| Functional dyspepsia (FD) refers to a group of clinical syndromes like persistent or recurrent epigastric pain and symptoms of fullness after eating, abdominal inflation, eructation, early satiety, and nausea which cannot be explained as organic diseases. It is a common and frequent disease in clinic and is closely related to psychological factors. It accounts for about 30%—70% in the outpatients of digestive department. It is estimated [1] that about 25%—30% people suffer from FD in a certain period of life. In recent years, the incidence rate in increasing year by year and it has received the attention of scholars home and abroad. As for the medication, most of the western medicines are the gastrointestinal motility modulators and acid inhibitors. The clinical effects are unsatisfactory and there are some side effects. In recent years, the reports on treatment of FD with traditional Chinese medicine are increasing and we have achieved great success. According to traditional Chinese medicine, weakness of the spleen and stomach and incoordination between the liver and stomach are the main causes of this disease. The treatment should be "smoothing the liver, regulating qi, invigorating the spleen and regulating the stomach" . "He wei medicinal" is used to treat FD with the guidance of the theory of traditional Chinese medicine, on the basis of summarizing clinical practice and in combination with modern pharmacological research result. Under the guidance of the supervisor, this research makes a further study of the therapeutic effect of "He wei Decoction" in the treatment of FD. The clinical observation and animal experiment result showed that: "He wei Decoction" has a good therapeutic effect on FD and there are no obvious toxic and side effects. It fully shows the advantage of traditional Chinese medicine in treating this disease and deserves clinical expansion.Objective To observe the therapeutic effect of He wei Decoction in the treatment of FD and make a preliminary study of the mechanism.Methods (1)Clinical observation: according to the principle of random grouping, the 90 cases of eligible subjects who were selected according to diagnosis standard, inclusion standard and exclusion standard were randomly divided into treatment group of 60 cases and control group of 30 cases; By differentiation of symptoms and signs of traditional Chinese medicine, it was divided into spleen and stomach qi deficiency type and liver qi stagnancy. It was divided into ulcerative type, dysmoti1ity-1ike and non specific type in western medicine. The treatment group was given He wei decoction for one dose a day, half in the morning and another in the evening. The control group was given Domperidone 10mg once, three times a day, 15 minutes before meal. During the treatment period, the patients were ordered to pay attention to diet, forbid taking other drugs and return visit once or twice a week. The diseases and symptoms and adverse reactions were recorded in detail. The therapeutic effect was observed according to "Integrated medicine diagnosis and treatment plan of FD" . At the same time, the levels of serum gastrin (GAS) and plasma motilin (MTL) of the patients in treatment group. were determined by radioimmunoassay method and the levels of GAS and MTL of two groups before and after treatment were observed. The courses of two groups were three weeks and the statistical result was made after three weeks. Besides, 20 cases of healthy people were used as normal control group. (2) Animal experiment: 40 Wistar rats were randomly divided into two groups: control group and model group with 20 rats in each group. The model group was divided into high-intensity TCM group and low-intensity TCM group with 10 rats in each group. The experiment was carried out 7 days after modeling. After fasting and normal drinking for 18-24h, the rats were injected with ketamine (75mg/kg) and Diazepam (2. 5mg/kg) for anesthesia in peritoneal. Under aseptic operation, the high sensitivity sensor was sutured to the serous membrane of the anterior surface of gastric antrum, being parallel to antral circular muscle to record the activity of antral circular muscle. The rat rest for 1h after operation and the gastric motility was recorded in conscious state. The gastric motility of the control group was observed 1h before saline gastric perfusion and 1h after perfusion (2ml/rat). The model group first received saline gastric perfusion (2ml/rat) and the change of gastric motility was observed 5, 15, 30, 45, 60, and 75 min before and after gastric perfusion. 90 min After operation, the rats were gavaged with He wei Decoction of a dosage of 20g/kg and 10g/kg. The gastric motility was observed 5, 15, 30, 45, 60, and 75 min before and after gastric perfusion. The change of gastric motility was observed by self-contrast method. A continuous observation for 5-10 min was made at each observation point. The motility signal of a stable 3min was chosen to be recorded and contractile amplitude index and frequency were taken as observation index. The experiment for each animal lasted for 3-4h. The scale should be made before the experiment and the electrical unit (mV) should be converted to unit of force (g).Results (1) Clinical observation: the total effective rate of the treatment group is 88.33% and that of the control group is 76.67% The total effective rate of the treatment group is obviously superior to that of the control group (p<0. 05). The levels of GAS and MTL of the treatment group have an obvious change after medication compared with those before treatment (p<0. 01) and the comparison with normal control group is statistically significant (p<0. 05). there is an obvious difference of total symptom scores between the two groups before and after treatment (p<0. 01); the improvement of total symptom score of the treatment group is obviously superior to that of the control group (p<0. 05), especially epigastric fullness and early satiety. (2) Animal experiment: from the recorded gastric shrinkage frequency and amplitude, the gastric motility of the model group obviously weakens compared with the control group. "He wei Decoction" water decoction of two intensities could increase the amplitude of gastric motility of the model group, while there is no significant change of frequency. "He wei Decoction" of high intensity has a longer time of effect. Compared with that before drug perfusion, the "He wei Decoction" of two intensities has similar onset time and duration.Conclusion "He wei Decoction" has the effect of "smoothing the liver, regulating qi, invigorating the spleen and regulating the stomach" and there is a significant clinical treatment effect of FD. It could promote the secretion of GAS and MTL and there are no obvious toxic or side effects. Besides, "He wei Decoction" could obvious promote the shrinkage of antral circular muscle of FD rats. "He wei Decoction" is an effective drug to treat "spleen stomach qi deficiency liver qi stagnation" type FD. |
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