{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T23:33:53Z","timestamp":1740180833702,"version":"3.37.3"},"reference-count":25,"publisher":"Consilium Medicum","issue":"5","license":[{"start":{"date-parts":[[2019,5,15]],"date-time":"2019-05-15T00:00:00Z","timestamp":1557878400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Terapevticheskii arkhiv"],"abstract":"<jats:p>The aim of the study was to evaluate the anti - Xa - activity (aXa) of selective and non - selective factor Xa inhibitors in patients with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS) patients according to clinical implications and laboratory parameters. Materials and methods. Clinical and laboratory data were analyzed retrospectively in SLE and APS patients who protractedly received low weight molecular heparins (LWMH) and selective factor Xa inhibitors fondaparinux and rivaroxaban. The study included 70 patients in the middle age 39 [31; 43] years: 15\/70 (21%) - with SLE, 10\/70 (14%) - with APS and 45\/70 (65%) - with SLE and APS (SLE+APS). All the patients received anticoagulants: 29 patients - nadroparin (98.3 [67.8; 129.5] IU\/kg\/day), 29 patients - fondaparinux (5 [5; 7.5] mg\/day), 3 patients - enoxaparin (1.2 [0.8; 1.5] mg\/day) and 9 patients - rivaroxaban (20 mg\/day). All the patients signed informed consents. Results. aXa therapeutic range of 0.1-1.5 IU\/ml was found in 43\/70 (61%) patients, low aXa - in 14\/70 (20%) and high aXa - in 13\/70 (19%) patients. Patients with low aXa underwent anticoagulant dose correction. There were not any major bleedings and thrombosis relapses in the study. Increased aXa was more common in patients, who took fondaparinux (31%), than in those, who took nadroparin (7%) and rivaroxaban (23%), p=0.02. Patients with enoxaparin had normal aXa range. In the absence of bleeding in SLE and APS patients, received anticoagulants in standardized therapeutic dose, the next factors influenced the aXa range excess: valvular heart disease (VHD) with the 3rd stage of mitral valve insufficiency as a result of aseptic Libman-Sacks endocarditis (odds ratio - OR 9.02, 95% confidential interval - CI [1.53; 53.12], p=0.015), peripheral artery disease in analogy with arteritis obliterans (AO) (OR 6.86, 95% CI [1.25; 37.71], p=0.027), and also triple - positivity of all types of antiphospholipid antibodies (OR 4.93, 95% CI [1.11; 21.99], p=0.036). According to found logistic regression model, aXa range excess risk can be prognosticated by the next formula: Z = -3.98 + 2.2 \u00d7 VHD (yes-1\/no-0) + 1.9 \u00d7 AO (yes-1\/no-0) + 1.6 \u00d7 Triple - positivity (yes-1\/no-0). Classified function value Z=0.39 defines the patients group with aXa range excess. Thus the value Z&gt;0.39 indicates aXa range excess in the absence of bleeding, herewith sensibility is of 77% and specificity is 86%, positive prognostic value is 84.3%. Conclusion. In SLE and APS patients the next clinical and immunologic manifestations influenced the aXa therapeutic range excess: peripheral artery disease in analogy with AO, earlier aseptic Libman-Sacks endocarditis with the 3rd stage of mitral valve insufficiency and triple - positivity of all types of antiphospholipid antibodies, that does not need LWMH and fondaparinux dose correction. In contrast, anticoagulant dose reduction can cause clinical symptoms progression. Therapeutic aXa range in such patients should be extended.<\/jats:p>","DOI":"10.26442\/00403660.2019.05.000235","type":"journal-article","created":{"date-parts":[[2019,6,26]],"date-time":"2019-06-26T11:37:45Z","timestamp":1561549065000},"page":"19-25","source":"Crossref","is-referenced-by-count":1,"title":["Effectiveness and safety of selective and non - selective factor Xa inhibitors in antiphospholipid syndrome and systemic lupus erythematosus: anti - Xa - activity range"],"prefix":"10.26442","volume":"91","author":[{"given":"N V","family":"Seredavkina","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T M","family":"Reshetnyak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M A","family":"Satybaldyeva","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L N","family":"Kashnikova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T A","family":"Temnikova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E L","family":"Nasonov","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"18344","published-online":{"date-parts":[[2019,5,15]]},"reference":[{"key":"ref1","unstructured":"\u041d\u0430\u0441\u043e\u043d\u043e\u0432 \u0415.\u041b. \u0410\u043d\u0442\u0438\u0444\u043e\u0441\u0444\u043e\u043b\u0438\u043f\u0438\u0434\u043d\u044b\u0439 \u0441\u0438\u043d\u0434\u0440\u043e\u043c. \u041c.: \u041b\u0438\u0442\u0442\u0435\u0440\u0440\u0430, 2004."},{"key":"ref2","unstructured":"\u041a\u0438\u0440\u0438\u0435\u043d\u043a\u043e \u0410.\u0418., \u041f\u0430\u043d\u0447\u0435\u043d\u043a\u043e \u0415.\u041f., \u0410\u043d\u0434\u0440\u0438\u044f\u0448\u043a\u0438\u043d \u0412.\u0412. \u0412\u0435\u043d\u043e\u0437\u043d\u044b\u0439 \u0442\u0440\u043e\u043c\u0431\u043e\u0437 \u0432 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0435 \u0442\u0435\u0440\u0430\u043f\u0435\u0432\u0442\u0430 \u0438 \u0445\u0438\u0440\u0443\u0440\u0433\u0430. \u041c.: \u041f\u043b\u0430\u043d\u0438\u0434\u0430, 2012."},{"key":"ref3","doi-asserted-by":"crossref","unstructured":"Streiff M.B, Agnelli G, Connors J.M, Crowther M, Eichinger S, Lopes R, Mc Bane R.D, Moll S, Ansell J. Guidance for the treatment of deep vein thrombosis and pulmonary embolism. J Thromb Thrombolysis. 2016;41(1):32-67. https:\/\/doi.org\/10.1007\/s11239-015-1317-0","DOI":"10.1007\/s11239-015-1317-0"},{"key":"ref4","unstructured":"\u0420\u0435\u0448\u0435\u0442\u043d\u044f\u043a \u0422.\u041c. \u041b\u0435\u0447\u0435\u043d\u0438\u0435 \u0430\u043d\u0442\u0438\u0444\u043e\u0441\u0444\u043e\u043b\u0438\u043f\u0438\u0434\u043d\u043e\u0433\u043e \u0441\u0438\u043d\u0434\u0440\u043e\u043c\u0430: \u0441\u043e\u0432\u0440\u0435\u043c\u0435\u043d\u043d\u044b\u0435 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u044b. \u0422\u0440\u043e\u043c\u0431\u043e\u0437, \u0433\u0435\u043c\u043e\u0441\u0442\u0430\u0437 \u0438 \u0440\u0435\u043e\u043b\u043e\u0433\u0438\u044f. 2016;1(65):11-20."},{"key":"ref5","doi-asserted-by":"crossref","unstructured":"Babin J.L, Traylor K.L, Witt D.M. Laboratory monitoring of low - molecular - weight heparin and fondaparinux. Semin Thromb Hemost. 2017;43(3):261-9. https:\/\/doi.org\/10.1055\/s-0036-1581129","DOI":"10.1055\/s-0036-1581129"},{"key":"ref6","doi-asserted-by":"crossref","unstructured":"Chighizola C.B, Moia M, Meroni P.L. New oral anticoagulants in thrombotic antiphospholipid syndrome. Lupus. 2014;23(12):1279-82. https:\/\/doi.org\/10.1177\/0961203314540968","DOI":"10.1177\/0961203314540968"},{"key":"ref7","doi-asserted-by":"crossref","unstructured":"\u0421\u0430\u0442\u044b\u0431\u0430\u043b\u0434\u044b\u0435\u0432\u0430 \u041c.\u0410., \u0420\u0435\u0448\u0435\u0442\u043d\u044f\u043a \u0422.\u041c. \u041d\u043e\u0432\u044b\u0435 \u043e\u0440\u0430\u043b\u044c\u043d\u044b\u0435 \u0430\u043d\u0442\u0438\u043a\u043e\u0430\u0433\u0443\u043b\u044f\u043d\u0442\u044b \u0432 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u0430\u043d\u0442\u0438\u0444\u043e\u0441\u0444\u043e\u043b\u0438\u043f\u0438\u0434\u043d\u043e\u0433\u043e \u0441\u0438\u043d\u0434\u0440\u043e\u043c\u0430. \u041d\u0430\u0443\u0447\u043d\u043e - \u043f\u0440\u0430\u043a\u0442\u0438\u0447\u0435\u0441\u043a\u0430\u044f \u0440\u0435\u0432\u043c\u0430\u0442\u043e\u043b\u043e\u0433\u0438\u044f. 2016;54(2):219-26. http:\/\/dx.doi.org\/10.14412\/1995-4484-2016-219-226","DOI":"10.14412\/1995-4484-2016-219-226"},{"key":"ref8","doi-asserted-by":"crossref","unstructured":"Cohen H, Hunt B.J, Efthymiou M, Arachchillage D.R, Mackie I.J, Clawson S, Sylvestre Y, Machin S.J, Bertolaccini M.L, Ruiz-Castellano M, Muirhead N, Dor\u00e9 C.J, Khamashta M, Isenberg D.A. RAPS trial investigators. Rivaroxaban versus warfarin to treat patients with thrombotic antiphospholipid syndrome, with or without systemic lupus erythematosus (RAPS): a randomized, controlled, open - label, phase 2\/3, non-inferiority trial. Lancet Haematol. 2016;3(9):426-36. https:\/\/doi.org\/10.1016\/S2352-3026(16)30079-5","DOI":"10.1016\/S2352-3026(16)30079-5"},{"key":"ref9","unstructured":"Gladman D.D, Iba\u00f1ez D, Urowitz M.B. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002;29(2):288-91."},{"key":"ref10","doi-asserted-by":"crossref","unstructured":"Levey A.S, Stevens L.A, Schmid C.H, Zhang Y.L, Castro A.F 3rd, Feldman H.I, Kusek J.W, Eggers P, Van Lente F, Greene T, Coresh J. CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604-12.","DOI":"10.7326\/0003-4819-150-9-200905050-00006"},{"key":"ref11","doi-asserted-by":"crossref","unstructured":"Miyakis S, Lockshin M.D, Atsumi T, Branch D.W, Brey R.L, Cervera R, Derksen R.H, De Groot P.G, Koike T, Meroni P.L, Reber G, Shoenfeld Y, Tincani A, Vlachoyiannopoulos P.G, Krilis S.A. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4(2):295-306. https:\/\/doi.org\/10.1111\/j.1538-7836.2006.01753.x","DOI":"10.1111\/j.1538-7836.2006.01753.x"},{"key":"ref12","unstructured":"\u0420\u0435\u0448\u0435\u0442\u043d\u044f\u043a \u0422.\u041c. \u0410\u043d\u0442\u0438\u0444\u043e\u0441\u0444\u043e\u043b\u0438\u043f\u0438\u0434\u043d\u044b\u0439 \u0441\u0438\u043d\u0434\u0440\u043e\u043c: \u0434\u0438\u0430\u0433\u043d\u043e\u0441\u0442\u0438\u043a\u0430 \u0438 \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u043f\u0440\u043e\u044f\u0432\u043b\u0435\u043d\u0438\u044f (\u043b\u0435\u043a\u0446\u0438\u044f). \u041d\u0430\u0443\u0447\u043d\u043e - \u043f\u0440\u0430\u043a\u0442\u0438\u0447\u0435\u0441\u043a\u0430\u044f \u0440\u0435\u0432\u043c\u0430\u0442\u043e\u043b\u043e\u0433\u0438\u044f. 2014;52(1):56-71. http:\/\/dx.doi.org\/10. 14412\/1995-4484-2014-56-71"},{"key":"ref13","doi-asserted-by":"crossref","unstructured":"Bertolaccini M.L, Amengual O, Andreoli L, Atsumi T, Chighizola C.B, Forastiero R, de Groot P, Lakos G, Lambert M, Meroni P, Ortel T.L, Petri M, Rahman A, Roubey R, Sciascia S, Snyder M, Tebo A.E, Tincani A, Willis R. 14th International Congress on Antiphospholipid Antibodies Task Force. Report on antiphospholipid syndrome laboratory diagnostics and trends. Autoimmun Rev. 2014;13:917-30. https:\/\/doi.org\/10.1016\/j.autrev. 2014.05.001","DOI":"10.1016\/j.autrev.2014.05.001"},{"key":"ref14","doi-asserted-by":"crossref","unstructured":"Pengo V, Banzato A, Denas G, Jose S.P, Bison E, Hoxha A, Ruffatti A. Correct laboratory approach to APS diagnosis and monitoring. Autoimmun Rev. 2013;12:832-4. https:\/\/doi.org\/10.1016\/j.autrev.2012.11.008","DOI":"10.1016\/j.autrev.2012.11.008"},{"key":"ref15","doi-asserted-by":"crossref","unstructured":"C\u0435\u0440\u0435\u0434\u0430\u0432\u043a\u0438\u043d\u0430 \u041d.\u0412., \u0420\u0435\u0448\u0435\u0442\u043d\u044f\u043a \u0422.\u041c. IX \u0415\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u0439 \u0444\u043e\u0440\u0443\u043c \u043f\u043e \u0430\u043d\u0442\u0438\u0444\u043e\u0441\u0444\u043e\u043b\u0438\u043f\u0438\u0434\u043d\u044b\u043c \u0430\u043d\u0442\u0438\u0442\u0435\u043b\u0430\u043c. \u041a\u0440\u0430\u0442\u043a\u0438\u0439 \u043e\u0431\u0437\u043e\u0440. \u041d\u0430\u0443\u0447\u043d\u043e - \u043f\u0440\u0430\u043a\u0442\u0438\u0447\u0435\u0441\u043a\u0430\u044f \u0440\u0435\u0432\u043c\u0430\u0442\u043e\u043b\u043e\u0433\u0438\u044f. 2014;52(1):115-21. http:\/\/dx.doi.org\/10.14412\/1995-4484-2014-115-121","DOI":"10.14412\/1995-4484-2014-115-121"},{"key":"ref16","doi-asserted-by":"crossref","unstructured":"Comarmond C, Cacoub P. Antiphospholipid syndrome: from pathogenesis to novel immunomodulatory therapies. Autoimmun Rev. 2013;12:752-7. https:\/\/doi.org\/10.1016\/j.autrev.2012.12.006","DOI":"10.1016\/j.autrev.2012.12.006"},{"key":"ref17","doi-asserted-by":"crossref","unstructured":"Garcia D.A, Baglin T.P, Weitz J.I, Samama M.M. Parenteral anticoagulants: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence - based clinical practice guidelines. Chest. 2012;141(2 Suppl):e24S-e43S. https:\/\/doi.org\/10.1378\/chest.11-2291","DOI":"10.1378\/chest.11-2291"},{"key":"ref18","doi-asserted-by":"crossref","unstructured":"Turpie A.G, Bauer K.A, Eriksson B.I, Lassen M.R. Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta - analysis of 4 randomized double - blind studies. Arch Intern Med. 2002;162(16):1833-40.","DOI":"10.1001\/archinte.162.16.1833"},{"key":"ref19","doi-asserted-by":"crossref","unstructured":"Turpie A.G, Bauer K.A, Eriksson B.I, Lassen M.R. Superiority of fondaparinux over enoxaparin in preventing venous thromboembolism in major orthopedic surgery using different efficacy end points. Chest. 2004;126(2):501-8.","DOI":"10.1378\/chest.126.2.501"},{"key":"ref20","doi-asserted-by":"crossref","unstructured":"Donath L, L\u00fctzner J, Werth S, Kuhlisch E, Hartmann A, G\u00fcnther K.P, Weiss N, Beyer-Westendorf J. Efficacy and safety of venous thromboembolism prophylaxis with fondaparinux or low molecular weight heparin in a large cohort of consecutive patients undergoing major orthopaedic surgery - findings from the ORTHO-TEP registry. Br J Clin Pharmacol. 2012;74(6):947-58. https:\/\/doi.org\/10.1111\/j.1365-2125.2012.04302.x","DOI":"10.1111\/j.1365-2125.2012.04302.x"},{"key":"ref21","doi-asserted-by":"crossref","unstructured":"Moore T.J. Optimal dosing of rivaroxaban is undefined. BMJ. 2016;355:i5549. https:\/\/doi.org\/10.1136\/bmj.i5549","DOI":"10.1136\/bmj.i5549"},{"key":"ref22","doi-asserted-by":"crossref","unstructured":"Joalland F, de Boysson H, Darnige L, Johnson A, Jeanjean C, Cheze S, Augustin A, Auzary C, Geffray L. Seronegative antiphospholipid syndrome, catastrophic syndrome, new anticoagulants: learning from a difficult case report. Rev Med Interne. (In French). 2014;35(11):752-6. https:\/\/doi.org\/10.1016\/j.revmed.2014.04.012","DOI":"10.1016\/j.revmed.2014.04.012"},{"key":"ref23","doi-asserted-by":"crossref","unstructured":"Holtan S.G, Knox S.K, Tefferi A. Use of fondaparinux in a patient with antiphospholipid antibody syndrome and heparin - associated thrombocytopenia. J Thromb Haemost. 2006;4(7):1632-4. https:\/\/doi.org\/ 10.1111\/j.1538-7836.2006.01961.x","DOI":"10.1111\/j.1538-7836.2006.01961.x"},{"key":"ref24","doi-asserted-by":"crossref","unstructured":"Costa R, Fazal S, Kaplan R.B, Spero J, Costa R. Successful plasma exchange combined with rituximab therapy in aggressive APS-related cutaneous necrosis. Clin Rheumatol. 2013;32(Suppl 1):S79-82. https:\/\/doi. org\/10.1007\/s10067-010-1506-3","DOI":"10.1007\/s10067-010-1506-3"},{"key":"ref25","doi-asserted-by":"crossref","unstructured":"Harenberg J. Treatment of a woman with lupus and thromboembolism and cutaneous intolerance to heparins using fondaparinux during pregnancy. Thromb Res. 2007;119(3):385-8. https:\/\/doi.org\/10.1016\/j.thromres.2006. 03.008","DOI":"10.1016\/j.thromres.2006.03.008"}],"container-title":["Terapevticheskii arkhiv"],"original-title":[],"link":[{"URL":"https:\/\/ter-arkhiv.ru\/0040-3660\/article\/viewFile\/33571\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ter-arkhiv.ru\/0040-3660\/article\/viewFile\/33571\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,10,13]],"date-time":"2021-10-13T21:50:20Z","timestamp":1634161820000},"score":1,"resource":{"primary":{"URL":"https:\/\/ter-arkhiv.ru\/0040-3660\/article\/view\/33571"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,5,15]]},"references-count":25,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2019,5,15]]}},"URL":"https:\/\/doi.org\/10.26442\/00403660.2019.05.000235","relation":{},"ISSN":["2309-5342","0040-3660"],"issn-type":[{"type":"electronic","value":"2309-5342"},{"type":"print","value":"0040-3660"}],"subject":[],"published":{"date-parts":[[2019,5,15]]}}}