减量利妥昔单抗治疗ANCA相关性血管炎的单中心观察研究
A single-center observational study of reduced-dose rituximab in the treatment of ANCA-associated vasculitis
单慧亭 1王钰博 2吉鹏 3徐跃洳 4王轶睿 5陈迹 2杨建华2
作者信息
- 1. 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
- 2. 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
- 3. 新疆医科大学第一附属医院风湿免疫科,新疆乌鲁木齐 830011
- 4. 新疆医科大学药学院,新疆乌鲁木齐 830017
- 5. 新疆医科大学第一附属医院药学部,新疆乌鲁木齐 830011
- 折叠
摘要
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.
Abstract
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.
关键词
利妥昔单抗/环磷酰胺/ANCA相关性血管炎/疗效/安全性Key words
rituximab/cyclophosphamide/ANCA-associated vasculitis/effectiveness/safety引用本文复制引用
基金项目
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(SKL-HIDCA-2023-YX7)
新疆维吾尔自治区药学会科研基金(YXH202206)
创新药物上市后临床研究科研专项(WKZX2023CX210008)
出版年
2024
NETL
NSTL
万方数据