| Objective Clinical Study:To observe the therapeutic efficacy of Shugan Hewei Jiangni Decoction(SHJD) in treating gastroesophageal reflux disease (GERD). Experimental Study:To observe the effects of the SHJD on gastric emptying and small bowel peristalsis activity in reflux esophagitis rat model. Measuring Ghrelin concentration in rats blood plasma to explorer the possible mechanism of SHJD in improve Gastrointestinal motility. Methods Clinical Study: Sixty-seven GERD patients conformed with the inclusive criteria were randomly divided into the treated group(33 patients)and the control group(34 patients). Patients in the treated group received SHJD orally, one dose per day, while those in the control group received Omeprazole,20 mg once per day, and Mosapride,5mg three times per day. The therapeutic course was 8 weeks. The efficacy on clinical symptoms, EE grades and scores determined by gastroscope and the condition of recurrence were evaluated. Experimental Study:The experiments were performed on 60 SD rats (wight at 220±20g).10 rats were picked out radomly as control group. As the same way, another 10 rats were chosen to be sham-operated group. The 40 left rats were induced to EE by operation, and 32 of them that been confirmed with EE were divided radomly into 3 group:11 for model group,10 for WM group and TCM group. SHJD (2ml/d,1.08g/ml)and western medicine (Omeprazole, 1ml/d,1.73mg/ml; Mosapride,1ml/d,0.324mg/ml) were given to TCM and WM group via gastric lavage daily one week after the operation (physiological saline were given to other groups,2ml/d).2% dextran blue-2000 (o.5ml) were given to each rat 30min after the last lavage.30min later, the residue rates of pigment in stomach and propulsive proportion of small intestine of dextran blue-2000 in rats were observed to evaluate the capacity of gastric emptying and small bowel peristalsis influenced by the operation and both wstern and TCM medicine. Meanwhile, the pathological changes of esophagus mucous in every group and ghrelin concentration in rats blood plasma in control group, model group and TCM group were also determined. Results Clinical Study:The therapeutic effect of SHJD on GERD was similar to that of Omeprazole and Mosapride in aspects of improving comprehensive clinical symptoms and curing esophageal mucous inflammation(under gastroscope). But the cure rate of chest pain and belching in treated group was obviously higher than that in the control group(P<0.05), while the recurrence in the SHJD group was obviously lower than that in the control group in 6 and 12 months after withdrawal of treatment(P<0.05). Experimental Study:Both WM and TCM can significantly improve the pathological changes of esophagus mucous (P<0.01 for macropathology, P<0.05 for micropathology, vs. model group), but the significant difference were P>0.05 when compare with eacher and control group separately. Similar results were turned up in the comparison of residue rates of pigment in stomach. The propulsive proportion of small intestine in TCM group were remarkably higher than model group (P<0.01), WM group (P<0.05)and even control group (P<0.05). Compared with control group, the ghrelin concentration in rats blood plasma in modle group were much lower(P<0.01). While the concentration of TCM group were significantly higher than that of modle group(P<0.01), but not exceeded control group yet (P>0.05). Conclusion Clinical Study:SHJD showed favorable therapeutic efficacy in treating GERD. The therapeutic effect of SHJD on GERD was similar to that of Omeprazole and Mosapride in aspects of improving comprehensive clinical symptoms and curing esophageal mucous inflammation(under gastroscope). Meanwhile, it was more brilliant in curing chest pain, belching and reducing long-term recurrence. Experimental Study:SHJD has similar efects with Omeprazole-Mosapride in aspects of improving pathological changes and promoting gastric emptying for rats with EE, and its small bowel peristalsis improving efect was much intense. The ghrelin concentration in rats blood plasma showed that increasing ghrelin concentration might be the possible mechanism of SHJD to promte gastrointestinal motility of rats with EE.
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