Обычный гепарин эффективен и безопасен для лечения ТГВ и без АЧТВ контроля!

[Dr.Vad]

Ну, наконец-то разрoдились журнальной публикацией: исследование Fixed-Dose Heparin (FIDO), результаты которого были оглашены еще в 2004 году на конференции ASH, опубликовано в свежем номере JAMA. Фишка исследования в том, что для лечения тромбоза глубоких вен можно использовать обычный гепарин БЕЗ АЧТВ-контроля, если назначать его с учетом массы тела (как низкомолекулярный) и эффективность/безопасность такого дозирования НЕ хуже, чем при назначении НМГ.

Исследование, проведенное в Канаде и Зеландии, где тоже озабочены актуальной ценой НМГ, крайне актуально для постсоветских территорий, где назначение реально работающих доз гепарина при ТГВ лимитировалось отсутствием 24-ч доступа к лаб. мониторингу путем определения АЧТВ. В статье также указывается на несостоятельность почти 30-тилетнего заблуждения о том, что при таком пути введения высокое АЧТВ опасно риском кровотечения, а низкое - ретромбозом, а также подсчеты, что такой режим введения почти в 20(!) раз дешевле, чем назначение НМГ.

JAMA. 2006 Aug 23;296(8):935-42. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism. Kearon C, et al. Fixed-Dose Heparin (FIDO) Investigators.

"We think this will be a big step to using heparin in a different way," lead investigator Clive Kearson, from McMaster University in Hamilton, Ontario, Canada, told Medwire News.

"The use of UFH in the way we used it in this study is an alternative to LMWH and in some cases it will be a much cheaper alternative."

The standard approach for deep vein thrombosis and pulmonary embolism has been initial treatment with continuous intravenous UFH infusion and ongoing dose adjustment in response to measurements of the activated partial thromboplastin time (aPTT).

However, LMWH is increasingly being used instead of intravenous UFH, due to its subcutaneous administration without the need for laboratory monitoring that makes it suitable for outpatient treatment so that, despite higher drug costs, healthcare costs are reduced.

The Fixed-Dose Heparin (FIDO) open-label trial examined the value of subcutaneous UFH injection without coagulation monitoring in 708 patients attending six university-affiliated clinical centers in Canada and New Zealand.

Participants were randomly assigned to receive subcutaneous UFH at an initial dose of 333 U/kg, followed by a fixed dose of 250 U/kg every 12 hours (n=345) or LMWH (dalteparin or enoxaparin) subcutaneously at 100 IU/kg every 12 hours (n=352). All patients received 3 months of warfarin therapy.

The primary efficacy endpoint of recurrent VTE at 3 months, assessed in all but 11 patients, occurred in 3.8% of the UFH group and 3.4% of the LMWH group, thereby supporting the noninferiority of UFH.

The primary safety analysis of major bleeding in the first 10 days of treatment, examined in all but eight patients, also occurred at similarly low levels in the two groups, at 1.1% and 1.4%, respectively.

Treatment was administered entirely out of hospital in 72% of the UFH group and 68% of the LMWH group. The researchers calculate that a 6-day course of treatment for a patient weighing 80 kg would cost US $712 (?556) for LMWH versus just $37 (?29) with UFH.

aPTT was measured midway between injections a mean of 2.8 days after starting therapy in 197 UFH patients, and the researchers note that the "lack of an association between low aPTT results and recurrent VTE or between high aPTT results and bleeding in the UFH group provides additional evidence that aPTT monitoring is not required with this dosing regimen."

[Dr.Vad]

Что бы не открывать новую тему, размещу ссылку здесь - кратенький легкочитаемый обзор в полной версии html, по ссылке есть и пдф:

Диагностика и лечение тромбоза глубоких вен.

[Ссылки доступны только зарегистрированным пользователям ]
Scarvelis D, Wells PS.
Diagnosis and treatment of deep-vein thrombosis.
CMAJ. 2006 Oct 24;175(9):1087-92.

[michmed]

[Ссылки доступны только зарегистрированным пользователям ]

The PROTECT Investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group

March 22, 2011 (10.1056/NEJMoa1014475)

Background
The effects of thromboprophylaxis with low-molecular-weight heparin, as compared with unfractionated heparin, on venous thromboembolism, bleeding, and other outcomes are uncertain in critically ill patients.

Methods
In this multicenter trial, we tested the superiority of dalteparin over unfractionated heparin by randomly assigning 3764 patients to receive either subcutaneous dalteparin (at a dose of 5000 IU once daily) plus placebo once daily (for parallel-group twice-daily injections) or unfractionated heparin (at a dose of 5000 IU twice daily) while they were in the intensive care unit. The primary outcome, proximal leg deep-vein thrombosis, was diagnosed on compression ultrasonography performed within 2 days after admission, twice weekly, and as clinically indicated. Additional testing for venous thromboembolism was performed as clinically indicated. Data were analyzed according to the intention-to-treat principle.

Results
There was no significant between-group difference in the rate of proximal leg deep-vein thrombosis, which occurred in 96 of 1873 patients (5.1%) receiving dalteparin versus 109 of 1873 patients (5.8%) receiving unfractionated heparin (hazard ratio in the dalteparin group, 0.92; 95% confidence interval [CI], 0.68 to 1.23; P=0.57). The proportion of patients with pulmonary emboli was significantly lower with dalteparin (24 patients, 1.3%) than with unfractionated heparin (43 patients, 2.3%) (hazard ratio, 0.51; 95% CI, 0.30 to 0.88; P=0.01). There was no significant between-group difference in the rates of major bleeding (hazard ratio, 1.00; 95% CI, 0.75 to 1.34; P=0.98) or death in the hospital (hazard ratio, 0.92; 95% CI, 0.80 to 1.05; P=0.21). In prespecified per-protocol analyses, the results were similar to those of the main analyses, but fewer patients receiving dalteparin had heparin-induced thrombocytopenia (hazard ratio, 0.27; 95% CI, 0.08 to 0.98; P=0.046).

Conclusions
Among critically ill patients, dalteparin was not superior to unfractionated heparin in decreasing the incidence of proximal deep-vein thrombosis.

На русском: [Ссылки доступны только зарегистрированным пользователям ]