Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases
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...
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| Format: | Article |
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MDPI AG
2021-06-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/13/6/2031 |
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| author | Giuseppe Gallelli Giulio Di Mizio Caterina Palleria Antonio Siniscalchi Paolo Rubino Lucia Muraca Erika Cione Monica Salerno Giovambattista De Sarro Luca Gallelli |
| author_facet | Giuseppe Gallelli Giulio Di Mizio Caterina Palleria Antonio Siniscalchi Paolo Rubino Lucia Muraca Erika Cione Monica Salerno Giovambattista De Sarro Luca Gallelli |
| author_sort | Giuseppe Gallelli |
| collection | DOAJ |
| description | 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 (<i>p</i> < 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. |
| first_indexed | 2024-03-10T10:27:46Z |
| format | Article |
| id | doaj.art-d507f508473647b68d9304e4466a21c9 |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-03-10T10:27:46Z |
| publishDate | 2021-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-d507f508473647b68d9304e4466a21c92023-11-21T23:56:50ZengMDPI AGNutrients2072-66432021-06-01136203110.3390/nu13062031Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular DiseasesGiuseppe Gallelli0Giulio Di Mizio1Caterina Palleria2Antonio Siniscalchi3Paolo Rubino4Lucia Muraca5Erika Cione6Monica Salerno7Giovambattista De Sarro8Luca Gallelli9Department of Vascular Surgery, Pugliese Ciaccio Hospital, 88100 Catanzaro, ItalyForensic Medicine, Department of Law, Magna Graecia University of Catanzaro, 88100 Catanzaro, ItalyDepartment of Health Science, School of Medicine, University of Catanzaro, Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini University Hospital, 88100 Catanzaro, ItalyDepartment of Neurology and Stroke Unit, Annunziata Hospital of Cosenza, 87100 Cosenza, ItalyDepartment of Vascular Surgery, Pugliese Ciaccio Hospital, 88100 Catanzaro, ItalyDepartment of General Medicine, ASP 7 Catanzaro, 88100 Catanzaro, ItalyDepartment of Pharmacy Helath and Nutritional Sciences, Department of Excellence 2018-2022, University of Calabria, 87036 Rende, ItalyDepartment of Medical, Surgical and Advanced Technologies “G.F. Ingrassia”, University of Catania, 95041 Catania, ItalyDepartment of Health Science, School of Medicine, University of Catanzaro, Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini University Hospital, 88100 Catanzaro, ItalyDepartment of Health Science, School of Medicine, University of Catanzaro, Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini University Hospital, 88100 Catanzaro, ItalyNattokinase (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 (<i>p</i> < 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.https://www.mdpi.com/2072-6643/13/6/2031nattokinasevascular diseasesclinical triallow-molecular-weight heparinClinical Risk Managementsafety of care in pharmacological treatments |
| spellingShingle | Giuseppe Gallelli Giulio Di Mizio Caterina Palleria Antonio Siniscalchi Paolo Rubino Lucia Muraca Erika Cione Monica Salerno Giovambattista De Sarro Luca Gallelli Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases Nutrients nattokinase vascular diseases clinical trial low-molecular-weight heparin Clinical Risk Management safety of care in pharmacological treatments |
| title | Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases |
| title_full | Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases |
| title_fullStr | Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases |
| title_full_unstemmed | Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases |
| title_short | Data Recorded in Real Life Support the Safety of Nattokinase in Patients with Vascular Diseases |
| title_sort | data recorded in real life support the safety of nattokinase in patients with vascular diseases |
| topic | nattokinase vascular diseases clinical trial low-molecular-weight heparin Clinical Risk Management safety of care in pharmacological treatments |
| url | https://www.mdpi.com/2072-6643/13/6/2031 |
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