舒脉胶囊治疗下肢动脉硬化闭塞症术后再狭窄临床疗效研究

发布时间：2018-01-02 10:03

本文关键词：舒脉胶囊治疗下肢动脉硬化闭塞症术后再狭窄临床疗效研究　出处：《北京中医药大学》2017年硕士论文　论文类型：学位论文

【摘要】：下肢动脉硬化闭塞症是老年人常见的周围血管疾病,近年来,西医学对下肢动脉硬化闭塞症形成的机制有所认识,治疗多采用抗凝、扩管、降脂药及手术疗法。但术后再狭窄发病率依然很高,效果并不理想,而且给患者带来了很大的经济负担。中医药治疗下肢动脉硬化闭塞症有悠久的历史,而且疗效确切。舒脉胶囊为我院院内常用制剂之一,经过反复验证及筛选,能够改善患者的临床症状和生活质量,维持术后平稳的血管状态,预防疾病进一步发展。研究目的:通过比较舒脉胶囊与贝前列素钠对带有间歇性跛行或疼痛感的下肢动脉硬化闭塞症患者治疗后3个月与治疗前有效率的差别,评估舒脉胶囊对下肢动脉硬化闭塞症术后再狭窄的临床疗效;监测相关生理、生化、物理等微观指标的动态变化,探讨舒脉胶囊对下肢动脉硬化闭塞症术后再狭窄的部分机理;为气血理论在中医周围血管疾病中的应用提供物质基础与临床支撑。研究方法:观察病例均来源于2016年9月—2017年2月北京中医医院疮疡血管外科的门诊及病房患者,按照实施方案纳入40例符合纳入标准的患者,采用随机对照的研究方法,分为治疗组和对照组。治疗组予常规内科基础治疗,加用舒脉胶囊口服,每次10g,每日3次,口服贝前列素钠模拟片40mg,每日3次;对照组予常规内科基础治疗,加用贝前列素钠片口服,每次40mg,每日3次,口服舒脉胶囊模拟片每次10g,每日3次。疗程均为3个月,于治疗3个月后进行经皮氧分压、激光多普勒、ABI的疗效评估,并与治疗前相比较。应用EXCEL建立数据库,SPSS 22.0软件进行分析,计量资料采用均数±标准差表示,检验判断是否符合正态分布和方差齐性。若符合正态分布、方差齐性的,采用独立样本的t检验。如不符合正态分布或者方差齐性,用非参数检验。计数资料进行卡方检验。另外,在治疗前和治疗后分别检测患者血常规、尿常规以及肝、肾功能等主要生化指标,注意在治疗过程中患者是否有任何不良反应产生,明确药物是否存在毒副作用。研究结果:1基线分析两组患者年龄、性别、入组前踝肱比、经皮氧分压、激光多普勒灌注量、中医证候积分表各条目和总分比较,经t检验、非参数检验,两组差异均无统计学意义(p0.05),可进行研究对照。2疗效分析2.1两组治疗后血流灌注量治疗第一、二、三个月后,治疗组均值为29.34、33.07、37.42,对照组均值为21.21、21.36、23.68,两组血流灌注量均呈上升趋势,采用非参数检验,p0.05,差异具有统计学意义,说明治疗组优于对照组。2.2两组治疗后左侧经皮氧治疗第一、二、三月后,治疗组均值为28.71、30.71、37.42,对照组均值为19.13、24.94、27.51,两组左侧经皮氧均呈上升趋势,采用独立样本t检验及非参数检验,p0.05,差异具有统计学意义,说明治疗第一、三月,治疗组优于对照组,治疗第二月,p0.05,治疗组与对照组无明显差异。2.3两组治疗后右侧经皮氧治疗第一、二、三月后,治疗组均值为29、31.9、36.52,对照组均值为26.9、29.4、31.55,两组右侧经皮氧均呈上升趋势,采用独立样本t检验及非参数检验,p0.05,两组均有疗效,但两组之间无明显差异。2.4两组治疗后左侧ABI治疗第一、二、三月后,治疗组均值为0.77、0.84、0.93,对照组均值为0.61、0.68、0.76,两组左侧ABI均呈上升趋势采用独立样本t检验及非参数检验,p0.05,具有统计学意义,说明治疗组优于对照组。2.5两组治疗后右侧ABI治疗第一、二、三月后,治疗组均值为0.82、0.93、1,对照组均值为0.75、0.69、0.77,采用非参数检验,p0.05,第二、三月治疗组优于对照组,具有统计学意义,第一月p0.05,两组间无明显差异。2.6两组治疗过程中的灌注量治疗第一、二、三月治疗组均值分别为29.34±10.99、33.07± 10.24、37.42±9.52,较治疗前明显升高,采用两配对样本t检验,p0.05,具有统计学意义;治疗第一、二、三月对照组均值分别为21.21±11.11、21.36±10.22、23.68±10.07,较治疗前明显升高,采用两配对样本t检验,p0.05,具有统计学意义。2.7两组治疗后中医症状评分治疗组治疗前后对比,本组疼痛、麻木、间歇跛行、皮温、踝肱比、氧分压、多普勒评分,经非参数检验,p0.05,差异有统计学意义;对照组治疗前后对比,本组疼痛、麻木、间歇跛行、皮温、踝肱比、氧分压、多普勒评分,经非参数检验,p0.05,差异有统计学意义;两组治疗后间歇跛行、皮温、踝肱比、氧分压评分比较,经非参数检验,p0.05,差异有统计学意义;两组治疗后疼痛、麻木、多普勒评分比较,经非参数检验,p0.05,无明显差异。结论舒脉胶囊治疗下肢动脉硬化闭塞症术后再狭窄的总体疗效优于贝前列素钠治疗;舒脉胶囊能够改善患者的临床症状和生活质量,维持术后平稳的血管状态。
[Abstract]:Lower extremity arterial occlusive disease is peripheral vascular disease, the elderly are common in recent years, western medicine disease occlusion mechanism on the formation of lower extremity arteriosclerosis aware, treated with anticoagulation, expanding drugs and surgical therapy of lipid-lowering. But restenosis incidence is still high, the effect is not ideal, and give the patients has brought great economic burden. The treatment of lower limb arterial occlusive disease of traditional Chinese medicine has a long history, and the curative effect of Shumai capsule. As one of the commonly used preparations in our hospital, after repeated verification and screening, can improve clinical symptoms and quality of life, vascular smooth maintenance after operation, further development of prevention Objective: To study the difference of disease. Effective 3 months before treatment with the treatment of patients with occlusion of lower extremity arteriosclerosis with intermittent claudication or pain by comparing Shumai capsule and beraprost sodium after assessment The clinical curative effect of Shumai capsule restenosis occlusion surgery on lower limb arteriosclerosis; physiological and biochemical monitoring, dynamic changes of physical micro indicators, explore the mechanism of restenosis of Shumai capsule surgery on lower limb arteriosclerosis obliterans; provide clinical support and material basis for the application of the theory of Qi and blood in TCM of peripheral vascular disease in the study. Methods: To observe the patients from September 2016 to February 2017 from Beijing Chinese Medicine Hospital vascular surgery clinic and ward patients, in accordance with the implementation of programs of 40 cases of patients who met the inclusion criteria, using the research methods of random control, divided into treatment group and control group. The treatment group received basic conventional medical treatment, combined with Shu Mai capsule orally, 10g each time, 3 times a day, oral beraprost sodium simulated tablets 40mg, 3 times a day; the control group received basic routine medical treatment combined with Beraprost Sodium Tablets oral, every time 4 0mg, 3 times a day, oral Shumai capsule simulated tablets 10g, 3 times a day. The treatment lasted for 3 months, percutaneous oxygen partial pressure, laser Doppler in 3 months after treatment, to evaluate the efficacy of ABI, and compared with before treatment. The application of EXCEL database, SPSS 22 software analysis the measurement data, expressed by the mean and standard deviation, check whether it accords with normal distribution and homogeneity of variance. If accorded with normal distribution and homogeneity of variance, with independent sample t test. If it does not meet the normal distribution or homogeneity of variance, non parametric test for count data by chi square test. In addition, the patients blood were detected before and after treatment, urine routine, liver, renal function and main biochemical indicators, pay attention to in the course of treatment in patients with whether there is any adverse reactions, clear whether drugs have side effects. Results: 1 baseline analysis between the two groups, Gender, before entering the group of ankle brachial index and transcutaneous oxygen pressure, laser Doppler perfusion, TCM syndromes scale of each item and total score compared with t test, non parametric test, the two groups had no statistically significant difference (P0.05), to study the control efficacy of.2 2.1 analysis of the two groups after treatment blood perfusion the amount for first, second, three months after treatment group, control group mean 29.34,33.07,37.42, mean 21.21,21.36,23.68, two groups of blood perfusion showed an upward trend, using non parametric test, P0.05, the difference was statistically significant, indicating that the treatment group than the control group.2.2 two group after treatment of percutaneous left oxygen treatment after first, second, March the treatment group, the control group mean 28.71,30.71,37.42, mean 19.13,24.94,27.51, two groups of left transcutaneous oxygen showed an upward trend, using independent samples t test and non parametric test, P0.05, the difference was statistically significant, indicating that the treatment first, In March, the treatment group than the control group, the treatment in February, P0.05, the treatment group and the control group had no significant difference between the two groups after treatment.2.3 right percutaneous oxygen therapy in first, second, after March, the treatment group and control group mean 29,31.9,36.52, mean 26.9,29.4,31.55, two on the right side of transcutaneous oxygen group showed an upward trend, the independent sample t test and non parametric test, P0.05 effect between the two groups, but no significant difference between the two groups in first, second, left ABI.2.4 two treatment group after treatment after March, treatment group, control group mean 0.77,0.84,0.93, mean 0.61,0.68,0.76, two groups of left ABI were increased by independent sample t test and non parametric test, P0.05, have statistical significance, indicating that the treatment group than the control group.2.5 two group after treatment right ABI treatment of first, second, after March, the treatment group in the control group mean 0.82,0.93,1, mean 0.75,0.69,0.77, using non parametric test Check, P0.05, second, March treatment group than the control group, with statistical significance, the first month of P0.05 perfusion for first, second, no significant difference between the two groups.2.6 two groups during the treatment, the treatment group in March the average was 29.34 + 10.99,33.07 + 10.24,37.42 + 9.52, compared with before treatment significantly increased by two paired samples t test, P0.05, with statistical significance; in first, second, March, the control group mean were 21.21 + 11.11,21.36 + 10.22,23.68 + 10.07, significantly higher than that before treatment, the two paired samples t test, P0.05, with scores of TCM symptoms before and after treatment compared statistically significant two.2.7 after treatment, the pain, numbness skin temperature, intermittent claudication, and ankle brachial ratio, oxygen partial pressure, the Doppler score, the non parametric test, P0.05, the difference was statistically significant; compared with control group before and after treatment, the pain, numbness, intermittent claudication, skin temperature, ankle brachial ratio , oxygen partial pressure, Doppler score, the non parametric test, P0.05, there was statistically significant difference between the two groups after treatment; skin temperature, intermittent claudication, ankle brachial index, oxygen pressure scores were compared by nonparametric test, P0.05, the difference was statistically significant; the two group after treatment, pain, numbness, Doppler score, the non parametric test, P0.05, no significant difference. Restenosis better than the overall effect of beraprost sodium treatment conclusion Shumai capsule in the treatment of lower extremity arterial occlusive disease after surgery; Shumai capsule can improve clinical symptoms and quality of life, vascular smooth maintenance after operation.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R269

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