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贝利尤单抗在淋巴细胞功能障碍患者复发性自然流产中的作用:一项回顾性病例对照研究。

Role of belimumab in recurrent spontaneous abortions amongst patients with lymphocyte dysfunction: a retrospective case-control study.

作者信息

Liu Lijuan, Ma Xiao, Liu Juan, Fu Jinhua, Li Ning, Yuan Guiling, Zhao Long

机构信息

Department of Obstetrics, Qingdao Jinhua Gynecology Hospital, Qingdao, Shandong, China.

Department of Nephrology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.

出版信息

BMC Pregnancy Childbirth. 2025 Apr 21;25(1):463. doi: 10.1186/s12884-025-07600-5.

DOI:10.1186/s12884-025-07600-5
PMID:40259254
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12013173/
Abstract

OBJECTIVE

In order to examine the impact of belimumab on recurrent spontaneous abortion (RSA) women exhibiting B lymphocyte dysfunction.

METHODS

This study conducted a retrospective case-control analysis of RSA patients with confirmed B lymphocyte dysfunction. The study included 102 women who had experienced at least two consecutive miscarriages and demonstrated elevated peripheral blood B cell percentages and/or counts. Participants were separated into two distinct groups: the belimumab group (n = 51), which received basic treatment supplemented with belimumab (BENLYSTA) at a dosage of 10 mg/kg BW at 2-week intervals for the first 3 doses and at 4-week intervals thereafter, from the end of menstrual period until the 12th week of pregnancy, if necessary; and the control group (n = 51), which received only standard treatment. Comparisons of Pregnancy outcomes, B cell percentage, B cell count and adverse reactions were made between 2 groups.

RESULTS

Healthy newborns were delivered by 45 participants (88.23%) in belimumab group and 36 participants (70.59%) in control group [P = 0.048, odds ratio (OR) = 3.13; 95% confidence interval (CI) (1.10-8.87)]. The belimumab group exhibited significantly lower peripheral blood B cell percentage and B cell count compared to the control group during gestational weeks 2-12 (P < 0.05).

CONCLUSION

The findings suggest that belimumab is both safe and effective for treating RSA with lymphocyte dysfunction, indicating its potential as a therapeutic strategy for RSA.

摘要

目的

探讨贝利尤单抗对表现出B淋巴细胞功能障碍的复发性自然流产(RSA)女性的影响。

方法

本研究对确诊为B淋巴细胞功能障碍的RSA患者进行回顾性病例对照分析。研究纳入了102名经历过至少两次连续流产且外周血B细胞百分比和/或计数升高的女性。参与者被分为两个不同的组:贝利尤单抗组(n = 51),在必要时,从月经周期结束至妊娠第12周,接受基础治疗并补充贝利尤单抗(倍力腾),前3剂每2周一次,剂量为10 mg/kg体重,此后每4周一次;对照组(n = 51),仅接受标准治疗。比较两组的妊娠结局、B细胞百分比、B细胞计数和不良反应。

结果

贝利尤单抗组45名参与者(88.23%)和对照组36名参与者(70.59%)分娩出健康新生儿[P = 0.048,优势比(OR)= 3.13;95%置信区间(CI)(1.10 - 8.87)]。在妊娠第2 - 12周期间,贝利尤单抗组外周血B细胞百分比和B细胞计数显著低于对照组(P < 0.05)。

结论

研究结果表明,贝利尤单抗治疗淋巴细胞功能障碍的RSA既安全又有效,表明其作为RSA治疗策略的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de39/12013173/fae9cc75f8b2/12884_2025_7600_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de39/12013173/fae9cc75f8b2/12884_2025_7600_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/de39/12013173/fae9cc75f8b2/12884_2025_7600_Fig1_HTML.jpg

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本文引用的文献

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Causal Relationship Between Circulating Immune Cells and Recurrent Spontaneous Abortion: A Bidirectional Mendelian Randomization Study.循环免疫细胞与复发性自发性流产之间的因果关系:双向孟德尔随机化研究。
Am J Reprod Immunol. 2024 Jun;91(6):e13888. doi: 10.1111/aji.13888.
2
Considering belimumab during pregnancy: A more viable option over time.考虑在怀孕期间使用贝利尤单抗:随着时间的推移,这是一个更可行的选择。
Lupus. 2024 Jun;33(7):700-715. doi: 10.1177/09612033241245549. Epub 2024 Apr 9.
3
Tacrolimus improved the pregnancy outcomes of patients with refractory recurrent spontaneous abortion and immune bias disorders: a randomized controlled trial.
他克莫司改善了难治性复发性自然流产和免疫偏倚性疾病患者的妊娠结局:一项随机对照试验。
Eur J Clin Pharmacol. 2023 May;79(5):627-634. doi: 10.1007/s00228-023-03473-9. Epub 2023 Mar 13.
4
The Update Immune-Regulatory Role of Pro- and Anti-Inflammatory Cytokines in Recurrent Pregnancy Losses.探讨促炎和抗炎细胞因子在复发性妊娠丢失中的免疫调节作用的更新。
Int J Mol Sci. 2022 Dec 21;24(1):132. doi: 10.3390/ijms24010132.
5
Transplacental passage of belimumab during pregnancy and follow-up of a child exposed in utero.贝利尤单抗在孕期的胎盘转运及对子宫内暴露儿童的随访
Ann Rheum Dis. 2023 Apr;82(4):577-579. doi: 10.1136/ard-2022-223684. Epub 2023 Jan 5.
6
Dilemma of belimumab therapy (dis)continuation during pregnancy: Results of a retrospective study in eudravigilance.妊娠期贝利尤单抗治疗(停药)的困境:一项在 EudraVigilance 中的回顾性研究结果。
Lupus. 2023 Feb;32(2):189-197. doi: 10.1177/09612033221143286. Epub 2022 Nov 30.
7
British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.英国风湿病学会关于孕期及哺乳期用药的指南:免疫调节抗风湿药物和皮质类固醇
Rheumatology (Oxford). 2023 Apr 3;62(4):e48-e88. doi: 10.1093/rheumatology/keac551.
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Belimumab use during pregnancy: a summary of birth defects and pregnancy loss from belimumab clinical trials, a pregnancy registry and postmarketing reports.贝利尤单抗在妊娠期的应用:来自贝利尤单抗临床试验、妊娠登记和上市后报告的出生缺陷和妊娠丢失汇总。
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Birth Defects Res. 2023 Jan 15;115(2):188-204. doi: 10.1002/bdr2.2091. Epub 2022 Sep 30.
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[Chinese expert consensus on diagnosis and management of recurrent spontaneous abortion (2022)].《复发性自然流产诊治的中国专家共识(2022年版)》
Zhonghua Fu Chan Ke Za Zhi. 2022 Sep 25;57(9):653-667. doi: 10.3760/cma.j.cn112141-20220421-00259.