Clinical Observation On Tongmai Hypoglycemic Capsules In Treatment Of Type 2 Diabetic Patients With Cerebral Infarction Convalescence

Objective:To investigate the clinical therapeutic effect and safety of Tongmai Hypoglycemic Capsules on type 2 diabetes mellitus with cerebral infarction. And study effective treatment of Chinese medicine on type 2 diabetic patients with cerebral infarction secondary recovering prevention, which also supply the therapeutic principle for clinical application of Tongmai Hypoglycemic Capsules.Methods:The patients were equally randomized into two groups:the test group and the control group according to a random number table. Both groups are composed of 35 patients either.1. The control group was treated with the routine drugs including anti-platelet aggregation drugs, lipid-lowering drugs plaque stabilization, hypoglycemic agents, and antihypertensive drugs, combined with the same rehabilitation programs as the test group.2. Besides the routine drugs used in the control group, the test group was also treated with Tongmai Hypoglycemic Capsules. The course of treatment lasted 90 days. Evaluation Contents:1. The fasting plasma glucose (FPG),2-hour postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc), fibrinogen (FIB), homocysteic acid (Hcy), low-density lipoprotein lipid (LDL-C), total cholesterol (TC), triglyceride (TG) and lipoprotein a (Lp (a)) was employed for evaluation and comparison. Meanwhile, the scores of traditional Chinese medicine syndrome、activities of daily living(ADL)、neurological deficit and the changes were also observed and compared at 3 different time points, which are before treatment, after 30 days treatment and 90 days follow-up.2. The liver function, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and renal function includingblood urea nitrogen (BUN), creatinine (CR) were scored and measured for statistical analysis before treatment and after 90 days treatment.Results:1.Syndrome score:the therapeutic effect evaluated by scores of Tongmai Hypoglycemic Capsules syndrome in the test group and the two different treatment time points were statistically significant (P<0.05). In the test group, the effective rate is 93.94%; better than the effective rate of control group which is 76.47%.2.Diabetes-related indicators:there were statistically significant(P<0.05) score differences of FPG and 2hPG evaluation in test group before and after 30 days treatment, and compared with the control group between groups after treatment.2.90 days follow-up after treatment, the significant differences (P<0.05)of HbAlc between two groups and in the test group were existed. The lower blood sugar effect of the treatment group is better than the control group.3.Infarction related indicators:1.The result, which the ADL, neurological deficit, TC, LDL-C and Lp(a) evaluation in the test group and between control and test group were scored and measured for statistical analysis at before treatment and after treatment, exhibit statistically significant(P<0.05).2.There was significant differences (P<0.05) of Hcy in the test group and compared with the control group after 90 days treatment.3.The score difference of FIB in the test group and between the two groups after 30 days treatment exhibit significant changes(P<0.05).4. Security Index:there was no significant difference (P>0.05) of the liver function in the test group and control group before and after treatment. Moreover no adverse events were recorded in the course of treatment.Conclusion:1.The Chinese traditional medicine (Tongmai Hypoglycemic Capsules), which caneffectively improve diabetes combined stroke, Yin deficiency, and blood stasis syndrome of patients, used on type 2 diabetes mellitus with cerebral infarction.2.Tongmai Hypoglycemic Capsules combined with hypoglycemic agents is superior to the control group in controlling the blood sugar of patients.3.Tongmai Hypoglycemic Capsules in combination is able to relieve clinical symptoms,reducing the levels of FIB, Hcy,Lp(a), TC and LDL-C, and improving the ADL, neurological deficit of patientseffectively.4.Tongmai Hypoglycemic Capsules were proved a safe drug in this study that make it can be broadly used in the clinical treatment in the future.