浏览全部资源
扫码关注微信
9例利妥昔单抗序贯贝利尤单抗治疗重症系统性红斑狼疮的临床观察
Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus
- 中国药房 2023年34卷第7期 页码：849-853
- 作者机构：
1.郑州大学第一附属医院药学部，郑州 450052
2.郑州大学第一附属医院风湿免疫科，郑州 450052
- 作者简介：
主管药师，硕士。研究方向：临床药理学。电话：0371-66913373。E-mail：904161211@qq.com
主任药师。研究方向：医院药学。电话：0371-66913373。E-mail：zhangxiaojian911@163.com
- 基金信息：重大新药创制科技重大专项(2020ZX09201009)
DOI：10.6039/j.issn.1001-0408.2023.07.15
中图分类号： R593.24;R969.3纸质出版日期：2023-04-15，
收稿日期：2022-11-26，
修回日期：2022-12-29，
扫 描 看 全 文
赵院霞,高冠民,卢晓静等.9例利妥昔单抗序贯贝利尤单抗治疗重症系统性红斑狼疮的临床观察 Δ[J].中国药房,2023,34(07):849-853.
ZHAO Yuanxia,GAO Guanmin,LU Xiaojing,et al.Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus[J].ZHONGGUO YAOFANG,2023,34(07):849-853.
赵院霞,高冠民,卢晓静等.9例利妥昔单抗序贯贝利尤单抗治疗重症系统性红斑狼疮的临床观察 Δ[J].中国药房,2023,34(07):849-853. DOI： 10.6039/j.issn.1001-0408.2023.07.15.
ZHAO Yuanxia,GAO Guanmin,LU Xiaojing,et al.Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus[J].ZHONGGUO YAOFANG,2023,34(07):849-853. DOI： 10.6039/j.issn.1001-0408.2023.07.15.
摘要
目的
2
探讨利妥昔单抗（RTX）序贯贝利尤单抗（BLM）在重症系统性红斑狼疮（SSLE）患者中的临床疗效与安全性。
方法
2
纳入2020年10月至2021年6月郑州大学第一附属医院风湿免疫科使用RTX序贯BLM治疗6个月以上的SSLE患者9例，回顾性收集患者的基线临床资料，用药第0、4、12、24周的实验室检查结果和基础治疗情况。分析患者系统性红斑狼疮疾病活动度指数（SLEDAI）评分、糖皮质激素用量和血清学指标（补体C3、补体C4、血清白蛋白和24 h尿蛋白定量）水平；同时收集患者不良反应发生情况。
结果
2
9例患者均完成超过24周的RTX序贯BLM药物治疗，所有患者均有肾脏损伤，其中7例（77.8%）有肾脏病理学支持，3例（33.3%）合并血液系统损伤，2例（22.2%）合并神经系统损伤。治疗期间，随着治疗时间的延长，患者的SLEDAI评分、24 h尿蛋白定量、糖皮质激素用量均呈显著的下降趋势，最终下降至正常指标水平（
P
＜0.05）；血清白蛋白、补体C3、补体C4均呈显著的升高趋势，最终升高至正常指标水平（
P
＜0.05）。在治疗及随访过程中，1例患者出现带状疱疹，1例患者出现上呼吸道病毒感染，1例患者出现泌尿系统细菌感染，给予对症处理后均痊愈。
结论
2
RTX序贯BLM治疗SSLE，早期给予RTX能快速稳定病情，使患者临床症状明显减轻，特异性血清学指标逐步趋于正常；后续给予BLM可减少基础治疗药物的种类和用量；同时未增加不良反应。
Abstract
OBJECTIVE
2
To investigate the clinical efficacy and safety of rituximab （RTX） followed by belimumab （BLM） in patients with severe systemic lupus erythematosus（SSLE）.
METHODS
2
Nine SSLE patients， who were treated with RTX followed by BLM for more than 6 months in the Department of Rheumatology and Immunology of the First Affiliated Hospital of Zhengzhou University from October 2020 to June 2021， were enrolled. Baseline clinical data of patients， laboratory examination results and basic treatment status at weeks 0， 4， 12， and 24 of medication were collected retrospectively. The patients’ systemic lupus erythematosus disease activity index （SLEDAI） score， glucocorticoid dosage and serological indicators （complement C3， complement C4， serum albumin， and 24-hour urine protein quantification） level were analyzed. At the same time， the occurrence of adverse drug reaction was collected.
RESULTS
2
All 9 patients completed more than 24 weeks of RTX followed by BLM therapy. All patients suffered from renal impairment， of which 7 （77.8%） had renal pathology support， 3（33.3%） had blood system damage and 2 （22.2%） had nervous system damage. During treatment， with the prolongation of treatment time， the SLEDAI score， 24-hour urinary protein quantification， and glucocorticoid dosage of patients showed a significant downward trend， and ultimately decreased to the normal index level （
P
＜0.05）； serum albumin， complement C3 and complement C4 all showed a significant upward trend， eventually rose to the normal index level （
P
＜0.05）. During treatment and follow-up， 1 patient developed herpes zoster， 1 patient developed upper respiratory tract virus infection， and 1 patient developed urinary system bacterial infection. All patients recovered after symptomatic treatment.
CONCLUSIONS
2
In sequential use of RTX followed by BLM for SSLE， early administration of RTX can quickly stabilize the condition， significantly alleviate clinical symptoms， and gradually normalize specific serological indicators； subsequent administration of BLM can reduce the type and dosage of basic treatment drugs； there is no increase in the incidence of adverse drug reactions.
关键词
贝利尤单抗利妥昔单抗重症系统性红斑狼疮临床疗效安全性
Keywords
rituximabsevere systemic lupus erythematosusclinical efficacysafety
references
KRAAIJ T，KAMERLING S W A，DE ROOIJ E N M， et al. The NET-effect of combining rituximab with beli- mumab in severe systemic lupus erythematosus[J]. J Autoimmun，2018，91：45-54.
MERRILL J，BUYON J，FURIE R，et al. Assessment of flares in lupus patients enrolled in a phase Ⅱ/Ⅲ study of rituximab （EXPLORER）[J]. Lupus，2011，20（7）：709-716.
MERRILL J T，NEUWELT C M，WALLACE D J，et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus：the randomized，double-blind，phase Ⅱ/Ⅲ systemic lupus erythematosus evaluation of rituximab trial[J]. Arthritis Rheum，2010，62（1）：222-233.
ROVIN B H，FURIE R，LATINIS K，et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis：the lupus nephritis assessment with rituximab study[J]. Arthritis Rheum，2012，64（4）：1215-1226.
FANOURIAKIS A，KOSTOPOULOU M，ALUNNO A， et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus[J]. Ann Rheum Dis，2019，78（6）：736-745.
GORDON C，AMISSAH-ARTHUR M B，GAYED M， et al. The British Society for Rheumatology Guideline for the management of systemic lupus erythematosus in adults[J]. Rheumatology （Oxford），2018，57（1）：e1-e45.
BAKER K P，EDWARDS B M，MAIN S H，et al. Generation and characterization of LymphoStat-B，a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator[J]. Arthritis Rheum，2003，48（11）：3253-3265.
NAVARRA S V，GUZMÁN R M，GALLACHER A E， et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus：a randomised，placebo-controlled，phase 3 trial[J]. Lancet，2011，377（9767）：721-731.
FURIE R，PETRI M，ZAMANI O，et al. A phase Ⅲ，randomized，placebo-controlled study of belimumab，a monoclonal antibody that inhibits B lymphocyte stimulator，in patients with systemic lupus erythematosus[J]. Arthritis Rheum，2011，63（12）：3918-3930.
CAMBRIDGE G，ISENBERG D A，EDWARDS J C， et al. B cell depletion therapy in systemic lupus erythematosus：relationships among serum B lymphocyte stimulator levels，autoantibody profile and clinical response[J]. Ann Rheum Dis，2008，67（7）：1011-1016.
GUALTIEROTTI R，BORGHI M O，GEROSA M，et al. Successful sequential therapy with rituximab and belimumab in patients with active systemic lupus erythematosus：a case series[J]. Clin Exp Rheumatol，2018，36（4）：643-647.
LIN W Y，SESHASAYEE D，LEE W P，et al. Dual B cell immunotherapy is superior to individual anti-CD20 depletion or BAFF blockade in murine models of spontaneous or accelerated lupus[J]. Arthritis Rheumatol，2015，67（1）：215-224.
SHIPA M，EMBLETON-THIRSK A，PARVAZ M，et al. Effectiveness of belimumab after rituximab in systemic lupus erythematosus：a randomized controlled trial[J]. Ann Intern Med，2021，174（12）：1647-1657.
TENG Y K O，BRUCE I N，DIAMOND B，et al. Phase Ⅲ，multicentre，randomised，double-blind，placebo-controlled，104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus （SLE）：bliss-BELIEVE study protocol[J]. BMJ Open，2019，9（3）：e025687.
DELBET J D，LECLERC G，ULINSKI T. Idiopathic nephrotic syndrome and rituximab：may we predict circula- ting B lymphocytes recovery[J]. Pediatr Nephrol，2019，34（3）：529-532.
VAN DAM L S，OSMANI Z，KAMERLING S W A，et al. A reverse translational study on the effect of rituximab，rituximab plus belimumab，or bortezomib on the humoral autoimmune response in SLE[J]. Rheumatology （Oxford），2020，59（10）：2734-2745.
ATISHA-FREGOSO Y，MALKIEL S，HARRIS K M， et al. Phase Ⅱ randomized trial of rituximab plus cyclophosphamide followed by belimumab for the treatment of lupus nephritis[J]. Arthritis Rheumatol，2021，73（1）：121-131.
0
浏览量
2
下载量
0
CSCD
- 网络PDF下载
- WORD下载
- Meta-XML下载
- BibTeX下载
- Endnote下载
- RefMan 下载
- NoteExpress下载
- NoteFirst下载
关联资源
相关文章
相关作者
相关机构
- 地址：重庆市渝中区大坪正街129号四环大厦8层 400042
- 技术支持由北京北大方正电子有限公司提供 渝ICP备15012710号
公网安备50010302001817 - 本系统建议在Chrome、 IE9+ 以上版本浏览器阅读本站内容，360浏览器请切换至极速模式
- Cookies帮助我们提供服务并提供个性化体验。使用本网站，即表示您同意我们使用Cookies