AHA/ASA科學建議委員會建議在中風之後3至4.5小時使用tPA


  May 28, 2009 — 美國心臟協會(AHA)/美國中風協會(ASA)的一項新科學建議,同意在急性缺血性中風症狀發生之後3至4.5小時使用組織胞漿素原活化劑(tissue plasminogen activator,tPA)。
  
  不過,這項線上登載於5月28日中風期刊上的建議,依舊強調中風治療時機的重要性。
  
  作者強調,雖然正式提出較長的治療許可時間,但仍應避免延遲評估與治療。撰寫小組主席是華盛頓大學的Gregory J. del Zoppo醫師。
  
  【ECASS 3試驗】
  這項建議主要根據European Cooperative Acute Stroke Study 3 (ECASS 3)試驗的發現更新了目前的指引,顯示在症狀發生之後3至4.5小時,使用血栓溶解治療對病患有助益。該試驗的排除規範,依照歐盟當局核准tPA時的排除授權,現在成為這些新版建議的排除規範。
  
  作者們寫道,在這段期間內適合治療的規範與稍早時期的治療規範相似,以及以下任何排除規範之一:80歲以上病患、服用口服抗凝血劑且國際標準化比率[INR]值≦1.7,開始時的國家健康研究中心中風量表分數>25,或者有中風或糖尿病史者。他們指出,至於後期,則是排除任何服用口服抗凝血劑的病患,不論他們的INR是多少。
  
  文件中聲明,這些符合排除規範的病患,中風之後3至4.5小時靜脈注射重組組織胞漿素原活化劑(recombinant tissue plasminogen activator,rtPA)的效果並未完整建立,需要後續研究。此外,在這段期間使用rtPA之外的再血管化方法如血栓溶解的相對效用,並未充分建立。
  
  作者們指出,在這延長時間內接受tPA之病患的後續照護,應與目前的2007年版美國心臟協會中風委員會指引相似。
  
  他們結論表示,這些建議是根據一些同儕回顧的期刊,當局若有更詳盡的未公開資料,應再度進行評估。
  
  【治療別猶豫】
  AHA主席候選人、邁阿密大學Miller醫學院的Ralph Sacco醫師在獲邀對此新版建議提出評論時表示,根據ECASS 3試驗的基礎,歐洲的指引已經改變。
  
  Sacco醫師表示,歐洲中風組織已經迅速改變指引。我認為美國心臟協會對於擴大使用時間顧慮太多。我們的想法之一是不希望人們猶豫,如果突然擴大使用時機,包括病患呼救以及健康照護專業人員給予tPA的時間上,有些人會認為自己有多一些時間。
  
  對我們來說,首先,越早治療越佳;越早確認症狀越佳;至於我們唯一顧慮的,如果擴大使用時機,是否會造成失去一些延後給藥的病患?
  
  他指出,這對於治療那些抵達時已經超過3小時治療時機患者的醫生來說,會感到寬慰一些。
  
  伊利諾大學醫學院的Phillip B. Gorelick醫師是新版科學建議的回顧者之一,他向Medscape Neurology & Neurosurgery表示,當考慮AHA/ASA建議的給予靜脈tPA時機時,有多個關鍵因素需謹記在心。一個就是,不要延遲治療,盡可能儘速給予,不要拖延到3至4.5小時。
  
  此外,他指出,前述的排除規範也要注意。Gorelick醫師表示,這項建議並未提及在這3至4.5小時的治療時機中,動脈內給予rtPA、或者使用機械或其他排除血塊裝置的角色。在擴大治療時機時,這些治療方式的效用仍需在後續的AHA/ASA急性中風治療指引與後續研究中表述。
  
  美國心臟協會/美國中風協會聲明指出,協會接受的資金主要來自個人與基金會,以及一些公司(包括藥廠、儀器製造商與其他公司)等提供贊助與基金。協會對於接受資金有嚴格規範,以避免影響科學結果。www.americanheart.org/corporatefunding中揭載獲自藥廠與儀器製造商的各項收入。
  
  Del Zoppo醫師無任何宣告。撰寫小組其他成員與回顧者的宣告資訊登載於建議文件中。
  
  Stroke. 線上發表於2009年5月28日。
  

AHA/ASA Science Advisory Recommends Use of tPA Between 3 and 4.5 Hours After Stroke

By Susan Jeffrey
Medscape Medical News

May 28, 2009 — A new science advisory from the American Heart Association (AHA)/American Stroke Association (ASA) has given the green light to the use of tissue plasminogen activator (tPA) to treat acute ischemic stroke between 3 and 4.5 hours after symptom onset.

However, the advisory, published online May 28 in Stroke, still emphasizes that time is of the essence when it comes to treatment of stroke.

"Although a longer time window for treatment has been tested formally, delays in evaluation and initiation of therapy should be avoided," the authors stress. The writing group is chaired by Gregory J. del Zoppo, MD, from the University of Washington, in Seattle.

ECASS 3

The advisory updates the current guidelines mainly on the basis of findings from the European Cooperative Acute Stroke Study 3 (ECASS 3), which showed a benefit from thrombolytic therapy in patients treated between 3 and 4.5 hours after symptom onset. Exclusion criteria for that trial — which followed exclusions mandated by European regulatory authorities for the approval of tPA there — now become exclusion criteria for these new recommendations.

"The eligibility criteria for treatment in this time period are similar to those treated at earlier time periods, with any 1 of the following additional exclusion criteria: patients older than 80 years, those taking oral anticoagulants with an international normalized ratio [INR] of ? 1.7, those with a baseline National Institutes of Health Stroke Scale score >?25, or those with both a history of stroke and diabetes," the authors write. For this later time period, all patients receiving oral anticoagulants are excluded, regardless of their INR, they note.

"The efficacy of intravenous treatment with [recombinant tissue plasminogen activator] rtPA within 3 to 4.5 hours after stroke in patients with these exclusion criteria is not well established and requires further study," the document states. In addition, the relative utility of rtPA in this time window to other methods of recanalization such as thrombus dissolution or approval is considered "not well established."

Ancillary care for patients receiving tPA In this expanded window should be similar to what has been established in the current 2007 American Heart Association Stroke Council Guidelines, the authors note.

"These recommendations, which are based on peer-reviewed publications, should be reevaluated after the results of regulatory agency review of detailed, non–publicly available data are known," they conclude.

Do Not Hesitate to Treat

Asked for comment on the new advisory, Ralph Sacco, MD, from the Miller School of Medicine at the University of Miami, in Florida, and president-elect of the AHA, pointed out that on the basis of ECASS 3, the guidelines in Europe have already changed.

"The European Stroke Organization was quick to change the guidelines," Dr. Sacco said. "I think the American Heart Association has been more cautious about widening the window. One of our concerns is that we don't want people to hesitate, and if you all of a sudden widen the window, some people may feel they have a little more time, both patients waiting to call or healthcare professionals waiting to give tPA," he said.

"First and foremost to us is, the earlier you treat, the better; the earlier you recognize the symptoms, the better; and that's the only concern — that if we widen the window, will we lose some patients giving it later rather than earlier?"

This may allow many physicians to be more comfortable at least in treating those who arrive late in the already-approved 3-hour time window, he added.

Phillip B. Gorelick, MD, from the University of Illinois College of Medicine at Chicago, was a reviewer on the new science advisory. "There are several key factors to keep in mind when contemplating administration of intravenous tPA, given the AHA/ASA advisory," he told Medscape Neurology & Neurosurgery. "One, treatment should not be delayed if it can be given sooner than the 3- to 4.5-hour time window."

In addition, the exclusions outlined above will also apply, he noted. "The advisory does not address the role of intra-arterial rtPA administration or the use of mechanical or other clot-extraction devices in the 3- to 4.5-hour time window," Dr. Gorelick said. "The role of these latter treatments in light of the expanded time-window advisory will need to be addressed in subsequent AHA/ASA guidelines on acute stroke therapy and in subsequent research."

The American Heart Association/American Stroke Association statement notes that the association receives funding "primarily from individuals and foundations, and corporations (including pharmaceutical, device manufacturers, and other companies) also make donations and fund specific association programs and events.?The association has strict policies to prevent these relationships from influencing science content.?Revenues from pharmaceutical and device corporations are disclosed at www.americanheart.org/corporatefunding ."

Dr. Del Zoppo reports no disclosures. Disclosure information for other members of the writing group and reviewers are included in the advisory.

Stroke. Published online May 28, 2009.

    
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