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Article(id=1193548060488856571, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193548058421064688, articleNumber=1001-2494(2025)05-0539-08, orderNo=null, doi=10.11669/cpj.2025.05.012, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1726156800000, receivedDateStr=2024-09-13, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1762493632670, onlineDateStr=2025-11-07, pubDate=1741363200000, pubDateStr=2025-03-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1762493632670, onlineIssueDateStr=2025-11-07, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1762493632670, creator=13701087609, updateTime=1762493632670, updator=13701087609, issue=Issue{id=1193548058421064688, tenantId=1146029695717560320, journalId=1190317699101192196, year='2025', volume='60', issue='5', pageStart='441', pageEnd='552', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1762493632178, creator=13701087609, updateTime=1762493856082, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1193548997664146365, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193548058421064688, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1193548997664146366, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1193548058421064688, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=539, endPage=546, ext={EN=ArticleExt(id=1193548060690183164, articleId=1193548060488856571, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Clinical Evaluation of Aspirin Combined with Huoxue Quyu Decoction in the Treatment of Lower Extremity Arteriosclerosis Obliterans, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To investigate the clinical efficacy of aspirin combined with Huoxue Quyu decoction in the treatment of lower extremity arteriosclerosis obliterans (ASO). METHODS A total of 136 patients with lower extremity ASO admitted to our hospital were selected as the research objects, aged 49-87 years, with an average age of (65.00±6.54) years. According to treatment methods, 68 cases of conventional aspirin treatment were included in the control group, and 68 cases of Huoxue Quyu prescription combined with aspirin were included in the study group. The platelet function, hemodynamic index, blood lipid index, arteriosclerosis index, health status and clinical effect of the two groups were compared before and after treatment. Generalized estimation equation (GEE) model was used to analyze the factors affecting the clinical efficacy of ASO in the lower extremities, and GEE model was used to analyze the interaction effects of ankle-brachial index(ABI) at different time points, different groups and different stages. RESULTS After 6 weeks of treatment, the platelet function, hemodynamic indexes, lipid indexes and arteriosclerosis indexes of the two groups were significantly different compared with those before treatment (P<0.05). PAR, D-D, FIB, HWBV, LWBV, ESR, TC, TG and LDL-C levels in the study group were significantly lower than those in the control group (P<0.05), while BT, HDL-C, ABI, TBI, lameness distance, health status score and clinical efficacy were significantly higher than those in the control group (P<0.05). GEE model analysis showed that treatment method, treatment time and Fontaine stage significantly affected the therapeutic effect of ASO in lower limbs (P<0.05). In the interaction effect analysis, after 2 and 4 weeks of treatment, the ABI values of ASO patients in the study group and the control group were significantly different (P<0.05). After 6 weeks of treatment, different treatment methods had statistically significant effects on ABI values of ASO patients in stage Ⅱ, Ⅲ and Ⅳ (P<0.05). CONCLUSION Aspirin combined with Huoxue Quyu decoction is better than aspirin alone in the treatment of lower extremity ASO in the aspect of improvement of platelet function, hemodynamics, blood lipids and arteriosclerosis. After 6 weeks of treatment, the total effective rate and health status SF-36 score of the study group with combined medication are significantly higher than those of the control group. Treatment method, treatment time and Fontaine stage significantly affect the therapeutic effect of lower extremity ASO.

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目的 探讨阿司匹林联合活血祛瘀方治疗下肢动脉硬化闭塞症(ASO)的临床疗效。方法 选择本院收治的下肢ASO患者136例作为研究对象,年龄范围为49~87岁,平均年龄(65.00±6.54)岁。根据不同治疗方法分为2组,常规阿司匹林治疗68例纳入对照组,活血祛瘀方联合阿司匹林治疗68例纳入研究组。比较两组患者治疗前后血小板功能、血流动力学指标、血脂指标、动脉硬化指标、健康状况(SF-36)及临床疗效。采用广义估计方程(GEE)模型分析下肢ASO临床疗效的影响因素以及踝肱指数(ankle-brachial index,ABI)在不同时点、不同组别和不同分期的交互效应。结果 2组患者接受治疗6周后各项血小板功能、血流动力学指标、血脂指标及动脉硬化指标与治疗前相比均具有显著差异(P<0.05),研究组患者血小板聚集率(platelet aggregation rate,PAR)、D二聚体(D-dimer,D-D)、纤维蛋白原(fibrinogen,FIB)、全血高切黏度(high whole blood viscosity,HWBV)、全血低切黏度(low whole blood viscosity,LWBV)、红细胞沉降率(erythrocyte sedimentation rate,ESR)、总胆固醇(total cholesterol,TC)、三酰甘油(triacylglycerol,TG)及低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)水平均显著低于对照组(P<0.05),而患者出血时间(bleeding time,BT)、高密度脂蛋白(high density lipoprotein cholesterol,HDL-C)、ABI、趾肱指数(toe-brachial index,TBI)、跛行距离、健康状况评分及临床疗效均显著高于对照组(P<0.05);GEE模型分析结果显示治疗方法、治疗时间及Fontaine分期均显著影响下肢ASO的临床疗效(P<0.05);交互效应分析中治疗2周、4周,研究组和对照组中Ⅲ期、Ⅳ期ASO患者ABI值差异显著(P<0.05),治疗6周时,不同治疗方式对Ⅱ期、Ⅲ期、Ⅳ期ASO患者ABI值的影响具有统计学意义(P<0.05)。结论 阿司匹林联合活血祛瘀方治疗下肢ASO在血小板功能、血流动力学、血脂及动脉硬化等指标的改善方面优于单独使用阿司匹林,且治疗6周后联合用药的研究组的治疗总有效率和健康状况SF-36评分显著高于对照组;治疗方法、治疗时间及Fontaine分期均显著影响下肢ASO的治疗效果。

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尹凌峰,男,硕士,主治医师 研究方向:中西医结合治疗周围血管病 Tel:(021)65415910

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尹凌峰,男,硕士,主治医师 研究方向:中西医结合治疗周围血管病 Tel:(021)65415910

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尹凌峰,男,硕士,主治医师 研究方向:中西医结合治疗周围血管病 Tel:(021)65415910

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journalId=1190317699101192196, articleId=1193548060488856571, language=CN, orderNo=1, keyword=下肢动脉硬化闭塞症), Keyword(id=1193607567759868168, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, orderNo=2, keyword=活血祛瘀方), Keyword(id=1193607567818588425, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, orderNo=3, keyword=阿司匹林), Keyword(id=1193607567873114378, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, orderNo=4, keyword=临床疗效)], refs=[Reference(id=1193607569219485977, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, doi=null, pmid=null, pmcid=null, year=2022, volume=9, issue=null, pageStart=853583, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=SUN J, DENG Q, WANG J, journalName=Front Cardiovasc Med, refType=null, unstructuredReference=SUN J, DENG Q, 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项目 对照组(n=68) 研究组(n=68) t/χ2 P
年龄/岁 64.72±7.64 65.23±8.64 0.365 0.716
男性 39(57.35) 37(54.41) 0.119 0.730
BMI/kg·m-2 23.76±3.29 23.94±3.58 0.305 0.761
病程/年 10.24±3.67 10.31±3.49 0.114 0.909
心脏病 16(23.53) 15(22.06) 0.042 0.838
糖尿病 24(35.29) 22(32.35) 0.131 0.717
吸烟史 27(39.71) 30(38.24) 0.031 0.860
饮酒史 31(45.59) 32(47.06) 0.030 0.863
左侧病变 40(58.82) 38(55.88) 0.120 0.729
SBP/mmHg 127.76±12.63 125.44±13.42 1.038 0.301
DBP/mmHg 87.34±8.26 88.63±7.72 0.941 0.348
SCr/μmol·L-1 67.32±9.46 66.74±10.98 0.330 0.742
BUN/mmol·L-1 5.33±1.25 5.37±1.43 0.174 0.862
ALT/U·L-1 27.86±8.62 27.58±7.34 0.204 0.839
AST/U·L-1 27.42±7.84 27.79±7.96 0.273 0.785
), ArticleFig(id=1193607568103801100, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, label=表1, caption=

对照组、研究组患者基本资料、血压及肝肾功能对比

, figureFileSmall=null, figureFileBig=null, tableContent=
项目 对照组(n=68) 研究组(n=68) t/χ2 P
年龄/岁 64.72±7.64 65.23±8.64 0.365 0.716
男性 39(57.35) 37(54.41) 0.119 0.730
BMI/kg·m-2 23.76±3.29 23.94±3.58 0.305 0.761
病程/年 10.24±3.67 10.31±3.49 0.114 0.909
心脏病 16(23.53) 15(22.06) 0.042 0.838
糖尿病 24(35.29) 22(32.35) 0.131 0.717
吸烟史 27(39.71) 30(38.24) 0.031 0.860
饮酒史 31(45.59) 32(47.06) 0.030 0.863
左侧病变 40(58.82) 38(55.88) 0.120 0.729
SBP/mmHg 127.76±12.63 125.44±13.42 1.038 0.301
DBP/mmHg 87.34±8.26 88.63±7.72 0.941 0.348
SCr/μmol·L-1 67.32±9.46 66.74±10.98 0.330 0.742
BUN/mmol·L-1 5.33±1.25 5.37±1.43 0.174 0.862
ALT/U·L-1 27.86±8.62 27.58±7.34 0.204 0.839
AST/U·L-1 27.42±7.84 27.79±7.96 0.273 0.785
), ArticleFig(id=1193607568166715661, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标 组别 例数 治疗前 治疗2周 治疗4周 治疗6周
PAR/% 对照组 68 67.29±8.62 54.63±7.461) 48.74±7.631)2) 44.76±7.651)2)3)
研究组 68 66.84±9.36 50.26±8.281) 45.67±7.411)2) 40.27±6.361)2)3)
t 0.292 3.233 2.380 3.722
P 0.771 0.002 0.019 <0.001
组间 F=26.906,P<0.001
时间 F=19.696,P<0.001
组间×时间 F=18.368,P<0.001
BT/min 对照组 68 5.73±1.22 7.54±1.271) 9.54±1.781)2) 10.32±2.391)2)3)
研究组 68 5.69±1.30 8.25±1.551) 10.36±1.611)2) 11.87±2.171)2)3)
t 0.185 2.922 2.817 3.959
P 0.853 0.004 0.006 <0.001
D-D/mg·L-1 对照组 68 13.34±2.52 11.28±2.421) 8.86±1.671)2) 7.54±1.421)2)3)
研究组 68 13.17±2.77 10.39±2.361) 7.34±1.581)2) 5.82±1.891)2)
t 0.374 2.171 5.452 6.000
P 0.709 0.032 <0.001 <0.001
组间 F=19.770,P<0.001
时间 F=24.430,P<0.001
组间×时间 F=12.029,P<0.001
FIB/g·L-1 对照组 68 4.51±0.37 4.25±0.381) 3.99±0.411)2) 3.75±0.471)2)3)
研究组 68 4.47±0.59 4.07±0.521) 3.58±0.501)2) 3.26±0.391)2)3)
t 0.474 2.305 5.229 6.616
P 0.637 0.023 <0.001 <0.001
组间 F=22.073,P<0.001
时间 F=25.006,P<0.001
组间×时间 F=11.785,P<0.001
HWBV/mPa·s 对照组 68 4.72±0.38 4.58±0.371) 4.36±0.341)2) 4.22±0.221)2)3)
研究组 68 4.74±0.37 4.33±0.261) 4.12±0.211)2) 4.04±0.361)2)
t 0.311 4.559 4.952 3.518
P 0.756 <0.001 <0.001 0.001
组间 F=25.591,P<0.001
时间 F=12.843,P<0.001
组间×时间 F=22.974,P<0.001
LWBV/mPa·s 对照组 68 22.74±2.54 21.26±3.461) 20.78±2.261) 20.21±2.861)
研究组 68 22.85±3.43 20.57±2.511) 19.63±2.381)2) 18.79±2.451)2)3)
t 0.213 1.331 2.889 3.109
P 0.832 0.185 0.004 0.002
组间 F=28.552,P<0.001
时间 F=11.374,P<0.001
组间×时间 F=17.255,P<0.001
ESR/mm·h-1 对照组 68 16.74±3.82 13.22±2.211) 11.86±2.641)2) 10.15±2.181)2)3)
研究组 68 16.86±3.34 12.31±3.351) 10.43±2.291)2) 8.77±1.791)2)3)
t 0.195 1.870 3.374 4.034
P 0.846 0.064 0.001 <0.001
组间 F=15.294,P<0.001
时间 F=23.251,P<0.001
组间×时间 F=16.577,P<0.001
), ArticleFig(id=1193607568250601742, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, label=表2, caption=

对照组、研究组患者各时点血小板功能及血流动力学指标水平对比

, figureFileSmall=null, figureFileBig=null, tableContent=
指标 组别 例数 治疗前 治疗2周 治疗4周 治疗6周
PAR/% 对照组 68 67.29±8.62 54.63±7.461) 48.74±7.631)2) 44.76±7.651)2)3)
研究组 68 66.84±9.36 50.26±8.281) 45.67±7.411)2) 40.27±6.361)2)3)
t 0.292 3.233 2.380 3.722
P 0.771 0.002 0.019 <0.001
组间 F=26.906,P<0.001
时间 F=19.696,P<0.001
组间×时间 F=18.368,P<0.001
BT/min 对照组 68 5.73±1.22 7.54±1.271) 9.54±1.781)2) 10.32±2.391)2)3)
研究组 68 5.69±1.30 8.25±1.551) 10.36±1.611)2) 11.87±2.171)2)3)
t 0.185 2.922 2.817 3.959
P 0.853 0.004 0.006 <0.001
D-D/mg·L-1 对照组 68 13.34±2.52 11.28±2.421) 8.86±1.671)2) 7.54±1.421)2)3)
研究组 68 13.17±2.77 10.39±2.361) 7.34±1.581)2) 5.82±1.891)2)
t 0.374 2.171 5.452 6.000
P 0.709 0.032 <0.001 <0.001
组间 F=19.770,P<0.001
时间 F=24.430,P<0.001
组间×时间 F=12.029,P<0.001
FIB/g·L-1 对照组 68 4.51±0.37 4.25±0.381) 3.99±0.411)2) 3.75±0.471)2)3)
研究组 68 4.47±0.59 4.07±0.521) 3.58±0.501)2) 3.26±0.391)2)3)
t 0.474 2.305 5.229 6.616
P 0.637 0.023 <0.001 <0.001
组间 F=22.073,P<0.001
时间 F=25.006,P<0.001
组间×时间 F=11.785,P<0.001
HWBV/mPa·s 对照组 68 4.72±0.38 4.58±0.371) 4.36±0.341)2) 4.22±0.221)2)3)
研究组 68 4.74±0.37 4.33±0.261) 4.12±0.211)2) 4.04±0.361)2)
t 0.311 4.559 4.952 3.518
P 0.756 <0.001 <0.001 0.001
组间 F=25.591,P<0.001
时间 F=12.843,P<0.001
组间×时间 F=22.974,P<0.001
LWBV/mPa·s 对照组 68 22.74±2.54 21.26±3.461) 20.78±2.261) 20.21±2.861)
研究组 68 22.85±3.43 20.57±2.511) 19.63±2.381)2) 18.79±2.451)2)3)
t 0.213 1.331 2.889 3.109
P 0.832 0.185 0.004 0.002
组间 F=28.552,P<0.001
时间 F=11.374,P<0.001
组间×时间 F=17.255,P<0.001
ESR/mm·h-1 对照组 68 16.74±3.82 13.22±2.211) 11.86±2.641)2) 10.15±2.181)2)3)
研究组 68 16.86±3.34 12.31±3.351) 10.43±2.291)2) 8.77±1.791)2)3)
t 0.195 1.870 3.374 4.034
P 0.846 0.064 0.001 <0.001
组间 F=15.294,P<0.001
时间 F=23.251,P<0.001
组间×时间 F=16.577,P<0.001
), ArticleFig(id=1193607568342876431, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标 组别 例数 治疗前 治疗2周 治疗4周 治疗6周
TC/mmol·L-1 对照组 68 5.79±0.62 5.54±0.571) 5.30±0.681)2) 5.12±0.691)2)
研究组 68 5.83±0.52 5.56±0.551) 5.01±0.611)2) 4.57±0.571)2)3)
t 0.408 0.208 2.618 5.068
P 0.684 0.835 0.010 <0.001
组间 F=18.716,P<0.001
时间 F=27.631,P<0.001
组间×时间 F=30.582,P<0.001
TG/mmol·L-1 对照组 68 1.64±0.34 1.61±0.42 1.57±0.33 1.41±0.411)
研究组 68 1.66±0.47 1.47±0.361) 1.35±0.381) 1.22±0.391)2)
t 0.284 2.087 3.605 4.663
P 0.777 0.039 <0.001 <0.001
组间 F=26.645,P<0.001
时间 F=25.008,P<0.001
组间×时间 F=25.195,P<0.001
LDL-C/mmol·L-1 对照组 68 2.96±0.37 2.88±0.32 2.81±0.391) 2.78±0.361)
研究组 68 3.03±0.59 2.81±0.461) 2.65±0.361)2) 2.54±0.481)2)
t 0.829 1.030 2.486 3.298
P 0.409 0.305 0.014 0.001
组间 F=13.412,P<0.001
时间 F=22.194,P<0.001
组间×时间 F=24.074,P<0.001
HDL-C/mmol·L-1 对照组 68 0.84±0.32 1.04±0.371) 1.12±0.341) 1.15±0.481)
研究组 68 0.86±0.34 1.13±0.311) 1.23±0.291) 1.37±0.391)2)3)
t 0.353 1.538 2.030 2.933
P 0.724 0.126 0.044 0.004
组间 F=25.100,P<0.001
时间 F=21.391,P<0.001
组间×时间 F=12.332,P<0.001
), ArticleFig(id=1193607568409985296, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, label=表3, caption=

研究组、对照组患者各时间点血脂指标比较

, figureFileSmall=null, figureFileBig=null, tableContent=
指标 组别 例数 治疗前 治疗2周 治疗4周 治疗6周
TC/mmol·L-1 对照组 68 5.79±0.62 5.54±0.571) 5.30±0.681)2) 5.12±0.691)2)
研究组 68 5.83±0.52 5.56±0.551) 5.01±0.611)2) 4.57±0.571)2)3)
t 0.408 0.208 2.618 5.068
P 0.684 0.835 0.010 <0.001
组间 F=18.716,P<0.001
时间 F=27.631,P<0.001
组间×时间 F=30.582,P<0.001
TG/mmol·L-1 对照组 68 1.64±0.34 1.61±0.42 1.57±0.33 1.41±0.411)
研究组 68 1.66±0.47 1.47±0.361) 1.35±0.381) 1.22±0.391)2)
t 0.284 2.087 3.605 4.663
P 0.777 0.039 <0.001 <0.001
组间 F=26.645,P<0.001
时间 F=25.008,P<0.001
组间×时间 F=25.195,P<0.001
LDL-C/mmol·L-1 对照组 68 2.96±0.37 2.88±0.32 2.81±0.391) 2.78±0.361)
研究组 68 3.03±0.59 2.81±0.461) 2.65±0.361)2) 2.54±0.481)2)
t 0.829 1.030 2.486 3.298
P 0.409 0.305 0.014 0.001
组间 F=13.412,P<0.001
时间 F=22.194,P<0.001
组间×时间 F=24.074,P<0.001
HDL-C/mmol·L-1 对照组 68 0.84±0.32 1.04±0.371) 1.12±0.341) 1.15±0.481)
研究组 68 0.86±0.34 1.13±0.311) 1.23±0.291) 1.37±0.391)2)3)
t 0.353 1.538 2.030 2.933
P 0.724 0.126 0.044 0.004
组间 F=25.100,P<0.001
时间 F=21.391,P<0.001
组间×时间 F=12.332,P<0.001
), ArticleFig(id=1193607568477094161, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
指标 组别 例数 治疗前 治疗2周 治疗4周 治疗6周
ABI 对照组 68 0.64±0.18 0.70±0.171) 0.74±0.081)2) 0.77±0.101)2)
研究组 68 0.66±0.21 0.76±0.151) 0.88±0.111)2) 0.94±0.111)2)3)
t 0.596 2.182 8.488 9.430
P 0.552 0.031 <0.001 <0.001
组间 F=24.007,P<0.001
时间 F=24.997,P<0.001
组间×时间 F=17.409,P<0.001
TBI 对照组 68 0.33±0.05 0.39±0.071) 0.46±0.081)2) 0.48±0.111)2)
研究组 68 0.32±0.07 0.44±0.061) 0.57±0.081)2) 0.64±0.091)2)
t 0.959 4.472 8.018 9.283
P 0.339 <0.001 <0.001 <0.001
组间 F=24.308,P<0.001
时间 F=22.741,P<0.001
组间×时间 F=26.033,P<0.001
跛行距离/m 对照组 68 862.26±76.34 915.38±79.331) 1 093.24±97.891)2) 1 197.72±135.741)2)3)
研究组 68 882.77±85.52 986.74±88.451) 1 155.16±101.731)2) 1 284.52±128.361)2)3)
t 1.475 4.953 3.617 3.831
P 0.142 <0.001 <0.001 <0.001
组间 F=27.199,P<0.001
时间 F=25.838,P<0.001
组间×时间 F=16.317,P<0.001
SF-36/分 对照组 68 407.52±46.32 444.17±48.851) 483.76±47.731)2) 514.55±47.371)2)3)
研究组 68 402.79±47.48 479.62±47.431) 557.28±56.251)2) 588.72±54.221)2)3)
t 0.588 4.293 8.218 8.495
P 0.557 <0.001 <0.001 <0.001
组间 F=25.820,P<0.001
时间 F=26.364,P<0.001
组间×时间 F=18.741,P<0.001
), ArticleFig(id=1193607568569368850, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, label=表4, caption=

研究组、对照组患者各时点动脉硬化指标及健康状况评分对比

, figureFileSmall=null, figureFileBig=null, tableContent=
指标 组别 例数 治疗前 治疗2周 治疗4周 治疗6周
ABI 对照组 68 0.64±0.18 0.70±0.171) 0.74±0.081)2) 0.77±0.101)2)
研究组 68 0.66±0.21 0.76±0.151) 0.88±0.111)2) 0.94±0.111)2)3)
t 0.596 2.182 8.488 9.430
P 0.552 0.031 <0.001 <0.001
组间 F=24.007,P<0.001
时间 F=24.997,P<0.001
组间×时间 F=17.409,P<0.001
TBI 对照组 68 0.33±0.05 0.39±0.071) 0.46±0.081)2) 0.48±0.111)2)
研究组 68 0.32±0.07 0.44±0.061) 0.57±0.081)2) 0.64±0.091)2)
t 0.959 4.472 8.018 9.283
P 0.339 <0.001 <0.001 <0.001
组间 F=24.308,P<0.001
时间 F=22.741,P<0.001
组间×时间 F=26.033,P<0.001
跛行距离/m 对照组 68 862.26±76.34 915.38±79.331) 1 093.24±97.891)2) 1 197.72±135.741)2)3)
研究组 68 882.77±85.52 986.74±88.451) 1 155.16±101.731)2) 1 284.52±128.361)2)3)
t 1.475 4.953 3.617 3.831
P 0.142 <0.001 <0.001 <0.001
组间 F=27.199,P<0.001
时间 F=25.838,P<0.001
组间×时间 F=16.317,P<0.001
SF-36/分 对照组 68 407.52±46.32 444.17±48.851) 483.76±47.731)2) 514.55±47.371)2)3)
研究组 68 402.79±47.48 479.62±47.431) 557.28±56.251)2) 588.72±54.221)2)3)
t 0.588 4.293 8.218 8.495
P 0.557 <0.001 <0.001 <0.001
组间 F=25.820,P<0.001
时间 F=26.364,P<0.001
组间×时间 F=18.741,P<0.001
), ArticleFig(id=1193607568640672019, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别 例数 头痛(%) 腹泻(%) 恶心呕吐(%) 瘙痒(%) 出血(%) 合计(%)
对照组 50 1(1.47) 2(2.94) 0(0.00) 2(2.94) 5(7.35) 10(14.71)
研究组 50 2(2.94) 1(1.47) 1(1.47) 1(1.47) 4(5.88) 9(13.24)
χ2 0.341 0.341 1.007 0.341 0.119 0.061
P 0.559 0.559 0.316 0.559 0.730 0.805
), ArticleFig(id=1193607568699392276, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, label=表5, caption=

研究组、对照组患者头痛、腹泻、恶心呕吐、瘙痒及出血发生情况对比

, figureFileSmall=null, figureFileBig=null, tableContent=
组别 例数 头痛(%) 腹泻(%) 恶心呕吐(%) 瘙痒(%) 出血(%) 合计(%)
对照组 50 1(1.47) 2(2.94) 0(0.00) 2(2.94) 5(7.35) 10(14.71)
研究组 50 2(2.94) 1(1.47) 1(1.47) 1(1.47) 4(5.88) 9(13.24)
χ2 0.341 0.341 1.007 0.341 0.119 0.061
P 0.559 0.559 0.316 0.559 0.730 0.805
), ArticleFig(id=1193607568795861269, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
因素 估计值 标准误 95% CI 参数估计 OR 95% CI
上限 下限 Wald χ2 OR P 上限 下限
年龄 0.557 0.901 -0.189 1.016 0.383 1.746 0.077 0.828 2.763
性别
男 -0.088 0.078 -0.435 0.291 1.265 0.916 0.432 0.647 1.338
女(参考组)
BMI 0.323 0.796 -0.132 0.622 0.164 1.381 0.070 0.876 1.862
病程 0.457 0.563 -0.297 0.877 0.658 1.579 0.125 0.743 2.403
心脏病
是 0.498 0.176 -0.146 0.799 7.998 1.645 0.075 0.864 2.223
否(参考组)
糖尿病
是 0.220 0.800 -0.644 0.602 0.076 1.246 0.243 0.525 1.826
否(参考组)
吸烟史
是 0.389 0.270 -0.202 0.771 2.072 1.475 0.078 0.817 2.163
否(参考组)
饮酒史
是 0.415 0.623 -0.286 0.825 0.443 1.514 0.098 0.751 2.283
否(参考组)
病变侧
左侧 -0.121 0.269 -0.973 0.373 0.202 0.886 0.241 0.378 1.452
右侧(参考组)
治疗方法
联合治疗 -1.155 0.658 -2.163 -0.149 3.082 0.315 0.020 0.115 0.862
阿司匹林治疗(参考组)
治疗时间
6周 -0.538 0.277 -1.370 -0.167 3.770 0.584 0.008 0.254 0.818
4周 -0.426 0.325 -1.510 -0.201 1.720 0.653 0.012 0.221 0.846
2周(参考组)
Fontaine分期
Ⅳ期 1.215 0.546 0.638 1.512 4.951 3.370 <0.001 1.892 4.536
Ⅲ期 0.764 0.772 0.242 1.354 0.978 2.146 0.014 1.274 3.872
Ⅱ期 0.076 0.241 -0.732 0.454 0.100 1.079 0.663 0.481 1.574
Ⅰ期(参考组)
), ArticleFig(id=1193607568879747350, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, label=表6, caption=

下肢动脉硬化闭塞症(ASO)的治疗效果影响因素广义估计方程(GEE)分析

, figureFileSmall=null, figureFileBig=null, tableContent=
因素 估计值 标准误 95% CI 参数估计 OR 95% CI
上限 下限 Wald χ2 OR P 上限 下限
年龄 0.557 0.901 -0.189 1.016 0.383 1.746 0.077 0.828 2.763
性别
男 -0.088 0.078 -0.435 0.291 1.265 0.916 0.432 0.647 1.338
女(参考组)
BMI 0.323 0.796 -0.132 0.622 0.164 1.381 0.070 0.876 1.862
病程 0.457 0.563 -0.297 0.877 0.658 1.579 0.125 0.743 2.403
心脏病
是 0.498 0.176 -0.146 0.799 7.998 1.645 0.075 0.864 2.223
否(参考组)
糖尿病
是 0.220 0.800 -0.644 0.602 0.076 1.246 0.243 0.525 1.826
否(参考组)
吸烟史
是 0.389 0.270 -0.202 0.771 2.072 1.475 0.078 0.817 2.163
否(参考组)
饮酒史
是 0.415 0.623 -0.286 0.825 0.443 1.514 0.098 0.751 2.283
否(参考组)
病变侧
左侧 -0.121 0.269 -0.973 0.373 0.202 0.886 0.241 0.378 1.452
右侧(参考组)
治疗方法
联合治疗 -1.155 0.658 -2.163 -0.149 3.082 0.315 0.020 0.115 0.862
阿司匹林治疗(参考组)
治疗时间
6周 -0.538 0.277 -1.370 -0.167 3.770 0.584 0.008 0.254 0.818
4周 -0.426 0.325 -1.510 -0.201 1.720 0.653 0.012 0.221 0.846
2周(参考组)
Fontaine分期
Ⅳ期 1.215 0.546 0.638 1.512 4.951 3.370 <0.001 1.892 4.536
Ⅲ期 0.764 0.772 0.242 1.354 0.978 2.146 0.014 1.274 3.872
Ⅱ期 0.076 0.241 -0.732 0.454 0.100 1.079 0.663 0.481 1.574
Ⅰ期(参考组)
), ArticleFig(id=1193607568963633431, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组合项 估计
值		 标准
误		 95% CI Z P
上限 下限
6周*研究组*Ⅳ期 10.283 1.502 4.576 16.342 66.315 <0.001
6周*研究组*Ⅲ期 4.549 0.972 2.065 7.143 36.726 <0.001
6周*研究组*Ⅱ期 1.496 0.843 0.224 2.523 8.053 0.027
6周*研究组*Ⅰ期 0.133 1.159 -0.428 0.846 0.734 0.341
6周*对照组*Ⅳ期 7.892 1.596 5.251 9.536 52.272 <0.001
6周*对照组*Ⅲ期 4.354 1.724 2.347 6.552 37.567 <0.001
6周*对照组*Ⅱ期 0.842 0.698 -0.124 1.866 1.876 0.133
6周*对照组*Ⅰ期 0
4周*研究组*Ⅳ期 9.674 1.502 4.956 12.475 60.748 <0.001
4周*研究组*Ⅲ期 3.769 0.972 1.645 5.372 28.644 <0.001
4周*研究组*Ⅱ期 0.547 0.843 -0.312 1.280 0.885 0.282
4周*研究组*Ⅰ期 -0.366 1.159 -0.653 0.765 0.357 0.700
4周*对照组*Ⅳ期 6.742 1.596 3.542 8.964 49.865 <0.001
4周*对照组*Ⅲ期 3.289 1.724 1.787 5.243 29.373 <0.001
4周*对照组*Ⅱ期 1.174 0.698 0.372 2.021 7.263 0.034
4周*对照组*Ⅰ期 0
2周*研究组*Ⅳ期 8.371 1.502 4.283 11.463 55.147 <0.001
2周*研究组*Ⅲ期 2.863 0.972 1.652 3.926 22.546 0.002
2周*研究组*Ⅱ期 0.376 0.843 -0.432 1.057 0.556 0.450
2周*研究组*Ⅰ期 -0.153 1.159 -0.849 0.703 0.268 0.933
2周*对照组*Ⅳ期 4.653 1.596 2.655 7.005 34.265 <0.001
2周*对照组*Ⅲ期 2.342 1.724 1.672 3.362 20.863 0.012
2周*对照组*Ⅱ期 1.165 0.698 0.386 1.994 5.746 0.044
2周*对照组*Ⅰ期 0
治疗前*研究组*Ⅳ期 5.472 1.502 3.368 7.256 36.853 <0.001
治疗前*研究组*Ⅲ期 0.574 0.972 -0.241 1.154 1.146 0.218
治疗前*研究组*Ⅱ期 0.275 0.843 -0.494 1.036 0.769 0.325
治疗前*研究组*Ⅰ期 0
治疗前*对照组*Ⅳ期 0
治疗前*对照组*Ⅲ期 0
治疗前*对照组*Ⅱ期 0
治疗前*对照组*Ⅰ期 0
), ArticleFig(id=1193607569051713816, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1193548060488856571, language=CN, label=表7, caption=

踝肱指数(ABI)在不同时点、不同组别、不同分期的GEE分析

, figureFileSmall=null, figureFileBig=null, tableContent=
组合项 估计
值		 标准
误		 95% CI Z P
上限 下限
6周*研究组*Ⅳ期 10.283 1.502 4.576 16.342 66.315 <0.001
6周*研究组*Ⅲ期 4.549 0.972 2.065 7.143 36.726 <0.001
6周*研究组*Ⅱ期 1.496 0.843 0.224 2.523 8.053 0.027
6周*研究组*Ⅰ期 0.133 1.159 -0.428 0.846 0.734 0.341
6周*对照组*Ⅳ期 7.892 1.596 5.251 9.536 52.272 <0.001
6周*对照组*Ⅲ期 4.354 1.724 2.347 6.552 37.567 <0.001
6周*对照组*Ⅱ期 0.842 0.698 -0.124 1.866 1.876 0.133
6周*对照组*Ⅰ期 0
4周*研究组*Ⅳ期 9.674 1.502 4.956 12.475 60.748 <0.001
4周*研究组*Ⅲ期 3.769 0.972 1.645 5.372 28.644 <0.001
4周*研究组*Ⅱ期 0.547 0.843 -0.312 1.280 0.885 0.282
4周*研究组*Ⅰ期 -0.366 1.159 -0.653 0.765 0.357 0.700
4周*对照组*Ⅳ期 6.742 1.596 3.542 8.964 49.865 <0.001
4周*对照组*Ⅲ期 3.289 1.724 1.787 5.243 29.373 <0.001
4周*对照组*Ⅱ期 1.174 0.698 0.372 2.021 7.263 0.034
4周*对照组*Ⅰ期 0
2周*研究组*Ⅳ期 8.371 1.502 4.283 11.463 55.147 <0.001
2周*研究组*Ⅲ期 2.863 0.972 1.652 3.926 22.546 0.002
2周*研究组*Ⅱ期 0.376 0.843 -0.432 1.057 0.556 0.450
2周*研究组*Ⅰ期 -0.153 1.159 -0.849 0.703 0.268 0.933
2周*对照组*Ⅳ期 4.653 1.596 2.655 7.005 34.265 <0.001
2周*对照组*Ⅲ期 2.342 1.724 1.672 3.362 20.863 0.012
2周*对照组*Ⅱ期 1.165 0.698 0.386 1.994 5.746 0.044
2周*对照组*Ⅰ期 0
治疗前*研究组*Ⅳ期 5.472 1.502 3.368 7.256 36.853 <0.001
治疗前*研究组*Ⅲ期 0.574 0.972 -0.241 1.154 1.146 0.218
治疗前*研究组*Ⅱ期 0.275 0.843 -0.494 1.036 0.769 0.325
治疗前*研究组*Ⅰ期 0
治疗前*对照组*Ⅳ期 0
治疗前*对照组*Ⅲ期 0
治疗前*对照组*Ⅱ期 0
治疗前*对照组*Ⅰ期 0
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阿司匹林联合活血祛瘀方治疗下肢动脉硬化闭塞症的临床评价
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尹凌峰 1 , 曹烨民 2 , 徐磊 1 , 倪皓轩 3 , 王御震 2
中国药学杂志 | 论著 2025,60(5): 539-546
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中国药学杂志 | 论著 2025, 60(5): 539-546
阿司匹林联合活血祛瘀方治疗下肢动脉硬化闭塞症的临床评价
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尹凌峰1, 曹烨民2, 徐磊1, 倪皓轩3, 王御震2
作者信息
  • 1 上海中医药大学附属上海市中西医结合医院脉管一科, 上海 200080
  • 2 上海市中西医结合医院脉管病诊疗中心, 上海 200082
  • 3 上海中医药大学附属市中医医院, 上海 200071

    • 尹凌峰,男,硕士,主治医师 研究方向:中西医结合治疗周围血管病 Tel:(021)65415910

Clinical Evaluation of Aspirin Combined with Huoxue Quyu Decoction in the Treatment of Lower Extremity Arteriosclerosis Obliterans
Lingfeng YIN1, Yemin CAO2, Lei XU1, Haoxuan NI3, Yuzhen WANG2
Affiliations
  • 1 Department of Vascular Science, Shanghai Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200080, China
  • 2 Vascular Disease Diagnosis and Treatment Center, Shanghai Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai 200082, China
  • 3 Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China
出版时间: 2025-03-08 doi: 10.11669/cpj.2025.05.012
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目的 探讨阿司匹林联合活血祛瘀方治疗下肢动脉硬化闭塞症(ASO)的临床疗效。方法 选择本院收治的下肢ASO患者136例作为研究对象,年龄范围为49~87岁,平均年龄(65.00±6.54)岁。根据不同治疗方法分为2组,常规阿司匹林治疗68例纳入对照组,活血祛瘀方联合阿司匹林治疗68例纳入研究组。比较两组患者治疗前后血小板功能、血流动力学指标、血脂指标、动脉硬化指标、健康状况(SF-36)及临床疗效。采用广义估计方程(GEE)模型分析下肢ASO临床疗效的影响因素以及踝肱指数(ankle-brachial index,ABI)在不同时点、不同组别和不同分期的交互效应。结果 2组患者接受治疗6周后各项血小板功能、血流动力学指标、血脂指标及动脉硬化指标与治疗前相比均具有显著差异(P<0.05),研究组患者血小板聚集率(platelet aggregation rate,PAR)、D二聚体(D-dimer,D-D)、纤维蛋白原(fibrinogen,FIB)、全血高切黏度(high whole blood viscosity,HWBV)、全血低切黏度(low whole blood viscosity,LWBV)、红细胞沉降率(erythrocyte sedimentation rate,ESR)、总胆固醇(total cholesterol,TC)、三酰甘油(triacylglycerol,TG)及低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)水平均显著低于对照组(P<0.05),而患者出血时间(bleeding time,BT)、高密度脂蛋白(high density lipoprotein cholesterol,HDL-C)、ABI、趾肱指数(toe-brachial index,TBI)、跛行距离、健康状况评分及临床疗效均显著高于对照组(P<0.05);GEE模型分析结果显示治疗方法、治疗时间及Fontaine分期均显著影响下肢ASO的临床疗效(P<0.05);交互效应分析中治疗2周、4周,研究组和对照组中Ⅲ期、Ⅳ期ASO患者ABI值差异显著(P<0.05),治疗6周时,不同治疗方式对Ⅱ期、Ⅲ期、Ⅳ期ASO患者ABI值的影响具有统计学意义(P<0.05)。结论 阿司匹林联合活血祛瘀方治疗下肢ASO在血小板功能、血流动力学、血脂及动脉硬化等指标的改善方面优于单独使用阿司匹林,且治疗6周后联合用药的研究组的治疗总有效率和健康状况SF-36评分显著高于对照组;治疗方法、治疗时间及Fontaine分期均显著影响下肢ASO的治疗效果。

下肢动脉硬化闭塞症  /  活血祛瘀方  /  阿司匹林  /  临床疗效

OBJECTIVE To investigate the clinical efficacy of aspirin combined with Huoxue Quyu decoction in the treatment of lower extremity arteriosclerosis obliterans (ASO). METHODS A total of 136 patients with lower extremity ASO admitted to our hospital were selected as the research objects, aged 49-87 years, with an average age of (65.00±6.54) years. According to treatment methods, 68 cases of conventional aspirin treatment were included in the control group, and 68 cases of Huoxue Quyu prescription combined with aspirin were included in the study group. The platelet function, hemodynamic index, blood lipid index, arteriosclerosis index, health status and clinical effect of the two groups were compared before and after treatment. Generalized estimation equation (GEE) model was used to analyze the factors affecting the clinical efficacy of ASO in the lower extremities, and GEE model was used to analyze the interaction effects of ankle-brachial index(ABI) at different time points, different groups and different stages. RESULTS After 6 weeks of treatment, the platelet function, hemodynamic indexes, lipid indexes and arteriosclerosis indexes of the two groups were significantly different compared with those before treatment (P<0.05). PAR, D-D, FIB, HWBV, LWBV, ESR, TC, TG and LDL-C levels in the study group were significantly lower than those in the control group (P<0.05), while BT, HDL-C, ABI, TBI, lameness distance, health status score and clinical efficacy were significantly higher than those in the control group (P<0.05). GEE model analysis showed that treatment method, treatment time and Fontaine stage significantly affected the therapeutic effect of ASO in lower limbs (P<0.05). In the interaction effect analysis, after 2 and 4 weeks of treatment, the ABI values of ASO patients in the study group and the control group were significantly different (P<0.05). After 6 weeks of treatment, different treatment methods had statistically significant effects on ABI values of ASO patients in stage Ⅱ, Ⅲ and Ⅳ (P<0.05). CONCLUSION Aspirin combined with Huoxue Quyu decoction is better than aspirin alone in the treatment of lower extremity ASO in the aspect of improvement of platelet function, hemodynamics, blood lipids and arteriosclerosis. After 6 weeks of treatment, the total effective rate and health status SF-36 score of the study group with combined medication are significantly higher than those of the control group. Treatment method, treatment time and Fontaine stage significantly affect the therapeutic effect of lower extremity ASO.

lower extremity arteriosclerosis obliterans  /  huoxue quyu formula  /  aspirin  /  clinical effect
尹凌峰, 曹烨民, 徐磊, 倪皓轩, 王御震. 阿司匹林联合活血祛瘀方治疗下肢动脉硬化闭塞症的临床评价. 中国药学杂志, 2025 , 60 (5) : 539 -546 . DOI: 10.11669/cpj.2025.05.012
Lingfeng YIN, Yemin CAO, Lei XU, Haoxuan NI, Yuzhen WANG. Clinical Evaluation of Aspirin Combined with Huoxue Quyu Decoction in the Treatment of Lower Extremity Arteriosclerosis Obliterans[J]. Chinese Pharmaceutical Journal, 2025 , 60 (5) : 539 -546 . DOI: 10.11669/cpj.2025.05.012
正文
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下肢动脉硬化闭塞症(arterio sclerosis obliterans,ASO)是由下肢动脉粥样斑块阻塞血管引起下肢慢性缺血所致的外周血管病变,临床较为常见,患者早期临床表现为患肢麻木、冷感、静息痛等,后期还会出现肢体溃疡及坏疽等症状,严重者面临截肢的风险[1-2]。目前,下肢ASO的首选临床治疗方法为药物治疗,主要以改善下肢缺血和延缓疾病进展为目的,选择溶栓、抗凝药物[3-4]。阿司匹林为临床广泛使用的抗血小板药物,常用于治疗和预防心血管疾病,近期大量研究证实,阿司匹林在预防和治疗下肢ASO中具有积极意义,但仍存在一定数量患者治疗无效的情况[5]。近期研究表明,利用活血祛瘀方辅助治疗心肌梗死、脑卒中等心脑血管疾病疗效较好,其以补益心气为治其本,佐以温阳活血通络散结治标,标本兼顾,共奏益气养心、温阳散结、活血通络之效,常规治疗联合活血祛瘀方更有利于疏通血管,帮助病变部位恢复供血,还可抗血小板聚集,血黏度的降低可防止血栓形成[6]。但目前活血祛瘀方应用于治疗下肢ASO相关研究较少,本研究探讨了阿司匹林联合活血祛瘀方治疗下肢ASO的临床疗效,现报道如下。
1 资料与方法
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1.1 研究对象
选择本院的下肢ASO患者136例作为研究对象,年龄49~87岁,平均年龄(65.00±6.54)岁。根据不同治疗方法分为2组,常规阿司匹林治疗68例纳入对照组,活血祛瘀方联合阿司匹林治疗68例纳入研究组。纳入标准:①单侧病变;②符合下肢ASO诊断标准[7];③具有完整的临床资料;④首次接受治疗者;⑤患者及家属均知情本次研究。排除标准:①血液系统疾病者;②严重的肝肾功能损伤者;③合并传染性疾病者;④合并有恶性肿瘤者;⑤研究中涉及药物过敏者。本研究应用的治疗方案通过本院医学伦理委员会批准。
1.2 研究方法
1.2.1 治疗方法
研究对象均给予常规抗凝、调脂药物,并根据患者自身情况选择下肢康复训练、降糖及降压等治疗,对照组给予阿司匹林肠溶片,每天1次,每次100 mg,治疗6周。研究组患者在对照组治疗方法的基础上加用活血祛瘀方进行治疗,活血祛瘀方:党参20 g,丹参、赤芍、黄芪、川芎各15 g,茯苓12 g,瓜蒌、薤白、水蛭、降香、炙甘草、虎杖各10 g,三七(冲服)3 g,由上海市中西医结合医院代煎,煎至200 mL,每天1剂,分2次口服,治疗6周。
1.2.2 资料收集
入院后询问获取患者基本资料用于本次研究,其中包括患者年龄、性别、身体质量指数(body mass index,BMI)、病程、糖尿病、心脏病、吸烟史及饮酒史等。
患者于治疗前和接受治疗2周、4周、6周时接受检查:①测定患者清晨收缩压(systolic blood pressure,SBP)、舒张压(diastolic blood pressure,DBP)。②出血时间测定器法检测患者出血时间(bleeding time,BT)。③采集患者清晨空腹血液样本3管,每管5 mL。1管血液样本离心15 min(3 000 r·min-1,离心半径10 cm)分离血清,检测低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)、尿素氮(urea nitrogen,BUN)、肌酐(serum creatinine,SCr)、总胆固醇(total cholesterol,TC)、三酰甘油(triacylglycerol,TG)、高密度脂蛋白(high density lipoprotein cholesterol,HDL-C),全自动血凝分析仪测定D二聚体(D-dimer,D-D)、纤维蛋白原(fibrinogen,FIB)水平。剩余血液样本离心处理出血浆或留取全血;样品经由二磷酸腺苷(adenosine diphosphate,ADP)诱导后通过比浊法测定血小板聚集率(platelet aggregation rate,PAR),其余样品采用全自动血液流变仪检测红细胞沉降率(erythrocyte sedimentation rate)、全血高切黏度(high whole blood viscosity,HWBV)及全血低切黏度(low whole blood viscosity,LWBV)。④患者仰卧,利用多普勒听诊器测取患肢足背或胫前动脉、胫后动脉以及肱动脉收缩压,计算趾肱指数(toe-brachial index,TBI)和踝肱指数(ankle-brachial index,ABI)。⑤患者充分休息后按照日常步行习惯直线行走,直至感觉患肢乏力、疼痛停止测试记录距离为跛行距离。⑥采用健康状况调查简表(SF-36)[8]评价患者生活质量,分数越高表示生活质量越好。
1.2.3 下肢ASO分期
Fontaine分期[9]:Ⅰ期,无症状、体征或仅下肢轻微不适;Ⅱ期,间歇性或严重跛行、红斑,趾温下降;Ⅲ期,患者静息痛,肢体萎缩或紫绀;Ⅳ期缺血性溃疡或坏疽。
1.2.4 临床疗效评定
临床疗效[10]:显效,治疗后溃疡愈合,无跛行和静息痛,ABI>0.9;有效,治疗后溃疡面积减小,静息痛明显减轻,跛行大幅缓解,ABI提高≥0.1;无效,跛行静息痛、溃疡面积等症状和体征无明显改善(公式1)。
总有效率%=(显效+有效)/患者例数×100%
1.3 统计学分析
应用SPSS 22.0软件进行数据分析,研究中计量资料和计数资料分别用均数±标准差( x -±s)和例数(%)表示,组间比较采用χ2检验、t检验。组间多个时间点采用重复测量数据的方差分析。采用广义估计方程(generalized estimating equation,GEE)模型分析下肢ASO治疗效果的影响因素,并利用GEE模型分析ABI在不同时间点、不同组别和不同分期的交互效应。
2 结果
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2.1 两组基线资料比较
将两组患者基线资料进行比较,两组患者中性别、心脏病、糖尿病、吸烟史、饮酒史及左侧病变的占比均无显著差异(P>0.05),对照组和研究组患者年龄、BMI、病程、SBP、DBP、SCr、BUN、丙氨酸氨基转移酶(alanine aminotransferase,ALT)及天门冬氨酸氨基转移酶(aspartate aminotransferase,AST)水平的差异均无统计学意义(P>0.05),见表1。
2.2 两组患者血小板功能及血流动力学指标比较
将研究组和对照组患者治疗前后血小板功能及血流动力学指标进行对比,经重复性方差分析显示两组间不同时间点差异具有统计学意义(P<0.05),治疗2周后血小板功能和血流动力学指标均得到显著改善(P<0.05)。接受治疗6周,研究组患者PAR、D-D、FIB、HWBV、LWBV及红细胞沉降率(erythrocyte sedimentation rate,ESR)水平均显著低于对照组,BT显著高于对照组(P<0.05),见表2。
2.3 两组患者血脂指标对比
对比两组患者血脂指标,经重复性方差分析显示两组间不同时间点差异具有统计学意义(P<0.05),治疗2周后研究组患者各项血脂指标均得到显著改善(P<0.05),研究组患者TC和HDL-C水平与治疗前相比差异显著(P<0.05),TG、LDL-C水平变化不具有统计学意义(P>0.05)。两组患者治疗6周后,TC、TG及LDL-C水平显著低于治疗前,HDL-C水平较治疗前显著升高(P<0.05),且研究组和对照组TC、TG、HDL-C及LDL-C水平差异显著(P<0.05),见表3。
2.4 两组患者动脉硬化指标及健康状况比较
将两组患者治疗前后动脉硬化指标和健康状况进行对比,经重复性方差分析显示两组间不同时间点差异具有统计学意义(P<0.05),治疗2周后,两组患者ABI、TBI、跛行距离及SF-36评分均显著高于治疗前(P<0.05)。治疗4、6周时,研究组ABI、TBI、跛行距离及SF-36评分均显著高于对照组(P<0.05),表4。
2.5 两组患者临床疗效及不良反应对比
患者接受治疗6周后,对照组显效22例、有效30例、无效16例,总有效率为76.47%,研究组显效36例、有效26例、无效6例,总有效率为91.18%,研究组总有效率显著高于对照组(P<0.05)。两组患者治疗期间不良反应发生率均无显著性差异(P>0.05),见表5。
2.6 临床疗效影响因素GEE分析
通过模型的参数估计和假设检验结果(表6)可知,治疗方法、治疗时间及Fontaine分期均显著影响下肢ASO的治疗效果(P<0.05),而年龄、性别、BMI、病程、心脏病、糖尿病、吸烟史、饮酒史及病变侧对ASO的治疗效果无显著影响(P>0.05),见表6。
2.7 不同时点、不同组别、不同分期对ABI影响的交互分析
建立GEE模型并分析ABI在不同时点、不同组别和不同分期的交互效应。结果显示,治疗2周、4周,研究组和对照组中Ⅰ期、Ⅱ期ASO患者ABI值的差异无统计学意义(P>0.05),而两组中Ⅲ期、Ⅳ期ASO患者ABI值差异显著(P<0.05)。治疗6周时,研究组和对照组中Ⅰ期ASO患者ABI值无显著差异(P>0.05),但不同治疗方式对Ⅱ期、Ⅲ期、Ⅳ期ASO患者ABI值的影响具有统计学意义(P<0.05),见表7。
3 讨论
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下肢ASO是全身动脉硬化的外周血管表现,易发于中老年人群,并随着年龄的增长,发病率逐渐增加。其主要发病机制说法不一,包括遗传学说、血流动力学说、脂质浸润学及损伤及平滑肌细胞增殖学说[11]。ASO早期可无临床症状或仅轻微不适,逐渐出现间歇性跛行,严重缺血者可出现静息痛,足背动脉搏动消失等,晚期常导致动脉严重狭窄或闭塞,引起下肢发绀、溃疡,甚至坏疽。若不及时治疗可能会影响患者生活质量,危害生命安全[12-13]。
外科手术常用于治疗ASO,但对合并高血压、高血糖、高血脂等老年患者,存在着较高的心血管疾病风险,不宜采用外科手术治疗,此类患者首选药物保守治疗[14-15]。阿司匹林是长期以来临床医生推荐为抗血小板治疗的主流药物,其药理作用是通过乙酰化环氧合酶-1(cyclooxygenase-1,COX-1)活性中心丝氨酸抑制血栓素A2(thromboxane A2,TXA2)的合成,从而抑制血栓形成,保护血管内皮功能[16-17]。但单独使用阿司匹林治疗动脉硬化性疾病未能显著减少患者致死率和致残率,甚至还有患者出现阿司匹林抵抗的情况,严重影响其预后,因此,为提高疗法收益与安全性,需联合使用其他抗血小板药物进行治疗[18-19]。实践表明,中药活血祛瘀方在治疗心血管疾病方面具有扩张动脉、调节血压、抗血小板聚集、降低血黏度的作用,其方中茯苓、黄芪、党参健脾补气;水蛭、丹参、三七、赤芍和川芎等皆为活血之品,诸活血药配伍益气药,达到气随血行;瓜蒌、薤白通阳理气,经炙甘草调和诸药共奏散结止痛、活血通络之功[6,20]。本研究结果显示,阿司匹林联合活血祛瘀方治疗下肢ASO可显著改善患者血小板功能、血流动力学指标、血脂指标、动脉硬化指标及健康状况等,且治疗6周后研究组总有效率显著高于对照组,此观点与既往报道结论类似,联合用药治疗下肢ASO的临床疗效优于单独使用阿司匹林[21-22]。研究还发现,除不同治疗外治疗时间和Fontaine分期也显著影响下肢ASO的治疗效果,患者接受治疗2周和4周时,2组中Ⅲ期、Ⅳ期ASO患者ABI值差异显著,而治疗6周时,不同治疗方式对Ⅱ期、Ⅲ期、Ⅳ期ASO患者ABI值的影响具显著差异。本研究尚存在一定的局限性,纳入的样本数据来自同一医疗中心,结果难免存在一定偏倚;研究对象均为中国汉族,未涉及其他民族、国家的下肢ASO患者,后续研究还需进一步扩大样本量;本研究观察时间为6个周,缺少治疗6周后相关数据和分析,可在后续研究中加以补充。
综上所述,阿司匹林联合活血祛瘀方治疗下肢ASO在血小板功能、血流动力学、血脂及动脉硬化等指标的改善方面优于单独使用阿司匹林,且治疗6周后联合用药的研究组的治疗总有效率和健康状况SF-36评分显著高于对照组;治疗方法、治疗时间及Fontaine分期均显著影响下肢ASO的治疗效果。
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2025年第60卷第5期
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doi: 10.11669/cpj.2025.05.012
  • 接收时间：2024-09-13
  • 首发时间：2025-11-07
  • 出版时间：2025-03-08
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  • 收稿日期：2024-09-13
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    1 上海中医药大学附属上海市中西医结合医院脉管一科, 上海 200080
    2 上海市中西医结合医院脉管病诊疗中心, 上海 200082
    3 上海中医药大学附属市中医医院, 上海 200071
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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