阳和汤改善乳腺癌新辅助化疗疗效及免疫功能的临床研究。
Clinical study on Yanghe decoction in improving neo-adjuvant chemotherapy efficacy and immune function of breast cancer patients.
机构信息
Department of Breast Surgery, Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
出版信息
Medicine (Baltimore). 2022 Mar 11;101(10):e29031. doi: 10.1097/MD.0000000000029031.
INTRODUCTION
Neoadjuvant chemotherapy (NAC) plays an important role in downgrading preoperative tumor size, providing information on regimen activity, and increases treatment efficacy in breast cancer patients. An increasing number of patients have sought Traditional Chinese Medicine (TCM) during NAC to relieve discomfort, regulate immune function, and improve survival. However, limited evidence is available on how concurrent TCM treatment combined with NAC affects tumor response. This study aims to assess the efficacy of Yanghe decoction, a classical warming Yang formula, on pathological complete response (pCR) and explore its mechanism via the phosphatidylinositol-3-kinase/ protein kinase B/nuclear factor kappa-B (PI3K/Akt/NF-κB) pathway-mediated immune-inflammation microenvironment.
METHODS
A single-center, randomized, placebo-controlled, double-blinded randomized control trial (RCT) was designed. This trial aims to recruit 128 participants with breast cancer scheduled to receive NAC in China. All participants will be randomly assigned (1:1) to the Neo-Yanghe group (Yanghe decoction plus NAC) or the control group (placebo plus NAC). The primary outcome will be evaluated by the proportion of participants achieving pCR. The secondary outcomes include the expression level of PI3K/Akt/NF-κB pathway-related proteins, the objective response rate, the time to response, serum level of immune-inflammatory indicators, quality of life, disease-free survival, and overall survival.
DISCUSSION
This study will be the first RCT to evaluate the efficacy of Yanghe decoction combined with NAC in treating breast cancer patients, and elucidate the antitumor mechanism via the PI3K/Akt/NF-κB pathway-mediated immune-inflammation microenvironment. If possible, Neo-Yanghe treatment pattern will be a better pharmacological intervention to manage breast cancer than chemotherapy alone. The results of the trial will provide research-based evidence for the development of integrated Chinese and Western medicine guidelines and expert consensus.Trial registration: Chinese Clinical Trial Registry ChiCTR-INR-2000036943. Registered on September 28, 2020 (https://www.chictr.org.cn/hvshowproject.aspx?id=57141).
简介
新辅助化疗（NAC）在降低术前肿瘤大小、提供方案活性信息以及提高乳腺癌患者治疗效果方面发挥着重要作用。越来越多的患者在 NAC 期间寻求中药（TCM）治疗，以缓解不适、调节免疫功能并提高生存率。然而，关于 NAC 期间同时进行 TCM 治疗如何影响肿瘤反应的证据有限。本研究旨在评估阳和汤（一种经典的温阳配方）对病理完全缓解（pCR）的疗效，并通过磷脂酰肌醇 3-激酶/蛋白激酶 B/核因子 kappa-B（PI3K/Akt/NF-κB）通路介导的免疫炎症微环境来探索其机制。
方法
设计了一项单中心、随机、安慰剂对照、双盲随机对照试验（RCT）。该试验旨在招募 128 名在中国接受 NAC 治疗的乳腺癌患者。所有参与者将被随机分配（1:1）至 Neo-Yanghe 组（阳和汤加 NAC）或对照组（安慰剂加 NAC）。主要结局将通过评估 pCR 的参与者比例来评估。次要结局包括 PI3K/Akt/NF-κB 通路相关蛋白的表达水平、客观缓解率、反应时间、免疫炎症指标的血清水平、生活质量、无病生存和总生存。
讨论
这将是第一项评估阳和汤联合 NAC 治疗乳腺癌患者疗效的 RCT，并通过 PI3K/Akt/NF-κB 通路介导的免疫炎症微环境阐明抗肿瘤机制。如果可能，与单独化疗相比，Neo-Yanghe 治疗模式将是管理乳腺癌的更好药理学干预措施。试验结果将为制定中西医结合指南和专家共识提供基于研究的证据。试验注册：中国临床试验注册中心 ChiCTR-INR-2000036943。于 2020 年 9 月 28 日注册（https://www.chictr.org.cn/hvshowproject.aspx?id=57141）。
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