老年人餐后不适综合征的治疗:一项多中心前瞻性随机对照临床研究  

Treatment of postprandial discomfort syndrome in the elderly:a multi-centered prospective randomized controlled clinical study

作　　者：王刚石[1] 许乐[2] 陈洪潭[3] 史丽萍[4] 黄敏菁 习玲[6] 徐丽姝[7] 王芬[8] 李虹义[9] 李姝[10] 张艺军 谭诗云[12] 洪汝涛[13] 吕农华[14] 叶梅[15] 甘华田[16] 刘淼[1] 吴本俨[1] 无 Wang Gangshi;Xu Le;Chen Hongtan;Shi Liping;Huang Minjing;Xi Ling;Xu Lishu;Wang Fen;Li Hongyi;Li Shu;Zhang Yijun;Tan Shiyun;Hong Rutao;Lyu Nonghua;Ye Mei;Gan Huatian;Liu Miao;Wu Benyan;无(Department of Gastroenterology,The Second Medical Center of PLA General Hospital,Beijing 100853,China;Department of Gastroenterology,Beijing Hospital,Beijing 100730,China;Department of Gastroenterology,The First Affiliated Hospital of Zhejiang University,Hangzhou 310003,China;Department of Geriatric Gastroenterology,Shaanxi Provincal People′s Hospital,Xi′an 710068,China;Department of Gastroenterology,The First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,China;Department of Geriatrics,The First Hospital of Shanxi Medical University,Taiyuan 030001,China;Department of Geriatrics,Guangdong Provincal People′s Hospital,Guangzhou 510080,China;Department of Gastroenterology,The Third Xiangya Hospital of Central South University,Changsha 410013,China;Department of Geriatrics,The Seventh Medical Center of PLA General Hospital,Beijing 100700,China;Department of Gastroenterology,Tianjin Medical University General Hospital,Tianjin 300052,China;Department of Geriatric Gastroenterology,PLA Southern Theater General Hospital,Guangzhou 510010,China;Department of Gastroenterology,Renmin Hospital of Wuhan University,Wuhan 430060,China;Department of Gastroenterology,The First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Department of Gastroenterology,The First Affiliated Hospital of Nanchang University,Nanchang 330006,China;Department of Gastroenterology,Zhongnan Hospital of Wuhan University,Wuhan 430071,China;Department of Gastroenterology,West China Hospital,Sichuan University,Chengdu 610041,China;On behalf of Committee of Geriatric Gastroenterology,Chinese Society of Gastroenterology)

机构地区：[1]解放军总医院第二医学中心消化科,北京100853 [2]北京医院消化科,100730 [3]浙江大学附属第一医院消化科,杭州310003 [4]陕西省人民医院老年消化科,西安710068 [5]广州医科大学附属第一医院消化科,510120 [6]山西医科大学第一医院老年科,太原030001 [7]广东省人民医院老年科,广州510080 [8]中南大学湘雅三医院消化科,长沙410013 [9]解放军总医院第七医学中心老年科,北京100700 [10]天津医科大学总医院消化科,300052 [11]解放军南部战区总医院老年消化科,广州510010 [12]武汉大学人民医院消化科,430060 [13]安徽医科大学第一附属医院消化科,合肥230022 [14]南昌大学第一附属医院消化科,330006 [15]武汉大学中南医院消化科,430071 [16]四川大学华西医院消化科,成都610041 [17]代表中华医学会消化病学分会老年消化协作组

出　　处：《中华内科杂志》2020年第2期117-123,共7页Chinese Journal of Internal Medicine

摘　　要：目的评估米曲菌胰酶片治疗老年人餐后不适综合征(PDS)的有效性和安全性,及其与促胃肠动力药物的疗效差异。方法采用前瞻性随机对照试验设计。将老年PDS患者用随机数表法抽样分为3组,莫沙必利组采用枸橼酸莫沙必利片治疗(5 mg/次,3次/d,餐前服用,疗程2周),米曲菌胰酶片组采用米曲菌胰酶片治疗(244 mg/次,3次/d,餐中或餐后服用,疗程2周),联合治疗组采用枸橼酸莫沙必利片和米曲菌胰酶片治疗(用法用量同前,疗程2周)。采用改良的尼平消化不良指数(NDSI)评分标准,分别于治疗前和治疗1周、2周、停药4周后,对患者进行NDSI评分、不适强度评分和PDS评分,同时进行疗效分析和药物不良反应评估。结果全国16家三级甲等医院参加本研究,共有323例患者入组,其中,莫沙必利组105例,米曲菌胰酶片组109例,联合治疗组109例。研究对象中,男148例(45.8%),女175例(54.2%),年龄60~100(71.4±9.0)岁;3组的基线特征无差异。治疗后,3组的NDSI评分均明显下降(P<0.001);不论是米曲菌胰酶片组还是联合治疗组,治疗1周、2周的NDSI评分与莫沙必利组相比差异均无统计学意义(P>0.05)。3组的不适强度评分和PDS评分在治疗后均下降(P<0.001),其中联合治疗组的评分下降最明显;米曲菌胰酶片组第1周和第2周的不适强度评分和PDS评分均低于莫沙必利组[不适强度评分:第1周,4.0(2.8,8.0)分比6.0(3.0,10.0)分;第2周,3.0(0.0,5.0)分比4.0(2.0,6.0)分;P值均<0.05。PDS评分:第1周,6.0(3.0,9.0)分比7.0(3.5,10.5)分;第2周,3.0(0.0,5.0)分比4.0(2.0,7.0)分;P值均<0.05]。莫沙必利组、米曲菌胰酶片组和联合治疗组在治疗1周时的总有效率均超过15.0%,治疗2周时总有效率分别为55.2%、68.8%和73.4%,其中米曲菌胰酶片组和联合治疗组的2周总有效率均高于莫沙必利组(P=0.041和P=0.006)。停药后,莫沙必利组的复发率最高(9.5%),显著高于米曲菌胰酶片组(1.8%,P<0.05)和联�ObjectiveTo evaluate the efficacy and safety of Oryz-Aspergillus enzyme and pancreatin tablets(Combizym■)in the treatment of postprandial distress syndrome(PDS)in the elderly,compared with gastrointestinal motility drugs.MethodsA prospective randomized controlled trial was designed and registered in the China Clinical Trials Registry(ChiCTR-IPR-16008185).The elderly patients with PDS were randomly divided into three groups,including Mosapride group with Mosapride citrate tablets 5 mg 3 times per day for 2 weeks;Combizym■ group with Combizym tablets 244 mg 3 times per day for 2 weeks;combined treatment group with both drugs and same doses for 2 weeks.The modified Nepean dyspepsia index(NDSI)score,discomfort intensity score and PDS score were calculated on patients before treatment,at the end of first and second week of treatment,as well as 4 weeks after treatment finished,respectively.Adverse effects were evaluated.ResultsA total of 323 patients from 16 tertiary hospitals in China were enrolled in this study.Among them,105 patients were in Mosapride group,109 in Combizym■ group and 109 in combined treatment group.There were 148 males(45.8%)and 175 females(54.2%)with median age 71.4±9.0 years(60-100 years).Baseline characteristics of three groups were comparable.After treatment,the NDSI scores in three groups all decreased significantly(P<0.001),while they were similar between groups(P>0.05).The discomfort intensity score and PDS score in three groups showed a significant reduction after treatment(P<0.001),especially in the combined treatment group.Compared with Mosapride group,the scores in Combizym■ group decreased significantly after one or two weeks[discomfort intensity score:after one week,4.0(2.5,8.0)vs.6.0(3.0,10.0);after two weeks,3.0(0.0,5.0)vs.4.0(2.0,6.0);all P<0.05.PDS score:after one week,6.0(3.0,9.0)vs.7.0(3.5,10.5);after two weeks,3.0(0.0,5.0)vs.4.0(2.0,7.0);all P<0.05].The efficacy rate in all patients after first week of treatment was over 15.0%.The efficacy rates after two weeks were 55.2

关 键 词：消化不良 老年人 餐后不适综合征 米曲菌胰酶片 莫沙必利 

分 类 号：R57[医药卫生—消化系统]