比较两种低分子量肝素的生物活性10健康志愿者。

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阿齐兹M, Veyssier-Belot C, Alhenc-Gelas M, Chatellier G, Billaud-Mesguish E, Fiessinger约,Aiach M

比较两种低分子量肝素的生物活性10健康志愿者。

Br中国新药杂志。1995;12月40 (6):577 - 84。

PubMed ID
8703665 (在PubMed
]
文摘

1。低分子量肝素(lmwh)是由不同的解聚过程,因此可能的区别在于其药代动力学性质。2。我们设计了一个单剂量,随机交叉研究10个健康志愿者比较24 h两个lmwh的药物动力学,reviparin伊诺肝素,之前已被证明是临床等效在术后深静脉血栓形成的预防方面,尽管在他们的体内生物活性显著差异。两lmwh在同一剂量皮下注射用于临床研究:4250年anti-Xa iu reviparin和40毫克伊诺肝素具有类似的体外anti-Xa活动。3所示。整个24小时的血浆anti-Xa anti-thrombin活动类似reviparin和伊诺肝素。Amax和AUC (0, 24 h)后血浆anti-Xa活动reviparin政府都轻微但显著低于观察肝素后管理(区别治疗0.03 - 95% CI 0.56 [0.01 - -0.05] iu ml-1 h和95%可信区间[0.22 - -0.90]iu ml-1 Amax和AUC(0, 24小时)分别)。调整后对于体外anti-Xa活动,统计差异的两个lmwh坚持AUC (0, 24 h)但不是等离子anti-Xa Amax的活动。最高温度和等离子体anti-Xa捷运值两种药物之间的活动没有显著差异。 The t1/2 for reviparin did not significantly differ from that of enoxaparin (2.7 +/- 0.7 h vs 3.5 +/- 0.9 h respectively, NS). The Amax of the plasma anti-thrombin activity after reviparin administration was also slightly but significantly lower than that observed after enoxaparin administration, (difference between treatments of 0.018 95% CI[0.01-0.025] iu ml-1) whereas the AUC(0, 24h) of anti-thrombin activity vs time was not. A slight but significant increase of the activated partial thromboplastin time of a similar magnitude was observed after both reviparin and enoxaparin injections. 4. The calculated surface under the thrombin generation curve vs time (or thrombin potential) at peak was significantly higher after reviparin than after enoxaparin (367 +/- 53 UA vs 305 +/- 48 UA respectively, P < 0.05). Four hours after injection, thrombin potential was significantly correlated to plasma anti-Xa activity after reviparin but not after enoxaparin injection (r = 0.65, n = 10, P = 0.05 and r = -0.38, n = 10, P = 0.25 respectively). 5. After a single-dose injection in healthy subjects, two LMWHs with comparable in vitro activities differed slightly kinetically. Such minor differences are probably of little importance in the prevention of post-operative deep vein thrombosis, since these two LMWHs were previously shown to be comparable in this setting.

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