At present,there is not a clear guideline for residual solvents in the new drugs in our country. In practice,the ICH Q3C is our important reference in general,but in practical research and evaluation of new drugs,some adjustment should be made on principles of ICH Q3C,making it suitable for the reality of the pharmaceutical industry in our country. In this article, we put forward some suggestions to improve the quality control of residual solvents in our country,and some initial ideas were provided to solve the question in practice.

The quantity and quality of the papers cited by SCI are key standards that measure the level of basic research,academic status and teaching quality of a university.In this paper,we studied on the papers cited by SCI by statistical analysis and comparative methods in 30 well-known Chinese and foreign medical universities from 2001 to 2005.The research result showed that there is some disparity in the scale and condition of the scientific research and the technical level among Chinese medical universities and foreign medical universities.Meanwhile,it Was suggested that how to improve the quantity and quality of the papers cited by SCI in Chinese medical universities.

y screen and prevent CAD in these people before diabetes sets in.

Objective To investigate the clinical and genetic characteristics in a male patient with 21hydroxylase deficiency combined with adrenal and testicular tumors.Methods Clinical features and laboratory data were collected from the patient.Testicular biopsy was performed.The CYP21 gene was sequenced for mutations.Results The patient presented left adrenal and testicular enlargements.The laboratory examinations showed that plasma ACTH,androstenedione,testosterone,progesterone,and 17-hydroxyprogesterone were markedly elevated.CT scan revealed that the right adrenal gland being resected and the left adrenal with nodular enlargement.Furthermore,testicular biopsy showed a prominent peritubular fibrosis with increased number of peritubular fibroblasts,tubular hyalinisation,and calcification.Sequencing analysis showed a A>G homozygous mutation at intron 2.Conclusion Patients with untreated 21-hydroxylage deficiency may.have adrenal adenomas and(or)testicular adrenal rest tumor simultaneously.

Objective To investigate the change of 25-hydroxyl vitamin D level and its impact on glucose metabolism and bone mineral density in type 2 diabetic patients.MethodsTwo hundred and fifty-eight cases of type 2 diabetic patients in our hospital were collected.In accordance with 25 (OH) D =50 nmol/L for the critical values,they were grouped into vitamin D deficiency group ( n =192) and the relative lack of vitamin D group ( n =66).Dual-energy X-ray absorptiometry (DXA) measurement of the lumbar vertebrae L2 - L4 and femoral neck bone mineral density were undertaking.Taking the total value of the lumbar spine,femoral neck and total value as judgment indicators,homeostasis model assessment of insulin resistance (HOMA-IR),we collected and statistically analyzed glucose metabolism and bone metabolism indicators in patients with diabetes.Results Among 258 cases of type 2 diabetes,there were 57 cases of osteoporosis accounting for 22.1％.There was significant difference on the duration of diabetes [ (7.98 ± 1.09 ) years old vs (3.77 ± 1.21 ) years old,t =4.849,P ＜0.05],FINS [ (6.42 ± 1.30) mU/L vs (5.79 ± 1.08) mU/L,t =3.871,P ＜0.05] and HOMA-IR [ (2.35 ±0.54) vs ( 1.85 ±0.41 ),t =2.705,P ＜0.05],but no significant difference on the FPG and HbA1c ( P ＞ 0.05 ) between two groups.PTH [ ( 36.51 ± 7.59) ng/L vs ( 32.02 ± 6.89 ) ng/L,t =2.008,P ＜ 0.05 ],bone mineral density in the lumbar total value [ (0.87 ±0.14) g/cm2 vs (0.99 ±0.12) g/cm2,t =2.799,P ＜0.05 ],femoral neck Neck [ ( 0.70 ± 0.10 ) g/cm2 vs ( 0.79 ± 0.11 ) g/cm2,t =2.564,P ＜ 0.05 ] and Total [ (0.84 ± 0.14) g/cm2 vs (0.97 ± 0.15 ) g/cm2,t =3.340 P ＜ 0.05 ] were statistically different,but no significant difference on the rest of the indicators.Conclusion The prevalence of vitamin D deficiency was found in patients with diabetes.Vitamin D level could affect insulin resistance and glycemic control and bone mineral density level.Therefore,routine vitamin D testing to the diabetic patients and giving vitamin D replacement therapy to vitamin D deficiency patients in a timely manner were necessary.

Objective · To explore the relationship between baseline lipid profiles and long-term cardiovascular outcomes after intervention with hypoglycemic drugs metformin and glipizide and to detect lipid components that can predict the long-term cardiovascular effect of metformin and glipizide.Methods· Liquid chromatography-quadrupole time of flight-mass spectrometry (LC-QTOF/MS) was used to measure 119 lipid components in baseline serum for 116 patients with type 2 diabetes (T2DM) and atherosclerotic heart disease (CHD) who were treated with glipizide (56 cases,the glipizide group)or metformin (60 cases,the metformin group).Cardiovascular complex end points (including cardiovascular death,all-cause death,nonfatal myocardial infarction,nonfatal stroke,and arterial revascularization) of all patients were followed up.The relationship between lipid components and cardiovascular complex end points was analyzed with Logistic regression analysis.The category-free net reclassification index (cfNRI) and the integrated discrimination improvement (IDI) were used to evaluate whether lipid components are helpful for predicting the recurrent cardiovascular events.Results· The differences in baseline drug distribution,clinical characteristics,and biochemical indexes between two groups were not statistically significant,except for diuretics use,serum PC (O-34:2) level,and SM (d18:0-24:0) level.Logistic regression analysis showed that baseline ChE (20:4) was a protective factor for recurrent cardiovascular events in the glipizide group (OR=0.87,P=0.039).ChE (20:4) significantly increased the cfNRI and IDI of cardiovascular complex end points by 69％ and 0.07,respectively (P=0.011,P=0.028).Baseline SM (dl 8:1-22:0) was a risk factor for recurrent cardiovascular events in the metformin group and all participants (OR=1.65,P=0.039;OR=1.64,P=0.014).SM (d18:1-22:0) significantly increased the cfNRI of cardiovascular complex end points in the metformin group and all participants by 74％ and 55％,respectively (P=0.012,P=0.005).Conclusion· Of 119 lipid components measured with LC-QTOF/MS,baseline ChE (20:4) is a protective factor and SM (d18:1-22:0) is a risk factor for cardiovascular complex end points in with T2DM and CHD patients after long-term treatment with metformin and glipizide.Both lipid components are helpful for improving the prediction of recurrent cardiovascular events.

Objective To investigate the factors which may affect the secretions of human leptin and free fatty acids (FFA) by measuring plasma glucose, serum insulin, leptin and FFA levels during reduced sample number intravenous glucose tolerance tests (IVGTT) in the subjects with different status of insulin resistance and ? cell function. Methods According to oral glucose tolerance test, 7 normal, 10 overweight/obese individuals, 12 subjects with impaired glucose tolerance (IGT) and 11 with type 2 diabetes mellitus (DM) were recruited. During IVGTT, serum insulin, leptin and FFA levels at 12 time points were simultaneously measured. Results Compared to the stable secretion of leptin, during 180 min in the IVGTT, the FFA secretion showed a "U" shape profile. The correlation analysis showed that the average serum leptin and FFA levels in 3 h were independent to fasting plasma glucose concentration. The partial correlation coefficient of leptin and insulin decreased after being adjusted for FFA (before r=0.77, P0.05). Conclusion The changes of serum FFA levels in IVGTT are more significant than those of leptin after glucose loading. Fasting plasma glucose levels do not significantly affect the average serum levels of leptin and FFA. On the contrary, insulin manifests such action but does not affect the secretion profile of these parameters.

Objective To evaluate the difference of carotid intimal medial thickness (IMT) among different glucose tolerance status and to investigate the association of IMT with different glucose levels of 4 time points during oral glucose tolerance test (OGTT) and the lipid metabolic indices in non-diabetic subjects. Methods Eleven normal control subjects, 69 subjects with impaired glucose regulation (IGR) newly diagnosed by OGTT (including 28 patients with non-elevated OGTT 30 min and 60 min glucose values (

Objective To investigate the changes in nunmber and function of natural killer ( NK ) cells in patients with newly-diagnosed type 1 diabetes mellitus.Methods Cell courning was performed in peripheral blood mononuclear cell ( PBMC ) subsets in 43 cases with newly diagnosed type 1 diabetes ( T1D ),14 cases with newly diagnosed type 2 diabetes( T2D ) and 21 cases of normal controls by flow cytometry sorting.And then,isolating and collecting NK cells were performed in T1D patients and normal controls.Real time PCR was performed to evaluate the mRNA expression levels of NK cell activity related genes IFN-γ,perforin,NKp46,and NKp30 in NK cells.Results Compared to normal controls,both the proportion and the absolute counting of NK cells in PBMC from patients with T1D were significantly decreased [( 102±86 )/μl vs ( 355±264 )/μ1,P＜0.01],while only the proportion of CD4+ cell were slightly increased( P＜0.05 ).No statistical difference was observed regarding CD8+ T cells ( P＞0.05 ).mRNA expression levels of NK cell activity related genes perforin and NKp46 in NK cells were remarkably down-regulated ( P＜0.05 ),while IFN-γ and NKp30 were not changed compared with normal controls.Conclusions The reduced number and functional deficiency of NK cells may lead to the immune dysfunction in T1D and play an important role in the development of T1D.

Objective To evaluate the clinical significance of CT angiography(CTA)in the diagnosis of arterioportal shunts(APS)associated with hepatocellular carcinoma(HCC).Methods One hundred and twenty-seven consecutive HCC patients accepted both dynamic enhancement CT and DSA examinations.The interval between CT and DSA exam was from 3 to 15 days.Based on transverse CT images in hepatic artery phase,CTA was performed for all the patients.By contrast with DSA results,the capabilities of transverse CT and transverse images combined with CTA in APS diagnosis were analyzed. Results In all 127 HCC cases,52 cases with APS were confirmed by DSA(40.94%),33 with central type of APS and 19 with peripheral type.Diagnostic sensitivity of APS based on transverse CT and combined CTA with transverse CT images were both 94.23%(49/52).However,specificity was 84.00%(63/75) and 97.33%(73/75),respectively,accuracy was 88.19%(112/127)and 96.06%(122/127),the predictive value of positive cases was 80.33%(49/61)and 96.08%(49/51),and the predictive value of negative cases was 95.45%(63/66)and 96.05%(73/76).Combined with CTA,false positive cases of 4 central type of APS and 6 peripheral type of APS were excluded which were demonstrated by transverse CT images.By contrast with DSA,the coincidence rate of the type of APS diagnosed by transverse images combined with CTA was 88.46%(46/52),including 90.91%(30/33)of central type of APS and 84.21%(16/19)of peripheral type.The supplying arteries of central type of APS were intuitively displayed by CTA in 23 cases,19 from proper hepatic artery and 4 from gastro-duodenal artery.Conclusion CTA techniques based on the dynamic enhancement CT exams could effectively promote the specificity and the accuracy of APS diagnosis.