单位：[1]Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory of Systems Medicine for Cancer, NHC Key Laboratory of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China[2]Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong Province, China[3]Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China[4]Department of Gastroenterology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine[5]Shanghai Key Laboratory of Gut Microecology and Associated Major Diseases Research[6]Center for Digestive Diseases Research and Clinical Translation of Shanghai Jiaotong University, Shanghai, China[7]Department of Gastroenterology and Hepatology, Jiangsu Province Hospital, Nanjing, Jiangsu Province, China江苏省人民医院[8]Department of Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China[9]Division of Gastroenterology and Hepatology, The Affiliated Drum Tower of Nanjing University Medical School, Nanjing, Jiangsu Province, China[10]Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China[11]Department of Gastroenterology and Hepatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China华中科技大学同济医学院附属协和医院[12]Department of Gastroenterology and Hepatology, Peking Union Medical College Hospital, Beijing, China[13]Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei Province, China[14]Department of Gastroenterology and Hepatology, Shengjing Hospital of China Medical University, Shenyang, Liaoning Province, China中国医科大学附属盛京医院中国医科大学盛京医院[15]Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, China[16]Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China内科学系消化内科华中科技大学同济医学院附属同济医院[17]Department of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China[18]Department of Digestive Diseases, Sichuan Provincial People's Hospital, Chengdu, Sichuan Province, China四川省人民医院[19]Department of Gastroenterology, Tongji Hospital of Tongji University, Shanghai, China[20]Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China[21]Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China[22]Department of Biostatistics, Peking University Clinical Research Institute, Beijing, China
Objective: To investigate the clinical potential and safety of Moluodan to reverse gastric precancerous lesions. Methods: Patients aged 18-70 years diagnosed with moderate-to-severe atrophy and/or moderate-to-severe intestinal metaplasia, with or without low-grade dysplasia, and negative for Helicobacter pylori were recruited in this randomized, double-blind, parallel-controlled trial. The primary outcome was the improvement of global histological diagnosis at 1-year follow-up endoscopy using the operative link for gastritis assessment, the operative link for gastric intestinal metaplasia assessment, and the disappearance rate of dysplasia. Results: Between November 3, 2017 and January 27, 2021, 166 subjects were randomly assigned to the Moluodan group, 168 to the folic acid group, 84 to the combination group, and 84 to the high-dose Moluodan group. The improvement in global histological diagnosis was achieved in 60 (39.5%) subjects receiving Moluodan, 59 (37.8%) receiving folic acid, 26 (32.1%) receiving the combined drugs, and 36 (47.4%) receiving high-dose Moluodan. Moluodan was non-inferior to folic acid (95% confidence interval: -9.2 to 12.5; P = 0.02). High-dose Moluodan had a trend for better protective efficacy, though there was no statistical significance. The disappearance rate of dysplasia was 82.8% in the Moluodan group, which was superior to folic acid (53.9%; P = 0.006). No drug-related serious adverse events were observed. Conclusions: One pack of Moluodan three times daily for 1 year was safe and effective in reversing gastric precancerous lesions, especially dysplasia. Doubling its dose showed a better efficacy trend.
第一作者单位：[1]Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory of Systems Medicine for Cancer, NHC Key Laboratory of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
共同第一作者：
通讯作者：
通讯机构：[1]Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory of Systems Medicine for Cancer, NHC Key Laboratory of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China[*1]Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai 200001, China
推荐引用方式(GB/T 7714)：
Zou Tian Hui,Gao Qin Yan,Liu Si De,et al.Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial[J].JOURNAL OF DIGESTIVE DISEASES.2024,25(1):27-35.doi:10.1111/1751-2980.13251.
APA：
Zou, Tian Hui,Gao, Qin Yan,Liu, Si De,Li, Yan Qing,Meng, Xiang Jun...&Fang, Jing-Yuan.(2024).Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial.JOURNAL OF DIGESTIVE DISEASES,25,(1)
MLA：
Zou, Tian Hui,et al."Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial".JOURNAL OF DIGESTIVE DISEASES 25..1(2024):27-35
