Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial
作者全名："Zou, Tian Hui; Gao, Qin Yan; Liu, Si De; Li, Yan Qing; Meng, Xiang Jun; Zhang, Guo Xin; Tian, Zi Bin; Zou, Xiao Ping; He, Song; Hou, Xiao Hua; Lin, Rong; Li, Jing Nan; Zhou, Zhong Yin; Li, Yan; Wang, Meng Chun; Wang, Bang Mao; Tian, De An; Chen, Shu Jie; Cao, Qian; Li, Liang Ping; Wang, Zhi Rong; Shen, Xi Zhong; Liu, Bing Rong; Yan, Xiao Yan; Chen, Ying Xuan; Fang, Jing-Yuan"
作者地址："[Zou, Tian Hui; Gao, Qin Yan; Chen, Ying Xuan; Fang, Jing-Yuan] Shanghai Jiao Tong Univ, Shanghai Inst Digest Dis, Div Gastroenterol & Hepatol, State Key Lab Syst Med Canc,NHC Key Lab Digest Dis, Shanghai, Peoples R China; [Liu, Si De] Southern Med Univ, Nanfang Hosp, Dept Gastroenterol, Guangzhou, Guangdong, Peoples R China; [Li, Yan Qing] Shandong Univ, Qilu Hosp, Dept Gastroenterol, Jinan, Shandong, Peoples R China; [Meng, Xiang Jun] Shanghai Jiao Tong Univ, Shanghai Peoples Hosp 9, Sch Med, Dept Gastroenterol, Shanghai, Peoples R China; [Meng, Xiang Jun] Shanghai Jiao Tong Univ, Shanghai Key Lab Gut Microecol & Associated Major, Shanghai, Peoples R China; [Meng, Xiang Jun] Shanghai Jiao Tong Univ, Ctr Digest Dis Res & Clin Translat, Shanghai, Peoples R China; [Zhang, Guo Xin] Jiangsu Prov Hosp, Dept Gastroenterol & Hepatol, Nanjing, Jiangsu, Peoples R China; [Tian, Zi Bin] Qingdao Univ, Affiliated Hosp, Dept Gastroenterol, Qingdao, Shandong, Peoples R China; [Zou, Xiao Ping] Nanjing Univ, Med Sch, Div Gastroenterol & Hepatol, Affiliated Drum Tower, Nanjing, Jiangsu, Peoples R China; [He, Song] Chongqing Med Univ, Affiliated Hosp 2, Dept Gastroenterol, Chongqing, Peoples R China; [Hou, Xiao Hua; Lin, Rong] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Gastroenterol & Hepatol, Wuhan, Hubei, Peoples R China; [Li, Jing Nan] Peking Union Med Coll Hosp, Dept Gastroenterol, Beijing, Peoples R China; [Zhou, Zhong Yin] Wuhan Univ, Renmin Hosp, Dept Gastroenterol, Wuhan, Hubei, Peoples R China; [Li, Yan; Wang, Meng Chun] China Med Univ, Shengjing Hosp, Dept Gastroenterol & Hepatol, Shenyang, Liaoning, Peoples R China; [Wang, Bang Mao] Tianjin Med Univ Gen Hosp, Dept Gastroenterol & Hepatol, Tianjin, Peoples R China; [Tian, De An] Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Gastroenterol, Wuhan, Hubei, Peoples R China; [Chen, Shu Jie; Cao, Qian] Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Gastroenterol, Hangzhou, Zhejiang, Peoples R China; [Li, Liang Ping] Sichuan Prov Peoples Hosp, Dept Digest Dis, Chengdu, Sichuan, Peoples R China; [Wang, Zhi Rong] Tongji Univ, Tongji Hosp, Dept Gastroenterol, Shanghai, Peoples R China; [Shen, Xi Zhong] Fudan Univ, Zhongshan Hosp, Dept Gastroenterol, Shanghai, Peoples R China; [Liu, Bing Rong] Zhengzhou Univ, Affiliated Hosp 1, Dept Gastroenterol, Zhengzhou, Henan, Peoples R China; [Yan, Xiao Yan] Peking Univ, Dept Biostat, Clin Res Inst, Beijing, Peoples R China; [Chen, Ying Xuan; Fang, Jing-Yuan] Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Div Gastroenterol & Hepatol, 145 Middle Shandong Rd, Shanghai 200001, Peoples R China"
通信作者："Chen, YX; Fang, JY (通讯作者)，Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Div Gastroenterol & Hepatol, 145 Middle Shandong Rd, Shanghai 200001, Peoples R China."
来源：JOURNAL OF DIGESTIVE DISEASES
ESI学科分类：CLINICAL MEDICINE
WOS号：WOS:001159354600001
JCR分区：Q3
影响因子：2.3
年份：2024
卷号：
期号：
开始页：
结束页：
文献类型：Article; Early Access
关键词：atrophy; chemoprevention; dysplasia; gastric neoplasms; intestinal metaplasia
摘要："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."
基金机构：
基金资助正文：
