나토키나제

Nattokinase supplementation for cognitive enhancement in asymptomatic intracranial/carotid stenosis: A randomized controlled trial.

1. J Stroke Cerebrovasc Dis. 2026 Jan;35(1):108511. doi: 10.1016/j.jstrokecerebrovasdis.2025.108511. Epub 2025 Nov 29. Nattokinase supplementation for cognitive enhancement in asymptomatic intracranial/carotid stenosis: A randomized controlled trial. Zhang K(1), Zhang X(1), Wang A(1), Zhong W(1)

The Effect of Nattokinase-Monascus Supplements on Dyslipidemia: A Four-Month Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

2. Nutrients. 2023 Sep 30;15(19):4239. doi: 10.3390/nu15194239. The Effect of Nattokinase-Monascus Supplements on Dyslipidemia: A Four-Month Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Liu X(1), Zeng X(1), Mahe J(1), Guo K(1), He P(1), Yang Q(1), Zhang Z(1), Li Z(2), Wang D(2),

Characteristics of Biofilms Formed by Co-Culture of Listeria monocytogenes with Pseudomonas aeruginosa at Low Temperatures and Their Sensitivity to Antibacterial Substances.

3. Biocontrol Sci. 2018;23(3):107-119. doi: 10.4265/bio.23.107. Characteristics of Biofilms Formed by Co-Culture of Listeria monocytogenes with Pseudomonas aeruginosa at Low Temperatures and Their Sensitivity to Antibacterial Substances. Yamakawa T(1), Tomita K(1), Sawai J(1). Author informatio

Cerebellar hemorrhage provoked by combined use of nattokinase and aspirin in a patient with cerebral microbleeds.

4. Intern Med. 2008;47(5):467-9. doi: 10.2169/internalmedicine.47.0620. Epub 2008 Mar 3. Cerebellar hemorrhage provoked by combined use of nattokinase and aspirin in a patient with cerebral microbleeds. Chang YY(1), Liu JS, Lai SL, Wu HS, Lan MY. Author information: (1)Department of Neurology,

Efficacy and Safety of Aronia, Red Ginseng, Shiitake Mushroom, and Nattokinase Mixture on Insulin Resistance in Prediabetic Adults: A Randomized, Double-Blinded, Placebo-Controlled Trial.

5. Foods. 2021 Jul 5;10(7):1558. doi: 10.3390/foods10071558. Efficacy and Safety of Aronia, Red Ginseng, Shiitake Mushroom, and Nattokinase Mixture on Insulin Resistance in Prediabetic Adults: A Randomized, Double-Blinded, Placebo-Controlled Trial. Park S(1), Kim CJ(2), Ha KC(3), Baek HI(3), Yan

Consumption of nattokinase is associated with reduced blood pressure and von Willebrand factor, a cardiovascular risk marker: results from a randomized, double-blind, placebo-controlled, multicenter North American clinical trial.

6. Integr Blood Press Control. 2016 Oct 13;9:95-104. doi: 10.2147/IBPC.S99553. eCollection 2016. Consumption of nattokinase is associated with reduced blood pressure and von Willebrand factor, a cardiovascular risk marker: results from a randomized, double-blind, placebo-controlled, multicenter

Nattospes as Effective and Safe Functional Supplements in Management of Stroke.

1. J Med Food. 2020 Aug;23(8):879-885. doi: 10.1089/jmf.2019.0183. Epub 2020 Jan 14. Nattospes as Effective and Safe Functional Supplements in Management of Stroke. Pham PT(1), Han B(2), Hoang BX(2). Author information: (1)Tue Tinh Hospital-Vietnamese Academy of Traditional Medicine, Hanoi, Vietnam. (2)Nimni-Cordoba Tissue Engineering and Drug Discovery Laboratory, Division of Plastic and Reconstructive Surgery, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA. Stroke remains a major cause of human disability worldwide. Interventions and rehabilitation at the poststroke stage are critical for recovery. A single-blinded randomized controlled trial was conducted on 61 patients diagnosed with subacute stage of ischemic stroke. Ingestion of Nattospecs was tested as an adjuvant to support rehabilitation when combined with standard of care (SOC) treatment (electroacupuncture and Naatrapyl) (Trial group) and compared to SOC treatment alone (Control group). After 60 days, results showed that both Trial and Control groups achieved significant improvements in physical activities, blood pressure control, serum lipid panels, and quality of life. Nattospes as a food supplement has good supportive effects on treatment and rehabilitation after ischemic stroke by showing statistically significant improvement of stroke-related symptom in scores from modified Rankin, Orgogozo, and Barthel scales. In addition, Nattospes showed a good safety profile, with no adverse effects reported in both clinical and paraclinical parameters. This study indicated that Nattospes as nutraceutical supplement can be applied safely and effectively in the management of subacute stage ischemic stroke. The findings of the study may also encourage further extensive clinical trials to fully explore the prospect of Nattospes as a nutraceutical adjunct in the management of cardiovascular disease. DOI: 10.1089/jmf.2019.0183 PMCID: PMC7415874 PMID: 31934821 [Indexed for MEDLINE] Conflict of interest statement: No competing financial interests exist.

The effects of nattokinase supplementation on collagen-epinephrine closure time, prothrombin time and activated partial thromboplastin time in nondiabetic and hypercholesterolemic subjects.

2. Food Funct. 2019 May 22;10(5):2888-2893. doi: 10.1039/c8fo02324g. The effects of nattokinase supplementation on collagen-epinephrine closure time, prothrombin time and activated partial thromboplastin time in nondiabetic and hypercholesterolemic subjects. Yoo HJ (1), Kim M , Kim M , Lee A , Jin C , Lee SP , Kim TS , Lee SH , Lee JH . Author information: (1)National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea. Erratum in Food Funct. 2019 Jul 17;10(7):4454. doi: 10.1039/c9fo90033k. The aim of this study was to investigate whether supplementation with nattokinase, which is considered one of the most active functional ingredients found in natto, alters hemostatic factors. Subjects presenting with hypercholesterolemia (serum cholesterol: 200-280 mg dL-1) were randomly divided into nattokinase and placebo groups (n = 50, respectively). No significant between-group differences were found at baseline in collagen-epinephrine closure time (C-EPI CT), prothrombin time (PT), or activated partial thromboplastin time (aPTT). After 8 weeks of treatment, the nattokinase group exhibited significant increases in C-EPI CT, PT, and aPTT. The nattokinase group showed significantly greater increases in C-EPI CT (P = 0.001) and aPTT (P = 0.016) than the placebo group. Moreover, at 8 weeks, the nattokinase group showed a significantly higher C-EPI CT than the placebo group (P = 0.001). Additionally, a significant correlation between PT and aPTT was observed (r = 0.491, P < 0.001). In conclusion, nattokinase supplementation was associated with prolonged C-EPI CT and aPTT in nondiabetic and borderline-to-moderate hypercholesterolemic subjects. DOI: 10.1039/c8fo02324g PMID: 31070609 [Indexed for MEDLINE]

A pilot study on the serum pharmacokinetics of nattokinase in humans following a single, oral, daily dose.

3. Altern Ther Health Med. 2013 May-Jun;19(3):16-9. A pilot study on the serum pharmacokinetics of nattokinase in humans following a single, oral, daily dose. Ero MP(1), Ng CM, Mihailovski T, Harvey NR, Lewis BH. Author information: (1)Machaon Diagnostics, Oakland, CA, USA. Mike.ero@machaondiagnostics.com CONTEXT: Nattokinase is a serine protease and is derived from natto, a traditional Japanese, fermented, soybean food meal. Multiple authors have described the significant fibrinolytic, antithrombotic, and antihypertensive effects of natto. Nattokinase has been growing in popularity for use as a dietary supplement for the benefit of cardiovascular health. Little is known regarding the pharmacokinetic and pharmacodynamic properties of this enzyme, and the bioavailability of nattokinase is currently unknown. OBJECTIVE: This study intended to (1) detect nattokinase directly and immunologically, (2) show that nattokinase and/or its metabolites were detectable in human blood following ingestion of a commercial preparation, and (3) chart a pharmacokinetic dosing effect for nattokinase. DESIGN: The research team designed the pilot study as an in vivo, human clinical trial. Healthy human subjects responded to an advertisement and were screened. Subjects who satisfied both inclusion and exclusion criteria were enrolled into the study. Subjects were then instructed to orally ingest a single capsule containing a known concentration of nattokinase immediately following a baseline blood draw. Subsequent blood draws occurred over a 24-h period. SETTING: This study was conducted in Oakland, California, at a clinical reference laboratory and was performed with the approval of an institutional review board (IRB) to ensure that appropriate ethical standards were met. PARTICIPANTS: Eleven healthy participants (five male, six female, ages 21-65), who met eligibility criteria, were enrolled. INTERVENTION(S): Administration of nattokinase occurred orally with the ingestion of a single daily dose (2000 FU) of nattokinase. Capsules, each containing approximately 100 mg of nattokinase, in softgel form (NSK-SD, Japan Bio Science Laboratory, Osaka, Japan), were used in the study. OUTCOME MEASURE(S): Baseline blood samples were collected, and participants were observed swallowing a single capsule of the nattokinase supplement before returning at 2, 4, 8, 12, 24, and 48 h post ingestion for subsequent blood draws. The presence of nattokinase in serum was measured by an enzyme-linked immunosorbent assay (ELISA), using a rabbit, polyclonal, antinattokinase-capture antibody. A pharmacokinetic pattern was observed for nattokinase between baseline and 48 h postdose. RESULTS: Peak serum levels of nattokinase were observed at approximately 13.3 h ± 2.5 h (mean ± standard error) postdose. Statistically significant increases in binding were detectable from baseline when comparing averaged data at time points t = 2 h-t = 24 h. CONCLUSIONS: These results provided the first evidence that nattokinase can be measured directly in the blood of humans. The results further suggest that a larger, more extensive, pharmacokinetic study of nattokinase is warranted. Additionally, looking for intact enzyme and bioactive nattokinase peptides should be a consideration for future studies investigating the pharmacokinetic profile of nattokinase. PMID: 23709455 [Indexed for MEDLINE]

Combined nattokinase with red yeast rice but not nattokinase alone has potent effects on blood lipids in human subjects with hyperlipidemia.

4. Asia Pac J Clin Nutr. 2009;18(3):310-7. Combined nattokinase with red yeast rice but not nattokinase alone has potent effects on blood lipids in human subjects with hyperlipidemia. Yang NC(1), Chou CW, Chen CY, Hwang KL, Yang YC. Author information: (1)Department of Nutrition and Health Science, Chungchou Institute of Technology, Changhua 510, Taiwan. naeboy@dragon.ccut.edu.tw. The purpose of this randomized, double-blind, placebo-controlled, parallel comparison study was to evaluate the lipid-lowering effect of orally administrated nattokinase and nattokinase combined with red yeast rice (RYR) extract on blood lipids in patients with hyperlipidemia. A total of 47 patients with hyperlipidemia were assigned to one of three groups: 1. nattokinase-mono formula (50 mg/capsule), 2. combined formula of nattokinase with RYR (300 mg of extract/capsule) and 3. placebo. Subjects received a twice daily dose of two capsules for six months. The mono formula showed no effects on blood lipids until month six, while the combined formula ameliorated all of measured lipids starting from month one. In the combined group significant decreases were found with regard to: triglycerides (TG) by 15%, total cholesterol (TC) by 25%, low-density lipoprotein cholesterol (LDL-C) by 41%, TC/high-density lipoprotein cholesterol (HDL-C) ratio by 29.5%, and increases in HDL-C by 7.5%. These changes were sustained until the end of study. After controlling for baseline levels, only the combined group, but not mono group, showed a significant difference (p<0.0001) in TC, LDL-C and TC/HDL-C ratio when compared with the placebo group. In summary, this study provides long-term efficacy of nattokinase supplementation and shows that the combined formula has relatively more potent effects than the mono formula on lowering of blood lipids, suggesting that combined nattokinase with RYR will be a better neutraceutical for patients with hyperlipidemia than nattokinase alone. PMID: 19786378 [Indexed for MEDLINE]

Effects of nattokinase on blood pressure: a randomized, controlled trial.

5. Hypertens Res. 2008 Aug;31(8):1583-8. doi: 10.1291/hypres.31.1583. Effects of nattokinase on blood pressure: a randomized, controlled trial. Kim JY(1), Gum SN, Paik JK, Lim HH, Kim KC, Ogasawara K, Inoue K, Park S, Jang Y, Lee JH. Author information: (1)Yonsei University Research Institute of Science for Aging, Department of Food and Nutrition, College of Human Ecology, Yonsei University, and Department of Family Medicine, Mizmedi Hospital, Seoul, Korea. The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension. DOI: 10.1291/hypres.31.1583 PMID: 18971533 [Indexed for MEDLINE]

Nattokinase Supplementation and Cardiovascular Risk Factors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

6. Rev Cardiovasc Med. 2023 Aug 15;24(8):234. doi: 10.31083/j.rcm2408234. eCollection 2023 Aug. Nattokinase Supplementation and Cardiovascular Risk Factors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Li X(1), Long J(2), Gao Q(2), Pan M(2), Wang J(2), Yang F(2), Zhang Y(2). Author information: (1)School of Traditional Chinese Medicine, Henan University of Chinese Medicine, 450046 Zhengzhou, Henan, China. (2)School of Rehabilitation Medicine, Henan University of Chinese Medicine, 450046 Zhengzhou, Henan, China. BACKGROUND: As a fibrinolytic enzyme from fermented soybean, nattokinase has been shown to be potentially beneficial for cardiovascular health, but current clinical evidences regarding the nattokinase supplementation on cardiovascular risk factors are various. This study aims to evaluate the cardiovascular efficacy of nattokinase. METHODS: Four electronic databases were systematically searched to collect eligible randomized controlled trials. Data were extracted and summarized in a pre-designed form by two independent reviewers. Review Manager 5.4 software (Cochrane Library Software, Oxford, U.K.) was used for meta-analysis and bias risk assessment. RESULTS: Six studies were eligible for quantitative analysis with 546 participants. The overall methodological quality of included studies was high. Relatively low total dosage of nattokinase had a negative effect on blood total cholesterol (MD [mean difference] = 5.27, 95% CI [confidence intervals]: 3.74 to 6.81, p  <  0.00001), high-density lipoprotein cholesterol (MD = -2.76, 95% CI: -3.88 to -1.64, p  <  0.00001), and low-density lipoprotein cholesterol (MD = 6.49, 95% CI: 0.83 to 12.15, p = 0.02). Nattokinase supplementation significantly reduced systolic blood pressure (MD = -3.45, 95% CI: -4.37 to -2.18, p  <  0.00001) and diastolic blood pressure (MD = -2.32, 95% CI: -2.72 to -1.92, p  <  0.00001), and led a slight increase in blood glucose (MD = 0.40, 95% CI: 0.20 to 0.60, p  <  0.0001) as compared to placebo. Nattokinase group with relatively high total dosage also had a higher total cholesterol (MD = 3.18, 95% CI: 2.29 to 4.06, p  <  0.00001) than control interventions, but no significant differences were found in levels of high-density lipoprotein cholesterol and low-density lipoprotein cholesterol. No significant correlation was found between nattokinase supplementation and triglyceride (p = 0.71). No notable adverse events were reported in all studies due to intake of nattokinase. CONCLUSIONS: This study further supports that nattokinase can be used as an effective adjunctive therapy for hypertension, but relatively low-dose supplementation of nattokinase may have no significant lipid-lowering effect. More work will need to be done to determine whether the positive efficacy of nattokinase on cardiovascular risk factors is dose-dependent. SYSTEMATIC REVIEW REGISTRATION: This work has been registered on PROSPERO (CRD42022315020). Copyright: © 2023 The Author(s). Published by IMR Press. DOI: 10.31083/j.rcm2408234 PMCID: PMC11266782 PMID: 39076715 Conflict of interest statement: The authors declare no conflict of interest.

Candidate treatments for long COVID: a narrative review of expert and patient-driven priorities.

7. Front Med (Lausanne). 2026 Feb 27;13:1734600. doi: 10.3389/fmed.2026.1734600. eCollection 2026. Candidate treatments for long COVID: a narrative review of expert and patient-driven priorities. Baptista SN(1), Atkins T(2), Chakraborty S(1), Bakhit M(2), Glasziou P(2), Byambasuren O(2). Author information: (1)Australian Living Evidence Collaboration, Monash University School of Public Health and Preventive Medicine, Melbourne, VIC, Australia. (2)Bond University Institute for Evidence-Based Healthcare, Robina, QLD, Australia. OBJECTIVE: To map the existing evidence for candidate treatments for long COVID that were prioritised by clinicians and people with lived experience, and to characterise their feasibility, acceptability and safety. STUDY DESIGN: The study was conducted as a narrative review using pragmatic methods including iterative stakeholder-informed decision-making a monthly-updated evidence search, rapid lay evidence summaries and a structured research prioritisation process. DATA SOURCES: Potential candidate treatments were identified via a combination of database and trial registry searches. These were then ranked by clinicians and people with lived experience using surveys. Evidence summaries for the top 14 interventions (low-dose naltrexone, antivirals, metformin, nicotine, vagus nerve stimulation, antihistamines, guanfacine, colchicine, nattokinase, intravenous immunoglobulins, monoclonal antibodies, coenzyme Q10, multicomponent rehabilitation packages, and exercise training) were created. Prioritised treatments were collated first by searching a collaborative living evidence database (updated monthly) of relevant systematic reviews and randomised controlled trials and then by conducting supplementary searches of other study designs. DATA SYNTHESIS: Six of 14 interventions had long-COVID-specific randomised controlled trial (RCT) evidence (exercise [16 RCTs], multicomponent packages [5 RCTs], coenzyme Q10 [2 RCTs], antivirals [1 RCT], vagus nerve stimulation [1 pilot RCT], monoclonal antibodies [1 small RCT]); the remainder relied on indirect or very low-certainty data (e.g., uncontrolled studies or mechanistic rationale). Across interventions, evidence certainty was mostly low to very low, and safety/feasibility varied. CONCLUSION: This review prioritises and maps candidate treatments for long COVID. There was insufficient direct evidence to inform clinical recommendations. Rather, the treatments presented in this review represent those that could be rigorously tested in clinical trials as they show biological plausibility and/or are feasible and acceptable to people with lived experience and clinicians. REGISTRATION: A review protocol was not prospectively registered because the review adopted an iterative approach to support priority setting rather than clinical guidance. Copyright © 2026 Baptista, Atkins, Chakraborty, Bakhit, Glasziou and Byambasuren. DOI: 10.3389/fmed.2026.1734600 PMCID: PMC12982061 PMID: 41836927 Conflict of interest statement: The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Nattokinase atherothrombotic prevention study: A randomized controlled trial.

8. Clin Hemorheol Microcirc. 2021;78(4):339-353. doi: 10.3233/CH-211147. Nattokinase atherothrombotic prevention study: A randomized controlled trial. Hodis HN(1)(2)(3), Mack WJ(1)(3), Meiselman HJ(4), Kalra V(5), Liebman H(2), Hwang-Levine J(1)(2), Dustin L(3), Kono N(3), Mert M(3), Wenby RB(4), Huesca E(5), Rochanda L(2), Li Y(1), Yan M(1), St John JA(1)(3), Whitfield L(1). Author information: (1)Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. (2)Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. (3)Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. (4)Department of Physiology and Biophysics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. (5)Department of Biochemistry and Molecular Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. BACKGROUND: Described to be antithrombotic and antihypertensive, nattokinase is consumed for putative cardiovascular benefit. However, no large-scale, long-term cardiovascular study has been conducted with nattokinase supplementation. OBJECTIVE: To determine the effect of nattokinase on subclinical atherosclerosis progression and atherothrombotic biomarkers. METHODS: In this double-blinded trial, 265 individuals of median age 65.3 years, without clinical evidence of cardiovascular disease (CVD) were randomized to oral nattokinase 2,000 fibrinolytic units or matching placebo. Primary outcome was rate of change in subclinical atherosclerosis measured by serial carotid ultrasound every 6 months as carotid artery intima-media thickness (CIMT) and carotid arterial stiffness (CAS). Additional outcomes determined at least every 6 months were clinical parameters including blood pressure and laboratory measures including metabolic factors, blood rheology parameters, blood coagulation and fibrinolysis factors, inflammatory markers and monocyte/macrophage cellular activation markers. RESULTS: After median 3 years of randomized treatment, annualized rate of change in CIMT and CAS did not significantly differ between nattokinase supplementation and placebo. Additionally, there was no significant effect of nattokinase supplementation on blood pressure or any laboratory determination. CONCLUSIONS: Results of this trial show that nattokinase supplementation has a null effect on subclinical atherosclerosis progression in healthy individuals at low risk for CVD. DOI: 10.3233/CH-211147 PMID: 33843667 [Indexed for MEDLINE]

A single-dose of oral nattokinase potentiates thrombolysis and anti-coagulation profiles.

9. Sci Rep. 2015 Jun 25;5:11601. doi: 10.1038/srep11601. A single-dose of oral nattokinase potentiates thrombolysis and anti-coagulation profiles. Kurosawa Y(1), Nirengi S(1), Homma T(1), Esaki K(2), Ohta M(3), Clark JF(4), Hamaoka T(1). Author information: (1)Department of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan. (2)Department of Economics, Tokuyama University, Shunan, Yamaguchi, Japan. (3)Department of Clinical Chemistry, Kobe Pharmaceutical University, Kobe, Hyogo, Japan. (4)Department of Neurology, University of Cincinnati, Cincinnati, Ohio, USA. Our aim was to determine the quantitative effects of a single-dose of Nattokinase (NK) administration on coagulation/fibrinolysis parameters comprehensively in healthy male subjects. A double-blind, placebo-controlled cross-over NK intervention study was carried out in 12 healthy young males. Following the baseline blood draw, each subject was randomized to receive either a single-dose of 2,000 FU NK (NSK-SD, Japan Bio Science Laboratory Co., Ltd) or placebo with subsequent cross-over of the groups. Subjects donated blood samples at 2, 4, 6 and 8 hours following administration for analysis of coagulation/fibrinolysis parameters. As a result, D-dimer concentrations at 6, and 8 hours, and blood fibrin/fibrinogen degradation products at 4 hours after NK administration elevated significantly (p < 0.05, respectively). Factor VIII activity declined at 4 and 6 hours (p < 0.05, respectively), blood antithrombin concentration was higher at 2 and 4 hours (p < 0.05, respectively), and the activated partial thromboplastin time prolonged significantly at 2 and 4 hours following NK administration (p < 0.05 and p < 0.01, respectively). All the changes, however, were within the normal range. In conclusion, thus, a single-dose of NK administration appears enhancing fibrinolysis and anti-coagulation via several different pathways simultaneously. DOI: 10.1038/srep11601 PMCID: PMC4479826 PMID: 26109079 [Indexed for MEDLINE]

Prevention of venous thrombosis in long-haul flights with Flite Tabs: the LONFLIT-FLITE randomized, controlled trial.

10. Angiology. 2003 Sep-Oct;54(5):531-9. doi: 10.1177/000331970305400502. Prevention of venous thrombosis in long-haul flights with Flite Tabs: the LONFLIT-FLITE randomized, controlled trial. Cesarone MR(1), Belcaro G, Nicolaides AN, Ricci A, Geroulakos G, Ippolito E, Brandolini R, Vinciguerra G, Dugall M, Griffin M, Ruffini I, Acerbi G, Corsi M, Riordan NH, Stuard S, Bavera P, Di Renzo A, Kenyon J, Errichi BM. Author information: (1)Department of Biomedical Sciences, Irvine2 Vascular Lab, G D'Annunzio University, San Valentino Vascular Screening Project (Pe), Pescara, Italy. The aim of this study was to evaluate the development of edema, and superficial and deep vein thrombosis (DVT) prophylaxis with an oral profibrinolytic agent (Flite Tabs, 150 mg pinokinase, Aidan, Tempe, AZ, USA) in long-haul flights (7-8 hours), in high-risk subjects. A group of 300 subjects was included; 76 were excluded for several problems including concomitant treatments; 204 were randomized into 2 groups (active treatment or placebo) to evaluate the effects of prophylaxis with Flite Tabs. An exercise program was used in both groups. The femoral, popliteal, tibial, and superficial veins were scanned with ultrasound before and within 90 minutes after flights. Of the included subjects, 92 of 103 controls and 94 of 101 treated subjects completed the study. Dropouts were due to connection problems. Age, gender, and risk distribution were comparable in the groups. In the treatment group, no DVT was observed. In the control group, 5 subjects (5.4%) had a DVT and there were 2 superficial thromboses (7 events in 92 subjects; 7.6%). At inclusion, edema was comparable in the 2 groups. After flights there was an increase in score in controls (+12%) in comparison with a decrease (-15%) in the Flite Tabs group (the difference in variation was statistically significant). Intention-to-treat analysis for thrombotic events shows 18 failures in controls (11 lost to follow-up + 7 thrombotic events) of 92 subjects (19.6%) in comparison with 7 failures (of 94 subjects, equivalent to 7.4%) in the treatment group (p < 0.05). Events were asymptomatic. In conclusion, Flite Tabs were effective in reducing thrombotic events and in controlling edema in high-risk subjects in long flights. DOI: 10.1177/000331970305400502 PMID: 14565628 [Indexed for MEDLINE]