| Objective:To evaluate the effects of Jin Lida particles intervening the IGR, observe the glucose metabolism status, islet β-cell function and insulin sensitivity, etc., to explore its clinical efficacy and safety.Methods: A randomized, open, controlled clinical trial. In between October 2013 to October 2014, screening our hospital endocrinology outpatient impaired glucose regulation (IGR).Including 101 cases who in line with standard of oral glucose tolerance test(OGTT) and insulin release test (IRT),and collected relevant data.Those for the study were randomly divided into two groups, the treatment group (Tianjin Lida particles combined lifestyle intervention) and control group (simple lifestyle intervention), treatment for three months, after the end of the treatment course, the line again OGTT test and IRT.The subjects were compared before and after treatment changes in glucose, insulin, lipids, liver and kidney function, weight, waist-hip ratio, TCM symptom scores and other indicators,and recorded their adverse reactions.The results:1. The study included 101 cases of IGR patients. 52 cases were randomly divided into treatment group and control group of 49 patients, a total of 93 cases completed, dropped out 8 cases, the total dropout rate of 7.9%.2.After 12 weeks treatment, the experimental group had 49 cases of patients with IGR 12 cases (24.49%) reversed to normal glucose tolerance (NGT), 44 patients in the control group had three cases (6.82%) reversed toNGT, the experimental group was significantly higher in the control group, the difference was statistically significant (P = 0.026);3. Test group fasting glucose, fasting blood glucose after glucose load half hour blood glucose, glycosylated protein and glucose control group, compared with the first half-hour glucose treatment were significantly lower (P<0.01 or P<0.05); seen between the two groups in the load After two hours on blood glucose and glycosylated hemoglobin hypoglycemic efforts experimental group than the control group (P<0.05 or P<0.01).:4. Fasting insulin levels before treatment were significantly decreased (P<0.01), but no statistically significant difference between groups; HOMA-IR were significantly decreased after treatment (P<0.01), between the control group HOMA-IR levels have statistically significant difference (P<0.05); compared with baseline levels decreased after the test group index HOMA-β treatment, but no significant difference between the control group was significantly higher (P<0.01) than before, but there was no significant difference between groups.5. TCM clinical symptoms have abated before integration than those after treatment compared with a significant difference (P<0.01) before and after the two groups within which the thirst lassitude, constipation and experimental groups like drinking symptom scores, group, which treatment group thirst for drink, reduce the degree of constipation symptoms significantly better than the control group (P<0.05 or P<0.01).6. Before and after treatment of liver and kidney function biochemical parameters (ALT, AST, BUN, CRE) are controlled within the normal range, within the group, showed no significant difference (P> 0.05) between the two groups. Total adverse events test group 1 cases (2.04%) in the control group 1 patients (2.27%), no statistically significant difference between two groups (P> 0.523). Adverse events were mild, moderate or severe adverse events seen by taking the time to adjust the structure and relief of symptoms after eating, withdraw from the study subjects were not arise, safety and well-tolerated.In conclusion:1 Jin Lida particles can be reversed with impaired glucose regulation for normal glucose tolerance, diabetes delay the process;2. Jin Lida particles can significantly reduce impaired glucose regulation in the 2-hour postprandial blood glucose and glycated hemoglobin levels;3.Jin Lida particles can reduce the patient’s fasting insulin levels, improve insulin sensitivity, without increasing the burden on the islet cell β;4. Jin Lida particles clinical symptoms improved significantly the role;5.Jin Lida particulate drug safety, no serious adverse reactions. |
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