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[1]孟祥亞,馬士超,陳秀民.加味桂枝茯苓丸口服聯(lián)合低分子量肝素鈣皮下注射預(yù)防全膝關(guān)節(jié)置換術(shù)后氣滯血瘀證患者深靜脈血栓形成的臨床研究[J].中醫(yī)正骨,2023,35(12):30-35.
　MENG Xiangya,MA Shichao,CHEN Xiumin.[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2023,35(12):30-35.
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加味桂枝茯苓丸口服聯(lián)合低分子量肝素鈣皮下注射預(yù)防全膝關(guān)節(jié)置換術(shù)后氣滯血瘀證患者深靜脈血栓形成的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第35卷
期數(shù):
2023年12期
頁碼:
30-35
欄目:
臨床研究
出版日期:
2023-12-20

文章信息/Info

作者:
孟祥亞1; 馬士超2; 陳秀民2
1.河南中醫(yī)藥大學(xué)骨傷學(xué)院,河南 鄭州 450046; 2.濮陽市中醫(yī)醫(yī)院,河南 濮陽 457003
Author(s):
MENG Xiangya1; MA Shichao2; CHEN Xiumin2
1.College of Orthopaedics and Traumatology of Henan University of Chinese Medicine,Zhengzhou 450046,Henan,China 2.Chinese Medicine Hospital of Puyang,Puyang 457003,Henan,China
關(guān)鍵詞:
靜脈血栓形成;  桂枝茯苓丸;  肝素; 低分子量;  血瘀氣滯;  關(guān)節(jié)成形術(shù); 置換; 膝;  臨床試驗(yàn)
Keywords:
venous thrombosis;  Guizhi Fuling Wan;  heparin; low-molecular-weight;  syndrome of blood stasis and Qi stagnation;  arthroplasty; replacement; knee;  clinical trial
摘要:
目的:觀察加味桂枝茯苓丸口服聯(lián)合低分子量肝素鈣皮下注射預(yù)防全膝關(guān)節(jié)置換術(shù)(total knee arthroplasty,TKA)后氣滯血瘀證患者深靜脈血栓形成(deep venous thrombosis,DVT)的臨床療效和安全性。方法:將TKA后辨證為氣滯血瘀證的患者隨機(jī)分為2組,分別采用加味桂枝茯苓丸口服聯(lián)合低分子量肝素鈣皮下注射(聯(lián)合治療組)與單純低分子量肝素鈣皮下注射(基礎(chǔ)治療組)治療。加味桂枝茯苓丸水煎后口服,每日2次,每次200 mL; 低分子量肝素鈣皮下注射,每日2次(間隔12 h),每次0.2 mL; 均連續(xù)治療14 d。比較2組患者的DVT發(fā)生率、膝部疼痛視覺模擬量表(visual analogue scale,VAS)評分、凝血酶原時(shí)間(prothrombin time,PT)、活化部分凝血活酶時(shí)間(activated partial thromboplastin time,APTT)、血漿纖維蛋白原(fibrinogen,FIB)含量、血漿D-二聚體含量及不良反應(yīng)發(fā)生率。結(jié)果:共納入92例患者,每組46例。聯(lián)合治療組2例發(fā)生DVT,均為脛后靜脈血栓; 基礎(chǔ)治療組9例發(fā)生 DVT,其中3例為脛前靜脈血栓、6例為脛后靜脈血栓; 聯(lián)合治療組的DVT發(fā)生率低于基礎(chǔ)治療組(χ2=5.059,P=0.024)。術(shù)后7 d、14 d,聯(lián)合治療組的膝部疼痛VAS評分均低于基礎(chǔ)治療組(t=2.141,P=0.035; t=9.528,P=0.001),聯(lián)合治療組的PT和APTT均長于基礎(chǔ)治療組(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),聯(lián)合治療組的血漿FIB含量和D-二聚體含量均低于基礎(chǔ)治療組(FIB:t=2.337,P=0.022; t=5.184,P=0.001; D-二聚體:t=2.119,P=0.037; t=18.913,P=0.001)。聯(lián)合治療組未發(fā)生不良反應(yīng),基礎(chǔ)治療組2例患者術(shù)后2 d出現(xiàn)廣泛皮下瘀斑; 2組患者不良反應(yīng)發(fā)生率比較,差異無統(tǒng)計(jì)學(xué)意義(χ2=0.511,P=0.475)。結(jié)論:加味桂枝茯苓丸口服聯(lián)合低分子量肝素鈣皮下注射預(yù)防TKA后氣滯血瘀證患者DVT的效果優(yōu)于單純應(yīng)用低分子量肝素鈣皮下注射,且前者減輕術(shù)后膝部疼痛的效果優(yōu)于后者,但兩者的安全性相當(dāng); 加味桂枝茯苓丸口服聯(lián)合低分子量肝素鈣皮下注射預(yù)防TKA后氣滯血瘀證患者DVT的作用機(jī)制,可能與其抑制機(jī)體內(nèi)源性和外源性凝血有關(guān)。
Abstract:
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(χ2=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=18.913,P=0.001).No patients experienced adverse reactions in combination treatment group; while 2 patients developed extensive subcutaneous ecchymosis at postoperative day 2 in basic treatment group.There was no statistical difference in the incidence rate of adverse reactions between the 2 groups(χ2=0.511,P=0.475).Conclusion:The clinical outcome of combination of oral application of JWGZFLW with subcutaneous injection of LMWH-Ca is better than that of monotherapy of subcutaneous injection of LMWH-Ca in preventing of DVT in patients with qi-stagnation and blood-stasis syndrome after TKA,furthermore,the former is superior in alleviating postoperative knee pain compared to the latter with similar safety,and its mechanisms may be that it works by inhibiting the endogenous and exogenous blood coagulation within the body.

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中醫(yī)正骨2023年12月第35卷第12期 J Trad Chin Orthop Trauma,2023,Vol.35,No.12(總915)
(總916)中醫(yī)正骨2023年12月第35卷第12期 J Trad Chin Orthop Trauma,2023,Vol.35,No.12
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備注/Memo

備注/Memo:
基金項(xiàng)目:河南省中醫(yī)藥科學(xué)研究專項(xiàng)課題項(xiàng)目(2022ZY1192)
通訊作者:陳秀民 E-mail:[email protected]
更新日期/Last Update: 1900-01-01