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桃红四物汤化裁辅助治疗慢性心力衰竭伴下肢深静脉血栓慢性期血脉瘀阻证患者临床研究——随机对照试验 被引量:2

Clinical Observation Adjuvant Treatment with Modified Taohong Siwu Decoction(桃红四物汤)forPatients of Chronic Heart Failure Complicated with Lower Limb Deep Vein Thrombosis in the Chronic Stage of Blood Stasis Syndrome:ARandomize Controlled Clinical Trial
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摘要 目的观察桃红四物汤化裁辅助治疗慢性心力衰竭伴下肢深静脉血栓慢性期血脉瘀阻证患者的临床疗效及安全性。方法120例慢性心力衰竭伴下肢深静脉血栓慢性期血脉瘀阻证患者随机分为对照组和观察组各60例,两组均给予西医基础治疗,观察组在西医基础治疗上给予桃红四物汤化裁口服,每日1剂,两组疗程均为4周。治疗后比较两组临床疗效总有效率及不良反应发生率,治疗前后比较心功能指标[包括左室射血分数(LVEF)、左室收缩末期内径(LVESd)、左室舒张末期内径(LVEDd)]、血清学指标[包括N-端脑利钠肽前体(NT-proBNP)、高敏C反应蛋白(hs-CRP)、血管内皮生长因子(VEGF)]、中医症状评分(包括胸痛、患肢肿胀、固定性压痛、青筋怒张)、血液流变学指标(包括高切全血黏度、低切全血黏度、红细胞压积)、凝血功能指标[包括活化部分凝血活酶时间(APTT)、凝血酶原时间(PT)、纤维蛋白原(FIB)]水平。结果研究期间观察组剔除3例、脱落2例;对照组剔除2例,脱落3例。共110例患者完成试验,两组各55例。观察组临床疗效总有效率为92.73%(51/55),显著高于对照组的78.18%(43/55,P<0.05)。与治疗前比较,两组治疗后LVEF、APTT、PT水平均升高,LVESd、LVEDd、NT-proBNP、hs-CRP、VEGF、高切全血黏度、低切全血黏度、红细胞压积、FIB水平均降低,胸痛、患肢肿胀、固定性压痛及青筋怒张评分均降低,且观察组治疗后上述各指标改善均优于对照组(P<0.05或P<0.01)。观察组不良反应发生率为7.27%(4/55),对照组为21.82%(12/55),观察组不良反应发生率显著低于对照组(P<0.05)。结论桃红四物汤化裁辅助治疗慢性心力衰竭伴下肢深静脉血栓慢性期血脉瘀阻证患者较西医基础治疗临床疗效更好,能有效改善患者临床症状、心功能、血液流变学和凝血功能指标,且安全性较好。 Objective To observe the effectiveness and safety of modified Taohong Siwu Decoction(桃红四物汤)for patients of chronic heart failure with lower limb deep vein thrombosis in the chronic stage of blood stasis syndrome.Methods A total of 120 patients of chronic heart failure with lower limb deep vein thrombosis in chronic stage of blood stasis syndrome were randomly divided into 60 cases each in control group and observation group.Both groups were given basic treatment of western medicine,and the observation group was additionally given modified Taohong Siwu Decoction(桃红四物汤)for oral administration,one dose per day.The treatment course for both groups lasted for 4 weeks.The total effective rate and the incidence of adverse reactions were compared between the two groups after treatment.Cardiac function indexes including left ventricular ejection fraction(LVEF),and left ventricular end-systolic internal diameter(LVESd),left ventricular end-diastolic internal diameter(LVEDd),serological indexes including N-terminal natriuretic natriuretic peptide precursor(NT-proBNP),high sensitivity C-reactive protein(hs-CRP)and vascular endothelial growth factor(VEGF),score of traditional Chinese medicine(TCM)symptom including chest pain,swelling of the affected limb,fixed tenderness,and bruising,haemodynamics indicators including high cut whole blood viscosity,low cut whole blood viscosity,and erythrocyte pressure,and coagulation indices including activated partial thromboplastin time(APTT),plasminogen time(PT),and fibrinogen(FIB)levels were compared before and after treatment.Results During the study,3 cases were excluded and 2 cases lost follow-up in the observation group,while 2 cases were excluded and 3 cases lost follow-up in the control group.A total of 110 patients completed the trial,55 cases in each of the two groups.The total effective rate in the observation group was 92.73%(51/55),which was significantly higher than that of the control group,78.18%(43/55,P<0.05).Compared within group before treatment,LVEF,APTT and PT levels increased,LVESd,LVEDd,NT-proBNP,hs-CRP,VEGF,high cut whole blood viscosity,low cut whole blood viscosity,erythrocyte pressure volume and FIB levels decreased,chest pain,swelling of the affected limbs,stationary pressure pain and bruising score decreased in both groups after treatment,and the improvement of all above indexes was better in the observation group than that in control group(P<0.05 or P<0.01).The incidence of adverse reactions was 7.27%(4/55)in the observation group and 21.82%(12/55)in the control group,and the incidence of adverse reactions in the observation group was significantly lower than that in the control group(P<0.05).Conclusion Modified Taohong Siwu Decoction(桃红四物汤)as adjuvant treatment for patients of chronic heart failure with lower limb deep vein thrombosis in the chronic stage of blood stasis syndrome showed better clinical effectiveness when compared with western basic treatment,which can improve the clinical symptoms,cardiac function,haemodynamics,and coagulation,with good safety.
作者 刘雪莲 牟丽娜 马莎莎 肖建东 张慧晶 LIU Xuelian;MOU Lina;MA Shasha;XIAO Jiandong;ZHANG Huijing(People's Hospital of Hengshui City,Hebei Province,053000;Sixth People's Hospital of Hengshui City)
出处 《中医杂志》 北大核心 2025年第12期1249-1256,共8页 Journal of Traditional Chinese Medicine
基金 河北省卫生厅科研基金项目(20232184)。
关键词 心力衰竭 下肢深静脉血栓 桃红四物汤 血脉瘀阻证 血液流变学 心功能 凝血功能 heart failure deep vein thrombosis of lower limbs Taohong Siwu Decoction(桃红四物汤) blood stasis syndrome haemodynamics cardiac function coagulation
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