| The research comes in a major scientific and technological achievements transformation project of Jilin Province," multi center clinical observation of Qizhi Jiangtang Capsule in the treatment of diabetes peripheral neuropathy (project number:11ZDZH002). Mainly divided into two parts:1 Meta analysis of the therapy of Yiqi Huoxue Tongluo in the treatment of diabetic peripheral neuropathyAccording to the requirements of the evidence based medicine (EBM), using the statistical methods of meta analysis, retrieving and evaluating randomized controlled clinical study which used the therapy of Yiqi Huoxue Tongluo in the treatment of diabetic peripheral neuropathy.The interventions and effects of treatment are analyzed and evaluated, to provide certain based evidence that the therapy of Yiqi Huoxue Tongluo is effective for diabetic peripheral neuropathy (DPN). In accordance with the requirements of the Cochrane system evaluation manual, this study retrievals the Chinese and English electronic databases, meanwhile manual searchs of the literature related to the clinical report or review of the literature. Extraction of data and assessment of the quality of the studies included use the modified Jadad criteria by 2 reviewers independently. Meta analysis was performed by Rev Man5.3 software. According to the results of the heterogeneity to choose correspond effective model. This study detects the existence of publication bias the study included of by funnel plot.The outcomes measured by risk ratio (RR) or mean deviation (MD) and 95% confidence interval (CI). The analysis included 44 domestic research tolally, including 4009 DPN patients.All studies included have clearly reported the total efficiency. The result of heterogeneity test indicates that all the studies are homogeneous, so the analysis carried out on the studies used the fixed effect model.The results support the therpy of Yiqi Huoxue Tongluo can effectively improve the symptoms of DPN. The total effective rate of the treatment group was better than western medicine group, and the difference was statistically significant (P<0.00001). The results of publication bias analysis showed asymmetry, suggesting that there was publication bias in the studies, so the results of Meta analysis existed the possibility of publication bias. There are 43 studies carried out to compare the nerve conduction velocity.The analysis results show that nerve conduction velocity of DPN patients has improved,including motor nerve conduction velocity and sensory nerve conduction velocity.The Yiqi Huoxue Method group were better than the control group, the difference was statistically significant (P<0.00001); There were 6 studies compared the fasting blood glucose and 4 studies compared postprandial 2h blood glucose.The therapy of Yiqi Huoxue Tongluo in the treatment group were better than the control group in refer to the improvement of blood glucose fasting and postprandial 2h blood glucose,the difference was significant (P<0.00001). There were 8 studies carried out on the determination of plasma viscosity and 6 studies carried out on the determination of total plasma viscosity.There were 4 studies carried out on determination of the red cell aggregation and 4 studies measured platelet adhesion rate.The results of analysis show that the therapy of Yiqi Huoxue Tongluo in treatment group were better than the control group for the improvement of blood rheology statistical difference was significant (P<0.00001).There were eight studies with intervention treatment measures of Yiqi Huoxue Tongluo prescription and studies with intervention of Yiqi Huoxue Tongluo Decoction Combined Western medicine.Analysis results show that compared with Yiqi Huoxue Tongluo prescription medicine and Western medicine alone, P< 0.00001, the effect of Yiqi Huoxue Tongluo single was better than that of Western medicine control group, differences in efficacy have significant; compared with Yiqi Huoxue Tongluo decoction combined with western medicine and Western medicine in treating, P<0.00001, Yiqi Huoxue Tongluo Decoction Combined Western medicine curative effect was better than that of Western medicine control group, curative effect difference has statistical significance. The method of Yiqi Huoxue alone or combined with western medicine in the treatment of diabetic peripheral neuropathy were better than that of Western medicine control group, which can improve the DPN patients with sensory and motor nerve conduction velocity, reduce blood glucose level and improve the level of blood rheology, indicating that the method of Yiqi Huoxue in the treatment of diabetic peripheral neuropathy is effective.2 Clinical observation of Qizhijiangtang capsule on the treatment of diabetic peripheral neuropathyObjective:To observe the therapeutic effect of Qizhi Jiangtang Capsule in the treatment of diabetic peripheral neuropathy, providing the clinical reference for the treatment of diabetic peripheral neuropathy, to verify the effect of Yiqi Huoxue Tongluo therapy in the treatment of diabetic peripheral neuropathy (DPN).Methods:On the basis of routine treatment,108 DPN patients meet the inclusion criteria were randomly divided into Qizhi Jiangtang Capsule treatment group (n=72), Mecobalamin capsule control group (n=36) according to 2:1 randomly digital table.The treatment group was gived Qizhi Jiangtang Capsule,5 capsules each time,3 times a day, while the control group was gived the mecobalamin capsules,0.5mg every time,3 times a day, Both group were treated for 12 weeks and followed up every 4 weeks. Before and after the treatment respectively, observed patients’ Chinese medicine symptom score of the two groups and diabetic peripheral neuropathy score, nerve conduction velocity, blood sugar level and liver and kidney function, etc.Results:After 12 weeks of treatment, the total efficiency of Qizhi Jiangtang capsule treatment group was 89.7%, while total effective rate of Mecobalamin Capsules group was 72.2%. The difference of total efficiency of the two groups was significant (P<0.05). The total efficiency of the treatment group of TCM syndrome was better than that of the control group.Before treatment the symptom scores of TCM were improved, which with significant difference (P< 0.05), the treatment group compared with control group, P<0.05, there was statistically significant difference between the two groups. Weakness, numbness, limb pain, hand or foot and heart heat, cold extremities, feeling abnormal scores of treatment group before treatment were comparative improved (P<0.05), the difference was statistically significant; Compared with the control group,there was a statistically significant difference between the two groups (P<0.05);The diabetic peripheral neuropathy scores and individual scores compared with were improved before the treatment, there are Statistically significant differences (P<0.05). In the treatment group and control group, the difference was statistically significant (P<0.05). Sural nerve, peroneal motor nerve, median sensory nerve conduction integral of two groups have improved, there was a statistically significant difference (P<0.05). Compared with the control group, the difference was statistically significant (P<0.05). The fasting and postprandial blood glucose two groups was not significantly improved than before, the difference was not statistically significant (P>0.05), between the two groups, P>0.05, no significant statistical difference.Conclusion:Qizhi Jiangtang Capsule can effectively improve the DPN patients with clinical symptoms, reduce DPN patients’diabetic peripheral neuropathy score. At the same time, improve the nerve conduction velocity in patients with DPN.Description of Qizhi Jiangtang Capsule in the treatment of diabetic peripheral neuropathy is safe and effective, being worthy of clinical application. DPN patients with fasting and postprandial blood glucose levels before and after treatment showed no significant fluctuations, Qizhi Jiangtang capsule can stabilize blood glucose. |
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