莪连颗粒治疗慢性萎缩性胃炎伴癌前病变的随机多中心双盲双模拟平行对照研究  

Randomized, multicenter, double-blind, double dummy, parallel controlled study of Elian granules in the treatment of chronic atrophic gastritis with precancerous lesions

作　　者：丛军[1] 凌江红 李莉[1] 顾志坚[1] 韩力[2] 贾庆玲 吴辰恒 蔡淦[1] CONG Jun;LING Jianghong;LI Li;GU Zhijian;HAN Li;JIA Qingling;WU Chenheng;CAI Gan(Department of Gastroenterology,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200021l,China;Department of Traditional Chinese Medicine,Huadong Hospital Affiliated to Fudan University)

机构地区：[1]上海中医药大学附属曙光医院消化内科,上海200021 [2]复旦大学附属华东医院中医内科

出　　处：《中国中西医结合消化杂志》2023年第5期340-345,共6页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：上海市科学技术委员会临床医学领域项目(No:18401971400);国家中医药管理局中医药循证能力建设项目(No:ZZ13-042-2,2019XZZX-XH013);国家中医药管理局第六批全国老中医药专家学术经验继承工作项目(No:国中医药人教发[2017]29号);科技部国家重点研发计划项目(No:2018YFC1704100,2018YFC1704102)。

摘　　要：目的:客观评价莪连颗粒治疗慢性萎缩性胃炎伴癌前病变的临床疗效及药物安全性。方法:纳入慢性萎缩性胃炎伴癌前病变脾虚瘀热证的病例169例,来自曙光医院、华东医院、龙华医院、岳阳医院、普陀区中医医院和奉贤区中医医院门诊,根据治疗方法分为两组,试验组采用莪连颗粒与胃复春片模拟剂治疗(n=87),对照组采用胃复春片和莪连颗粒模拟剂治疗(n=82),疗程12周。比较两组患者胃黏膜组织病理学疗效、治疗前后中医证候积分及单项症状积分、并进行安全性分析。结果:两组的病理总有效率在胃黏膜慢性炎症、活动性、萎缩、肠化和异型增生等方面分别为:试验组24.68%、55.56%、57.14%、54.43%、75.00%,对照组21.92%、60.00%、54.79%、55.41%、62.50%,组间比较均差异无统计学意义(P>0.05)。两组在症状总积分的疗效分别为试验组89.66%,对照组87.80%,组间比较差异无统计学意义(P>0.05);胃脘疼痛、胃脘痞满、胃脘不适、纳差、乏力、便溏、口苦、口气重等单个症状的疗效比较,组间差异无统计学意义(P>0.05)。结论:莪连颗粒治疗脾虚瘀热证型慢性萎缩性胃炎伴癌前病变,可明显改善患者临床症状,逆转胃黏膜的萎缩及肠化生,且安全性较好,与胃复春疗效相当。Objective: To objectively evaluate the clinical efficacy and drug safety of Elian granules in the treatment of chronic atrophic gastritis with precancerous lesions. Methods: One hundred and sixty-nine cases of chronic atrophic gastritis with precancerous lesions conforming to the syndrome of spleen deficiency and blood stasis heat were included. They were from Shuguang Hospital, Huadong Hospital, Longhua Hospital, Yueyang Hospital, Putuo District Hospital of TCM and Fengxian District Hospital of TCM. According to the treatment methods, they were divided into two groups. The test group was treated with Elian granules and Weifuchun tablets simulants(n=87), and the control group was treated with Weifuchun tablets and Elian granules simulants(n=82) for 12 weeks. The score of TCM syndromes and efficacy, score of single symptom, pathological analysis of gastric mucosa and safety of the two groups were compared and summarized. Results: The total pathological effective rates of the two groups were 24.68%, 55.56%, 57.14%, 54.43%, 75.00% in the experimental group and 21.92%, 60.00%, 54.79%, 55.41%, 62.50% in the control group in terms of gastric mucosa chronic inflammation, activity, atrophy, intestinal metaplasia and dysplasia, respectively. There was no significant difference between the two groups(P>0.05).The total scores of the two groups in the symptoms of epigastric pain, epigastric distension, epigastric discomfort, anorexia, fatigue, loose stools, bitter mouth, and heavy breath were 89.66% in the test group and 87.80% in the control group, respectively, with no statistical difference between the two groups(P>0.05);There was no significant difference in the efficacy of single symptom between the groups(P>0.05). Conclusion: Elian granule can significantly improve the clinical symptoms of patients with chronic atrophic gastritis with precancerous lesions of spleen deficiency and blood stasis heat type, reverse the atrophy of gastric mucosa and intestinal metaplasia, and has good safety, which is equivalent to the effe

关 键 词：莪连颗粒 脾虚瘀热型 慢性萎缩性胃炎 癌前病变 多中心临床研究 平行对照 

分 类 号：R259[医药卫生—中西医结合]