【作者】 许瑞卿；

【导师】 伊娜；

【作者基本信息】 广州中医药大学 ， 中西医结合临床， 2009， 硕士

【摘要】 研究背景:糖尿病下肢血管病变(Lower extremity arterial disease in diabetespatients)是一组以下肢间歇性跛行、疼痛、麻木、冷重着感为主要表现的慢性闭塞性动脉粥样硬化性病变。糖尿病患者并发下肢血管病变是非糖尿病患者的7～10倍,其发病率高,病变进展快,发病年龄要比非糖尿病患者平均提前10年,并且随着病程延长,病情逐渐加重,会发生血管狭窄、阻塞,造成下肢及足部缺血,最终导致截肢。LEADDP不仅给病人也给社会带来了沉重的经济负担,影响了病人的生活质量,也造成了医疗资源的极大浪费。越来越多的流行病学家、内分泌专家、临床药理学家都已投入到本病早期干预及治疗中来。研究目的:本课题将从临床角度探讨归龙丸方治疗糖尿病下肢血管病变的作用机制,观察用药前后患者ABI,血清C反应蛋白,D-二聚体以及血脂水平,下肢血管彩超变化.探讨此药作用特点和部分生理机制,为临床应用提供可信的依据。研究方法:按2007年《中国糖尿病防治指南》中糖尿病诊断标准并进行ABI及下肢彩色多普勒检查提示有下肢血液循环障碍的,并参照2007年《中药新药临床研究指导原则》中除外阴虚热盛证的糖尿病下肢血管病变住院及门诊病人共68例,随机分为治疗组和对照组各34例。两组患者均经严格饮食控制及运动治疗,常规给予胰岛素控制血糖,治疗组给予归龙丸方加减,温服,日两剂;对照组予西洛他唑片,50mg口服,每日两次,疗程为12周。观察治疗前后患者临床症状及体征改善情况,同时监测治疗前后血脂水平、血清CRP、DD水平以及ABI、下肢血管彩色多普勒超声变化,比较有效率,从而得出归龙丸方在糖尿病下肢血管病变中有无治疗作用。研究结果:在治疗前后,患者症状评分如间歇性跛行、疼痛感、麻木感、冷沉着感四个方面,治疗组与对照组比较有明显改善(P＜0.05):治疗组内比较,12周后患者在四个症状方面亦均较治疗前明显改善(P＜0.05)。治疗后ABI值、下肢彩色多普勒积分,组间比较,治疗组都明显优于对照组(P＜0.05);组内比较,12周后,治疗组内治疗后亦明显优于治疗前(P＜0.05);血清TC、TRIG水平、血清CRP方面,组间比较,治疗组都明显优于对照组(P＜0.05):组内比较,12周治疗后,治疗组内亦明显优于治疗前(P＜0.05);治疗的总有效率治疗组亦明显优于对照组(P＜0.05)。结论:归龙丸方能明显改善糖尿病下肢血管病变患者的下肢疼痛、麻木及间歇性跛行感、改善治疗前后的血清TC及TRIG水平从而改善血液粘稠度及高凝状态、改善治疗前后的CRP水平从而减轻血管的免疫炎症反应、改善ABI值及下肢彩超评分,证实归龙丸方的综合治疗作用,但对血清DD无改善,证实了对改善LEADDP下肢深静脉血栓无特异治疗作用。特色与创新:针对疑难病LEADDP,应用现代诊疗手段、中医辨证标准疗效判定标准及科学研究方法,采用归龙丸方对LEADDP进行前瞻性随机对照试验,验证中药归龙丸方治疗LEADDP的疗效,同时探讨其对LEADDP患者ABI的影响,也为临床证实ABI对LEADDP患者可作为早期初筛的检查手段及疗效判断的标准。所有的观察方法综合了临床症状积分、下肢血管彩超及ABI积分、炎症因子情况,具有一定的创新性。更多还原

【Abstract】 Background:Lower Extremity Arterial Disease in Diabetes Patients is symptom complex,including claudication、pain、anaesthesia and sense of heaviness, and which is the disease of chronic obliterative atherosclerotic.The Diabetic patients who incorporate Lower Extremity Arterial have more chances than no DM patients.Also the time of happening will ten years advance in DM.Owing to the course of disease prolonging and pathogenetic condition aggravates, blockage and angiostegnosis will appear,the amputation is the finally result. Not only LEADDP makes society and patients have serious burden of economy,but also to influence they lives and results a serious waste of medical resources. So more and more epidemiologists,endocrinologists,clinic pxperts and pharmacologists began to study and research the curing LEADDP early.Objective:To research the mechanism of Gut Long-Pullet curing LEADDP,and to observe the ABI、CRP、DD、CDU、blood fat before and after in the treatment. To research the effective and physiological mechanism of Gui Long-Pullet,in result the clinical will has based on it.Methods:Accord to the diagnostic code of China Guideline for Type 2 Diabetes 2007,the DM will be checked up the ABI and CDU,which have PVD and to accord with the TCM syndrome differentitation(excluding the syndrom of heat due to deficiency of yin group) were randomly divided into two groups.The patients is totally 68,who came from hospital and out-patient clinic.Control group(34 cases) were given Cilostazol(50mg Bid).Treatment group(34 cases) were given Gui Long-Pullet.After treatment for 12 weeks,observing and comparing the two groups LEADDP symptom and the blood fat、CRP、DD、ABI、CDU between treatment before and later.We compare the effective rate of the two groups the medicine which they given and result in whether the Gui Long-Pullet has effcets in curing LEADDP.Results:The claudication、pain、anaesthesia and sense of heaviness symptom score of the two groups patients,there were significant differences between the two groups before treatment and after treatment(P＜0.05);after treatment, treatment group is prefer to control group in the improvement of the ABI、CDU、CRP、TC and TRIG(P＜0.05).In patients of Gui Long-Pullet,prior treatment also surpass post-treatment(P＜0.O5);The effective rate and the proportion of patients still choosing the medicine which they were given of treatment group is also more high than control group.Conclusion:Gui Long-Pullet can improve claudication、pain、anaesthesia and sense of heaviness,ameliorate the blood viscidity and coagulate by the TC and TRIG,reduce the CRP to mitigate the inflammatory reaction,and improve the ABI and CDU quickly and manifestly.Gui Long-Pullet is an effective method to treat LEADDP.But it has no effect to improve DD to cure the deep vein thrombus of lower limb.Characteristics and new ideas:Making use of contemporary diagnosis diplomacy, dialectical standard of TCM,standard of curative effect judgement and scientific study method and deploying experiment which Gui Long-Pullet randomly treats LEADDP prospectively authenticate its therapeutic effect.And approach the influence to ABI,to confirm ABI is an effective screening early and an index of discriminating therapeutic effect in LEADDP.We make use of the methods which includs symptom intergral and ABI、CDU and inflammatory factor.更多还原