治胃丸治疗肝胃不和证胆汁反流性胃炎的临床疗效  

Clinical Effect of Zhiwei Pill of Bile Reflux Gastritis with Symptoms of Disharmony of Liver and Stomach

作　　者：蔡翠珠[1] 王奇[2] 黄少君[3] 刘德喜[1] CAI Cui-zhu;WANG Qi;HUANG Shao-jun;LIU De-xi(Sanya Traditional Chinese Medicine(TCM)Hospital,Sanya 572000,China;Guangzhou University of Chinese Medicine,Guangzhou 510006,China;Haikou City Hospital of TCM,Haikou 570216,China)

机构地区：[1]三亚市中医院,海南三亚572000 [2]广州中医药大学,广州510006 [3]海口市中医院,海口570216

出　　处：《中国实验方剂学杂志》2021年第15期57-62,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：海南省卫生计生行业科研项目(18A200122);三亚医疗卫生科技创新项目(2019YW14)。

摘　　要：目的:采用三臂试验评价治胃丸治疗肝胃不和证胆汁反流性胃炎(BRG)的临床疗效与安全性,及对胃肠激素的调节作用。方法:将180例患者按随机数字表法分为安慰剂组、对照组和观察组各60例。三组均给予非药物治疗的生活方式干预。对照组采用铝碳酸镁片,2片/次,3次/d,餐后1~2 h或睡前或胃部不适时服用;安慰剂组采用治胃丸模拟药,6 g/次,3次/d,餐后1 h口服;观察组采用治胃丸,6 g/次,3次/d,餐后1 h口服。三组疗程均为4周。进行治疗前后肝胃不和证各症状评分和慢性胃肠疾病患者报告临床结局评价量表(PRO)评分;治疗前后检查胃镜,进行胆汁反流程度和胃镜下黏膜评分;检测治疗前后胃泌素(GAS),胃动素(MTL),胆囊收缩素(CCK)和P物质(SP)等胃肠激素水平,比较中医证候疗效和胃镜疗效;进行安全性评价。结果:治疗后观察组肝胃不和证各主要症状和7个次症状总分均低于对照组和安慰剂组(P<0.01),观察组肝胃不和证积分和PRO积分均低于对照组和安慰剂组(P<0.01);治疗后观察组胆汁反流程度评分和胃镜下黏膜评分均低于对照组和安慰剂组(P<0.01);治疗后观察组CCK水平均低于对照组和和安慰剂组(P<0.01),MTL,GAS和SP水平均高于对照组和安慰剂组(P<0.01);观察组中医证候疗效总有效率为(53/58)91.38%,高于对照组的(41/57)71.93%,安慰剂组的(18/52)34.62%(χ^(2)=15.248,P<0.01);观察组的胃镜疗效总有效率为(54/58)93.10%,高于对照组的(45/57)78.95%,安慰剂组的(15/52)28.85%(χ^(2)=27.581,P<0.05,P<0.01)。未发现服用治胃丸相关不良反应。结论:治胃丸用于肝胃不和证(BRG)患者可改善胆汁反流,促进胃镜下黏膜的愈合,并能调节胃肠激素、改善胃肠运动功能,明显缓解临床症状,提高生活质量,有着较好的中医证候疗效和胃镜下黏膜疗效,且临床使用安全。Objective:To evaluate the clinical efficacy of Zhiwei pill for bile reflux gastritis(BRG)with symptoms of disharmony of liver and stomach,evaluate the safety after treatment by three-arm study,and investigate the regulatory action to gastrointestinal hormones.Method:One hundred and eighty patients were randomly divided into placebo group(60 cases),control group(60 cases)and observe group(60 cases)by random number table.Patients in three groups got lifestyle intervention of non-drug therapy.Patients in control group got hydrotalcite tablets 1-2 hours after meal or untimely bedtime or in case of stomach pain,2 tablets/time,3 times/day.Patients in placebo group got simulated medicine of Zhiwei pill 1 hour after meal,6 g/time,3 times/day.Patients in observe group got Zhiwei pill 1 hour after meal,6 g/time,3 times/day.The treatment continued for 4 weeks in all 3 groups.Before and after treatment,scores were graded for symptoms of disharmony of liver and stomach and patient reported outcome(PRO)scale for patients with chronic gastrointestinal diseases.Gastroscopy was taken to grade the scores of bile reflux and mucosa under gastroscope.Levels of gastrin(GAS),motilin(MTL),cholecystokinin(CCK),substance P(SP)and gastrointestinal hormones were detected.Efficacy for traditional Chinese medicine(TCM)syndrome and efficacy under gastroscope were compared,and safety after treatment was evaluated.Result:After treatment,the total scores of the main symptoms and 7 secondary symptoms of disharmony of liver and stomach in observe group were all lower than those in placebo group and control group(P<0.01),and scores of symptoms of disharmony of liver and stomach and PRO were all lower than those in control group and placebo group(P<0.01).After treatment,scores of degree of bile reflux and mucosa under gastroscope in observe group were all lower than those in placebo group and control group(P<0.01).Level of CCK was lower than that in placebo group and control group(P<0.01),while levels of MTL,GAS and SP were higher than those in place

关 键 词：胆汁反流性胃炎 肝胃不和证 治胃丸 胃肠激素 生活质量 三臂试验设计 

分 类 号：R289[医药卫生—方剂学] R256[医药卫生—中药学]