Journal of thrombosis and haemostasis : JTH · 2015
Bemiparin for thromboprophylaxis after benign gynecologic surgery: a randomized clinical trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Alalaf S K, Jawad A K, Jawad R K, Ali M S, Al Tawil N G
Аннотация
BACKGROUND: Venous thromboembolism (VTE) is the leading cause of mortality and morbidity in women following gynecologic surgery.
OBJECTIVES: To determine the efficacy of a second-generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery.
METHODS: We performed a single-blind randomized controlled trial including women in the moderate-risk, high-risk and highest-risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1 : 1 ratio into parallel groups to receive either seven daily doses of 3500 IU of subcutaneous bemiparin or to a non-intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7 days and 30 days postoperatively for symptomatic VTE, which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE.
RESULTS: In total, 387 participants were randomized to the bemiparin group and 387 to the non-intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [CI] 0.002-0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [OR] 7.1; 95% CI 1.3-36.2), varicose veins (OR 16.8; 95% CI 3.1-76.2), and thrombophilia (OR 39.3; 95% CI 1.5-1006.7). There were no major bleeding events or side effects related to the use of bemiparin.
CONCLUSIONS: Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery.
OBJECTIVES: To determine the efficacy of a second-generation low molecular weight heparin (bemiparin) for thromboprophylaxis after benign gynecologic surgery.
METHODS: We performed a single-blind randomized controlled trial including women in the moderate-risk, high-risk and highest-risk groups for developing VTE after benign gynecologic surgery. Participants were randomized at a 1 : 1 ratio into parallel groups to receive either seven daily doses of 3500 IU of subcutaneous bemiparin or to a non-intervention group receiving standard rehydration and advice on ambulation. Participants were followed up for 7 days and 30 days postoperatively for symptomatic VTE, which was confirmed by compression Doppler ultrasound, magnetic resonance imaging, or computed tomographic pulmonary angiography, according to the type of VTE.
RESULTS: In total, 387 participants were randomized to the bemiparin group and 387 to the non-intervention group. The incidence of symptomatic VTE (deep vein thrombosis and pulmonary embolism) events was lower (0/377) in participants who received bemiparin than in those who received no pharmacologic intervention (12/380, 3.2%; 95% confidence interval [CI] 0.002-0.6). Logistic regression analysis showed significant associations between VTE and immobility (odds ratio [OR] 7.1; 95% CI 1.3-36.2), varicose veins (OR 16.8; 95% CI 3.1-76.2), and thrombophilia (OR 39.3; 95% CI 1.5-1006.7). There were no major bleeding events or side effects related to the use of bemiparin.
CONCLUSIONS: Bemiparin was an effective thromboprophylactic agent for preventing venous thrombosis after benign gynecologic surgery.
Предметные рубрики MeSH
AdolescentAdultAgedAged, 80 and overAnticoagulantsFemaleGynecologic Surgical ProceduresHeparin, Low-Molecular-WeightHumansIncidenceIraqLogistic ModelsMagnetic Resonance ImagingMiddle AgedOdds RatioPulmonary EmbolismRisk AssessmentRisk FactorsSingle-Blind MethodTime FactorsTomography, X-Ray ComputedTreatment OutcomeUltrasonography, DopplerVenous ThromboembolismVenous ThrombosisYoung Adult