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Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases.
Gallelli, G, Di Mizio, G, Palleria, C, Siniscalchi, A, Rubino, P, Muraca, L, Cione, E, Salerno, M, De Sarro, G, Gallelli, L
Nutrients. 2021;(6)
Abstract
Nattokinase (NK) is a serine protease enzyme with fibrinolytic activity. Even if it could be used for the treatment of several diseases, no data have been published supporting its use patients who underwent vascular surgery. In this study, we evaluated both the efficacy and the safety of nattokinase (100 mg/day per os) in patients admitted to vascular surgery. Patients were of both sexes, >18 years of age, with vascular diseases (i.e., deep vein thrombosis, superficial vein thrombosis, venous insufficiency), and naïve to specific pharmacological treatments (anticoagulants or anti-platelets). Patients were divided into three groups. Group 1: patients with deep vein thrombosis, treated with fondaparinux plus nattokinase. Group 2: patients with phlebitis, treated with enoxaparin plus nattokinase. Group 3: patients with venous insufficiency after classical surgery, treated with nattokinase one day later. During the study, we enrolled 153 patients (age 22-92 years), 92 females (60.1%) and 61 males (39.9%;), and documented that nattokinase was able to improve the clinical symptoms (p < 0.01) without the development of adverse drug reactions or drug interactions. Among the enrolled patients, during follow-up, we did not record new cases of vascular diseases. Attention to patients' clinical evolution, monitoring of the INR, and timely and frequent adjustment of dosages represent the cornerstones of the safety of care for patients administered fibrinolytic drugs as a single treatment or in pharmacological combination. Therefore, we can conclude that the use of nattokinase represents an efficient and safe treatment able to both prevent and treat patients with vascular diseases.
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Early prophylaxis of central venous catheter-related thrombosis using 1% chlorhexidine gluconate and chlorhexidine-gel-impregnated dressings: a retrospective cohort study.
Yamashita, T, Takamori, A, Nakagawachi, A, Tanigawa, Y, Hamada, Y, Aoki, Y, Sakaguchi, Y
Scientific reports. 2020;(1):15952
Abstract
To determine the prophylactic effect of using combined 1% alcoholic chlorhexidine gluconate and chlorhexidine gel-impregnated dressings (CGCD) on catheter-related thrombosis (CRT) in critically ill patients. This retrospective cohort study was performed in an intensive care unit from November 2009 to August 2014. The CRT incidence diagnosed with ultrasound examination was compared between patients applying CGCD and combined 10% aqueous povidone-iodine and standard transparent dressings (PITD) after central venous catheter insertion into the internal jugular vein for ≥ 48 h. CRT was stratified into early (within 7 days) and late (days 8-14) thromboses. Multivariate analyses using logistic regression models clarified the relationships between early- and late-CRT risks and skin antiseptic and catheter site dressing combinations. CRT occurred in 74 of 134 patients (55%), including 52 with early CRT and 22 with late CRT. Patients receiving CGCD had a significantly lower incidence of early CRT than those receiving PITD (odds ratio = 0.18; 95% confidence interval = 0.07-0.45, p < .001). No significant association was evident between using CGCD and late CRT (p = .514). Compared to PITD, CGCD reduced the CRT risk over 7 days in critically ill patients.UMIN Clinical Trials Registry: UMIN000037492.
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Indirect comparison and cost-utility of dabigatran etexilate and rivaroxaban in the treatment and extended anticoagulation of venous thromboembolism in a UK setting.
Jugrin, AV, Hösel, V, Ustyugova, A, De Francesco, M, Lamotte, M, Sunderland, T
Journal of medical economics. 2016;(1):1-10
Abstract
BACKGROUND Acute venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is traditionally managed with a short course of parenteral anticoagulation followed by 3-6 months of a vitamin-K antagonist. Non-vitamin K oral anticoagulants (NOACs) do not require routine monitoring and dose adjustment, thus potentially provide an alternative treatment option. METHODS AND RESULTS Because of the lack of head-to-head clinical studies, an indirect comparison was conducted of dabigatran etexilate and rivaroxaban based on the respective phase III clinical trial. The derived relative safety and efficacy estimates were used to evaluate the cost-utility of dabigatran compared with rivaroxaban in the treatment and secondary prevention of VTE. The results of the indirect comparison showed no significant difference between dabigatran and rivaroxaban in avoiding recurrent VTE following index PE, index DVT, or DVT/PE combined, in treatment and extended anticoagulation. Dabigatran has significantly less major or clinically relevant bleeds (MCRBE) compared to rivaroxaban in treatment after index DVT and treatment after DVT or PE combined, but was not significantly different from rivaroxaban after index PE or in extended anticoagulation. In cost-utility deterministic analyses, dabigatran was projected dominant in all analyzed settings, given its marginally lower total cost and marginally higher QALYs gained compared to rivaroxaban. Probabilistic analyses results showed a high likelihood of dabigatran being considered good value for money in the UK, in treatment and in secondary prevention of VTE. CONCLUSION The cost-effectiveness evaluations showed that dabigatran can be considered the dominant treatment strategy compared to rivaroxaban in the patients' sub-groups considered, given the projected marginally higher clinical benefits and lower treatment costs.
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Activation of coagulation system during air travel: a crossover study.
Schreijer, AJ, Cannegieter, SC, Meijers, JC, Middeldorp, S, Büller, HR, Rosendaal, FR
Lancet (London, England). 2006;(9513):832-8
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Abstract
BACKGROUND There is an increased risk of venous thrombosis after air travel, but the underlying mechanism is unclear. Our aim was to ascertain whether flying leads to a hypercoagulable state. METHODS We did a crossover study in 71 healthy volunteers (15 men, 56 women), in whom we measured markers of activation of coagulation and fibrinolysis before, during, and after an 8-h flight. The same individuals participated in two control exposure situations (8-h movie marathon and daily life) to separate the effect of air travel on the coagulation system from those of immobilisation and circadian rhythm. To study the effect of risk factors for thrombosis, we included participants with the factor V Leiden mutation (n=11), those who took oral contraceptives (n=15), or both (n=15), as well as 30 individuals with no specific risk factors. FINDINGS After the flight, median concentrations of thrombin-antithrombin (TAT) complex increased by 30.1% (95% CI 11.2-63.2), but decreased by 2.1% (-11.2 to 14) after the cinema and by 7.9% (-16.2 to -1.2) after the daily life situation. We recorded a high response in TAT levels in 17% (11 of 66) of individuals after air travel (3% [2 of 68] for movie marathon; 1% [1 of 70] in daily life). These findings were most evident in the group with the factor V Leiden mutation who used oral contraceptives. We noted a high response in all variables (prothrombin fragment 1 and 2, TAT, and D-dimer) in four of 63 (6.3%) volunteers after the flight, but in no-one after either of the control situations. INTERPRETATION Activation of coagulation occurs in some individuals after an 8-h flight, indicating an additional mechanism to immobilisation underlying air travel related thrombosis.
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Value of a blood pool contrast agent in MR venography of the lower extremities and pelvis: preliminary results in 12 patients.
Aschauer, M, Deutschmann, HA, Stollberger, R, Hausegger, KA, Obernosterer, A, Schöllnast, H, Ebner, F
Magnetic resonance in medicine. 2003;(5):993-1002
Abstract
The purpose of this study was to determine the value of a blood-pool contrast media (NC100150, Nycomed Imaging (now Amersham Health) Oslo, Norway) for evaluation of venous thrombosis of the deep veins of the pelvis and lower extremities. Twelve patients were prospectively evaluated with conventional X-ray venography (XRV) and MR venography (MRV) after injection of NC100150 (2 ml/kg body weight). The source images and 3D maximum intensity projection (MIP) were viewed on an independent workstation. Diagnosis was made in consensus from two radiologists. Diagnostic image quality was achieved in 87 veins with XRV and MRV. As determined by XRV, thrombus was present in 30 out of 87 veins (34.5%). There was agreement concerning absence or presence of thrombi in 83 out of 87 veins (95.4%; kappa = 0.9 +/- 0.05). Compared to XRV, overall sensitivity and specificity of blood-pool MRV were 93.3% and 96.5%, respectively. Two venous thromboses of the popliteal and posterior tibial vein were diagnosed in MRV, but not in XRV. Conversely, two venous thromboses below the knee had been missed by MRV. NC100150 allows prolonged and improved visualization of the peripheral vasculature and may overcome some limitations of gadolinium contrast media. A more complete examination of the proximal venous tree may be possible than with conventional XRV. Arterial and venous enhancement and motion artifacts can limit image interpretation.
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Leg compression and ambulation is better than bed rest for the treatment of acute deep venous thrombosis.
Blättler, W, Partsch, H
International angiology : a journal of the International Union of Angiology. 2003;(4):393-400
Abstract
AIM: Treatment of acute deep venous thrombosis (DVT) with low-molecular-weight heparin and vitamin K-antagonists reduces the risk of thrombus progression and pulmonary embolism but has no immediate effect on signs and symptoms. We addressed the question whether adding compression and walking would lead to a more rapid clinical improvement than bed rest. METHODS Fifty-three symptomatic outpatients with proximal DVT were randomly treated, in addition to dalteparin and phenprocoumon, with either firm inelastic bandages (n=18), elastic compression stockings (n=18), both combined with immediate deliberate ambulation, or bed rest without any compression (n=17). We assessed daily walking distance, well-being, quality of life, pain, swelling and clinical scores over a period of 9 days. Lung scans and ultrasound of the leg were performed on days 0 and 9. RESULTS In the compression groups the walking distance increased with time to 4 km/day on average. Improvement of well-being and DVT-related quality of life was significantly faster and more pronounced with compression than with bed rest (p<0.05 for stockings, p<0.001 for bandages). Pain monitored by visual analogue scale decreased with time in a linear pattern in all groups (p<0.001). There was a significant difference between the groups (p<0.01), the best effect being achieved with bandages. Pain assessed by a provocation test was reduced by half on day 3 with bed rest but remained constantly present over the subsequent 6 days. With compression it was reduced to near baseline on day 3. Swelling was almost completely removed with compression and clinical scores also improved more than with bed rest (p<0.001). Thrombus progression, as studied with ultrasound, was less frequent and less pronounced in the compression groups than with bed rest. There was no difference of new pulmonary embolism on repeat lung scans. CONCLUSION Leg compression combined with walking is the better alternative to bed rest for the treatment of symptomatic outpatients with proximal DVT.
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Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.
Bergqvist, D, Agnelli, G, Cohen, AT, Eldor, A, Nilsson, PE, Le Moigne-Amrani, A, Dietrich-Neto, F, ,
The New England journal of medicine. 2002;(13):975-80
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Abstract
BACKGROUND Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown. METHODS We conducted a double-blind, multicenter trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin (40 mg subcutaneously) daily for 6 to 10 days and were then randomly assigned to receive either enoxaparin or placebo for another 21 days. Bilateral venography was performed between days 25 and 31, or sooner if symptoms of venous thromboembolism occurred. The primary end point with respect to efficacy was the incidence of venous thromboembolism between days 25 and 31. The primary safety end point was bleeding during the three-week period after randomization. The patients were followed for three months. RESULTS The intention-to-treat analysis of efficacy included 332 patients. The rates of venous thromboembolism at the end of the double-blind phase were 12.0 percent in the placebo group and 4.8 percent in the enoxaparin group (P=0.02). This difference persisted at three months (13.8 percent vs. 5.5 percent, P=0.01). Three patients in the enoxaparin group and six in the placebo group died within three months after surgery. There were no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods. CONCLUSIONS Enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis, as compared with enoxaparin prophylaxis for one week.