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When is urokinase treatment an effective sole or adjunctive treatment for acute limb ischemia secondary to native artery occlusion?

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AMERICAN JOURNAL OF SURGERY 1999年第2期178卷 103-106页

作者： Suggs, WD Cynamon, J Martin, B Sanchez, LA Wahl, SI Aronoff, B Veith, FJ Montefiore Med Ctr Div Vasc Surg Bronx NY 10467 USA Montefiore Med Ctr Div Intervent Radiol Bronx NY 10467 USA

BACKGROUND: Intra-arterial thrombolytic therapy is currently a therapeutic option for the treatment of acute limb ischemia, A recent large prospective randomized trial (TOPAS) comparing lytic therapy and operative intervention showed that both forms of treatment had similar results in terms of amputation-free survival. However, the exact role for lytic treatment is unclear. METHOD: Over a 4-year period we treated 60 cases of acute limb ischemia in 57 patients secondary to native artery occlusion with thrombolytic therapy with urokinase, All patients were evaluated at 1 week, 1 month, and then at 3-month intervals posttreatment. Follow-up evaluations included pulse examination, pulse volume recordings, and duplex examinations to confirm arterial patency, No patients were lost to follow-up with a range of 8 to 54 months (mean 26). RESULTS: Of these 60 native arterial occlusions, complete lysis was achieved in 46 cases (76%), Of these 46 cases, 18 required lysis only, 19 cases (9 iliac, 7 superficial femoral artery (SFA), and 3 popliteal) required angioplasty of lesions uncovered by clot lysis, and 9 patients had lysis and angioplasty of iliac arteries followed by infrainguinal bypasses. Eight of the 57 patients (14%) who had been asymptomatic presented with symptoms limited to new onset claudication, all of which were successfully lysed, Cumulative patency for the 43 successful cases was 90% +/- 5% at 1 year and 75% +/- 4% at 2 years. The 1-year amputation-free survival for all native artery occlusions was 85% +/- 6%. CONCLUSION: Thrombolysis with urokinase simplified the treatment of native arterial occlusion proving to be the sole therapy in 18 (29%) patients or a valuable adjunct by facilitating the angioplasty of arterial lesions and avoiding open surgery in 60% of patients treated, In addition, the correction of inflow lesions reduced the magnitude of required subsequent bypass procedures to achieve limb salvage. In conclusion, successful thrombolysis of native a

关键词：急性病血管成形术气囊动脉闭塞性疾病/并发症动脉闭塞性疾病/药物疗法动脉闭塞性疾病/外科学动脉闭塞性疾病/治疗血量/生理学综合疗法无病生存股动脉/外科学股动脉/超声检查随访研究髂动脉/外科学髂动脉/超声检查注射动脉内间歇性跛行/药物疗法缺血/药物疗法缺血/病因学腿/血液供给腿/超声检查纤溶酶原激活剂/投药和剂量纤溶酶原激活剂/治疗应用腘动脉/外科学腘动脉/超声检查脉搏血栓溶解疗法超声检查多普勒双功能尿纤溶酶原激活物/投药和剂量尿纤溶酶原激活物/治疗应用血管未闭女(雌)性人类男(雄)性中年人

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Ginkgo biloba extract for the treatment of intermittent claudication:: A meta-analysis of randomized trials

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AMERICAN JOURNAL OF MEDICINE 2000年第4期108卷 276-281页

作者： Pittler, MH Ernst, E Univ Exeter Sch Postgrad Med & Hlth Sci Dept Complementary Med Exeter EX2 4NT Devon England

PURPOSE: The optimal treatment of intermittent claudication has not yet been identified. Ginkgo biloba extract has been reported to have beneficial effects. We performed a metaanalysis of the efficacy of Ginkgo biloba extract for intermittent claudication based on the results of randomized, placebo-controlled, double-blind trials. METHODS: Literature searches of MEDLINE, EMBASE, BIOSIS, AMED, CISCOM, and the Cochrane Library were performed to identify studies on the topic. Manufacturers of commercial Ginkgo biloba products and authors of original publications and reviews were contacted to provide additional information. No language restrictions were imposed. RESULTS: Eight randomized, placebo-controlled, double-blind trials were included. Meta-analysis found a significant difference in the increase in pain-free walking distance in favor of Ginkgo biloba (weighted mean difference: 34 meters, 95% confidence interval [CI]: 26 to 43 meters). In studies using similar methodological features (ergometer speed: 3 km/h, inclination: 12%) this difference was 33 meters in favor of Ginkgo biloba (95% CT: 22 to 43 meters). Adverse effects were rare, mild, and transient. CONCLUSIONS: These results suggest that Ginkgo biloba extract is superior to placebo in the symptomatic treatment of intermittent claudication. However, the size of the overall treatment effect is modest and of uncertain clinical relevance. Am J Med. 2000;108:276-281. (C) 2000 by Excerpta Medica, Inc.

关键词：双盲法银杏/治疗应用间歇性跛行/药物疗法植物药疗法植物药用步行人类

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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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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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Ginkgo biloba:: A living fossil

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AMERICAN JOURNAL OF MEDICINE 2000年第4期108卷 341-342页

作者： Jacobs, BP Browner, WS Univ Calif San Francisco Osher Ctr Integrat Med San Francisco CA 94143 USA Univ Calif San Francisco Dept Med San Francisco CA 94143 USA

In 1998, Americans spent about 4 billion dollars on botanical medicines (1, 2) and Ginkgo biloba ranked first among herbal medications sold in health food stores (3). Ginkgo biloba, whose medicinal uses were described in the Chinese Materia Medica more than 2,000 years ago, is used most frequently to treat memory and cognitive impairment, for which it has moderate efficacy with minimal side effects (4–9). Some patients also use ginkgo to treat symptoms of claudication, a condition for which the German Federal Health Agency considers it to be effective (10).

关键词：银杏/治疗应用间歇性跛行/药物疗法植物药疗法植物提取物/化学植物提取物/分离和提纯植物药用人类

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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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The effect of withdrawal of drugs treating intermittent claudication

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AMERICAN JOURNAL OF SURGERY 1999年第2期178卷 141-146页

作者： Dawson, DL DeMaioribus, CA Hagino, RT Light, JT Bradley, DV Britt, KE Charles, BE Wilford Hall USAF Med Ctr Dept Gen Surg Surg Res Serv Lackland AFB TX 78236 USA

BACKGROUND: Pharmacologic treatment for intermittent claudication is a management option. This study evaluated the effect of withdrawal of drug therapies, cilostazol and pentoxifylline, on the walking ability of peripheral artery disease patients. METHODS: Single-blind placebo crossover from a randomized, double-blind trial;45 claudication patients received either cilostazol 100 mg orally twice daily (n = 16), pentoxifylline 400 mg orally three times daily (n = 13), or placebo (n = 16) for 24 weeks. After 24 weeks of double-blind therapy, treatment for all groups was placebo only, and follow-up continued through week 30. Treatment efficacy was established with treadmill testing. RESULTS: Profile analysis demonstrated a highly significant loss of treatment benefit after crossover (P = 0.001) for cilostazol-treated patients, but no significant change after crossover was observed with pentoxifylline. CONCLUSIONS: Drug withdrawal worsened the walking of claudicants who had benefited from cilostazol therapy. This decline with crossover to placebo suggests that the initial improvement with cilostazol treatment was due to the drug's action. Withdrawal of pentoxifylline did not adversely affect walking. Am J Surg. 1999;178: 141-146. (C) 1999 by Excerpta Medica, Inc.

关键词：投药口服交叉研究双盲法运动试验随访研究间歇性跛行/药物疗法间歇性跛行/病理生理学己酮可可碱/投药和剂量己酮可可碱/治疗应用安慰剂血小板聚集抑制剂/投药和剂量血小板聚集抑制剂/治疗应用单盲法四唑类/投药和剂量四唑类/治疗应用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/生理学成年人老年人女(雌)性人类男(雄)性中年人

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Antithrombotic drugs in the primary medical management of intermittent claudication:: A meta-analysis

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THROMBOSIS AND HAEMOSTASIS 1999年第5期81卷 715-722页

作者： Girolami, B Bernardi, E Prins, MH ten Cate, JW Prandoni, P Hettiarachchi, R Marras, E Stefani, PM Girolami, A Büller, HR Univ Hosp Padua Inst Med Semeiot Padua Italy Univ Amsterdam Acad Med Ctr Dept Clin Epidemiol NL-1105 AZ Amsterdam Netherlands Univ Amsterdam Acad Med Ctr Ctr Haemostasis Thrombosis Atherosclerosis & Info NL-1105 AZ Amsterdam Netherlands

Background. There is no consensus on the efficacy of the antithrombotic drugs available for patients with intermittent claudication. Methods. A Medline and manual search was used to identify relevant publications. Uncontrolled or retrospective studies, double reports or trials without clinical outcomes were excluded. Included studies were graded as level 1 (randomised and double- or assessor-blind), level 2 (open randomised), or level 3 (non-randomised comparative). Mortality, cerebro- or cardiovascular events, amputations, arterial occlusions or number of revascularization procedures performed in the lower limbs, pain-free and total walking distance, ankle brachial index and calf blood flow, were the main outcomes considered. When feasible, end of treatment results, either continuous or binary, were combined with appropriate statistical methods. Results. Mortality was significantly decreased by ticlopidine compared to placebo (common odds ratio 0.68, 95% C.I., 0.49-0.95);clopidogrel decreased vascular events in comparison to aspirin (odds ratio 0.76, 95% C.I., 0.63 - 0.92) in level 1 studies. Arterial occlusions and the number of revascularization procedures performed were statistically significantly decreased by aspirin and ticlopidine, respectively. A small but statistically significant improvement in pain-free walking distance was determined by picotamide, indobufen, low molecular weight heparins, sulodexide and defibrotide, in small studies. Conclusions. Clopidogrel and ticlopidine do reduce clinically important events in patients with intermittent claudication and could be added to the primary medical treatment of these patients. The use of aspirin in these patients cannot be based on direct evidence, but only on analogy with coronary and cerebral atherosclerosis, where it has documented efficacy. Other antithrombotic drugs were not properly evaluated in patients with intermittent claudication.

关键词：纤维蛋白溶解药/治疗应用间歇性跛行/药物疗法间歇性跛行/死亡率间歇性跛行/病理生理学治疗结果人类

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PHENOL SYMPATHECTOMY IN TREATMENT OF INTERMITTENT CLAUDICATION - CONTROLLED CLINICAL TRIAL

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BRITISH JOURNAL OF SURGERY 1975年第1期62卷 68-71页

作者： FYFE, T QUIN, RO WESTERN INFIRM DEPT MED GLASGOW SCOTLAND WESTERN INFIRM DEPT SURG GLASGOW SCOTLAND

Twenty‐five patients with intermittent claudication were randomly allocated to treatment either by injection of phenol into the lumbar sympathetic chain or by injection of local anaesthetic subcutaneously. On the day after the injection, sympathectomy, assessed by skin temperature change, was achieved in 85 per cent of the phenol group. At 1 month subjective improvement was claimed by 45 per cent of the patients in the sympathectomized group and by 64 per cent in the control group; at 3 months the figures were 25 and 45 per cent respectively. Treadmill testing at two exercise loads showed no significant difference in claudication distance or stopping time between the two groups. Calf blood pressure response following exercise was not affected by sympathectomy. There is no subjective or objective evidence that phenol sympathectomy improves intermittent claudication.

关键词：血压用力注射注射皮下间歇性跛行/药物疗法间歇性跛行/治疗腿/血液供给利多卡因/治疗应用酚类/投药和剂量酚类/治疗应用皮肤温度交感神经系统女(雌)性人类男(雄)性中年人

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Basic fibroblast growth factor in patients with intermittent claudication: Results of a phase I trial

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2000年第4期36卷 1239-1244页

作者： Lazarous, DF Unger, EF Epstein, SE Stine, A Arevalo, JL Chew, EY Quyyumi, AA NHLBI Cardiol Branch NIH Bethesda MD 20892 USA NEI NIH Bethesda MD 20892 USA

OBJECTIVES This phase I study was designed to evaluate the safety, tolerability and pharmacokinetics of intra-arterial basic fibroblast growth factor (bFGF) in patients with atherosclerotic peripheral arterial disease (PVD) and intermittent claudication. We also assessed the effects of basic fibroblast growth factor (bFGF) on calf blood flow as a measure of biologic activity. BACKGROUND Preclinical studies have shown that bFGF, an angiogenic peptide, promotes collateral development in animal models of myocardial and hind limb ischemia. The safety and efficacy of bFGF in patients is unknown, and early clinical trials are underway in coronary and peripheral arterial disease. METHODS A double-blind, placebo-controlled, dose-escalation trial was conducted in patients with claudication demonstrating ankle/brachial index <0.8. Patients were randomly assigned to placebo (n = 6), 10 mu g/kg of bFGF (n = 4), 30 mu g/kg of bFGF once (n = 5) and 30 mu g/kg of bFGF on two consecutive days (n = 4). Study drug was infused into the femoral artery of the ischemic leg. Detailed safety information including retinal photography for neovascularization were obtained through one year. Calf blood flow was measured with strain gauge plethysmography in the two higher dose treatment groups and in four placebo patients at baseline, one month and three to seven months after treatment. RESULTS Intra-arterial bFGF was safe and well-tolerated. The half-life was 46 +/- 21 min. Calf blood flow increased at one month by 66 +/- 26% (mean +/- SEM) and at six months by 153 +/- 51% in bFGF-treated patients (n = 9, p = 0.002). Flow did not change significantly in the placebo group. CONCLUSIONS In this initial randomized, double-blind, placebo-controlled trial in patients with atherosclerotic PVD and claudication, bFGF was well-tolerated. The data suggest a salutary biologic effect, and initiation of phase 2 trials is warranted. (J Am Coil Cardiol 2000;36:1239-44) (C) 2000 by the American College of Cardi

关键词：踝/血液供给血流速度/药物作用肱动脉/药物作用肱动脉/病理生理学双盲法成纤维细胞生长因子2/投药和剂量成纤维细胞生长因子2/药代动力学半衰期注射动脉内间歇性跛行/血液间歇性跛行/药物疗法间歇性跛行/病理生理学体积描记术安全老年人女(雌)性人类男(雄)性

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