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减量利妥昔单抗治疗ANCA相关性血管炎的单中心观察研究

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目的:比较减量利妥昔单抗(rituximab,RTX)与环磷醜胺(cyclophosphamide,CYC)治疗抗中性粒细胞胞浆抗体相关性血管炎[antineutrophil cytoplasmic antibody(ANCA)-associated vasculitis,AAV]的有效性和安全性.方法:回顾性分析新疆医科大学第一附属医院2017年1月至2023年4月新诊断和复发AAV患者的临床资料,根据治疗方案分为RTX组和CYC组.同时收集2组基线及3、6、12个月患者的伯明翰血管炎评分(Birmingham Vasculitis Activity Score,BVAS)、糖皮质激素用量、白蛋白、血肌酐(serum creatinine,Scr)、24 h尿蛋白定量,并记录药物使用期间发生的不良反应,比较2组缓解率、复发率和不良反应发生率的差异.结果:共纳入RTX组患者41例和CYC组患者81例,治疗后6个月,2组患者缓解率无明显差异(P>0.05),RTX组的BVAS评分、糖皮质激素用量低于CYC组(P<0.05);治疗后12个月,RTX组缓解率高于CYC组(P<0.05),RTX组患者BVAS评分、糖皮质激素用量、Scr低于CYC组(P<0.05).2组复发率在6个月、12个月均无明显差异(P>0.05).安全性方面,RTX组低丙种球蛋白发生率高于CYC组(P<0.05),CYC组治疗期间出现胃肠道反应,其余不良事件2组间无显著差异.结论:减量RTX联合糖皮质激素治疗AAV可明显缓解疾病活动度,减少激素剂量,延缓疾病进展.
A single-center observational study of reduced-dose rituximab in the treatment of ANCA-associated vasculitis
OBJECTIVE To compare the effectiveness and safety of low-dose rituximab(RTX)with cyclophosphamide(CYC)in antineutrophilcytoplasmic antibody-associated vasculitis(AAV)patients.METHODS From January 2017 to April 2023,the relevant clinical data were retrospectively reviewed for newly diagnosed and recurrent AAV patients.Based upon spe-cific treatment protocols,they were assigned into two groups of RTX(n=41)and CYC(n=81).Birmingham Vasculitis Activity Score(BVAS),glucocorticoid dosage,albumin,serum creatinine(SCr)and 24-hour proteinuria were collected for two groups at baseline and Month 3/6/12.The inter-group differences in remission rate,relapse rate and incidence of adverse drug reactions(ADR)were compared.RESULTS After treatment,no significant inter-group difference existed in remission rate at Month 6(P>0.05).However,BVAS score and glucocorticoid dosage were lower in RTX group than those in CYC group(P<0.05).After 12-month treatment,remission rate was higher in RTX group than that in CYC group(P<0.05).However,relapse rate was lower in RTX group than that in CYC group(P>0.05).Regarding safety,the incidence of hypogammaglobulinemia was higher in RTX group than that in CYC group(P<0.05).Gastrointestinal reactions were noted in CYC group.CONCLUSION Reduced-dose RTX plus glucocorticoids may significantly alleviate disease activity,reduce glucocorticoid dose and arrest disease progression in AAV patients.

rituximabcyclophosphamideANCA-associated vasculitiseffectivenesssafety

单慧亭、王钰博、吉鹏、徐跃洳、王轶睿、陈迹、杨建华

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新疆医科大学药学院,新疆乌鲁木齐 830017

新疆医科大学第一附属医院药学部,新疆乌鲁木齐 830011

新疆药物临床研究重点实验室,新疆乌鲁木齐 830011

新疆医科大学第一附属医院风湿免疫科,新疆乌鲁木齐 830011

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利妥昔单抗 环磷酰胺 ANCA相关性血管炎 疗效 安全性

省部共建中亚高发病成因与防治国家重点实验室药学专项新疆维吾尔自治区药学会科研基金创新药物上市后临床研究科研专项

SKL-HIDCA-2023-YX7YXH202206WKZX2023CX210008

2024

中国医院药学杂志
中国药学会

中国医院药学杂志

CSTPCD北大核心
影响因子:1.198
ISSN:1001-5213
年,卷(期):2024.44(14)
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