RESUMEN
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 follow-up 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 （<italic>P</italic><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 （<italic>P</italic><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 （<italic>P</italic><0.01）. Observation group was superior to the control group in terms of efficacy for traditional Chinese medicine（TCM） syndrome and efficacy under gastroscope （<italic>Z</italic>=2.083， <italic>P</italic><0.05； <italic>Z</italic>=2.104， <italic>P</italic><0.05）. Clinical recurrence rate in observation group was 20.37% （11/54）， lower than 40.82% （20/49） in control group （<inline-formula><alternatives><mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:msup><mml:mrow><mml:mi>χ</mml:mi></mml:mrow><mml:mrow><mml:mn mathvariant="normal">2</mml:mn></mml:mrow></mml:msup></mml:math><graphic specific-use="big" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/CD75C203-D673-4226-A5C3-F3D84A74EF61-M002.jpg"><?fx-imagestate width="3.30199981" height="3.64066648"?></graphic><graphic specific-use="small" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/CD75C203-D673-4226-A5C3-F3D84A74EF61-M002c.jpg"><?fx-imagestate width="3.30199981" height="3.64066648"?></graphic></alternatives></inline-formula>=5.105， <italic>P</italic><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.