贝利尤单抗治疗系统性红斑狼疮的有效性和安全性分析  

Analysis of the efficacy and safety of Belimumab in the treatment of systemic lupus erythematosus

作　　者：王信[1] 郭文静[1] 孙超[1] 孙旭 李志军[1] 谢长好[1] Wang Xin;Guo Wenjing;Sun Chao;Sun Xu;Li Zhijun;Xie Changhao(First affiliated hospital,Bengbu Medical College,Bengbu,Anhui,233000,China;the second affiliated hospital,Bengbu Medical College,Bengbu,Anhui,233000,China)

机构地区：[1]蚌埠医学院第一附属医院,安徽蚌埠233000 [2]蚌埠医学院第二附属医院,安徽蚌埠233000

出　　处：《齐齐哈尔医学院学报》2022年第14期1312-1316,共5页Journal of Qiqihar Medical University

基　　金：安徽省自然科学基金重点项目(2108085MH258)。

摘　　要：目的探讨贝利尤单抗治疗系统性红斑狼疮(Systemic Lupus Erythematosus,SLE)的有效性和安全性。方法回顾性分析2020年4月—2021年11月于蚌埠医学院第一附属医院及第二附属医院风湿免疫科住院应用贝利尤单抗治疗的30例SLE患者的临床资料、实验室检查结果。此后每3个月收集1次上述资料,同时记录随访过程中的不良事件,采用SPSS软件进行统计学分析。结果30例SLE患者中男性2例(6.7%)、女性28例(93.3%);血液系统受损者11例(36.7%)、肾脏受损者11例(36.7%);患者围治疗期初始阶段、治疗3个月、治疗6个月期,SLEDAI-2000评分、每日泼尼松用药剂量、抗ds-DNA抗体水平、24 h尿蛋白定量水平均持下降趋势,差异有统计学意义(P<0.05)。患者C3及C4水平、白蛋白/球蛋白比值、血红蛋白水平、血小板水平持增长趋势,差异有统计学意义(P<0.05);贝利尤单抗治疗相关安全性统计提示不良事件共4例(13.3%)。如肠胃系统不良事件1例(3.3%,急性肠胃炎),身体感染3例(10.0%,上呼吸道感染2例+带状疱疹1例)。结论贝利尤单抗持续时间≥6个月后系统性红斑狼疮患者疾病活动水平明显改善,安全性与有效性已得到统计证实,可辅助降低糖皮质激素用药剂量,对改善贫血疾病及血小板减少症状亦有一定效果,值得深入推广分析。Objective To investigate the efficacy and safety of belimumab in the treatment of systemic lupus erythematosus(SLE). Methods A retrospective analysis was carried out on the clinical data and laboratory resluts of 30 SLE patients those were treated with beliumumab in the department of rheumatology and immunology of the first affiliated hospital and second affiliated hospital of Bengbu Medical College from April 2020 to November 2021. After that, the above data will be collected every 3 months. Meanwhile the adverse events were recorded during the follow-up process. Statistical analysis was performed using SPSS software.Results Among the 30 SLE patients, there were 2 males(6.7%), 28 females(93.3%);11 patients(36.7%) with impaired blood system, 11(36.7%) with renal impairment. SLEDAI-2000 score, daily prednisone dosage, anti-ds-DNA antibody level, 24 h urine protein quantitative level maintained a downward trend from initial stage of peri-treatment period, 3 months of treatment, till 6 months of treatment, the difference was statistically significant(P<0.05). The C3 and C4 levels, albumin/globulin ratio, hemoglobin level, platelet level of patients increase continuously, and the difference was statistically significant(P<0.05). Four cases(13.3%) of adverse events occurred. Including 1 case of gastrointestinal adverse events(3.3%, acute gastroenteritis), 3 cases of body infection(10.0%, 2 cases of upper respiratory tract infection and 1 case of herpes zoster).Conclusions The disease activity level of patients suffered with systemic lupus erythematosus has been significantly improved after the duration of belimumab for more than or equal to 6 months, and its safety and efficacy have been statistically confirmed. It could help to reduce the dosage of glucocorticoid and improve the symptoms of anemia and thrombocytopenia, which is worthy of in-depth promotion and analysis.

关 键 词：贝利尤单抗 系统性红斑狼疮 围治疗期 不良反应 

分 类 号：R593.241[医药卫生—内科学]