| Objective: By use of intervention of Huangzhi capsules on diabetic constipation patients.in order to observe the changes of Traditional Chinese Medicine(TCM)clinical symptoms and related test indicators of patients before and after the study,evaluate the clinical efficacy of Huangzhi capsules on these patients and analyze the influence of SP,SS and GC and other gastrointestinal hormones,as well as the relationship between the changes of gastrointestinal hormones and clinical efficacy,so that finally to explore the mechanism of action of the drug.Methods: 60 diabetic constipation patients who conformed to the inclusion criteria were randomly divided into the treatment group and the control group,each with 30 cases.The control group were given the basic treatment and Mosapride dispersible tablets,while the treatment group were given the basic treatment and Huangzhi capsules,each time 4 pieces,3 times a day,be taken after meals,and both groups were treated for 1 month.(1)Making a comparison of the levels of plasma Substance P(SP),Somatostatin(SS),Glucagon(GC)between the two groups before treatment;(2)Observing the varition of the levels of plasma SP,SS,GC,plasma glucose(FBG,2h PG),insulin resistance index(HOMA-IR)and TCM syndrome scores between the two groups of diabetic constipation patients before and after therapy.(3)To analyze the correlation with the variation of the levels of plasma SP,SS and GC in diabetic constipation patients and their clinical efficacy.(4)Carrying out testing and evaluation of the relevant safety indicators such as blood routine examination,liver and kidney function.Results:(1)Compared with before treatment,the level of plasma SP in Huangzhi Capsules group were significantly higher,the levels of SS and GC were significantly lower.Statistical analysis was used to find out that there were significant differences in the data of the treatment group before and after treatment(P<0.01).Comparing the data after treatment with those before treatment of the control group,which found that the level of SP increased(P <0.05),the level of SS decreased(P <0.05),the change of GC was insignificant(P> 0.05).Comparing the indicators of the two groups after treatment,the results showed that the level of SP in the treatment group was higher than that in the control group,and the levels of SS and GC decreased more obviously(P<0.01).Indicating that Huangzhi capsules group was superior to improve the levels of gastrointestinal hormones such as SP,SS and GC than the Mosapride group.(2)The level of HOMA-IR in treatment group after treatment was compared with its own before treatment and the control group after treatment by statistical methods,showing that the difference was statistically significant(P<0.05);While there was no significant difference in HOMA-IR between the control group before and after therapy(P>0.05).(3)The levels of FBG,2h PG and Hb A1 C in the two groups after treatment were significantly lower than those before treatment(P<0.05 or P<0.01);Comparing the data of the two groups after treatment,the decrease of the indicators in the treatment group was more obvious than that in the control group(P <0.05).The results showed that Huangzhi capsules had a certain degree of hypoglycemic effect.(4)After comparing the TCM clinical efficacy between the two groups of patients after therapy,it was found that the total effective rate of the treatment group was 93.34%,while the total effective rate of the control group was 66.67%,the difference was statistically significant(P<0.05).(5)The analysis of safety indicators and adverse reaction: There was no significant difference between the safety indicators of the two groups in the normal range before and after treatment(P>0.05).In addition,the incidence of adverse reactions was lower in Huangzhi Capsules group than that in the control group(P<0.05).Conclusion:Most diabetic constipation patients in the presence of gastrointestinal hormones secretion disorders.On the basis of conventional hypoglycemic drug therapy,coupled with Huangzhi Capsules,this treatment not only can significantly relieve clinical symptoms,but also can regulate the abnormal secretion of gastrointestinal hormones in patients,reduce blood glucose and relieve insulin resistance.The indicators of Huangzhi capsules treatment group were better than those of the control group.The results showed that Huangzhi capsules had a good clinical efficacy.In addition the drug was safe and reliable,led to fewer adverse reactions.Patients can well follow the doctor's advice to take and tolerate. |
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