快胃片治疗慢性浅表性胃炎上腹痛的有效性和安全性:一项多中心、随机、双盲、双模拟对照研究  

Efficacy and safety of Kuaiwei Tablet for epigastria pain caused by chronic superficial gastritis:a multicenter,randomized,double-blind,double-simulated controlled study

作　　者：张北华[1] 付万发[2] 杨祖福[3] 徐陆周[4] 张志杰 唐旭东[1] ZHANG Beihua;FU Wanfa;YANG Zufu;XU Luzhou;ZHANG Zhijie;TANG Xudong(Institute of Digestive Disease,Xiyuan Hospital,China Academy of Chinese Medical Science,Beijing,100091,China;Department of Gastroenterology,Beijing Geriatric Hospital;Department of Rehabilitation,Traditional Chinese Medicine,Beijing Charity Hospital;Department of Gastroenterology,Jiangsu Province Hospital of Traditional Chinese Medicine;Department of Gastroenterology,Liuzhou Traditional Chinese Medicine Hospital)

机构地区：[1]中国中医科学院西苑医院脾胃病研究所,北京100091 [2]北京老年医院消化科 [3]北京博爱医院中医康复科 [4]江苏省中医院消化科 [5]柳州市中医医院消化内科

出　　处：《中国中西医结合消化杂志》2023年第10期775-780,共6页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：国家中医药传承创新团队项目(No:ZYYCXTD-C-202010)。

摘　　要：目的:评价快胃片治疗慢性浅表性胃炎上腹痛的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、阳性药对照研究,纳入来自中国中医科学院西苑医院、北京老年医院、北京博爱医院、江苏省中医院、柳州市中医医院的60例慢性浅表性胃炎上腹痛患者,随机分为试验组和对照组,每组30例。试验组口服快胃片和替普瑞酮胶囊模拟剂,对照组口服快胃片模拟剂和替普瑞酮胶囊,疗程均为4周。比较2组上腹痛视觉模拟评分(VAS)、应答率、有效率、上腹痛快速缓解情况、次要症状(食欲不振、腹胀、嗳气、反酸、烧心、便秘、腹泻)评分、慢性胃肠疾病患者报告临床结局评价量表(PRO量表)评分、应急药物使用情况、用药依从性、幽门螺杆菌感染情况及用药安全性。结果:服药4周后,试验组主要症状上腹痛VAS评分、次要症状(食欲不振、腹胀、嗳气、反酸、烧心)评分及PRO量表评分较基线显著下降,差异均有统计学意义(P<0.05)。组间比较差异无统计学意义。试验组服药2周的腹胀评分、服药4周和停药2周PRO量表评分低于对照组(P<0.05)。试验组服药2周的VAS评分、腹胀评分、PRO量表评分较基线的差值与对照比较差异均有统计学意义(P<0.05),试验组下降幅度较大。其余指标组间差异均无统计学意义(P>0.05)。2组均未出现与药物有关的不良事件。结论:快胃片治疗慢性浅表性胃炎上腹痛安全且有效、快速,对患者上腹痛改善效果与替普瑞酮胶囊相比改善程度更大;对腹胀、反酸、烧心及PRO量表评分的改善作用优于替普瑞酮胶囊。Objective To observe the safety and efficacy of Kuaiwei Tablet for epigastria pain caused by chronic superficial gastritis.Methods A multicenter,randomized,double-blind,double-dummy,positive drug controlled study was adopted,from Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine,Beijing Geriatric Hospital,Beijing Charity Hospital,Jiangsu Province Hospital of Traditional Chinese Medicine and Liuzhou Traditional Chinese Medicine Hospital,60 cases with epigastria pain caused by chronic superficial gastritis were randomly divided into test group and control group,with 30 cases in each group.The test group was administered with Kuaiwei Tablet and Teprenone capsule simulation agent,while the control group was given Kuaiwei Tablet simulation agent and Teprenone capsule.The treatment lasted for 4 weeks.The epigastria pain visual analogue scale(VAS),response rate,effective rate,rapid relief of upper abdominal pain,minor symptom(inappetence,abdominal distension,belching,acid reflux,heartburn,constipation,diarrhea)score,PRO scale score,emergency medication usage,drug compliance,Helicobacter pylori infection status and safety were compared.Results Compared with baseline values,the main symptom of epigastria pain VAS score,minor symptom(inappetence,abdominal distension,belching,acid reflux,heartburn,constipation)scores and PRO scale score in test group decreased,and the differences were statistically significant(P<0.05).There were no significant differences between groups.In test group,the abdominal distension score of after 2 weeks of medication,PRO scale scores for 4 weeks of medication and 2 weeks of discontinuation were lower than those in control group(P<0.05).The VAS score,abdominal distension score and PRO scale score after 2 weeks of medication minus the baseline value in test group were larger than those in control group,the decreases in trial group were significant(P<0.05).While the other indicators showed no statistically differences between groups(P>0.05).There were no adverse events related to me

关 键 词：慢性浅表性胃炎 上腹痛 快胃片 安全性 有效性 

分 类 号：R573.3[医药卫生—消化系统]