摘要
目的探讨贝利尤单抗治疗中、重度活动性系统性红斑狼疮(SLE)的临床疗效及安全性。方法选取2019年9月至2022年3月在该院风湿免疫科就诊的60例中、重度活动性SLE患者。根据患者是否使用贝利尤单抗治疗将60例中、重度活动性SLE患者分为对照组(激素+免疫抑制剂)30例和试验组[激素+免疫抑制剂+贝利尤单抗(8次)]30例,分别在治疗前及治疗3、6、9、12个月时评估患者疾病活动度、甲泼尼龙片用量、实验室检测[包括血常规、尿常规、肝肾功、补体、抗双链DNA抗体(Ds-DNA)等]及不良事件发生;同时记录患者治疗前及治疗12个月时的临床症状及脏器受累情况。结果两组患者性别、年龄及治疗前病情等基线资料比较,差异均无统计学意义(P>0.05)。治疗12个月,试验组的SLE应答指数(SRI-4)应答率明显高于对照组(60.0%vs.33.33%,P=0.038);两组患者多数临床症状和脏器受累均有不同程度改善,其中两组患者白细胞下降、血红蛋白下降、白蛋白下降、肌肉骨骼受累均较治疗前明显改善,差异有统计学意义(P<0.05);在白蛋白下降、肾脏受累的改善方面,试验组较对照组更为明显,差异有统计学意义(P<0.05);试验组SLE疾病活动指数-2K(SLEDAI-2K)评分较对照组减少更明显,差异有统计学意义(P<0.05);治疗9、12个月时,试验组患者补体C3、补体C4较对照组上升更明显,差异有统计学意义(P<0.05);而在甲泼尼龙片用量方面,在治疗3、6、9、12个月,试验组均较对照组少,差异有统计学意义(P<0.05)。两组患者的不良事件发生率比较,差异无统计学意义(P=0.793)。结论在常规治疗下,联合贝利尤单抗治疗中、重度活动SLE,可明显提高患者SRI-4应答率,明显改善临床症状及脏器受累情况,降低疾病活动度,并且更有助于激素减量,贝利尤单抗的临床安全性良好。
Objective To investigate the efficacy and safety of belizumab in the treatment of moderate and severe active systemic lupus erythematosus(SLE).Methods A total of 60 patients with moderate to severe active SLE who were admitted to the Department of Rheumatology and Immunology of the hospital from September 2019 to March 2022 were selected.According to whether the patients were treated with belizumab,60 SLE patients were divided into the control group(hormone+immunosuppressive agent)30 cases and the experimental group[hormone+immunosuppressive agent+belizumab(8 times)]30 cases.Disease activity,hormone dosage,laboratory tests(such as blood routine,urine routine,liver and kidney function,complement,DS-DNA,etc.)and adverse events were evaluated before treatment and 3,6,9 and 12 months after treatment.The clinical symptoms and organ involvement of the patient were also recorded before treatment and 12 months after treatment.Results There was no significant difference in baseline data such as gender,age and condition before treatment between the two groups(P>0.05).12 months after treatment,the composite response rate of SLE response index(SRI-4)in the experimental group was significantly higher than that in the control group(60.0%vs.33.33%,P=0.038).Most of the clinical symptoms and organ involvement of the two groups were improved to varying degrees.The white blood cell reduction,hemoglobin reduction,albumin reduction,and musculoskeletal involvement of the two groups were significantly improved compared with before treatment,and the differences were statistically significant(P<0.05).In the improvement of albumin decrease and renal involvement,the experimental group was more obvious than the control group,and the difference was statistically significant(P<0.05).The SLE disease activity index-2K(SLEDAI-2K)score in the experimental group was significantly lower than that in the control group(P<0.05).9 and 12 months after treatment,the levels of complement C3 and complement C4 in experimental group were significantly higher
作者
黄文辉
邓运明
黄晓春
陈腾云
苏晓燕
HUANG Wenhui;DENG Yunming;HUANG Xiaochun;CHEN Tengyun;SU Xiaoyan(Department of Rheumatology and Immunology,Dongguan Tungwah Hospital,Dongguan,Guangdong 523000,China)
出处
《重庆医学》
CAS
2024年第3期418-422,430,共6页
Chongqing medicine
基金
广东省东莞市社会科技发展(一般)项目(20211800901202)。