Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Kidney Int. 2013 Dec;84(6):1108-18. doi: 10.1038/ki.2013.276. Epub 2013 Jul 17.
Traditional Chinese herbal medications (TCHMs) are frequently used in conjunction with western pharmacotherapy for treatment of chronic kidney diseases (CKD) in China and many other Asian countries. The practice of traditional Chinese medicine is guided by cumulative empiric experience. Recent in vitro and animal studies have confirmed the biological activity and therapeutic effects of several TCHMs in CKD. However, the level of evidence supporting TCHMs is limited to small, nonrandomized trials. Due to variations in the prescription pattern of TCHMs and the need for frequent dosage adjustment, which are inherent to the practice of traditional Chinese medicine, it has been challenging to design and implement large randomized clinical trials of TCHMs. Several TCHMs are associated with significant adverse effects, including nephrotoxicity. However, reporting of adverse effects associated with TCHMs has been inadequate. To fully realize the therapeutic use of TCHMs in CKD, we need molecular studies to identify active ingredients of TCHMs and their mechanism of action, rigorous pharmacologic studies to determine the safety and meet regulatory standards required for clinical therapeutic agents, and well-designed clinical trials to provide evidence-based support of their safety and efficacy.
中草药（TCM）经常与西药联合用于治疗中国和许多其他亚洲国家的慢性肾脏病（CKD）。中医的实践是基于累积的经验。最近的体外和动物研究证实了几种 TCM 在 CKD 中的生物活性和治疗效果。然而，支持 TCM 的证据水平仅限于小型、非随机试验。由于 TCM 的处方模式存在差异，且需要经常调整剂量，这是中医实践固有的特点，因此设计和实施 TCM 的大型随机临床试验一直具有挑战性。一些 TCM 与显著的不良反应有关，包括肾毒性。然而，对 TCM 相关不良反应的报告一直不足。为了充分实现 TCM 在 CKD 中的治疗用途，我们需要分子研究来确定 TCM 的活性成分及其作用机制，需要严格的药理学研究来确定安全性并符合临床治疗剂的监管标准，还需要精心设计的临床试验来为其安全性和疗效提供基于证据的支持。
