Page 95 - 《中国药房》2023年7期
P. 95
3.5 本研究的局限性 controlled,phase 3 trial[J]. Lancet,2011,377(9767):
本研究为单中心研究,纳入样本量较小,研究对象 721-731.
存在异质性,研究观察时间较短。今后需要多中心、大 [ 9 ] FURIE R,PETRI M,ZAMANI O,et al. A phase Ⅲ,ran‐
样本、前瞻性的研究进一步探索 RTX 序贯 BLM 治疗 domized,placebo-controlled study of belimumab,a mono‐
SSLE 更合理的给药方案和疗程,以更好地指导临床 clonal antibody that inhibits B lymphocyte stimulator,in
用药。 patients with systemic lupus erythematosus[J]. Arthritis
综上所述,本研究采用 RTX 序贯 BLM 治疗 SSLE, Rheum,2011,63(12):3918-3930.
[10] CAMBRIDGE G,ISENBERG D A,EDWARDS J C, et al.
早期给予RTX能快速稳定病情,使患者临床症状明显减
B cell depletion therapy in systemic lupus erythematosus:
轻,特异性血清学指标逐步趋于正常;后续给予BLM可
relationships among serum B lymphocyte stimulator
减少基础治疗药物的种类和用量;同时未增加不良
levels,autoantibody profile and clinical response[J]. Ann
反应。
Rheum Dis,2008,67(7):1011-1016.
参考文献
[11] GUALTIEROTTI R,BORGHI M O,GEROSA M,et al.
[ 1 ] KRAAIJ T,KAMERLING S W A,DE ROOIJ E N M, Successful sequential therapy with rituximab and belimumab
et al. The NET-effect of combining rituximab with beli- in patients with active systemic lupus erythematosus:a
mumab in severe systemic lupus erythematosus[J]. J Auto‐
case series[J]. Clin Exp Rheumatol,2018,36(4):643-647.
immun,2018,91:45-54. [12] LIN W Y,SESHASAYEE D,LEE W P,et al. Dual B cell
[ 2 ] MERRILL J,BUYON J,FURIE R,et al. Assessment of immunotherapy is superior to individual anti-CD20 deple‐
flares in lupus patients enrolled in a phase Ⅱ/Ⅲ study of tion or BAFF blockade in murine models of spontaneous
rituximab (EXPLORER)[J]. Lupus,2011,20(7): or accelerated lupus[J]. Arthritis Rheumatol,2015,67(1):
709-716. 215-224.
[ 3 ] MERRILL J T,NEUWELT C M,WALLACE D J,et al. [13] SHIPA M,EMBLETON-THIRSK A,PARVAZ M,et al.
Efficacy and safety of rituximab in moderately-to-severely Effectiveness of belimumab after rituximab in systemic
active systemic lupus erythematosus:the randomized, lupus erythematosus:a randomized controlled trial[J]. Ann
double-blind,phase Ⅱ/Ⅲ systemic lupus erythematosus Intern Med,2021,174(12):1647-1657.
evaluation of rituximab trial[J]. Arthritis Rheum,2010,62 [14] TENG Y K O,BRUCE I N,DIAMOND B,et al. Phase
(1):222-233. Ⅲ ,multicentre,randomised,double-blind,placebo-
[ 4 ] ROVIN B H,FURIE R,LATINIS K,et al. Efficacy and controlled,104-week study of subcutaneous belimumab
safety of rituximab in patients with active proliferative lupus administered in combination with rituximab in adults with
nephritis:the lupus nephritis assessment with rituximab systemic lupus erythematosus (SLE):bliss-BELIEVE
study[J]. Arthritis Rheum,2012,64(4):1215-1226. study protocol[J]. BMJ Open,2019,9(3):e025687.
[ 5 ] FANOURIAKIS A,KOSTOPOULOU M,ALUNNO A, [15] DELBET J D,LECLERC G,ULINSKI T. Idiopathic ne‐
et al. 2019 update of the EULAR recommendations for the phrotic syndrome and rituximab:may we predict circula-
management of systemic lupus erythematosus[J]. Ann ting B lymphocytes recovery[J]. Pediatr Nephrol,2019,34
Rheum Dis,2019,78(6):736-745. (3):529-532.
[ 6 ] GORDON C,AMISSAH-ARTHUR M B,GAYED M, [16] VAN DAM L S,OSMANI Z,KAMERLING S W A,et al.
et al. The British Society for Rheumatology Guideline for A reverse translational study on the effect of rituximab,
the management of systemic lupus erythematosus in adults rituximab plus belimumab,or bortezomib on the humoral
[J]. Rheumatology (Oxford),2018,57(1):e1-e45. autoimmune response in SLE[J]. Rheumatology (Ox‐
[ 7 ] BAKER K P,EDWARDS B M,MAIN S H,et al. Genera‐ ford),2020,59(10):2734-2745.
tion and characterization of LymphoStat-B,a human [17] ATISHA-FREGOSO Y,MALKIEL S,HARRIS K M,
monoclonal antibody that antagonizes the bioactivities of et al. Phase Ⅱ randomized trial of rituximab plus cyclo‐
B lymphocyte stimulator[J]. Arthritis Rheum,2003,48 phosphamide followed by belimumab for the treatment of
(11):3253-3265. lupus nephritis[J]. Arthritis Rheumatol,2021,73(1):
[ 8 ] NAVARRA S V,GUZMÁN R M,GALLACHER A E, 121-131.
et al. Efficacy and safety of belimumab in patients with ac‐ (收稿日期:2022-11-26 修回日期:2022-12-29)
tive systemic lupus erythematosus:a randomised,placebo- (编辑:舒安琴)
中国药房 2023年第34卷第7期 China Pharmacy 2023 Vol. 34 No. 7 · 853 ·