贝利尤单抗联合糖皮质激素治疗系统性红斑狼疮的临床疗效观察

Clinical efficacy of belimumab combined with glucocorticoid in the treatment of systemic lupus erythematosus

目的:研究贝利尤单抗与糖皮质激素(GC)共同作用于系统性红斑狼疮(SLE)患者的有效性和安全性。方法:选取就诊的60例SLE患者,随机分为试验组和对照组,两组均使用环磷酰胺治疗,此外,根据患者的病情、体质等给予适当剂量的泼尼松治疗,试验组在该基础上给予贝利尤单抗联合治疗,6个月后,观察两组炎性因子[白细胞介素(IL)-4,IL-6,干扰素-γ(IFN-γ)]水平和试验前后糖皮质激素使用量的变化以及其免疫学功能相关指标(IgA、IgG、补体C3以及C4)的含量变化及差异。并比较两组不良反应的情况。结果:研究开始前,两组患者各指标无明显差异,给药6个月后,两组患者各指标均有一定程度的改善,但试验组患者的IL-4,IL-6,IFN-γ及糖皮质激素的用量明显低于对照组,C3、C4水平显著高于对照组,IgA、IgG含量明显低于对照组且不良反应的发生率也更低。差异均有统计学意义(均P<0.05)。结论:贝利尤单抗对于系统性红斑狼疮的治疗有较好的安全性和有效性,能有效减少糖皮质激素的用量,可以应用于系统性红斑狼疮的治疗中。

Objective To study the effectiveness and safety of belimumab combined with glucocorticoid in patients with systemic lupus erythematosus.Method 60 patients with systemic lupus erythematosus were selected. The patients were randomly divided into experimental group and control group. Both groups were treated with cyclophosphamide. In addition, doctors need to give appropriate doses of prednisone to the two groups according to the patient′s condition and constitution. On this basis, the experimental group was treated with belimumab. Six months later, the inflammatory factors(IL-4, IL-6, IFN-γ) of the subjects in the two groups, changes of glucocorticoid use before and after the experiment, and related indexes of its immunological function(IGA, IgG, complement C3 and complement C4) were observed. The adverse reactions of the two groups during the study were compared. Results Before the start of the study, there was no remarkable distinction in the indexes between the two groups. After 6 months of administration, the indexes of the two groups were improved, but the IL-4, IL-6 and IFN-γ of the experimental group were improved. The dosage of and glucocorticoid was notablely lower than that of the control group, the levels of C3 and C4 were significantly higher than that of the other group, the contents of IgA and IgG were obviously lower than that of the other group, and the incidence of adverse reactions was also lower. Conclusion Belimumab has good safety and effectiveness in the treatment of systemic lupus erythematosus, and can effectively reduce the dosage of glucocorticoid, it can be applied to the treatment of systemic lupus erythematosus.