J Am Soc Nephrol:多学科讨论:多靶向治疗作为狼疮性肾炎的维持治疗效果喜人

2017-12-29 吴星 环球医学

狼疮性肾炎(LN)的治疗通常包括两个阶段:积极诱导治疗和更长期的维持治疗。2017年12月,发表在《J Am Soc Nephrol》的一项由中国科学家进行的研究考察了多靶向治疗作为LN维持治疗的效果。

狼疮性肾炎(LN)的治疗通常包括两个阶段:积极诱导治疗和更长期的维持治疗。2017年12月,发表在《J Am Soc Nephrol》的一项由中国科学家进行的研究考察了多靶向治疗作为LN维持治疗的效果。请看本期多学科讨论组临床药师各抒己见为您梳理本文看点——

既往研究表明,多靶向治疗对比静脉环磷酰胺作为亚洲人群狼疮性肾炎诱导治疗的有效性更佳。研究者进行了一项为期18个月的开放性多中心研究,该研究作为之前在中国19个肾脏中心进行的诱导治疗试验的扩展,旨在评估在诱导治疗24周时产生应答的患者中,多靶向维持治疗的有效性和安全性。进行多靶向诱导治疗的患者继续接受多靶向治疗(他克莫司2~3mg/d,吗替麦考酚酸酯0.50~0.75g/d,泼尼松10mg/d),已经接受静脉环磷酰胺诱导治疗的患者接受了硫唑嘌呤(2mg/kg/d)+泼尼松(10mg/d)治疗。研究者评估了维持治疗期间的狼疮性肾炎复发率作为首要结局。研究者在多靶向组招募了116例患者,在硫唑嘌呤组招募了90例患者。多靶向治疗组和硫唑嘌呤组具有相似的累积肾病复发率(5.47% vs 7.62%;调整风险比,0.82;95% CI,0.25~2.67;P=0.74),两组血清肌酐水平和eGFR均保持稳定。硫唑嘌呤组具有更多的不良事件(44.4% vs 16.4%;P<0.01),多靶向组具有较少的不良事件造成的脱落率(1.7% vs 8.9%;P=0.02)。总之,多靶向治疗作为狼疮性肾炎的维持治疗可造成较低的肾病复发率和更少的不良事件,表明多靶向治疗是狼疮性肾炎患者一种有效且安全的维持治疗方法。

多学科讨论记实:

肾损害一直是SLE患者发病和死亡的主要因素。疾病复发是诱导治疗后达到缓解的LN患者的主要问题,其影响LN患者的长期结局。诱导治疗后需要维持治疗,以预防达到缓解的患者疾病复发。如研究者的既往研究显示,与IVCY治疗相比,多靶向治疗24周的LN的诱导治疗,达到更高的CR率。在本研究中,研究者观察到多靶向治疗的疗效和安全性,作为对诱导治疗应答的LN患者的连续的维持治疗。

本研究显示,多靶向治疗的LN患者的复发率为5.47%,但与AZA治疗的患者(7.62%)相比差异不显着。根据既往文献,接受MMF维持治疗(2.0 g/d)3年的狼疮患者的复发率为12.9%~19%,接受AZA治疗(2 mg/kg/天)的患者的复发率为23.4%~25%。本研究中,多靶向维持治疗的复发率小于既往研究报告的复发率。两个原因可能导致本试验汇总观察到的较低复发率。本研究中,多靶向组59.5%的患者在维持研究前达到CR,而Aspreva狼疮管理研究(ALMS)中,诱导治疗结束时CR率为10%。与达到CR的受试者相比,获得PR的患者更可能经历复发和疾病进展。更高的CR率可能解释了为什么本研究在维持治疗期间显示出更低的复发率。因此,诱导治疗期多靶向治疗的更高的疗效为临床医生提供了在维持治疗期预防复发和稳定肾功能的机会。更低复发率的另一个理由可能与本研究中使用的维持治疗的相对更短时间相关。观察仅持续18个月。AZA治疗的LN患者的复发率也小于文献中报告的复发率。这也可能与更高的基线CR率相关。本研究中,AZA组44.4%的患者在进入维持研究前达到CR。复发率可能随治疗和观察期的延长而增加。

本研究存在一些局限性。未纳入对诱导治疗未应答的患者;因此,数据缺失,这是研究设计的缺点。研究仅在中国人群中进行。需要随机对照试验,来进一步评估多靶向治疗作为LN患者维持治疗的疗效和安全性。

原始出处:

Zhang H, Liu Z, Zhou M,et al. Multitarget Therapy for Maintenance Treatment of Lupus Nephritis. J Am Soc Nephrol. 2017 Dec;28(12):3671-3678. doi: 10.1681/ASN.2017030263. Epub 2017 Jul 31.

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    2017-12-31 villahu
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    2017-12-29 hhh678

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