Kidney Int Rep:他克莫司联合霉酚酸酯和糖皮质激素三联免疫抑制治疗狼疮性肾炎的远期疗效

2022-03-26 从医路漫漫 MedSci原创

狼疮肾炎是系统性红斑狼疮患者常见而严重的器官损害,仍然是慢性肾脏病的重要原因,与许多发病率和死亡率有关。

背景:狼疮肾炎是系统性红斑狼疮患者常见而严重的器官损害,仍然是慢性肾脏病的重要原因,与许多发病率和死亡率有关。目前对严重狼疮肾炎的标准治疗包括中到大剂量皮质类固醇联合MMF或环磷酰胺作为活动性肾炎的初始治疗,继而使用小剂量皮质类固醇联合MMF或硫唑嘌呤作为长期维持免疫抑制。在治疗的第一年内,肾脏应答率为30.4%至66.2%。肾脏反应良好与较好的长期肾脏存活率相关。

   CNI通过抑制IL-2的分泌对T淋巴细胞发挥免疫抑制作用。此外,CNI还直接作用于足细胞肌动蛋白细胞骨架,从而降低各种肾小球疾病的蛋白尿。 CNI的免疫抑制效果得到了很好的证明,它在预防器官移植排斥反应的标准预防性免疫抑制治疗中发挥着关键作用。环孢素(CyA)和TAC在治疗过程中的不同阶段都被用于治疗LN,作为活动性肾炎的初始治疗或维持治疗的一部分。当在双重免疫抑制方案中与皮质类固醇联合使用时,CNI在相对较小的样本量的研究中显示出与环磷酰胺或MMF类似的短期疗效。在这些研究中,CNI的治疗不受常规治疗药物监测(TDM)的指导,在许多报告中,随访时间相对较短。与CyA相比,TAC具有较少的美容不良反应和较轻的牙龈增生,因此通常是LN患者的首选CNI。关于日本患者的TAC的初步数据,结合了各种免疫抑制方案,表明它可以作为LN人群的长期治疗。

   在糖皮质激素和霉酚酸酯的基础上加用钙调神经磷酸酶抑制剂(CNI)可减少蛋白尿,从而提高狼疮性肾炎(LN)的肾脏应答率,但这种三联免疫抑制方案的长期疗效和安全性数据很少。

方法:这是一项队列研究,研究对象为III/IV/V狼疮肾炎患者,他们的蛋白尿持续存在,尽管最初的标准治疗是霉酚酸酯(MMF)和强的松龙(Pred),其中加用他克莫司(TAC)(目标12小时TAC血药浓度为4-6 mg/l)。

目的:到目前为止,几乎没有关于狼疮肾炎患者使用CNI三联免疫抑制方案的长期数据,也没有关于药物暴露与临床结果之间关系的数据。在此背景下,我们分析了22名LN患者的结果,这些患者在蛋白尿对PRED和MMF的治疗不满意时加入了TAC,根据TDM进行滴定。

结果:22例LN患者接受三联免疫抑制治疗,随访61.1~28.1个月。TAC和麦考酚酸的最低浓度分别为3.8~5.7 mg/l和1.3~2.1 mg/l。6个月后蛋白尿明显减少,并持续5年。12个月、24个月和36个月的完全缓解率(CR)和部分缓解率(PR)分别为59.1%、72.7%和77.3%。加入TAC后,估计肾小球滤过率(EGFR)随时间的斜率没有改变。慢性肾脏病(CKD)进展期7例(31.8%)。两名患者在随访期间达到终末期肾脏疾病。术后1、3、5年肾存活率分别为100.0%、95.0%、88.7%。2例(9.1%)在8.5±0.7个月后出现肾脏复发。高血压加重5例(22.7%),高脂血症加重3例(13.6%)。其他主要不良事件包括感染(16例,7个病人年1例)和胃肠道不适(6例)。

图1.接受皮质类固醇、他克莫司和霉酚酸酯三联免疫抑制方案治疗的22例狼疮性肾炎患者的连续变化:(A)蛋白尿(B)EGFR(C)抗dsDNA和C3水平,以及(D)空腹血糖和总胆固醇。DsDNA,双链DNA;EGFR,估计肾小球滤过率;Fg,空腹血糖;TC,总胆固醇。

图2:22例狼疮性肾炎患者接受激素、他克莫司和霉酚酸酯三联免疫抑制方案治疗后的肾脏和患者存活率。

表1 接受激素、他克莫司和霉酚酸酯三联免疫抑制疗法治疗的22例狼疮性肾炎患者的不良事件

结论:对于蛋白尿对标准治疗效果不佳的LN患者,联合应用TAC、霉酚酸酯和Pred的三联免疫抑制治疗可进一步减少蛋白尿,使病情持续缓解。

原文出处:Yap DYH,  Li PH,  Tang C,et al.Long-Term Results of Triple Immunosuppression With Tacrolimus Added to Mycophenolate and Corticosteroids in the Treatment of Lupus Nephritis.Kidney Int Rep 2022 Mar;7(3)

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  4. 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    2022-03-28 villahu
  8. 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    2022-03-28 gwc389

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