脾胃培源方加减联合针刺治疗慢性萎缩性胃炎伴肠化生效果的多中心临床随机对照试验  

A Multicenter Randomized Controlled Clinical Trial Study on the Effect of Piwei Peiyuan Decoction Combined with Acupuncture in the Treatment of Chronic Atrophic Gastritis with Intestinal Metaplasia

作　　者：吴凯瑞 叶宇 李娇月 裴蓓 李学军[3] 程红亮[4] WU Kairui;YE Yu;LI Jiaoyue;PEI Bei;LI Xuejun;CHENG Hongliang(The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230061,China;The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine,Beijing 100029,China;Department of Spleen and Stomach Diseases,the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230061,China;Department of Brain Disease,the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230061,China)

机构地区：[1]安徽中医药大学第二附属医院,安徽省合肥市230061 [2]北京中医药大学第三附属医院,北京市100029 [3]安徽中医药大学第二附属医院脾胃科,安徽省合肥市230061 [4]安徽中医药大学第二附属医院脑病科,安徽省合肥市230061

出　　处：《中国全科医学》2024年第20期2466-2475,共10页Chinese General Practice

基　　金：安徽省中医药科技攻关专项项目(202303a07020003);安徽省重点研究与开发计划项目(2022e07020023);安徽省重大疑难疾病中西医协同攻关项目(0708-2021)。

摘　　要：背景慢性萎缩性胃炎(CAG)伴肠化生(IM)是胃癌的独立危险因素,长期的炎症与氧化应激反应刺激患者的身心状态。现代医疗模式下质子泵抑制剂和胃黏膜保护剂满足不了患者的高抗药性,寻求有效的中医新疗法、多手段治疗CAG伴IM已迫在眉睫。目的评价中药复方脾胃培源方加减联合针刺治疗CAG伴IM临床疗效及其安全性。方法选取2022年1月—2023年9月就诊于安徽中医药大学第二附属医院脾胃科、治未病中心和北京中医药大学第三附属医院经胃镜及病理组织检查确诊结果为CAG伴IM患者202例,采用随机数字表法分为对照组67例,治疗组A 68例,治疗组B 67例,均参与6周治疗。(1)对照组:铝镁加混悬液联合叶酸片(3次/d);(2)治疗组A:予脾胃培源方分证型加减(2次/d);(3)治疗组B:脾胃培源方(用法同组A)联合针刺(1次/d),以足三里、梁丘、公孙、内关、中脘为主穴,据证型选用配穴。治疗前及治疗6周后记录OLGA、OLGIM分期,胃黏膜病理疗效,胃黏膜病理评分,临床症状评分,患者报告结局(PRO)量表评分,药物相关不良事件(AE)和药物不良反应(ADR)情况。结果完成6周疗程的患者共192例(对照组:62例,治疗组A:66例,治疗组B:64例)患者。对照组有效率为48.39%(30/62),治疗组A有效率为69.70%(46/66),治疗组B有效率为71.88%(46/64);三组有效率比较,差异有统计学意义(χ^(2)=9.144,P=0.01)。三组治疗后胃黏膜病理评分、临床症状评分、PRO量表评分均较同组治疗前降低(P<0.05)。胃黏膜病理评分:治疗组A和治疗组B慢性炎症、萎缩、IM评分均低于对照组,活动性炎症、发育不良评分均高于对照组(P<0.05)。临床症状评分:治疗组A和治疗组B胃脘胀满、胃脘痛评分均低于对照组(P<0.05)。PRO量表评分:治疗组A和治疗组B反酸、消化不良、排便、心理状态、全身症状及总分均低于对照组(P<0.05)。三组AE、ADR发生率比较,差异均无统计学意Background Chronic atrophic gastritis(CAG)with intestinal metaplasia(IM) is an independent risk factor for gastric cancer.Long-term inflammation and oxidative stress response stimulate the physical and mental state of patients.Under the modern medical model,proton pump inhibitors and gastric mucosal protective agents are increasingly unable to meet the high drug resistance of patients.It is urgent to seek effective new Chinese medicine treatments and multiple methods to treat CAG and IM.Objective To evaluate the clinical efficacy and safety of modified Piwei Peiyuan Decoction combined with acupuncture in the treatment of CAG with IM.Methods From January 2022 to September 2023,202 patients with CAG and IM diagnosed by gastroscopy and pathological examination in the Department of Spleen and Stomach,the Center for Preventive Treatment of Disease,the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine and the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine were selected.The patients were divided into control group(n=67),treatment group A(n=68) and treatment group B(n=67) by random number table method.All patients participated in 6 weeks of treatment:(1)Control group:aluminum magnesium suspension combined with folic acid tablets(3 times/d);(2)Treatment group A:to add and subtract syndrome types of Piwei Peiyuan Decoction(2 times/d);(3)Treatment group B:Piwei Peiyuan Decoction(the same as group A)combined with acupuncture(1 time/d),with Zusanli,Liangqiu,Gongsun,Neiguan,Zhongwan as the main points,according to the syndrome type selection of acupoints.Before and 6 weeks after treatment,OLGA,OLGIM staging,gastric mucosal pathological efficacy,gastric mucosal pathological score,clinical symptom score,PRO scale score,drug-related adverse events(AE)and adverse drug reactions(ADR)were recorded.Results A total of 192 patients completed the 6-week course of treatment(62 in the control group,66 in the treatment group A,and 64 in the treatment group B).The effective rate

关 键 词：慢性萎缩性胃炎 肠化生 脾胃培源方 针药联合 临床疗效 随机对照试验 

分 类 号：R573.32[医药卫生—消化系统]