摘要
背景氧化亚氮可能增加患者长期心血管事件的发病率和死亡率,并具有病理生理的理论基础。然而,临床上尚未确认两者之1'4的关系。ENIGMA试验将2050例超过2小时非心脏手术患者,随机分组进入持续吸入氧化亚氮组或未吸入氧化亚氮组。我们对ENIGMA患者进行随访研究,评估其心血管事件的长期风险。方法回顾所有研究病例的报告和医疗记录;收集死亡病例的日期和原因、心肌梗死或卒中事件发生率,对每例患者进行电话随访。研究的首要终点是生存率。结果中位随访时间是3.5年(区间:0—5.7年)。380例(19%)患者手术后死亡,随访期间,91例(4.5%)发生心肌梗死,44例(2.2%)发生卒中。氧化亚氮并未显著增加死亡的风险{风险比=0.98[95%可信区间(confidenceinterval,CI):0.80—1.20]};P=0.82)。吸入氧化亚氮的患者罹患心肌梗死的校正比值比为1.59(95%CI:1.O1-2.51;P=0.04)、卒中的校正比值比为1.01(95%CI:0.55—1.87;P=0.97)。结论氧化亚氮与长期心肌梗死的风险增加有关,但与死亡或卒中无关。氧化亚氮与其远期严重不良后果的关系,需要设计合理的大样本随机对照研究以明确。
BACKGROUND: There is a plausible pathophysiologic rationale for increased long-term cardiovascular morbidity and mortality in patients receiving significant exposure to nitrous oxide. However, this relationship has not been established clinically. The ENIGMA trial randomized 2050 patients having noncardiac surgery lasting more than 2 hours to nitrous oxide-based or nitrous oxide-free anesthesia. We conducted a follow-up study of the ENIGMA patients to evaluate the risk of cardiovascular events in the longer term. METHODS: The trial case report forms and medical records of all study patients were reviewed. The date and cause of death and occurrence of myocardial infarction or stroke were recorded. A telephone interview was then conducted with all surviving patients. The primary endpoint of the study was survival. RESULTS: The median follow-up time was 3.5 (range: 0 to 5.7) years. Three hundred eightypatients (19%) had died since the index surgery, 91 (4.5%) were recorded as having myocardial infarction, and 44 (2.2%) had a stroke during the entire follow-up period. Nitrous oxide did not significantly increase the risk of death [ hazard ratio = 0.98 (95% confidence interval, CI: 0.80 to 1.20; P = 0.82)1. The adjusted odds ratio for myocardial infarction in patients administered nitrous oxide was 1.59 (95% Ch 1.01 to 2.51; P = 0.04) and for stroke was 1.01 (95% Ch 0. 55 to 1.87; P = 0.97). CONCLUSIONS: The administration of nitrous oxide was associated With increased long-term risk of myocardial infarction, but not of death or stroke in patients enrolled in the ENIGMA trial. The exact relationship between nitrous oxide administration and serious long-term adverse outcomes will require confirmation by an appropriately designed large randomized controlled trial.
作者
Kate Leslie, MBBS, MD, MEpi, FANZCA
Paul S. Myles, MBBS, MD, MPH, FANZCA, FCARSCI, FRCA
Matthew T. V. Chan, MBBS, FANZCA
黄萍(译)
杭燕南(校)
出处
《麻醉与镇痛》
2013年第6期23-30,共8页
Anesthesia & Analgesia