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Tolerability and efficacy of carvedilol in patients with New York Heart Association class IV heart failure

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 1999年第4期33卷 924-931页

作者： Macdonald, PS Keogh, AM Aboyoun, CL Lund, M Amor, R McCaffrey, DJ St Vincents Hosp Heart & Lung Transplant Unit Sydney NSW 2010 Australia

OBJECTIVES The purpose of this study was to assess the tolerability and efficacy of carvedilol in patients with New York Heart Association (NYHA) functional class IV symptoms. BACKGROUND Carvedilol, a nonselective beta-adrenergic blocking drug with alpha-adrenergic blocking and antioxidant properties, has been shown to improve left ventricular function and clinical outcome in patients with mild to moderate chronic heart failure. METHODS We retrospectively analyzed the outcomes of 230 patients with heart failure treated with carvedilol who were stratified according to baseline functional class: 63 patients were NYHA class IV and 167 were NYHA class I, II or III. Carvedilol was commenced at 3.125 mg b.i.d. and titrated to 25 mg b.i.d. as tolerated. Patients with class IV symptoms were older (p = 0.03), had lower left ventricular fractional shortening (p < 0.001), had lower six-min walk distance (p < 0.001) and were receiving more heart failure medications at baseline compared with less symptomatic patients. RESULTS Nonfatal adverse events while taking carvedilol occurred more frequently in class IV patients (43% vs. 24%, p < 0.0001), and more often resulted in permanent withdrawal of the drug (25% vs. 13%, p < 0.01). Thirty-seven (59%) patients who were NYHA class IV at baseline had improved by one or more functional class at 3 months, 8 (13%) were unchanged and 18 (29%) had deteriorated or died. Among the less symptomatic group, 62 (37%) patients had improved their NYHA status at 3 months, 73 (44%) were unchanged and 32 (1946) had deteriorated or died. The differences in symptomatic outcome at three months between the two groups were statistically significant (p = 0.001, chi-square analysis). Both groups demonstrated similar significant improvements in left ventricular dimensions and systolic function. CONCLUSIONS Patients with chronic NYHA class IV heart failure are more likely to develop adverse events during initiation and dose titration when compared with less sy

关键词：保险统计分析肾上腺素能β受体拮抗剂/副作用肾上腺素能β受体拮抗剂/治疗应用药物副反应报告系统澳大利亚卡唑类/副作用卡唑类/治疗应用剂量效应关系药物用药计划表运动试验/药物作用心力衰竭/分类心力衰竭/诊断心力衰竭/药物疗法心力衰竭/死亡率丙醇胺类/副作用丙醇胺类/治疗应用回顾性研究存活率治疗结果心室功能左/药物作用成年人老年人女(雌)性人类男(雄)性中年人

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Intermittent preventive treatment against malaria in infants in Gabon -: A randomized, double-blind, placebo-controlled trial

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JOURNAL OF INFECTIOUS DISEASES 2007年第11期196卷 1595-1602页

作者： Grobusch, Martin P. Lell, Bertrand Schwarz, Norbert G. Gabor, Julian Dornemann, Jenny Poetschke, Marc Oyakhirome, Sunny Kiessling, Georg C. Necek, Magdalena Laengin, Matthias U. Klouwenberg, Peter Klein Kloepfer, Anna Naumann, Benjamin Altun, Handan Agnandji, Selidji T. Goesch, Julia Decker, Marieluise Salazar, Carmen L. Ospina Supan, Christian Kombila, Davy U. Borchert, Lea Koester, Kai B. Pongratz, Peter Adegnika, Akim A. von Glasenapp, Isabelle Issifou, Saadou Kremsner, Peter G. Univ Witwatersrand Fac Hlth Sci Natl Hlth Lab Serv Sch PatholInfect Dis UnitDiv Clin Microbiol Inf Parktown South Africa Albert Schweitzer Hosp Med Res Unit Lambrene Gabon Univ Tubingen Inst Trop Med D-72074 Tubingen Germany

Background. Intermittent preventive treatment aims to maximize the protective effects of malaria chemoprophylaxis while minimizing the deleterious effects. Methods. In Gabon, 1189 infants received either sulfadoxine-pyrimethamine (SP;250 and 12.5 mg, respectively) or placebo at 3, 9, and 15 months of age. Children were actively followed-up until 18 months of age. Results. In the intention-to-treat population at 18 months of follow-up, 84 children (17%) in the SP group had >= 1 episode of anemia, versus 108 (21%) in the placebo group (protective efficacy, 22% [95% confidence interval {CI}, -1% to 40%];P = .06). In the intervention group, there were 66 episodes during 485 person-years at risk, compared with 79 episodes during 497 years in the placebo group (protective efficacy, 17% [95% CI, -24% to 45%;P = .36). The effects were similar at 12 months of follow-up. The study drug was safe and well tolerated. Conclusions. The intervention was efficacious, producing a reduction in risk for anemia but a smaller effect against malaria. It is a valuable additional tool to control malaria in a highly vulnerable age group. Remaining important questions are currently being addressed in further studies. Trial registration. *** identifier: NCT00167843.

关键词： Anemia Antimalarials Double-Blind Method Drug Administration Schedule 贫血抗疟药双盲法用药计划表复方合剂加蓬血细胞比容血红蛋白类 SP GROUPS Malaria Antimalarials Double-Blind Method Placebos Drug Administration Schedule Anemia

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Comparative response in growth and bone status to three dexamethasone treatment regimens in infant piglets

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PEDIATRIC RESEARCH 2000年第2期48卷 238-243页

作者： Guo, CY Ward, W Cairns, P Atkinson, S McMaster Univ Med Ctr Dept Pediat Hamilton ON L8N 3Z5 Canada

The objectives of this study were 1) to determine whether a zenith in bone formation (indicated by circulating osteocalcin) existed at night in early life, and 2) to compare the effects of three different dexamethasone (DEX) treatment regimens on bone turnover, bone mineral content, and growth. Three DEX treatment regimens were tested in 8-d-old piglets (n = 8/group): I) low evening dose of DEX (0.5 mg/kg/d) as 70% in the morning and 30% in the evening for 10 d;2) tapering course of DEX (0.5, 0.3, and 0.2 mg/kg/d) as 50% in the morning and 50% in the evening for 14 d;and 3) constant dose of DEX (0.5 mg/kg/d) as 50% in the morning and 50% in the evening for 10 d. Oral water placebo groups were tested with the same time courses. At pretreatment, plasma osteocalcin was significantly higher (p < 0.05) at 0100 than at 0900 and 1700. At necropsy, measures for DEX groups were calculated as Z-scores using values from the placebo groups. The low evening DEX dose led to a significantly lower reduction in plasma osteocalcin compared with the tapered and constant dosing regimens (p < 0.05). The significant weight reduction in the DEX group occurred at d 3 in the low evening dose regimen but at d 7 in the constant dosing regimen, compared with the placebo group. Bone mineral content Z-score was reduced similarly in all DEX-treated groups across the three dosing regimens. We conclude that a plasma osteocalcin zenith at night exists in early life. A high DEX dose in the morning and low DEX dose in the evening may partially attenuate corticosteroid-induced suppression of bone formation and growth restriction.

关键词：动物新生体重/药物作用骨发育/药物作用骨发育/生理学地塞米松/投药和剂量地塞米松/药理学用药计划表生长/药物作用婴儿极低出生体重骨钙素/血液猪/生长和发育动物人类婴儿新生男(雄)性

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Effects of inhalation exposures to an M₁-receptor agonist on ventilation in rhesus monkeys

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DRUG AND CHEMICAL TOXICOLOGY 1999年第4期22卷 595-611页

作者： Allen, DL Leiter, PA Tielking, RL Hoffman, WP Vidyashankar, AN van Lier, RBL Wolff, RK Eli Lilly & Co Lilly Res Labs Toxicol Res Labs Greenfield IN 46140 USA

Information was needed on effects of possible occupational inhalation exposure to an M-1-receptor agonist (xanomeline) such as might occur during the manufacturing process. Both acute and repeated inhalation exposures to xanomeline were carried out in six male rhesus monkeys using a head-dome exposure system. Exposure concentrations ranged from 0.3 to 10 mg/m(3). The exposure durations were up to 2 weeks. Decreases in tidal volume and increases in respiratory frequency were both time and concentration related during acute exposures.;These effects were blocked with ati-opine pre-treatment. Correlation with pulmonary resistance measurements in two monkeys suggested that these were bronchoconstrictive changes that increased with severity with time at a given concentration and with concentration when measured after a constant exposure time. The dose-response was relatively steep with 10 mg/m(3) becoming intolerable to the monkeys after approximately 15 minutes, but no measurable effects were observed at 0.3 mg/m(3) after up to 4 hours of exposure. To investigate the effects of repeated exposures, monkeys were exposed for 4 hr/day, 5 days/wk for 2 weeks to 0.0 (air only), 0.3 and 1.2 mg xanomeline/m(3) of air. When compared to the air-only exposure, 0.3 mg/m(3) caused no significant changes in tidal volume. In contrast, 1.2 mg/m(3) caused a rapid and significant decrease in tidal volume that was sustained throughout the 4-hr exposure. A slower rise in breathing frequency also occurred Repeated exposures did not alter the effects seen after a single exposure. It is concluded that xanomeline, a M-1-receptor agonist, can acutely alter normal ventilation in non-human primates at airborne concentrations greater than or equal to 0.6 mg/m(3) and should be carefully controlled in a manufacturing environment. The no-observed-effect concentration was 0.3 mg/m(3).

关键词：投药吸入气道阻力/药物作用大气暴露室阿托品/药理学支气管收缩剂量效应关系药物用药计划表猕猴毒蕈碱激动剂/投药和剂量毒蕈碱激动剂/毒性肺通气/药物作用肺通气/生理学吡啶类/投药和剂量吡啶类/毒性呼吸/药物作用噻二唑类/投药和剂量噻二唑类/毒性潮气量/药物作用动物男(雄)性

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Antepartum or postpartum isoniazid treatment of latent tuberculosis infection

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OBSTETRICS AND GYNECOLOGY 2000年第5期96卷 757-762页

作者： Boggess, KA Myers, ER Hamilton, CD Duke Univ Med Ctr Dept Obstet & Gynecol Durham NC 27710 USA Duke Univ Med Ctr Dept Internal Med Durham NC 27710 USA

Objective: To compare health outcomes and costs of different strategies for treatment of latent tuberculosis infection in pregnancy. Methods: Using a Markov decision-analysis model, the following three strategies were evaluated for treatment of latent tuberculosis infection in pregnancy, defined as positive tuberculin skin reaction of 10 mm or greater and negative chest radiograph: no treatment, antepartum isoniazid administration, in which women were given 300 mg of isoniazid with pyridoxine beginning at 20 weeks' gestation for 6 months;and postpartum isoniazid, in which women were given isoniazid and pyridoxine for 6 months after delivery. Sensitivity analyses were performed for a wide range of probability and cost estimates, and considered discount rates. Results: Under base-case assumptions, the fewest cases of tuberculosis within the cohort occurred with antepartum treatment (1400 per 100,000) compared with no treatment (3300 per 100,000) or postpartum treatment (1800 per 100,000). Antepartum treatment resulted in a marginal increase in life expectancy due to the prevented cases of tuberculosis, despite more cases of isoniazid-related hepatitis and deaths, compared with no treatment or postpartum treatment. Antepartum treatment was the least expensive. Only if the case-fatality rate for tuberculosis was tenfold lower than the base-case and the risk of fatal hepatitis tenfold higher did antepartum treatment become the least advantageous strategy. Conclusion: Rather than delaying treatment until postpartum, consideration for antepartum treatment of latent tuberculosis during pregnancy should be given. If isoniazid is not administered antepartum, then efforts to improve postpartum compliance should be instituted, as either antepartum or postpartum treatment is better than no treatment. (Obstet Gynecol 2000;96:757-62. (C) 2000 by The American College of Obstetricians and Gynecologists.).

关键词：抗结核药/投药和剂量抗结核药/经济学队列研究成本及成本分析决策支持技术用药计划表异烟肼/投药和剂量异烟肼/经济学 Markov链北卡罗来纳产后期妊娠并发症感染性/药物疗法产前保健/经济学结核肺/药物疗法成年人女(雌)性人类妊娠

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An Evidence-Based Review of the Cardiovascular Risks of Nonsteroidal Anti-Inflammatory Drugs

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AMERICAN JOURNAL OF CARDIOLOGY 2009年第9期103卷 1227-1237页

作者： Farkouh, Michael E. Greenberg, Bruce P. Mt Sinai Sch Med Mt Sinai Heart Clin Trials Unit New York NY 10029 USA MDG Dev Grp Basking Ridge NJ USA

Nonsteroidal anti-inflammatory drugs (NSAIDs), both nonselective and cyclooxygenase-2-specific inhibitors, are commonly used medications for the relief of acute and chronic pain associated with a wide range of medical conditions. Because of the extensive use of these agents, adverse events that occur infrequently may still affect the overall risk/benefit ratio of this class of medications. Serious adverse cardiovascular (CV) events have been reported with NSAID use, but unfortunately, definitive evidence regarding the precise CV risk associated with these drugs, as a class and individually, is lacking. Therefore, it is an issue of public health importance that physicians be guided by careful assessment of the existing evidence to make reasonable choices in prescribing these medications. The investigators review the key clinical trials, meta-analyses of clinical trials, and epidemiologic studies on the subject of the CV safety of NSAIDs and identify key variables that define the CV risk of the NSAIDs. In conclusion, it is important that cardiologists, who are not among those physicians frequently prescribing NSAIDs, have a particular responsibility to have up-to-date, thoughtfully synthesized information about the CV risks of these drugs, especially when administered to patients receiving low-dose aspirin for cardioprotection. (C) 2009 Published by Elsevier Inc. (Am J Cardiol 2009;103:1227-1237)

关键词： Anti-Inflammatory Agents Non-Steroidal Aspirin Cardiovascular Diseases Cyclooxygenase 2 Inhibitors Dose-Response Relationship Drug Drug Administration Schedule Drug Interactions Evidence-Based Medicine Female Humans Incidence Male Pain Prognosis Randomized Controlled Trials as Topic Risk Assessment Severity of Illness Index Survival Analysis Time Factors *消炎药非甾类阿司匹林心血管疾病剂量效应关系药物用药计划表药物相互作用证据医学发病率疼痛预后危险性评估疾病严重程度指数存活率分析时间因素 Risk Assessment Cardiovascular Diseases Survival Analysis Severity of Illness Index Drug Administration Schedule Drug Interactions Cyclooxygenase 2 Inhibitors Aspirin Risk Management Non-Steroidal Anti-Inflammatory Agents Pharmaceutical Preparations Time Factors Dose-response relationship Randomized Controlled Trials as Topic Anti-Inflammatory Agents

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SUCCESSFUL THERAPY IN RESISTANT HYPERTENSION

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ANGIOLOGY 1976年第6期27卷 347-357页

作者： DAVIDOV, M GEORGETOWN UNIV SCH MEDDEPT MED WASHINGTON DC 20003 USA GEORGETOWN UNIV DIST COLUMBIA GEN HOSPDIV MED WASHINGTON DC 20003 USA

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COMPARISON OF A 9-PHENANTHRENE METHANOL (WR33063), A 4-QUINOLINE METHANOL (WR30090), AND QUININE FOR FALCIPARUM MALARIA IN THAILAND

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TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE 1975年第3期69卷 342-349页

作者： HALL, AP SEGAL, HE PEARLMAN, EJ PHINTUYOTHIN, P KOSAKAL, S USA MED COMPONENT SEATO MED RES LAB BANGKOK THAILAND

Quinine was compared with a 9-phenanthrene methanol (WR33063) and a 4-quinoline methanol (WR30090) for the treatment of 207 patients with falciparum malaria in Southeast Thailand. Quinine eradicated parasitaemia (average 70 hours) more rapidly than either WR30090 (72 hours) or WR33063 (77 hours). But WR33063 had a higher cure rate (92%) than WR30090 (86%) or quinine (85%). The mean duration of fever and of parasitaemia were combined with the failure rate to form an arbitrary efficacy index. Using this concept WR33063 was the most effective drug. The recrudescence rate correlated with the degree and duration of parasitaemia and with the duration of fever. WR33063 was the least toxic drug. Side effects associated with WR30090 appeared to be headache, backache and urticaria. Quinine was the most toxic drug. All 3 drugs were inconvenient in having to be administered every 8 hours for 6 days. One patient did not respond to oral quinine but did respond to an intravenous quinine infusion (IVQ). A "Medication Ward Round" was perfected during the study and comprised sequential history, drug administration, physical examination, dose notation and patient observation. Falciparum nephrosis was diagnosed in one patient.

关键词：用药计划表药物评价药物过敏/病因学抗药性微生物疟疾/药物疗法菲类/投药和剂量菲类/副作用菲类/治疗应用恶性疟原虫/药物作用蛋白尿/化学诱导奎宁/投药和剂量奎宁/副作用奎宁/治疗应用喹啉类/投药和剂量喹啉类/副作用喹啉类/治疗应用泰国荨麻疹/化学诱导青少年人类男(雄)性

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Weekly polyethylene glycol conjugated L-asparaginase compared with biweekly dosing produces superior induction remission rates in childhood relapsed acute lymphoblastic leukemia: a pediatric oncology group study

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BLOOD 2000年第5期96卷 1709-1715页

作者： Abshire, TC Pollock, BH Billett, AL Bradley, P Buchanan, GR Emory Univ Sch Med Atlanta GA USA Pediat Oncol Grp Stat Off Gainesville FL USA Univ Florida Coll Med Gainesville FL USA Harvard Univ Sch Med Boston MA USA Enzon Inc Piscataway NJ USA Univ Texas SW Med Ctr Dallas TX USA

The relapse rate in childhood acute lymphoblastic leukemia (ALL) is approximately 30% but few reinduction regimens have investigated the intensive use of polyethylene glycol Escherichia coli asparaginase (PEG-Asp). Therefore, we assessed the pharmocokinetics and efficacy of PEG-Asp in this setting, Children with B-precursor ALL, in first marrow and/or extramedullary relapse were eligible. Reinduction included doxorubicin on day 1, prednisone for 28 days, vincristine weekly for 4 weeks, and PEG-Asp either weekly or biweekly by randomization. Asparaginase levels and antibody to both E coli asparaginase and PEG-asp were measured weekly just before each PEG-asp dose. Overall, 129 of 144 patients (pts) (90%) achieved a complete remission (CR). There was a highly significant difference in CR rates between weekly (69 of 71;97%) and biweekly (60 of 73;82%) PEG-Asp dosing (P = .003). Grade 3 or 4 infectious toxicity was common (50%), but only 4 pts died of sepsis during induction. Other toxicities were infrequent and hypersensitivity was rare (6 of 144;4%). Low asparaginase levels were associated with high antibody titers to either native (P = .024) or PEG asp (P = .0013), The CR rate was significantly associated with higher levels of asparaginase (P = .012), Patients with ALL in first relapse receiving weekly PEG-Asp had a higher rate of second remission compared with biweekly dosing. Low levels of asparaginase were associated with high antibody titers, Increased asparaginase levels may correlate with an improved CR rate. The use of intensive PEG-Asp should be explored further in the treatment of ALL. (C) 2000 by The American Society of Hematology.

关键词：天冬酰胺酶/投药和剂量天冬酰胺酶/药代动力学骨髓细胞/药物作用骨髓细胞/病理学脑出血/化学诱导剂量效应关系药物多柔比星/投药和剂量用药计划表肿瘤复发局部聚乙烯二醇类/投药和剂量泼尼松/投药和剂量缓解诱导静脉血栓形成/化学诱导长春新碱/投药和剂量儿童儿童学龄前女(雌)性人类婴儿男(雄)性

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Antiretroviral effect of two different dose regimens of ritonavir and saquinavir on HIV-infected adults in a population-based setting

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ANTIVIRAL THERAPY 1999年第3期4卷 151-156页

作者： Jahnke, N Seminari, E Hogg, RS Yip, B O'Shaughnessy, MV Montaner, JSG St Pauls Hosp British Columbia Ctr Excellence HIV AIDS Vancouver BC V6Z 1Y6 Canada Univ British Columbia Fac Med Dept Hlth Care & Epidemiol Vancouver BC Canada Univ British Columbia Fac Med Dept Pathol Vancouver BC V6T 1W5 Canada Univ British Columbia Fac Med Dept Med Vancouver BC V6T 1W5 Canada

Objective: To characterize the antiviral effect and tolerability of higher dose (HD, 600 mg two times daily) and lower dose (LD, 400 mg two times daily) combination regimens of ritonavir and saquinavir in British Columbia (BC), Canada. Design: Intent-to-treat analysis with suppression of plasma viral load to levels below 500 copies/ml as the main outcome measure. Patients: Adult human immunodeficiency virus (HIV)positive individuals in the province of British Columbia prescribed ritonavir and saquinavir in combination between 1 September 1996 and 30 June 1997, with a minimum of two plasma viral loads, one at baseline and one after the initiation of therapy. Results: A total of 84 participants [27 HD (32%) and 57 LD (68%)] were prescribed ritonavir and saquinavir. There was no difference at baseline in the two groups with respect to age (P=0.466), CD4 cell count (P=0.373) and baseline plasma viral load (P=0.656). However, LD were more likely to have had prior protease experience than HD participants (65 versus 40%, P=0.037). The median follow-up time was 9 months. A total of 44 (52%) subjects demonstrated a decrease in plasma viral load to levels <500 copies/ml. After adjusting for length of follow-up, baseline CD4 cell count and prior AIDS diagnosis, HD participants were as likely to be suppressed to <500 copies/ml as LD individuals (P=0.760). HD participants did report more adverse effects (P=0.042) than LD subjects. Conclusion: Our results provide confirmatory evidence that lower doses of ritonavir and saquinavir in combination ave better tolerated and as effective as the standard doses of these drugs. This response, however, is seriously compromised by prior exposure to protease inhibitors.

关键词：抗HIV药/投药和剂量 CD4淋巴细胞计数剂量效应关系药物用药计划表药物疗法联合 HIV感染/药物疗法 HIV感染/免疫学 HIV感染/病毒学利托纳韦/投药和剂量沙喹纳韦/投药和剂量病毒载量成年人女(雌)性人类男(雄)性中年人

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