1.衡水市人民医院,河北省衡水市人民东路180号,053000
2.衡水市第六人民医院
lx_lian@163.com
收稿:2024-12-04,
修回:2025-04-03,
纸质出版:2025-06-17
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刘雪莲,牟丽娜,马莎莎等.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[J].中医杂志,2025,66(12):1249-1256.
LIU Xuelian,MOU Lina,MA Shasha,et al.Clinical Observation Adjuvant Treatment with Modified Taohong Siwu Decoction (桃红四物汤) for Patients of Chronic Heart Failure Complicated with Lower Limb Deep Vein Thrombosis in the Chronic Stage of Blood Stasis Syndrome:A Randomize Controlled Clinical Trial[J].Journal of Traditional Chinese Medicine,2025,66(12):1249-1256.
刘雪莲,牟丽娜,马莎莎等.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[J].中医杂志,2025,66(12):1249-1256. DOI: 10.13288/j.11-2166/r.2025.12.010.
LIU Xuelian,MOU Lina,MA Shasha,et al.Clinical Observation Adjuvant Treatment with Modified Taohong Siwu Decoction (桃红四物汤) for Patients of Chronic Heart Failure Complicated with Lower Limb Deep Vein Thrombosis in the Chronic Stage of Blood Stasis Syndrome:A Randomize Controlled Clinical Trial[J].Journal of Traditional Chinese Medicine,2025,66(12):1249-1256. DOI: 10.13288/j.11-2166/r.2025.12.010.
目的
2
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
2
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
2
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
2
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
2
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
2
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
2
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 observa
tion 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
2
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.
张亚男 , 斯日古楞 , 杨宏昕 , 等 . 2023欧洲心脏病学会心力衰竭协会《临床共识声明:慢性心力衰竭恶化的定义、流行病学、管理和预防》解读 [J]. 世界临床药物 , 2023 , 44 ( 10 ): 1017 - 1021 .
中国微循环学会周围血管疾病专业委员会下肢静脉腔内治疗专业委员会 . 下肢深静脉血栓形成后综合征腔内治疗专家共识 [J]. 血管与腔内血管外科杂志 , 2023 , 9 ( 7 ): 769 - 776,787 .
吕丽琼 , 曹晓璐 , 邓宏平 , 等 . 下肢深静脉血栓患者抗凝治疗依从性的研究进展 [J]. 血管与腔内血管外科杂志 , 2022 , 8 ( 6 ): 694 - 698 .
KIM KA , CHOI SY , KIM R . Endovascular treatment for lower extremity deep vein thrombosis: an overview [J]. Korean J Radiol , 2021 , 22 ( 6 ): 931 - 943 .
中华中医药学会慢性心力衰竭中医诊疗指南项目组 . 慢性心力衰竭中医诊疗指南(2022年) [J]. 中医杂志 , 2023 , 64 ( 7 ): 743 - 756 .
陈红风 . 中医外科学 [M]. 北京 : 中国中医药出版社 , 2021 : 337 .
中华医学会心血管病学分会心力衰竭学组 , 中国医师协会心力衰竭专业委员会 , 中华心血管病杂志编辑委员会 . 中国心力衰竭诊断和治疗指南2018 [J]. 中华心血管病杂志 , 2018 , 46 ( 10 ): 760 - 789 .
李晓强 , 张福先 , 王深明 . 深静脉血栓形成的诊断和治疗指南(第三版) [J]. 中国血管外科杂志 (电子版), 2017 , 9 ( 4 ): 250 - 257 .
郑筱萸 . 中药新药临床研究指导原则(试行) [M]. 北京 : 中国医药科技出版社 , 2002 : 77 - 81 .
万霞 , 刘建平 . 临床研究中的样本量估算:(2)观察性研究 [J]. 中医杂志 , 2007 , 48 ( 7 ): 599 - 601 .
叶晓岚 . 分析心力衰竭并下肢深静脉血栓形成中西医结合治疗效果 [J]. 双足与保健 , 2018 , 27 ( 24 ): 65 - 66 .
李晓良 , 葛占洲 . 桃红四物汤对髋关节骨折术后下肢深静脉血栓形成防治效果观察 [J]. 实用中医药杂志 , 2022 , 38 ( 7 ): 1086 - 1088 .
余晓威 . 芪参茯苓膏治疗气虚血瘀型慢性心力衰竭的临床研究 [D]. 合肥 : 安徽中医药大学 , 2022 .
国家中医药管理局 . 中医病证诊断疗效标准 [M]. 南京 : 南京大学出版社 , 1994 : 258 - 259 .
NAVARRETE S , SOLAR C , TAPIA R , et al . Pathophysiology of deep vein thrombosis [J]. Clin Exp Med , 2023 , 23 ( 3 ): 645 - 654 .
BRODERICK C , WATSON L , ARMON MP . Thrombolytic strategies versus standard anticoagulation for acute deep vein thrombosis of the lower limb [J]. Cochrane Database Syst Rev , 2021 , 1 ( 1 ): CD002783 .
来晓磊 , 黄明月 , 刘红旭 , 等 . 中医药治疗慢性心力衰竭系统评价/Meta分析的方法学与报告质量评价 [J]. 中医杂志 , 2023 , 64 ( 15 ): 1544 - 1549 .
张玉婷 , 詹红生 , 俞仲翔 . 补肾活血方联合低分子肝素等防治老年髋部骨折术后下肢深静脉血栓的临床研究 [J]. 上海中医药杂志 , 2021 , 55 ( 12 ): 61 - 64,73 .
王静 , 冯晓丹 , 王卫友 . 柴黄活血汤防治髋关节置换术后下肢深静脉血栓形成疗效观察 [J]. 四川中医 , 2020 , 38 ( 7 ): 160 - 163 .
邓晶晶 , 江华娟 , 兰兴 , 等 . 基于网络药理学和分子对接探究经典名方桃红四物汤异病同治作用机制 [J]. 中草药 , 2021 , 52 ( 10 ): 3018 - 3029 .
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