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    贝利尤单抗在诱导系统性红斑狼疮病情缓解过程中的作用及安全性

    Role and safety of belimumab in inducing remission of systemic lupus erythematosus

      摘要
    • 摘要:
      目的了解贝利尤单抗在诱导活动性系统性红斑狼疮(SLE)缓解过程中的作用及安全性。
      方法选择符合入组条件的SLE病人31例作为观察组, 在病情活动期常规治疗的基础上联合应用贝利尤单抗3~6个月; 选取同期常规治疗的SLE病人作为对照组, 比较2组治疗前后相关实验室指标、SLE病情活动指数(SLEDAI评分)、糖皮质激素剂量的变化及不良事件的发生情况, 统计学分析2组的病情变化与安全性观测指标。
      结果治疗3个月后, 2组CRP、ESR、IgG、ANA定量、dsDNA定量、抗核小体抗体定量、SLEDAI评分及泼尼松剂量均低于治疗前, C3、C4、血小板计数高于治疗前, 且治疗后的观察组C4水平、血小板计数高于对照组, dsDNA定量水平、SLEDAI评分低于对照组, 差异均有统计学意义(P < 0.05~P < 0.01)。观察组20例应用贝利尤单抗6个月, 其CRP、ESR、IgG、C3、C4、dsDNA定量、抗核小体抗体定量、SLEDAI评分及泼尼松剂量在不同时间段进行对比差异均有统计学意义(P < 0.05~P < 0.01)。2组在治疗随访期间耐受性较好。
      结论贝利尤单抗联合常规治疗应用于SLE病人, 可以提升治疗效果, 使病情早期得到改善, 持续性治疗, 获益率更高, 同时具有良好的安全性。

       

      Abstract:
      ObjectiveTo understand the role and safety of belimumab in inducing remission of systemic lupus erythematosus (SLE).
      MethodsA total of 31 patients with SLE who met the inclusion conditions were selected as the observation group, belimumab was combined with routine treatment for 3-6 months in the active phase of the disease.Patients with SLE treated with routine therapy in the same period were selected as the control group.The changes of laboratory indicators, disease activity index of systemic lupus erythematosus (SLEDAI score), change in glucocorticoid dose and adverse events were compared between the two groups before and after treatment.The illness changes and safety observation indexes of the two groups were statistically analyzed.
      ResultsAfter 3 months of treatment, the CRP, ESR, IgG, ANA, dsDNA, anti-nucleosome antibody, SLEDAI score and prednisone dose in the two groups were lower than those before treatment, and the C3, C4 and platelet count were higher than those before treatment.The C4 level and platelet count in the observation group after treatment were higher than those in the control group, while the dsDNA and SLEDAI scoreand prednisone dose were significantly different in different time periods (P < 0.05 to P < 0.01).The two groups were well tolerated during the treatment and follow-up.
      ConclusionsBelimumab combined with routine treatment can improve the therapeutic effect in patients with SLE, significantly improve the condition in the early stage, have higher benefit rate with continuous using and have good safety.

       

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