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化瘀丸治疗中晚期恶性肿瘤患者血液高凝状态的临床研究

Clinical Study of Huayu Pills in the Treatment of Blood Hypercoagulability in Patients with Advanced Malignant Tumors
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摘要 目的:探讨化瘀丸治疗中晚期恶性肿瘤患者血液高凝状态的临床疗效和安全性。方法:选取2018年6月至2021年12月北京中医医院肿瘤科门诊和病房的中晚期恶性肿瘤血液高凝状态患者72例作为研究对象。采用前瞻性队列研究,根据是否应用化瘀丸分为观察组(n=35)和对照组(n=37)。对照组接受必要的物理对症支持治疗,观察组在对照组基础上口服化瘀丸8周,2组共随访24周。观察2组患者的血液高凝状态改善率、凝血指标变化、中医证候积分、静脉血栓栓塞(VTE)大出血发生,以及不良事件发生情况。结果:4周后,观察组血液高凝状态改善率为43.75%,对照组为29.41%(P>0.05);8周后,观察组血液高凝状态改善率为65.63%,对照组为41.18%(P<0.05)。进一步分析凝血相关指标变化,发现4周和8周后观察组血浆纤维蛋白原(FIB)低于对照组(P<0.05)。观察组患者中医证候积分改善的总有效率为50.00%,对照组为14.81%(P<0.05),2组患者均未出现大出血情况,观察组未发生药物相关不良事件。结论:化瘀丸可以在必要的物理支持治疗外,进一步改善中晚期恶性肿瘤患者血液高凝状态,缓解血瘀证相关症状。 Objective:To investigate the clinical efficacy and safety of Huayu Pills in treating blood hypercoagulability in patients with advanced malignant tumors.Methods:Seventy-two blood hypercoagulability patients with advanced malignant tumors from the Oncology Department and inpatient wards of Beijing Hospital of Traditional Chinese Medicine between June 2018 and December 2021 were enrolled.A prospective cohort study design was used,and patients were divided into an observation group(n=35)and a control group(n=37)based on whether they received Huayu Pills.The control group received necessary physical symptomatic support,while the observation group received Huayu Pills orally for 8 weeks in addition to the support treatment.Both groups were followed for a total of 24 weeks.Improvement rates in blood hypercoagulability,changes in coagulation indicators,TCM syndrome scores,incidence of venous thromboembolism(VTE)and major bleeding,and adverse events of the two groups were observed.Results:After 4 weeks,the improvement rate of blood hypercoagulability in the observation group was 43.75%,higher than 29.41%in the control group(P>0.05).After 8 weeks,the improvement rate in the observation group was 65.63%,significantly higher than 41.18%in the control group(P<0.05).Further analysis showed that plasma fibrinogen(FIB)levels were lower in the observation group than the control group at both 4 and 8 weeks(P<0.05).The total effective rate of improvement in TCM syndrome score was 50.00%in the observation group and 14.81%in the control group(P<0.05).No major bleeding occurred in either group,and no drug-related adverse events were reported in the observation group.Conclusion:Huayu Pills,in addition to necessary physical support treatment,can further improve blood hypercoagulability and alleviate symptoms related to blood stasis in patients with advanced malignant tumors.
作者 张怡 李晓晓 杨国旺 富琦 王笑民 ZHANG Yi;LI Xiaoxiao;YANG Guowang;FU Qi;WANG Xiaomin(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)
出处 《世界中医药》 CAS 北大核心 2024年第15期2329-2333,共5页 World Chinese Medicine
基金 国家自然科学基金青年科学基金项目(82104949) 北京市属医院科研培育计划项目(PZ2018013)。
关键词 中医药 化瘀丸 中晚期恶性肿瘤 血液高凝状态 血瘀证 凝血指标 中医证候 临床研究 Traditional Chinese medicine Huayu Pills Advanced malignant tumors Blood hypercoagulability Blood stasis syndrome Coagulation indicators Traditional Chinese medicine syndrome Clinical study
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