POSZUKIWANIE NASTĘPCÓW PROTAMINY: SKUTECZNE I BEZPIECZNE HAMOWANIE KRWAWIENIA WYWOŁANEGO PODANIEM POZAJELITOWYCH ŚRODKÓW PRZECIWKRZEPLIWYCH

Emilia Sokołowska, Andrzej Mogielnicki

Bibliografia

1.  Transparency Market Research, 2015. Heparin Market – Europe Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 – 2022”. Dostępny: http://globenewswire.com/news-release/2015/10/20/778033/10153283/en/LMWH-is-the-Dominant-Heparin-Product-Market-in-Europe-and-is-Expected-to-Reach-USD-3-14-Billion-in-2022-Transparency-Market-Research.html (ostatnia aktualizacja Marzec 2016).

2.  Mozzaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2015 Update: a report from the American Heart Association. Circulation 2015, 131, e29-322.

3.  Lu G, DeGuzman FR, Hollenbach SJ, Karbarz MJ, Abe K, Lee G, Luan P, Hutchaleelaha A, Inagaki M, Conley PB, Phillips DR, Sinha U. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 2013, 19, 446-451.

4.  Cook JJ, Niewiarowski S, Yan Z, Schaffer L, Lu W, Stewart GJ, Mosser DM, Myers JA, Maione TE. Platelet factor 4 efficiently reverses heparin anticoagulation in the rat without adverse effects of heparin-protamine complexes. Circulation 1992, 85 (3), 1102-1109.

5.  Lowenstein E, Johnston WE, Lappas DG, D'Ambra MN, Schneider RC, Dagget WM, Akins CW, Philbin DM. Catastrophic pulmonary vasoconstriction associated with protamine reversal of heparin. Anesthesiology 1983, 59 (5), 470-473.

6.  Bromfield SM, Wilde E, Smith DK. Heparin sensing and binding-taking supramolecular chemistry towards clinical applications. Chem Soc Rev 2013, 42 (33), 9184-9195.

7.  Shenoi, RA, Kalathottukaren, MT, Travers, RJ, Lai BFL, Creag AL, Lange D, Yu K, Weinhart M, Chew BH, Du C, Brooks DE, Carter CJ, Morrissey JH, Haynes CA, Kizhakkedathu JN. Affinity-based design of a synthetic universal reversal agent for heparin anticoagulants. Sci Transl Med 2014, 6 (260), 260ra150.

8.  Kalaska B, Sokolowska E, Kaminski K, Szczubialka K, Mogielnicki A, Nowakowska M, Buczko W. Cationic derivative of dextran reverses anticoagulant activity of unfractionated heparin in animal models of arterial and venous thrombosis. Eur J Pharmacol 2012, 686 (1-3), 81-89.

9.  Kalaska B, Kaminski K, Sokolowska E, Czaplicki D, Kujdowicz M, Stalińska K, Bereta J, Szczubialka K, Pawlak D, Nowakowska M, Mogielnicki A. Nonclinical evaluation of novel cationically modified polysaccharide antidotes for unfractionated heparin. PLoS ONE 2015, 10 (3), e0119486.

10. Ansell J, Bakhru SH, Laulicht SS, Steiner SS, Grosso M, Brown K, Dishy V, Noveck RJ, Costin JC. Use of PER977 to reverse the anticoagulant effect of edoxaban. N Engl J Med 2014, 371 (22), 2141-2142.

11. Mahan CE. A 1-year drug utilization evaluation of protamine in hospitalized patients to identify possible future roles of heparin and low molecular weight heparin reversal agents. J Thromb Thrombolysis 2014, 37 (3), 271-278.

12. Burke PA. The Ups and Downs of Clinical Translation of New Technologies: Déjà Vu All Over Again. Molecular Therapy 2015, 3 (5), 791-792.

13. Cushing DJ, Cooper WD, Cohen ML, McVoy JR, Sobel M, Harris RB. Reversal of heparin-induced increases in aPTT in the rat by PM102, a novel heparin antagonist. Eur J Pharmacol 2010, 635 (1-3), 165-170.

14. Horrow JC. Protamine: a review of its toxicity. Anesth Analg 1985, 64 (3), 248-261.

15. Miescher F. Das Protamin, eine neue organische Base aus den Samenfäden des Rheinlachses. Ber deut chem Ges 1874, 7, 376-379.

16. Hirsh J, Bauer KA, Donati MB, Gould M, Samama MM, Weitz JI. Parenteral anticoagulants. Chest 2008, 133 (6 Suppl), 141S-159S.

17. Carr JA, Silverman N. The heparin-protamine interaction: a review. J Cardiovasc Surg 1999, 40 (5), 659-666.

18. Taylor S, Folkman J. Protamine as an inhibitor angiogenesis. Nature 1982, 297 (5864), 307-312.

19. Mochizuki T, Olson PJ, Szlam F, Ramsay JG, Levy JH. Protamine reversal of heparin affects platelet aggregation and activated clotting time after cardiopulmonary bypass. Anesth Analg 1998, 87 (4), 781-785.

20. Nielsen VG. Protamine enhances fibrinolysis by decreasing clot strength: role of tissue factor-initiated thrombin generation. Ann Thorac Surg 2006, 81 (5), 720-1727.

21.  NiAnile F, Preston RJS, Jenkins PV, Nel HJ, Jonhson JA, Smith OP, White B, Fallon PG, O’Donnell JSO. Protamine sulfate down-regulates thrombin generation by inhibiting factor V activation. Blood 2009, 114 (8), 1658-1665.

22.  Woltz M, Weltermann A, Nieszpaur-Los M, Schneider B, Fassolt A, Lechner K, Eichler HG, Kyrle PA. Studies on the neutralizing effect of protamine on unfractionated and low molecular weight heparin (Fragmin) at the site of activation of the coagulation system in man. Thromb Haemost 1995, 73 (3), 439-443.

23.  Crowther MA, Berry LR, Monagle PT, Chan AKC. Mechanisms responsible for the failure of protamine to inactivate low-molecular-weight heparin. Br J Haematol 2002, 116 (1), 178-186.

24.  Delucia A, Wakefield TW, Kadell AM, Wroblewski SK, VanDort M, Stanley JC. Tissue distribution, circulating half-life, and excertion of intravenously administrated protamine sulfate. ASAIO 1993, 39 (3), M7 15-18.

25.  Butterworth J, Lin YA, Prielipp R, Bennett J, James R. The pharmacokinetics and cardiovascular effects of a single intravenous dose of protamine in normal volunteers. Anesth Analg 2002, 94 (3) , 514-522.

26.  Kimmel SE, Sekeres MA, Berlin JA, Ellison N, Siessa VJ, Strom BL. Risk factor for clinically important adverse events after protamine administration following cardiopulmonary bypass. Am J Cardiol 1998, 32 (7), 1916-1922.

27.  Knape JTA, Schuller JL, de Haan P, de Jong AP, Bovill JG. An anaphylactic reaction to protamine in a patient allergic to fish. Anesthesiology 1981, 55 (3), 324-325.

28.  Levy JH, Schweiger IM, Zaidan JR, Faraj BA, Weintraub WS. Evaluation of patients at risk for protamine reactions. J Throac Cardiovasc Surg 1989, 98 (2), 200-204.

29.  Adourian U, Shampaine EL, Hirshman CA, Fuchs E, Adkinson NF Jr. High-titer protamine-specific IgG antibody associated with anaphylaxis: report of a case and quantitative analysis of antibody in vasectomized men. Anesthesiology 1993, 78 (2), 368-372.

30.  Samuel T, Linnet L, Rumke P. Post vasectomy autoimmunity to protamines in relation to the formation of granulomas and sperm agglutinating antibodies. Clin Exp Immunol 1978, 33 (2), 261-269.

31.  Kurtz AB, Gray RS, Markanday S, Nabarro JD. Circulating IgG antibody to protamine in patients treated with protamine-insulins. Diabetologia 1983, 25 (4), 322-324.

32.  Pearson PJ, Evora PR, Ayrancioglu K, Schaff HV. Protamine releases endothelium-derived relaxing factor from systemic arteries. A possible mechanism of hypotension during heparin neutralization. Circulation 1992, 86 (1), 289-294.

33.  Chu YQ, Cai LJ, Jiang DC, Jia D, Yan SY, Wang YQ. Allergic shock and death associated with protamine administration in a diabetic patient. Clin Ther 2010, 32 (10), 1729-1732.

34.  Horrow JC. Protamine allergy. J Cardiothor Anesth 1988, 2 (2), 225-242.

35.  Moncada S, Higgs AE. Endogenous nitric oxide: physiology, pathology and clinical relevance. E J Clin Inv 1991, 21 (4), 361-374.

36.  Furlong B, Henderson AH, Lewis MJ, Smith JA. Endothelium-derived relaxing factor inhibits in vitro platelet aggregation. Br J Pharmacol 1987, 90 (4), 687-692.

37.  Buckley BS, Mirza Z, Whorton AR. Regulation of Ca2+ dependent nitric oxide synthase in bovine aortic endothelial cells. Am J Physiol 1995, 269 (3 Pt 1), C757-765.

38.  Alderton WK, Cooper CE, Knowles RG. Nitric oxide synthases: structure, function and inhibition. Biochem J 2001, 357 (Pt 3), 593-615.

39.  Pevni D, Gurevich J, Frolkis I, Keren G, Schapira I, Paz J, Kramer A, Locker C, Mohr R. Protamine induces vasorelaxation of human internal thoracic artery by endothelial NO-synthase pathway. Ann Thorac Surg 2000, 70 (6), 2050-2053.

40.  Hayashi Y, Sawa Y, Fukuyama N, Nakazawa H, Matsuda H. Inducible nitric oxide production is an adaptation to cardiopulmonary bypass-induced inflammatory response. Ann Thorac Surg 2001, 72 (1), 149-155.

41.  Ruvolo G, Greco E, Speziale G, Tritapepe L, Marino B, Mollace V, Nisticò G. Nitric oxide formation during cardiopulmonary bypass. Ann Thorac Surg 1994, 57 (4), 1055-1057.

42.  Takakura K, Mizogami M, Fukuda S. Protamine sulfate causes endothelium-independent vasorelaxation via inducible nitric oxide synthase pathway. Can J Anesth 2006, 53 (2), 162-167.

43.  Orescanin-Dusic Z, Milovanovic S, Spasie M, Radojicic R, Blagojevic D. Effect of protamine sulfate on the isolated mesenteric arteries of normotensive and aspontaneously hypertensive rats. Arch Biol Sci 2008, 60 (2), 163-168.

44.  Chudasama SL, Espinasse B, Hwang F, Qi R, Joglekar M, Afonina G, Wiesner MR, Welsby IJ, Ortel TL, Arepally GM. Heparin modifies the immunogenicity of positively charged proteins. Blood 2010, 116 (26), 6046-6053.

45.  Levy J, Zaidan J, Faraj B. Prospective evaluation of risk of protamine reactions in patients with NPH insulin-dependent diabetes. Anesth Analg 1986, 65 (7), 739-742.

46.  Nybo M, Madsen JS. Serious anaphylactic reactions due to protamine sulfate: a systemic literature review. Basic Clin Pharmacol Toxicol 2008, 103 (2), 192-196.

47.  Gurses KM, Kocyigit D, Yalcin MU, Evranos B, Yorgun H, Sahiner ML, Kaya EB, Oto ML, Ozer N, Aytemir K. Safety and efficacy outcomes of protamine administration for heparin reversal following cryoballoon-based pulmonary vein isolation. J Interv Card Electrophysiol 2015, 43 (2), 161-167.

48.  Chilukuri K, Henrikson CA, Dalal D, Scherr D, MacPherson EC, Cheng A, Spragg D, Nazarian S, Sinha S, Berger R, Marine JE, Calkins H. Incidance and outcomes of protamine reactions in patients undergoing catheter ablation of atrial fibrillation. J Interv Card Electrophysiol 2009, 25 (3), 175-181.

49.  Weiss ME, Nyhan D, Peng Z, Horrow JC, Lowenstein E, Hirshman C, Adkinson NF Jr. Association of protamine IgE and IgG antibodies with life-threatening reactions to intravenous protamine. N Engl J Med 1989, 320 (3-4), 886-892.

50.  Porsche R, Brenner Z. Allergy to protamine sulfate. Heart Lung 1999, 28 (6), 418-428.

51.  Laubser PG. Effect of methylprednisolone on complement activation during heparin neutralization. J Cardiovasc Pharmacol 1997, 29 (5), 23-27.

52.  Nuttall GA, Murray MJ, Bowie W. Protamine-heparin-induced pulmonary hypertension in pigs: effects of treatment with a thromboxane receptor antagonist on hemodynamics and coagulation. Anesthesiology 1991, 74 (1), 138-145.

53.  Conzen PF, Habazettl H, Gutmann R, Hobbhahn J, Goetz AE, Peter K, Brendel W. Thromboxane mediation of pulmonary hemodynamic responses after neutralization of heparin by protamine in pigs. Anesth Analg 1989, 68 (1), 25-31.

54.  Stafford-Smith M, Lefrak EA, Qazi AG, Welsby IJ, Barber L, Hoeft A, Dorenbaum A, Mathias J, Rochon JJ, Newman MF. Efficacy and safety of heparinase I versus protamine in patients undergoing coronary artery bypass grafting with and without cardiopulmonary bypass. Anesthesiology 2005, 103 (2), 229-240.

55.  Rucinski B, Niewiarowski S, Strzyzewski M, Holt JC, Mayo KH. Human platelet factor 4 and its C-terminal peptides: Heparin binding and its clearance from the circulation. Thromb Haemost 1990, 63 (3), 493-498.

56.  Moore S, Pepper DS, Cash JD. Platelet antiheparin activity. The isolation and characterization of platelet factor 4 released from thrombin-aggregated washed human platelets and its dissociation into subunits and the isolation of membrane bound antiheparin activity. Biochim Biophys Acta 1975, 379 (2), 370-384.

57.  Kuziej J, Litinas E, Hoppensteadt DA, Liu D, Walenga JM, Fareed J, Jeske W. In vivo neutralization of unfractionated heparin and low-molecular-weight heparin by a novel salicylamide derivative. Clin Appl Thromb Hemost 2010, 16 (4), 377-386.

58.  Shah N, Mohammad AR. Reversal Agents for Anticoagulants: Focus on Andexanet Alfa. AMSRJ 2014, 1, 16-28.

59.  Adams M. Tissue factor pathway inhibitor: new insights into an old inhibitor. Semin Thromb Hemost 2012, 38 (2), 129-134.

60.  Paty I, Trellu M, Destors JM, Cortez P, Boëlle E, Sanderink G. Reversibility of the anti-FXa activity of idrabiotaparinux by intravenous avidin infusion. J Thromb Haemost 2010, 8 (4), 722-729.

61.  Sokolowska E, Kalaska B, Kaminski K, Lewandowska A, Błażejczyk A, Wietrzyk J, Kasacka I, Szczubialka K, Pawlak D, Nowakowska M, Mogielnicki A. The toxicokinetic profile of Dex40-GTMAC3 - a novel polysaccharide candidate for reversal of unfractionated heparin. Front Pharmacol 2016, 7, 60.

62.  Regan-Shaw S, Nihil M, Ahmad N. Dose translation from animals to human studies revised. FASEB J 2008, 22 (3), 659-661.

63.  Mehvar R, Robinson MA, Reynolds JM. Molecular weight dependent tissue accumulation of Dextrans: in vivo studiem in rats. J Pharm Sci 1994, 83 (10), 1495-1499.