Titon J P, Auger D, Grange P, Hecquet J P, Remond A, Ulliac P, Vaissié J J
Centre médical Montréal, La Flèche.
Ann Cardiol Angeiol (Paris). 1994 Mar;43(3):160-6.
This multicentre, randomised, open trial compared the efficacy and safety/acceptability of calcium nadroparin, a non-steroidal anti-inflammatory drug, naproxen, in the treatment of superficial venous thrombosis of the lower limbs, in 117 patients. Calcium nadroparin was given at two dosage regimens: a fixed dose (daily subcutaneous injection of 0.6 ml, i.e. 6150 anti-Xa IU, n = 38) or a dose adjusted for body weight (31.5 anti-Xa IU/kg, n = 40). The naproxen was given orally (500 mg as a single daily dose, n = 39). Treatment duration was 6 days in both groups. A very marked difference was found to the advantage of calcium nadroparin, although this difference did not reach the threshold of statistical significance with regard to repermeabilisation of the thrombosed superficial vein at the end of treatment. The most striking result concerned the regression of symptoms and signs. At the end of treatment (D7), there was a significant difference to the advantage of the calcium nadroparin groups, particularly regarding feelings of heat and redness (p < 0.001 in both cases). The persistence of symptoms and signs at 8 weeks was statistically less frequent (p = 0.007) in the calcium nadroparin groups than in the naproxen group. Efficacy did not differ between the calcium nadroparin fixed dose and calcium nadroparin weight-adjusted dose groups. No adverse events nor clinically significant laboratory abnormalities were encountered. Antithrombotic treatment of superficial venous thromboses with calcium nadroparin is well tolerated and appears to be associated with a greater improvement in symptoms and signs, in the short and mid-terms, than that obtained with an oral non-steroidal anti-inflammatory.
这项多中心、随机、开放试验比较了非甾体抗炎药那屈肝素钙与萘普生在117例下肢浅静脉血栓形成治疗中的疗效及安全性/可接受性。那屈肝素钙采用两种给药方案:固定剂量(每日皮下注射0.6 ml,即6150抗Xa国际单位,n = 38)或根据体重调整剂量(31.5抗Xa国际单位/千克,n = 40)。萘普生采用口服给药(每日单次剂量500 mg,n = 39)。两组治疗持续时间均为6天。结果发现那屈肝素钙具有显著优势,尽管在治疗结束时血栓形成的浅静脉再通方面,这种差异未达到统计学意义的阈值。最显著的结果涉及症状和体征的消退。在治疗结束时(第7天),那屈肝素钙组具有显著优势,尤其是在发热和发红感觉方面(两种情况均p < 0.001)。在第8周时,那屈肝素钙组症状和体征持续存在的情况在统计学上比萘普生组少见(p = 0.007)。那屈肝素钙固定剂量组和那屈肝素钙体重调整剂量组的疗效无差异。未出现不良事件,也未发现具有临床意义的实验室异常。与口服非甾体抗炎药相比,那屈肝素钙用于浅静脉血栓形成的抗血栓治疗耐受性良好,并且在短期和中期似乎能使症状和体征得到更大改善。