In this paper,the management process of Chinese-Western medicine compound preparation is briefly reviewed.the existing problems were analyzed from the perspective of registration supervision and quality control.It is pointed out that there are still some types of management in the registration of supervision,such as the weak basic research,approval number of multiple pecifications,not uniform name,and not standardized specification.In the area of quality control,correlation analysis between the lack of key items (such as related substances,uniformity of contents,and dissolution test items) and the hidden dangers in medical security of preparations was performed.To explore the need for reevaluation,and put forward some suggestions for improvement in order to provide a useful reference for the scientific supervision of Chinese-Western medicine compound preparation.

Humans ; In Situ Hybridization, Fluorescence ; Tissue Array Analysis ; methods

To evaluate the association of ealpain-10 gene UCSNP-43 polyorphism with type 2 diabetes in Chinese Han population.Meta-analysis showed that calpain-10 gene UCSNP-43 polymorphism may be associated with type 2 diabetes in Chinese Han population.Allele G and genotypo GG may be risk factors for type 2 diabetes,while allele A and genotype GA may be the protective factors.

Objective To compare efficacy of two intensive therapies:continuous subcutaneous insulin infusion(CSⅡ) and multiple subcutaneous insulin infusion (MSⅡ) for treatment of type 2 diabetes mellitus.Methods 60 patients with type 2 diabetes mellitus were randomly divided into 2 groups. Patients in CSⅡ group were treated by insulin (Novolin R) through a infusion pump. Patients in MSⅡ group were treated by Novolin R before meals (3 times a day) and Novolin N at bedtime. Blood glucose was monitored the whole day before and after treatment. Time required for blood glucose to reach the standard level, insulin dosage and hypoglycemia incidence were compared between the 2 groups before and after treatment. Results Both of the 2 therapeutic methods effectively controlled blood glucose (P＜0.05). However, the 2 groups had significant difference in terms of the time required for blood glucose to reach the standard level ( 3.6 ± 1.2 d vs. 9.4 ± 3.2 d, P ＜ 0. 01 ), daily insulin consumption (35.2 ± 8.5 u vs. 43.2 ± 10. 1 u, P ＜0. 01 ) and hypoglycemia incidence (2. 1% vs.9.7%, P ＜0.01 ). Conclusions CSⅡ and MSⅡ are effective for treatment of type 2 diabetes mellitus. CSⅡ is superior to MSⅡ due to its advantages of quick response, safety, and less insulin consumption.

Objective To evaluate the association of apM1 gene single nucleotide polymorphisms (SNP) with type 2 diabetes mellitus in Chinese population. Methods Odds ratios (OR) of apM1 gene SNP distribution were analyzed. The Meta-analysis software (RevMan 4.3.1) was employed for summarizing the studies,calculating the pooled OR and its 95% CI and testing the overall effects. Egger's test and fail-safe number for P=0.05 (Nfs<,0.05>) were performed for evaluating the publication bias. The sensitivity analysis by different effect models and sample sizes were employed for the reliability of Meta-analysis. Results Nine literatures were obtained, apM1 gene SNP45 showed remarkable heterogeneity among the studies (P<0.10). Sub-group analysis revealed that the discrepancy based on southern Chinese individuals was the main source of the total heterogeneity.The distribution frequencies of apM1 gene SNP45G, SNP45GG, SNP276G and SNP276GG were significantly higher in Chinese type 2 diabetes mellitus group than those in NGT group (P<0.05). Their pooled OR and 95% C/were 1.50[1.12,2.02], 2.15[1.53, 3.02],1.23[1.03, 1.46] and 1.26[1.00,1.59], respectively (all P<0.05). The distribution of apM1 gene SNP45TG and SNP276GT between type 2 diabetes mellitus and normal glucose tolerance group revealed no difference among these studies. The results of publication bias diagnostics and sensitivity analysis accounted for the reliability and stability of this Meta-analysis. Conclusion apM1 gene SNPs are strongly associated with type 2 diabetes mellitus in Chinese population. SNP45G and SNP276G seem to be risk factors for type 2 diabetes mellitus.

ObjectiveTo investigate the in vivo effects of down-regulating the FGF-21 gene expression by shRNA on glucose and lipids metabolism in high fat diet (HFD) fed ApoE-/- mice.MethoedsMale ApoE-/- mice were randomly divided into chow diet (CF)fed group ( NF,n =10),CF fed + pAd-shFGF-21 group ( NFG,n =9),and HFD fed group ( HF,n =10),HFD fed + Adv-null vector ( pAd-GFP ) group ( GFP,n =6) and HFD fed + pAd-shFGF-21 group ( HFG,n =10).Mice were fed for 16 weeks.C57BL/6J mice were set as control group ( NC group,n=10).NFG,HFG,and GFP groups were injected with pAd-shFGF-21or pAd-GFP by tail vein at the end of 15 weeks.The insulin sensitivity and glucoselipid metabolism were assessed by the hyperinsulinemic- euglycemic clamp technique using 3-[ 3 H] glucose as a tracer at the end of 16 week.ResultsThe plasma FGF-21 levels in NFG and HFG groups were significantly degraded than those in NF and HF groups(20％-27％,P＜0.05),respectively.In the basal state,the fasting blood glucose,fasting plasma insulin,free fatty-acids,triglycerides,total cholesterol,and LDL-C were significantly higher,while the HDL-C was lower in NFG and HFG groups compared with those in NF and HF groups,respectively (P＜0.05 or P＜0.01 ).During the steady-state of clamp,FFA was suppressed in all groups,but it was still higher in NFG and HFG groups than NF and HF groups ( P＜0.05or P＜0.01 ).The glucose infusion rate (GIR)and glucose disappearance rate (GRd)in NFG and HFG groups were significantly decreased compared with NF and HF groups (all P＜0.01 ).In addition,insulin's ability to suppress hepatic glucose production (HGP) during clamps was significantly decreased in HFG and NFG group compared with HF and NF groups (49％ and 20％,respectively; all P＜0.01 ).ConclusionFGF-21 knockdown and low FGF-21 level facilitate the development of metabolic disorder and insulin resistance.

Objective To evaluate the reliability and validity of the Chinese version of the Diabetes,Hypertension and Hyperlipidemia(DHL) Knowledge Instrument in community diabetic patients.Methods A face-to-face interview was conducted among 513 patients with diabetes in the community from January to March 2016 by using the Chinese version of DHL Knowledge Instrument.Forty of them were randomly sampled and reinvestigated 4 weeks later.The analyses on Cronbach's α coefficient,test-retest reliability,content validity,discriminant validity and construct validity were performed to evaluate reliability and validity of the DHL Knowledge Instrument.Results The qualified questionnaires were collected from 488 participants,including 232 males and 256 females with a mean age of (66 ± 6)years.The overall scores of the Chinese version of DHL Knowledge Instrument was 67.7 ± 18.0 and the scores of diabetes,hypertension,hyperlipidemia,medications and general issues sub-scales were 82.0 ± 22.5,65.9 ± 25.2,38.2 ± 34.3,75.5 ± 20.8 and 72.1 ± 22.9,respectively.The standardized Cronbach's α coefficient of the total scale was 0.849 and the test-retest reliability of the total scale was 0.706 (P ＜ 0.01).In term of content validity,the correlation coefficient was from 0.580 to 0.827 among total scale and sub-scales (P ＜ 0.01).In term of discriminant validity,the difference between the high and the low score group on total scale and sub-scales were significant (t value =-13.486 to-35.528,all P ＜ 0.01).In term of construct validity,based on exploratory factor analysis,the scale was revised.According to confirmatory factor analysis of revised scale,four factor model containing 20 items was well fitted (X2 =159.689,df =134,P =0.064);the GFI (goodness of fit index) =0.966,AGFI (adjusted goodness of fit index) =0.952,RMSEA (root mean square error of approximation) =0.020.Conclusion The Chinese version of DHL Knowledge Instrument possesses good reliability and validity and is suitable to evaluate the knowledge of community diabetic patients,and the modified version may work better than the original one.

Eighty-two newly-diagnosed type 2 diabetic patients with poor glycemic control were treated by mitiglinide calcium for 16 weeks.Plasma fibroblast growth factor-21 ( FGF-21 ) level were evaluated.The relationship of plasma FGF-21 levels with body mass index,body fat,waist-to-hip ratio,lipid,blood glucose,HbA1c,and free fatty-acid were analyzed.Plasma FGF-21 was decreased significantly by treatment with mitiglinide calcium in type 2 diabetic patients,and it may play a role in the pathogenesis of type 2 diabetes mellitus.

Objective To investigate the effects of liraglutide on gene expression related to cholesterol metabolism in ApoE-/-mice with adiponectin deficiency. Methods Thirty six ApoE-/-mice fed with the high-fat diet were subdivided into four groups. One group was given 100 μl(1×109PFU) of adenoviral pAd-U6-GFP(GFP group, n=6). The second group received 100 μl of adenoviral pAd-U6-Acrp30(ADI group, n=10). The third group was given 100 μl of adenoviral pAd-U6-Acrp30 and liraglutide(HEA group, n=10) and the fourth group was given only 100 μl sterile saline(HF group, n=10). Insulin sensitivity and glucose metabolism were assessed by the hyperinsulinemic-euglycemic clamp technique using 3-[3H] glucose as a tracer. Plasma adiponectin level was evaluated using a commercially available ELISA kit. The mRNA expressions of genes involved in cholesterol metabolism were measured by quantitative realtime PCR. Results Fasting blood glucose(FBG), free fatty acids(FFA), total cholesterol, triglyceride, low density lipoprotein cholesterol, adiponectin, and fasting plasma insulin(FINS) in ADI mice were significantly higher than those in the other groups(P＜0.01), while high density lipoprotein cholesterol was significantly lower(P＜0.05). During the clamp, glucose infusion rate(GIR) in ADI group was significantly lower than the other groups(P＜0.01), and hepatic glucose production(HGP) significantly higher in ADI group(P＜0.01). The mRNA expressions of INSIG2 and LDLR in ADI group were significantly down-regulated in HEA group(P＜0.01 or P＜0.05), while HMGCR and SREBP-2 were significantly up-regulated in HEA group(P＜0.01 or P＜0.05). Conclusions Liraglutide regulates a number of genes involved in cholesterol metabolism and ameliorates hypercholesterolemia by elevating plasma adiponectin level.