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皮下注射肝素与静脉注射肝素治疗深静脉血栓形成的随机临床试验

Subcutaneous vs intravenous heparin in the treatment of deep venous thrombosis--a randomized clinical trial.

作者信息

Pini M, Pattachini C, Quintavalla R, Poli T, Megha A, Tagliaferri A, Manotti C, Dettori A G

机构信息

5a Divisione Medica e Centro Emostasi, Ospedale Maggiore, Parma, Italy.

出版信息

Thromb Haemost. 1990 Oct 22;64(2):222-6.

PMID:2270531
Abstract

271 patients with acute symptomatic deep venous thrombosis of lower limbs, confirmed by strain-gauge plethysmography and/or venography, were randomly assigned to receive intermittent subcutaneous heparin calcium or heparin sodium by continuous intravenous infusion for 6-10 days. Heparin dosage was adjusted to maintain activated partial thromboplastin time values (Thrombofax reagent) at 1.3-1.9 times the basal ones. Strain-gauge plethysmography was repeated at the end of heparin treatment, and evaluation of therapy was performed by comparing the indexes of venous hemodynamics and by assessing the incidence of pulmonary embolism and of bleeding complications. In the intravenous group, Maximal Venous Outflow (MVO) increased from 20.8 +/- 12.8 to 28.4 +/- 17.5 ml/min per 100 ml of tissue and Venous Capacitance (VC) from 1.39 +/- 0.92 to 1.94 +/- 1.0 ml/100 ml of tissue (mean +/- SD). In the subcutaneous group, MVO increased from 21.0 +/- 12.7 to 27.5 +/- 18.1 and VC from 1.60 +/- 0.86 to 2.06 +/- 1.0. The median improvement of MVO and VC were 22% and 36% respectively in the IV group and 20% and 24% in the SC group. Clinical pulmonary embolism occurred in 2 patients in the intravenous group (1 fatal) and in 4 in the subcutaneous group (1 fatal). 9 major bleeding complications occurred in the intravenous group (1 fatal) and 5 in the subcutaneous group (1 fatal). The differences were not significant at the statistical analysis. The results suggest that subcutaneous intermittent heparin has a comparable efficacy to continuous intravenous heparin in the treatment of deep venous thrombosis. To the same conclusion points an overview of the seven randomized trials which compared these treatment modalities.

摘要

271例经应变容积描记法和/或静脉造影确诊为急性症状性下肢深静脉血栓形成的患者,被随机分配接受皮下间歇性肝素钙或静脉持续输注肝素钠治疗6 - 10天。调整肝素剂量以维持活化部分凝血活酶时间值(Thrombofax试剂)为基础值的1.3 - 1.9倍。在肝素治疗结束时重复应变容积描记法,并通过比较静脉血流动力学指标以及评估肺栓塞和出血并发症的发生率来进行疗效评估。静脉注射组中,每100毫升组织的最大静脉流出量(MVO)从20.8±12.8增加至28.4±17.5毫升/分钟,静脉容量(VC)从1.39±0.92增加至1.94±1.0毫升/100毫升组织(均值±标准差)。皮下注射组中,MVO从21.0±12.7增加至27.5±18.1,VC从1.60±0.86增加至2.06±1.0。静脉注射组中MVO和VC的中位数改善分别为22%和36%,皮下注射组为20%和24%。静脉注射组有2例发生临床肺栓塞(1例死亡),皮下注射组有4例(1例死亡)。静脉注射组发生9例严重出血并发症(1例死亡),皮下注射组发生5例(1例死亡)。统计学分析差异无显著性。结果表明,皮下间歇性肝素在治疗深静脉血栓形成方面与静脉持续输注肝素具有相当的疗效。比较这些治疗方式的七项随机试验的综述也得出了相同结论。

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Subcutaneous vs intravenous heparin in the treatment of deep venous thrombosis--a randomized clinical trial.皮下注射肝素与静脉注射肝素治疗深静脉血栓形成的随机临床试验
Thromb Haemost. 1990 Oct 22;64(2):222-6.
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Anticoagulation by constant subcutaneous heparin infusion.
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[Heparin treatment. Comparison between intravenous and subcutaneous administration].[肝素治疗。静脉注射与皮下注射给药的比较]
Schweiz Med Wochenschr. 1979 Sep 22;109(36):1322-5.

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