Wu Cun-En, Xue Wei-Wei, Zhuang Yu-Wen, Ding Da-Wei, Zhou Jin-Yong, Liu Shen-Lin, Wang Rui-Ping, Shu Peng
Department of Oncology, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine.
Traditional Chinese Medicine Department, Jinling Hospital, School of Medicine, Nanjing University.
Medicine (Baltimore). 2020 Nov 25;99(48):e23417. doi: 10.1097/MD.0000000000023417.
Gastric cancer (GC) is one of the top 10 malignant tumors worldwide and poses a great threat to human life and health, the prevention and treatment of which has become the focus and difficulty of medical research. With its unique advantages, traditional Chinese medicine (TCM) is widely used in the prevention and treatment of postoperative recurrence and metastasis of GC as well as the improvement of patients' quality of life. The aim of this study is to elucidate the curative effect and the underlying mechanism of Yiqi Huayu Jiedu (YQHYJD) decoction.
METHODS/DESIGN: This is a prospective, multicenter, randomized controlled trial continuing 3 years. Two hundred ninety-eight eligible patients will be randomly divided into 2 groups, the chemotherapy combined with placebo and the chemotherapy combined with YQHYJD group at a ratio of 1:1. All patients will receive the treatment for 6 months and follow up for 3 years. The primary outcomes are disease-free survival, and 1-year, 2-year, 3-year progression-free survival rate, while the secondary outcomes are tumor makers, TCM syndrome score, quality of life score, overall chemotherapy completion rate, intestinal flora diversity test, immune function (T, B lymphocyte subsets and NK cells) test. The Security index includes blood, urine and stool routine, electrocardiogram, liver function (ALT), and renal function (BUN, Scr). All of these outcomes will be analyzed at the end of the trial.
This research will provide the valuable evidence for the efficacy and safety of Yiqi Huayu Jiedu decoction in postoperative GC. Furthermore, it will be helpful to form a higher level of evidence-based medical basis for TCM in the treatment of GC recurrence and metastasis.
ChiCTR2000039038.
胃癌是全球十大恶性肿瘤之一，对人类生命健康构成巨大威胁，其防治已成为医学研究的重点和难点。中医药凭借其独特优势，广泛应用于胃癌术后复发转移的防治及患者生活质量的改善。本研究旨在阐明益气化瘀解毒（YQHYJD）汤的疗效及潜在机制。
方法/设计：这是一项为期3年的前瞻性、多中心、随机对照试验。298例符合条件的患者将按1:1的比例随机分为两组，即化疗联合安慰剂组和化疗联合YQHYJD组。所有患者将接受6个月的治疗，并随访3年。主要结局指标为无病生存期、1年、2年、3年无进展生存率，次要结局指标为肿瘤标志物、中医证候评分、生活质量评分、总体化疗完成率、肠道菌群多样性检测、免疫功能（T、B淋巴细胞亚群及NK细胞）检测。安全性指标包括血常规、尿常规、大便常规、心电图、肝功能（ALT）、肾功能（BUN、Scr）。所有这些结局指标将在试验结束时进行分析。
本研究将为益气化瘀解毒汤治疗胃癌术后的疗效和安全性提供有价值的证据。此外，有助于为中医药治疗胃癌复发转移形成更高水平的循证医学依据。
ChiCTR2000039038。
