| PURPOSEThe incidence of lower limb ischemia diseases have a rising trend in recent years, the rates is high as 15-20% in the crowd of over 70 years age. At present, the drug treatment can alleviate the symptom of the patients, but cannot make revascularization the occluded artery. With the development of modern medicine, interventional therapy in lower limb ischemia disease is more and more widely used. The intervention therapy can improve the vascular blood flow,but the same time, we often have to face another problem----the limb ischemia reperfusion. Ischemia reperfusion can cause physical symptoms, such as pain, swelling, numbness, etc., also cause a remote organ damage, such as heart, brain, kidney, liver, gastrointestinal tract etc, seriously can threaten life. There is no particular effective therapy against reperfusion treatment, but a few studies of traditional Chinese medicine in the treatment of limb ischemia reperfusion injury shows good curative effect. Professor Yang Bo-hua has obtained the good clinical curative effect in the treatment of limb ischemia reperfusion injury with TCM theory wet stasis mutual junction, but have not take the clinical summary.This study,60 patients conformed to the wet stasis mutual junction in traditional Chinese medicine dialectical classification with lower limb ischemia reperfusion after vascular intervention operation were randomly divided into two groups:regular treatment group and group of regular treatment combined taking Chinese herbal of clearing damp and promoting circulation. To evaluate the clinical curative effect of prescription of clearing damp and promoting circulation in the treatment of limb ischemia reperfusion and find more ways of treatment to ensure more precise curative effect through the analysis of the symptoms score between two groups after treatment. The activity of SOD and the concentration of TNF-a in serum was detected at 1,3,7,14 days after treatment between two groups to compare two groups whether there is a difference and find the changing tendency after longer duration of treatment in order to explore the mechanism of limb ischemia reperfusion injury treated by prescription of clearing damp and promoting circulation and provide more evidence and theoretical support for the effective treatment of Chinese medicine on limb ischemia reperfusion.METHODSFrom January 1,2013 to October 1,2015,60 patients with lower limb ischemia who got limb ischemia reperfusion after intervention operation and conforms to TCM dialectical classification wet stasis mutual junction were randomly divided into treatment group and control group, control group were given intravenous drip 250 ml+0.9% sodium chloride lipoic acid 600mg injection and 0.9% sodium chloride injection 250 ml+7 Ye Zao glycosides injection 15 mg, once per day. Antihypertensive lipid hypoglycemic is foundation treatment and taking oral aspirin to inhibit platelet aggregation. Besides the same treatment of control group the treatment group also take the clearing damp and promoting circulation formula prescribed by Professor Yang Bohua (Kang Rentang pharmaceuticals granule production) FORMULA:huangbail5g chaocangzhulOg niuxi lOg fuling15g danshen20g honghua6g zelanl2g; MEDICATION:when the reperfusion injury is happened, take the formula orally 14 days,two times a day, before breakfast and before dinner, each time a bag; OBSERVATION INDEX:to observe the patient’s pain, numbness, swelling, distant organ is damaged and the symptoms score were evaluated at 1,3,7,14 days; and after treatment in 1, 3,7 and 14 days the activity of SOD and the concentration of TNF-a were detected. All the data were analyzed by SPSS.RESULTS1. symptom score:In the treatment group and control group, there was no significant difference in the symptom scores between the first day treatment group and the control group, the symptom scores of the treatment group were better than those of the control group at 7rd day and 14th day after treatment, P<0.05;2. TNF-a concentration:Comparison between groups:there is no significant difference (P> 0.05) at day 1 and day 14, but TNF-a concentration of the treatment group was significantly lower than that of the control group (P< 0.05) at day 3 and day 7. Comparison in the same group at different time points:TNF-a concentrations between the first day and the third day, the 3rd day and the 7th day had significant difference (P< 0.05) in the treatment group. The concentrations between the 7th day and the 14th day had no significant difference (P> 0.05); The TNF-a concentrations between the first day and the third day,3rd day and 7th day,7th day and 14th day of had significant difference (P< 0.05) in the control group.3.the activity of SOD in serum:Comparison between groups:the activity of serum SOD at 7th day and 14th day had no significant difference (P>0.05), SOD activity of the treatment group was significantly higher than the control group at first day and third day(P<0.05). Comparison in the same group at different time points:the activity of SOD between first day and third day were significantly different (P<0.05), but there is no obvious difference between 3rd day and 7th day,7th days and 14th day (P<0.05) in the treatment group; the SOD activity between 1st day and 3rd day, 3rd day and 7th days were significantly different (P<0.05), but there is no significant difference between the 7th day and 14th day(P>0.05) in the control group.CONCLUSIONThe clearing damp and promoting circulation formula is a definitive and effective drug in treatment for the limb ischemia-reperfusion(TCM dialectical classification wet stasis mutual junction), which worth clinical promotion. The clearing damp and promoting circulation formula can quickly decrease serum TNF-a concentration, indicating a better effect of anti-inflammatory and removal inflammatory mediums.The clearing damp and promoting circulation formula can quickly enhance SOD activity, whichshowed high efficacy on scavenging oxygen free radicals and Anti-Oxidation Stress Reaction.After the limb ischemia-reperfusion, serum TNF-a concentration shows a high expression, then decreased gradually; while activity of SOD decreased firstly and then increased; which proves the inflammatory mediums is activated, the expression of inflammatory factors is strengthen. At the same time, Some antioxidant enzyme activity shows consumption decreasing, induced to remove large amounts of free radicals. This indirectly proves that, the participation of the inflammatory factors and free radicals led to the organic damage.
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