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Objective:To describe the current status and efficacy of additional acarbose combined with insulin therapy in adult patients with type 1 diabetes mellitus (T1DM) .Methods:Adult T1DM patients with acarbose combined with insulin (acarbose group) or insulin alone (insulin group), age≥18 years and disease course≥1 year, who were registered in the T1DM Translational Medicine Research Project of Guangdong Province from June 2011 to December 2014 were enrolled in the study. The hemoglobin A1c (HbA 1c), body weight, body mass index (BMI), waist-to-hip ratio (WHR), insulin dosage and hypoglycemia of acarbose group and insulin group after 1 year were compared. Results:A total of 717 adult patients with T1DM were included (62 cases in acarbose group and 655 cases in insulin group). At the time of enrollment, the onset age of acarbose group was higher than that of insulin group [(31.1±12.3)years vs (27.4±12.4)years, P=0.019]; There were no significant differences in gender, age, course of disease, body weight, BMI, WHR, proportion of carbohydrate heat ≥50%, proportion of exercise time ≥150 min per week, HbA 1c, dosage of insulin, occurence of hypoglycemia and proportion of patients with dyslipidemia between the 2 groups (all P>0.05). After 1 year of follow-up, the HbA 1c in acarbose and insulin group decreased from baseline ( P=0.014, P<0.001), the body weight and BMI increased from baseline (all P<0.05), but WHR, insulin dosage and hypoglycemia occurrence were not statistically significant between the two groups (all P>0.05). After 1 year of follow-up, there were no significant difference in changes of HbA 1c, body weight, BMI, WHR, insulin dosage and hypoglycemia occurrence in acarbose group compared with insulin group from baseline (all P>0.05). Conclusions:In the clinical practice of T1DM treatment, acarbose is used more frequently in patients with a slightly older age of onset. Treatment of T1DM with insulin combined with acarbose did not increase the incidence of hypoglycemia, and no benefit was observed in improving HbA 1c, maintaining body weight, and reducing insulin use.
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Acarbose is widely used as α-glucosidase inhibitor in the treatment of type Ⅱ diabetes. Actinoplanes sp. is used for industrial production of acarbose. As a secondary metabolite, the biosynthesis of acarbose is quite complex. In addition to acarbose, a few acarbose structural analogs are also accumulated in the culture broth of Actinoplanes sp., which are hard to remove. Due to lack of systemic understanding of the biosynthesis and regulation mechanisms of acarbose and its structural analogs, it is difficult to eliminate or reduce the biosynthesis of the structural analogs. Recently, the advances in omics technologies and molecular biology have facilitated the investigations of biosynthesis and regulatory mechanisms of acarbose and its structural analogs in Actinoplanes sp.. The genes involved in the biosynthesis of acarbose and its structural analogs and their regulatory mechanism have been extensively explored by using bioinformatics analysis, genetic manipulation and enzymatic characterization, which is summarized in this review.
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Humanos , Acarbose/metabolismo , Diabetes Mellitus Tipo 2/tratamento farmacológico , Técnicas GenéticasRESUMO
OBJECTIVE：To summarize and analyze t he clinical characteristics of acarbose-induced skin ADR ，and to provide reference for its therapy. METHODS ：Clinical pharmacists participated in the treatment of a patient with acarbose-induced skin ADR. The patient developed erythema multiforme several days after oral administration of Acarbose tablets （100 mg/d）. After consultation by dermatology and clinical pharmacy ，considering that the adverse reaction was related to acarbose ，clinical pharmacists suggested to stop the drug. Based on the above cases ，clinical pharmacists searched Wanfang database ，CNKI， PubMed，Embase and other databases to collect case reports of skin ADR caused by acarbose ，summarize its general situation （gender，age，usage and dosage ，etc.），latency，ADR（diagnosis and manifestation ），intervention and outcome ，etc. RESULTS ： The doctor adopted the pharmacist s’advice，stopped the use of acarbose ，and gave symptomatic treatment as Methylprednisolone sodium succinate for injection 40 mg（intravenous injection ，qd）+Medloratadine tablets 8.8 mg（oral administration ，qd）+Calamine lotion（for external use ）. The patient improved and was discharged after 10 days. A total of 12 literatures involving 12 patients were retrieved. Among the 13 patients included in the analysis （including the above clinical case and 12 literature cases ），there were 8 males and 5 females，and 8 patients of them aged 50 and over；the dosage of acarb ose in most patients was within the requirements of the drug instructions. The primary diseases of 12 patients were diabetes mellitus. The latency of skin ADR in 11 patients was within 6 days of administration. Among the 13 patients，the ADR were diagnosed as rash in 4 cases，pustulosis in 3 cases， erythema multiforme in 2 cases， urticaria in 2 cases， maculopapular rash in 1 case and lip swelling in 1 case. The ADR of 1 patient improved after drug withdrawal ，and 12 patients also improved after drug withdrawal and symptomatic treatment such as glucocorticoid or antihistamine. Acarbose was re-used in 2 patients after the improvement of first skin ADR ，and skin ADR occurred again ，and the ADR were improved after drug withdrawal and symptomatic treatment. CONCLUSIONS ：Skin ADR are acarbose-induced rare ADR ，mostly within 6 days of medication ，and are more likely to occur in middle-aged and older men. When the patients suffer from ADR ，the drug should be stopped in time and given glucocorticoids or antihistamines for symptomatic treatment. Clinical pharmacists should do a good job in drug publicity and education ，remind patients to closely monitor relevant indicators and ensure drug safety.
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Objective:To observe the changes of skeletal muscle indexes in elderly patients with type 2 diabetes complicated with sarcopenia treated with sitagliptin and acarbose.Methods:A total of 60 patients over 60 years old with type 2 diabetes complicated with sarcopenia in Dalian Municipal Central Hospital from January 2019 to January 2020 were selected and divided into two groups by random number table method.One group received sitagliptin and metformin,and the other group received acarbose and metformin. The changes of skeletal muscle indexes, glucagon-like peptides-1 (GLP-1), insulin resistance index (HOMA-IR) and inflammatory indexes were compared between the two groups at baseline and 36 weeks after treatment.Results:After treatment, the skeletal muscle index (SMI) of sitagliptin group was increased (5.94 ± 1.52 vs. 5.99 ± 1.52), and the difference was statistically significant ( P<0.05). Muscle strength and SMI decreased in acarbosse group (18.75 ± 4.64 vs. 17.72 ± 4.44, 6.09 ± 1.74 vs. 6.00 ± 1.71), with statistical significance ( P<0.05). GLP-1 increased in sitagliptin group, 0 min: (10.65 ± 1.68) pmol/L vs. (12.41 ± 1.88) pmol/L; 60 min: (22.79 ± 2.85) pmol/L vs. (25.51 ± 2.79) pmol/L; 120 min: (24.26 ± 2.94) pmol/L vs. (29.49 ± 2.91) pmol/L; 180 min: (11.68 ± 1.84) pmol/L vs. (12.88 ± 1.83) pmol/L. There were significant differences ( P<0.05). HOMA-IR and CRP decreased: 4.73 ± 3.04 vs. 3.16 ± 2.41, (2.39 ± 0.50) mg/L vs. (2.33 ± 0.43) mg/L, and the differences were statistically significant ( P<0.05). HOMA-IR in acarbose group decreased after treatment (5.80 ± 3.94 vs. 4.00 ± 1.63), and the difference was statistically significant ( P<0.05). Comparison between the two groups after treatment, the decreased value of muscle strength in sitagliptin group was less than that in acarbose group, and the difference was statistically significant ( P<0.05). GLP-1 and overall GLP-1 area under the curve in sitagliptin group were higher than those in acarbose group (67.64 ± 6.81 vs. 58.98 ± 6.72), with statistical significance ( P<0.05). HOMA-IR and CRP in sitagliptin group were lower than those in acarborose group: 3.16 ± 2.42 vs. 4.00 ± 1.63, (2.33 ± 0.43) mg/L vs. (2.41 ± 0.70) mg/L, with statistical significances ( P<0.05). Conclusions:Sitagliptin therapy improves muscle mass and protects muscle strength in elderly patients with type 2 diabetes mellitus and sarcopenia.
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Objective:To explore the effect of Shenqi Maiwei Dihuangtang （SQMWDH） combined with acarbose on the level of 2-hour oral glucose tolerance test （2 h OGTT），body mass index （BMI）， and abdominal fat thickness in patients with impaired glucose tolerance （IGT）. Method:A total of 130 patients with IGT admitted to the First People's Hospital of Shuangliu District from February 2017 to January 2019 were divided into a control group and a treatment group by a random number table. All patients received conventional treatment， such as diet regulation and exercise. The patients in the control group received additional oral administration of acarbose，while those in the treatment group were treated with SQMWDH based on the control group. Fasting blood glucose （FBG），2 h OGTT， and glycated hemoglobin A1c（HbA1c）levels were measured by the blood glucose meter. Abdominal fat thickness was measured by ultrasound tomography，and serum total cholesterol （TC），triglyceride （TG），adiponectin， and leptin levels in fasting venous blood were measured. Result:After treatment，the total response rate of the treatment group was higher than that of the control group （95.00% vs. 81.67%， <italic>χ</italic><sup>2</sup>=5.175，<italic>P</italic><0.05）. Before treatment，there was no significant difference in FBG，2 h OGTT，HbA1c， BMI，waist circumference，abdominal fat thickness，TC，TG，adiponectin， and leptin of IGT patients between the two groups. After treatment，the levels of FBG，2 h OGTT，HbA1c， BMI，waist circumference，abdominal fat thickness，TC，TG，and leptin of IGT patients were lower than those before treatment in both groups （<italic>P</italic><0.05）， and the treatment group was inferior to the control group（<italic>P</italic><0.05，<italic>P</italic><0.01）. The level of adiponectin after treatment was higher than that before treatment in both groups （<italic>P</italic><0.05），and the treatment group was superior to the control group （<italic>P</italic><0.05）. Conclusion:SQMWDH combined with acarbose is effective in treating IGT patients by effectively reducing 2 h OGTT and abdominal fat thickness to alleviate obesity and improve the constitution of patients.
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Objective@#To analyze the clinical efficacy of Acarbose on type 2 diabetes mellitus combined with postprandial hypotension (PPH) in elderly patient.@*Methods@#A total of 60 elderly patients with type 2 diabetes mellitus and PPH who were diagnosed and treated at our hospital from July 2016 to December 2017 were enrolled in this study.Patients were given Acarbose intervention for two weeks.The changes of blood pressure, heart rate and blood glucose before and after treatment were monitored, and the therapeutic effects and side effects were evaluated.@*Results@#After Acarbose intervention, postprandial systolic pressure (F=9.311, P=0.033), diastolic pressure (F=8.710, P=0.026) and mean arterial pressure (F=7.710, P=0.021) were decreased significantly in elderly patients with type 2 diabetes mellitus and PPH by comparison with those before intervention.There was no significant difference in heart rate fluctuation(F=8.091, P=0.069)and in fasting blood glucose level(t=0.209, P=0.120)before and after treatment.The 2-hour postprandial blood glucose level was lower in elderly patients with diabetes mellitus and PPH after treatment of acarbose than before treatment [(7.9±0.9)mmol/L vs. (8.9±1.9)mmol/L, t=18.310, P=0.003]. The incidence rate of PPH was 100.0% before treatment, and decreased to 43.3% (26/60) after acarbose intervention (χ2=51.430, P=0.000). There were 5 patients with adverse reactions, and the incidence rate of adverse reactions was 8.3%(5/60), and no patients had cerebral ischemia.@*Conclusions@#Acarbose can alleviate postprandial blood pressure, decrease the fluctuation of postprandial blood glucose and reduce the incidence of PPH, which has a high safety.It may be one of the effective measures in treating diabetes mellitus combined with postprandial hypotension in the elderly.
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Objective To analyze the clinical efficacy of Acarbose on type 2 diabetes mellitus combined with postprandial hypotension (PPH) in elderly patient.Methods A total of 60 elderly patients with type 2 diabetes mellitus and PPH who were diagnosed and treated at our hospital from July 2016 to December 2017 were enrolled in this study.Patients were given Acarbose intervention for two weeks.The changes of blood pressure,heart rate and blood glucose before and after treatment were monitored,and the therapeutic effects and side effects were evaluated.Results After Acarbose intervention,postprandial systolic pressure (F =9.311,P =0.033),diastolic pressure (F =8.710,P =0.026) and mean arterial pressure (F =7.710,P =0.021) were decreased significantly in elderly patients with type 2 diabetes mellitus and PPH by comparison with those before intervention.There was no significant difference in heart rate fluctuation(F =8.091,P =0.069) and in fasting blood glucose level(t =0.209,P =0.120) before and after treatment.The 2-hour postprandial blood glucose level was lower in elderly patients with diabetes mellitus and PPH after treatment of acarbose than before treatment [(7.9±0.9)mmol/L vs.(8.9±1.9)mmol/L,t =18.310,P=0.003].The incidence rate of PPH was 100.0％ before treatment,and decreased to 43.3％ (26/60) after acarbose intervention (x2 =51.430,P =0.000).There were 5 patients with adverse reactions,and the incidence rate of adverse reactions was 8.3 ％ (5/60),and no patients had cerebral ischemia.Conclusions Acarbose can alleviate postprandial blood pressure,decrease the fluctuation of postprandial blood glucose and reduce the incidence of PPH,which has a high safety.It may be one of the effective measures in treating diabetes mellitus combined with postprandial hypotension in the elderly.
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BACKGROUND: We evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin. METHODS: A total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, sitagliptin, and acarbose (Met+Sita+Acarb, n=66) and sitagliptin and acarbose (Sita+Acarb, exploratory assessment, n=34) therapy in five institutions in Korea. After 16 weeks of acarbose add-on or metformin-switch therapy, a triple combination therapy was maintained from week 16 to 24. RESULTS: The add-on of acarbose (Met+Sita+Acarb group) demonstrated a 0.44%±0.08% (P<0.001 vs. baseline) decrease in glycosylated hemoglobin (HbA1c) at week 16, while changes in HbA1c were insignificant in the Met+Sita group (−0.09%±0.10%, P=0.113). After 8 weeks of triple combination therapy, HbA1c levels were comparable between Met+Sita and Met+Sita+Acarb group (7.66%±0.13% vs. 7.47%±0.12%, P=0.321). Acarbose add-on therapy demonstrated suppressed glucagon secretion (area under the curve of glucagon, 4,726.17±415.80 ng·min/L vs. 3,314.38±191.63 ng·min/L, P=0.004) in the absence of excess insulin secretion during the meal tolerance tests at week 16 versus baseline. The incidence of adverse or serious adverse events was similar between two groups. CONCLUSION: In conclusion, a 16-week acarbose add-on therapy to metformin and sitagliptin, effectively lowered HbA1c without significant adverse events. Acarbose might be a good choice as a third-line therapy in addition to metformin and sitagliptin in Korean subjects with T2DM who have predominant postprandial hyperglycemia and a high carbohydrate intake.
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Humanos , Acarbose , Diabetes Mellitus Tipo 2 , Quimioterapia Combinada , Glucagon , Hemoglobinas Glicadas , Hiperglicemia , Incidência , Insulina , Coreia (Geográfico) , Refeições , Metformina , Fosfato de SitagliptinaRESUMO
OBJECTIVE: To evaluate the bioequivalence of acarbose tablet in healthy Chinese volunteers through the use of pharmacodynamics endpoint parameters of serum glucose. METHODS: Following the Food and Drug Administration (FDA) guidance, a single oral dose of test and reference formulations was given to 32 healthy Chinese volunteers according to a randomized crossover design. Serum glucose concentrations after sucrose administration and co-administration of sucrose and acarbose on the following day were both determined. The reduction of serum glucose concentration were calculated following treatment with acarbose and sucrose together relative to the baseline serum glucose concentration observed. The parameters of Δcmax and AUEC0-4 h recommended by the FDA were used for bioequivalence evaluation. Four pharmacodynamics parameters of AUEC0-2 h,AUEC0-1.5 h, AUEC0-1.0 hand ΔGE were also tested in the evaluation. RESULTS: The main pharmacodynamics parameters of serum glucose in test and reference formulations were as follows:Δcmax (1.169±0.719) and (0.878±0.571) mmol·L-1, AUEC0-2 h(46±25) and (50±21) mmol·min·L-1, AUEC0-1.5 h(62±42) and (70±29) mmol·min·L-1, AUEC0-1 h(59±52) and (73±32) mmol·min·L-1, ΔGE(1.829±0.952) and (1.656±0.764) mmol·L-1, respectively. The parameter AUEC0-4 h could not be evaluated due to the presence of negative values. CONCLUSION: Acarbose tablet is bioinequivalent to the reference tablet.This might be related to acarbose dose, the 50 mg dose of acarbose tablet is inadequate. Pharmacodynamics parameters which is suitable to demonstrate acarbose bioequivalence might also need to be optimized.
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Objective To evaluate efficacy and safety of acarbose compared with metformin as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled with insulin. Methods This was a randomized, open-labeled, and parallel group study. Ninety-one type 2 diabetic patients ( HbA1C7.5%-11.0%) who were suboptimally controlled despite receiving twice daily injection of insulin (30-60 U/d for at least 8 weeks) were enrolled. They were randomly assigned 1 ∶ 1 ∶ 1 to continuation of insulin, insulin with acarbose (Ins+Aca), and insulin with metformin (Ins+Met) groups to insulin treatment. The levels of HbA1C, oral glucose tolerance test, blood lipids etc were measured at baseline and 12 weeks, and adverse events were recorded. Results The mean HbA1C levelsdecreasedfrom(7.9±0.4)%atbaselineto(7.0±0.3)%atweek12(P＜0.01)intheIns+Acagroupand(7.8 ±0.2)%to(7.0±0.3)%in the Ins+Met group(P＜0.01), while no significant change in HbA1Cin the insulin alone group. Adding acarbose to insulin resulted in similar reductions in HbA1Crelative to metformin (P＝0.431). The achievement rate of HbA1Cbelow 7.0%at week 12 was the same(both 70%) between the Ins+Aca group and the Ins+Met group. Insulin combined with acarbose in improving blood glucose fluctuation effect was more significant than that incombinationwithmetformin(P＜0.01),withstandarddeviation(SD)ofbloodglucose[(1.1±0.5vs2.7±0.6) mmol/L, P＜0.01], postprandial blood glucose fluctuations [(0.5 ± 0.7 vs 2.8 ± 0.4) mmol/L, P＜0.01], the maximumbloodglucosefluctuations[(2.8±0.7vs4.6±0.6)mmol/L,P＜0.01].Theweightlossoccurredinboththe Ins+AcaandtheIns+Metgroups[-(0.5±0.8vs1.0±0.4)kg].Therewasnosignificantchangesinbloodpressure and lipid profile. Hypoglycemic episodes were comparable in all groups. No serious adverse event was noted in any group. Conclusions Adding acarbose or metformin to insulin therapy could achieve improvements in glycemic control with similar reductions in HbA1Clevels and weight, when comparing with insulin treatment alone. Add-on acarbose to insulin therapy may exist more effectively on glucose fluctuation than that of add-on metformin, which may have important clinical implications in those patients with postprandial hyperglycemia, large blood glucose fluctuation, and intolerance to metformin.
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Pre-diabetes is at increased risk of development of type 2 diabetes and future cardiovascular events. Preventing the progression of pre-diabetic populations to diabetes is important. The Acarbose Cardiovascular Evaluation(ACE) trial was the largest pre-diabetes intervention study conducted in China. The study found that acarbose treatment can significantly reduce the risk of new-onset diabetes in IGT patients with CVD on the basis of life interventions,but the cardiovascular benefits for the population are not significant. ACE study showed that acarbose can prevent the conversion of IGT to diabetes,which plays a key role in the prevention of diabetes.
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ACE is an important clinical trial. It attracted much attention in the field of diabetes and cardiology worldwide. Acarbose did not increase the number of cardiovascular events in ACE, which demonstrated it′s safety in pre-diabetes people who experienced a cardiovascular disease previously. But this agent also did not reduce the composite CVD endpoints, shedding a challenge to the notion that postprandial glucose rise is a specific risk factor to predict cardiovascular events. ACE trial successfully confirmed the effect of acarbose on the prevention of diabetes in subjects with impaired glucose tolerance, bnt to a less extent compared with the STOP-NIDDM trial. The higher number of subjects needed to be treated for the prevention of diabetes in ACE trial than that seen in other intervention trials should be taken into account in the decision making for using acarbose to prevent diabetes in a large scale population as far as the cost-effectiveness is concerned.
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Objective:To observe the intervention effect of acarbose on cerebral arterial thrombosis complicated with impaired glu-cose tolerance(IGT).Methods: Totally 120 cases of IGT patients with ischemic stroke were randomly divided into the observation group (58 cases) and the control group(62 cases). The two groups were given the same basic treatment,while the observation group was treated with acarbose 50 mg,po,tid for 3 months additionally. Before and after the treatment,the levels of blood lipid and blood glucose,serum high-sensitivity C reactive protein(hsCRP) and carotid intima media thickness(IMT) and the other adverse drug reac-tions were detected in the two groups. After 6-month follow-up,the new incidence of IGT was compared between the groups.Results:After the treatment,2 hPG,HbAlc,hsCRP and the other indicators in the observation group were significantly improved when com-pared with those before the treatment(P<0.01 or P<0.05),while only hsCRP in the control group was significantly improved when compared with that before the treatment(P<0.05) and that in the observation group. 2 hPG,HbAlc,hsCRP,IMT and the other in-dicators in the observation group were significantly better than those in the control group(P<0.01 or P<0.05). There was no signifi-cant change in the level of blood lipid in the two groups. There was no adverse drug reaction during the treatment. After the 6-month follow-up,the new incidence of IGT in the observation group was 1.82%,which was significantly lower than that in the control group (7.27%,P<0.05).Conclusion: Among the patients with cerebral arterial thrombosis complicated with impaired glucose tolerance, the normal treatment measures plus acarbose can effectively delay carotid artery IMT incrassation and decrease the risk of cardiovascular events recurrence with better relative safety.
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The Acarbose Cardiovascular Evaluation ( ACE ) trial assessed whether acarbose could reduce the incidence of cardiovascular event ( CVE) s in Chinese patients suffering from impaired glucose tolerance ( IGT) and coronary heart disease. ACE differs from a previous study on IGT people, the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus ( STOP-NIDDM) trial in terms of sample size, number of CVE, mean age, acarbose dose, and population. ACE supported STOP-NIDDM's results by showing that acarbose prevents the progression of prediabetes to diabetes in IGT people, and extended the effect to people with coronary heart disease. However it did not reduce CVE incidence, probably due to the low dose used (50 mg tid). Overall, ACE is well-designed and high-powered enough to confirm that acarbose can prevent progression of prediabetes to diabetes, but is not able to reduce CVE incidence. However, in light of the fast growing prediabetic Chinese population, usage of acarbose is warranted to avert an explosion of diabetes.
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OBJECTIVE:To investigate the effects of acarbose combined with metformin on related indexes of patients with type 2 diabetes mellitus.METHODS:A total of 100 patients with type 2 diabetes mellitus were randomly divided into control group (50 cases) and observation group (50 cases).Control group was given Acrbose tablet 50 mg orally,3 times a day.Observation group was additionally given Metformin hydrochloride tablet 0.5 g orally,3 times a day,on the basis of control group.Both groups were treated for 12 weeks.The levels of fasting plasma glucose (FPG),fasting plasma insulin (FINS),glycosylated hemoglobin (HbA1c),2 h postprandial plasma glucose (2 hPG),postprandial 2 h insulin (2 hFINS),insulin resistance index (HOMA-IR),the proportion of Th cell subsets in CD4+ T cells,IL-22,IL-17A and IFN-γ,mRNA expression of IL-22,IL-17A and IFN-γ were observed in 2 groups before and after treatment.The occurrence of ADR was recorded.RESULTS:After treatment,FPG,FINS,HbA1c,2 hPG,2 hFINS,HOMA-IR,the proportion of Th cell subsets in CD4+ T cells,the concentrations of IL-22,IL-17A and IFN-γ,expression of IL-22 mRNA,IL-17A mRNA and IFN-γ mRNA in 2 groups were significantly lower than before treatment,with statistical significance (P＜0.05);there was no significant difference in the proportion of Th1 in T cells between 2 groups (P＞0.05).Other indexes of observation group were significantly lower than those of control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of ADR between 2 groups (P＞0.05).CONCLUSIONS:For patients with type 2 diabetes mellitus,acarbose combined with metformin can effectively control the level of blood glucose,improve insulin resistance,balance Th cell subsets,reduce inflammatory factors levels but don't increase the occurrence of ADR.
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OBJECTIVE:To investigate the effects of acarbose combined with metformin on related indexes of patients with type 2 diabetes mellitus.METHODS:A total of 100 patients with type 2 diabetes mellitus were randomly divided into control group (50 cases) and observation group (50 cases).Control group was given Acrbose tablet 50 mg orally,3 times a day.Observation group was additionally given Metformin hydrochloride tablet 0.5 g orally,3 times a day,on the basis of control group.Both groups were treated for 12 weeks.The levels of fasting plasma glucose (FPG),fasting plasma insulin (FINS),glycosylated hemoglobin (HbA1c),2 h postprandial plasma glucose (2 hPG),postprandial 2 h insulin (2 hFINS),insulin resistance index (HOMA-IR),the proportion of Th cell subsets in CD4+ T cells,IL-22,IL-17A and IFN-γ,mRNA expression of IL-22,IL-17A and IFN-γ were observed in 2 groups before and after treatment.The occurrence of ADR was recorded.RESULTS:After treatment,FPG,FINS,HbA1c,2 hPG,2 hFINS,HOMA-IR,the proportion of Th cell subsets in CD4+ T cells,the concentrations of IL-22,IL-17A and IFN-γ,expression of IL-22 mRNA,IL-17A mRNA and IFN-γ mRNA in 2 groups were significantly lower than before treatment,with statistical significance (P＜0.05);there was no significant difference in the proportion of Th1 in T cells between 2 groups (P＞0.05).Other indexes of observation group were significantly lower than those of control group,with statistical significance (P＜0.05).There was no statistical significance in the incidence of ADR between 2 groups (P＞0.05).CONCLUSIONS:For patients with type 2 diabetes mellitus,acarbose combined with metformin can effectively control the level of blood glucose,improve insulin resistance,balance Th cell subsets,reduce inflammatory factors levels but don't increase the occurrence of ADR.
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Objective To observe the efficacy of acarbose combined with metformin in the treatment of newly diagnosed type 2 diabetes mellitus with hyperlipidemia. Methods 160 patients with newly diagnosed type 2 diabetes mellitus with hyperlipidemia were randomly divided into the observation group and the control group,80 cases in each group. The patients in the control group were treated with metformin alone. The patients in the observation group were treated with acarbose plus metformin. The changes of blood glucose and blood lipid index and the adverse reactions were observed before and after treatment. Results After treatment, the blood glucose and blood lipid index were significantly improved in both two groups compared with before treatment. Compared with the control group,the fasting blood glucose (FBG),postprandial 2h blood glucose (2hPG),glycosylated hemoglobin (HbAlc) levels in the observation group were significantly lower (t=5. 18,4. 16,8. 55,all P <0. 01). The total cholesterol (TC), triglyceride (TG),low density lipoprotein cholesterol (LDL-C) levels in the observation group were significantly lower than those in the control group (t=12. 97,7. 72,18. 77,all P<0. 01),the high density lipoprotein cholesterol (HDL-C) level was significantly higher than that in the control group (t=9. 64,P<0. 01). The total effective rate of blood glucose control in the observation group was 93. 7%,which was higher than 81. 3% in the control group,the difference was statistically significant (χ2 =5. 89,P<0. 05). Conclusion Acarbose combined with metformin in the treatment of newly diagnosed type 2 diabetes mellitus with hyperlipidemia has significant clinical efficacy, it is beneficial to control blood glucose and blood lipid level,and worthy of clinical application.
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Objective To observe the efficacy of acarbose combined with metformin in the treatment of newly diagnosed type 2 diabetes mellitus with hyperlipidemia. Methods 160 patients with newly diagnosed type 2 diabetes mellitus with hyperlipidemia were randomly divided into the observation group and the control group,80 cases in each group. The patients in the control group were treated with metformin alone. The patients in the observation group were treated with acarbose plus metformin. The changes of blood glucose and blood lipid index and the adverse reactions were observed before and after treatment. Results After treatment, the blood glucose and blood lipid index were significantly improved in both two groups compared with before treatment. Compared with the control group,the fasting blood glucose (FBG),postprandial 2h blood glucose (2hPG),glycosylated hemoglobin (HbAlc) levels in the observation group were significantly lower (t=5. 18,4. 16,8. 55,all P <0. 01). The total cholesterol (TC), triglyceride (TG),low density lipoprotein cholesterol (LDL-C) levels in the observation group were significantly lower than those in the control group (t=12. 97,7. 72,18. 77,all P<0. 01),the high density lipoprotein cholesterol (HDL-C) level was significantly higher than that in the control group (t=9. 64,P<0. 01). The total effective rate of blood glucose control in the observation group was 93. 7%,which was higher than 81. 3% in the control group,the difference was statistically significant (χ2 =5. 89,P<0. 05). Conclusion Acarbose combined with metformin in the treatment of newly diagnosed type 2 diabetes mellitus with hyperlipidemia has significant clinical efficacy, it is beneficial to control blood glucose and blood lipid level,and worthy of clinical application.
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OBJECTIVE: To develop an high-performance liquid chromatography (HPLC) method with diode array detector (DAD) for determination of acarbose in acarbose tablets. METHODS: An Alltima C18 column (4.6 mm×250 mm, 5 μm) was used for the separation, with acetonitrile-10 mmol·L-1 ammonium dihydrogen phosphate (containing 0.04% sodium 1-octanesulfonate, adjusted pH to 3.3 with H3PO4) (15∶85) as the mobile phase at the flow rate of 0.8 mL·min-1. The detection wavelength was set at 200 nm and the column temperature was maintained at 30℃. RESULTS: The method showed good linearity with a correlation coefficients (r) of 1.000 0. The specificity study demonstrated satisfactory resolutions between acarbose, other ingredients in the drug and forced degradation products. The precision and stability were satisfactory with the relative standard deviations (RSDs) of 0.088% and 0.22%, respectively. The average spiked recovery was 98.49% with RSD of 0.24% (n=9). The content of acarbose in four batches of acarbose tablets was 51.69, 51.75, 51.72 and 51.62 mg·tablet-1, respectively. CONCLUSION: The established method is accurate, simple and rapid, and can be utilized for determination of acarbose in acarbose tablets.
RESUMO
The prevalence of prediabetes is increasing rapidly in China, and with higher prevalence in coronary heart disease and hypertension patients. Diabetes can be controlled and prevented, previous studies have confirmed that lifestyle interventions and drug interventions can delay the progression of prediabetes to diabetes, and acarbose can be used for the primary prevention of cardiovascular events in impaired glucose tolerance(IGT) and diabetic patients, but benefits of drug intervention for secondary prevention of cardiovascular disease in IGT population are uncertain. The Acarbose Cardiovascular Evaluation(ACE) Study is a multicentre, randomized, placebo-controlled, double-blind study, with the aim of assessing the use of acarbose to reduce the risk of cardiovascular events and the onset of diabetes in IGT patients with cardiovascular disease in China , the results will be very meaningful and valuable for the prevention and treatment of diabetes. We will predict the results of ACE Study based on previous evidences.