加味桂枝茯苓丸口服联合低分子量肝素钙皮下注射预防全膝关节置换术后气滞血瘀证患者深静脉血栓形成的临床研究  

Oral application of Jiawei Guizhi Fuling Wan(加味桂枝茯苓丸)combined with subcutaneous injection of low-molecular-weight heparin calcium for prevention of deep venous thrombosis in patients with qi-stagnation and blood-stasis syndrome after total knee arthroplasty:a clinical study

作　　者：孟祥亚 马士超 陈秀民 MENG Xiangya;MA Shichao;CHEN Xiumin(College of Orthopaedics and Traumatology of Henan University of Chinese Medicine,Zhengzhou 450046,Henan,China;Chinese Medicine Hospital of Puyang,Puyang 457003,Henan,China)

机构地区：[1]河南中医药大学骨伤学院,河南郑州450046 [2]濮阳市中医医院,河南濮阳457003

出　　处：《中医正骨》2023年第12期30-35,共6页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：河南省中医药科学研究专项课题项目(2022ZY1192)。

摘　　要：目的:观察加味桂枝茯苓丸口服联合低分子量肝素钙皮下注射预防全膝关节置换术(total knee arthroplasty,TKA)后气滞血瘀证患者深静脉血栓形成(deep venous thrombosis,DVT)的临床疗效和安全性。方法:将TKA后辨证为气滞血瘀证的患者随机分为2组,分别采用加味桂枝茯苓丸口服联合低分子量肝素钙皮下注射(联合治疗组)与单纯低分子量肝素钙皮下注射(基础治疗组)治疗。加味桂枝茯苓丸水煎后口服,每日2次,每次200 mL;低分子量肝素钙皮下注射,每日2次(间隔12 h),每次0.2 mL;均连续治疗14 d。比较2组患者的DVT发生率、膝部疼痛视觉模拟量表(visual analogue scale,VAS)评分、凝血酶原时间(prothrombin time,PT)、活化部分凝血活酶时间(activated partial thromboplastin time,APTT)、血浆纤维蛋白原(fibrinogen,FIB)含量、血浆D-二聚体含量及不良反应发生率。结果:共纳入92例患者,每组46例。联合治疗组2例发生DVT,均为胫后静脉血栓;基础治疗组9例发生DVT,其中3例为胫前静脉血栓、6例为胫后静脉血栓;联合治疗组的DVT发生率低于基础治疗组(χ^(2)=5.059,P=0.024)。术后7 d、14 d,联合治疗组的膝部疼痛VAS评分均低于基础治疗组(t=2.141,P=0.035;t=9.528,P=0.001),联合治疗组的PT和APTT均长于基础治疗组(PT:t=5.292,P=0.001;t=3.160,P=0.002;APTT:t=3.007,P=0.003;t=2.975,P=0.004),联合治疗组的血浆FIB含量和D-二聚体含量均低于基础治疗组(FIB:t=2.337,P=0.022;t=5.184,P=0.001;D-二聚体:t=2.119,P=0.037;t=18.913,P=0.001)。联合治疗组未发生不良反应,基础治疗组2例患者术后2 d出现广泛皮下瘀斑;2组患者不良反应发生率比较,差异无统计学意义(χ^(2)=0.511,P=0.475)。结论:加味桂枝茯苓丸口服联合低分子量肝素钙皮下注射预防TKA后气滞血瘀证患者DVT的效果优于单纯应用低分子量肝素钙皮下注射,且前者减轻术后膝部疼痛的效果优于后者,但两者的安全性相当;加味桂枝茯Objective:To observe the clinical outcomes and safety of oral application of Jiawei Guizhi Fuling Wan(加味桂枝茯苓丸,JWGZFLW)combined with subcutaneous injection of low-molecular-weight heparin calcium(LMWH-Ca)for prevention of deep venous thrombosis(DVT)in patients with qi-stagnation and blood-stasis syndrome who underwent total knee arthroplasty(TKA).Methods:The patients who were diagnosed with qi-stagnation and blood-stasis syndrome after TKA were randomized into 2 groups,and were treated with oral application of JWGZFLW in combination with subcutaneous injection of LMWH-Ca(combination treatment group)and subcutaneous injection of LMWH-Ca alone(basic treatment group)respectively.The JWGZFLW was decocted and then taken twice a day,200 mL at a time for consecutive 14 days,and the subcutaneous injection of LMWH-Ca was performed twice a day with a 12-hour interval between injections,0.2 mL at a time for consecutive 14 days.The incidence rate of DVT,knee pain visual analogue scale(VAS)score,prothrombin time(PT),activated partial thromboplastin time(APTT),plasma fibrinogen(FIB)level,plasma D-dimer level and incidence rate of adverse reactions were recorded and compared between the 2 groups respectively.Results:Ninety-two patients were enrolled in the study,46 cases in each group.Two patients experienced the posterior tibial vein thrombosis in combination treatment group;while,3 ones experienced the anterior tibial vein thrombosis and 6 ones experienced the posterior tibial vein thrombosis in basic treatment group.The incidence rate of DVT was lower in combination treatment group compared to basic treatment group(χ^(2)=5.059,P=0.024).At postoperative day 7 and 14,the combination treatment group displayed the lower knee pain VAS score,longer PT and APTT,decreased plasma FIB and D-dimer levels compared with that of basic treatment group(VAS score:t=2.141,P=0.035;t=9.528,P=0.001;PT:t=5.292,P=0.001;t=3.160,P=0.002;APTT:t=3.007,P=0.003;t=2.975,P=0.004;FIB:t=2.337,P=0.022;t=5.184,P=0.001;D-dimer:t=2.119,P=0.037;t=1

关 键 词：静脉血栓形成 桂枝茯苓丸 肝素 低分子量 血瘀气滞 关节成形术 置换 膝 临床试验 

分 类 号：R687.4[医药卫生—骨科学]