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PATIENT COMPLIANCE WITH MEDICATION REGIMENS

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DRUG INTELLIGENCE & CLINICAL PHARMACY 1976年第7期10卷 386-393页

作者： SMITH, DL SUNNYBROOK MED CTR TORONTOONTARIOCANADA

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Valsartan in Acute Myocardial Infarction trial (VALIANT): Rationale and design

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AMERICAN HEART JOURNAL 2000年第5期140卷 727-734页

作者： Pfeffer, MA McMurray, J Leizorovicz, A Maggioni, AP Rouleau, JL Van de Werf, F Henis, M Neuhart, E Gallo, P Edwards, S Sellers, MA Velazquez, E Califf, R Brigham & Womens Hosp Div Cardiovasc Boston MA 02115 USA Univ Glasgow Clin Res Initiat Heart Failure Glasgow Lanark Scotland Univ Lyon Clin Pharmacol Unit Lyon France ANMCO Res Ctr Florence Italy Univ Toronto Div Cardiol Toronto ON Canada Leuven Coordinating Ctr Louvain Belgium Novartis Pharmaceut E Hanover NJ USA Novartis Pharma AG Basel Switzerland Duke Univ Med Ctr Durham NC USA

Background survivors of acute myocardial infarction (MI) complicated by heart failure and/or resulting in left ventricular dysfunction are at heightened risk for subsequent death and major nonfatal cardiovascular events. Inhibition of the renin-angiotensin system with an angiotensin-converting enzyme inhibitor has consistently been demonstrated to result in reductions in these risks by approximately 20%. The development of angiotensin II receptor blockers offers a new, more specific, and theoretically more complete pharmacologic mode to inhibit the adverse influence of angiotensin II. Methods Valsartan in Acute Myocardial Infarction (VALIANT) is a multicenter, double-blind, randomized, active controlled parallel group study comparing the efficacy and safety of long-term treatment with valsartan, captopril, and their combination in high-risk patients after MI. The trial is designed with 3 arms, giving equal statistical consideration to survival comparisons of captopril versus the angiotensin II receptor blocker valsartan, as well as the combination of captopril plus valsartan, compared with a proven effective dose of captopril. This 14,500-patient trial is designed with an 86% power to detect a 15% reduction in mortality rate with either use of valsartan compared with captopril. The trial encourages optimal individualization of other proven therapies in acute and chronic infarction, and the international patient body ensures good representation of multiple practice patterns. Conclusion VALIANT ii a large international investigative effort that will evaluate the role of valsartan in the menage ment of patients with MI associated with heart failure and/or left ventricular dysfunction. The use of a proven dose of captopril and the comparator arms with valsartan alone or in combination with captopril provides a unique test of whether the angiotensin II receptor blocker can make an additional improvement in clinical outcomes beyond angiotensin-converting enzyme inhibitors

关键词：血管紧张素Ⅱ/代谢血管紧张素转换酶抑制药/治疗应用抗高血压药/治疗应用卡托普利/治疗应用死亡原因双盲法用药计划表药物疗法联合心肌梗死/药物疗法心肌梗死/死亡率比值比病人遴选比例危险度模型受体血管紧张素/拮抗剂和抑制剂研究设计样本大小四唑类/治疗应用缬氨酸/类似物和衍生物缬氨酸/治疗应用人类

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Pharmacological studies of the acute and chronic effects of (+)-3,4-methylenedioxymethamphetamine on locomotor activity:: Role of 5-hydroxytryptamine_1A and 5-hydroxytryptamine_1B/1D receptors

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JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS 1999年第3期290卷 965-973页

作者： McCreary, AC Bankson, MG Cunningham, KA Univ Texas Med Branch Dept Pharmacol & Toxicol Galveston TX 77555 USA

The 5-hydroxytryptamine(1B/1D) (5-HT1B/1D) antagonist 2'-methyl-4'-(5-methyl-[1,2,4]oxadiazol-3-yl)-biphenyl-4-carboxylic acid [4-methoxy-3-(4-methyl-piperazin-1-yl)-phenyl]-amide (GR 127935) and 5-HT1A antagonist N-(2-(4-(2-methoxyphenyl)-1-piperazinyl)ethyl)-N-(2-pyridinyl)cyclohexanecarboxamide (WAY 100635) were used to assess whether hyperactivity induced by 3 mg/kg (+)-3,4-methylenedioxymethamphetamine [(+)-MDMA] is mediated by 5-HT1B/1D and/or 5-HT1A receptors. Activity in the periphery and center of an open field as well as rearing activity were measured in photobeam monitors. (+)-MDMA-induced peripheral and central activities were blocked by GR 127935 (0.3, 0.625, 1.25, and 2.5 mg/kg);central hyperactivity was blocked by 0.1, 0.3, and 0.625 mg/kg GR 127935. WAY 100635 (0.5-2 mg/kg) had little effect on (+)-MDMA-induced activity except for an enhancement of central activity at one dose (0.5 mg/kg). Central activity induced by (+)-MDMA increased from day 1 to day 5 of treatment with (+)-MDMA (3 mg/kg), whereas peripheral, central, and rearing activity significantly increased in (+)-MDMA-treated rats pretreated daily with GR 127935 (2.5 mg/kg). Withdrawal from (+)-MDMA, but not GR 127935 + (+)-MDMA, pretreatment was associated with heightened hyperactivity induced by the 5-HT1B/1A agonist RU 24969 (2 mg/kg i.p.);treatments were not associated with alterations in 5-HT and 5-hydroxyindoleacetic acid content or turnover in frontal cortex. These data support a role for 5-HT1B/1D in mediating the acute hyperactivity evoked by (+)-MDMA. The development of sensitization to (+)-MDMA was associated with supersensitivity to a 5-HT1B/1A agonist, suggesting that these receptors may contribute to sensitization. However, sensitization to (+)-MDMA developed even under conditions of 5-HT1B/1D receptor blockade, which is somewhat counter to this speculation. Perhaps, under circumstances of continued 5-HT1B/1D. blockade, other mechanisms (e.g., dopamine) predominate in the progr

关键词： 3 4-亚甲二氧苯丙胺/药理学行为动物/药物作用用药计划表额叶/药物作用额叶/代谢吲哚类/药理学运动活动/药物作用恶二唑类/药理学哌嗪类/药理学吡啶类/药理学大鼠 Sprague-Dawley 受体血清素 5-HT1B 受体血清素 5-HT1D 受体血清素/分类受体血清素/生理学受体血清素 5-HT1 血清素类药/药理学血清素拮抗药/药理学血清素受体激动剂/药理学氯化钠/药理学动物男(雄)性大鼠

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Extended adjuvant therapy with anastrozole among postmenopausal breast cancer patients: Results from the randomized Austrian Breast and Colorectal Cancer Study Group Trial 6a

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JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE 2007年第24期99卷 1845-1853页

作者： Jakesz, Raimund Greil, Richard Gnant, Michael Schmid, Marianne Kwasny, Werner Kubista, Ernst Mineritsch, Brigitte Tausch, Christoph Stierer, Michael Hofbauer, Friedrich Renner, Karl Dadak, Christian Ruecklinger, Ernst Samonigg, Hellmut Vienna Med Univ Dept Surg Vienna Austria Vienna Med Univ Dept Gynecol Vienna Austria Paracelsus Med Univ Dept Med 3 Salzburg Austria Graz Med Univ Dept Med 1 Graz Austria Wiener Neustadt Gen Hosp Dept Surg Wiener Neustadt Austria Sisters Mercy Hosp Dept Surg Linz Austria Hanusch Hosp Dept Surg Vienna Austria Oberpullendorf Hosp Dept Surg Oberpullendorf Austria Social Med Ctr Sozialmed Zentrum Dept Surg Vienna Austria

Background Clinical trial data have shown that among breast cancer patients who were disease free after 5 years of adjuvant treatment with tamoxifen, further extended treatment with the nonsteroidal aromatase inhibitor letrozole reduces breast cancer recurrence. We examined the efficacy and tolerability of extended adjuvant therapy with another aromatase inhibitor, anastrozole, for 3 years among women who had completed 5 years of adjuvant therapy. Methods Austrian Breast and Colorectal Cancer Study Group (ABCSG) Trial 6a is an extension of ABCSG Trial 6, in which hormone receptor-positive postmenopausal patients received 5 years of adjuvant tamoxifen, with or without the aromatase inhibitor aminoglutethimide, for the first 2 years of therapy. For ABCSG Trial 6a, patients who were disease free at the end of Trial 6 were randomly assigned to receive either 3 years of anastrozole or no further treatment. Efficacy data were analyzed with the use of a Cox proportional hazards regression model with two-sided P values and Kaplan-Meier curves, and tolerability data were estimated using logistic regression analysis with odds ratios and 95% confidence intervals (Cls). Results ABCSG Trial 6a included 856 patients. At a median follow-up of 62.3 months, women who received anastrozole (n = 387) had a statistically significantly reduced risk of recurrence (locoregional recurrence, contralateral breast cancer, or distant metastasis) compared with women who received no further treatment (n = 469;hazard ratio = 0.62;95% Cl = 0.40 to 0.96, P=.031). Anastrozole was well tolerated, and no unexpected adverse events were reported. Conclusions These data confirm the benefit of extending adjuvant tamoxifen therapy beyond 5 years with anastrozole compared with no further treatment. Further research is required to define the optimum length of extended adjuvant therapy and to investigate the possibility of tailoring this period to suit different disease types.

关键词： Aged 80 and over Aminoglutethimide Antineoplastic Agents Hormonal 老年人 80以上奥地利化学疗法辅助无病生存用药计划表 Logistic模型 Aminoglutethimide Aromatase Inhibitors Trials anastrozole adjuvant therapy Antineoplastic Agents Breast Cancer

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In vivo drug-drug interaction studies - A survey of all new molecular entities approved from 1987 to 1997

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CLINICAL PHARMACOLOGY & THERAPEUTICS 2000年第3期68卷 280-285页

作者： Marroum, PJ Uppoor, RS Parmelee, T Ajayi, F Burnett, A Yuan, R Svadjian, R Lesko, LJ Balian, JD US FDA Ctr Drug Evaluat & Res OPS OCPBDPE 1 Rockville MD 20857 USA

Ninety-eight new molecular entities applications approved between 1987 to 1991 (period I) and 193 applications for new molecular entities between 1992 to 1997 (period II) were surveyed for drug-drug interaction studies. In period I (used as a comparator), 32 applications contained drug-drug interaction studies for a total of 117 studies. In period II, 106 applications reported drug-drug interaction studies, and the number of studies per new molecular entity ranged from 0 to 15. Most studies (77%) were performed in healthy subjects, with 44% using crossover designs, 7% using parallel designs, and the remaining using fixed sequence designs, The most common dosing scheme for new molecular entities/interacting drug was multiple dose (47%), whereas single dose/multiple dose was used in 31% of studies, and single dose/single dose was used in 18% of studies. Of the 540 drug-drug interaction studies submitted in period II, 80 (15%) resulted in clinically significant labeling statements, Submissions for new molecular entities to the Center for Drug Evaluation and Research divisions most likely to include drug-drug interaction studies were neuropharmacology, cardiorenal, antiviral, and antiinfective drugs, Some drug classes such as oncology drug products and radioimaging products were least likely to include drug-drug interaction studies in their submissions. We conclude that the use of drug-drug interaction studies in the drug development process has increased between the two periods.

关键词：生物药学交叉研究数据库事实型剂量效应关系药物用药计划表药物相互作用美国美国食品和药物管理局人类

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Cancer in the elderly: Tailoring treatment

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HOSPITAL PRACTICE 2000年第3期35卷 73-80页

作者： Balducci, L Carbone, PP Univ S Florida Coll Med Tampa FL 33620 USA

The body's ability to meet the stresses of cancer therapy declines in later life. Because the decline may vary and is only weakly linked to chronologic age, a thorough functional assessment should be undertaken in... 详细信息

关键词：日常生活活动抗肿瘤联合化疗方案/投药和剂量乳腺肿瘤/药物疗法癌小细胞/药物疗法用药计划表虚弱老人老年人保健服务肺肿瘤/药物疗法淋巴瘤大B细胞弥漫性/药物疗法肿瘤/药物疗法病人医护管理胃肿瘤/药物疗法老年人老年人 80以上女(雌)性人类男(雄)性

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Heparin after percutaneous intervention (HAPI): A prospective multicenter randomized trial of three heparin regimens after successful coronary intervention

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 1999年第2期34卷 461-467页

作者： Rabah, M Mason, D Muller, DWM Hundley, R Kugelmass, AD Weiner, B Cannon, L O'Neill, WW Safian, RD William Beaumont Hosp Div Cardiol Royal Oak MI 48073 USA St Vincents Hosp Dept Cardiol Sydney NSW 2010 Australia Baptist Med Ctr Dept Cardiol Little Rock AR USA Univ Oklahoma Hlth Sci Ctr Dept Cardiol Oklahoma City OK USA Univ Massachusetts Med Ctr Dept Cardiol Worcester MA USA Dept Cardiol Saginaw MI USA

OBJECTIVES The purpose of this study was to determine the incidence of bleeding, vascular, and ischemic complications using three different heparin regimens after successful intervention. BACKGROUND The ideal dose and duration of heparin infusion after successful coronary intervention is unknown. METHODS Patients were randomized to one of three heparin strategies after coronary intervention: Group 1 (n = 157 patients) received prolonged (12 to 24 h) heparin infusion followed by sheath removal;Group 2 (n = 120 patients) underwent early removal of sheaths, followed by reinstitution of heparin infusion for 12 to 18 h;Group 3 (n = 137 patients) did not receive any further heparin after intervention with early sheath removal. The primary end point of the study was the combined incidence of in-hospital bleeding and vascular events. Secondary end points included in-hospital ischemic events, length of stay, cost and one-month outcome. RESULTS After successful coronary intervention, 414 patients were randomized. Unstable angina or postinfarction angina was present in 83% of patients before intervention. The combined incidence of bleeding and vascular events was 21% in Group 1, 14% in Group 2 and 8% in Group 3 (p = 0.01). The overall incidence of in-hospital ischemic complications was 2.2%;there were no differences between groups. Length of hospital stay was shorter (p = 0.033) and adjusted hospital cost was lower (p < 0.001) for Group 3. At 30 days, the incidence of delayed cardiac and vascular events was similar for all three groups. CONCLUSIONS Heparin infusion after successful coronary intervention is associated with more minor bleeding and vascular injury, prolonged length of stay and increased cost. In-hospital and one-month ischemic events rarely occur after successful intervention, irrespective of heparin use. Routine postprocedure heparin is not recommended, even in patients who present with unstable ischemic syndromes. (C) 1999 by the American College of Cardiology.

关键词：血管成形术气囊冠状动脉/副作用抗凝药/投药和剂量抗凝药/副作用斑块切除术冠状动脉/副作用血管/损伤用药计划表出血/化学诱导肝素/投药和剂量肝素/副作用输注静脉内住院时间心肌缺血/病因学前瞻性研究全血凝固时间女(雌)性人类男(雄)性中年人

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Management of venous thromboembolism in patients with advanced cancer: a systematic review and meta-analysis

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LANCET ONCOLOGY 2008年第6期9卷 577-584页

作者： Noble, Simon I. R. Shelley, Mike D. Coles, Bernadette Williams, Susan M. Wilcock, Andrew Johnson, Miriam J. Cardiff Univ Royal Gwent Hosp Dept Palliat Med Newport NP20 2UB Gwent Wales Velindre Hosp Res Dept Cochrane Unit Cardiff S Glam Wales Cardiff Univ Velindre Hosp Dept Informat Serv Cardiff S Glam Wales Univ Nottingham Nottingham Univ Hosp NHS Trust Fac Med & Hlth Sci Nottingham NG7 2RD England St Catherines Hosp Scarborough England

Venous thromboembolism is common in patients with cancer. However, no management guidelines exist for venous thromboembolism specific to patients with advanced progressive cancer. To help develop recommendations for practice, we have done a comprehensive review of anticoagulation treatment in patients with cancer, with particular focus on studies that included patients with advanced disease. Data from 19 publications, including randomised, prospective, and retrospective studies suggest that: long-term full-dose low-molecular-weight heparin (LMWH) is more effective than warfarin in the secondary prophylaxis of venous thromboembolism in patients with cancer of any stage, performance status, or prognosis;warfarin should not be used in patients with advancing progressive disease;and in patients at high risk of bleeding, full-dose LMWH for 7 days followed by a long-term decreased fixed dose long term can be considered. The optimum treatment duration is unclear, but because the prothrombotic tendency will persist in patients with advanced cancer, indefinite treatment is generally recommended. For patients with contraindications to anticoagulation, inferior-vena-caval filters can be considered, but their use needs careful patient selection. Ultimately, the decision to initiate, continue, and stop anticoagulation will need to be made on an individual basis, guided by the available evidence, the patient's circumstances, and their informed preferences.

关键词： Anticoagulants Disease Progression Drug Administration Schedule Hemorrhage 抗凝药疾病恶化用药计划表出血肝素低分子量肿瘤分期肿瘤病人选择 Patients Drug Administration Schedule Venous Thromboembolism Advanced Malignant Neoplasm Disease Progression Low Molecular Weight Heparin Anticoagulants Secondary Prevention Meta-Analysis Cancer Hemorrhage Warfarin anticoagulation

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A phase II double-blind randomized study of the simultaneous administration of recombinant human interleukin-6 and recombinant human granulocyte colony-stimulating factor following paclitaxel and carboplatin chemotherapy in patients with advanced epithelial ovarian cancer

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GYNECOLOGIC ONCOLOGY 1999年第3期72卷 292-297页

作者： Hochster, H Speyer, JL Mandeli, JP Runowicz, C Wadler, S Berk, G Wallach, R Holland, JF NYU Med Ctr Kaplan Comprehensive Canc Ctr New York NY 10016 USA NYU Sch Med New York NY USA Mt Sinai Med Ctr New York NY 10029 USA Cornell Univ Med Ctr New York Hosp New York NY 10021 USA Albert Einstein Coll Med Bronx NY 10467 USA NYU Med Ctr Dept Med New York NY 10016 USA

Purpose. Recombinant human interleukin-6 (rhuIL-6) is a glycosylated cytokine with hematopoietic stimulatory effects. In particular, preclinical studies suggest the agent can stimulate thrombopoiesis, even in conjunction with chemotherapy. We attempted to determine whether higher dose chemotherapy for ovarian cancer was possible given the pharmacologic use of this important growth factor. Methods. We conducted a randomized, double-blind phase II study of IL-6 plus granulocyte colony-stimulating factor (G-CSF) versus placebo plus G-CSF in combination with a standard chemotherapy regimen. Patients with epithelial ovarian cancer, stages Ic to IV, were eligible. All patients were previously untreated with chemotherapy and had Karnofsky performance status greater than or equal to 60. rhuIL-B (Escherichia coli, SDZ ILS 969) 1.0 mu g/kg or placebo was given subcutaneously on days 2-8 every cycle together with G-CSF 5.0 mu g/kg subcutaneously days 2-15, following administration of paclitaxel 175 mg/m(2) as a 3-h infusion and carboplatin given to a desired AUC of 7.5 on day 1 every 21 days. Results. Fifty patients were entered in this study, although the study was temporarily suspended by the FDA in midstudy over manufacturing concerns. Therefore, 37 patients were evaluable for efficacy of growth factor;19 patients received placebo plus G-CSF and 18 rhIL-6 plus G-CSF, There was no difference in prognostic variables between these two groups. Platelet nadirs were lower in the first cycle for the placebo group (P = 0.004, Wilcoxon sum-rank test) but not in other cycles. There was no statistically significant difference in cycle treatment delays, carboplatin dose delivered, number of patients with grade 4 thrombocytopenia, or platelet transfusion. Nonetheless, the trend of the data favored IL-6 in all cases. Conclusions. This study demonstrated a minimal effect (statistically significant in the first cycle only) on thrombopoiesis in women undergoing paclitaxel and carboplatin th

关键词：腺癌/药物疗法抗肿瘤联合化疗方案/治疗应用卡铂/投药和剂量双盲法用药计划表粒细胞集落刺激因子/投药和剂量白细胞介素6/投药和剂量卡诺夫斯基能力状态卵巢肿瘤/药物疗法紫杉酚/投药和剂量重组蛋白质类/投药和剂量成年人老年人老年人 80以上女(雌)性人类中年人

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Amphetamine and fenproporex levels following multidose administration of fenproporex

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JOURNAL OF ANALYTICAL TOXICOLOGY 1999年第3期23卷 187-194页

作者： Cody, JT Valtier, S Wilford Hall USAF Med Ctr Clin Res Squadron Lackland AFB TX 78236 USA Univ Alabama Dept Justice Sci Grad Program Forens Sci Birmingham AL 35294 USA

Drugs that are metabolized to amphetamine or methamphetamine are potentially of significant concern in the interpretation of positive drug-testing results for amphetamines. A number of different drugs have been reported to produce amphetamine in the urine of users. One of these compounds, fenproporex, has been shown to be metabolized to amphetamine, and previous reports indicated the parent compound could be detected at low levels for up to 48 h. Administration of fenproporex for seven days (one 10-mg dose per day) to five healthy volunteers resulted in amphetamine being detected in the urine of all subjects. Peak concentrations of amphetamine ranged from approximately 2850 to 4150 ng/mL. Amphetamine could be detected (≥ 5 ng/mL) in the urine for up to nearly 170 h after the last dose. Analysis of the metabolically produced amphetamine showed the presence of both enantiomers, which can be helpful in the differentiation of some illicit amphetamine use from the use of this precursor drug. In addition, evaluation of the enantiomeric composition of the metabolite (amphetamine) can be a valuable tool in the interpretation of time since last dose. More significantly, all samples that contained amphetamine at a concentration of ≥ 500 ng/mL were shown to also contain detectable amounts of the parent compound. ? Previous | Next Article ?Table of Contents This Article J Anal Toxicol (May-June 1999) 23 (3): 187-194. doi: 10.1093/jat/23.3.187? Free Full Text (PDF)Free Classifications ArticlesServices Alert me when cited Alert me if corrected Find similar articles Similar articles in Web of Science Similar articles in PubMed Add to my archive Download citation Request Permissions Citing Articles Load citing article information Citing articles via CrossRef Citing articles via Scopus Citing articles via Web of Science Citing articles via Google Scholar Google Scholar Articles by Cody, J. T. Articles by Stillman, S. Search for related content PubMed PubMed citation Artic

关键词：苯丙胺/尿苯丙胺类/投药和剂量苯丙胺类/代谢苯丙胺类/尿食欲抑制药/投药和剂量食欲抑制药/代谢中枢神经系统刺激剂/尿用药计划表假阳性反应氢离子浓度立体异构现象物质滥用检测女(雌)性人类男(雄)性

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