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肺動脈導管臨床試驗的混雜結果

【?2005-01-17 發布?】 美迪醫訊
美迪網領先的醫療器械電子商務平臺

一項叫做ESCAPE的大規模臨床試驗發現:死亡與使用肺動脈導管并不相關、入院治療并不增加,但是提示肺動脈導管不應當做為常規來指導治療。

肺動脈導管是一種很薄的導管,插入頸靜脈穿過右側心腔進入肺動脈,測量來自右側心腔流和肺組織的壓力與血流。使用一個微小充氣氣囊測量來自左側心腔的壓力。有3%~5%住院治療的心衰患者使用肺動脈導管。醫生還使用肺動脈導管為每一個患者進行個體化藥物治療,測量藥物對心臟功能和癥狀的作用。

ESCAPE試驗包括26個地區的433例患者。初始目標是評估肺動脈導管測量心臟和肺壓力精確度的提高,與其它基于對生理體征與癥狀臨床評估的治療方法相比較,是否能夠提高患者生存率以及在6個月內減少住院時間。

Brigham and Women醫院的首席研究員Lynne Stevenson博士質問說:“我們知道接受肺動脈導管的患者感覺好了許多,但是為什么他們的死亡與住院治療并不減少?” Stevenson醫生相信,隱藏于事實后面的答案是:用于治療患者的肺動脈導管的資料存在巨大差異。研究人員正在對臨床試驗中的超聲心動圖資料進行深度分析,這或許能夠提供調整治療方法的手段,而無需冒肺動脈導管的風險。
 
Mixed Results in PAC Trial
 
The results of a large clinical trial called ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) revealed no deaths related to the use of a pulmonary artery catheter (PAC) and no increase in hospitalizations but did suggest that a PAC should not be routinely used to guide therapy.

A PAC is a thin catheter inserted into a neck vein and passed through the right side of the heart into a pulmonary artery in order to measure pressures and flows from the right side of the heart and the lungs. A tiny balloon is inflated to allow the measurement of pressures from the left side of the heart. A PAC is used in 3-5% of heart-failure patients who are hospitalized. Doctors also use a PAC to individualize medications for each patient and gauge their effects on heart function and symptoms.

ESCAPE involved 433 patients at 26 sites. The primary goal was to evaluate whether the increased precision offered by a PAC regarding heart and lung pressures results in improved patient survival and reduced time spent in the hospital over six months, compared with other therapies based on clinical assessment of physical signs and symptoms.

“We know that patients who received a PAC felt better, but then why didn’t they have fewer deaths or hospitalizations?” asked principal investigator Dr. Lynne Stevenson, of Brigham and Women’s Hospital (Boston, MA, USA). Dr. Stevenson believes the answer may lie in the fact that there was a big variation in how PAC information was used to treat patients. The researchers are conducting an in-depth analysis of the echocardiogram data in the trial, which may suggest some ways to adjust therapy without the risks of a PAC.

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