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Cilostazol pharmacokinetics after single and multiple oral doses in healthy males and patients with intermittent claudication resulting from peripheral arterial disease

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CLINICAL PHARMACOKINETICS 1999年第2-Sup期37卷 1-11页

作者： Bramer, SL Forbes, WP Mallikaarjun, S Otsuka Amer Pharmaceut Inc Dept Clin Pharmacokinet Pharmacodynam & Metab Rockville MD 20850 USA

Objective: To study the pharmacokinetics of cilostazol following single oral administration of 50 to 200mg in healthy young males, and after repeated oral administration of 100mg every 12 hours to patients with peripheral arterial disease (PAD). Design: The healthy male single dose study was a single-centre, randomised sequence, open-label, incomplete block, 3-period, 4-treatment, crossover design. The patient study was a single-centre, multiple dose, open-label study. Study Participants: 20 healthy nonsmoking male volunteers were enrolled and successfully completed the single dose study. 26 patients (21 males, 5 females) with intermittent claudication resulting from PAD were enrolled and completed the single/multiple dose study. Main Outcome Measures: Noncompartmental pharmacokinetic parameters, the area under the plasma concentration-time curve from zero to the time of last measurable plasma concentration, and maximum plasma concentration. Results: Peak plasma concentrations of cilostazol occurred about 3 hours after drug administration and then declined biexponentially with concentrations detectable (>20 mu g/L) in the plasma for at least 36 hours postdose. The apparent elimination half-life of cilostazol (approximately 11 hours) was similar after a single dose or after multiple doses, with steady state being reached within 4 days. Cilostazol accumulated 1.7-fold following multiple dose administration. The apparent volume of distribution (V-2/F;2.76 L/kg) suggested extensive distribution of cilostazol in the tissues. The oral clearance of cilostazol (CL/F;0.18 L/h/kg) was much lower than liver blood flow, indicating a low extraction ratio drug, and hence low probability of a significant first-pass effect. None of the administered doses were recovered in the urine as unchanged cilostazol, suggesting that metabolism, rather than urinary excretion, is the major elimination route. Following single oral doses of 50 to 200mg, the plasma concentrations of cilostazol and

关键词：投药口服方差分析曲线下面积交叉研究用药计划表间歇性跛行/药物疗法间歇性跛行/病因学代谢清除率外周血管疾病/并发症外周血管疾病/药物疗法四唑类/投药和剂量四唑类/血液四唑类/药代动力学四唑类/治疗应用组织分布血管舒张药/投药和剂量血管舒张药/血液血管舒张药/药代动力学血管舒张药/治疗应用女(雌)性人类男(雄)性

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Peripheral vascular disorders - A pharmacoeconomic and quality-of-life review

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PHARMACOECONOMICS 1997年第3期11卷 225-236页

作者： Langley, PC Coons, SJ 1.Center for Pharmaceutical Economics Department of Pharmacy Practice and Science College of Pharmacy The University of Arizona Tucson Arizona 85721 USA

The purpose of this article is to review the literature on the pharmacoeconomics and quality of life of therapy interventions for patients with peripheral vascular disorders. The paper is in 4 parts. The first presents a framework for the analysis of such drug interventions, which contrasts studies that have a clinical focus with these that take a system or modelling focus and presents a research typology for studies in this area. The second part of the paper reviews pharmacoeconomic studies of selected interventions and assesses their contribution to decision-making within healthcare systems. The particular focus is on the pharmacoeconomics of therapy for atherosclerosis. While there are no studies which have evaluated the overall costs of treatment in this disease area or considered the cost effectiveness of the range of alternative treatment strategies, the issues of good clinical practice and the implicit cost effectiveness of identifying patients for treatment options and prevention strategies has been addressed. The few studies which have considered the cost consequences of particular intervention strategies, specifically pentoxifylline therapy and surgical options, are limited in scope and are difficult to generalise due to their age, their study design or the treating environment from which data are drawn. The third part reviews quality-of-life studies and, once again, assesses their contribution to formulary decision-making. There are no published studies which have compared quality-of-life outcomes associated with alternative treatment approaches or which have reported changes associated with pharmacotherapy in patients with peripheral vascular disorders. Finally, given the dearth of studies in this area, a research agenda is proposed for ongoing investigations.

关键词：费用效益分析己酮可可碱/治疗应用外周血管疾病/药物疗法外周血管疾病/心理学生活质量人类

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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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Rationale and design of the arterial disease multiple intervention trial (ADMIT) pilot study

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AMERICAN JOURNAL OF CARDIOLOGY 1999年第4期83卷 569-575页

作者： Egan, DA Garg, R Wilt, TJ Pettinger, MB Davis, KB Crouse, J Herd, JA Hunninghake, DB Sheps, DS Kostis, JB Probstfield, J Waclawiw, MA Applegate, W Elam, MB NHLBI Div Epidemiol & Clin Applicat Clin Trials Sci Res Grp Bethesda MD 20892 USA Eli Lilly & Co Indianapolis IN 46285 USA Minneapolis VAMC Minneapolis MN USA Stat & Epidemiol Res Corp Seattle WA USA Wake Forest Univ Bowman Gray Sch Med Winston Salem NC USA Baylor Univ Houston TX 77030 USA Univ Minnesota Minneapolis MN 55455 USA Univ N Carolina Chapel Hill NC 27515 USA Univ Med & Dent New Jersey Robert Wood Johnson Med Sch New Brunswick NJ USA Univ Washington Seattle WA 98195 USA Univ Tennessee Memphis TN USA

The primary objectives of the pilot study were to: (1) evaluate the feasibility of recruiting patients with peripheral arterial disease (PAD);(2) measure the efficacy and safety of high-density lipoprotein (HDL)-raising treatment, low-density lipoprotein (LDL)-lowering therapy, antioxidant therapy, antithrombotic therapy, and their combinations;and (3) assess adherence to a complex multiple drug regimen. Secondary objectives included measurement of the effect of the interventions on prespecified biochemical markers, maintenance of therapy masking (in particular with niacin), and measurement of the intervention's impact on functional status and on quality of life. To date, no secondary prevention trial has been conducted specifically among patients with PAD. Intermittent claudication affects about 0.5% to 1.0% of persons aged >35 years. There is a striking increase in incidence of PAD with age, particularly among those aged >50 years in bath sexes, although men are twice as likely as women to develop PAD. The Arterial Disease Multiple Intervention Trial was a double-blind randomized pilot trial of 458 participants with documented PAD. A 2 x 2 x 2 factorial design was used to evaluate the effect of 3 interventions. The pilot incorporated several major novel design features: first, the use of a simple noninvasive method (measurement of ankle brachial index) to identify a population with either symptomatic or asymptomatic PAD;and second, a lipid modifying strategy to increase HDL with nicotinic acid in the intervention group while lowering LDL levels equally with an hydroxymethylglutaryl-coenzyme A reductase inhibitor as needed in the intervention and control group. Two other arms, the antioxidant arm (consisting of beta-carotene and vitamins E and C) and the antithrombotic arm (using warfarin) were also added. Adherence to therapy was measured by pill count, and success in treatment was measured by the proportion of values in target range for HDL, LDL, and the internat

关键词：双盲法羟甲基戊二酰基CoA还原酶抑制剂/治疗应用尼克酸/治疗应用外周血管疾病/药物疗法试点项目普伐他丁/治疗应用研究设计成年人女(雌)性人类男(雄)性中年人

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Reduction in the need for hospitalization for recurrent ischemic events and bleeding with clopidogrel instead of aspirin

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AMERICAN HEART JOURNAL 2000年第1期140卷 67-73页

作者： Bhatt, DL Hirsch, AT Ringleb, PA Hacke, W Topol, EJ Cleveland Clin Fdn Dept Cardiol Cleveland OH 44195 USA Univ Minnesota Sch Med Vasc Med Program Minneapolis MN 55455 USA Heidelberg Univ Sch Med Dept Neurol Heidelberg Germany

Background Repeat hospitalizations of patients with atherosclerosis represent a considerable burden on the health care system. We sought to determine whether clopidogrel compared with aspirin decreases the need for rehospitalization for ischemia and bleeding. Methods and Results The Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial was a randomized, blinded, multicenter, trial of 19,185 patients with atherosclerotic disease manifested as recent ischemic stroke or myocardial infarction or symptomatic peripheral arterial disease. Without any double-counting of events, the number of rehospitalizations for ischemic events (defined as angina, transient ischemic attack, or limb ischemia) or bleeding events was determined for the entire cohort. There was a significant reduction in the total number of rehospitalizations for ischemic events or bleeding with clopidogrel use compared with aspirin (1502 vs 1673;P = .010) over an average of 1.6 years of treatment. This reduction in rehospitalization was consistent across individual outcomes of angina, transient ischemic attack, limb ischemia, and bleeding. Compared with aspirin, clopidogrel also resulted in a 7.9% relative risk reduction in a combined end point of vascular death, stroke, myocardial infarction, or rehospitalization for ischemic events or bleeding (15.1% to 13.7% at 1 year;P = .011). Adjusting for baseline prognostic variables, clopidogrel therapy was an independent predictor for reduction of vascular death, stroke, myocardial infarction, or rehospitalization for ischemic events or bleeding (P = .009). Conclusions Treatment with clopidogrel results in a significant decrease in the need for rehospitalization for ischemic events or bleeding compared with aspirin. This meaningful end point tracks well with other, more traditional measures of outcome and has incremental value beyond such end points.

关键词：阿司匹林/投药和剂量脑缺血/药物疗法脑缺血/病因学脑缺血/死亡率死亡原因置信区间双盲法出血/药物疗法出血/死亡率住院/统计学和数值数据发病率缺血/药物疗法缺血/病因学缺血/死亡率多元分析心肌梗死/并发症心肌梗死/药物疗法心肌梗死/死亡率外周血管疾病/并发症外周血管疾病/药物疗法外周血管疾病/死亡率血小板聚集抑制剂/投药和剂量概率预后比例危险度模型复发/预防和控制危险性评估存活率分析噻氯匹定/投药和剂量噻氯匹定/类似物和衍生物女(雌)性人类男(雄)性中年人

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Intravenous prostaglandin E₁ reduces soluble vascular cell adhesion molecule-1 in peripheral arterial obstructive disease

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AMERICAN HEART JOURNAL 2001年第4期142卷 733-739页

作者： Gianetti, J De Caterina, M de Cristofaro, T Ungaro, B Biol, D Del Guercio, R De Caterina, R CNR Inst Clin Physiol Lab Thrombosis & Vasc Res I-56100 Pisa Italy Univ G dAnnunzio Dept Cardiol Chieti Italy Univ Naples 2 Dept Internal Med Naples Italy Univ Naples Federico II Dept Biochem Naples Italy Univ Naples Federico II Dept Med Biotechnol Naples Italy

Objectives Elevated levels of soluble (s) vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1, pointing to activation of cells involved in vascular inflammation, have been previously reported in peripheral arterial obstructive disease (PAOD). We tested the hypothesis that intravenous prostaglandin E-1 (PGE(1)) treatment, which produces clinical benefits in this condition, might decrease such levels. Methods Ten subjects (age range 58 +/- 10 years, 6 male, 4 female) with characterized Fontaine stage IIa to IV PAOD (ankle/arm pressure index <0.96) were entered into a treatment protocol with twice daily intravenous infusions of PGE(1) (alprostadil) at 120 mug per day, repeated for 10 consecutive days. Preinfusion and postinfusion plasma samples were stored for blind enzyme immunoassays of soluble adhesion molecules and the fibrinolytic marker tissue plasminogen activator, type-1 plasminogen-activator inhibitor, and D-dimer. Results Estimates of severity of pain at rest, consumption of analgesics, magnitude of trophic lesions, remission to lower Fontaine stages, and favorable changes in the venoarteriolar reflex documented significant beneficial effects of the treatment. Significant (P < .01) pretreatment and posttreatment reductions of in all soluble markers explored were found. Particularly, sVCAM-1 exhibited a significant decrease after each infusion, which was sustained at the last day of treatment (from 854 +/- 214 ng/mL to 775 +/- 215 ng/mL across the first infusion, from 773 +/- 146 ng/mL to 680 +/- 110 ng/mL across the last infusion). Conclusion Thus a global decrease of vascular cell activation appears to occur as a result of PGE, administration and may contribute to the observed clinical benefits in PAOD.

关键词：前列地尔/投药和剂量前列地尔/药理学前列地尔/治疗应用动脉闭塞性疾病/血液动脉闭塞性疾病/诊断动脉闭塞性疾病/药物疗法运动试验/统计学和数值数据纤维蛋白溶解/药物作用输注静脉内胞间黏附分子1/血液胞间黏附分子1/药物作用疼痛测定外周血管疾病/血液外周血管疾病/诊断外周血管疾病/药物疗法治疗结果血管细胞黏附分子1/血液血管细胞黏附分子1/药物作用老年人女(雌)性人类男(雄)性中年人

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Preliminary thermographic evaluation of new nitroglycerine tape on the peripheral circulatory disturbance in systemic sclerosis

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ANNALS OF THE RHEUMATIC DISEASES 2002年第2期61卷 177-179页

作者： Kan, C Akimoto, S Abe, M Okada, K Ishikawa, O Gunma Univ Sch Med Dept Dermatol Maebashi Gumma 3718511 Japan

Objective: To evaluate the effects of newly developed nitroglycerine (NTG) tape on the peripheral circulatory disturbance in systemic sclerosis (SSc). Methods: The finger temperature (FT) of 25 patients with SSc was monitored by thermography before the application of NTG tape to the wrist and one hour afterwards. To check the placebo effect, the change of FT with placebo tape in six patients who had shown a distinct rise in FT (>2degreesC) with NTG tape was monitored. Results: Twenty one patients with SSc had a low FT before the application of NTG tape (colder than mean-2SD of normal controls). FT was significantly raised in patients with SSc after the application of NTG tape (p<0.01). Patients with low FT showed a distinct rise in FT more often than patients with a normal FT (71% v 0%, p<0.01). FT was raised with NTG tape more than with placebo tape (4.2 (SD 1.9)degreesC v 2.2 (2.8)degreesC, p<0.05). Conclusion: The application of NTG tape increases peripheral circulation in patients with SSc who have distinct circulatory disturbance. The application of NTG tape may improve peripheral circulatory disturbance in SSc.

关键词：投药皮肤病例对照研究药物释放系统指/血液供给硝酸甘油/投药和剂量外周血管疾病/药物疗法外周血管疾病/病因学硬皮病系统性/并发症硬皮病系统性/药物疗法温度记录法血管舒张药/投药和剂量成年人老年人女(雌)性人类男(雄)性中年人

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Antihypertensives

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Physical Medicine and Rehabilitation Clinics of North America 1999年第2期10卷 319-335页

作者： Daniels, V. Casey, A. Div. of Phys. Med./Rehabilitation University of Manitoba Winnipeg Man. R3A 1M4 RR 139-800 Sherbrook Street Canada

Management of hypertension requires a thorough knowledge of currently available antihypertensive drugs. This article reviews the mode of action of the major classes of antihypertensives, indications for their use, and... 详细信息

关键词：抗高血压药/药理学抗高血压药/治疗应用脑血管障碍/药物疗法脑血管障碍/康复剂量效应关系药物药物疗法联合高血压/药物疗法高血压/康复外周血管疾病/药物疗法外周血管疾病/康复脊髓损伤/药物疗法脊髓损伤/康复治疗结果女(雌)性人类男(雄)性

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姜黄素治疗外周动脉疾病研究进展

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现代医药卫生 2018年第1期34卷 46-49页

作者：黄和金熊国祚庹勤慧南华大学附属第二医院血管外科湖南衡阳421000 湖南中医药大学医学院湖南长沙410208

姜黄素是姜黄属植物的主要活性成分之一。目前,已有大量研究表明,姜黄素类成分具有抗氧化应激、抗炎、抗血管平滑肌细胞（VSMCs）增生、抗肿瘤、抗人类免疫缺陷病毒、保护心肌等多种重要的药理作用。随着对姜黄素研究的不断深入,姜黄素... 详细信息

姜黄素是姜黄属植物的主要活性成分之一。目前,已有大量研究表明,姜黄素类成分具有抗氧化应激、抗炎、抗血管平滑肌细胞（VSMCs）增生、抗肿瘤、抗人类免疫缺陷病毒、保护心肌等多种重要的药理作用。随着对姜黄素研究的不断深入,姜黄素在治疗外周动脉疾病（PAD）方面的研究有了一定突破,同时发现,新型姜黄素类衍生物具有巨大的医用价值。本文就姜黄素通过多种途径有效缓解PAD的研究进展作一简要综述。

关键词：姜黄素/治疗应用动脉外周血管疾病/药物疗法综述

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