ࡱ> 685 0bjbjqq 8ee  HJJJJJJ$'VnnNHHL9h40}}}>(,T$xnn |} :  Presented in XXI st congress of International Society on Thrombosis & Hemostasis, Geneva, 2007 0884: EFFICACY AND SAFETY OF A NOVEL HANSENULA POLYMORPHA -DERIVED RECOMBINANT RB-VARIANT HIRUDIN FOR THROMBOPROPHYLAXIS IN ORTHOPAEDIC PATIENTS H. A. Goubran(1), A. A. Z. Hanna(2), S. Sholkamy(3)(1)Department of Internal Medicine, (2)Orthopaedic department, Faculty of Medicine Cairo University, (3)Vascular Surgery Department, Ain Shams University, Cairo, Egypt Disclosure of Interest: Drug Partly supplied free from Rhein Minapharm EGYPT Introduction: The efficacy of hirudins in dose of 15mg bid s.c. for thromboprophylaxis in orthopaedic patients were documented in many trials [1-2]. A novel recombinant hirudin RB-variant (RB-Hirudin) (with isoleucine in position-1) from the yeast Hansenula polymorpha as an expression system (Thrombexx 15mg) was produced by Rhein-Minapharm-EGYPT. Methods: 48 orthopaedic patients undergoing major interventions received thromboprophylaxis using 15mg s.c. bid RB-Hirudin for a duration of 10-12 days with the first dose given 30 minutes before surgery. Patients with suspected DVT were subjected to duplex studies. Side effects were reported on standard adverse event forms that highlighted excessive bleeding, drop of haemoglobin, local bruising, local and systemic allergic reactions. Results: Efficacy: 3 cases had clinical suspicion of DVT but proved negative when subjected to duplex. Safety: No drug discontinuation, local or systemic allergic reactions were reported in the treated population. Local bruising was noted at the site injection in 8 cases, 5 of whom were receiving aspirin postoperatively. Minor soaking of the dressing was reported in one case. Conclusions: RB-Hirudin administered in a dose of 15mg s.c twice daily for thromboprophylaxis in major orthopaedic surgeries seems effective in preventing clinically detectable DVT. The drug is well tolerated with no major bleeding reported. Apart from local bruising at the injection sites, no local or systemic allergic reactions were reported highlighting the safety of this agent. References: 1-Erikson BI, Wille-Jrgensen P, Klebo P et al.,A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement. N Engl J Med. 1997 Nov 6;337(19):1329-35. 2- Eriksson BI, Ekmam S, Klebo Pet al., Prevention of deep-vein thrombosis after total hip replacement: direct thrombin inhibition with recombinant hirudin, CGP 39393. Lancet. 1996 Mar 9;347(9002):635-9. _a 8 b   ! A a  5 a W Z  1 > @ U u 0ǼǮǼǣǣǼǕǣǣǣǼǣǣǣǣǣǣǣǣǣhGhuh(5OJQJ\hGhu5OJQJ\hGhuhGhu5OJQJ\h(5OJQJ\hGhuh 5OJQJ\hPh3h(h h^|h^|mH sH h^|h^|\mH sH h^|:`a ! ? @ AB7gd(gd rgd^|ENw *@BLl67>Chh h r5OJQJ\hGhuh 5OJQJ\hGhu5OJQJ\6&P 1h:pJS. 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