Recombinant factor VIIa in paediatric bleeding disorders - A 2006 review

Haemophilia

Volumn 12, Issue 5, 2006, Pages 457-472

  Mathew, Prasad ^a   Young, G ^b  

^a UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^b CHILDREN S HOSPITAL OF ORANGE COUNTY   (United States)

Author keywords

Coagulation disorders; Paediatrics; Recombinant factor VIIa

Indexed keywords

BLOOD CLOTTING FACTOR 8 INHIBITOR; BLOOD CLOTTING INHIBITOR; CYCLOPHOSPHAMIDE; PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A; THROMBIN; TRANEXAMIC ACID;

BLEEDING DISORDER; BLOOD CLOTTING FACTOR 7 DEFICIENCY; BLOOD VESSEL GRAFT; BOLUS INJECTION; BONE MARROW TRANSPLANTATION; BRAIN HEMORRHAGE; CARDIOPULMONARY BYPASS; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; CONTINUOUS INFUSION; DENGUE; DENGUE VIRUS; DISSEMINATED INTRAVASCULAR CLOTTING; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG LABELING; DRUG MEGADOSE; DRUG SAFETY; DRUG UTILIZATION; EXPERIENCE; EXTRACORPOREAL OXYGENATION; GASTROINTESTINAL HEMORRHAGE; GLANZMANN DISEASE; GRAFT OCCLUSION; HEART INFARCTION; HEMARTHROSIS; HEMOPHILIA A; HEMOPHILIA B; HEMORRHAGIC CYSTITIS; HEMOSTASIS; HUMAN; IMMUNOLOGICAL TOLERANCE; INTENSIVE CARE; LIVER FAILURE; LIVER TRANSPLANTATION; LUNG EMBOLISM; LUNG HEMORRHAGE; MUSCLE BLEEDING; ORTHOPEDIC SURGERY; POSTOPERATIVE HEMORRHAGE; PREMATURITY; PRIORITY JOURNAL; REVIEW; SCOLIOSIS; SKIN BLEEDING; SPINE SURGERY; THALASSEMIA MAJOR; THROMBOEMBOLISM; TOOTH EXTRACTION; TRAFFIC ACCIDENT; TRAUMATOLOGY; TREATMENT OUTCOME; VIRUS HEMORRHAGIC FEVER;

BLOOD COAGULATION FACTORS; BLOOD PLATELET DISORDERS; CHILD; DRUG ADMINISTRATION SCHEDULE; FACTOR VII; FACTOR VII DEFICIENCY; FACTOR VIIA; HEMOPHILIA A; HEMORRHAGE; HUMANS; IMMUNE TOLERANCE; INFANT, NEWBORN; INFANT, PREMATURE, DISEASES; INFUSIONS, PARENTERAL; INTENSIVE CARE; LIVER DISEASES; RECOMBINANT PROTEINS; THORACIC SURGICAL PROCEDURES; WOUNDS AND INJURIES;

EID: 33747194403     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2006.01321.x     Document Type: Review

References (103)

1. Hedner U. Recombinant coagulation factor VIIa: From Concept to clinical application in hemophilia treatment in 2000. Semin Thromb Hemost 2000; 26: 363-6.
2. Hedner U. Recombinant activated factor VII as a universal hemostatic agent. Blood Coagul Fibrinolysis 1998; 9: S147-52.
3. Hedner U. Treatment of patients with factor VIII and factor IX inhibitors with special focus on the use of recombinant factor VIIa. Thromb Haemost 1999; 82: 531-9.
4. Jones ML, Wight J, Paisley S, Knight C. Control of bleeding in patients with haemophilia A with inhibitors: A systematic review. Haemophilia 2003; 9: 464-520.
5. Guyatt GH, Haynes RB, Jaeschke RZ et al. for the Evidence-Based Medicine Working Group. Evidence-based medicine: Principles for applying the users' guides to patient care. JAMA 2000; 284: 1290-6.
6. Hedner U, Kristensen H, Berntrop E et al. Pharmacokinetics of rFVIIa in children. Haemophilia 1998; 4: 355 (abstract).
7. Shapiro AD. Recombinant factor VIIa in the treatment of bleeding in hemophilic children with inhibitors. Semin Thromb Hemost 2000; 26: 413-9.
8. Villar A, Aronis S, Morfini M et al. Pharmacokinetics of activated recombinant coagulation factor VII in children vs. adults with hemophilia A. Haemophilia 2004; 10: 352-9.
9. Abshire T, Kenet G. Recombinant factor VIIa: Review of efficacy, dosing regimens and safety in patients with congenital and acquired factor VIII or IX inhibitors. J Thromb Haemost 2004; 2: 899-909.
10. Lusher JM, Roberts HR, Davignon G et al. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous hemorrhages in persons with hemophilia A and B, with and without inhibitors. Haemophilia 1998; 4: 790-8.
11. Key NS, Aledort LM, Beardsley D et al. Home treatment of mild to moderate bleeding episodes using recombinant factor VIIa in haemophiliacs with inhibitors. Thromb Haemost 1998; 80: 912-8.
12. Santagostino E, Gringeri A, Mannucci PM. Home treatment with rFVIIa in patients with factor VIII inhibitors: The advantages of early intervention. Br J Haematol 1999; 104: 22-6.
13. Scharrer I. Recombinant factor VIIa for patients with inhibitors to factor VIII or IX or factor VII deficiency. Haemophilia 1999; 5: 253-9.
14. McPherson J, Teague L, Lloyd J et al. Experience with rFVIIa in Australia and New Zealand. Haemostasis 1996; 26: 109-17.
15. Arkin S, Blei F, Fetten J et al. rFVIIa in the management of limb-threatening bleeds unresponsive to alternative therapies: Results from the NovoSeven emergency-use program in patients with severe haemophilia or with acquired inhibitors. Blood Coagul Fibrinolysis 2000; 11: 255-9.
16. Liebman HA, Chediak J, Fink KI et al. rFVIIa therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII. Am J Hematol 2000; 63: 109-13.
17. O'Connell N, McMahon C, Smith J et al. Recombinant factor VIIa in the management of surgery and acute bleeding episodes in children with haemophilia and high responding inhibitors. Br J Haematol 2002; 116: 632-5.
18. Rice KM, Savidge GF. NovoSeven in central nervous system bleeds. Haemostasis 1996; 26: 131-4.
19. Arkin S, Cooper HA, Hutter JJ et al. Activated recombinant human coagulation factor VII therapy for intracranial hemorrhage in patients with hemophila A or B with inhibitors. Haemostasis 1998; 28: 93-8.
20. Schmidt ML, Gamerman S, Smith HE, Scott JP, DiMichele DM. rFVIIa therapy for intracranial hemorrhage in hemophilia A patients with inhibitors. Am J Hematol 1994; 47: 36-40.
21. Shapiro AD, Gilchrist GS, Hoots WK et al. Prospective, randomized trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost 1998; 80: 773-8.
22. Rodriguez-Merchan EC, Weidel JD, Wallny T et al. Elective orthopedic surgery in inhibitor patients. Haemophilia 2003; 9: 625-31.
23. Smith OP, Hann IM. rFVIIa therapy to secure hemostasis during central line insertion in children with high responding FVIII inhibitors. Br J Haematol 1996; 92: 1002-4.
24. Ingerslev J. Efficacy and safety of rFVIIa in the prophylaxis of bleeding in various surgical procedures in hemophilic patients with factor VIII and IX inhibitors. Semin Thromb Haemost 2000; 26: 425-32.
25. Brackmann HH, Effenberger W, Hess L, Schwabb R, Oldenburg J. Immune tolerance induction: A role for rFVIIa. Eur J Haematol 1998; 61: 18-23.
26. Petrini R, Klementz G. Treatment of acute bleeds with rFVIIa during immune tolerance therapy. Blood Coagul Fibrinolysis 1998; 9: S143-6.
27. Cooper HA, Jones CP, Campion E et al. Successful use of high dose rFVIIa in a high titer inhibitor patient with haemophilia B during major orthopaedic manipulations and rehabilitation to release fixed flexion contractures of both knees. Haemophilia 2000; 6: 297-8 (abstract).
28. Jimenez-Yuste V, Villar A, Morado M et al. Are higher doses needed of rFVIIa in haemophilic paediatric patients with inhibitor? Haemophilia 2000; 6: 298(a).
29. Chuansumrit A, Sri-Udomporn N, Srimuninnimit V, Juntarukha R. A single dose of rFVIIa combining adjuvant therapy for controlling bleeding episodes in haemophiliacs with inhibitors. Haemophilia 2001; 7: 532-6.
30. Kenet G, Lubetsky A, Luboshitz J, Martinowitz U. A new approach to treatment of bleeding episodes in young hemophilia patients: A single megadose of rFVIIa. J Thromb Haemost 2003; 1: 450-5.
31. Parmeshwaran R, Shapiro AD, Gill JC, Kessler CM. Dose effect and efficacy of rFVIIa in the treatment of hemophilia patients with inhibitors: Analysis from the HTRS registry. Haemophilia 2005; 11: 100-6.
32. Santagostino E, Mancuso ME, Rocino A, Mancuso G, Scaraggi F, Mannucci PM. A prospective randomized trial of high and standard dosages of recombinant factor VIIa for treatment of hemarthroses in hemophiliacs with inhibitors. J Thromb Hemost 2006; 4: 367-71.
33. Kavakli K, Makris M, Sulfikar B, Erhardtsen E, Abrams ZS, Kenet G. Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. Thromb Haemost 2006; 95: 600-5.
34. Kjalke M, Ezban M, Monroe DM, Hoffman M, Roberts HR, Hedner U. High dose factor VIIa increases initial thrombin generation and mediates faster platelet activation in thrombocytopenia-like conditions in a cell-based model. Br J Hematol 2001; 114: 114-20.
35. Poon M-C. Use of recombinant factor VIIa in hereditary bleeding disorders. Curr Opin Hematol 2001; 8: 312-8.
36. Montoro JB, Altisent C, Pico M et al. rFVIIa in continuous infusion during central line insertion in a child with factor VIII high-titer inhibitor. Haemophilia 1998; 4: 762-5.
37. Lorenzo JI, Montoro JM, Aznar JA. Postoperative use of rVIIa by continuous infusion in haemophilic boy. Haemophilia 1999; 5: 135-8.
38. Chuansumrit A, Israngkura P, Angchaisuksiri P et al. Controlling acute bleeding episodes with rFVIIa in haemophiliacs with inhibitor: continuous infusion and bolus infusion. Haemophilia 2000; 6: 61-5.
39. Santagostino E, Morfini M, Rocino A et al. Relationship between factor VII activity and clinical efficacy of rFVIIa given by continuous infusion to patients with factor VIII inhibitors. Thromb Haemost 2001; 86: 954-8.
40. Young G, McDaniel M, Nugent D. Prophylactic rFVIIa in hemophilia patients with inhibitors. Haemophilia 2005; 11: 203-7.
41. Mathew P. The use of rFVIIa in non-hemophilia bleeding conditions in paediatrics: A systematic review. Thromb Haemost 2004; 92: 738-46.
42. Mariani G, Testa MG, Di Paolantonio T et al. Use of recombinant activated factor VII in the treatment of congenital factor VII deficiencies. Vox Sang 1999; 77: 131-6.
43. Wong WY, Huang WC, Miller R et al. Clinical efficacy and recovery levels of recombinant FVIIa (NovoSeven) in the treatment of intracranial haemorrhage in severe neonatal FVII deficiency. Haemophilia 2000; 6: 50-4.
44. Billio A, Pescosta N, Rosanelli C et al. Successful short term oral surgery prophylaxis with rFVIIa in severe congenital factor VII deficiency. Blood Coagul Fibrinolysis 1997; 8: 249-50.
45. Huang W-Y, Kruskal MS, Bauer KA, Uhl L, Shaz BH. The use of recombinant activated factor VII in three patients with central nervous system hemorrhages associated with factor VII deficiency. Transfusion 2004; 44: 1544-6.
46. Tcheng WY, Donkin J, Konzal S, Wong WY. Recombinant factor VIIa prophylaxis in a patient with severe congenital factor VII deficiency. Haemophilia 2004; 10: 295-8.
47. Michaels LA, Philipp CS, Eisele J, Pappas H, Saidi P. Prophylactic treatment of a small child with severe factor VII deficiency using repeat dosing from a ingle vial of rFVIIa. Pediatr Blood cancer 2005; [Epub ahead of print].
48. Brown JB, Emerick KM, Brown DL et al. Recombinant factor VIIa improves coagulopathy caused by liver failure. J Pediatr Gastroenterol Nutr 2003; 37: 268-72.
49. Chuansumrit A, Chantarojanasiri T, Isarangkura P et al. Recombinant factor VIIa in children with acute bleeding resulting from liver failure and DIC. Blood Coagul Fibrinolysis 2000; 11 (Suppl. 1): S101-5.
50. Kalicinski P, Kaminski A, Drewniak T et al. Quick correction of hemostasis in two patients with fulminant liver failure undergoing liver transplantation by recombinant activated factor VII. Transplant Proc 1999; 31: 378-9.
51. Tobias JD, Berkenbosch JW. Synthetic factor VIIa concentrate to treat coagulopathy and gastrointestinal bleeding in an infant with end-stage liver disease. Clin Pediatr 2002; 41: 613-6.
52. Chuansumrit A, Treepongkaruna S, Phuapradit P. Combined fresh frozen plasma with recombinant factor VIIa in restoring hemostasis for invasive procedures in children with liver diseases. Thromb Haemost 2001; 85: 748-9.
53. Young G, Nugent DJ. Prevention of bleeding complications in neonates with liver failure undergoing surgery using recombinant factor VIIa. Hematology 2001; 6: 341-6.
54. Pettersson N, Fischler B, Petrini P, Schulman S, Nemeth A. Recombinant FVIIa in children with liver disease. Thromb Res 2005; 116: 185-97.
55. Atkinson PR, Jardine L, Williams S, Barr RM, Quan D, Wall W. Use of recombinant factor VIIa in pediatric patients with liver failure and severe coagulopathy. Transplant Proc 2005; 37: 1091-3.
56. Kalicinski P, Markiewicz M, Kaminski A et al. Single pretransplant bolus of rFVIIa ameliorates influence of risk factors for blood loss during orthotopic liver transplantation. Pediatr Transplant 2005; 9: 299-304.
57. Al Douri M, Shafi T, Al Khudairi D et al. Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery. Blood Coagul Fibrinolysis 2000; 11 (Suppl. 1): S121-7.
58. Tobias JD, Berkenbosch JW, Russo P. Recombinant factor VIIa to treat bleeding after cardiac surgery in an infant. Pediatr Crit Care Med 2003; 4: 49-51.
59. Kenet G. rFVIIa for profuse bleeding in surgical patients. Bloodline Rev 2001; 1: 12-3.
60. Leibovitch L, Kenet G, Mazor K et al. Recombinant activated factor VII for life-threatening pulmonary hemorrhage after pediatric cardiac surgery. Pediatr Crit Care Med 2003; 4: 444-6.
61. Pychynska-Pokorska M, Moll JJ, Krajewski W, Jarosik P. The use of rFVIIa in uncontrolled postoperative bleeding in children undergoing cardiac surgery with cardiopulmonary bypass. Pediatr Crit Care Med 2004; 5: 246-50.
62. Razon Y, Rez E, Vidne B et al. Recombinant factor VIIa as a hemostatic agent after surgery for congenital heart disease. Paediatr Anaesth 2005; 15: 235-40.
63. Tobias JD, Simsic JM, Weinstein S et al. Recombinant factor VIIa to control excessive bleeding following surgery for congenital heart disease in pediatric patients. J Intensive Care Med 2004; 19: 270-3.
64. Veldman A, Fischer D, Voight B et al. Life-threatening hemorrhage in neonates: Management with recombinant activated factor VII. Intensive Care Med 2002; 28: 1635-7.
65. Chuansumrit A, Nuntnarumit P, Okascharoen C et al. The use of recombinant activated factor VII to control bleeding in a preterm infant undergoing exploratory laparotomy. Pediatrics 2002; 107: 169-71.
66. Olomu N, Kulkarni R, Manco-Johnson M. Treatment of severe pulmonary hemorrhage with activated recombinant factor VII in very low birth weight infants. J Perinatol 2002; 22: 672-4.
67. Greisen G, Andreasen RB. Recombinant factor VIIa in preterm neonates with prolonged prothrombin time. Blood Coagul Fibrinolysis 2003; 14: 117-20.
68. Veldman A, Josef J, Fischer D, Volk WR. A prospective pilot study of prophylactic treatment of preterm neonates with recombinant activated factor VII during the first 72 hours of life. Pediatr Crit Care Med 2006; 7: 34-9.
69. Tengborn L, Petruson B. A patient with Glanzmann thrombasthenia and epistaxis successfully treated with recombinant factor VIIa. Thromb Haemost 1996; 75: 981-2.
70. Ancliff P, Leisner R, Khair K et al. The use of recombinant factor VIIa in a patient with severe Glanzmann's thrombasthenia to facilitate insertion of a Port-a-cath. Blood Coagul Fibrinolysis 1999; 10: 447-8.
71. Ameri A, Stolte S. Correlation of activated clotting time with rFVIIa infusion and clinical efficacy in a patient with Glanzmann Thrombasthenia and platelet alloantibodies. Thromb Haemost 2002; 87: 1084.
72. Chuansumrit A, Suwannuraks M, Sri-Udomporn N et al. Recombinant activated factor VII combined with local measures in preventing bleeding from invasive dental procedures in patients with Glanzmann thrombasthenia. Blood Coagul Fibrinolysis 2003; 14: 187-90.
73. Devecioglu O, Unuvar A, Anak S et al. Pyelolithomy in a patient with Glanzmann Thrombasthenia and antiglycoprotein IIb/IIIa antibodies: The shortest possible duration of treatment with recombinant activated factor VII and platelet transfusions. Turk J Pediatr 2003; 45: 64-66.
74. Caglar K, Cetinkaya A, Aytac S et al. Use of recombinant factor VIIa for bleeding in children with Glanzmann thrombasthenia. Pediatr Hematol Oncol 2003; 20: 435-8.
75. Poon M-C, Demers C, Jobin F et al. Recombinant factor VIIa is effective for bleeding and surgery in patients with Glanzmann thrombasthenia. Blood 1999; 94: 3951-3.
76. Poon M-C, D'Orion R, Von Depka M et al. Prophylactic and therapeutic rFVIIa administration to patient's with Glanzmann's thombasthenia: results of an international survey. J Thromb Haemost 2004; 2: 1096-103.
77. Almeida AM, Khair K, Hann I et al. The use of recombinant factor VIIa in children with inherited platelet function disorders. Br J Haematol 2003; 121: 477-81.
78. Peters M, Heijboer H. Treatment of a patient with Bernard-Soulier syndrome and recurrent nosebleeds with recombinant factor VIIa. Thromb Haemost 1998; 80: 352.
79. Kenet G, Walden R, Eldad A et al. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999; 354: 1879.
80. Martinowitz U, Kenet G, Segal E et al. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma 2001; 51: 431-9.
81. Martinowitz U, Kenet G, Lubetsky A et al. Possible role of recombinant factor VII (rFVIIa) in the control of hemorrhage associated with massive trauma. Can J Anesth 2002; 49: S15-20.
82. Morenski JD, Tobias JD, Jimenez DF. rVIIa for cerebral-induced coagulopathy in pediatric patients. J Neurosurg 2003; 98: 611-6.
83. Kulkarni R, Daneshmand A, Guertin S et al. Successful use of rFVIIa in traumatic liver injuries in children. J Trauma 2004; 56: 1348-52.
84. Chino J, Paolini D, Tran A, Mathew P, Howdieshell TR. rFVII as an adjunct to packing for liver injury with hepatic venous disruption. Am Surg 2005; 71: 595-7.
85. Dutton RP, McCunn M, Hyder M et al. Factor VIIa for correction of traumatic coagulopathy. J Trauma 2004; 57: 709-19.
86. Millar CG, Stringer MD, Sugarman I, Richards M. The use of rFVIIa for bleeding in paediatric practice. Haemophilia 2005; 11: 171-4.
87. Chuansumrit A, Tangnararatchakit K, Lektakul Y et al. The use of rFVIIa for controlling life-threatening bleeding in dengue shock syndrome. Blood Coagul Fibrinolysis 2004; 15: 335-42.
88. Chuansumrit A, Wangruangsatid S, Lektrakul Y et al. Control of bleeding in children with Dengue hemorrhagic fever using rFVIIa: A randomized, double-blind, placebo-controlled study. Blood Coagul Fibrinolysis 2005; 16: 549-55.
89. Wittenstein B, Ng C, Ravn H, Holdman A. Recombinant factor VII for sever bleeding during extracorporeal membrane oxygenation following open heart surgery. Pediatr Crit Care 2005; 6: 473-6.
90. Dominguez TE, Mitchell M, Friess SH et al. Use of recombinant factor VII for refractory hemorrhage during extracorporeal membrane oxygenation. Pediatr Crit Care 2005; 6: 348-51.
91. Blatt J, Gold SH, Wiley JM, Monahan PE, Cooper HC, Harvey D. Off-label use of recombinant factor VIIa in patients following bone marrow transplantation. Bone Marrow Transplant 2001; 28: 405-7.
92. Karimi M, Zakerina M, Khojasteh HN, Ramzi M, Ahmad E. Successful treatment of cyclophosphamide induced intractable hemorrhagic cystitis with recombinant FVIIa after allogeneic bone marrow transplantation. J Thromb Haemost 2004; 2: 1853-5.
93. Kolban M, Balachowska-Kosciolek I, Chmielnicki M. Recombinant coagulation factor VIIa - a novel haemostatic agent in scoliosis surgery? Eur Spine J 2006; 15: 944-52.
94. Tobias JD, Groeper K, Berkenbosch. Preliminary experience with the use of recombinant factor VIIa to treat coagulation disturbances in pediatric patients. South Med J 2003; 96: 12-6.
95. Park P, Fewel ME, Garton HJ et al. Recombinant activated factor VII for the rapid correction of coagulopathy in non-hemophilic neurosurgical patients. Neurosurgery 2003; 53: 34-9.
96. Heisel M, Nagib M, Madsen L, Alshiekh M, Bendel A. Use of recombinant factor VIIa to control intraoperative bleeding in pediatric brain tumor patients. Pediatr Blood Cancer 2004; 43: 703-5.
97. Brenner B, Hoffman R, Balashov D, Shutluko E, Culic S, Nizamoutdinova E. Control of bleeding caused by thrombocytopenia associated with hematologic malignancy: An audit of the clinical use of recombinant activated factor VII. Clin Appl Thromb/Hemost 2005; 11: 401-10.
98. Das P, Carcao M, Hitzler J. Use of recombinant factor VII a prior to lumbar puncture in pediatric patients with acute leukemia. Pediatr Blood Cancer 2005; xx: [Epub ahead of print].
99. Lusher J, Ingerslev J, Roberts H et al. Clinical experience with recombinant factor VIIa. Blood Coagul Fibrinolysis 1998; 9: 119-28.
100. Roberts HR, Monroe DM, Hoffman M. Safety profile of recombinant factor VIIa. Semin Hematol 2004; 41: 101-8.
101. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 2006; 295: 293-8.
102. Hedner U, Erhardtsen E. Potential role for rFVIIa in transfusion medicine. Transfusion 2002; 42: 114-24.
103. Hendricks HG, Meijer K, de Wolf JT et al. Effects of rFVIIa on coagulation measured by thromboelastography in liver transplantation. Blood Coagul Fibrinolysis 2002; 13: 309-13.