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Prophylactic Use of Enoxaparin in Adolescents During Bariatric Surgery-a Prospective Clinical Study

机译:雌激素在肥胖手术期间的预防性用途 - 一种前瞻性临床研究

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Introduction Severe obesity predisposes youth to a higher risk of venous thromboembolism (VTE). This study evaluates a BMI-stratified prophylactic dosing regimen of enoxaparin in adolescents with severe obesity undergoing surgery. Methods Adolescents aged 12-20 years received prophylactic enoxaparin at 40 mg SC (for a BMI = 50 kg/m(2)) every 12 h until discharge. Blood samples were drawn at pre-dose, 1, 2, 4, 6, and 12 h. Plasma Anti-Factor Xa (Anti-FXa) activity was used as a surrogate marker for enoxaparin pharmacokinetics. Results Ten female and two male obese adolescents (age range 14-19 years) had a mean BMI of 49.9 kg/m(2) (38.4-58 kg/m(2)). Four patients had a BMI of less than 50 kg/m(2) and received 40 mg enoxaparin, resulting in a mean dosage of 0.352 +/- 0.070 mg/kg body weight. Eight patients were dosed with 60 mg enoxaparin every 12 h, resulting in a mean dosage of 0.395 +/- 0.028 mg/kg. Peak plasma anti-FXa activity (C-max) ranged from 0.14 to 0.30 IU/mL, median C-max was 0.205 IU/mL. Median T-max was 5.67 h (range 3.78-7.52 h). Median AUC(i) was 1.00 h IU/mL (range 0.42-1.67 h IU/mL). Ten out of 12 patients (83%) reached the primary endpoint with anti-FXa activity in the range for VTE prevention (0.1-0.3 IU/mL). Conclusions Our dosing scheme of 40 mg vs. 60 mg enoxaparin stratified according to BMI proved to be effective in reaching prophylactic anti-FXa activity in 83% of adolescent patients.
机译:引言严重肥胖使青年促使青少年静脉血栓栓塞(VTE)的风险更高。该研究评估了在患有严重肥胖接受手术的青少年中烯醇素的BMI分层预防剂量治疗方法。方法12-20岁的青少年在40mg sc下接受预防烯醇素(对于BMI = 50kg / m(2)),每12小时直至放电。在预剂量,1,2,4,6和12h下拉出​​血液样品。血浆抗因子Xa(抗FXA)活性用作烯脱蒿素药代动力学的替代标志物。结果十个女性和两只男性肥胖青少年(14-19岁)的平均BMI为49.9 kg / m(2)(38.4-58 kg / m(2))。 4名患者的BMI小于50 kg / m(2)并接受40mg烯脱肝素,导致平均剂量为0.352 +/- 0.070mg / kg体重。八名患者每12小时用60毫克烯脱蒿素给药,导致平均剂量为0.395 +/- 0.028mg / kg。峰等离子体抗FXA活性(C-MAX)的范围为0.14至0.30 IU / mL,中值C-MAX为0.205 IU / mL。中位数T-MAX为5.67小时(范围3.78-7.52小时)。中位数AUC(I)为1.00小时IU / ml(范围0.42-1.67 HI / ml)。 12名患者中有10名(83%)达到vTE预防范围内的抗FXA活性的主要终点(0.1-0.3 iu / ml)。结论我们的给药方案为40毫克与60毫克烯脱西素根据BMI分层,证明有效地在83%的青少年患者中达到预防性抗FXA活性。

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