| Background and ObjectionThe Venous thrombotic diseases of DVT, which is one of the The most common complication in Clinical surgery, is secondary to wound or operation. The treatment of DVT is always a Clinical treatment of difficulty. And The Common treatment, methods include Operation thrombectomy, anti-freezing, thrombolysis, Mechanical ablation, Angioplasty and so on.It is proved by dozens of years of clinical practice that anti-freezing and thrombolysis make important and remarkable treatment effect in the treatment of Deep vein thrombosis. The purpose of Thrombolytic therapy expects complete recovery of lower limb vein function. In order to facilitate the recovery of blood flow and maintain the normal valve function, Clinical treatment should strive for early dissolved completely primary thrombus. Commonly used thrombolytic drugs contant Streptokinase, Urokinase(UK), Recombinant tissue type plasminogen activator(rt-PA), Vermis kinase, Batroxobin, Reteplase etc, UK in especial. Anticoagulation therapy is the treatment of foundation, which Applied to DVT patient without bleeding tendency, malignant hypertension and with peptic ulcer, and Heparin, low molecular weight heparin in New (including danaparoid and heparin etc.), coumarin drugs and other new anticoagulant drugs inhibiting fibrin are The main application in it.Current anticoagulant therapy drugs are widely used heparin or low molecular weight heparin, But its role has many limitations. It performance for that heparin can not make binding to thrombin inactivation, which is the major stimulus of thrombosis and keeps the properties of always maintaining the enzyme activity, and not be inactivated by inhibitor in circle. A large number of applications of heparin, low molecular weight heparin in clinical can cause severe side effects,and heparin induced thrombocytopenia and thrombosis syndrome, HIT/HITTS, are Gradually recognized.At present, heparin-induced thrombocytopenia (HIT) is divided into two type. Type Ⅰ is mainly the use of early (less than4days) heparin platelet decreased slightly without stopping drugs. And the platelet count can be recovered within3days. Now that type I is a non immune response, which due to heparin on platelet direct impact, mainly appeared in the intravenous drip when large doses of heparin. Type Ⅱ is the application of heparin after4-14days blood platelet decrease (more than50%), and the platelet is usually count in between50x109and80x109Type Ⅱ is due to the immune response. Patients can produce antibodies (mainly IgG), and It happened without heparin dose and route of administration of influence and general at the injection site lesions. Despite a serious decline in platelet number in such patients are at risk for the formation of heparin induced thrombosis, but no risk of bleeding. Common thrombectomy in type Ⅱ are deep vein thrombosis, pulmonary embolism, cerebral thrombosis etc.Based on the above disadvantages of heparin, scholars continue to explore new anticoagulant drugs. Argatroban, larginine derived from, is chemical synthesis of the low molecular direct inhibition of thrombin preparations,and the relative molecular mass of whom is527u. Argatroban, directly related to the catalytic site of thrombin binding (including serine-histidine-arginine structure), inactivated thrombin. Because argatroban molecular weight is small, it can go into the thrombosis of the internal,and directly inactivate fibrin-bound thrombin has been associated with. Its role as these:(1) It can directly inactivate thrombin (Ila factor) activity, which has no direct effect on the generation of thrombin, and its action is not dependent on antithrombin.(2) It is not only the inactivation of thrombin in liquid phase, but also be able to inactivate with fibrin thrombus combined with thrombin.(3) It blocks the blood coagulation cascade positive feedback, and indirectly by inhibits thrombin generation.(4) Its therapeutic doses no effect on platelet function, and does not cause thrombocytopenia.(5) It has a good dose-response relationship, that effects and safety can be predicted.(6) It is associated with partial thromboplastin time (APTT) or activated clotting time (ACT) correlation.(7) It does not produce the associated antibodies.(8) It is mainly metabolized by the liver and renal impairment in patients do not require medication adjustment. At present argatroban has been approved for use in thrombotic diseases, such as:heparin induced thrombocytopenia and thrombosis, percutaneous coronary intervention, stroke thrombolysis, chronic arterial occlusive disease, superior mesenteric venous thrombosis etc. In vivo and in vitro studies show its broad application prospects, It also inhibits other roles of thrombin, for example, it could inhibit tumor metastasis, inflammatory process, restenosis after angioplasty etc.This research observe the clinical efficacy and complications,and explore treatment of acute traumatic deep vein thrombosis value by using argatroban combined with urokinase through the vascular ultrasound dynamic observation changes of limb blood flow, calibre, thrombus. To observe the possible complications and side effects of the treatment of acute traumatic deep vein thrombosis value by using argatroban combined with urokinase, In order to explore the therapeutic measures of safety.Methods1.1Inclusion and exclusion criteria1.1.1Diagnostic standard:①Patients with positive homan’s sign,whose affected limbs are painful, swollen, red, and warm,even worse are cyanosed or edematous.②Color doppler ultrasound scanning of the double lower limbs veins can reveal a blood clot and its extent.③Patients who is not with acute arterial embolism, acute lymphangitis or traumatic hematoma.1.1.2Inclusion criteria:①Patients with DVT,who have fracture of lower limb within one week,are only can be treated by anticoagulation.②Patients with no contraindications for anticoagulation and with no liver and kidney function damage.③Patients under60year of age.④Patients with no other diseases due to internal bleeding in the short term.1.1.3Exclusion criteria:①Patients with severe cardiovascular complications,liver complications or kidneycomplications.②Patients who are pregnant or lactating women.③Patients with psychological disorders④Patients with hematologic diseases or active bleeding within two weeks. ⑤Patients with stroke or intracranial lesions orbiopsy,⑥Patients with internal bleeding caused by trauma,surgery in two months.⑦Patients with unstable hypertension⑧Patients with subacute endocarditis or blood clot in the left atrium.⑨Patients who have incomplete information.Patients who meet the standard are diveded into two groups randomly.They will do color doppler ultrasound on the affected limb and take blood tests before the treatment as a contrast. This is a randomised controlled trial carried out by the same method and the same experimenters.1.2Anticoagulation1.2.1Study group①Anticoagulation:argatroban20mg added to250ml of0.9%saline Intravenous infusion within3hours twice a day,two weeks as a course of treatment.②Thrombolysis:urokinase(UK)300000U added to500ml of0.9%saline injection via superficial dorsal vein of foot by small dose,twist the tourniquet10cm above the ankle,once a day,two weeks is a course of treatment,③Antiplatelet:Enteric coated aspirin by oral twice a day,6months is a course of treatment.④General treatment:Bed rest and raise the affected limb high. A serious complication of a early onset TDVT is that the clot could dislodge and travel to the lungs, which is called a pulmonary embolism (PE).So patients need absolute bed rest.Don’t press on the affected limb or use a hot compress or massage.The affected limb should be raised above the cardiac plane20to30cm.The knee joint should be laid down5°to10°so that patients can relieve from edema and pain by venous return. Patient should wear the stretch socks and get out of the bed after10days of treatment. 1.2.2Control group①Anticoagulation:Low molecular heparin calcium5000U subcutaneous injection twice a day,two weeks is a course of treatment.②Thrombolysis:urokinase(UK)300000U added to500ml of0.9%saline injection via superficial dorsal vein of foot by small dose,twist the tourniquet10cm above the ankle,once a day,two weeks is a course of treatment,③Antiplatelet:Enteric coated aspirin by oral twice a day,6months is a course of treatment.④General treatment’.Bed rest and raise the affected limb high. A serious complication of a early onset TDVT is that the clot could dislodge and travel to the lungs, which is called a pulmonary embolism (PE).So patients need absolute bed rest.Don’t press on the affected limb or use a hot compress or massage.The affected limb should be raised above the cardiac plane20to30cm.The knee joint should be laid down5°to10°so that patients can relieve from edema and pain by venous return. Patient should wear the stretch socks and get out of the bed after10days of treatment.1.3Observation index and Detection index1.3.1Clinical examination①Clinical efficacy:include the symptoms and limb circumference difference. Limb circumference measurement:standars,determination of bilateral limb circumference difference of knee15cm below the knee15era circumference. Limb circumference<1cm of normal people.②Complication:Pulmonary embolism which causes dyspnea or hemoptysis and intracranial hemorrhage which causes headache or vomit.③Adverse reaction:such as hematuria,fecal occult blood,allergy,subcutaneous hemorrhage ect.1.3.2Color doppler ultrasoundScan the color doppler ultrasound of the double lower limbs before treatment and after the1,3,7,10,14day of treatment to observe the blood clot and the changes in blood flow.1.3Efficacy criterion:①markedly:thesigns and symptoms completely disappeared,color Doppler ultrasound confirmed that the blood flow,limb circumference difference between the affected limb and the healthy limb<2cm.②effective:symptoms and signs disappeared,mild limb swelling and discomfort after the event,color doppler shows blood flow to improve that is part of recanalization and limb circumference difference>2cm.③Less effective:symptoms and signs disappeared in some drgree, color Doppler shows no blood flow and limb circumference difference>2cm.④Invalid:signs and symptoms are the same, color Doppler shows no blood flow and limb circumference difference<2cm.1.4Statistics AnalysisThe data processing is analyze by SPSS13.0software.Measurement data is represented by (x±s).The rank sum test is used to analyze the efficacy.The t-test of two independent samples is used to analyze the differences between experimental group and control group before treatment. Enumeration data is represented by rate.The x2test is used to analyze the differences between groups of experimental group and control group before treatment. The Mann-Whitney test is used to analyze the differences of the healing efficacy and the rusults with color doppler after treatment. P<0.05indicate that the difference has statistical significance.ResultsThe total effective rate of study group was100%while the control group was76.7%(P<0.05).There was no side reactions in both groups.But there were cases of subcutaneous hemorrhage and pain after Low molecular heparin calcium subcutaneous injection in control group.ConclusionsTo conclude,the total effective rate of study group is higher and complication rate is lower. We can indicate that the treatment of acute traumatic deep vein thrombosis by using Argatroban combined with urokinase is safe and effective.Moreover, it’s worthy of clinical application. |
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