Search

Objective To study the quality comparability of human coagulation factor Ⅷ (FⅧ) produced before and after the change of factory site. Methods A comparative study was carried out on quality quantitative indexes, related impurities and stability data of FⅧ produced before and after the change of factory site. Results The FⅧ quantitative quality before and after the change of factory site all met the quality standard, and the related impurities including aluminum residue, tributyl phosphate residue, polysorbate 80 residue and PEG residue all met the quality standard. Other impurities including human fibrinogen, fibronectin, plasminogen, IgA, IgM and IgG were extremely low in content and equivalent in quality. The content of VWF (von Willebrand factor) had no obvious change before and after the change of factory site, but was significantly higher than that of other domestic manufacturers’ commercial products. The results of accelerated stability and long-term stability tests showed that the titer of FⅧ fluctuated within the methodological error range, and the results all met the quality standard. Conclusion The change of factory site of FⅧ has no effect on the quality.

Diabetic ketosis had been identified as a characteristic of type 1 diabetes mellitus (T1DM), but now emerging evidence has identified that they were diagnosed as T2DM after long time follow up. This case control study was aimed at comparing the clinical characteristic, β-cell function, and insulin resistance of ketosis and nonketotic onset T2DM and providing evidence for treatment selection. 140 cases of newly diagnosed T2DM patients were divided into ketosis (62 cases) and nonketotic onset group (78 cases). After correction of hyperglycemia and ketosis with insulin therapy, plasma C-peptide concentrations were measured at 0, 0.5, 1, 2, and 3 hours after 75 g glucose oral administration. Area under the curve (AUC) of C-peptide was calculated. Homoeostasis model assessment was used to estimate basal β-cell function (HOMA-β) and insulin resistance (HOMA-IR). Our results showed that ketosis onset group had higher prevalence of nonalcoholic fatty liver disease (NAFLD) than nonketotic group (P = 0.04). Ketosis onset group had increased plasma C-peptide levels at 0 h, 0.5 h, and 3 h and higher AUC(0-0.5), AUC₀₋₁, AUC₀₋₃ (P < 0.05). Moreover, this group also had higher HOMA-β and HOMA-IR than nonketotic group (P < 0.05). From these data, we concluded that ketosis onset T2DM had better islet β-cell function and more serious insulin resistance than nonketotic onset T2DM.

Objective To investigate the characteristics of bone metabolism in postmenopausal women with type 2 diabetes mellitus (T2DM) and its relationship with blood glucose fluctuation. Methods From June 2018 to December 2020, 211 postmenopausal women with T2DM who hospitalized in the Department of Endocrinology of Hefei Second People's Hospital were enrolled in this study. The age, menopausal years, body mass index (BMI) and other general data of all the subjects were collected. The levels of blood sugar, blood lipid serum uric acid (UA), thyroid function, calcium, phosphorus, alkaline phosphatase, 25-hydroxyvitamin D (25-VitD), osteocalcin, β-carboxyl terminal peptide (β-CTX) and other biochemical indexes were measured. The data of mean amplitude of glycemic excursions (MAGE), coefficient of variation (CV), standard deviation of blood glucose (SDBG), mean of daily differences (MODD), time in range (TIR) and time above range (TAR) were obtained by continuous glucose monitoring system. Bone mineral density (BMD) was measured by dual energy X-ray absorptiometry for the diagnosis of osteoporosis. The patients were divided into osteoporosis group (OP) and the non-osteoporosis group (NOP) based on BMD results. The clinical data, biochemical indexes and related indexes of blood glucose fluctuation were compared between the two groups. Multivariate logistic regression analysis was used to analyze the relationship between osteoporosis and blood glucose fluctuation in postmenopausal women with T2DM. Results There were 104 cases in OP group and 107 cases in NOP group. The prevalence of osteoporosis in postmenopausal women with T2DM was about 49.29% (104/211). There were significant differences in age, menopause, BMI, UA, free triiodothyronine, blood phosphorus, 25-VitD between the OP and NOP group (all P<0.05). The level of osteocalcin in the OP group was lower than that in the NOP group, and the β-CTX were significantly higher than that in NOP group (P<0.05). The related indexes of blood glucose fluctuation such as MAGE, CV, SDBG, MODD, TIR and TAR were significant different between the OP and NOP group. All the risk factors were included in the multivariate logistic regression equation. The results of multivariate logistic regression analysis indicated that age, menopausal years and MAGE were risk factors for osteoporosis while BMI and 25-VitD were protective factors. Conclusions Bone metabolism in postmenopausal women with T2DM is characterized by reduced bone formation and enhanced bone resorption. BMI and 25-VitD are protective factors while age, menopause years and MAGE are risk factors. To careful control of glucose, especially the within-day blood glucose fluctuation, is beneficial to the early prevention and treatment of osteoporosis in postmenopausal women with T2DM. [ABSTRACT FROM AUTHOR]

Diabetic ketosis had been identified as a characteristic of type 1 diabetes mellitus (T1DM), but now emerging evidence has identified that they were diagnosed as T2DM after long time follow up. This case control study was aimed at comparing the clinical characteristic, β-cell function, and insulin resistance of ketosis and nonketotic onset T2DM and providing evidence for treatment selection. 140 cases of newly diagnosed T2DM patients were divided into ketosis (62 cases) and nonketotic onset group (78 cases). After correction of hyperglycemia and ketosis with insulin therapy, plasma C-peptide concentrations were measured at 0, 0.5, 1, 2, and 3 hours after 75 g glucose oral administration. Area under the curve (AUC) of C-peptide was calculated. Homoeostasis model assessment was used to estimate basal β-cell function (HOMA-β) and insulin resistance (HOMA-IR). Our results showed that ketosis onset group had higher prevalence of nonalcoholic fatty liver disease (NAFLD) than nonketotic group (P = 0.04). Ketosis onset group had increased plasma C-peptide levels at 0 h, 0.5 h, and 3 h and higher AUC(0-0.5), AUC₀₋₁, AUC₀₋₃ (P < 0.05). Moreover, this group also had higher HOMA-β and HOMA-IR than nonketotic group (P < 0.05). From these data, we concluded that ketosis onset T2DM had better islet β-cell function and more serious insulin resistance than nonketotic onset T2DM.