Search

Background: This study was designed to clarify the influence of metformin on serum carbohydrate antigen 199 (CA199) levels and its associated factors in Chinese type 2 diabetes mellitus (T2DM) patients. Subjects and Methods: In total, 1,253 T2DM patients were enrolled, including a non-metformin group ( n=616), a short-term metformin group (at least 1 week to 2 years; n=325), and a long-term metformin group (≥2 years; n=312). Their clinical and biochemical characteristics were collected and compared. After 1 year, the biochemical parameters were re-examined in 296 patients. Sex hormones were determined, and associations between CA199 and other variables were assessed. Results: At baseline, the incidence of abnormal CA199 levels was 14.7%, 8.9%, and 4.7% in the non-metformin, short-term metformin, and long-term metformin groups, respectively. CA199 levels in females were significantly higher than in males ( P<0.01) and decreased significantly with the time of taking metformin (25.60±13.68 U/mL in non-metformin controls vs. 17.62±10.87 U/mL in the short-term group vs. 10.54±8.14 U/mL in the long-term group; P=0.000). The correlation and multiple stepwise regression analysis revealed that glycosylated hemoglobin, metformin, gender, total cholesterol, and follicle-stimulating hormone were independent impact factors on CA199 concentrations (all P<0.05). Binary logistic regression revealed that the risk of abnormal CA199 concentrations of the total population with short-term metformin or long-term metformin treatment decreased 11% (odds ratio=0.89; P=0.001) and 30% (odds ratio=0.70; P=0.000), respectively, at baseline. After a 1-year follow-up, the incidence of high CA199 level decreased in both the short-term and the long-term metformin group compared with that of controls ( P<0.05). The extent of CA199 decrease in the long-term metformin group was the greatest (−17% vs. −4.9% in the short-term group vs. 3% in controls, P=0.000), and the group's risk of high blood CA199 level was reduced 67% (odds ratio=0.33; P=0.023). The reduction in women was more apparent than that in men (−18% vs. −5%, P=0.000). Conclusions: Metformin therapy reduced the CA199 level in Chinese T2DM patients, and its greatest decrease occurred in women with longer therapeutic time. [ABSTRACT FROM AUTHOR]

Background: This study investigated the performance of the A1CNow+® test (Bayer Diabetes Care, Sunnyvale, CA) in a large population of Chinese patients with diabetes. Subjects and Methods: Hemoglobin A1c (HbA1c) levels in 1,618 Chinese patients with diabetes 10-94 years of age were measured with both the A1CNow+ test, from a fingerstick blood sample, and the high-performance liquid chromatography (HPLC) test, using a venous blood sample, within 24 h. The reportable ranges of the HbA1c values were 4.0-13.0% (A1CNow+) and 4.1-16.8% (HPLC). An error grid analysis (EGA) method was developed to quantify the accuracy of the A1CNow+ results against the HPLC reference results. Results: The A1CNow+ results were highly correlated with the HPLC reference results ( r=0.945, P<0.01). Passing-Bablok regression analysis showed a good linear agreement between the two variables, and the linear regression equation fitted as y=−0.10+1.00 x ( P=0.21). The Bland-Altman difference plot presented that the mean bias of the A1CNow+ results minus the HPLC reference results was −0.09% ( P<0.001); the 95% confidence intervals for the limits of agreement were −1.28% to 1.09%, with 96.5% of the data points lying within this zone. The results of the EGA showed that 80.2% of the A1CNow+ results were accurate, 17.7% were acceptable, 1.9% may lead to inappropriate treatment, and 0.3% may lead to severe clinical consequence. Conclusions: The A1CNow+ test values demonstrated a slight negative bias from the HPLC values. The majority of A1CNow+ test values were accurate when compared with results from the reference method. [ABSTRACT FROM AUTHOR]