化肝煎合金铃子散加减治疗胆汁反流性胃炎肝胃郁热证的临床观察

Clinical Observation on Addition and Subtraction Therapy of Huaganjian Combined with Jinlingzisan in Patients with Bile Reflux Gastritis with Stagnancy Heat of Liver and Stomach Syndrome

目的:评价化肝煎合金铃子散加减治疗胆汁反流性胃炎(BRG)肝胃郁热证的疗效及对炎症因子和胃肠激素的影响。方法:按随机数字表法将150例患者分为对照组和观察组各75例。对照组脱落、失访5例,剔除2例,完成68例;观察组脱落、失访3例,剔除4例,完成68例。对照组口服达立通颗粒,1袋/次,3次/d,饭前服用。观察组给予化肝煎合金铃子散加减内服,1剂/d。两组疗程均为4周。进行治疗前胃镜检查,评价胆汁反流程度和胃镜下黏膜情况;进行治疗前后肝胃郁热证、慢性胃肠疾病患者报告临床结局(PRO)评价量表、焦虑自评量表(SAS),抑郁自评量表(SDS)评分;进行6个月随访,记录临床复发情况;检测治疗前后胃泌素(GAS),胃动素(MTL),胆囊收缩素(CCK),前列腺素E2(PGE2),肿瘤坏死因子-α(TNF-α),白细胞介素-8(IL-8)水平;进行安全性评价。结果:观察组胆汁反流程度评分、胃镜下黏膜评分和肝胃郁热证积分均低于对照组(P<0.01);观察组PRO量表6个维度(消化不良、反流、排便、社会、心理、全身状态)评分均低于对照组(P<0.01);观察组SAS和SDS评分均低于对照组(P<0.01);观察组CCK水平低于对照组(P<0.01),GAS和MTL均高于对照组(P<0.01);观察组PGE2水平高于对照组(P<0.01),TNF-α和IL-8水平均低于对照组(P<0.01);观察组中医证候疗效优于对照组(Z=2.083,P<0.05);观察组胃镜疗效优于对照组(Z=2.104,P<0.05);观察组临床复发率为20.37%(11/54),低于对照组的40.82%(20/49)(χ^(2)=5.105,P<0.05)。没有发现服用中药不良反应。结论:化肝煎合金铃子散加减治疗BRG肝胃郁热证患者,可改善临床症状,减轻焦虑、抑郁,提高患者生活质量,改善胆汁反流程度,促进胃黏膜的愈合,并可减轻炎症反应,调节胃肠激素,近期有较好的中医证候疗效和胃镜疗效,远期可降低复发率,且安全。

Objective: To evaluate the efficacy of addition and subtraction therapy of Huaganjian combined with Jinlingzisan for bile reflux gastritis(BRG)with stagnancy heat of liver and stomach syndrome,and to investigate its effect on inflammatory factors and gastrointestinal hormones. Method: One hundred and fifty patients were divided into control group and observation group evenly according to random number table.The 68 patients in control group finished the treatment(5 cases of dropout,loss of follow-up and 2 cases of withdrawal),and 69 patients in observation group completed the treatment(3 cases of dropout,loss of followup and 3 cases of withdrawal). Patients in control group got oral Dalitong granules before the meal,1 bag/time,3 times/day. Patients in observation group got addition and subtraction therapy of Huaganjian combined with Jinlingzisan,1 dose/day. The treatment continued for 4 weeks in both groups. Before the treatment,gastroscope was used to evaluate the degree of bile reflux and the condition of mucosa under gastroscope. Before and after treatment,scores of stagnancy heat of liver and stomach syndrome,patient reported outcome(PRO)scale of chronic gastrointestinal diseases,self rating anxiety scale(SAS),and self rating depression scale(SDS)were recorded. A follow-up of 6 months was conducted to record the clinical recurrence. Levels of gastrin(GAS),motilin(MTL),cholecystokinin(CCK),prostaglandin E2(PGE2),tumor necrosis factor-α(TNF-α),and interleukin-8(IL-8)were detected both before and after treatment. In addition,the safety was discussed. Result:Scores of degree of bile reflux,mucosa under gastroscope and stagnancy heat of liver and stomach syndrome in the observation group were lower than those in control group(P<0.01). Scores of 6 dimensions in PRO scale(dyspepsia,reflux,defecation,social,psychological,and general state)and scores of SAS and SDS in the observation group were lower than those in control group(P<0.01). Levels of CCK,TNF-α and IL-8 in the observation group were all lower than those detected in control group(P<0.01),while levels of GAS and MTL were higher than those in control group(P<0.01). Observation group was superior to the control group in terms of efficacy for traditional Chinese medicine(TCM)syndrome and efficacy under gastroscope(Z=2.083,P<0.05;Z=2.104,P<0.05). Clinical recurrence rate in observation group was 20.37%(11/54),lower than40.82%(20/49)in control group(χ^(2)=5.105,P<0.05). No adverse reaction was found after oral administrationh of TCM. Conclusion: Addition and subtraction therapy of Huaganjian combined with Jinlingzisan can ameliorate the clinical symptoms,relieve anxiety and depression,improve the quality of life in patients with BRG and stagnancy heat of liver and stomach syndrome,improve the degree of bile reflux,promote the healing of gastric mucosa,reduce inflammatory reaction and regulate gastrointestinal hormones. It has good efficacy for TCM syndrome and under gastroscopy in a short term,and can reduce the recurrence rate with high safety in a long term.