本文關(guān)鍵詞：舒脈膠囊治療下肢動(dòng)脈硬化閉塞癥術(shù)后再狹窄臨床療效研究　出處：《北京中醫(yī)藥大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

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【摘要】：下肢動(dòng)脈硬化閉塞癥是老年人常見的周圍血管疾病,近年來(lái),西醫(yī)學(xué)對(duì)下肢動(dòng)脈硬化閉塞癥形成的機(jī)制有所認(rèn)識(shí),治療多采用抗凝、擴(kuò)管、降脂藥及手術(shù)療法。但術(shù)后再狹窄發(fā)病率依然很高,效果并不理想,而且給患者帶來(lái)了很大的經(jīng)濟(jì)負(fù)擔(dān)。中醫(yī)藥治療下肢動(dòng)脈硬化閉塞癥有悠久的歷史,而且療效確切。舒脈膠囊為我院院內(nèi)常用制劑之一,經(jīng)過(guò)反復(fù)驗(yàn)證及篩選,能夠改善患者的臨床癥狀和生活質(zhì)量,維持術(shù)后平穩(wěn)的血管狀態(tài),預(yù)防疾病進(jìn)一步發(fā)展。研究目的:通過(guò)比較舒脈膠囊與貝前列素鈉對(duì)帶有間歇性跛行或疼痛感的下肢動(dòng)脈硬化閉塞癥患者治療后3個(gè)月與治療前有效率的差別,評(píng)估舒脈膠囊對(duì)下肢動(dòng)脈硬化閉塞癥術(shù)后再狹窄的臨床療效;監(jiān)測(cè)相關(guān)生理、生化、物理等微觀指標(biāo)的動(dòng)態(tài)變化,探討舒脈膠囊對(duì)下肢動(dòng)脈硬化閉塞癥術(shù)后再狹窄的部分機(jī)理;為氣血理論在中醫(yī)周圍血管疾病中的應(yīng)用提供物質(zhì)基礎(chǔ)與臨床支撐。研究方法:觀察病例均來(lái)源于2016年9月—2017年2月北京中醫(yī)醫(yī)院瘡瘍血管外科的門診及病房患者,按照實(shí)施方案納入40例符合納入標(biāo)準(zhǔn)的患者,采用隨機(jī)對(duì)照的研究方法,分為治療組和對(duì)照組。治療組予常規(guī)內(nèi)科基礎(chǔ)治療,加用舒脈膠囊口服,每次10g,每日3次,口服貝前列素鈉模擬片40mg,每日3次;對(duì)照組予常規(guī)內(nèi)科基礎(chǔ)治療,加用貝前列素鈉片口服,每次40mg,每日3次,口服舒脈膠囊模擬片每次10g,每日3次。療程均為3個(gè)月,于治療3個(gè)月后進(jìn)行經(jīng)皮氧分壓、激光多普勒、ABI的療效評(píng)估,并與治療前相比較。應(yīng)用EXCEL建立數(shù)據(jù)庫(kù),SPSS 22.0軟件進(jìn)行分析,計(jì)量資料采用均數(shù)±標(biāo)準(zhǔn)差表示,檢驗(yàn)判斷是否符合正態(tài)分布和方差齊性。若符合正態(tài)分布、方差齊性的,采用獨(dú)立樣本的t檢驗(yàn)。如不符合正態(tài)分布或者方差齊性,用非參數(shù)檢驗(yàn)。計(jì)數(shù)資料進(jìn)行卡方檢驗(yàn)。另外,在治療前和治療后分別檢測(cè)患者血常規(guī)、尿常規(guī)以及肝、腎功能等主要生化指標(biāo),注意在治療過(guò)程中患者是否有任何不良反應(yīng)產(chǎn)生,明確藥物是否存在毒副作用。研究結(jié)果:1基線分析兩組患者年齡、性別、入組前踝肱比、經(jīng)皮氧分壓、激光多普勒灌注量、中醫(yī)證候積分表各條目和總分比較,經(jīng)t檢驗(yàn)、非參數(shù)檢驗(yàn),兩組差異均無(wú)統(tǒng)計(jì)學(xué)意義(p0.05),可進(jìn)行研究對(duì)照。2療效分析2.1兩組治療后血流灌注量治療第一、二、三個(gè)月后,治療組均值為29.34、33.07、37.42,對(duì)照組均值為21.21、21.36、23.68,兩組血流灌注量均呈上升趨勢(shì),采用非參數(shù)檢驗(yàn),p0.05,差異具有統(tǒng)計(jì)學(xué)意義,說(shuō)明治療組優(yōu)于對(duì)照組。2.2兩組治療后左側(cè)經(jīng)皮氧治療第一、二、三月后,治療組均值為28.71、30.71、37.42,對(duì)照組均值為19.13、24.94、27.51,兩組左側(cè)經(jīng)皮氧均呈上升趨勢(shì),采用獨(dú)立樣本t檢驗(yàn)及非參數(shù)檢驗(yàn),p0.05,差異具有統(tǒng)計(jì)學(xué)意義,說(shuō)明治療第一、三月,治療組優(yōu)于對(duì)照組,治療第二月,p0.05,治療組與對(duì)照組無(wú)明顯差異。2.3兩組治療后右側(cè)經(jīng)皮氧治療第一、二、三月后,治療組均值為29、31.9、36.52,對(duì)照組均值為26.9、29.4、31.55,兩組右側(cè)經(jīng)皮氧均呈上升趨勢(shì),采用獨(dú)立樣本t檢驗(yàn)及非參數(shù)檢驗(yàn),p0.05,兩組均有療效,但兩組之間無(wú)明顯差異。2.4兩組治療后左側(cè)ABI治療第一、二、三月后,治療組均值為0.77、0.84、0.93,對(duì)照組均值為0.61、0.68、0.76,兩組左側(cè)ABI均呈上升趨勢(shì)采用獨(dú)立樣本t檢驗(yàn)及非參數(shù)檢驗(yàn),p0.05,具有統(tǒng)計(jì)學(xué)意義,說(shuō)明治療組優(yōu)于對(duì)照組。2.5兩組治療后右側(cè)ABI治療第一、二、三月后,治療組均值為0.82、0.93、1,對(duì)照組均值為0.75、0.69、0.77,采用非參數(shù)檢驗(yàn),p0.05,第二、三月治療組優(yōu)于對(duì)照組,具有統(tǒng)計(jì)學(xué)意義,第一月p0.05,兩組間無(wú)明顯差異。2.6兩組治療過(guò)程中的灌注量治療第一、二、三月治療組均值分別為29.34±10.99、33.07± 10.24、37.42±9.52,較治療前明顯升高,采用兩配對(duì)樣本t檢驗(yàn),p0.05,具有統(tǒng)計(jì)學(xué)意義;治療第一、二、三月對(duì)照組均值分別為21.21±11.11、21.36±10.22、23.68±10.07,較治療前明顯升高,采用兩配對(duì)樣本t檢驗(yàn),p0.05,具有統(tǒng)計(jì)學(xué)意義。2.7兩組治療后中醫(yī)癥狀評(píng)分治療組治療前后對(duì)比,本組疼痛、麻木、間歇跛行、皮溫、踝肱比、氧分壓、多普勒評(píng)分,經(jīng)非參數(shù)檢驗(yàn),p0.05,差異有統(tǒng)計(jì)學(xué)意義;對(duì)照組治療前后對(duì)比,本組疼痛、麻木、間歇跛行、皮溫、踝肱比、氧分壓、多普勒評(píng)分,經(jīng)非參數(shù)檢驗(yàn),p0.05,差異有統(tǒng)計(jì)學(xué)意義;兩組治療后間歇跛行、皮溫、踝肱比、氧分壓評(píng)分比較,經(jīng)非參數(shù)檢驗(yàn),p0.05,差異有統(tǒng)計(jì)學(xué)意義;兩組治療后疼痛、麻木、多普勒評(píng)分比較,經(jīng)非參數(shù)檢驗(yàn),p0.05,無(wú)明顯差異。結(jié)論舒脈膠囊治療下肢動(dòng)脈硬化閉塞癥術(shù)后再狹窄的總體療效優(yōu)于貝前列素鈉治療;舒脈膠囊能夠改善患者的臨床癥狀和生活質(zhì)量,維持術(shù)后平穩(wěn)的血管狀態(tài)。
[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.

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R269

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