ABSTRACT
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.
ABSTRACT
Objective: To establish the UPLC specific chromatogram and HPLC content determination methods of multi-index components about the material reference of classical Huaganjian and build its quality control system. Methods: According to the ancient books and combining with the previously inspected process, 18 batches of Huaganjian material reference from different origins were prepared. The specific chromatogram was established by using UPLC. Similarity was calculated by using TCM Chromatographic Fingerprint Similarity Evaluation Software (2012). Combining with orthogonal partial least squares discriminant analysis, we excavated the main components that affected the quality of Huaganjian material reference from different batches and origins. Three of these index components (paeoniflorin, hesperidin, paeonol) from prescription sovereign drug, minister drug, and assistant drug were selected and used as indicators for content determination of Huaganjian material reference. HPLC content determination methods were established and the content of 18 batches of samples was determined respectively. Results: The similarity of the specific chromatogram was ≥ 0.989. Thirty-three common peaks were calibrated, and eight common peaks were identified by chemical composition (gallic acid, geniposide, paeoniflorin, hesperidin, didymin, paeonol, sinensetin, and 3,5,6,7,8,3',4'- heptamethoxyflavone). Nine index components that affected the stability between batches were found out (Peak 31, 20, 11, 13, 22, 33, 21, 29, 1). Paeoniflorin, hesperidin, and paeonol were selected as content determination indicators. The content range of these components in material reference was 1.28%-1.95% paeoniflorin, 0.91%-1.02% hesperidin, 0.48%-0.57% paeonol. Conclusion: The quality control method of the material reference of classic prescription Huaganjian was established preliminarily through the UPLC specific chromatogram and HPLC content determination of index components. This method was rapid, simple, feasible, reproducible, stable and could provide a theoretical basis for the subsequent development and quality control of Huaganjian preparations.