| Objective:To Observe modified Taohongyin and cilostazol treatment on diabetes mellitus (DM) with ankle/brachial index (ABI)≤0.9 in patients with clinical symptoms, ankle/brachial index (ABI), blood rheology, Lipid metabolism effects, prevent diabetes mellitus (DM) with peripheral vascular disease (PVD). Analysis of mechanism of action, and to explore the side in the clinical application value.Methods:94 patients with diabetes mellitus with ankle/brachial index (ABI)≤0.9 blood stasis permits were randomly divided into three groups, Chinese medicine group (modified Taohongyin group) 30 cases, modified Taohongyin side decoction daily one, sooner or later take; Western medicine group (cilostazol group) 31 cases of cilostazol (brand name:Peter Kam 50mg/film, China Otsuka Pharmaceutical Co., Ltd. Production, authentication code:State medicine accurate H10960014) orally, each 100mg, twice a day; combination of Chinese and Western medicine group (modified Taohongyin+cilostazol group) 33 cases, the oral administration of cilostazol was based on Chinese medicine group, each 100mg, twice a day. Three groups were treated for 3 consecutive months. Observed three groups of patients before and after treatment the clinical symptom score, ankle/brachial index (ABI), blood rheology, blood lipid analysis, fasting blood glucose (FPG),2 hours postprandial blood glucose (2hPG) and glycosylated hemoglobin Alc (HbAlc) and other changes.Results:(1) Compared three groups of symptom score:before treatment, three groups of patients with syndrome points no significant difference between (P>0.05), does not have statistical significance.After treatment,three groups of patients with syndrome points decreased significantly compared With before treatment, there is a very significant difference (P<0.01); combination of Chinese and Western medicine group compared with Chinese medicine group and western medicine group was significantly different (P<0.05); Western medicine group in symptom score was slightly better than Chinese medicine group, but no significant difference (P>0.05).(2)Compared three groups of Integrated traditional Chinese medicine syndromes:Chinese medicine group of 30 cases,4 cases of clinical markedly effective in 17 cases,9 cases ineffective, the total effective rate 70.00%; Western group of 31 cases,3 cases of clinical markedly effective in 20 cases,8 cases, the total efficiency 74.19%; in 33 cases of combination of Chinese and Western medicine group of clinical markedly effective in 10 cases, effective in 21 cases and ineffective in 2 cases, the total effective rate 93.94% The rank sum test, combination of Chinese and western medicine group, the total efficiency was greatly superior to Chinese medicine group and western medicine group (P<0.05), Chinese medicine group and western medicine group, the total efficiency is not significantly different (P>0.05);(3) Three groups before and after treatment in patients with ankle/brachial index (ABI) comparison:before treatment, three groups of patients with ankle/brachial index (ABI) were no significant difference between (P>0.05), does not have statistical significance. After treatment, three groups of patients with ankle /brachial index (ABI) were significantly decreased compared with before treatment, there is a very significant difference (P<0.01); combination of Chinese and western medicine group in patients with ankle/brachial index (ABI) compared with Chinese medicine group was significant difference (P<0.01), compared with western medicine group was significant difference (P<0.05);western medicine group in ankle/brachial index (ABI) was slightly better than Chinese medicine group, but no significant difference (P>0.05);(4) Hemorheology three groups before and after treatment have different degrees of change:by the t test, whole blood viscosity and high shear, low shear whole blood viscosity before and after treatment were significantly different (P<0.05). Comparing the three groups after treatment, the efficacy of combination is superior to Chinese medicine group, western medicine group, P <0.05;(5) Three groups of patients before and after treatment comparison of changes in lipid metabolism:Before treatment, three groups of lipid levels in patients with no significant difference between (P>0.05), After treatment, Chinese medicine group and combination levels of serum total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) decreased compared with before treatment, were significant difference (P<0.05), high density lipoprotein (HDL) have increased, but was no significant difference (P>0.05); but there was no significant difference between them (P> 0.05)。(6) Three groups before and after treatment in patients with fasting blood glucose (FPG),2 hours postprandial blood glucose (2hPG), glycosylated hemoglobin Alc (HbAlc) changes in comparison: Before treatment, three groups of patients with FPG,2hPG, HbAlc was no significant difference between (P>0.05), does not have statistical significance. After treatment, three groups of patients with FPG,2hPG, HbAlc, no significant change compared with before treatment, no significant difference (P>0.05), among the three groups no significant difference (P>0.05);(7) Security observation:three groups of patients had no apparent adverse reactions, patients can be tolerated, three groups of patients were completion of the pilot, there is no cases of serious adverse reactions due to interruption of treatment. Through treatment before and after the blood routine, urine routine, stool routine, liver and kidney function and ECG examination resuits showed that during treatment, three groups of patients with liver and kidney function, blood cell analysis were within the normal rang, found no abnormal changes.Conclusion:The experimental results show that:modified Taohongy can not only significantly reduced diabetes mellitus with ankle/brachial index (ABI)≤0.9 in patients with blood stasis syndrome card points to improve the clinical symptoms, effectively improve the ankle/brachial index (ABI), to improve the blood rheology. Overall clinical efficacy was slightly worse than the current expansion of blood vessels commonly used in formulations--cilostazol, but no significant difference. But also on blood lipids have a certain therapeutic effect, can significantly lower serum total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) in particular, improve lipid metabolism disorder; pairs of blood glucose levels, glycated hemoglobin Ale (HbAlc) had no significant effect. modified Taohongy has no significant adverse reactions and toxic side effects and good safety. This study also shows that modified Taohongy and cilostazol combination could significantly improve the curative effect. In the symptom score, clinical symptoms, ankle/brachial index (ABI), improvement of blood rheology and other indicators are better than modified Taohongy alone treatment group and the pure cilostazol treatment group (P<0.05), markedly improved the overall efficiency. Have clinical value.
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