| Objective: Since the reform and opening up, people’s living standards gradually improved, the prevalence of fast food and junk food, transport facilities and lack of exercise, making more and more number of obese, obesity has become a common disease, explains the reasons of the sharp rise in the number of Patients NAFLD. Current treatment methods include insulin sensitizers, vitamin E, cholesterol-lowering drug, orlistat and obesity surgery, etc. There are a variety of drugs, but all the drugs have their disadvantages, so for the Patients with T2 DM and NAFLD the best method of treatment is not only to reduce the blood glucose,we also need improve the drugs to reduce the blood glucose effectivly. Sitagliptin is a new class of antidiabetic drugs, it time to market is only five years, it has been widely used clinically, both the medical staff and Patients are fond of t he drug, it belongs DPP- 4 inhibitors, but also because of its short time to market clinical studies in Patients with T2 DM with NAFLD efficacy and safety still need large samples and clinical trial support. This study was to investigate when sitagliptin(SITA) and metformin(MET) in combination with NAFLD in T2 DM treatment efficacy, tolerability and safety, choose a hospital diagnosed T2 DM Patients with NAFLD, for the treatment of Patients with SITA joint MET clinical observation for a Period of three months of research, to Provide reference for clinical Practice.Methods: Selected in June 2013-2014 December Yan’an University Affiliated Hospital of Dongguan Branch comprehensive outpatient and inpatient onset T2 DM or a history of less than five years without regular treatment of T2 DM Patients with NAFLD and as research subjects, A total of 51 cases, Method will be selected by random digit 51Patients were divided into 2 groups, 25 cases of the treatment group, 16 males and 9 females; 26 cases in the control group, 16 males and 10 females. All Patients on the basis of a balanced diet, reasonable exercise and other daily intervention on the use of oral medications, Observation group SITA(100mg, qd, morning service) + MET(0.5g, tid, with meals); control group was given MET(0.5g, tid, with meals), These drugs have to be adjusted according to the patient’s blood glucose, if necessary, increase or reduce the amount of the drugs, make the Patient’s blood glucose levels reach ideal, temporarily given to lipid-lowering drugs; If Patients with hypertension, antihypertensive drugs may be given the first choice is ACEI, if Patients can not tolerate dry cough, can be changed ARB class, and calcium channel blockers can be combined when Should Poorly controlled. After three months of treatment, both groups of patients before and after treatment using Paired t test, t-test between the two groups; Count data using χ2 test, observe the Patient’s BMI, glucose, blood lipids, blood Pressure, liver function, uric acid, insulin, C- Peptide,( observe indicators are measured two times the mean value), insulin resistance index, pancreatic β-cell function index other indicators.Results:1. The comparwason of the BMI, blood Pressure before and after the treatment between the two groupsAfter the treatment for three months, the BMI and blood Pressure of the Patients of the two groups reduced significantly, and there was significant differences(P<0.01). And after the treatment, the BMI and blood Pressure of the Patients between the two grou Ps had no obvious changes, so there was no significant differences(P> 0.05).2. The comparwason of the FPG, 2h PG, Hb Alc of the Patients before and after the treatment of the two groupsAfter three months’ treatment, the FBG, 2hPG and HbAlc of the Patients in the two groups significantly decreased, there was significant differences(P<0.01). After the treatment, the FBG, 2h PG and Hb Alc of the Patients of the two group significantly decreased compared to that of the control group, so there was no significant differences(P <0.01).3. The comparwason of the FCP, 2h CP, HOMA-IR and HOMA-β of the Patients before and after the treatment between the two groupsAfter 3 months’ treatment, the FCP, 2h CP and HOMA-β of the Patients in the observation grou P significantly elevated compared to that before the treatment, while the HOMA-IR decreased, and the IR and the function Pancreatic β-cell improved, there was significant differences(P<0.01). The HOMA-IR in the control group became higher than before, and there was significant differences(P<0.01), however, the Patients’ FCP, 2h CP and HOMA-β has no obvious change, there was no significant differences( P>0.05). Compared to the controlled group, the FCP, 2h CP and HOMA-β of the Patients in the treatment group were significantly increased, while HOMA-IR was significantly lower, so there was no significant differences(P<0.01).4. The comparison of the blood lipids, liver and uric acid of the Patient before and after the treatment between the two groupsAfter 3 months’ treatment, the TC, TG, LDL-C, GGT and UA of the Patients in the observation group were significantly decreased, while the HDL-C increased, there was no significant differences(P<0.05). And the LDL-C,TC and GGT in the control group decreased, so there was significant differences(P<0.05), however, the TG, HDL-C, AST, ALT and UA decreased, so there was no significant differences(P>0.05). After three months’ treatment, the TG, GGT and UA in the treatment group significantly decreased, while the HDL-C was significantly increased, so there was significant differences(P<0.05), but there was no significant differences of the differences of TC, LDL-C and GGT between the two groups(P> 0.05).5. The comparison of the effect of the treatment for fatty liverAfter three months’ treatment, the observation that the total effective rate was 81.0% in the treatment group, while the total effective rate was 43.5% in the control group, indicated that on the condition of adjusting the blood sugar of Patients to the idealrange, the effect of the treatment for fatty liver of the treatment group was significantly superior than the controlled group, there was significant differences(χ2 = 5.80, P = 0.02).6. The comparison of the adverse reactions happened in the early times between the two groupsDuring the treatment, observe the urinalysis, blood amylase and adverse reactions in the observed and controlled groups. The hypoglycemia was not happened in the observed group, the rate of other adverse reactions was 14.29%, including gastrointestinal symptoms(nausea, bloating, abdominal Pain), rash and so on, but the symptoms were mild, and after given symptomatic treatment, the symptoms changed better; while the adverse reaction rate in the control grou P was 22.72 %, including gastrointestinal symptoms, fatigue, headache, etc., and all the symptoms were improved after symptomatic treatment. There were no incidence of liver and kidney function damage, pancreatitis and anemia, so there was no significant differences of the adverse reactions between the two groups(χ2 = 0.51, P = 0.48).In conclusion:Sitagliptin and Metformin relative to metformin monotherapy1 Both the blood sugar, HBA1 c of the Patients were significantly reduced.2 C-peptide and HOMA-β of the Patients were elevated, HOMA-IR drop.3 The BMI, blood Pressure, lipids, GGT, uric acid of the Patients were improved.4 Treating T2 DM with NAFLD by Sitagliptin and Metformin was clear efficacy than metformin alone.5 The hypoglycemia, acute pancreatitis, liver and kidney dysfunction, nasopharyngitis was not happened after using the drugs. the adverse reactions can be found in the very little people after use the drugs in the early time,all the symptoms are mild, then can be improved after symptomatic treatment. |
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