| Study objectives:With the clinical and experiment study of Costustoot&Amomum Stomach-nourishing Decoction,discuss the effectiveness and safety of yin-deficiency prescription that is included in Korean medicine used for functional gastrointestinal disorder in order to provide a reliable basis for clinical application.Study methods:1.Clinical studies:60 patients who meet the diagnostic criteria enrolled the criteria of yin-deficiency are divided into the treatment group and control group,30 patients in each group.Give Costustoot&Amomum Stomach-nourishing Decoction in treatment group,increase amount of each drug by 1 times than original prescription,1 dose per day,decoction with water,take before morning and evening meal.Give Mosapride Tablet in control group,5mg/time,tid.oral.The course of treatment is 2 weeks.After the treatment course is over,observe the good improvement rate,total symptom score,overall efficiency and peripheral blood motilin value of pre-treatment and post-treatment in both groups in order to finally determine the clinical efficacy of this prescription.2.Experimental studies:60 rats are randomly divided into 6 groups including normal control group,model control group,positive control group,Costustoot&Amomum Stomach-nourishing Decoction high-dose group,Costustoot&Amomum Stomach-nourishing Decoction medium-dose group and Costustoot&Amomum Stomach-nourishing Decoction low-dose group,10 rats including half male and half female in each group.After 5 days of adaptive feed,make a functional dyspepsia model with Reserpine method.Give 2ml sterilized physiological saline in normal group and model group every day,give 2ml Mosapride Tablet suspension at 0.3mg/kg in positive control group,give Costustoot&Amomum Stomach-nourishing Decoction at 4.4g/kg,2.2g/kg and 1.lg/kg respectively in Costustoot&Amomum Stomach-nourishing Decoction high-dose group,Costustoot&Amomum Stomach-nourishing Decoction medium-dose group and Costustoot&Amomum Stomach-nourishing Decoction low-dose group,the dosing volume is 2ml,after 14 days of feeding,the rats are fasting but with water for 24 hours,draw blood from eyeball when the rats are under the anesthesia condition then treat the samples on next day.At last,determine the serum motilin and gastrin of rats for comparison and analysis.Results:1.Result of clinical trial study:(1)The good improvement rate is 60%,The control group was 51.7%,There was no significant difference between the two groups(P>0.05);The total effective rate was 93.3%in the treatment group,The control group was 65.5%,There was significant difference between the two groups(P<0.05),Costustoot&Amomum Stomach-nourishing Decoction is better than the overall effect of mosapride on functional dyspepsia of mosapride.The total symptom score and symptoms including epigastric pain,desire for pressure and warmth,lack of warmth in the extremities and burnout in Costustoot&Amomum Stomach-nourishing Decoction group have a significant difference compare with control group(P<0.05),which suggests Costustoot&Amomum Stomach-nourishing Decoction is superior to control group on overall improvement of various symptoms especially on some symptoms such as epigastric pain,desire for pressure and warmth,lack of warmth in the extremities and burnout.(2)The human serum motilin concentration of pre-treatment and post-treatment with Costustoot&Amomum Stomach-nourishing Decoction has a statistical significant difference(P<0.05),which suggests Costustoot&Amomum Stomach-nourishing Decoction can increase the motilin concentration of venous blood in patients who have functional dyspepsia(FD);Compare serum motilin concentration in Costustoot&Amomum Stomach-nourishing Decoction and Mosapride treatment groups,we find the effect of Costustoot&Amomum Stomach-nourishing Decoction that increases the motilin concentration of venous blood in patients who have functional dyspepsia(FD)is superior to that in control group.(3)No significant abnormalities occurred before and after specific treatment by comparison and reexamination of three routine tests,liver-renal function and ECG during this study.2.Result of animal experimental study:(1)The effect of Costustoot&Amomum Stomach-nourishing Decoction on serum motilin of rats has a statistical significant difference compare with model group,all dose groups of Costustoot&Amomum Stomach-nourishing Decoction and Mosapride group(P<0.05),serum motilin concentration increases,but there is no statistical significance between Costustoot&Amomum Stomach-nourishing Decoction group and Mosapride group(P>0.05),which shows all dose of Costustoot&Amomum Stomach-nourishing Decoction and Mosapride can increase gastrointestinal motility function,but there is no significant difference between the effects of these two drugs.(2)The effect of Costustoot&Amomum Stomach-nourishing Decoction on gastrin of rats has a statistical significant difference compare with model group,all dose groups of Costustoot&Amomum Stomach-nourishing Decoction and Mosapride group(P<0.05),but there is no statistical significance between Costustoot&Amomum Stomach-nourishing Decoction group and control group(P>0.05),which shows that the high and medium doses group of Costustoot&Amomum Stomach-nourishing Decoction and Mosapride group can increase gastrointestinal motility function,but there is no significant difference between the effects of these two drugs.Conclusions:With a clinical trial,Costustoot&Amomum Stomach-nourishing Decoction is superior to control group on overall improvement of all symptoms in patients who have functional dyspepsia,which can increase the motilin concentration of venous blood and effectively remove discomfort symptoms and improve effectiveness in patients who have functional dyspepsia.We find Costustoot&Amomum Stomach-nourishing Decoction can increase serum motilin and gastrin content of rats which can increase gastrointestinal motility and regulate gastrointestinal function with an animal experiment.There are no significantly abnormal reaction and toxic and adverse effects during the clinical trial and animal experiment,which suggests the prescription of Costustoot&Amomum Stomach-nourishing Decoction has no toxic and side effects,it is safe and reliable. |
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