下肢骨折例行使用抗凝血剂并不保证疗效


  Dec. 14, 2005(亚特兰大)-- 加拿大研究团队于亚特兰大召开之第47届美国血液学协会年会中指出,对下肢骨折患者例行使用抗凝血剂以预防血栓,并不保证疗效,且不甚经济。
  
  多伦多大学研究团队追踪1200名下肢骨折患者三个月,发现患者中症状型血栓的发生率低于1%。
  
  安大略省多伦多大学Rita Selby医师表示,发病率很低,以致于副作用的治疗,较对下肢骨折血栓预防所得来的好处要来得重要;在这种患者族群中,为预防血栓而例行使用抗凝血剂并未带来保证,而且并不会较经济。
  
  下肢骨折是北美常见的外伤病例,每年有超过500,000件病例,就象是其它的骨折一样会造成患者行动不便,而因为外伤及行动不便,将导致深层静脉栓塞(deep vein thrombosis,DVT)的风险提高。
  
  Selby医师向与会者表示,当DVT的风险在下肢骨折的患者中升高时,这些患者在临床上重要的静脉血栓栓塞风险则是未知的。
  
  膝盖至脚踝间的骨折(Knee to Ankle Fracture,KAF)群组研究,是首次对膝盖以下骨折的患者进行大规模、多中心共同合作的前瞻性研究,执行时间为期三年,于2005年6月完成,并有5间加拿大医院参与其中。
  
  研究对象共有1200名患者,他们在发生下肢、脚踝或脚的骨折后96小时内被纳入研究;这些骨折病例最大的原因是跌倒,高达75%;运动伤害则有17%,车祸有7%,而另有3%是因为职业伤害;82%被研究观察的患者,在骨折后穿戴固定架或是支架的时间平均是6周长。
  
  患者被追踪观察3个月,禁用薄血药(blood thinner),患者被告知可能会有静脉血栓栓塞的症状,并告知得反应任何症状;DVT或肺栓塞的症状则是以标准检验流程来进行研究。
  
  Selby医师表示,在1174名完成3个月追踪观察的患者中,7名患者恶化成症状型静脉血栓栓塞,其中5名是DVT,2名是肺栓塞;没有患者罹患致命性肺栓塞。
  
   7名患者为静脉血栓栓塞确认病例(0.6%),其中包括2例近端深层静脉血栓(proximal DVT),3例的小腿深层静脉血栓(calf DVT),以及2例的非致命性肺栓塞。
  
   Selby医师于记者会中表示,假设所有接受研究观察的患者都被以预防疾病的角度,用低分子量的肝素来予以治疗,治疗费用约为美金350,000元。
  
  Stanley Schrier医师于寻求外部意见的访谈中向Medscape表示,研究提出一个有趣的论点:发现能为健保系统省钱,并有潜力帮助患者免受抗凝血剂的副作用所苦;Schrier医师为ASH甫卸任的主席,并为加州史丹佛大学医学院荣誉医学教授。
  
  虽然当髋部或大腿发生骨折时,医师有理由怀疑会发生静脉血栓栓塞的可能性,但Schrier医师表示,似乎小腿会形成血栓的机率少了些,而当血栓真的成形时,恶化的可能性也较低。
  
  这项研究由加拿大瑞辉药厂所赞助,Shelby医师表示其间无任何财务上的关联。

Routine Anticoagulant Use Not<

By Linda Little
Medscape Medical News

Dec. 14, 2005 (Atlanta) Routine use of anticoagulants to prevent blood clots is unwarranted and not cost-effective in patients with lower limb fractures, Canadian researchers reported here at the 47th annual meeting of the American Society of Hematology (ASH).

University of Toronto researchers followed 1200 patients with lower limb fractures for 3 months and found that the incidence of symptomatic blood clots in the patients was less than 1%.

"The event rate is so low that the side effects of treatment outweigh any benefit that is derived from clot prevention in fractures of the lower leg," said Rita Selby, MD, from the University of Toronto in Ontario. "Routine use of anticoagulants to prevent blood clots in this patient population is not warranted, nor is it cost-effective."

Lower leg fractures are common injuries affecting more than 500,000 individuals in North America each year. As with all fractures where the patient is immobilized, the risk for deep vein thrombosis (DVT) increases due to the injury and immobilization.

While the risk of DVT increases in patients with lower limb fractures, the risk of clinically important venous thromboembolism in these patients was unknown, Dr. Selby told those attending the ASH session.

The Knee to Ankle Fracture (KAF) Cohort study the first large, multicenter prospective study of patients with fractures below the knee was conducted during a 3-year period ending in June 2005 and involved 5 Canadian hospitals.

A total of 1200 patients were enrolled within 96 hours of fracture to the lower leg, ankle, or foot. The patients, aged 16 to 93 years, had fractures to the patella, tibia, fibula, or foot. The largest number of fractures resulted from falls (75%), sports injuries caused 17%, car accidents caused 7%, and 3% were due to occupational injury. Eighty-two percent of participants had a cast or brace for an average of 6 weeks after fracture.

Patients were followed for a 3-month period, and the use of blood thinners was not allowed. Participants were advised of the symptoms of venous thromboembolism and told to report any symptoms. Symptoms of DVT or pulmonary embolism were investigated in a standardized manner.

Of the 1174 patients who completed the 3-month follow-up, 7 patients developed symptomatic venous thromboembolism, with 5 patients having DVT and 2 having pulmonary embolism, said Dr. Selby. "None of the patients had a fatal pulmonary embolism."

Confirmed venous thromboembolism occurred in 7 patients (0.6%), Dr. Selby said. These included 2 cases of proximal DVT, 3 cases of calf DVT, and 2 cases of nonfatal pulmonary embolism.

Dr. Selby said during a press conference that if all the study participants had all been treated prophylactically with low-molecular-weight heparin, the cost of treatment would have been about $350,000.

"This study makes an interesting point," Stanley Schrier, MD, told Medscape in an interview seeking outside comment. Dr. Schrier is the immediate past president of ASH and an emeritus professor of medicine at Stanford University School of Medicine in California. "The findings could save the healthcare system money and potentially save patients from the side effects from anticoagulants."

Although there is reason for physicians to be concerned about the possibility of venous thromboembolism when fractures occur in the hip or the thigh, Dr. Schrier said it appears that there is less of a tendency for clots to form in the lower leg, and when clots do form, there is less of a tendency to progress.

The study was funded by Pfizer Canada, Inc. Dr. Shelby reported no other pertinent financial relationships.

ASH 47th Annual Meeting: Abstract 583. Presented Dec. 14, 2005.

Reviewed by Margie Miller

    
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