早期应用贝利尤单抗治疗系统性红斑狼疮患者的效果及对激素减量的影响分析

The effect analysis of early application of belimumab in the treatment of patients with systemic lupus erythematosus and its impact on hormone reduction

目的观察早期应用(诱导缓解期3个月内)贝利尤单抗治疗系统性红斑狼疮(SLE)的效果及对激素减量的影响。方法选取83例使用贝利尤单抗治疗的SLE患者,两组均使用甲泼尼龙及吗替麦考酚酯作为背景用药。根据患者诱导缓解期开始使用贝利尤单抗的时间分为早期组(35例)和对照组(48例)。早期组在诱导缓解期≤3个月时开始使用贝利尤单抗治疗,对照组在诱导缓解期>3个月时开始使用贝利尤单抗治疗。比较两组血常规指标[白细胞计数(WBC)、中性粒细胞计数(Neut)、淋巴细胞计数(Lym)、血小板计数(PLT)、血红蛋白(Hb)]、肝肾功能指标[白蛋白(ALB)、血肌酐(SCr)]和血沉(ESR)水平、免疫功能指标[免疫球蛋白G(IgG)、免疫球蛋白A(IgA)、免疫球蛋白M(IgM)、球蛋白、补体C3、补体C4]、激素减量值和系统性红斑狼疮疾病活动指数(SLEDAI-2000评分)及主要器官损害情况。结果早期组治疗24周时的Neut水平(4.39±1.59)×10^(9)/L明显低于对照组的(6.56±3.09)×10^(9)/L,治疗12周时的Lym水平(1.73±0.49)×10^(9)/L、Hb水平(122.85±15.38)g/L和治疗24周时的Lym水平(1.59±0.49)×10^(9)/L、Hb水平(123.20±16.70)g/L明显高于对照组的(1.48±0.42)×10^(9)/L、(105.89±16.91)g/L和(1.38±0.34)×10^(9)/L、(103.42±25.63)g/L,有统计学差异(P<0.05)。早期组治疗24周时的ALB水平(41.20±3.07)g/L明显高于对照组的(38.50±6.06)g/L,治疗12周时的SCr水平(55.46±16.40)μmol/L和治疗24周时的SCr水平(54.79±16.15)μmol/L明显低于对照组的(74.46±24.21)、(69.34±20.95)μmol/L,治疗12周时的ESR水平(24.44±10.63)mm/h明显低于对照组的(32.37±11.21)mm/h,有统计学差异(P<0.05)。早期组治疗12和24周时的IgG和IgA水平明显低于对照组,治疗12周时的球蛋白水平明显低于对照组,治疗12和24周时的C3水平明显高于对照组,有统计学差异(P<0.05)。治疗12和24周时,早期组的激素减量值(60.49±27.42)、(68.23±22.12)mg明显高于对照组的(21.00±6.96)、(28.37±7.60)mg,SLEDAI-2000评分(3.77±1.06)、(2.74±0.44)分明显低于对照组的(4.79±1.46)、(2.96±0.40)分,有统计学差异(P<0.05)。两组各种主要器官损害发生率对比,无统计学差异(P>0.05)。结论早期应用贝利尤单抗治疗SLE患者可改善贫血情况、肝肾功能、ESR水平及免疫功能,有利于更快降低激素用量,且不会增加主要器官损害发生风险。

Objective To observe the effects of early application(within 3 months of induced remission)of belimumab in the treatment of systemic lupus erythematosus(SLE)and its impact on hormone reduction.Results 83 SLE patients treated with belimumab was selected,and methylprednisolone and mycophenolate mofetil were used as background drugs in both groups.The patients were divided into early group(35 cases)and control group(48 cases)based on the time they began using belimumab during the induced remission period.Patients in the early group started using belimumab after an induced remission period of≤3 months,and patients in the control group started using belimumab after an induced remission period of>3 months.Both groups were compared in terms of blood routine indexes[white blood cell count(WBC),neutrophil count(Neut),lymphocyte count(Lym),platelet count(PLT),hemoglobin(Hb)],liver and kidney function indexes[albumin(ALB),serum creatinine(SCr)],erythrocyte sedimentation rate(ESR)levels,immune function indexes[immunoglobulin G(IgG),immunoglobulin A(IgA),immunoglobulin M(IgM),globulin,complement C3,complement C4],hormone reduction,Systemic Lupus Erythematosus Disease Activity Index(SLEDAI-2000 score)and major organ damage.Results At 24 weeks of treatment,Neut of(4.39±1.59)×10^(9)/L in the early group was obviously lower than(6.56±3.09)×10^(9)/L in the control group;Lym and Hb were(1.73±0.49)×10^(9)/L and(122.85±15.38)g/L at 12 weeks of treatment,and(1.59±0.49)×10^(9)/L and(123.20±16.70)g/L at 24 weeks of treatment,which were significantly higher than(1.48±0.42)×10^(9)/L,(105.89±16.91)g/L and(1.38±0.34)×10^(9)/L,(103.42±25.63)g/L in the control group;there was statistical difference(P<0.05).In early group,ALB level of(41.20±3.07)g/L at 24 weeks of treatment was significantly higher than(38.50±6.06)g/L in the control group;SCr level was(55.46±16.40)μmol/L at 12 weeks of treatment and(54.79±16.15)μmol/L at 24 weeks of treatment,which were significantly lower than(74.46±24.21)and(69.34±20.95)μmol/L in the control group;ESR level of(24.44±10.63)mm/h at 12 weeks of treatment was significantly lower than(32.37±11.21)mm/h in the control group;there was statistical difference(P<0.05).The IgG and IgA levels in the early group at 12 and 24 weeks of treatment were significantly lower than those in the control group,the globulin level at 12 weeks of treatment were significantly lower than that in the control group,and the C3 levels at 12 and 24 weeks of treatment were significantly higher than those in the control group.There was statistical difference(P<0.05).At 12 and 24 weeks of treatment,the hormone reduction were(60.49±27.42)and(68.23±22.12)mg in the early group,which were significantly higher than(21.00±6.96)and(28.37±7.60)mg in the control group;SLEDAI-2000 score were(3.77±1.06)and(2.74±0.44)points,which were significantly lower than(4.79±1.46)and(2.96±0.40)points in the control group;there was statistical difference(P<0.05).There was no significant difference in the incidence of major organ damage between the two groups(P>0.05).Conclusion Early application of belimumab in the treatment of patients with SLE can improve anemia,liver and kidney function,ESR,and immune function,which is conducive to faster reduction of hormone dosage and does not increase the risk of major organ damage.