Front Pharmacol:中草药对特发性膜性肾病 (REACH-MN) 的影响

2022-06-17 August MedSci原创

在临床试验中获得的中草药(CHM)治疗特发性膜性肾病(IMN)的一些令人鼓舞的发现由于在实践中的复杂治疗场景而难以在日常临床实践中得到验证。

膜性肾病 (MN) 是一种影响肾小球的自身免疫性疾病。它是非糖尿病成人肾病综合征的主要原因,在大多数年龄占 20-37%,在 60 岁以上的患者中高达 40%。据报道,中国的发病率呈上升趋势。大约 80% 的病例是特发性的,其中 20% 的病例与其他系统性疾病(即继发性 MN)有致病性相关。糖皮质激素联合环磷酰胺或钙调神经磷酸酶抑制剂以及利妥昔单抗是不同风险 IMN 患者的主要治疗方案。它们是有效的,但也伴随着风险,包括毒性作用和高复发率。对于利妥昔单抗而言,高昂的成本是患者接受度的一大障碍。其他药物,例如包括中草药 (CHM) 在内的植物药,在中国也广泛用于治疗 IMN 。

研究表明,CHM 可以作为成人 IMN 的替代单一疗法或辅助疗法。两例病例报告表明,黄芪中草药Fisch 治疗 1 年。单独使用前邦吉与肾病综合征和对环孢素和霉酚酸酯耐药的患者完全缓解相关。回顾性病例系列包括 15 例免疫抑制治疗无效的 IMN 病例,接受健脾祛湿方治疗 6 个月,其中 80% 在治疗后第 12 个月达到完全或部分缓解。这些发现是在临床试验环境中获得的,需要在日常临床实践中进行验证,因为 CHM 的治疗方案在实践中比在试验中更复杂。在临床试验中,中药的方剂是个体化的,并根据辨证或病情状况灵活变化,而不是在临床试验的整个研究期间使用固定的配方或专有的中药。因此,提出了中国第一个基于注册的INM队列研究。

方法和分析:这是一个前瞻性、多中心队列,将包括 2000 名患有 IMN 的成人,无论尿蛋白水平如何,将从中国 11 个肾病中心招募。参与者将被跟踪至少 2 年。主要结果是入组后 24 个月的复合缓解(完全缓解或部分缓解)。次要结局是完全缓解、部分缓解、缓解时间、无缓解、复发、蛋白尿、肾小球滤过率的年度变化、抗 PLA2R 抗体,以及肾小球滤过率降低 40%、血清肌酐翻倍、结束-阶段肾病,和死亡。倾向得分分析将用于匹配和调整。

这个全国性的、前瞻性的、观察性的登记处为 IMN 的多中心纵向研究提供了一个平台。在注册的第一个 5 年研究阶段,预计将提供对中国 IMN 患者治疗模式的描述,并提供对接受各种治疗方案的该人群临床缓解的估计日常练习。

质量控制在临床研究中至关重要,尤其是在多中心研究中。多中心注册中心使用 EDC 收集数据并提高数据质量。EDC 允许研究人员构建逻辑检查和可预先填写的答案,而不是在数据收集期之后发现错误,这可以减少收集站点数据中的错误数量。此外,EDC保留所有操作痕迹,以确保数据的真实性。

原文:Yang L, Chen X, Li C, et al. Real-World Effects of Chinese Herbal Medicine for Idiopathic Membranous Nephropathy (REACH-MN): Protocol of a Registry-Based Cohort Study. Front Pharmacol. 2022;12:760482. Published 2022 Jan 3. doi:10.3389/fphar.2021.760482

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    2023-03-05 lifestar 来自上海
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    2022-06-19 zll0637
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    2022-08-07 jj000001
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    2023-04-29 yb6560

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