7例贝利尤单抗治疗系统性红斑狼疮的有效性和安全性分析

Efficacy and safety analysis of belimumab in the treatment of seven patients with systemic lupus erythematosus

目的:评估贝利尤单抗在活动性或难治性系统性红斑狼疮(systemic lupus erythematosus,SLE)患者中的有效性和安全性。方法:回顾性分析重庆医科大学附属第二医院风湿免疫科7例使用贝利尤单抗半年以上的SLE患者临床资料,收集基线时系统性红斑狼疮疾病活动度评分(systemic lupus erythematosus disease activity index,SLEDAI)、泼尼松和免疫抑制剂用量、全血细胞计数、抗dsDNA抗体、C3和C4,同时收集肾受累患者的血清肌酐、尿常规和24 h蛋白尿,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:7名患者(100%为女性)使用贝利尤单抗超过6个月。使用贝利尤单抗最常见的临床表现为血液系统受损(71.4%),其次为肾脏受损(42.9%)。随访过程中SLEDAI评分降低有统计学意义(P=0.006)。治疗期间抗dsDNA抗体水平明显降低(P=0.022),补体C4水平明显升高(P=0.017)。泼尼松平均剂量随着时间增长逐渐减少,泼尼松剂量在基线时达到最大值[(40.71±12.72)mg/d],6个月时达到最小值[(14.64±15.91)mg/d](P=0.001)。患者对贝利尤单抗耐受性较好,3名患者(42.9%)发生不良事件,1例为尿路感染,1例为带状疱疹,1例为病毒性结膜炎。结论:7例使用贝利尤单抗治疗的SLE患者,疾病活动性明显下降,糖皮质激素剂量明显减少,且具有较好的安全性。

Objective:To evaluate the efficacy and safety of belimumab in patients with active or refractory systemic lupus erythematosus(SLE).Methods:Retrospective analysis was made of 7 patients with SLE who were treated with belimumab for more than half a year in the Department of Rheumatology and Immunology,The Second Affiliated Hospital of Chongqing Medical University.Systemic lupus erythematosus disease activity index(SLEDAI),prednisone and immunosuppressor dose,complete blood count,anti-dsDNA anti body,C3 and C4 were collected,and serum creatinine,urine routine,and total proteinuria of patients with renal involvement were collected at the same time.Then,the above indexes were collected every 3 months,and adverse events during follow-up were also recorded.SPSS software was used for statistical analysis.Results:Seven patients(all female)received belimumab for more than 6months.The most common clinical manifestation of belimumab was impaired blood system(71.4%),followed by renal impairment(42.9%).The SLEDAI decreased during the follow-up,with statistical significance(P=0.006).During the treatment,the anti-dsDNA antibody level significantly decreased(P=0.022)and the complement C4 level significantly increased(P=0.017).The mean dose of prednisone decreased over time,reaching a maximum at baseline and a minimum at 6 months[(40.71±12.72)mg/d to(14.64±15.91)mg/d,P=0.001)].Patients were well tolerated with belimumab,and 3 patients(42.9%)had adverse events,including 1 case of urinary tract infection,1 case of herpes zoster,and 1 case of viral conjunctivitis.Conclusion:In 7 patients with systemic lupus erythematosus treated with belimumab,SLE disease activity and glucocorticoid dose were significantly reduced,with good safety.