| Objective Type 2 diabetes mellitus combined with non-alcoholic fatty liver disease is a common clinical condition,and its prevalence is increasing year by year,but the pathogenesis of this disease is still unclear,and effective interventions are still lacking.In this study,the clinical efficacy of the combination of Xinrunkuxie recipe combined with Dulaglutide was objectively evaluated in the treatment of type 2 diabetes combined with non-alcoholicfatty liver disease（liver stagnation and gastric heat evidence）,and its safety was assessed.Methods①Sixty-eight patients who met the inclusion criteria and were seen in the outpatient clinic and ward of the Department of Endocrinology,Hubei Provincial Hospital of Traditional Chinese Medicine from April 2021 to October 2021 were used as study subjects and were grouped into a control group（n=34cases）and a test group（n=34cases）using a random number table.The general data（age,gender,disease duration）and efficacy indexes（FPG,2hPG,HbAlc,FINS,HOMA-IR,TC,TG,HDL-C,LDL-C,ALT,AST,GGT,liver ultrasound score,BMI,TCM evidence score）of the subjects in both groups were analyzed for comparability,and the differences were not statistically significant and were comparable（P>0.05）.②The enrolled patients were patients with T2DM combined with NAFLD who had a first episode or a history of no more than 2 years and whose blood glucose still did’t reach the standard（HbA1c≥7.0%）after more than 3 months of conventional treatment.The control group was treated with subcutaneous injection of dulaglutide（the initial dose was 0.75mg once a week,and the dose was increased to 1.50mg once a week after two weeks if no significant adverse reactions occurred）;the experimental group was treated with oral dosing of Xinrunkuxie recipe on top of the control group（200ml each time,taken warmly half an hour after breakfast and dinner）.③Both groups of subjects were treated for 12 weeks and the overall efficacy of the trial was evaluated by comparing theclinical efficacy in dexes and the changes in the TCM syndromes core before and after treatment,and conducting statistical analysis.④During the trial,patients’vital signs were monitored,adverse reactions were recorded and dealt with in a timely manner,and safety indicators such as three major routine,renal function and electrocardiogram were tested before and after the subjects’treatment for safety assessment.Results①Actual selection of cases:There were 4 dropout cases in the experimental group（2 cases lost contact during followup,2 cases dropped out due to intolerance of adverse drug reactions）,and 4 dropout cases in the control group（1 case did’t cooperate with treatment and discontinued the drug on theirown,and could not tolerate adverse drug reactions,3 cases dropped out）,and finally 30 cases in the experimental group and 30 cases in the control group were included in the study.②Baseline comparison between the two groups before treatment:There was no statistically significant difference in gender,age,course of disease,BMI and other baseline conditions of the two groups of patients before treatment（P>0.05）,which was comparable.③In terms of body mass index:Comparison within the group before and after treatment showed that the body mass index of the two groups was significantly decreased compared with that before treatment,with a significant difference（P<0.01）.④Blood glucose and insulin-related indexes:compared before and after treatment,blood glucose and insulin-related indexes in the experimental group were significantly lower than those before treatment（P<0.01）.HOMA-IR decreased compared with that before treatment,but there was no statistical difference（P>0.05）;after treatment,compared with the control group,the indexes of the experimental group decreased more significantly,and the difference was statistically significant（P<0.05）,and the improvement of FPG,FINS,HOMA-IR and HbA1c in the experimental group was significantly different than that in the control group（P<0.01）.⑤Blood lipid-related indicators:after treatment,the levels of TC,TG and LDL-C in the two groups were significantly decreased,and the level of HDL-C was significantly increased,and the difference was statistically significant（P<0.01）,LDL-C was significantly better than the control group（P<0.05）,especially in reducing the levels of TC and LDL-C,there was a very significant difference compared with the control group（P<0.01）.Compared,the difference was not statistically significant（P>0.05）.⑥Liver function-related indicators:after treatment,the levels of ALT,AST and GGT in the experimental group were significantly lower than those before treatment,and the levels of ALT in the control group were lower than those before treatment,and the difference was statistically significant（P<0.01）.The decrease was not obvious,and there was no significant difference（P>0.05）;after treatment,the efficacy of the experimenttal group was significantly different（P<0.01）.⑦Liver color Doppler ultrasound indexing:Compared with before treatment,the liver color Doppler ultrasound scores in the two groups were significantly decreased after treatment（P<0.01）.⑧The total clinical efficacy of T2DM combined with NAFLD:in terms of total clinical efficacy,the overall effective rate of the experimental group was 83.33%,and that of the control group was 56.67%.The efficacy of the experimental group was significantly better than that of the control group（P<0.05）.⑨Efficacy of TCM syndromes:After 12 weeks of treatment,the total effective rate of the experimental group was as high as 90.00%,which was significantly better than that of the control group（P<0.05）.After treatment,the total scores of TCM syndromes in the experimental group were significantly lower than those before treatment（P<0.01）,while the total scores in the control group did not decrease significantly（P>0.05）;compared between groups,the curative effect of the experimental group was significantly better than that of the control group（P<0.01）.Compared with the control group in terms of individual symptoms of traditional Chinese medicine after treatment,the experimental group was significantly different from the control group in improving the symptoms of fullness of the chest and flank,bitter mouth,irritability,dry stool,thirst and preference for cold drinks,excessive food and easy hunger,and good health（P<0.05）;there was no significant difference in the curative effect between the two groups in improving the symptoms of abdominal distention（P>0.05）.⑩In terms of clinical safety:the relevant safety indicators of the two groups of patients before and after treatment were normal,and at the same time,no hypoglycemia occurred in the two groups of patients during treatment.The main adverse reactions were gastrointestinal discomfort,mainly nausea,vomiting and diarrhea in the early stage of treatment.The symptoms were mild or moderate,and most of them were relieved after symptomatic treatment.The incidence of adverse reactions in the control group was 23.3%（7/30）;the incidence of adverse reactions in the experimental group was 16.7%（5/30）,and there was no significant difference in the incidence of adverse reactions between the two groups（P>0.05）.Conclusion Xinrunkuxie recipe combined with dulaglutide has a significant clinical effect in the treatment of type 2 diabetes mellitus patients with non-alcoholic fatty liver,liver stagnation and stomach heat type.It can reduce insulin resistance to a certain extent,and at the same time,it can also significantly reduce TCM symptoms such as fullness of the chest and flank,bitter mouth,irritability,constipation,excessive food and easy hunger.Therefore,Xinrunkuxie recipe combined with dulaglutide is more effective than dulaglutide alone in the treatment of this disease,and has the advantages of high safety and less toxic and side effects.The new solution foralcoholic fatty liver disease with liver depression and stomachheat syndrome has a very broad application prospect and is worthy of clinical application. |
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