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氯毗格雷对住院治疗后存活出院的急性ST段抬高心肌梗死患者1年死亡率的影响

心血管病学进展 2007年第1期28卷 153页

作者： Zeymer U Gitt AK Junger C 谭真刘兴斌中山大学附属第一医院心内科四川大学华西医院

氯吡格雷与阿司匹林作用机制不同,与阿司匹林联用抗血小板有协同作用。既往一些临床研究发现,与单用阿司匹林相比.阿司匹林加氯吡格雷可进一步改善预后。CURE试验证明了在非ST段抬高的急性冠脉综合征患者加用氯吡格雷的长期益处;CREDO... 详细信息

氯吡格雷与阿司匹林作用机制不同,与阿司匹林联用抗血小板有协同作用。既往一些临床研究发现,与单用阿司匹林相比.阿司匹林加氯吡格雷可进一步改善预后。CURE试验证明了在非ST段抬高的急性冠脉综合征患者加用氯吡格雷的长期益处;CREDO等试验证明了在冠脉介入治疗患者中的长期益处;COMMIT和CLARITY证明了ST段抬高的急性心肌梗死(STEMI)患者无论是否接受溶栓治疗,在阿司匹林、肝素或低分子肝素的基础上加用氯吡格雷,可以增加梗死相关动脉通畅率及不良事件发生率(随访≤1月)。但对STEMI病人长期预后的影响不明。本研究通过分析德国急性冠脉综合征ACOS注册研究(一项前瞻性、多中心注册研究)的资料来研究氯吡格雷对STEMI患者出院后1年时临床情况的影响。

关键词：病人出院急性病前瞻性研究心电描记术心肌梗死/药物疗法心肌梗死/死亡率噻氯匹定/治疗应用噻氯匹定/类似物和衍生物人类

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Clinical predictors of morbidity and mortality in patients with myocardial infarction or revascularization who underwent cardiac rehabilitation, and importance of diabetes mellitus and exercise capacity

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AMERICAN JOURNAL OF CARDIOLOGY 2000年第3期85卷 344-349页

作者： Yu, CM Lau, CP Cheung, BMY Fong, YM Ho, YY Lam, KB Li, LSW Univ Hong Kong Queen Mary Hosp Div Cardiol Dept Med Hong Kong Peoples R China Univ Hong Kong Tung Wah Hosp Dept Med Hong Kong Peoples R China

This investigation was a prospective, follow-up study to assess whether baseline clinical and investigational parameters were predictors of cardiovascular morbidity and mortality in patients enrolled into the cardiac rehabilitation program. A cohort of 418 patients (70% were men) with coronary heart disease was followed up 3.2 +/- 1.1 years. Two hundred twenty-seven of them (54%) had a recent myocardial infarction (MI), with a thrombolytic rare of 54%. Percutaneous transluminal coronary angioplasty (PTCA) was performed in 45% of patients. The covariates assessed include age, gender, smoking habit, body mass index, the presence of hypertension or diabetes mellitus, exercise habit, site and severity of MI, status of thrombolytic therapy, peak creatine phosphokinase, plasma lipid profiles, ejection fraction, PTCA performed, number of diseased coronary arteries, and exercise capacity. Low-density lipoprotein cholesterol decreased significantly (3.2 +/- 1.0 vs 2.7 +/- 0.7 mmol/L, p <0.001). The cumulative mortality was 13%. In a univariate model, the parameters that significantly predict mortality included older age, diabetes, low exercise capacity (less than or equal to 4 metabolic equivalents) 3-vessel disease, those without PTCA performed, and a low ejection fraction. In the Cox proportional-hazards model analysis, the independent factors were coexisting diabetes (chi-square 6.1, p = 0.01) and a low metabolic equivalent (chi-square 6.5, p = 0.01). One hundred six patients were rehospitalized for nonfatal cardiovascular events that included unstable angina (48%), heart failure (21%), acute MI (6%), symptomatic arrhythmia (6%), and severe hypertension (1%). Factors that independently predicted rehospitalization were low exercise capacity (p = 0.02) and the presence of diabetes (chi-square 4.8, p = 0.03). Diabetes was also associated with more episodes of hospital admission (2.3 +/- 2.1 vs 1.6 +/- 1.4, p = 0.04) and a longer cumulative hospital stay (25.5 +/- 34.6 vs 11.

关键词：队列研究糖尿病并发症无病生存运动(Exercise) 随访研究香港/流行病学住院/统计学和数值数据年患病率心肌梗死/并发症心肌梗死/死亡率心肌梗死/康复比例危险度模型前瞻性研究危险因素女(雌)性人类男(雄)性中年人

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Formal approaches to safety monitoring of clinical trials in life-threatening conditions

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STATISTICS IN MEDICINE 2000年第21期19卷 2899-2917页

作者： Bolland, K Whitehead, J Univ Reading Med & Pharmaceut Stat Res Unit Reading RG6 6FN Berks England

Large clinical trials in life-threatening conditions are usually conducted under the surveillance of a Data and Safety Monitoring Board (DSMB), whose remit is to protect the ethical and safety interests of the patients. The purpose of this paper is to describe a formal approach to safety monitoring, using a sequential safety procedure to aid the decisions made by the DSMB. This procedure is designed to recommend termination of the study as soon as evidence that the experimental treatment is worse than the control in terms of the primary safety response is so strong that it is unethical to proceed. The use of this formal sequential procedure enables probabilities of the study stopping erroneously and stopping correctly, under various degrees of experimental treatment disadvantage, to be examined. Also scenarios depicting data sets which lead to continuing or stopping can be presented. Such explorations are useful in encouraging all DSMB members to consider carefully, prior to the start of a study, the conditions under which they would seriously wish to consider termination. The implementation of these methods is described for three recently completed trials in which it has been used. Finally, our current recommendations for the design of these procedures, arising from these and other similar experiences, are given. Copyright (C) 2000 John Wiley & Sons, Ltd.

关键词：临床试验(主题)/统计学和数值数据临床试验 Ⅲ期(主题)/统计学和数值数据颅脑损伤/药物疗法颅脑损伤/死亡率数据说明统计模型统计学多中心研究(主题)/统计学和数值数据心肌梗死/药物疗法心肌梗死/死亡率正态分布概率安全/统计学和数值数据卒中/药物疗法卒中/死亡率人类

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Low serum magnesium level predicts major adverse cardiac events after coronary artery bypass graft surgery

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AMERICAN HEART JOURNAL 2003年第6期145卷 1108-1113页

作者： Booth, JV Phillips-Bute, B McCants, CB Podgoreanu, MV Smith, PK Mathew, JP Newman, MF Duke Univ Med Ctr Dept Anesthesiol Durham NC 27710 USA Duke Univ Med Ctr Dept Surg Durham NC 27710 USA Duke Clin Res Inst Durham NC USA

Background Despite improved myocardial protection strategies and enhanced surgical techniques, mortality after coronary artery bypass graft surgery (CABG) remains essentially unchanged. This may be because of the increasing age of patients who undergo primary CABG. Magnesium is an important regulator of vascular tone, reperfusion injury, and thrombosis. Therefore, we decided to investigate the relationship between serum magnesium levels and major adverse cardiac events (MACE) after CABG. Methods A total of 957 patients undergoing primary CABG we're prospectively recruited into the Duke Cardiovascular database and had daily serum magnesium levels measured. Low magnesium was defined as <1.8 mmol/L-1 at any point during the first 8 days after surgery. Adverse events were defined as Q-wave infarction or death measured 1 year, after surgery. A Kaplan-Meier survival analysis was performed, followed by a Cox proportional hazards model, to account for other known predictors of adverse events. Results in the. low magnesium group, 12.3% of patients had adverse events, compared with 9.2% of patients in the normal magnesium group. A serum magnesium level <1.8 mmol/L-1 decreased the event-free survival rate (2-fold increased risk of death or myocardial infarction at 1 year;hazard ratio 2.0, 95% CI 1.19-3.37). Conclusions We demonstrated a robust relationship between low serum magnesium levels after CABG and a 2-fold increased incidence of Q-wave infarction and all-cause mortality rate as long as 1 year after surgery. This relationship is independent of known preoperative and intraoperative predictors of adverse outcomes. This study provides a rationale for a randomized controlled trial of magnesium therapy during CABG.

关键词：生物学标记/血液死亡原因冠状动脉分流术/死亡率镁/血液心肌梗死/血液心肌梗死/死亡率试验预期值比例危险度模型前瞻性研究统计学非参数时间因素老年人女(雌)性人类男(雄)性中年人

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C-Reactive protein levels on admission are associated with response to thrombolysis and prognosis after ST-segment elevation acute myocardial infarction

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AMERICAN HEART JOURNAL 2002年第5期144卷 782-789页

作者： Zairis, MN Manousakis, SJ Stefanidis, AS Papadaki, OA Andrikopoulos, GK Olympios, CD Hadjissavas, JJ Argyrakis, SK Foussas, SG Tzanio Hosp Dept Cardiol Piraeus Greece

Background several studies have shown the independent association of high plasma C-reactive protein (CRP) levels with an adverse prognosis in patients with acute myocardial infarction. However, the possible association of plasma CRP levels with response to thrombolysis and short- and long-term cardiac mortality has not been investigated. The aim of this study was to evaluate these possible associations. Methods Three hundred nineteen consecutive patients who received intravenous thrombolysis because of ST-segment elevation acute myocardial infarction were prospectively studied. Patients were classified according to tertiles of plasma CRP levels on admission. Results Patients at the top tertile had a significantly lower incidence of complete ST-segment resolution (third vs first, P<.001, third vs second, P=.009) or Thrombolysis In Myocardial Infarction (TIMI) 3 flow in the infraction-related artery (third vs first, P<.001, third vs second, P=.02), more. compromised left ventricular function (third vs first, P=.02, second vs third, P=.04), greater inhospital mortality (third vs first, P=.03, third vs second, P=.06), and greater 3-year cardiac mortality (third vs first, P=.01 'third vs second, P=.07). Conclusions Plasma levels of CRP on admission may be a predictor of reperfusiun failure and of short- and long-term prognosis in patients with ST-segment elevation acute myocardial infarction.

关键词：方差分析生物学标记/血液 C反应蛋白质/分析医院死亡率心肌梗死/血液心肌梗死/药物疗法心肌梗死/死亡率前瞻性研究存活率分析血栓溶解疗法治疗失败女(雌)性人类男(雄)性中年人

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Multicenter randomized trial and a systematic overview of lidocaine in acute myocardial infarction

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AMERICAN HEART JOURNAL 1999年第5期137卷 792-798页

作者： Sadowski, ZP Alexander, JH Skrabucha, B Dyduszynski, A Kuch, J Nartowicz, E Swiatecka, G Kong, DF Granger, CB Duke Clin Res Inst Durham NC USA Inst Kardiol Warsaw Poland

Background More than 20 randomized trials and 4 meta-analyses have been conducted on the use of prophylactic lidocaine in acute myocardial infarction (MI). The results suggest that lidocaine reduces ventricular fibrillation (VF) hut increases mortality rates in acute MI. Methods and Results Patients with ST-elevation MI who were examined <6 hours after symptom onset (n = 903) were randomly assigned to either lidocaine or no lidocaine and to either streptokinase and heparin or heparin alone. Lidocaine was given as 4 boluses of 50 mg each every 2 minutes, then an infusion of 3 mg/min for 12 hours, then 2 mg/min for 36 hours. We compared the incidence of in-hospital death and ventriculor arrhythmias. We then performed a meta analysis of prophylactic lidocaine in acute MI that included these and prior trial results. The rates of VF and death with and Without lidocaine were calculated For each trial, then odds ratios (OR) with confidence intervals (Cl) were calculated for the risk of these events;overall with and without lidocaine. Patients given lidocaine in the randomized study had significantly less VF (2.0% vs 5.7% without lidocaine, P = .004) and a trend toward increased mortality rates (9.7% vs 70%, P = .145). Metaanalysis revealed nonsignificant trends toward reduced VF (OR 0.71,95% Cl 0.47 to 1.09) and increased mortality rates (OR 1.12, 95% Cl 0.91 to 1.36) with lidocaine. Conclusions Lidocaine reduces VF but may adversely affect mortality rates. The routine use of prophylactic lidocaine in acute MI is not recommended.

关键词：抗心律失常药/投药和剂量抗心律失常药/治疗应用药物疗法联合心电描记术纤维蛋白溶解药/投药和剂量纤维蛋白溶解药/治疗应用随访研究肝素/投药和剂量肝素/治疗应用医院死亡率发病率输注静脉内利多卡因/投药和剂量利多卡因/治疗应用心肌梗死/并发症心肌梗死/药物疗法心肌梗死/死亡率波兰/流行病学链激酶/投药和剂量链激酶/治疗应用心动过速室性/流行病学心动过速室性/病因学心动过速室性/预防和控制血栓溶解疗法女(雌)性人类男(雄)性中年人

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First report of an intravenous and oral glycoprotein IIb/IIIa inhibitor (RPR 109891) in patients with recent acute coronary syndromes: Results of the TIMI 15A and 15B trials

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AMERICAN HEART JOURNAL 2000年第1期140卷 81-+页

作者： Giugliano, RP McCabe, CH Sequeira, RF Frey, MJ Henry, TD Piana, RN Tamby, JF Jensen, BK Nicolas, SB Jennings, LK Wise, RJ Braunwald, E Brigham & Womens Hosp Dept Med Div Cardiovasc Boston MA 02115 USA Brigham & Womens Hosp Dept Med Div Hematol Boston MA 02115 USA Harvard Univ Sch Med Boston MA USA Jackson Mem Hosp Div Cardiol Miami FL 33136 USA Heart Ctr Sarasota Sarasota FL USA Hennepin Cty Med Ctr Minneapolis MN 55415 USA Rhone Poulenc Rorer Collegeville PA USA Rhone Poulenc Rorer Antony France Univ Tennessee Vasc Biol Program Memphis TN USA

Background RPR 109891 is a modified tetrapeptide glycoprotein IIb/IIIa inhibitor available in intravenous and oral formulations. Two phase II dose-ranging studies were performed to investigate pharmacodynamics and safety in acute coronary syndromes. Methods The Thrombolysis In Myocardial Infarction (TIMI) 15A trial was a randomized, open-label, study of RPR 109891 administered intravenously for 24 to 96 hours in 91 patients. TIMI 15B was a randomized, double-blind comparison of intravenous RPR 109891 plus 4 weeks of oral RPR 109891 (n = 142) compared with placebo (n = 50). Results Intravenous RPR 109891 exhibited a dose-response inhibition of platelet aggregation;mean inhibition after a bolus ranged from 53% to 92%, and at steady state 49% to 98%. Oral RPR 109891 demonstrated less platelet inhibition (peaks, range 48% to 59%;troughs, range 18% to 39%). Mean glycoprotein IIb/IIIa receptor occupancy and platelet inhibition were highly correlated (r = 0.82, 95% confidence interval 0.74-0.88). There were trends for increased major hemorrhage (10% vs 6%, P = .57), thrombocytopenia <90,000 cells/mm(3) (13% vs 4%, P = .11), and profound thrombocytopenia <20,000 (3.5% vs 0%, P = .33) with intravenous plus oral RPR 109891 compared with placebo. In 3 of 5 cases of profound thrombocytopenia, RPR 109891 had been interrupted because of bypass surgery, and a precipitous fall in platelet count occurred after the first postoperative oral dose. Conclusions Intravenous RPR 109891 is a potent, predictable, dose-related platelet inhibitor. Oral RPR 109891 (less than or equal to 600 mg/d) achieves moderate platelet inhibition. Interrupted glycoprotein IIb/IIIa blockade may be associated with a higher risk of profound thrombocytopenia and deserves closer examination in future studies.

关键词：投药口服剂量效应关系药物双盲法随访研究出血/化学诱导出血/流行病学输注静脉内心肌梗死/药物疗法心肌梗死/死亡率肽类/投药和剂量血小板聚集抑制剂/投药和剂量概率参考值存活率血小板减少/化学诱导血小板减少/流行病学治疗结果青少年成年人老年人女(雌)性人类男(雄)性中年人

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Prognostic significance of ST segment depression in lateral leads I, aVL, V₅ and V₆ on the admission electrocardiogram in patients with a first acute myocardial infarction without ST segment elevation

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2000年第7期35卷 1813-1819页

作者： Barrabés, JA Figueras, J Moure, C Cortadellas, J Soler-Soler, J Hosp Gen Univ Vall Dhebron Serv Cardiol Unitat Coronaria Barcelona 08035 Spain

OBJECTIVES We sought to investigate the short-term prognostic value of the admission electrocardiogram (ECG) in patients with a first acute myocardial infarction (MI)without ST segment elevation. BACKGROUND ST segment depression on hospital admission predicts a worse outcome in patients with a first acute MI, but the prognostic information provided by the location of ST segment depression remains unclear. METHODS In 432 patients with a first acute MI without Qwaves or greater than or equal to 0.1 mV of ST segment elevation, we evaluated the ability of the initial ECG to predict in-hospital death. RESULTS The presence, magnitude and extent of ST segment depression were associated with an increased mortality, but the only electrocardiographic variable that was significant in predicting death after adjusting for baseline predictors was ST segment depression in two or more lateral (I, aVL, V-5-, or V-6) leads (odds ratio 3.5, 95% confidence interval 1.2 to 10.6). Patients with lateral ST segment depression (n = 91, 21%) had higher rates of death (14.3% vs. 2.6%, p < 0.001), severe heart failure (14.3% vs. 4.1%, p < 0.001) and angina with electrocardiographic changes (20.0% vs. 11.6%, p = 0.04) than did the remaining patients, even though they had similar peak creatine kinase, MB fraction levels (129 +/- 96 vs. 122 +/- 92 IU/liter, p = NS). In contrast, ST segment depression not involving the lateral leads did nor predict a poor outcome. Among patients who were catheterized, those with lateral ST segment depression had a lower left ventricular ejection fraction (57 +/- 12% vs. 66 +/- 13%, p = 0.001) and more frequent left main coronary artery or three-vessel disease than did the remaining patients (60% vs. 22%, p < 0.001). CONCLUSIONS In patients with a first non-ST segment elevation acute MI, ST segment depression in the lateral leads on hospital admission predicts a poor in-hospital outcome. (J Am Coll Cardiol 2000;35:1813-9) (C) 2000 by the American College of Cardiol

关键词：心电描记术心肌梗死/死亡率心肌梗死/病理生理学病人入院试验预期值预后老年人女(雌)性人类男(雄)性中年人

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DIABETES AND HEART

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AMERICAN HEART JOURNAL 1975年第3期90卷 283-289页

作者： SCOTT, RC UNIV CINCINNATI COLL MED DEPT MED DIV CARDIOL CINCINNATI OH 45229 USA UNIV CINCINNATI MED CTR CARDIAC LAB B-4 234 GOODMAN ST CINCINNATI OH 45229 USA

An enormous experience, both clinical and experimental, has accumulated during the past several years about the broad topics of diabetes, hyperlipoproteinemia, and premature CAD. This editorial attempts to place some of these advances in perspective and at the same time to speculate about their complex interrelationships. As more knowledge (especially at the biochemical and molecular level) is gained, perhaps some inroads can be made against the devastating vascular complications that these metabolic abnormalities produce.

关键词：碳水化合物代谢乳糜微粒/血液冠心病/血液冠心病/流行病学冠心病/病因学糖尿病并发症糖尿病/流行病学糖尿病/死亡率糖尿病 1型/病理生理学膳食碳水化合物高胆固醇血症/并发症高血糖症/并发症高胰岛素血症/并发症高脂血症/并发症胰岛素/缺乏胰岛素/代谢心肌梗死/流行病学心肌梗死/死亡率肥胖症甘油三酯类/血液成年人女(雌)性人类男(雄)性

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Long-term outcome of primary percutaneous transluminal coronary angioplasty for low-risk acute myocardial infarction in patients older than 80 years: A single-center, open, randomized trial

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AMERICAN HEART JOURNAL 2002年第3期143卷 497-505页

作者： Minai, K Horie, H Takahashi, M Nozawa, M Kinoshita, M Shiga Univ Med Sci Dept Internal Med 1 Otsu Shiga 5202192 Japan

Background Although coronary reperfusion therapy with thrombolytic agents or percutaneous transluminal coronary angioplasty (PTCA) immediately after acute myocardial infarction (AMI) has survival benefits for younger patients, the effect of coronary reperfusion therapy for very elderly (aged 80 years and older) patients with AMI remains controversial. Methods and Results We studied 120 patients aged 80 years and older at relatively low risk with AMI. The patients were randomized into a primary PTCA group In = 61) or a "conservative" no-PTCA group In = 59). Long-term follow-up examination was conducted with regard to endpoints, which included all causes of death, cardiac death, nonfatal re-MI, the development of congestive heart Failure, and cerebral vascular accident. End-diastolic volume index and end-systolic volume index were significantly increased in both groups at follow-up examination 6 months after AMI However, left ventricular ejection fraction, end-diastolic volume index, and end-systolic volume index were similar between both groups. With endpoints of all causes of death, cardiac death, reinfarction, congestive heart failure, and cerebral vascular accident, a 3-year Kaplan-Meier event-free survival rate analysis revealed no significant benefits in the PTCA group. Anteroseptal MI, multivessel disease, and left ventricular ejection Fraction were significantly associated with the combined events with multivariate Cox proportional hazards analysis results. Conclusion First, primary PTCA for very elderly patients with AMI appears to have few beneficial effects on combined events during a 3-year period. Second, early PTCA did not prevent left ventricle remodeling after AMI in patients with AMI at relatively low risk.

关键词：血管成形术经腔经皮冠状动脉/死亡率抗凝药/治疗应用生物学标记/血液死亡原因冠状血管造影术肌酸激酶/血液随访研究肝素/治疗应用日本多元分析心肌梗死/死亡率心肌梗死/放射摄影术心肌梗死/治疗比值比复发回归分析存活率心室功能左心室重构老年人 80以上老年人女(雌)性人类男(雄)性

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