| ObjectiveTo observe the curative effective and safety of Jiangtang'an capsule to type 2 diabetes mellitus which could not be controlled well by sulfaurea drugs lonely, and explorate it's dosage.Methods1.select patientsAccording with the following 4 conditions, then this patient can be brought into clinical examination:1.1 according with the diagnosis standard of type 2 diabetes mellitus1.2 age between 25～65 years old.1.3 according with the standard of type 2 diabetes mellitus poorlly controlled by sulfaurea drugs,and fasting blood glucose between 7mmol/L and 13mmo/L, which fluctuated between negative 1.5mmol/L and 1.5mmol/L.1.4 The patient accepted this clinical examination, and signs correlative document.2. delete patientsAccording with the following anyone conditions, then this patient can't be brought into clinical examination:2.1 age is not between 25 and 65 years old.2.2 the people who have been diagnosed type 1 diabetes mellitus2.3 megalakria, Cushing syndrome, chromaffin cell tumor and so much more deases which can provoke type 2 diabetes mellitus and glucose tolerance reducing.2.4 be down with diabetic ketoacidosis or hyperosmolar nonketotic diabetic coma in one month2.5 be diagnosed type 1 diabetes mellitus.2.6 accompanying other serious diseases.2.7have used insulin.2.8 pregnant woman or suckling period woman.3.clinical patientsAll patients came from the outpatient department of my hospital. 90 patients according with diagnosis standard were divided randomly into the megadose group the small dose group and the controll group. There were patients in each group without significant differences in sex, age, symptom pattern (P＞0.05). 4 treatment project:4.1 treatment group: the megadose group: Jiangtang'an capsule 6 granule per os third; the small dose group: Jiangtang'an capsule 3 granule and Jiangtang'an capsule placebo 3 granule per os third.4.2 the controll group: Jiangtang'an capsule placebo 6 granule per os third.4.3 treatment time: 12weeks.5 observation index:5.1 safety observation:5.1.1 medical examination(avoirdupois, bloodpressure, heart rate).5.1.2 the blood-routine, the urine-routine, the stool-routine.5.1.3 electrocardiogram, liver function, kidney function.5.2 therapeutic efficiency observation.5.2.1 Writing down the corresponding mainly clinical symptoms and physical signs.5.2.2 fasting blood glucose.5.2.3 postprandial blood sugar.5.2.4 glycosylated hemoglobin.5.2.5 Blood fat: TC, TG; HDL-C, LDL-C.Results1 The megadose group's total effective rate was 68.97%, the small dose group's effective rate was 33.71%, the controll group's effective rate was 10.34%. The total effective rate of the megadose group was better than that of the small dose group and the controll group.2 After treatment the megadose group had better results of fasting blood glucose. When the megadose group compared with other two groups, there were significant differences(P＜0.05).3 After treatment the megadose group had better results of postprandial blood glucose. When the megadose group compared with othertwo groups, there were significant differences(P＜0.05).4 After treatment the treatment group had better results of glycosylated hemoglobin. When compared with the controll group, there were significant differences (P＜0.05).5 There were not manifest curative effects of blood- fat in this test.6 The badness and side-effect: There were no side-effects in each group.ConelisionJiangTang'an Capsule has a costant effect on type 2 diabetes mellitus in clinical practice: it could relieve the symptoms and improve physical signs and the related indexs of type 2 diabetes meUitus patients. It is a kind of safe medicine. It could educe the preponderance of traditional Chinese medicine and be worth generalizing to clinicaluse. |
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