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Intravenous prostaglandin E1 reduces monocyte chemoattractant protein-1 levels in peripheral arterial obstructive disease

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AMERICAN HEART JOURNAL 2003年第2期145卷 330-333页

作者： Matsui, K Ikeda, U Murakami, Y Yoshioka, T Shimada, K Jichi Med Sch Div Cardiovasc Med Minami Kawachi Tochigi 3290498 Japan

Objectives Blood monocytes are the precursors of the lipid-laden foam cells that are the hallmark of early atherosclerotic lesions, and monocyte chemoattractant protein-1 (MCP-1) plays important roles in their recruitment to the vessel wall. In this study, we measured serum levels of MCP-1 in patients with peripheral arterial obstructive disease (PAOD) and investigated whether intravenous prostaglandin E 1 (PGE1) treatment, which produces clinical benefits in PAOD, might decrease such levels. Methods Eight patients with PAOD at Fontaine stage 11 to IV were treated with a daily intravenous infusion of 10 mug of PGE1 for 7 consecutive days. Blood samples before and after 7-day PGE1 treatment were used for assays of MCP-1, interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), von Willebrand factor (vWF), and endothelin-1 (ET-1). Results Serum MCP-1 levels in patients with PAOD were significantly higher than those in healthy control subjects (263.8 +/- 52.8 vs 136.5 +/- 15.0 pg/mL, P = .002). PGE1 administration for 7 days resulted in a significant decrease in the MCP-1 level, from 263.8 +/- 52.8 to 196.1 +/- 25.5 pg/mL (P = .02), whereas levels of IL-6, hs-CRP, and ET-1 and the activity of vWF were not affected. Conclusions Serum MCP-1 levels were elevated in patients with PAOD, indicating the involvement of activation of monocytes in the pathogenesis of this disorder. Parenteral administration of PGE1 appeared to decrease circulating MCP-1 levels, which might lead to the suppression of the development of atherosclerotic lesions in patients with PAOD.

关键词：前列地尔/投药和剂量前列地尔/治疗应用动脉闭塞性疾病/血液动脉闭塞性疾病/药物疗法生物学标记/血液 C反应蛋白质/分析病例对照研究趋化因子CCL2/血液内皮缩血管肽1/血液纤维蛋白溶解药/投药和剂量纤维蛋白溶解药/治疗应用注射静脉内白细胞介素6/血液间歇性跛行/血液间歇性跛行/药物疗法外周血管疾病/血液外周血管疾病/药物疗法血管舒张药/投药和剂量血管舒张药/治疗应用 vonWillebrand因子/分析成年人老年人女(雌)性人类男(雄)性中年人

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Intravenous nicorandil can preserve microvascular integrity and myocardial viability in patients with reperfused anterior wall myocardial infarction

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 1999年第3期33卷 654-660页

作者： Ito, H Taniyama, Y Iwakura, K Nishikawa, N Masuyama, T Kuzuya, T Hori, M Higashino, Y Fujii, K Minamino, T Sakurabashi Watanabe Hosp Div Cardiol Kita Ku Osaka 5300001 Japan Osaka Univ Sch Med Dept Med 1 Osaka 553 Japan

OBJECTIVES We assessed whether the intravenous administration of nicorandil, an adenosine triphosphate (ATP)-sensitive K+ channel opener, exerts beneficial effect-on microvascular function and functional and clinical outcomes in patients with acute myocardial infarction (AMI). BACKGROUND Experimental studies documented that ATP-sensitive K+ channel opener exerts cardioprotection after prolonged ischemia. METHODS We randomly divided 81 patients with a first anterior AMI into two groups, nicorandil (n = 40) and control groups (n = 41). All patients received successful coronary angioplasty within 12 h after the symptom onset and underwent myocardial contrast echcardiography (MCE) with the intracoronary injection of sonicated microbubbles. In the nicorandil group, we injected 4 mg of nicorandil followed by the infusion at 6 mg/h for 24 h and by oral nicorandil (15 mg/day). RESULTS The improvement in regional left ventricular function, nail motion score and regional wall motion was significantly better in the nicorandil group then in the control group. Intractable congestive heart failure, malignant ventricular arrhythmia and pericardial effusion were more frequently found in the control group than in the nicorandil group (15% vs. 37%, 5% vs. 20% and 8% vs. 37%, p < 0.05, respectively). The frequency of sizable MCE no reflow phenomenon was significantly lower in the nicorandil group than in the control group (15% vs. 33%, p < 0.05). CONCLUSIONS Intravenous nicorandil in conjunction with coronary angioplasty is associated with better functional and clinical outcomes compared to angioplasty alone in patients with an anterior AMI. Myocardial contrast echocardiography findings imply that an improvement in microvascular function with nicorandil may be attributable to this better outcome. CT Am (C) 1999 by the American College of Cardiology.

关键词：血管成形术气囊冠状动脉冠状血管造影术冠状血管/药物作用冠状血管/病理生理学超声心动描记术随访研究心室/药物作用心室/代谢注射静脉内心肌收缩/药物作用心肌梗死/病因学心肌梗死/病理生理学心肌梗死/外科学心肌再灌注损伤/并发症心肌再灌注损伤/病理生理学尼可地尔/投药和剂量尼可地尔/治疗应用钾通道/药物作用钾通道/代谢预后放射性核素心室显像术回顾性研究钠钾交换ATP酶/药物作用钠钾交换ATP酶/代谢血管舒张药/投药和剂量血管舒张药/治疗应用女(雌)性人类男(雄)性中年人

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Simultaneous intracoronary velocity- and pressure-derived assessment of adenosine-induced collateral hemodynamics in patients with one- to two-vessel coronary artery disease

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 1999年第7期34卷 1985-1994页

作者： Seiler, C Fleisch, M Billinger, M Meier, B Inselspital Bern Swiss Cardiovasc Ctr Div Cardiol CH-3010 Bern Switzerland

OBJECTIVES The purpose of this investigation in patients with poorly and well developed coronary collaterals was to assess the influence of collateral and collateral adjacent vascular resistances and, in part, a stenotic lesion of the collateral supplying vessel on the hemodynamic collateral responses to adenosine. BACKGROUND In humans, little is known about the functional behavior of the coronary collateral circulation. METHODS In 50 patients with one- and two-vessel coronary artery disease (CAD) undergoing percutaneous transluminal coronary angioplasty (PTCA), collateral flow index (CFI, no unit) changes and vascular resistance index (R, cm/mm Hg) changes of the collateral (R-coll) and the distal collateral receiving (R-4) vessel in response to adenosine (140 mu g/min/kg ITT) were measured by intracoronary (i.c.) Doppler and pressure guidewires. The variables were determined at baseline and during adenosine in patients with poor (angiographic collateral degree before PTCA <2 of 0 to 3) and good coronary collaterals. RESULTS Pressure-derived CFI (CFI,) decreased under adenosine in patients with poor collaterals, and it increased in the group with good collaterals. There were inverse correlations between the adenosine-induced change in CFIp and the change in R-coll (r = 0.61, p = 0.0001). In the group with good, but not with poor collaterals, there was also a significant correlation between CFIp increase and the decrease in R-4, between the severity of the contralateral stenosis and CFIp augmentation and among the left versus right coronary artery as ipsilateral vessel and CFIp change. CONCLUSIONS Overall, patients with well, versus poorly developed coronary collaterals do better regarding the capacity to increase collateral flow in response to adenosine, In patients with good, but not poor, collaterals, an adenosine-induced collateral flow increase depends on the ipsilateral distal vascular resistance decrease, but is also directly influenced by the severity of a c

关键词：腺苷/投药和剂量血管成形术气囊冠状动脉血流速度/药物作用血压/药物作用侧支循环/药物作用冠状血管造影术冠状动脉循环/药物作用冠心病/诊断冠心病/病理生理学冠心病/治疗冠状血管/诊断显像冠状血管/药物作用超声心动描记术多普勒输注静脉内疾病严重程度指数超声检查介入性血管阻力/药物作用血管舒张药/投药和剂量女(雌)性人类男(雄)性中年人

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Assessment of left internal mammary artery graft patency and flow reserve alter minimally invasive direct coronary artery bypass

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AMERICAN JOURNAL OF CARDIOLOGY 1999年第7期84卷 795-801页

作者： Katz, WE Zenati, M Mandarino, WA Cohen, HA Gorcsan, J Univ Pittsburgh Med Ctr Div Cardiol Pittsburgh PA 15213 USA Univ Pittsburgh Med Ctr Div Cardiothorac Surg Pittsburgh PA 15213 USA

Despite its merits, minimally invasive direct coronary artery bypass surgery (MIDCAB) has been criticized for variable left internal mammary artery (LIMA) graft patency rates, prompting the frequent use of postoperative LIMA angiography. Noninvasive transthoracic Doppler interrogation of LIMA grafts has recently been shown to have utility for assessing potency and flow: reserve after conventional bypass surgery, but data after MIDCAB has been limited. The objective of this study was to assess LIMA graft anatomy and physiology in 54 patients after MIDCAB using angiography and noninvasive LIMA Doppler imaging. The right internal mammary artery (RIMA) was studied as a control. LIMA flow reserve in response to adenosine was evaluated in a subgroup of 18 randomly chosen patients with parent grafts, LIMA angiographic patency was 93%. Forty-four patients (81%) had obtainable LIMA:Doppler data. Patent grafts had a diastolic dominant flow pattern with a peak diastolic/systolic velocity ratio of 1.3 +/- 0.6 and a percent diastolic time-velocity integral (TVI) of 70 +/- 11%. These data were significantly different than the RIMA control valves of 0.2 +/- 0.1 and 30 +/- 10%, respectively (p < 0.05). Occluded grafts had absent flow or a systolic dominant pattern. Adenosine-induced increases in LIMB peak:diastolic velocity from 48 +/- 20 to 105 +/- 28 cm/s (p < 0.05 vs baseline) and diastolic TVI from 21 +/- 10 to: 37 +/- 19 cm (p < 0.05 vs baseline), yielding adenosine/baseline ratios of 2.4 +/- 0.9 and 2.0 +/- 0.7, respectively, which was consistent with normal flow reserve. The diastolic flow velocity reserve response was inversely related to baseline diastolic flow (r = -0.69). In conclusion, MIDCAB can be associated with a high rate of LIMA potency and favorable physiologic Doppler flow patterns. Correlation of these findings to long-term patient outcome offer MIDCAB is warranted. (C) 1999 by Excerpta Medica, Inc.

关键词：腺苷/投药和剂量方差分析血流速度冠状血管造影术冠状动脉分流术/方法冠心病/外科学冠心病/超声检查冠状血管/超声检查超声心动描记术多普勒胸廓内动脉-冠状动脉吻合术线性模型乳房动脉/超声检查局部血流外科手术微创性胸廓切开术/方法血管未闭血管舒张药/投药和剂量老年人女(雌)性人类男(雄)性中年人

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Prophylactic intravenous use of Milrinone after cardiac operation in Pediatrics (PRIMACORP) study

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AMERICAN HEART JOURNAL 2002年第1期143卷 15-21页

作者： Hoffman, TM Wernovsky, G Atz, AM Bailey, JM Akbary, A Kocsis, JF Nelson, DP Chang, AC Kulik, TJ Spray, TL Wessel, DL Childrens Hosp Philadelphia Div Cardiol Philadelphia PA 19104 USA Med Univ S Carolina Charleston SC 29425 USA Emory Univ Sch Med Atlanta GA USA Sanofi Synthelabo Inc New York NY USA Childrens Hosp Med Ctr Cincinnati OH USA Univ Michigan Hosp Ann Arbor MI 48109 USA Boston Childrens Hosp Boston MA USA

Background Many pediatric patients undergoing cardiac surgery involving cardiopulmonary bypass have a predictable fall in the cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Because patients who have LCOS require more monitoring and support and have a prolonged stay in the intensive care unit, the syndrome is associated with a costly morbidity. Milrinone, a phosphodiesterase III inhibitor, improves cardiac muscle contractile force and vascular muscle relaxation through positive inotropic and vasodilatory effects. The purpose of the Prophylactic Intravenous Use of Milrinone After Cardiac Operation in Pediatrics (PRIMACORP) study is to evaluate the safety and efficacy of the prophylactic use of milrinone in pediatric patients at high risk for development of LCOS after undergoing cardiac surgery. Methods Patients in the multicenter, randomized, double-blind, placebo-controlled, parallel treatment study will be randomized to I of 3 treatment arms: (I) low-dose milrinone (25 mug/kg intravenous bolus over 60 minutes followed by a 0.25 mug/kg/min infusion for 35 hours), (2) high-dose milrinone (75 mug/kg intravenous bolus over 60 minutes followed by a 0.75 mug/kg/min infusion for 35 hours), or (3) placebo. Results The primary end point for efficacy evaluation will be based on a composite variable consisting of death or development of LCOS requiring additional mechanical or pharmacologic support, up to 36 hours after randomization. A 2-sided test with a 0.025 type 1 error will be used for the primary end point analysis. The PRIMACORP study will enroll a total of 240 patients. Six additional secondary end points will be analyzed. Conclusions The PRIMACORP study will address several questions regarding the safety and efficacy of prophylactic milrinone use in pediatric patients at high risk for development of LCOS after cardiac surgery.

关键词：心排血量低/预防和控制强心药/投药和剂量双盲法心脏缺损先天性/外科学米力农/投药和剂量病人遴选综合征血管舒张药/投药和剂量儿童学龄前女(雌)性人类婴儿男(雄)性

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Nitroglycerin is preferable to diltiazem for prevention of coronary bypass conduit spasm

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ANNALS OF THORACIC SURGERY 2000年第3期70卷 883-888页

作者： Shapira, OM Alkon, JD Macron, DSF Keaney, JF Vita, JA Aldea, GS Shemin, RJ Boston Univ Med Ctr Sch Med Dept Cardiothorac Surg Boston MA 02118 USA Boston Univ Sch Med Evans Dept Med Boston MA 02118 USA

Background. Diltiazem is widely used to prevent radial artery spasm after coronary bypass grafting (CABG). However, recent in vitro and in vivo studies have shown that nitroglycerin is a superior conduit vasodilator compared to diltiazem. A clinical comparison of these agents in patients undergoing CABG has not been previously performed. Methods. One hundred sixty-one consecutive patients undergoing isolated CABG with the radial artery were prospectively randomized to 24-hour intravenous infusion of nitroglycerin or diltiazem followed by 6-month treatment with a daily dose of isosorbide mononitrate (n = 84) or diltiazem CD (n = 77). Analyses were performed on "intention-to-treat" basis. Results. Crossovers because of low cardiac output, complete heart block, or sinus bradycardia occurred in 5 patients in the diltiazem group and none in the nitroglycerin group (p = 0.05). Operative mortality (nitroglycerin, 1.2% versus diltiazem, 1.3%), major morbidity (14% versus 16%), perioperative myocardial infarction (1.2% versus 0%), peak serum creatinine phosphokinase MB fraction levels (27 versus 21 U), intensive care unit stay (34 +/- 19 versus 38 +/- 30 hours) and total hospital length of stay (4.7 +/- 1.4 versus 4.7 +/- 1.3 days) were similar (p = not significant for all). Cardiac pacing was required more often in the diltiazem group (28% versus 13%, p = 0.01). Follow-up longer than 2 months was available in 145 patients (90%). Follow-up mortality (nitroglycerin, 1.2%;diltiazem, 1.3%), myocardial infarction (6%, versus 5%), and reintervention (8% versus 6%) rates and average angina class (1.3 +/- 0.7 versus 1.1 +/- 0.4) were similar (p = not significant for all). Thallium stress test obtained in 117 patients showed abnormal perfusion in the radial artery territory in only 4 patients (3%), 2 in each group (P = not significant). Treatment with diltiazem was more costly ($16,340 versus $1,096). Conclusions. Nitroglycerin is preferable to diltiazem for prevention of conduit sp

关键词：住院时间硝酸甘油/投药和剂量硝酸甘油/治疗应用手术后并发症前瞻性研究桡动脉痉挛/预防和控制血管舒张药/投药和剂量血管舒张药/治疗应用男(雄)性中年人

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Effect of omeprazole on the metabolism of cilostazol

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CLINICAL PHARMACOKINETICS 1999年第2-Sup期37卷 53-59页

作者： Suri, A Bramer, SL Otsuka Amer Pharmaceut Inc Dept Clin Pharmacokinet Pharmacodynam & Metab Rockville MD 20850 USA

Objective: In vitro results suggest that cilostazol is metabolised by cytochrome P450 (CYP) isoforms 1A2, 2D6, 3A4 and 2C19. This study was designed to evaluate the effect of concomitant administration of omeprazole (a CYP2C19 inhibitor) on the pharmacokinetics of a single 100mg oral dose of cilostazol. Design: This study was conducted as a single-centre, open-label, nonrandomised, 2-period, crossover pharmacokinetic trial. A single 100mg dose of cilostazol was administered orally on days 0 and 14. Oral omeprazole (40mg every day) was administered on days 7 to 18. Study Participants: 20 healthy nonsmoking male and female volunteers. Main Outcome Measures: Serial blood samples were collected before and after cilostazol administration to characterise the pharmacokinetics of cilostazol and its metabolites. Results: Following omeprazole coadministration, the increases in cilostazol maximum plasma concentration (C-max) and area under the plasma concentration-time curve at time t (AUC(t)) were 18% (p = 0.062) and 26% (p < 0.001), respectively. For the 2 major circulating metabolites, OPC-13015 and OPC-13213, the OPC-13015 C-max and AUC(t) increased by 29 and 69%, respectively (p < 0.001). However, for OPC-13213, the Cmax and AUC(t) decreased by 22 and 31%, respectively (p < 0.001). The plasma protein binding of cilostazol was unaffected by coadministration of omeprazole. Conclusions: Coadministration of cilostazol with omeprazole resulted in an increase in the systemic exposure of cilostazol and its active metabolite, OPC-13015, by 26 and 69%, respectively. For the other active metabolite, OPC-13213, systemic exposure decreased by 31% because of inhibition of cilostazol metabolism to this metabolite. These changes in systemic exposure were well tolerated. A dose of 50mg cilostazol twice a day should be considered during coadministration of inhibitors of CYP2C19, such as omeprazole.

关键词：投药口服曲线下面积血蛋白质类/代谢色谱法高压液相交叉研究药物相互作用酶抑制剂/药理学半衰期奥美拉唑/药理学四唑类/投药和剂量四唑类/血液四唑类/代谢四唑类/药代动力学血管舒张药/投药和剂量血管舒张药/血液血管舒张药/代谢血管舒张药/药代动力学成年人女(雌)性人类男(雄)性中年人

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Low density lipoprotein cholesterol and coronary microvascular dysfunction in hypercholesterolemia

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2000年第1期36卷 103-109页

作者： Kaufmann, PA Gnecchi-Ruscone, T Schäfers, KP Lüscher, TF Camici, PG Hammersmith Hosp MRC Cyclotron Unit Clin Sci CtrImperial Coll Sch Med London W12 0NN England Univ Zurich Hosp CH-8091 Zurich Switzerland

OBJECTIVES The present study evaluates the impact of total cholesterol (TC) and its subfractions on coronary flow reserve (CFR), an index of the integrated function of the coronary circulation, in asymptomatic subjects. BACKGROUND Endothelial dysfunction of the coronary microcirculation has been reported in asymptomatic subjects with hypercholesterolemia. METHODS Using oxygen-15-labeled water and positron emission tomography, myocardial blood flow (MBF, in ml/min per g) was measured at rest and during intravenous adenosine (140 mu g/kg body weight per min) in 80 asymptomatic nonsmoking men: group 1 (n = 61;age 45 +/- 7 years) had normal TC (less than or equal to 6.5 mmol/liter or less than or equal to 250 mg/dl) and group 2 (n = 19;age 48 +/- 10 years) had elevated TC. RESULTS Total cholesterol were 5.1 +/- 0.8 and 7.2 +/- 0.7 mmol/liter in groups 1 and 2 (p < 0.0005), respectively;low density lipoprotein (LDL) cholesterol levels were 3.2 +/- 0.8 and 4.9 +/- 0.7 mmol/liter (p < 0.0005);high density lipoprotein (HDL) cholesterol levels were 1.1 +/- 0.3 and 1.0 +/- 0.4 mmol/liter (p = NS);and triglyceride levels were 1.8 +/- 1.3 and 3.0 +/- 1.8 mmol/liter (p < 0.005). Groups 1 and 2 did not differ with regard to MBF at rest (0.87 +/- 0.14 vs. 0.84 +/- 0.14), MBF during adenosine (3.63 +/- 1.02 vs. 3.30 +/- 0.86) or CFR (4.23 +/- 1.29 vs. 3.95 +/- 0.93). A significant but weak correlation was found between CFR and HDL in group 1 (r = 0.29, p < 0.05), but not in group 2. In contrast, a significant inverse correlation between LDL and CFR was found in group 2 (r = -0.61, p < 0.05), but not in group 1. CONCLUSION Low density lipoprotein cholesterol but not TC correlated inversely with CFR in hypercholesterolemic subjects. Thus, LDL-induced coronary microvascular dysfunction could play an important role in the pathogenesis of coronary artery disease and its complications. (J Am Coil Cardiol 2000;36:103-9) (C) 2000 by the American College of Cardiology.

关键词：腺苷/投药和剂量血流速度胆固醇 LDL/血液冠状动脉循环冠心病/病因学冠心病/病理生理学冠状血管/诊断显像冠状血管/病理生理学高胆固醇血症/血液高胆固醇血症/诊断显像高胆固醇血症/病理生理学注射静脉内微循环/病理生理学预后体层摄影术发射型计算机血管舒张药/投药和剂量人类男(雄)性中年人

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Low-dose dipyridamole infusion acutely increases exercise capacity in angina pectoris - A double-blind, placebo controlled crossover stress echocardiographic study

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2000年第1期35卷 83-88页

作者： Tommasi, S Carluccio, E Bentivoglio, M Corea, L Picano, E CNR Inst Clin Physiol I-56100 Pisa Italy Univ Perugia Dept Clin & Expt Med Cardiol Unit Perugia Italy

OBJECTIVES The aim of this study was to assess whether endogenous accumulation of adenosine, induced by low-dose dipyridamole infusion, protects from exercise-induced ischemia. BACKGROUND Adenosine is a recognized mediator of ischemic preconditioning in experimental settings. METHODS Ten patients (all men: mean age 63.4 +/- 7.3 years) with chronic stable angina, angiographically assessed coronary artery disease (n = 7) or previous myocardial infarction (n = 3) and exercise-induced ischemia underwent on different days two exercise-stress echo tests after premedication with placebo or dipyridamole (15 mg in 30 min, stopped 5 min before testing) in a double-blind, placebo controlled, randomized crossover design. RESULTS In comparison with placebo, dipyridamole less frequently induced chest pain (20% vs. 100%, p = 0.001) and >0.1 mV ST segment depression (50% vs. 100%, p < 0.05). Wall motion abnormalities during exercise-stress test were less frequent (placebo = 100% vs. dipyridamole = 70%, p = ns) and significantly less severe (wall motion score index at peak stress: placebo = 1.55 +/- 0.17 vs, dipyridamole = 1.27 +/- 0.2, p < 0.01) following dipyridamole, which also determined an increase in exercise time up to echocardiographic positivity (placebo = 385.9 +/- 51.4 vs. dipyridamole = 594.4 +/- 156.9 s, p < 0.01). CONCLUSIONS Low-dose dipyridamole infusion increases exercise tolerance in chronic stable angina, possibly by endogenous adenosine accumulation acting on high affinity Al myocardial receptors involved in preconditioning or positively modulating coronary flow through collaterals. (C) 1999 by the American College of Cardiology.

关键词：腺苷/代谢心绞痛/药物疗法心绞痛/病理生理学交叉研究双嘧达莫/投药和剂量双嘧达莫/副作用剂量效应关系药物双盲法运动试验/药物作用术前用药法受体嘌呤能P1/药物作用受体嘌呤能P1/生理学血管舒张药/投药和剂量血管舒张药/副作用老年人女(雌)性人类男(雄)性中年人

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A comparison of cilostazol and pentoxifylline for treating intermittent claudication

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AMERICAN JOURNAL OF MEDICINE 2000年第7期109卷 523-530页

作者： Dawson, DL Cutler, BS Hiatt, WR Hobson, RW Martin, JD Bortey, EB Forbes, WP Strandness, DE Wilford Hall USAF Med Ctr Lackland AFB TX 78236 USA Univ Massachusetts Worcester MA 01605 USA Univ Colorado Hlth Sci Ctr Denver CO USA Univ Med & Dent New Jersey New Jersey Med Sch Newark NJ 07103 USA Otsuka Amer Pharmaceut Inc Rockville MD USA Univ Washington Seattle WA 98195 USA

PURPOSE: We performed a randomized, double-blind, placebo-controlled, multicenter trial to evaluate the relative efficacy and safety of cilostazol and pentoxifylline. PATIENTS AND METHODS: We enrolled patients with moderate-to-severe claudication from 54 outpatient vascular clinics, including sites at Air Force, Veterans Affairs, tertiary care, and university medical centers in the United States. Of 922 consenting patients, 698 met the inclusion criteria and were randomly assigned to blinded treatment with either cilostazol (100 mg orally twice a day), pentoxifylline (400 mg orally 3 times a day), or placebo. We measured maximal walking distance with constant-speed, variable-grade treadmill testing at baseline and at 4, 8, 12, 16, 20, and 24 weeks. RESULTS: Mean maximal walking distance of cilostazol-treated patients (n = 227) was significantly greater at every postbaseline visit compared with patients who received pentoxifylline (n = 232) or placebo (n = 239). After 24 weeks of treatment, mean maximal walking distance increased by a mean of 107 m (a mean percent increase of 54% from baseline) in the cilostazol group, significantly more than the 64-m improvement (a 30% mean percent increase) with pentoxifylline (P <0.001). The improvement with pentoxifylline was similar (P = 0.82) to that in the placebo group (65 m, a 34% mean percent increase). Deaths and serious adverse event rates were similar in each group. Side effects (including headache, palpitations, and diarrhea) were more common in the cilostazol-treated patients, but withdrawal rates were similar in the cilostazol (16%) and pentoxifylline (19%) groups. CONCLUSION: Cilostazol was significantly better than pentoxifylline or placebo for increasing walking distances in patients with intermittent claudication, but was associated with a greater frequency of minor side effects. Pentoxifylline and placebo had similar effects. Am J Med. 2000;109:523-530. (C) 2000 by Excerpta Medica, Inc.

关键词：双盲法用药计划表运动试验间歇性跛行/药物疗法己酮可可碱/投药和剂量己酮可可碱/治疗应用疾病严重程度指数四唑类/投药和剂量四唑类/治疗应用时间因素治疗结果血管舒张药/投药和剂量血管舒张药/治疗应用步行老年人女(雌)性人类男(雄)性中年人

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