- 期刊Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association(Nephrol Dial Transplant)
- 发表时间2026-10-26
- 作者Chen Q, Liang Y, Bai J, Chen Z, Zhou J
- DOI10.1093/ndt/gfag247
- PMID42931903
摘要机译
中医在慢性肾脏病(CKD)患者中的应用越来越多,特别是在医疗资源、可及性和文化接受度影响治疗选择的地区。然而,中医在CKD治疗中的作用仍然存在争议,从治疗前景到对未经证实的疗效和潜在毒性的担忧,人们对中医的看法相互矛盾。
在这篇综述中,我们通过循证医学的框架批判性地检查了一些关于中医在CKD中使用的神话和事实。随机证据仍然有限,但一些试验报告了临床相关信号。在2型糖尿病和CKD患者中,多中心SCHEMATIC试验发现,添加地黄-6-base中药与eGFR在48周内缓慢下降有关。
在膜性肾病中,一项早期的参芪颗粒多中心随机试验报告了与常规免疫抑制疗法相当的蛋白尿减少和缓解结果。这些发现hypothesis-supporting而不是决定性的:两项试验都没有确定肾衰竭、心血管事件或死亡率的减少,也缺乏独立的证实。
重要的是,安全性不应该从自然来源或历史使用中推断出来。产品质量、植物认证、药代动力学、毒理学评估、草药-药物相互作用和药物警戒是负责任的临床评估的重要组成部分。
未来的研究应该超越“中药是否有效”的广泛问题,而是关注使用严格的试验方法论、标准化制造、精确的CKD表型和国际适用的结果测量来进行特定产品的评估。中草药既不应该仅仅因为它们是传统的就被拒绝,也不应该仅仅因为它们是天然的就被接受。
它们在CKD护理中的未来作用应由适用于任何治疗干预的相同原则决定:可重复的质量、已证明的临床益处和可接受的益处-风险概况。
展开英文摘要原文
Traditional Chinese medicine (TCM) is increasingly used among patients with chronic kidney disease (CKD), particularly in regions where healthcare resources, accessibility and cultural acceptance influence treatment choices. However, its role in the treatment of CKD remains controversial, with conflicting perceptions ranging from therapeutic promise to concerns regarding unproven efficacy and potential toxicity. In this review, we critically examine some myths and facts surrounding TCM use in CKD through the framework of evidence-based medicine. Randomized evidence remains limited, but a few trials have reported clinically relevant signals. In patients with type 2 diabetes and CKD, the multicenter SCHEMATIC trial found that add-on Rehmannia-6-based Chinese medicine was associated with a slower decline in eGFR over 48 weeks. In membranous nephropathy, an earlier multicenter randomized trial of Shenqi particle reported reductions in proteinuria and remission outcomes comparable with conventional immunosuppressive therapy. These findings are hypothesis-supporting rather than definitive: neither trial established a reduction in kidney failure, cardiovascular events or mortality, and independent confirmation is lacking. Importantly, safety should not be inferred from natural origin or historical use. Product quality, botanical authentication, pharmacokinetics, toxicological evaluation, herb-drug interactions and pharmacovigilance are essential components of responsible clinical evaluation. Future research should move beyond the broad question of whether 'TCM works' and instead focus on product-specific assessment using rigorous trial methodology, standardized manufacturing, precision CKD phenotyping and internationally applicable outcome measures. Chinese herbal medicines should neither be dismissed solely because they are traditional nor accepted solely because they are natural. Their future role in CKD care should be determined by the same principles applied to any therapeutic intervention: reproducible quality, demonstrated clinical benefit and an acceptable benefit-risk profile.
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