Objective To investigate the self‐management and cognitive situation of the patients with gestational diabetes melli‐tus (GDM) dietary and to discuss the influence of individualized diet intervention on patients .Methods Forty‐one pregnant women diagnosed with GDM were selected as the research objects .logistic regression analysis was used as well as questionnaire to evaluate the influence factors of comprehensive evaluation of the follow diet control ,detecting the 2 h plasma glucose(2 h PG) ,hemoglobin (HbAlc) ,total cholesterol (TC) ,three acyl glycerin (TG) change in value after individualized nutritional intervention ,which were compared with pre‐intervention index .Results (1)90 .2% of diet cognitive received diet educators ,26 .8% of the patients thought only diet and exercise therapy could effectively control blood sugar .Patients got 2 .4% correct overall about questions about food and 85 .4% patients followed diet .(2)Logistic regression analysis showed that the influencing factors of GDM patients following di‐et were age ,BMI ,cultural degree ,receiving diet education ,self monitoring of blood sugar ,regular review to the hospital regularly . (3) After the intervention(41 cases) ,the level of 2 h PG ,HbAlc ,TC ,TG of 38 cases were significantly lower than before ,and the difference was statistically significant (P<0 .01) .Conclusion Individualized diet intervention treatment in GDM patients shows obvious effect .

Objective To evaluate the value of IL-17 and IL-23 expression in response prediction of infliximab treatment in Crohn's disease (CD).Methods A total of 23 CD patients were enrolled in this study including 19 males and 4 females.Another 17 patients with colonic polyps were recruited as control group.The tissue expression of IL-17 and IL-23 in intestinal mucosa was measured by immunohistochemistry (IHC).In each specimen, IL-17 or IL-23 positive cells were counted and recorded in 10 random high power fields (HPFs).Results Infliximab was effective in sixteen patients (69.6％), while 7 patients (30.4％) did not response.The numbers of IL-17 or IL-23 positive cells were much more in responders than those in nonresponders.The median numbers of IL-17 positive cells were 26.7 (18.0, 38.6)/HPF in responders, 11.8 (7.0, 14.0)/HPF in nonresponders, 3.0 (2.0,4.0)/HPF in controls (P =0.004).The median numbers of IL-23 positive cells were 74.5(44.8, 128.6)/HPF in responders, 22.4(19.0, 38.8)/HPF in nonresponders, 3.0(2.0, 4.0)/HPF in controls (P =0.018).IL-17 or IL-23 positive mucosal cells were significantly decreased after infliximab treatment.Conclusion High expression of IL-17 and IL-23 in mucosa may predict the response to infliximab in CD patients.

Objective To evaluate the preclinical safety of 2-methoxyestradiol nanosuspension. Methods The safety of 2-methoxyestradiol nanosuspension for injection was observed through vascular stimulation test of the ear vein on rabbits, hemolytic test using rabbit erythrocytes, active systemic anaphylaxis (ASA) test on guinea pigs and acute toxicity test on mice. Results 2-Methoxyestradiol nanosuspension injection had no irritating effects on vessels, and no haemocytolysis, agglutination and ASA occurred.ASA test showed no allergy symptoms such as piloerection, nose rubbing and dyspnea in guinea pigs 30 min after sensitization.Acute toxicity test revealed that no pathological changes, including black spots and hyperaemia, were visually observed on the heart, liver and lungs after 14 days of intravenous administration. Conclusion 2-Methoxyestradiol nanosuspension injection is relatively safe, with low toxicity, and no hemolytic, anaphylactic and irritating effects. It may be clinically used for injection.

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

Objective To investigate the value of CT scans in differential diagnosis of thyroid neoplasm.Methods CT findings ofthyroid neoplasm in 29 cases including 8 cases thyroid adenoma,4 cases nodular goiter and 17 cases thyroid carcinoma identified by operation and pathology were analyzed retrospectively.Results The contour of thyroid adenoma was distinct,a completely enhanced ring in 5 cases and enhanced nodules in 3 cases were showed on contrast-enhanced scan.4 cases of nodular goiter showed homogenous cystic low density the lesions were localized and distinct in contour,the cystic wall could be seen.Thyroid carcinoma appeared unhomogenous density,the edges contour of lesion was not distinct and infiltration on adjacent tissue might be seen.Conclusion CT scan might play an important role in diagnosis and differential diagnosis of thyroid neoplasm.

Objective To prospectively investigate the characteristics and correlative influential factors for the changes in pulmonary artery hypertension (PAH)in chronic kidney disease (CKD) patients without end-stage renal disease.Methods Complete clinical and laboratory data of 133 outpatients without ESRD (CKD stage 2,3 and 4)in Beijing Hospital between January 2012 and January 2013 were retrospectively analyzed.Pulmonary artery systolic pressure(PASP)was assessed by echocardiography according to the guideline from the American Society of Echocardiography in 2010,and PASP more than 35 mmHg(1 mmHg=0.133 kPa)was diagnosed as PAH.Results PAH was found in twelve(9.0 ％) patients,including 7 females and 5 males,with mean age(82.9 ± 5.4 years).The prevalence of PAH was 2.3％,10.9％ and 17.6％ in the patients of CKD stage 2,3 and 4(P＜ 0.05) respectively.PASP could be calculated in 67 patients in whom tricuspid regurgitation was present.The mean PASP was (27.1 ± 5.4) mmHg,(31.0 ± 8.3) mmHg and (37.3 ± 13.8) mmHg in patients with CKD stage 2,3 and 4,respectively(P ＜ 0.05).Body mass index(BMI),eGFR and BUN showed significant differences between PAH group and non-PAH group with statistical significance (P＜0.05).Multivariate logistic regression analysis revealed that the lower BMI and the higher stage of CKD were independent risk factors for PAH (P ＜ 0.05).Conclusions PAH is not a rare complication in the CKD patients without end-stage renal disease.The incidence of PAH is significantly associated with lower BMI and the higher stage of CKD.Doppler echocardiography should be performed periodically to detect PAH in CKD patients in order to improve the prognosis of these patients.

Objective To analyze factors affecting quality of life (QOL)in patients with chronic hepatitis B (CHB),and provide reference for improving QOL of patients. Methods The MOS 36-item short form health sur-vey (SF-36)was adopted to survey QOL of patients with CHB,Morisky medication adherence scale was used to measure patients'adherence to medication,factors affecting QOL of patients with CHB were analyzed. Results Of 357 CHB patients,271(75.91% )were married,107(29.97% )received college or above education,163(45.66% ) patients'average household monthly income were ￥ 2000-￥ 5000,138(38.66% )patients'family members were also with CHB,198 (55.46% )patients smoked,150 (42.02% )drank. The average score of CHB patients' adherence to medication was (2.15±1.29). Factors affecting QOL in patients with CHB were age,education level, duration of disease,whether or not hospitalized,whether or not drink,as well as adherence to medication. Age, drink,and duration of hepatitis B,and previous hospitalization were negative factors affecting QOL in patients with CHB,education level and adherence to medication were positive factors affecting QOL in patients with CHB. Conclusion Strengthening CHB patients'understanding on disease and improving their medication adherence can help them to improve QOL.

Objective To study the bone turnover and its related molecular mechanism in STZ-induced diabetic rats. Methods Of 30 male SD rats studied, 15 were induced diabetics by intravenous injection of streptozotocin (50 mg/kg)and fed for 8 weeks. After the sacrifice of both the diabetic and control groups, serum Ca, P, alkaline phosphatase (ALP), and osteocalcin were determined, and 24 h urinary Ca and urinary cross-linked N-telopeptide of type Ⅰ collagen (NTx)and creatinine (Cr)ratio were also determined. The left tibia was dissected for bone histomorphometry analysis. Right femur and lumbar vertebrae (L1-L4) were reserved for bone mineral density (BMD) determination. The right tibia was separated for the study of bone tissue RANKL/osteoprotegerin, Core binding factor 1 (Cbfa1) ,osterix and osteocalcin mRNA level which was performed by real-time quantitative reverse transcription polymerase chain reaction assay. Results No significant difference was found in serum Ca, P, and ALP levels between 2 groups of rats. ST-Z-induced diabetic rats were characterized by extreme hyperglycemia, marked weight loss, polyuria, and hypercalciuria. A low-turnover osteopenia was evidenced in diabetic rats by decreased BMD in both femur [(0. 099±0.013) vs (0. 139 ± 0.013 g/cm~3) , P < 0.01] and lumbar vertebrae [(0. 107±0.011)vs (0. 149±0.009) g/cm~3, P<0.01] , reduced serum osteoealcin level [a marker of formation, (3.03±0.52) vs (6. 18±0.71) ng/ml ,P<0. 01]) ,decreased urine NTx/Cr ratio [(5. 67±0.86) vs (5.23±0.98) nmol/g Cr, P<0. 05], decreased trabeeular volume and thickness, and reduced bone label surface and bone formation rate [(0. 44±0. 11) vs (0. 78±0. 14) μm/d,P<0. 01] by bone dynamic study. The RANKL/ osteoprotegerin [(0.57±0.11)vs (0.89±0.13) ,P<0.01] ,osterix [(1.93×10~(-4)±0.65×10(~-4))vs (4.19×10~(-4)± 0.71×10~(-4)) ,P<0.01] ,Cbfa1 [(26.68×10~(-4)±6.53×10~(-4))vs (37.21×10~(-4)±7.14×10~(-4)) ,P<0.01] ,and osteocalcin [(2.25×10~(-4)±1.19×10~(-4))vs (3.43×10~(-4)±1.63×10~(-4)) ,P<0.01] mRNA expressions were declined in the bone tissue of the tibia in the ST-Z-induced diabetic rats, as compared with the control. Conclusion A low-turnover osteopenia is evidenced in STZ-induced diabetic rats by significant decrease of both osteoclastic marker(RANKL/ osteoprotegerin)and osteoblastic marker (osterix ,Cbfa1 ,osteocalcin)mRNA levels in tibia.

Objective To investigate the dynamic changes of platelets (PLT) and white blood cells (WBC) after traumatic brain injury (TBI) and discuss its clinical significance. Methods The number of PLT and WBC were examined in 63 patients with TBI by using cytoanalyze and also analyzed together with Glasgow Outcome Scale and concurrent infection, in the meantime, enzyme-linked immu-nosorbent was used to investigate concentration changes of C reactive protein (CRP) and thrombospondin 1 (TSPI) and analyze the correlation between CRP and TSP1. Results The number of WBC in all pa-tients, whether concurred with infection or not, was significantly increased within 24 hours after TBI (P < 0.01), with no statistical difference between patients without infection at day 4 and normal patients (P >0.05). However, the number of WBC was decreased to below 10 × 109/L in patients without infec-tion, which was significantly higher than that in normal patients (P < 0.05). In patients with infection and unfavorable prognosis, the number of WBC was increased again ay days 7-14, whereas that of PLT rose significantly at days 14-21 (P <0. 01). The concentration of TSPI was positively correlated with that of CRP (r = 0.720, P < 0.01). Conclusions Monitoring the dynamic changes of PLT and WBC is promising. The change of WBC at day 4 post injury is a key indicator to provide evidences of prophylactic antibiotic usage. Much attention should be paid to the dynamic change of PLT at days 14-21 post injury so as to evaluate the condition of hypercoagulability that can be potentially caused by inflammation response. Secondary increase of WBC and later increase, of PLT may affect prognosis of the patients. TSP1 and CRP may participate in thrombosis formation induced by inflammation.

Objective To detect mitochondrial gene 3243 A to 1507 Chinese and analyze their clinical characteristics.Methods Classical PCR－ RFLP was used to detect the mutation and statistical analysis was performed on the data after stratification in accordance with presence or absence of diabetes.Results (1)In this study,prevalence of mitochondrial gene 3243 A to G mutation was 1.16～ 1.20％ .(2)Compared with MDM(mitochondrial diabetes),M－ NGT(normal glucose to lerance with mutation)showed no significant difference in body fat parameters,blood lipid and C－ peptide except for early onset and hearing loss(P=0.0028).(3)Compared with type 2 DM,MDM presented characteristics of early onset,weight loss,hearing loss,islet cell function decrease and maternal hereditary.Conclusion Follow－ up should be given to the carrying the mitochondrial gene 3243 A to G mutation but presenting generally normal clinical manifestation in order to give the patient in－ time diagnosis and treatment.