Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial

被引:11
作者
Zou, Tian Hui [1 ]
Gao, Qin Yan [1 ]
Liu, Si De [2 ]
Li, Yan Qing [3 ]
Meng, Xiang Jun [4 ,5 ,6 ]
Zhang, Guo Xin [7 ]
Tian, Zi Bin [8 ]
Zou, Xiao Ping [9 ]
He, Song [10 ]
Hou, Xiao Hua [11 ]
Lin, Rong [11 ]
Li, Jing Nan [12 ]
Zhou, Zhong Yin [13 ]
Li, Yan [14 ]
Wang, Meng Chun [14 ]
Wang, Bang Mao [15 ]
Tian, De An [16 ]
Chen, Shu Jie [17 ]
Cao, Qian [17 ]
Li, Liang Ping [18 ]
Wang, Zhi Rong [19 ]
Shen, Xi Zhong [20 ]
Liu, Bing Rong [21 ]
Yan, Xiao Yan [22 ]
Chen, Ying Xuan [1 ,23 ]
Fang, Jing-Yuan [1 ,23 ]
机构
[1] 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
[2] Southern Med Univ, Nanfang Hosp, Dept Gastroenterol, Guangzhou, Guangdong, Peoples R China
[3] Shandong Univ, Qilu Hosp, Dept Gastroenterol, Jinan, Shandong, Peoples R China
[4] Shanghai Jiao Tong Univ, Shanghai Peoples Hosp 9, Sch Med, Dept Gastroenterol, Shanghai, Peoples R China
[5] Shanghai Jiao Tong Univ, Shanghai Key Lab Gut Microecol & Associated Major, Shanghai, Peoples R China
[6] Shanghai Jiao Tong Univ, Ctr Digest Dis Res & Clin Translat, Shanghai, Peoples R China
[7] Jiangsu Prov Hosp, Dept Gastroenterol & Hepatol, Nanjing, Jiangsu, Peoples R China
[8] Qingdao Univ, Affiliated Hosp, Dept Gastroenterol, Qingdao, Shandong, Peoples R China
[9] Nanjing Univ, Med Sch, Div Gastroenterol & Hepatol, Affiliated Drum Tower, Nanjing, Jiangsu, Peoples R China
[10] Chongqing Med Univ, Affiliated Hosp 2, Dept Gastroenterol, Chongqing, Peoples R China
[11] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Gastroenterol & Hepatol, Wuhan, Hubei, Peoples R China
[12] Peking Union Med Coll Hosp, Dept Gastroenterol, Beijing, Peoples R China
[13] Wuhan Univ, Renmin Hosp, Dept Gastroenterol, Wuhan, Hubei, Peoples R China
[14] China Med Univ, Shengjing Hosp, Dept Gastroenterol & Hepatol, Shenyang, Liaoning, Peoples R China
[15] Tianjin Med Univ Gen Hosp, Dept Gastroenterol & Hepatol, Tianjin, Peoples R China
[16] Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Gastroenterol, Wuhan, Hubei, Peoples R China
[17] Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Gastroenterol, Hangzhou, Zhejiang, Peoples R China
[18] Sichuan Prov Peoples Hosp, Dept Digest Dis, Chengdu, Sichuan, Peoples R China
[19] Tongji Univ, Tongji Hosp, Dept Gastroenterol, Shanghai, Peoples R China
[20] Fudan Univ, Zhongshan Hosp, Dept Gastroenterol, Shanghai, Peoples R China
[21] Zhengzhou Univ, Affiliated Hosp 1, Dept Gastroenterol, Zhengzhou, Henan, Peoples R China
[22] Peking Univ, Dept Biostat, Clin Res Inst, Beijing, Peoples R China
[23] Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Div Gastroenterol & Hepatol, 145 Middle Shandong Rd, Shanghai 200001, Peoples R China
关键词
atrophy; chemoprevention; dysplasia; gastric neoplasms; intestinal metaplasia; HELICOBACTER-PYLORI ERADICATION; FOLIC-ACID; INTESTINAL METAPLASIA; ATROPHIC GASTRITIS; RISK; SUPPLEMENTATION; CARCINOGENESIS;
D O I
10.1111/1751-2980.13251
中图分类号
R57 [消化系及腹部疾病];
学科分类号
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.
引用
收藏
页码:27 / 35
页数:9
相关论文
共 28 条
[1]   The staging of gastritis with the OLGA system by using intestinal metaplasia as an accurate alternative for atrophic gastritis [J].
Capelle, Lisette G. ;
de Vries, Annemarie C. ;
Haringsma, Jelle ;
Ter Borg, Frank ;
de Vries, Richard A. ;
Bruno, Marco J. ;
van Dekken, Herman ;
Meijer, Jos ;
van Grieken, Nicole C. T. ;
Kuipers, Ernst J. .
GASTROINTESTINAL ENDOSCOPY, 2010, 71 (07) :1150-1158
[2]   SPIRIT 2013: new guidance for content of clinical trial protocols [J].
Chan, An-Wen ;
Tetzlaff, Jennifer M. ;
Altman, Douglas G. ;
Dickersin, Kay ;
Moher, David .
LANCET, 2013, 381 (9861) :91-92
[3]   Where Do We Stand With Aspirin for the Prevention of Colorectal Cancer? The USPSTF Recommendations [J].
Chan, Andrew T. ;
Ladabaum, Uri .
GASTROENTEROLOGY, 2016, 150 (01) :14-18
[4]   Mass eradication of Helicobacter pylori to reduce gastric cancer incidence and mortality: a long-term cohort study on Matsu Islands [J].
Chiang, Tsung-Hsien ;
Chang, Wei-Jung ;
Chen, Sam Li-Sheng ;
Yen, Amy Ming-Fang ;
Fann, Jean Ching-Yuan ;
Chiu, Sherry Yueh-Hsia ;
Chen, Yi-Ru ;
Chuang, Shu-Ling ;
Shieh, Chun-Fu ;
Liu, Cheng-Ying ;
Chiu, Han-Mo ;
Chiang, Hung ;
Shun, Chia-Tung ;
Lin, Ming-Wei ;
Wu, Ming-Shiang ;
Lin, Jaw-Town ;
Chan, Chang-Chuan ;
Graham, David Y. ;
Chen, Hsiu-Hsi ;
Lee, Yi-Chia .
GUT, 2021, 70 (02) :243-250
[5]  
CORREA P, 1992, CANCER RES, V52, P6735
[6]   Gastric cancer risk in patients with premalignant gastric lesions: A nationwide cohort study in the Netherlands [J].
de Vries, Annemarie C. ;
van Grieken, Nicole C. T. ;
Looman, Caspar W. N. ;
Casparie, Mariel K. ;
de Vries, Esther ;
Meijer, Gerrit A. ;
Kuipers, Ernst J. .
GASTROENTEROLOGY, 2008, 134 (04) :945-952
[7]   Classification and grading of gastritis - The updated Sydney System [J].
Dixon, MF ;
Genta, RM ;
Yardley, JH ;
Correa, P ;
Batts, KP ;
Dahms, BB ;
Filipe, MI ;
Haggitt, RC ;
Haot, J ;
Hui, PK ;
Lechago, J ;
Lewin, K ;
Offerhaus, JA ;
Price, AB ;
Riddell, RH ;
Sipponen, P ;
Solcia, E ;
Watanabe, H .
AMERICAN JOURNAL OF SURGICAL PATHOLOGY, 1996, 20 (10) :1161-1181
[8]   Guidelines for diagnosis and treatment of chronic gastritis in China (2022, Shanghai) [J].
Fang, Jing-Yuan ;
Du, Yi Qi ;
Liu, Wen Zhong ;
Xiao, Ying Lian ;
Chen, Wei Chang ;
Ren, Jian Lin ;
Li, Yan Qing ;
Li, Peng ;
Liu, Ling ;
Chen, Xiao Yu ;
Jin, Zhu ;
Li, Jing Nan ;
Chen, Ying Xuan ;
Lyu, Nong Hua ;
Lyu, Bin ;
Shi, Yong Quan .
JOURNAL OF DIGESTIVE DISEASES, 2023, 24 (03) :150-180
[9]   Chinese consensus on chronic gastritis (2017, Shanghai) [J].
Fang, Jing-Yuan ;
Du, Yi Qi ;
Liu, Wen Zhong ;
Ren, Jian Lin ;
Li, Yan Qing ;
Chen, Xiao Yu ;
Lv, Nong Hua ;
Chen, Ying Xuan ;
Lv, Bin .
JOURNAL OF DIGESTIVE DISEASES, 2018, 19 (04) :182-203
[10]  
Ford AC, 2020, COCHRANE DB SYST REV, DOI [10.1002/14651858.CD005583.pub3, 10.1002/14551858.00005583.pub3]