| Objective:1Literature research partIn order to better understand the treatment and research of functional dyspepsia (FD) at present, this paper systematically studies the related literature in recent years, the reacher progress of FD in TCM and Western medicine, at the same time molding method of animal model of the spleen deficiency syndrome were analyzed, trying to find out the best FD animal model.2Clinical research partIn view of the current clinical studies on TCM treatment of FD lacked of placebo, double blind design, therefore the treatment effect has low reliability.This clinical studies have demonstrated that The Invigorating Spleen Method of TCM treating the FD can achieve a satisfactory effect, by random, control, the double blind, placebo method, but also through the gastric motility of B type ultrasonography to explore the pathogenesis of FD.3Animal experiment partAnimal experiment as an extension of clinical research, to further explore the mechanism of The Invigorating Spleen Method of TCM treating FD, the change volum of serum gastrointestinal hormone——Ghrelin and number of mast cells of gastric antrum of SD rats by the XJZ Decoction cause the gastric motility and visceral sensitivity changes.Method: 1Literature research partAccess to relevant information on the FD in the past ten years, and then analyze the data, the system of TCM etiology and pathogenesis, clinical therapy and Western Medicine on FD pathogenesis, treatment were summarized and reviewed, also the methods of building model of spleen deficiency syndrome of TCM are collated, to provide a theoretical basis that FD animal model can be replaced by spleen deficiency syndrome animal model.2Clinical research part70cases of FD were randomly divided into the treatment group of45cases,25cases in the control group, through randomized, controlled, double blind, placebo-studies. The treatment group according to the fullness of the spleen deficiency and qi stagnation syndrome, spleen deficiency-and dampness, spleen yang deficiency were treated with the invigorating spleen prescription of traditional Chinese medicine, â… , â…¡, â…¢, respectively, while the control group received a placebo corresponding. The main efficacy indicators: Integral of syndrome of Traditional Chinese Medicine, gastric motility by B type ultrasound examination and secondary efficacy indicators:SF-36Quality of Life Scale, The postprandial distress severity points, Hospital Anxiety and depression scale, were observed, to understand the situation of each group before and after treatment.3Animal experiment partThe SD rat (40) as the research object, randomly divided into four groups, as the blank group, model group, Chinese medicine group (SJZ Decoction), western medicine group (mosapride),10rats in each group. The rats in blank group were not modeled, while rats in the remaining three groups were modeled by spleen deficiency syndrome animal model, similar to the model of functional dyspepsia. Rats in the blank group and the model group were given physiological saline, traditional Chinese medicine group was given SJZ Decoction, western medicine group were given mosapride by intragastric administration, respectively, for15days. The body weight of rats were observed,the amount of drinking water, food intake, gastric emptying and the number of mast cells of the gastric antrum mucosa, Degranulation of mast cells of the gastric antrum mucosa, Rate of degranulation of mast cells of the gastric antrum mucosa and the level of serum Ghrelin. Result:1The Clinical Research Part1.1Postprandial distress severity scores comparisonAfter2weeks of treatment, compared with before treatment, the treatment group and the control group with postprandial distress severity scores were decreased, the difference was significant (P<0.01), the integral differences between two groups has no statistical significance (P>0.05). After4weeks of treatment, compared with before treatment, the control group integral showed no significant difference (P>0.05), while there are significant differences in scores of treatment group (P<0.01).Compared between the two groups, there is a significant integral difference between the two groups (P<0.01).1.2SF-36Quality of Life Points1.2.1Comparison of the quality of life points of SF-36in the treatment group before and after treatmentPatients in the treatment group after treatment of invigorating spleen prescription of traditional Chinese medicine, scores of Role-Physical (RP), vitality (VT), Social Functioning(SF), emotional function (RE), mental health (MH) and Bodily Pain (BP) six dimensions were improved significantly (P<0.01)compare with before treatment. While the physiological function (PF),·general health (GH) to improve the two dimensions scores had no statistical significance (P>0.05).1.2.2Comparison of the quality of life points of SF-36in the control group before and after treatmentThe control group patients after placebo treatment, scores of Social Functioning (SF), mental health (MH) two dimensions were improved significantly than before treatment (P<0.01), While the Physical Functioning (PF), Role-Physical (RP),body pain (BP), general health (GH), vitality (VT), role-emotional (RE) six dimensions scores increase had no statistical significance (P>0.05).1.2.3Comparison of the quality of life points of SF-36between the two groups after treatmentPatients in the treatment group were treated by invigorating spleen prescription of traditional Chinese medicine, score of general health (GH), vitality (VT), role-emotional (RE),mental health (MH) four dimensions are Significantly improved comparing with the placebo group (P<0.01). While cores of the physical function (PF), Role-Physical (RP),body pain (BP) and social functioning (SF) four dimensions improve, there is no statistical significance (P>0.05).1.3Comparison of Integral of syndrome of Traditional Chinese Medicine1.3.1Comparison between the control group and the treatment group after4weeks of treatmentIn the treatment group compared with after treatment, scores of epigastric fullness, belching and acid reflux, belching and acid reflux, vomit clear saliva, sense of pharyngeal obstruction, thirst without desire to drink water, fatigue, shortness of breath, body and limbs trapped heavy, aversion to cold, loose stool eleven symptom have obvious reduced. There was statistically significant (P<0.01). Whoever scores of the epigastric pain, heartburn or burning sensation, distending pain in the lower abdomen, lazy words four symptoms were not different from before treatment, there is no statistical significance (P>0.05). Scores of epigastric fullness, loss of appetite, sense of pharyngeal obstruction, vomit clear saliva, thirst without desire to drink, fatigue six symptoms significantly decreased in the control group, the difference was statistically significant (P<0.01, P<0.05), but scores of the epigastric pain, heartburn or burning sensation, belching and acid reflux, distending pain in the lower abdomen, shortness of breath, lazy words, body and limbs trapped heavy, aversion to cold, loose stool nine symptom were not different from before treatment,the change had no significant difference (P>0.05).1.3.2Comparison between the two groups after4weeks of treatmentIn the treatment group, scores of epigastric fullness, belching and acid reflux, vomit clear saliva, thirst without desire to drink water, shortness of breath, body and limbs trapped heavy, aversion to cold, loose stool eight symptom have decreased significantly compared with the control group, the difference was statistically significant (P<0.01, P<0.05), whoever the epigastric pain, loss of appetite, heartburn or burning sensation, sense of pharyngeal obstruction, distending pain in the lower abdomen, fatigue, lazy words seven symptoms between the two groups had no significant difference (P>0.05). 1.4Comparison of the total efficiency of TCM syndromesAfter4weeks of treatment, the total effective rate of treatment group was82.9%, ineffective rate was17.1%;the control group the total effective rate was55%, ineffective rate was45%;the total efficiency of two groups analyzed by chi square test, P<0.01, the difference has statistical significance.1.5Comparison of Anxiety and Depression Scale scoreAfter4weeks of treatment,scores of the treatment group patients with anxiety were decreased compared with before treatment, the difference was statistically significant (P<0.01), but the reduction of depression score was not statistically significant (P>0.05); scores of anxiety in the control group were reduced compared with before treatment, the difference is statistically significant (P<0.01), reduction of score of depression were no significant difference (P>0.05). Compared with the control group, score of the depression was no significant difference between the two groups points (P>0.05), change in score of anxiety was significantly (P<0.05).1.6Gastric motility1.6.1Comparison of two groups of proximal/distal gastric volume ratio after treatmentThe proximal/distal stomach volume ratio of the treatment group and the control group in the fasting and postprandial60min, postprandial120min were no statistically significant difference (P>0.05), while the proximal/distal stomach volume ratio of the treatment group and the control group in the maximum satiety, postprandial30min, postprandial90min were are different, there was statistically significant (P<0.05, P<0.01).1.6.2Comparison of the ratio of proximal gastric and distal gastric emptying between two groups after treatmentAfter the treatment, compared with the control group, difference of the treatment group had statistical significance in the proximal stomach in postprandial30min, postprandial60min, postprandial90min, postprandial120min (P<0.01), this phenomenon suggesting that gastric emptying of the treatment group significantly enhanced;While difference of the treatment group in the distal stomach in after meal,postprandial30min, postprandial 60min, postprandial90min, postprandial120min had statistical significance (P<0.05). The distal stomach in postprandial30min had negative emptying ratio, indicating that the liquid food flowed into the stomach distal antrum slowly, causing false appearance of prolonged emptying, while in postprandial60min, postprandial90min, postprandial120min, rate of distal gastric emptying in the treatment group was higher than the control group.1.6.3Comparison of ratio of proximal stomach and distal gastric emptying in the treatment group before and after treatmentAfter4weeks of treatment, rate of proximal gastric emptying in the treatment group in postprandial30min, postprandial60min, postprandial90min, postprandial120min higher than before treatment, it had significant difference (P<0.01), suggesting that gastric emptying of proximal stomach in the treatment group is enhanced;Furthermore, rate of distal gastric emptying in treatment group in postprandial60min, postprandial90min, postprandial120min also higher than before treatment, the difference was statistically significant (P<0.01), although in postprandial30min, rate of gastric emptying in the treatment group showed negative, indicating that liquid food flowed into the stomach antrum slowly, causing false appearance of prolonged emptying, while in postprandial60min, postprandial90min, postprandial120min, rate of distal gastric emptying of after treatment relatively was higher than before group.1.6.4Comparison of ratio of proximal/distal gastric volume and proximal/distal gastric area in the treatment group before and after the treatmentAfter4weeks of treatment, ratio of the proximal/distal stomach area in the treatment group in the largest satiety, postprandial60min was different from before treatment, the difference was statistically significant (P<0.01, P<0.05), while in the fasting, postprandial30min, postprandial90min, postprandial120min, ratio difference had no statistical significance (P>0.05);Treatment group ratio of proximal/distal gastric volume in the max satiety, postprandial30min was different from before treatment, the difference was statistically significant (P>0.05), but in the fasting, postprandial60min, postprandial90min, postprandial120min, the difference of ratio was not statistically significant (P>0.05). 1.6.5Comparison of ratio of proximal/distal gastric volume and proximal/distal gastric area in the control group before and after the treatmentAfter4weeks of placebo treatment, ratio of proximal/distal gastric volume in the control group was different from after treatment, the difference was statistically significant (P<0.05), but in the largest satiety, postprandial30min, postprandial60min, postprandial90min, postprandial120min, the difference of ratio was not statistically significant (P>0.05);Ratio of proximal/distal gastric volume in control group in fasting, the largest satiety, postprandial30min, postprandial60min, postprandial90min, postprandial120min was different from before treatment, the difference of ratio was not statistically significant (P>0.05).1.6.6Comparison of ratio of proximal stomach and distal gastric emptying in the control group before and after treatmentAfter4weeks of placebo treatment, ratio of proximal gastric emptying in the control group in postprandial30min, postprandial60min, postprandial90min, postprandial120min was different from before treatment, while the differences were not statistically significant (P>0.05);ratio of distal gastric emptying in the control group in postprandial90min is different from before treatment, the difference was statistically significant (P<0.05), but in postprandial30min, postprandial60min, postprandial120min, the difference of ratio was not statistically significant (P>0.05).2Animal Experiments Part2.1Comparison of body weight of ratsThe rats weight had no significant difference before model between.every groups(P>0.05);Compared with the rats in the blank group, after modeling for14days, the weight of rats in each group were obviously alleviated, it has significant difference (P<0.01);After giving drug intervention, compared with the model group, rats weight between Traditional Chinese medicine and Western medicine group were significantly increased, it has significant difference (P<0.05);Compared with the western medicine group, rats weight in Chinese medicine group has increased, while there was no significant difference (P>0.05).2.2Comparison of Rat food intake Before making model, rats food intake had no significant difference between each groups (P>0.05); Compared with the rats in the blank group, after modeling for14days, the rats food intake were significantly reduced there was significant difference (P<0.05);After giving drug intervention, compared with model group, rats food intake between Traditional Chinese medicine and Western medicine group was significantly increased,it has significant difference (P<0.05);Compared with the western medicine group, rats food intake in Chinese medicine group has increased, while there were no significant differences (P>0.05).2.3Comparison of Rat water intakeBefore making model, rats water intake had no significant difference between each groups (P>0.05); Compared with the rats in the blank group, after modeling for14days, the rats water intake were significantly reduced there was significant difference (P<0.05);After giving drug intervention, compared with model group, rats water intake between Traditional Chinese medicine and Western medicine group was significantly increased,it has significant difference (P<0.05);Compared with the western medicine group, rats water intake in Chinese medicine group has increased, while there were no significant differences (P>0.05).2.4Comparison of the rate of gastric emptying in ratsCompared with the rats in the blank group, rate of gastric emptying in the model group rats was significantly decreased, there was significant difference (P<0.05), there was no significant difference among the Traditional Chinese Medicine group and the Western medicine group and the blank group (P<0.05);After giving drug intervention, compared with model group, rate of gastric emptying between Traditional Chinese medicine and Western medicine group was significantly increased, it has significant difference (P<0.05); Compared with the western medicine group, rate of gastric emptying in Chinese medicine group has increased, while there were no significant differences (P>0.05).2.5Comparison of serum Ghrelin levels in ratsCompared with the rats in the blank group, the content of Ghrelin in serum of model group rats decreased obviously, there was significant difference (P<0.05). Compared with the blank group, the contents of Ghrelin in serum in Chinese Medicine group and Western medicine group were significantly elevated,it has significant difference (P<0.05);After giving drug intervention, Compared with the model group, the content of Ghrelin in serum between Traditional Chinese medicine and Western medicine group was significantly increased, it has significant difference (P<0.05);Compared with the western medicine group, the content of Ghrelin in serum in Chinese Medicine group has decreased, there were no significant differences (P>0.05).2.6Comparison of the amount of MC in gastric antral mucosa of ratsCompared with the rats in the blank group, the number of MC in gastric antral mucosa of rats in the model group had increased obviously, there was significant difference (P<0.05). The amount of MC in gastric antral mucosa of rats between traditional Chinese medicine group and Western medicine group had increased, there was no significant difference (P>0.05);After giving drug intervention, Compared with the model group, the amount of MC in gastric antral mucosa of rats between Traditional Chinese medicine and Western medicine group was significantly decreased, it has significant difference (P<0.05);Compared with the western medicine group,the amount of MC in gastric antral mucosa of rats in Chinese Medicine group has decreased, while there were no significant differences (P>0.05).2.7Comparison of the amount of MC degranulation in Gastric antral mucosa of ratsCompared with the rats.in blank group, the amount of MC degranulation in Gastric antral mucosa of rats in the model group had increased obviously, there was significant difference (P<0.05). The amount of MC degranulation in Gastric antral mucosa of rats between traditional Chinese medicine group and Western medicine group had increased, there was no significant difference (P>0.05);After giving drug intervention, Compared with the model group, the amount of MC degranulation in Gastric antral mucosa of rats between Traditional Chinese medicine and Western medicine group was significantly decreased, it has significant difference (P<0.05);Compared with the western medicine group, the amount of MC degranulation in Gastric antral mucosa of rats in Chinese Medicine group has decreased, while there were no significant differences (P>0.05).2.8Comparison of the degranulation ratio of MC in the gastric antrum of rats Compared with the rats in the blank group, the degranulation ratio of MC in the gastric antrum of rats in the model group had increased obviously, there was significant difference (P<0.05). The degranulation ratio of MC in the gastric antrum of rats between traditional Chinese medicine group and Western medicine group had increased, there was no significant difference (P>0.05);After giving drug intervention, Compared with the model group, the degranulation ratio of MC in the gastric antrum of rats between Traditional Chinese medicine and Western medicine group was significantly decreased, it has significant difference (P<0.05); Compared with the western medicine group, the degranulation ratio of MC in the gastric antrum of rats in Chinese Medicine group has decreased, whlie there were no significant differences (P>0.05).Conclusion:1The Clinical Research PartThe Invigorating Spleen Method of Traditional Chinese Medicine is through the traditional Chinese medicine prescription specific treatment of spleen deficiency and qi stagnation syndrome, spleen deficiency and dampness syndrome and deficiency of Spleen Yang fullness patients to reflect its curative effect on the treatment of FD.1.1The Invigorating Spleen Prescription of Traditional Chinese Medicine can improve the patients with FD discomfort of the postprandial distress severity.1.2The Invigorating Spleen Prescription of Traditional Chinese Medicine can improve the patients with FD scores in vitality (VT), Social Functioning(SF), Role-Emotional(RE), Mental Health (MH) and Bodily Pain (BP) six dimensions, further in General Health (GH), vitality (VT), Role-Emotional (RE), Mental Health (MH) four dimensions are better than placebo, but in improving the efficacy of Bodily Pain(BP) dimension is not superior to placebo.1.3The effect in the treatment of patients with FD of the Invigorating Spleen Prescription of Traditional Chinese Medicine was significant, compared with placebo.It can improve patients with FD TCM syndrome in terms of epigastric fullness, loss of appetite, belching and acid reflux, vomit clear saliva, sense of pharyngeal obstruction, thirst without desire to drink, body and limbs trapped heavy, shortness of breath, aversion to cold, loose stool, but it is not superior to placebo in terms of sense of pharyngeal obstruction, loss of appetite, fatigue. The Invigorating Spleen Prescription of Traditional Chinese Medicine in the improvement of epigastric pain, heartburn or burning sensation, lazy words, distending pain in the lower abdomen symptoms had no significant effect, compared with the placebo. The Invigorating Spleen Prescription of Traditional Chinese Medicine in the treatment of functional dyspepsia of postprandial distress syndrome has greater efficacy than placebo.1.4The Invigorating Spleen Prescription of Traditional Chinese Medicine can alleviate the anxiety symptoms in FD with patients, its curative effect is better than placebo, but it had no significant effect for depression symptoms same as placebo.1.5The Invigorating Spleen Prescription of Traditional Chinese Medicine can adjust the proximal stomach and distal stomach food distribution, in order to increase the proximal stomach food storage and reduce distal food storage to alleviate the patients with FD discomfort feeling of fullness, to improve gastric motility.to increase rate of proximal and distal gastric emptying, whoever placebo did not have the same effect.2Animal Experimental Study PartThe Invigorating Spleen Method of Traditional Chinese Medicine is through the XJZ Decoction on the changes of serum Ghrelin and the number of cells of gastric mucosa in MC rats and degranulation rate to explain the mechanism of treatment of spleen deficiency syndrome.2.1The XJZ Decoction and Mosapride all can increase the content of Ghrelin in serum in rats with spleen deficiency model, food intake, water intake, promote gain weight and improve the spleen deficiency symptoms. Effect of Mosapride increasing the content of serum Ghrelin in rats with spleen deficiency has the same advantage as the XJZ Decoction’s.2.2The XJZ Decoction and Mosapride all can reduce the amount of MC degranulation in Gastric antral mucosa of rats with spleen deficiency, the amount of MC in gastric antral mucosa of rats with spleen deficiency, the degranulation ratio of MC in the gastric antrum of rats with spleen deficiency. The effect between XJZ Decoction and Mosapride has no obvious difference. |
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