Objective:To observe the clinical efficacy and safety of Jianpi Jiangzhuo soup on patients with primary bile reflux gastritis (PBRG) in stagnation of liver-Qi and stomach-QiMethods:Using random control method, choose60cases in the spleen and stomach disease outpatient service of the first hospital of hunan university of TCM from January2014to January2015, up to the standard of cases of primary bile reflux gastritis (with stagnation of liver-Qi and stomach-Qi), according to the proportion of1:1, these60patients were randomly divided into two groups named the experimental group (the Jianpi Jiangzhuo soup) and control group (talcid+mosapride), with a course of4weeks. According to the change of clinical curative effect, the integral, bile regurgitation and gastric mucosa under gastroscope degree, and security index before and after the treatment, to evaluating the effect of the soup to the disease, syndrome curative effect of traditional Chinese medicine (including the recent curative effect and the long curative effect), the integral and individual integral of TCM syndrome and the security.Results:The Jianpi Jiangzhuo soup were better than the control group in the curative effect of disease, syndromes in the near and the forward curative effect, improving the total score of syndromes (P<0.05). It Can obviously improve the TCM syndrome integral of PBRG, and significantlier improving the stomach bilges, anti acid and heartburn, loss of appetite than the control group (P<0.05); but equal in improving stomach pain, nausea and vomiting (P>0.05). the treatment group is superior to the control group in improving the bile reflux curative effect (P<0.05), but equal to the change of gastric mucosa (P>0.05). No bad reaction occured in the process of observation prompting a good safety.Conclusion:The Jianpi Jiangzhuo soup can obviously improve the gastroscope performance and the symptom of TCM in patients with PBRG in stagnation of liver-Qi and stomach-Qi, especially improve the stomach bilges, anti acid and heartburn, and loss of appetite, it has a good effect in recent and forward curative compared with the western medicine, and its good safety permit its clinical application and promotion. |