Home Therapy of Venous Thrombosis with Long-term LMWH versus Usual Care: Patient Satisfaction and Post-thrombotic Syndrome
Home Therapy of Venous Thrombosis with Long-term LMWH versus Usual Care: Patient Satisfaction and Post-thrombotic Syndrome
复制标题
DOI：
10.1016/j.amjmed.2008.12.023
复制
发表时间：
2009-08-01
影响因子：
5.9
通讯作者：
Raskob, Gary
中科院分区：
文献类型：
--
作者：
Hull, Russell D.;Pineo, Graham F.;Raskob, Gary
目得：家庭-LITE比较长期治疗在家里与tinzaparin或常规护理的疗效，安全性，患者的治疗满意度，血栓后综合征的发病率，以及相关的下肢静脉溃疡。METHODS：这个多中心，随机，对照试验纳入了480例记录，急性，近端深静脉血栓形成。患者接受汀扎肝素175 IU/kg皮下注射，每日一次，持续12周，或汀扎肝素≥ 5天+口服华法林，从第1天开始，国际标准化比率调整，并持续≥ 12周（“常规治疗”）。结果：两组患者12周时静脉血栓栓塞复发率均为3.3%（绝对差异0%; 95%置信区间-3.2-3.2），1年时替扎肝素/常规治疗组分别为10.4%/8.3%，（差异2.1%; 95%置信区间-3.1-7.3）。在12周或1年时的死亡或12周时的出血方面没有组间差异。汀扎肝素组的患者对治疗的满意度明显更高（P = 0.0024），特别是关于免于血液监测的不便;不太可能报告血栓形成后综合征的体征/症状（个体比值比0.66至0.91，总体比值比0.77，P = .001）; 12周时报告的腿部溃疡较少：1例（0.5%）与8例（4.1%）（P = 0.02）与常规护理。结论：长期家庭治疗与汀扎肝素或常规护理导致类似的复发性静脉血栓栓塞，死亡和出血率。在汀扎肝素组中观察到的血栓后综合征和下肢溃疡的发生率显著较低，这是一个潜在的重要获益，值得进一步研究。(C)2009 Elsevier Inc. All rights reserved.美国医学杂志（2009）122，762-769
PURPOSE: Home-LITE compared long-term treatment at home with tinzaparin or usual care in terms of efficacy, safety, patients' treatment satisfaction, incidence of post-thrombotic syndrome, and associated venous leg ulcers.METHODS: This multicenter, randomized, controlled trial enrolled 480 patients with documented, acute, proximal deep vein thrombosis. Patients received tinzaparin 175 IU/kg subcutaneously once daily for 12 weeks, or tinzaparin for >= 5 days plus oral warfarin, commenced on day 1, international normalized ratio-adjusted, and continued for >= 12 weeks ("usual care"). Patients received 1 in-clinic injection, then home treatment.RESULTS: The rate of recurrent venous thromboembolism at 12 weeks was 3.3% in both groups ( absolute difference 0%; 95% confidence interval -3.2-3.2), and at 1 year was 10.4%/8.3% in the tinzaparin/usualcare groups, respectively (difference 2.1%; 95% confidence interval -3.1-7.3). There were no between-group differences in deaths at 12 weeks or 1 year, or bleeding at 12 weeks. Patients in the tinzaparin group expressed significantly greater treatment satisfaction (P = .0024), particularly regarding freedom from the inconvenience of blood monitoring; were less likely to report signs/symptoms of post-thrombotic syndrome (individual odds ratios 0.66 to 0.91, overall odds ratio 0.77, P = .001);and reported fewer leg ulcers at 12 weeks: 1 (0.5%) versus 8 (4.1%) (P = .02) with usual care.CONCLUSIONS: Long-term home treatment with tinzaparin or usual care resulted in similar rates of recurrent venous thromboembolism, death, and bleeding. The significantly lower incidence of post-thrombotic syndrome and leg ulcers observed in the tinzaparin group is a potentially important benefit and deserves further study. (C) 2009 Elsevier Inc. All rights reserved. The American Journal of Medicine (2009) 122, 762-769