贝利尤单抗治疗初发系统性红斑狼疮的短期疗效观察

Short-term clinical efficacy observation of belizumab in the treatment of primary systemic lupus erythematosus

目的探讨贝利尤单抗治疗初发系统性红斑狼疮(SLE)的短期疗效和安全性。方法选取初发SLE患者60例,分为标准治疗组和贝利尤单抗联合标准治疗组(贝利尤单抗组),每组30例。标准治疗组采用糖皮质激素联合免疫抑制剂治疗。贝利尤单抗组在标准治疗的基础上联合应用贝利尤单抗治疗。记录2组患者治疗前和治疗10个月后的指标,包括血白细胞(WBC)、血红蛋白(Hb)、血小板计数(PLT)、补体C3、补体C4、免疫球蛋白G(IgG)、红细胞沉降率(ESR)、C-反应蛋白(CRP)、血白球比(AGR)、双链DNA(ds-DNA)、抗核抗体(ANA)滴度、24 h尿蛋白定量、疾病活动指数(SLEDAI-2000)、醋酸泼尼松用量,并记录不良事件发生情况。结果治疗后2组患者WBC、Hb、PLT、C3、C4、AGR均较治疗前升高,且贝利尤单抗组WBC、C3、AGR高于标准治疗组(P<0.05)。治疗后2组患者IgG、ESR、ds-DNA均较治疗前下降,且贝利尤单抗组均低于标准治疗组(P<0.05)。治疗后2组患者SLEDAI-2000、醋酸泼尼松剂量均较治疗前下降,且贝利尤单抗组治疗后均低于标准治疗组(P<0.05)。治疗后2组患者中肾脏受累者24 h尿蛋白定量均低于治疗前,且贝利尤单抗组低于标准治疗组(P<0.05)。治疗后贝利尤单抗组总有效率高于标准治疗组(P<0.05)。治疗期间2组患者的不良反应发生率差异无统计学意义(P=1.000)。结论贝利尤单抗可协助减少糖皮质激素用量,控制疾病活动,且未增加不良事件,建议用于初发轻中度病情活动的狼疮患者治疗。

Objective To investigate the efficacy and safety of belimumab in the treatment of new-onset systemic lupus erythematosus(SLE).Methods Sixty patients with newly diagnosed SLE were selected and divided into 2 groups,with 30 patients in each group.One group received standard treatment,and the other group received beliumab combined with standard treatment.The indexes of the two groups before and after 10-month treatment were recorded,including white blood cell(WBC),platelet(PLT),hemoglobin(Hb),complement C3(C3),complement C4(C4),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),serum white sphere ratio(AGR),immunoglobulin G(IgG),double-stranded DNA(dsDNA),antinuclear antibody titer(ANA),24 h urine protein quantification,prednisone acetate dosage before and after treatment and disease activity index(SLEDAI-2000).Adverse events were also recorded.Results After treatment,blood WBC,PLT,Hb,C3,C4 and AGR were higher than those before treatment in the two groups,and WBC,C3 and AGR were significantly higher in the belliumab group than those in the standard treatment group(P<0.05).IgG,ESR and ds-DNA were all decreased after treatment in the two groups of patients,and those of belliumab group were lower than the other groups after treatment(P<0.05).After treatment,doses of SLEDAI-2000 and prednisone acetate decreased in the 2 groups compared with before treatment,and those of belliumab group were lower than the standard treatment group after treatment(P<0.05).After treatment,24 h urinary protein quantity of renal affected patients was lower in 2 groups than before treatment,and that of the belliumab group was lower than that of the standard treatment group(P<0.05).After treatment,the total effective rate was higher in the belliumab group than that of the standard treatment group(P<0.05).There was no significant difference in the incidence of adverse reactions during treatment between the two groups(P=1.000).Conclusion Beliumab can assist in reducing glucocorticoid dosage to help control disease activity without increasing adverse events,and it is recommended for the treatment of lupus patients with initial mild to moderate disease activity.