| Objective: To evaluate the clinical efficacy,quality of life,and safety of "Ganshi health paste" on FD patients with spleen deficiency and qi stagnation,and to conduct an acute toxicity test,which provides an experimental basis for the safety of theclinical medication of "Ganshi health paste".Methods: 1.Clinical research: A randomized controlled study method was used to randomly divide 62 patients with functional dyspepsia of the spleen deficiency and qi stagnation type into the treatment group and the control group.The treatment group was given the "Ganshi health paste" and the control group was given the mosapride citrate dispersible tablets,which lasted for 4 weeks.Observed and compare the TCM syndrome integral,functional dyspepsia quality of life scale(FDDQL)scores and adverse reactions before and after treatment in the two groups,and to compare the clinical curative effect evaluation.2.Experimental research: Acute toxicity test: Before the formal experiment,the Pre-experiment was conducted in advance.No animal died during the experiment and median lethal dose(LD50)could not be detected,so the maximum dose experiment(formal experiment)was performed.The SPF level of 40 Kunming mice were randomly divided into experimental group and control group with 20 rats in each group by sex stratification.The maximum concentration of stomach was 0.75g/ml,and the maximum volume was 0.4ml/10 g.The stomach was continuously administered twice.The experimental group was given "Ganshi health paste".The control group was given intragastrically with an equal volume of normal saline.After 14 days of conventional feeding,the body weight,diet,appearance,behavior,excrement,mental state,general condition,death,and toxic reaction of the mice were observed and recorded continuously for 14 days.At the end of the experiment,blood was collected from some mice to test blood routine and biochemical indicators.After gross anatomy,the abnormal organs such as liver,heart,spleen,lung and kidney were observed under naked eye and microscope.Results: 1.Clinical research: Comparison of TCM syndromes and symptom scores: After 4 weeks of treatment,the total effective rate of TCM syndromes in the treatment group was higher than that of the control group,and the difference was statistically significant(P<0.05).The total scores of TCM syndromes in both groups decreased compared with before treatment.The total TCM syndrome scores in the treatment group decreased significantly compared with the control group,and the difference was statistically significant(P<0.05).The scores of the single symptom in the treatment group decreased compared with those before the treatment,and the difference was statistically significant(P<0.05).The scores of the single symptom in the control group decreased compared with those before the treatment.Except for fatigue,the scores of other symptoms were statistically significant compared with those before treatment(P<0.05).After treatment,the scores of individual symptoms in the treatment group decreased significantly compared with the control group.There were statistically significant differences between the two groups in gastric dyspepsia,poor appetite,and fatigue(P<0.05).There was no significant difference in the three symptoms of hernia,belching and loose stools(P>0.05).Comparison of quality of life: After treatment,the treatment group improved in all areas compared with before treatment,and the difference was statistically significant(P<0.05);in the control group,the other areas were improved in addition to the pressure area,and the difference was statistically significant(P<0.05).After treatment,the treatment group improved in the daily life,sleep,health feeling,stress and total score compared with the control group,and the difference was statistically significant(P<0.05).But there was no significant difference in anxiety,diet,discomfort and disease control(P>0.05).2.Acute toxicity test: According to the results of the pre-experiment,median lethal dose(LD50)could not be detected,so the maximum dose experiment was carried out.During 14 days of observation,no abnormal reactions and obvious toxic side effects were observed in all mice and no death was observed.The blood analysis,liver and kidney function of the experimental and control mice were normal,and the gross anatomical results and HE staining of the liver,heart,spleen,lung,kidney,and stomach were all normal,and no obvious abnormal changes were observed.Conclusion: 1."Ganshi health paste" can effectively improve TCM syndromes and individual TCM symptoms of patients with spleen deficiency and qi stagnation FD,and improve their quality of life.It is clinically safe and effective,and worthy of clinical promotion.2."Ganshi health paste" had no acute toxicity and it is safe for oral administration at the recommended daily dose for clinical adults. |
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