birth rates, incidence of low birth weights, and congenital anomalies similar to those of general population (P>0.05). Furthermore, no serious adverse reactions were reported during lactation. Conclusions The use of biologic agents in pregnant and breastfeeding women with psoriasis does not significantly increase the risk of adverse pregnancy outcomes and does not affect neonatal health or growth. However, the limited available safety data underscores the necessity of further studies to establish the relationship between psoriasis, biologic agents, and pregnancy/lactation outcomes, thereby providing comprehensive guidance for clinical practice.

psoriasis  /  pregnancy  /  lactation  /  biological agents  /  safety
李宗阳, 谷峥, 王慧静, 方雨诗, 李姿, 张晓艳. 妊娠及哺乳期银屑病患者生物制剂治疗安全性的系统评价. 解放军医学杂志, 2025 , 50 (5) : 545 -552 . DOI: 10.11855/j.issn.0577-7402.0911.2025.0219
Zong-Yang Li, Zheng Gu, Hui-Jing Wang, Yu-Shi Fang, Zi Li, Xiao-Yan Zhang. Systematic review of biologic therapy safety in pregnant and breastfeeding psoriasis patients[J]. Medical Journal of Chinese People’s Liberation Army, 2025 , 50 (5) : 545 -552 . DOI: 10.11855/j.issn.0577-7402.0911.2025.0219
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银屑病是一种免疫介导的慢性炎症性系统性疾病，不同性别和年龄的人群均可发病，女性患者超过50%，高峰发病年龄(15~30岁)与生育年龄重合。在妊娠期，大多数患者病情不会恶化，部分患者皮损甚至缓解，但小部分患者(约23%)病情加重[1]。研究显示，银屑病是不良母婴结局的独立危险因素之一[2]。因此，安全有效的治疗对于女性患者在妊娠期获得良好的病情管理具有重要意义。
由于传统治疗中局部用药、光疗效果有限，而甲氨蝶呤、阿维A等药物致畸作用较强，使计划怀孕及妊娠期银屑病患者的常规系统治疗受到较大限制[3]。随着生物制剂的问世，银屑病有了安全性更高、疗效更好的治疗方式，但其临床前瞻性对照试验因伦理原因均未纳入孕产妇等特殊群体，因此目前对其在妊娠期、哺乳期使用的安全性了解非常有限，可检索到的相关文献多为临床试验中意外暴露的个案报告、回顾性病例分析以及其他使用生物制剂的免疫炎症类疾病的试验结果推断。未知的安全性给临床治疗决策造成很大困难，女性银屑病患者在孕产期往往选择停用生物制剂，可能导致病情复发或加重。本研究通过系统评价和Meta分析，评估生物制剂治疗妊娠期及哺乳期银屑病患者的安全性，旨在为相关的临床应用提供参考。
1 资料与方法
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1.1 研究设计
本研究采用系统综述与Meta分析的方法。遵循系统评价和Meta分析的优先报告条目(PRISMA)指南，对妊娠及哺乳期银屑病患者使用生物治疗的不良结局发生率进行系统综述和Meta分析。
1.2 纳排标准
纳入符合以下入选标准、已发表的英文文献。(1)研究对象：妊娠前3个月、妊娠期或哺乳期银屑病患者；(2)干预措施：在妊娠前3个月及妊娠期或哺乳期的任何时间暴露于治疗银屑病的生物制剂；(3)结果：妊娠结局或所哺乳婴儿的健康指标；(4)研究类型：随机对照试验、非随机对照试验(包括队列研究、病例对照研究、病例系列、病例报告、患者登记等)。
排除标准：(1)数据不完整且无法联系作者；(2)与另一项所纳入研究对象有重合的研究(排除发表较早或数据相对不全的一篇)。不限制纳入文章的发表时间。
1.3 检索策略
计算机检索文献数据库MEDLINE(PubMed)、Embase、the Cochrane Library和Web of Science中建库以来至2023年6月27日的文献；采用主题词与自由词相结合的方式进行检索，检索策略见附表S1(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)。由两位作者各自独立检索文献，并将结果导出到Endnote软件。
1.4 文献筛选
首先剔除重复的文献，而后由两名研究人员独立筛选文献的标题及摘要，排除无关文献。对可能相关的文献，检索并阅读全文，按照纳入和排除标准对文章进行评估。如有分歧，加入第3位研究者共同协商解决。
1.5 数据提取
两位研究者独立使用Excel表格从纳入的研究中提取并总结以下数据，需要时联系相关文献的作者获取关于研究的更多信息。主要数据内容包括以下4个部分。(1)暴露变量：处于妊娠前3个月内、妊娠期或哺乳期的银屑病患者所使用的生物制剂。(2)主要结局指标：妊娠结局[包括活产、自然流产(包括宫外孕和先天畸形造成的流产)、选择性流产、未阐明的流产、死胎(妊娠20周以上的胎儿死亡)、死产(妊娠28周及以上的胎儿在分娩过程中死亡)、早产(妊娠37周之前出生)、低出生体重(出生时体重<2.5 kg)、先天畸形(活产时存在的器官结构或功能异常)等]及哺乳婴儿结局。(3)次要结局指标：胎儿/新生儿/哺乳婴儿健康及发育状况，包括宫内生长受限、新生儿并发症、长期生长发育情况等。(4)其他数据：纳入研究的特征包括第一作者、发表时间、国家、研究类型、样本量，妊娠/哺乳期母亲基线特征包括妊娠年龄、银屑病类型、病程、妊娠前曾采用的银屑病治疗方式、妊娠期及哺乳期使用的其他银屑病治疗方式、生物制剂暴露时间、并发症。
1.6 偏倚风险评估
由两位研究者使用澳大利亚JBI循证卫生保健中心病例系列的质量评价工具[4](附表S2)(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)对纳入的文献质量进行评估，如有分歧，加入第3位研究者共同协商解决。
1.7 统计学处理及Meta分析
采用SPSS 25.0软件进行统计分析。计数资料以例(%)表示，多组间比较采用χ2检验，进一步两两比较采用Bonferroni法。计量资料符合正态分布时以$\bar{x}±s$表示，两组间比较采用t检验，多组间比较采用单因素方差分析，进一步两两比较采用LSD-t检验；不符合正态分布时以M(Q1，Q3)表示，组间比较采用Mann-Whitney U检验。P<0.05为差异有统计学意义。
采用R 4.4.0软件对暴露于银屑病生物制剂的妊娠结局(自然流产、选择性流产、胎儿总死亡率)和活产结局(早产、低出生体重、先天畸形)的发生率进行Meta分析。首先对原始率进行Shapiro-Wilk检验，如数据符合正态分布，使用原始率进行Meta分析，如不符合正态分布则使用对数转换等方法对数据进行处理。使用森林图展示Meta分析汇总不良结局发生率的结果(95%CI)。使用Q统计量和I2评估异质性。P≤0.1或I2≥50%提示研究间存在异质性。预期研究间存在较大异质性，因此无论计算结果如何，均采用随机效应模型进行Meta分析。使用漏斗图评估发表偏倚，并使用Egger线性回归进行量化检验(P<0.10提示存在明显的发表偏倚)。
2 结果
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2.1 文献检索结果
共检索到相关文献767篇，其中202篇通过阅读全文进行评估，最后纳入54篇符合标准的文献(图1、附录1)(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)。
2.2 纳入研究的特征
纳入研究的患者银屑病病史、所接触生物制剂、暴露时间、妊娠结局、哺乳情况的详细信息见附表S3(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)。纳入的大多数研究(57.4%，31/54)发表于2019-2023年，研究类型多为病例报道(48.1%，26/54)和病例系列(18.5%，10/54)(附表S4)(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)；研究主要评估了乌司奴单抗(UST)(40.7%，22/54)、英夫利昔单抗(IFX)(29.6%，16/54)、阿达木单抗(ADA)(16.7%，9/54)、司库奇尤单抗(SEC)(14.8%，8/54)、依那西普(ETA)(14.8%，8/54)等生物制剂；13项(24.1%)研究质量良好，26项(48.1%)研究质量中等，12项(22.2%)研究质量偏差(附表S5)(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)。
2.3 纳入病例的临床特征
1177例在妊娠期、妊娠前期或哺乳期暴露于生物制剂的银屑病患者的临床特征见附表S6(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)。患者年龄18~45岁，银屑病主要类型是寻常型银屑病1022例(86.8%)，妊娠前采用较多的银屑病系统治疗药物为甲氨蝶呤(17.9%，20/112)和环孢素(15.2%，17/112)；妊娠期除生物制剂外，选用较多的治疗药物为系统性非甾体抗炎药(16.3%，31/190)及外用类固醇激素(12.1%，23/190)。
2.4 暴露于银屑病生物制剂的妊娠特征
暴露于银屑病生物制剂的妊娠特征见表1。共纳入1206次暴露于治疗银屑病的生物制剂的妊娠，涉及的生物制剂主要为UST 502次(41.6%)、培塞利珠单抗(CZP)182次(15.1%)、ETA 138次(11.4%)、IFX 121次(10.0%)等，134次(11.1%)妊娠未明确暴露于何种生物制剂。
288例妊娠的生物制剂暴露时间明确，166例(57.6%)暴露仅限于妊娠早期，101例(35.1%)暴露持续于整个孕期。妊娠期间除生物制剂外使用的银屑病相关治疗或其他系统用药，最常见的为非甾体抗炎药(16.3%)，多用于缓解银屑病关节炎的疼痛等症状，其次为类固醇，包括局部外用类固醇(12.1%)和系统性类固醇治疗(4.2%)。有4例(2.1%)同时使用了具有致畸性的药物(甲氨蝶呤)治疗，2例(1.1%)使用了妊娠期禁用的阿片类镇痛药，4例(2.1%)使用了妊娠期禁用的柳氮磺吡啶，但文献未说明应用了相关药物的孕妇是否终止妊娠。
2.5 按生物制剂分组的妊娠结局
根据生物制剂分组的妊娠结局见表2。不同生物制剂之间的基线母亲年龄差异无统计学意义(P>0.05)。不同生物制剂在孕期暴露时间上不完全相同(P<0.001)，仅在孕早期接触CZP的比例较总体偏低(P<0.001)，而在孕晚期暴露的比例较总体偏高(P<0.001)。依奇珠单抗(IXE)孕早期暴露率高于总体(P<0.001)，孕中、晚期暴露率低于总体(P=0.001，P<0.001)。古塞奇尤单抗(GUS)孕早期暴露率高于总体(P<0.001)。但IXE、GUS两种生物制剂纳入的研究数量偏少(均为2篇)，可能对统计结果有较大影响。
在妊娠是否全程应用生物治疗方面，各生物制剂使用率不完全相同(P<0.001)；进一步对各组使用率与总体间进行多重比较，各组与总体使用率之间差异均无统计学意义(P>0.05；IXE、TIL、GUS 3组数据较少，未进一步行多重比较)。
不同生物疗法的妊娠总活产率差异有统计学意义，其中IXE组活产率明显低于其他生物制剂组(P<0.001)。接触IFX和IXE的妊娠选择性流产率较总选择性流产率偏高(IFX：15.6%，P=0.002；IXE：24.4%，P<0.001)，而接触CZP的妊娠选择性流产率偏低(1.6%，P=0.003)；各生物制剂之间自然流产率差异无统计学意义(P=0.266)。同样，有关IXE的统计结果可能受到其研究数量较少的影响。
接触不同生物制剂的活产结局差异无统计学意义(早产率P=0.479，低出生体重率P=0.403，先天异常率P=0.791)。
2.6 妊娠及活产结局合并发生率
对各项妊娠及活产结局相对于暴露于生物制剂的总妊娠/总活产发生率进行Meta分析，结果见表3。除一篇研究[5]外，所有文献均报告了妊娠的流产或活产等主要结局指标，但部分文献未报告妊娠或活产的其他结局指标，如早产、先天畸形、低出生体重、新生儿结局以及长期生长和发育结果。
各妊娠结局汇总结果显示(附图S1-S6)(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)，自然流产(包括死胎)发生率12.04%(95%CI 9.88%~14.19%)，异质性较低(I2=16.4%，P=0.157)；选择性流产发生率6.72%(95%CI 3.57%~9.87%)，异质性较低(I2=32.1%，P=0.015)；总死亡率18.73%(95%CI 13.48%~23.99%)，研究间有较大异质性(I2=57.8%，P<0.001)。对以上合并结果进行发表偏倚分析，漏斗图显示对称分布(附图S7)(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)，Egger's检验结果提示无明显发表偏倚(P值分别为0.932、0.113、0.987)。
由于部分活产结局数据偏少，只对早产、低出生体重及先天异常相对于暴露于生物制剂的总活产发生率进行Meta分析，结果显示，早产发生率14.19%(95%CI 7.06%~21.32%)，研究间有较大异质性(I2=60.8%，P<0.001)；低出生体重发生率4.59%(95%CI 2.28%~6.90%)，异质性较小(I2=26.3%，P=0.110)；先天异常发生率1.85%(95%CI 0.79%~2.92%)，研究间无异质性(I2=0.0%，P=0.999)。漏斗图未显示不对称性(附图S7)(https://dx.doi.org/10.11855/j.issn.0577-7402.0911.2025.0219FJ)，Egger's检验结果提示无明显发表偏倚(P值分别为0.070、0.200、0.632)。
另外，12项研究对38名在胎儿期母体接触生物制剂的新生儿进行了1个月至12年的随访，所有这些新生儿的生长发育均未见异常。
2.7 暴露于生物制剂的妊娠哺乳特征及结局
共有9篇文献[6-14]报告了妊娠或哺乳期接触生物制剂患者的哺乳特征(表4)，但部分文献未说明所哺乳婴儿的健康状况。共纳入28例银屑病女性患者35次暴露于生物制剂的妊娠，育有36名活产婴儿；其中11次妊娠在哺乳期持续生物治疗，所接触的生物制剂分别为IFX(n=7)、UST(n=2)、CZP(n=1)、IXE(n=1)，除Huang等[6]外，均报告了所哺乳婴儿结局。其中，Ishikawa等[7]对所哺乳婴儿血清IFX浓度进行了多次检测，哺乳期内婴儿血药浓度持续下降。余研究中婴儿均未报告不良反应。
15例妊娠在停止治疗的情况下给予婴儿母乳喂养，这些患者生物制剂的末次暴露时间均在妊娠期前3个月，所哺乳婴儿未报告不良反应，部分患者在哺乳期结束后恢复生物治疗。所接触生物制剂分别为UST(n=7)、IFX(n=2)、SEC(n=2)、ETA(n=1)、ADA(n=2)。
另外报告中还有10例妊娠未行母乳喂养，其中在Lund等[8]2017年报道1例患者2次妊娠期及产后全程应用ADA，但未说明未哺乳的原因。Watson等[9]2019年报道7例患者8次暴露于UST的妊娠，末次暴露时间均为妊娠早期或中期，其中7次妊娠在产后恢复用药，另1次产后经其他全身治疗后疾病控制满意。
3 讨论
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生物制剂是治疗银屑病安全有效的一类药物，但其应用于妊娠或哺乳期的安全性证据不足。为解决这一问题，本研究对现有的关于妊娠和(或)哺乳期接受生物制剂治疗的银屑病女性的研究进行了系统评价及Meta分析；共纳入54项研究，包括1177例女性1206次暴露于生物制剂的妊娠，并对其各项妊娠及活产结局发生率进行了汇总分析，结果显示：(1)大部分生物制剂暴露集中在妊娠前3个月，多为意外暴露，发现妊娠后立即停药。CZP仅孕早期暴露比例较低，说明使用该药物的女性更倾向于孕期持续治疗，或在其他药物无法控制妊娠期银屑病症状时更倾向于选择CZP治疗。(2)暴露于生物制剂的妊娠合并流产率为12.04%，与一般人群相近(约15.3%)[15]。接触不同的生物疗法的妊娠总活产率有统计学差异，接触IFX和IXE的妊娠选择性流产率较高，而接触CZP的妊娠选择性流产率较低，但受纳入研究数量及研究类型的限制，结果可能存在较大偏倚。(3)活产结局方面，暴露于生物制剂的妊娠合并早产率、低出生体重发生率、先天畸形发生率与一般人群无明显差异[16-18]，接触不同生物制剂的活产结局无统计学差异。长期随访显示，妊娠期暴露于生物制剂的婴儿健康状况、生长发育未见明显异常。(4)关于银屑病患者哺乳期应用生物制剂方面的研究较少，但本次纳入的研究显示，选择哺乳的同时应用生物制剂的女性比例较低，所哺乳婴儿未报告不良反应。
关于妊娠期生物制剂暴露与不良妊娠结局之间的相关性，目前尚存在争议。2023年韩国一项基于全国人口数据库分析的研究显示，妊娠期使用生物制剂与早产、先兆子痫/子痫、宫内生长迟缓的风险增高相关[19]；2021年的一项Meta分析显示，与疾病匹配的对照组比较，怀孕期间接触抗TNF-α药物会增加患免疫介导炎症性疾病女性早产、低出生体重和新生儿感染的风险[20]。但2021年美国一项多中心观察性登记研究结果显示，暴露于生物制剂的银屑病妇女的妊娠结局与非暴露妇女相似[21]；Tsao等[22]对调整了风险因素的观察性研究进行Meta分析，结果显示，与生物制剂使用相关的先天性异常风险没有增加，表明不良事件的原因是疾病活动或其他混杂因素，而不是生物疗法。有研究显示，患有银屑病的女性在怀孕前更有可能超重/肥胖、吸烟或被诊断为抑郁症，且较少服用孕前维生素补充剂[23]。因此，应针对肥胖、血脂异常、抑郁、糖尿病和高血压等所有银屑病相关并发症对结果进行调整。但遗憾的是，本次纳入的研究中并没有一致报告母体的基础情况，无法对结果进行风险因素调整及回归分析，可能在一定程度上影响了统计结果。
胎儿在怀孕期间接触生物制剂取决于通过胎盘的运输。一般认为，妊娠12周内是胎儿致畸的高危阶段，而这段时间内IgG通过胎盘的转运受限，直到妊娠晚期胎盘上的Fc受体促进IgG的主动转运，脐静脉血中IgG才超过母体水平[24]。因此，妊娠晚期接触生物制剂对胎儿影响较大。但本研究纳入的妊娠期银屑病研究中，大部分生物制剂暴露均仅限妊娠早期(57.6%)，这造成了研究结果阐释的相对局限性。
在IgG的4个亚类中，IgG1(ADA、IFX、UST、SEC、GUS、TIL、GLM)运输最有效，其次是IgG4(IXE)、IgG3和IgG2。ETA是由人IgG1的Fc片段与人TNF受体-2的细胞外配体结合域融合而成，但经胎盘转运效率较差。CZP是一种聚乙二醇化的抗原结合片段(Fab)抗体，缺少IgG1 Fc部分，故不能通过胎盘上的FcRN进行主动转运[25]。
本研究中，CZP在孕中晚期暴露率偏高，暴露于CZP的妊娠选择性流产率偏低，这可能与其较高的安全性有关。英国皮肤科医师协会银屑病生物治疗指南建议将CZP作为妊娠期间生物制剂治疗的一线选择[26]。暴露于IFX的妊娠选择性流产率较高，但既往研究使用来自全球安全数据库的20年数据调查暴露于IFX的妊娠，结果显示，选择性流产率为6.5%，不良妊娠、分娩和婴儿结局的发生率与一般人群相近[27]。因此，本研究中的差异性可能源于纳入研究数量和类型的限制，同样，IXE、GUS等暴露时间及妊娠结局的差异性也可能来源于此。
另外，在妊娠期间，特别是妊娠晚期接受生物制剂治疗的妇女娩出的新生儿可能出现免疫反应受损的情况。有报道妊娠期接受IFX治疗的母亲所生的婴儿在接种活卡介苗后死于播散性卡介苗感染[28]。因此，美国疾病控制与预防中心建议，妊娠期接触生物制剂的妇女娩出的新生儿在出生至少6个月内应避免接种活疫苗。然而，本研究纳入的研究中缺乏对新生儿感染等不良事件的报告，进行长期随访的病例数也较少，可能遗漏部分迟发性的不良事件。
母乳中主要的免疫球蛋白为IgA。因此，以IgG为主的生物制剂在母乳中的分泌可能非常有限。有研究表明，大部分银屑病生物制剂在母乳中的浓度非常低，CZP在母乳样本中几乎检测不到；并且，由于生物制剂的有效成分均为大分子蛋白，它们很可能会被婴儿胃肠道中的酸和蛋白水解酶破坏[29]。本研究未检索到哺乳期应用生物制剂造成婴儿不良结局的报道，但必须考虑到药物对婴儿胃肠道黏膜的局部影响以及致敏的可能性[30]。因此，生物制剂理论上是哺乳期银屑病治疗的安全选择，但决策应因人而异，仔细权衡风险与收益。
本研究还存在其他局限性。例如，纳入的研究多为病例报告或病例系列，缺乏相匹配的对照组，难以对风险因素进行调整，因此生物制剂带来的影响可能与疾病本身或其他混杂因素相混淆，较小的研究规模也增加了偏倚风险。此外，缺乏较新的生物制剂如布达罗单抗(Brodalumab)、瑞莎珠单抗(Risankizumab)、佩索利单抗(Spesolimab)等的研究报道。
综上所述，本研究结果显示，妊娠期及哺乳期女性银屑病患者使用生物制剂后，流产、早产、低出生体重、先天畸形等不良事件的发生风险未见明显增高，新生儿健康及生长发育未见明显影响。但本研究仍存在一些不足，如纳入文献证据等级较低、研究规模较小、多数暴露限于妊娠早期、未调整风险因素等。目前相关的安全性数据仍非常有限，因此在临床选用时应结合个体情况评估风险获益比，并在使用过程中或使用后监测母亲及胎儿状况。今后尚需通过进一步研究来确定银屑病、生物制剂以及妊娠/哺乳结局之间的关系，以指导临床诊疗。
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doi: 10.11855/j.issn.0577-7402.0911.2025.0219
  • 接收时间：2024-06-24
  • 首发时间：2025-10-29
  • 出版时间：2025-05-28
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  • 收稿日期：2024-06-24
  • 录用日期：2024-08-05
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    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

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2种不同金属材料的力学参数
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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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