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Objective:To compare the efficacy and safety of Tonghua Dongbao′s insulin aspart injection (Rishulin) and NovoRapid (Novo Nordisk) in the treatment of diabetes.Methods:A 26-week, randomized, open-label, parallel-group, positive control drug and non-inferiority trial was conducted in 23 centers in China. A total of 563 diabetes with poor blood glucose control treated with insulin for at least 3 months before were included. The subjects were randomized(stratified block random method) into those receiving Rishulin or NovoRapid at a ratio of 3∶1. Both groups were combined with basal insulin (Lantus). The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to the end of 24 weeks of treatment.Results:For full analysis set, after 24 weeks of treatment, HbA1c level of Ruishulin group decreased from (8.66±1.28)% to (7.77±1.09)% ( P<0.001), and that of NovoRapid group decreased from (8.47±1.28) % to (7.65±0.97) % ( P<0.001). Treatment difference in HbA1c (NovoRapid group-Ruishulin group) was -0.061% (95% CI -0.320-0.199). HbA1c<7.0% target reacing rates were 24.26% and 21.21% ( P=0.456), and HbA1c<6.5% target reacing rates were 9.65% and 6.82% ( P=0.310) in Ruishulin group and NovoRapid group, repectively. The standard 2 hours postprandial blood glucose (2hPG) in Ruishulin group decreased from (16.23±5.22) mmol/L to (12.65±4.57) mmol/L ( P<0.001), and 2hPG in NovoRapid group decreased from (16.13±5.37) mmol/L to (11.91)±4.21) mmol/L ( P<0.001). The fingertips blood glucose at 7-point of both groups exhibited varying degrees of reduction compared with those at baseline, repectively. Positive ratios of specific antibodies were 31.68% in Ruishulin group and 36.36% in NovoRapid group ( P=0.320). Ratios of negative to positive were 7.43% and 10.61% ( P=0.360), and ratios of positive to negative were 10.40% and 7.58% ( P=0.360) in Ruishulin group and NovoRapid group, respectively. The incidence of hypoglycemia was 60.05% and 55.40% ( P=0.371), and the incidence of adverse events was 76.60% and 77.70% ( P=0.818) in Ruishulin group and NovoRapid group, respectively. Conclusions:Rishulin is not inferior to NovoRapid, and has shown good efficacy and safety. It can be an ideal choice for clinicians in patients with poor blood glucose control with insulin.
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Objective To observe the analgesic and anti-inflammatory effects of the water extract of Glycosmis citrifolia (Willd.) Lindl.on mice and explore the mechanism. Methods The analgesic and anti-inflammatory effects were evaluated by 0.7% acetic acid-induced writhing test,the hot plate test,tests of dimethylbenzene-induced ear swelling,1% carrageenan-induced paw edema,determination of PGE2 in inflammatory feet,0.6% acetic acid-induced increase in peritoneal capillary permeability and cotton ball granuloma. Results The water extract of Glycosmis citrifolia (Willd.) Lindl.at low,medium and high doses can reduce the acetic acid-induced writhing times (P<0.01 or P<0.05),increase the pain threshold of mice (P<0.01 or P<0.05), inhibit dimethylbenzene-induced ear swelling (P<0.01 or P<0.05),1% carrageenan-induced paw edema (P<0.01 or P<0.05) and PGE2 production (P<0.01),0.6% acetic acid-induced increase of peritoneal capillary permeability (P<0.05),and the de-velopment of cotton ball granuloma (P<0.01 or P<0.05). Conclusion The water extract of Glycosmis citrifolia (Willd.) Lindl.shows analgesic and anti-inflammatory effects on mice.
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Objective To explore the correlation of adiponectin (ADP) and type 2 diabetes mellitus (T2DM) depressive symptoms.Methods Random sample of hospitalized confirmed patients with T2DM were 76 cases,who were divided in to T2DM group (DM group,30 cases) and T2DM with depressive symptoms group (DD group,40 cases) and randomly selected 36 cases in the medical center as control group.The level of height,weight,waist circumference,hip circumference,plasma ADP,fasting plasma glucose (FPG),total cholesterol (TC),triglyceride (TG),high density lipoprotein cholesterol (HDL-C),low-density lipoprotein protein cholesterol (LDL-C),C-reactive protein (CRP),fasting plasma cortisol (COR),fasting insulin (FINS) were measured.Body mass index (BMI),waist to hip ratio (WHR) and insulin resistance index (HOMA-IR) was calculated.Results The plasma ADP level in DD group was lower than that in DM group and control group [(3.05 ± 1.07) g/L vs.(4.06 ± 1.12),(6.97 ± 1.64) g/L],there was significant difference (P ＜ 0.01).The plasma ADP level was negatively correlated with CRP,HOMA-IR,TC,FPG and SDS,but positively correlated with HDL-C.HDL-C and SDS was the independent risk factor influencing the ADP level in DD group.Conclusions T2DM patients with depressive symptoms exist the greater insulin resistance,the level of plasma ADP is specific drop; the lower level of plasma ADP is an independent risk factor for T2DM patients with depressive symptoms,there is independent correlation between them.
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Objective To study the relationship among depression associated type 2 deabetes mellitus (T2DM) and personality and quality of life.Methods A total of 246 cases of hospitalized T2DM patients were investigated by schedule tables:self-rating depression scale (SDS),Eysenck personality questionaire (EPQ) and adjusted diabetes-specific quality of life scale (A-DQOL).According to the results of SDS,patients were divided into depression group (171 cases) and non-depression group (75 cases).Correlation analysis and regression analysis were carried out for the collected data.Results There were differences in satisfaction,influence,anxiety Ⅰ,anxiety Ⅱ,neuroticism and extraversion between the two groups(P ＜ 0.05 or P ＜ 0.01).Depression extents was related to the quality of life,neuroticism,extraversion and course(r =-0.243-0.392,P ＜ 0.05 or P ＜ 0.01).Anxiety Ⅱ,satisfaction and course enter the regression equation of depression (β =-0.205-0.322,P ＜ 0.05 or P ＜ 0.01).Conclsion Anxiety Ⅱ,satisfaction and course are key factors inducing depression in T2DM.Neuroticism and extroversion may be the predisposing personality characteristics in T2DM patients with depression.In clinical work,it is helpful for treatment by changing personality and mood of patients.
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Objective To investigate the relationship between serum visfatin level and coronary artery stenosis.Methods Based on coronary angiography,85 patients were diagnosed as coronary heart disease.According to oral glucose tolerance test,these patients were divided into 3 groups,34 patients with normal glucose tolerance(CHD group),25 with impaired glucose regulation(CIG group),and 26 with type 2 diabetes mellitus(CDM group).30 non-comary heart disease subjects with normal glucose tolerance were selected as the control group(CON group),and they underwent coronary CT angiography scan and were confirmed coronary disease-free.Blood pressure,body mass index(BMI),waist circumference(WC),waist hip ratio(WHR),fasting plasma glucose(FPG),blood lipid analysis,fasting insulin,and HbA1C were determined.Serum visfatin concentration was assayed and the status of coronary artery was assessed.Coronary artery stenosis was screened by coronary interventional angiography and assessed by Gemini scoring system in CHD,CIG,and CDM groups.Results Compared with control group,serum visfatin in CHD,CIG,and CDM groups were significantly higher(all P<0.05).Compared with CHD group,serum visfatin in CIG and CDM groups were significantly higher(all P<0.05).The correlation analysis showed that serum visfatin level was positively correlated with the involved branches of coronary arteries(r=0.807,P<0.01),serum visfatin level was positively related with Gensini coronary artery score(r=0.669,P<0.01).Visfatin was also positively correlated with WC,WHR,triglyceride(TG,r=0.200,P=0.032,r=0.185,P=0.047,r=0.321,P<0.01),while high density lipoprotein cholesterol(HDL-C)was negatively correlated with visfatin(r=-0.354,P<0.01).Multiple regression analysis showed that senlm hvel of TG and WC were the main influencing factors of visfatin.Conclusion (1)The level of serum visfatin may reflect the severity of coronary artery stenosis,detection of visfatin helps to make early diagnosis of CHD.(2)The raised serum level of visfatin in comary heart disease patients with imparied glucose tolerance is consistent with clinical evidence that diabetic patients have more severe coronary diseases.(3)WC and serum TG are main inilucencing factors,suggesting that visfatin is correlated with abdominal obesity.
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ObjectiveTo study the role of the myenteric plexus (ENS) nitrergic neurons in type 2 diabetic rats with gastroparesis.MethodsThiry male 8-week-SD rats were randomly divided into control group (CON),type 2 diabetic group (DM),insulin-treated group ( INS ) and insulin-lipoie acid group( LA ),each 15.The rats were sacrificed at 16 weeks after diabetic model established,the stomach relative residual rate of pigmented was measured and the protein content of neuronal nitric oxide synthase (nNOS) was evaluate,the level of malondialdehyde (MDA) and superoxide dismutase (SOD),were measured,the the morphological changes of gastric antrum nitrergic neurons was observed.ResultsCompared with CON group,gastric motility,gastric antrum nitrergic neuron count,T-SOD and CuZn-SOD,and were significantly decreased in DM group ( P ＜0.05).Compared with the CON group,DM group gastric antrum nitrergic neurons nNOS expression decreased,while MDA levels significantly increased ( P ＜ 0.05 ).Compared with DM group,INS group and LA group has significantly rapider gastric motility than that of DM group ( P＜ 0.05 ),the neuron counting markly increased in nitrergic neuron of gastic sinus ( P ＜ 0.05 ),increased expressions of nNOS in gastric sinus,while still lower than control group( P ＜0.05).compared with the INS group,antrum nitrergic neuron counts of LA group significantly increased ( P ＜ 0.05 ).Conclusion The gastrointestinal dyskinesis of type 2 diabetic rats might be associated with lesions of gastric myenteric plexus nitrergic neuron.Insulin intensive therapy and treated with alpha-lipoic acid as an antioxidant can inhibit the abnormally high levels of oxidative stress,protect gastrointestinal nitrergic neurons,delay the progress of diabetic gastrointestinal motility disorders.Insulin combined with a-lipoic acid treatment is superior to single-use insulin.
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Objective To investigate the effect on prevention and treatment autoimmune diabetes mellitus in NOD mice by oral administration porcine insulin.Methods One hundred and twenty female NOD mice were divided randomly into insulin group(n=60) and control group(n=60).Beginning from 6 week old, NOD mice were fed porcine insulin 500ul or phosphate buffered saline(PBS) 500ul seperately till 40 week old. At 6 ?12 ?20 ?25 ?30 week old,serum insulin of healthy mice was measured and pancreas were used for histology.Results Oral administration of insulin can marked decreased incidence of diabetes ( P