摘要
OBJECTIVE:Through experiment on animals and clinical trials to explore the safety and efficacy of hypoglycemic anti-deafness capsules on diabetic patients with deafness.METHODS:Total 296 patients with non-insulin dependent diabetes mellitus(NIDDM)were randomly divided into two groups.A treatment group of 164patients(208 ears)was treated with hypoglycemic anti-deafness capsules based onTCM syndrome differentiation.A control group of 132 patients(184ears)was treated with glibenclamide and conventional drug treatment for deafness.The following were observed:hearing,fasting plasma glucose(FPG),2 h postprandial plasma glucose(2hPG),24 h urine glucose(24hUG),improvement of main symptoms,platelet function,and changes in superoxidedismutase(SOD)and lipid peroxide(LPO)levels.In animal studies,Kunming mice,weighing 18-22 g were used.Half of the mice were males and half were females.Wistar rats,weighing 80-120 g were used.Half of the rats were males and half were females.Male Wistar rats,weighing 200-220 g,were also used.Their acute and chronic toxicity was studied.RESULTS:The hearing improvement was 56.7%in the treatment group and 26.6%in the control group.FPG,2hPG,and 24hUG were improved significantly(P<0.05,P<0.01,P<0.01,respectively)in the treatment group and 2hPG and 24hUG improved significantly in the control group(P<0.05,P<0.05).The improvement in 2hPG and 24hUG in the treatment group was significantly greater than that in the control group P<0.01).There was no significant difference in FPG between the two groups(P<0.05).Main symptoms in the treatment group were significantly more improved than those in the control group(P<0.05,P<0.01).In the treatment group,platelet adhesion and aggregation,SOD,and LPO were all significantly improved from before treatment(P<0.05,P<0.01).However,in the control group,except LOP(P<0.05),there were no significant differences from before treatment to after(P<0.05).In animal studies,no obvious acute or long-term toxicity was observed from capsule administration.CONCLUSION:Through experiment on animals and clinical trials,we can found that hypoglycemic anti-deafness capsules could decrease blood glucose and serum triglycerides of alloxan-induced diabetic rats.This herbal capsule is effective for safely treating diabetic patients with deafness.
OBJECTIVE： Through experiment on animals and clinical trials to explore the safety and efficacy of hypoglycemic anti-deafness capsules on diabetic patients with deafness.METHODS： Total 296 patients with non-insulin dependent diabetes mellitus（NIDDM） were randomly divided into two groups. A treatment group of 164patients（208 ears） was treated with hypoglycemic anti-deafness capsules based onTCM syndrome differentiation. A control group of 132 patients（184ears） was treated with glibenclamide and conventional drug treatment for deafness. The following were observed： hearing, fasting plasma glucose（FPG）, 2 h postprandial plasma glucose（2hPG）, 24 h urine glucose（24hUG）, improvement of main symptoms, platelet function, and changes in superoxidedismutase（SOD） and lipid peroxide（LPO） levels. In animal studies, Kunming mice, weighing 18-22 g were used. Half of the mice were males and half were females. Wistar rats, weighing 80-120 g were used. Half of the rats were males and half were females. Male Wistar rats, weighing 200-220 g, were also used.Their acute and chronic toxicity was studied.RESULTS： The hearing improvement was 56.7% in the treatment group and 26.6% in the control group. FPG, 2hPG, and 24hUG were improved significantly（P0.05, P0.01, P0.01, respectively） in the treatment group and 2hPG and 24hUG improved significantly in the control group（P0.05,P0.05）. The improvement in 2hPG and 24hUG in the treatment group was significantly greater than that in the control group P0.01）. There was no significant difference in FPG between the two groups（P0.05）. Main symptoms in the treatment group were significantly more improved than those in the control group（P0.05, P0.01）. In the treatment group, platelet adhesion and aggregation, SOD,and LPO were all significantly improved from before treatment（P0.05, P0.01）. However, in the control group, except LOP（P0.05）, there were no significant differences from before treatment to after（P0.05）. In animal studies, no obvious acute or long-term toxicity was observed from capsule administration.CONCLUSION： Through experiment on animals and clinical trials, we can found that hypoglycemic anti-deafness capsules could decrease blood glucose and serum triglycerides of alloxan-induced diabetic rats. This herbal capsule is effective for safely treating diabetic patients with deafness.
基金
Supported by Projects of Hebei Provincial Administration of Traditional Chinese Medicine,China(No.20122068)
