Clinical Study On Modified XiaoJianZhong Decoction With Stomach-oriented Prescription Ⅰ For Treatment Of Functional Dyspepsia With Deficiency-cold In Spleen And Stomach Syndrome

Objective:Modified XiaoJianZhong decoction with stomach-oriented prescription I(MXD-SPI)was used to treat patients with functional dyspepsia with deficiency-cold in spleen and stomach syndrome,and was compared with therapeutic effect of the Western medicine rabeprazole enteric-coated tablet to study the clinical effectiveness and safety of MXD-SPI for treatment of functional dyspepsia with deficiency-cold in spleen and stomach syndrome and,therefore,to establish TCM dialectical therapy for functional dyspepsia with deficiency-cold in spleen and stomach syndrome and to better guide clinical application,hoping to realize the objective of improving TCM diagnosis and treatment of functional dyspepsia.Method:On the basis of strict enrollment and exclusion criteria,a total of 60 inpatients and outpatients,who were treated in our hospital from February 1st,2016 to January 31st,2017 in our hospital and were diagnosed as functional dyspepsia with epigastric pain syndrome.The patients were divided into the control group(n=30)and the treatment group(n=30)according to computer random number table method.The control group was treated with the Western medicine rabeprazole enteric-coated tablet,while the treatment group was treated with MXD-SPI,both for four weeks.Variations of TCM symptoms as well as scores before and after the treatments were observed,while the data was analyzed and summarized to draw relevant conclusion.Result:1.A total of 60 cases(30 cases in either group)were collected in the study.In the control group,1 case was healed,8 cases showed obvious improvement,11 cases showed fair improvement,while 8 cases showed ineffective outcome;the total effective rate was 73.33%.In the treatment group,the amounts of healed cases,cases with obvious improvement,cases with fair improvement and cases with ineffective outcome were 3,15,9 and 3 respectively;the total effective rate was 90.00%.The two groups showed statistically significant difference of effective rate(P<0.05).2.Data concerning improvement of TCM clinical symptoms are as follows.①TCM syndrome scores declined in both groups(P<0.05).Rank sum test of the after-treatment total TCM syndrome scores of the two groups showed z=-3.379 and p=0.001<0.01,and the improvements of symptom after treatment were statistically significant in both groups,indicating that improvement of the treatment groups was obviously superior to the control group.②Rank sum test of improvement of epigastric dull pain and warm and pressure-relieved abdominal pain was conducted and showed z=-2.780 and p=0.005<0.01,indicating that the treatment group was superior to the control group for improvement of the symptoms.With respect to improvement of fatigue,lack of warmth in the limbs and thin sloppy stool symptoms,p values of rank sum test were 0.032,0.012 and 0.02(all<0.06),indicating that the treatment was superior to the control group in improving the symptoms.③For improvement of extensive vomit of water and anorexia and appetite reduction,rank sum test showed p values of 0.288 and 0.10,suggesting that the two groups showed no difference concerning improvement of the two symptom.3.With respect to safety profile,after-treatment blood analysis,urine analysis,stool-RT,liver function test,kidney function test and EKG were all within normal ranges in both groups,and there was no obvious allergy or other adverse reaction.Conclusion:Modified XiaoJianZhong decoction with stomach-oriented prescription I(MXD-SPI)shows exact therapeutic effect for treatment of functional dyspepsia with deficiency-cold in spleen and stomach syndrome.It is a safe and feasible method,shows certain application prospect,and is worth further studying.