CAJ | 학술논문

目的：探讨桃红四物汤预防全髋关节置换术后并发下肢深静脉血栓形成的有效性及安全性。方法：初次行单侧全髋关节置换术患者60例，随机分为2组，每组30例。观察组予以桃红四物汤口服，对照组予以利伐沙班片口服，连续服用2周。观察2组患者凝血指标、下肢深静脉血栓形成情况及用药安全情况。结果：手术前后不同时间点间活化部分凝血酶时间、凝血酶原时间及D-二聚体检测结果比较，差异均有统计学意义，存在时间效应（F＝3．803，P＝0．025；F＝25．584，P＝0．000；F＝26．099，P＝0．000）；2组间活化部分凝血酶时间、凝血酶原时间及 D-二聚体检测结果比较，差异均无统计学差异，不存在分组效应（F＝0．271，P＝0．605；F＝1．653，P＝0．204；F＝0．930，P＝0．339）；时间因素与分组因素不存在交互效应（F＝2．312，P＝0．104；F＝0．528，P＝0．591；F＝0．351，P＝0．694）。手术前后不同时间点间国际标准化比率检测结果比较，差异无统计学意义，不存在时间效应（F＝3．814，P＝0．052）；2组间国际标准化比率检测结果比较，差异均无统计学差异，不存在分组效应（F＝0．006，P＝0．936）；时间因素与分组因素不存在交互效应（F＝0．092，P＝0．786）。观察组并发深静脉血栓形成3例，股静脉2例，静脉1例；对照组并发深静脉血栓形成2例，股静脉1例，静脉1例；2组间深静脉血栓形成发生率比较，差异无统计学意义（χ2＝0．218，P＝0．640）。2组间术中出血量、输血量及术后引流量比较差异均无统计学意义[（449．33±87．74）mL，（455．76±76．88） mL；t＝-0．302，P＝0．764；（273．33±108．07）mL，（263．33±115．92）mL；t＝0．346，P＝0．731；（269．68±72．36）mL，（271．59±66．96）mL；t＝-0．106，P＝0．916]。手术前后不同时间点间血红蛋白含量比较，差异有统计学意义，存在时间效应（F＝18．019， P＝0．000）；2组间血红蛋白含量比较，差异无统计学意义，不存在分组效应（F＝1．950，P＝0．168）；时间因素与分组因素不存在交互效应（F＝0．343，P＝0．710）。2组患者用药期间均无消化道出血、皮肤黏膜出血及消化道不适等不良反应发生，均未发生药物过敏反应，肝、肾功能检查无异常。结论：桃红四物汤口服用于全髋关节置换术后深静脉血栓形成的预防，有效性和安全性与口服利伐沙班片相当。目的：探討桃紅四物湯預防全髖關節置換術後併髮下肢深靜脈血栓形成的有效性及安全性。方法：初次行單側全髖關節置換術患者60例，隨機分為2組，每組30例。觀察組予以桃紅四物湯口服，對照組予以利伐沙班片口服，連續服用2週。觀察2組患者凝血指標、下肢深靜脈血栓形成情況及用藥安全情況。結果：手術前後不同時間點間活化部分凝血酶時間、凝血酶原時間及D-二聚體檢測結果比較，差異均有統計學意義，存在時間效應（F＝3．803，P＝0．025；F＝25．584，P＝0．000；F＝26．099，P＝0．000）；2組間活化部分凝血酶時間、凝血酶原時間及 D-二聚體檢測結果比較，差異均無統計學差異，不存在分組效應（F＝0．271，P＝0．605；F＝1．653，P＝0．204；F＝0．930，P＝0．339）；時間因素與分組因素不存在交互效應（F＝2．312，P＝0．104；F＝0．528，P＝0．591；F＝0．351，P＝0．694）。手術前後不同時間點間國際標準化比率檢測結果比較，差異無統計學意義，不存在時間效應（F＝3．814，P＝0．052）；2組間國際標準化比率檢測結果比較，差異均無統計學差異，不存在分組效應（F＝0．006，P＝0．936）；時間因素與分組因素不存在交互效應（F＝0．092，P＝0．786）。觀察組併髮深靜脈血栓形成3例，股靜脈2例，靜脈1例；對照組併髮深靜脈血栓形成2例，股靜脈1例，靜脈1例；2組間深靜脈血栓形成髮生率比較，差異無統計學意義（χ2＝0．218，P＝0．640）。2組間術中齣血量、輸血量及術後引流量比較差異均無統計學意義[（449．33±87．74）mL，（455．76±76．88） mL；t＝-0．302，P＝0．764；（273．33±108．07）mL，（263．33±115．92）mL；t＝0．346，P＝0．731；（269．68±72．36）mL，（271．59±66．96）mL；t＝-0．106，P＝0．916]。手術前後不同時間點間血紅蛋白含量比較，差異有統計學意義，存在時間效應（F＝18．019， P＝0．000）；2組間血紅蛋白含量比較，差異無統計學意義，不存在分組效應（F＝1．950，P＝0．168）；時間因素與分組因素不存在交互效應（F＝0．343，P＝0．710）。2組患者用藥期間均無消化道齣血、皮膚黏膜齣血及消化道不適等不良反應髮生，均未髮生藥物過敏反應，肝、腎功能檢查無異常。結論：桃紅四物湯口服用于全髖關節置換術後深靜脈血栓形成的預防，有效性和安全性與口服利伐沙班片相噹。
목적：탐토도홍사물탕예방전관관절치환술후병발하지심정맥혈전형성적유효성급안전성。방법：초차행단측전관관절치환술환자60례，수궤분위2조，매조30례。관찰조여이도홍사물탕구복，대조조여이리벌사반편구복，련속복용2주。관찰2조환자응혈지표、하지심정맥혈전형성정황급용약안전정황。결과：수술전후불동시간점간활화부분응혈매시간、응혈매원시간급D-이취체검측결과비교，차이균유통계학의의，존재시간효응（F＝3．803，P＝0．025；F＝25．584，P＝0．000；F＝26．099，P＝0．000）；2조간활화부분응혈매시간、응혈매원시간급 D-이취체검측결과비교，차이균무통계학차이，불존재분조효응（F＝0．271，P＝0．605；F＝1．653，P＝0．204；F＝0．930，P＝0．339）；시간인소여분조인소불존재교호효응（F＝2．312，P＝0．104；F＝0．528，P＝0．591；F＝0．351，P＝0．694）。수술전후불동시간점간국제표준화비솔검측결과비교，차이무통계학의의，불존재시간효응（F＝3．814，P＝0．052）；2조간국제표준화비솔검측결과비교，차이균무통계학차이，불존재분조효응（F＝0．006，P＝0．936）；시간인소여분조인소불존재교호효응（F＝0．092，P＝0．786）。관찰조병발심정맥혈전형성3례，고정맥2례，정맥1례；대조조병발심정맥혈전형성2례，고정맥1례，정맥1례；2조간심정맥혈전형성발생솔비교，차이무통계학의의（χ2＝0．218，P＝0．640）。2조간술중출혈량、수혈량급술후인류량비교차이균무통계학의의[（449．33±87．74）mL，（455．76±76．88） mL；t＝-0．302，P＝0．764；（273．33±108．07）mL，（263．33±115．92）mL；t＝0．346，P＝0．731；（269．68±72．36）mL，（271．59±66．96）mL；t＝-0．106，P＝0．916]。수술전후불동시간점간혈홍단백함량비교，차이유통계학의의，존재시간효응（F＝18．019， P＝0．000）；2조간혈홍단백함량비교，차이무통계학의의，불존재분조효응（F＝1．950，P＝0．168）；시간인소여분조인소불존재교호효응（F＝0．343，P＝0．710）。2조환자용약기간균무소화도출혈、피부점막출혈급소화도불괄등불량반응발생，균미발생약물과민반응，간、신공능검사무이상。결론：도홍사물탕구복용우전관관절치환술후심정맥혈전형성적예방，유효성화안전성여구복리벌사반편상당。
Objective:To observe the effectiveness and safety of oral application of TAOHONG SIWU decoction in preventing deep ve-nous thrombosis(DVT)after total hip arthroplasty(THA).Methods:Sixty patients underwent unilateral THA were randomly divided into 2 groups,30 cases in each group.The patients in the treatment group were treated with oral application of TAOHONG SIWU decoction,while the others in control group were treated with Rivaroxaban orally.All patients in both groups were treated for 2 weeks.Then the coagulation indicators,DVT incidence and the safety indicators were observed.Results:There was statistical difference in APTT,PT and D-dimer level between different time points,in other words,there was time effect(F=3.803,P=0.025;F=25.584,P=0.000;F=26.099,P=0.000).There was no statistical difference in APTT,PT and D-dimer level between the 2 groups,in other words,there was no group effect (F=0.271 ,P=0.605;F=1 .653,P=0.204;F=0.930,P=0.339).There was no interaction between time factor and grouping factor (F=2.31 2,P=0.1 04;F=0.528,P=0.591;F=0.351 ,P=0.694).There was no statistical difference in INR between different time points,in other words,there was no time effect(F=3.81 4,P=0.052).There was no statistical difference in INR between the 2 groups,in other words,there was no group effect(F=0.006,P=0.936).There was no interaction between time factor and grouping factor(F=0.092,P=0.786).DVT was found in 3 cases of treatment group,2 in femoral vein and one in popliteal vein.DVT was found in 2 cases of control group,one in femoral vein and one in popliteal vein.There was no statistical significance in the incidence of DVT between the 2 groups(χ2 =0.21 8,P=0.640).There was no statistical difference in intraoperative blood loss,total blood transfusions and postoperative drainage between the two groups(449.33+/-87.74 vs 455.76+/-76.88 mL,t=-0.302,P=0.764;273.33+/-1 08.07 vs 263.33+/-1 1 5.92 mL,t=0.346,P=0.731;269.68+/-72.36 vs 271 .59 +/-66.96 mL,t=-0.1 06,P=0.91 6).There was statistical difference in HGB between different time points(F=1 8.01 9,P=0.000),in other words,there was time effect.There was no statistical difference in HGB between the 2 groups(F=1 .950,P=0.1 68),in other words,there was no group effect.There was no interaction between time factor and grouping factor(F=0.343,P=0.71 0).No adverse effect was observed such as alimentary tract hemorrhage,skin and mucosa hemor-rhage,alimentary tract indisposition,drug allergy,hepatic disfunction and renal disfunction in both groups.Conclusion:Oral application of TAOHONG SIWU decoction is similar to oral application of Rivaroxaban in effectiveness and safety in preventing DVT after THA.