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【medical-news】冠脉搭桥术中使用抑肽酶增加死亡
21 February 2008
MedWire News: Patients treated with aprotinin during coronary-artery bypass graft (CABG) surgery are more likely to die than patients treated with aminocaproic acid or no antifibrinolytic treatment, US researchers report in two studies published the New England Journal of Medicine.
Aprotinin is used to reduce bleeding in patients undergoing cardiac surgery, but accumulating evidence suggests that its use might increase mortality, say Sebastian Schneeweiss (Harvard Medical School, Boston, Massachusetts) and colleagues.
For the first study, Schneeweiss and team used records from the Premier Perspective Comparative Database to examine mortality rates following CABG surgery. The analysis included 33,517 patients who received aprotinin and 44,682 patients treated with aminocaproic acid on the day surgery was performed.
In all, 4.5% of patients treated with aprotinin and 2.5% of those who received aminocaproic acid died. After adjustment for patient and hospital characteristics, and hospitals, patients in the aprotinin group had a 64% higher risk for death than those in the aminocaproic acid group.
Furthermore, the adjusted relative risk for in-hospital death in the first 7 days after surgery was 1.78 in the aprotinin group, compared with those receiving aminocaproic acid. Their relative risk in a propensity-score-matched analysis was 1.32.
Postoperative revascularization and dialysis were also more frequent among patients receiving aprotinin than among those treated with aminocaproic acid.
In the second study, Andrew Shaw and colleagues from Duke University Medical Center in Durham, North Carolina, used data from 10,275 patients undergoing CABG, of whom 1343 received aprotinin, 6776 received aminocaproic acid, and 2029 had no antifibrinolytic therapy.
One year after surgery, 15.8% of patients treated with aprotinin had died, compared with 6.4% of those receiving aminocaproic acid, and 6.5% of patients who had no antifibrinolytic therapy.
Patients treated with aprotinin had a hazard ratio for death of 1.32 compared with patients receiving no antifibrinolytic therapy (p=0.003), and of 1.27 compared with those treated with aminocaproic acid (p=0.004).
Patients receiving aprotinin also had increased serum creatinine levels compared with patients in the other groups (p<0.001), but not an increased incidence of dialysis.
Wayne Ray (Vanderbilt University School of Medicine, Nashville, Tennessee, USA) wrote in an accompanying editorial: "The key lesson from the aprotinin story is that when a new drug has alternatives, as is the case for aprotinin, head-to-head comparative trials powered for important clinical end points are needed before the drug is routinely prescribed for large numbers of patients.
"If, as is often the case, these trials are not part of the premarketing testing, then they should be conducted as soon as possible after licensing."
N Engl J Med 2008; 358: 771-783, 784-793, 840-842
http://www.incirculation.net/NewsItem/Aprotinin-use-in-cardiac-surgery-linked-to-increas.aspx 关注，这是抑肽酶停用的又一证据。
Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death
http://content.nejm.org/cgi/content/full/358/8/771
The Effect of Aprotinin on Outcome after Coronary-Artery Bypass Grafting
http://content.nejm.org/cgi/reprint/358/8/784.pdf
The Effect of Aprotinin on Outcome.pdf (222.76k) 欢迎阅读全文
Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death
rotinin during Coronary-Artery Bypass Grafting.pdf (207.4k) 有人翻译啦
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作者:admin@医学,生命科学 2011-03-05 05:21
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