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Reduction of the inhibitory effect of ketoconazole on budesonide pharmacokinetics by separation of their time of administration

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CLINICAL PHARMACOLOGY & THERAPEUTICS 2000年第1期68卷 13-17页

作者： Seidegård, J AstraZeneca R&D Lund Expt Med SE-22187 Lund Sweden

Background: Budesonide is a glucocorticosteroid used in the treatment of, for example, inflammatory bowel diseases, with a recommended once-daily morning dosing regimen. Ketoconazole is a potent inhibitor of the cytochrome P450 3A (CYP3A) activities and known to inhibit the elimination of drugs metabolized by CYP3A, including budesonide. It is of therapeutic interest to know whether the influence of ketoconazole can be reduced by administration on an occasion different in time to CYP3A substrates. Methods: Eight healthy men completed this randomized, open crossover study that comprised three different periods. In period 1, a single oral dose of 3 mg budesonide was given in the morning. In period 2, a 200-mg ketoconazole tablet was administered once daily in the morning on 4 consecutive days. On the fourth day, 3 mg budesonide was administered at the same time as the ketoconazole. In period 3, 200 mg ketoconazole was administered once daily in the evening on 4 consecutive days. On the fourth day, 3 mg budesonide was administered 12 hours before the ketoconazole. One-week washout periods separated the budesonide administrations. Results: The mean area under the plasma drug concentration-time curve [AUC(0-24)] for budesonide was increased by 6.5 times when it was given simultaneously with ketoconazole. When the administrations of the two drugs were separated by 12 hours, the mean AUC(0-24) for budesonide was increased by only 3.8 times. Conclusion: This study shows that the capability of ketoconazole to inhibit the elimination of budesonide is significantly reduced (by 50%) by a 12-hour separation of the administration times.

关键词：抗真菌药/投药和剂量抗真菌药/药理学曲线下面积芳基烃羟化酶类布地奈德/投药和剂量布地奈德/拮抗剂和抑制剂交叉研究细胞色素P-450CYP3A 细胞色素P450酶系统/拮抗剂和抑制剂细胞色素P450酶系统/代谢用药计划表酮康唑/投药和剂量酮康唑/药理学氧化还原酶类 N-脱甲基/拮抗剂和抑制剂氧化还原酶类 N-脱甲基/代谢参考值时间因素人类男(雄)性

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Cardioversion with sotalol in selected patients with vagally and adrenergically mediated paroxysmal atrial fibrillation

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ANGIOLOGY 1999年第9期50卷 729-733页

作者： Yesil, M Bayata, S Postaci, N Yücel, Ö Aslan, Ö Izmir State Hosp Dept Cardiol Izmir Turkey

This study was designed to evaluate and compare the effects of oral sotalol for the treatment of vagal and adrenergic paroxysmal atrial fibrillation (PAF). Thirty-five eligible patients with atrial fibrillation of >12 hours and <7 days were enrolled in the study. Patients were classified as vagally mediated (group I, n: 14) and adrenergically mediated (group II, n: 21) PAF groups. All patients were given racemic sotalol at a dose up to 120 mg bid for 2 days. At the end of the observation period of 48 hours, 36% of patients (n: five) in group I returned to sinus rhythm. Conversion rate in group II was 71% (n: 15), and this figure was significantly higher than the success rate in group I. Mean times to cardioversion were 22 +/- 15 hours in group I and 16 +/- 14 hours in group II (p < 0.05). The result of this study suggests that oral sotalol is more effective for adrenergic PAF. This beneficial effect of sotalol is not apparent in vagal PAF patients.

关键词：肾上腺素能纤维/药物作用肾上腺素能纤维/生理学肾上腺素能β受体拮抗剂/投药和剂量抗心律失常药/投药和剂量心房颤动/药物疗法心房颤动/病理生理学综合疗法剂量效应关系药物用药计划表电抗休克心电描记术便携式/药物作用心脏/神经支配索他洛尔/投药和剂量心动过速阵发性/药物疗法心动过速阵发性/病理生理学治疗结果迷走神经/药物作用迷走神经/病理生理学成年人老年人女(雌)性人类男(雄)性中年人

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'Hold the Mayo': Solid facts or pulp fiction?

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ANNALS OF ONCOLOGY 2000年第8期11卷 919-920页

作者： Punt, CJA Univ Med Ctr St Radboud Nijmegen Dept Med Oncol Nijmegen Netherlands

‘Hold the Mayo’: Solid facts or pulp fiction? C. J. A. Punt Search for other works by this author on: Oxford Academic PubMed Google Scholar C. J. A. Punt Annals of Oncology, Volume 11, Issue 8, 1 August 2000, Pages ... 详细信息

关键词：抗代谢药抗肿瘤/投药和剂量抗代谢药抗肿瘤/治疗应用抗肿瘤联合化疗方案化学疗法辅助顺铂临床试验(主题) 结直肠肿瘤/药物疗法结直肠肿瘤/外科学用药计划表药物疗法联合氟尿嘧啶/投药和剂量氟尿嘧啶/治疗应用输注静脉内注射静脉内醛氢叶酸/投药和剂量醛氢叶酸/治疗应用人类

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Modeling of sertindole pharmacokinetic disposition in healthy volunteers in short term dose-escalation studies

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JOURNAL OF PHARMACEUTICAL SCIENCES 1998年第12期87卷 1629-1631页

作者： Wong, SL Granneman, GR Abbott Labs Dept Pharmacokinet & Biopharmaceut Abbott Pk IL 60064 USA

The pharmacokinetics of sertindole were studied in young, healthy volunteers after single and multiple oral dose administered under an escalating manner. In a low-dose study (study 1), subjects received 4-8 mg with a maintenance dose period of 7 days. Ina high-dose study (study 2), subjects received 4 mg daily for 2 days, and the dose was increased by 4 mg increments every third day until reaching 20 mg daily. The mean terminal t(1/2) was 73 h after the final 8 mg dose in study 1 and 60 h after the 20 mg dose in study 2. The terminal elimination phase appeared to be monophasic in all the study subjects, suggesting that Michaelis-Menten saturable metabolism was not involved in the elimination of sertindole. Compartmental analyses suggested that the disproportional increase of the C(max) and AUC values from 4 mg to 20 mg during multiple dosing may be explained by saturable presystemic elimination of sertindole, leading to a higher fraction of sertindole available for-absorption at higher doses.

关键词：投药口服抗精神病药/投药和剂量抗精神病药/药代动力学用药计划表半衰期咪唑类/投药和剂量咪唑类/药代动力学吲哚类/投药和剂量吲哚类/药代动力学青少年成年人人类男(雄)性

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Effect of Oxymetholone on left ventricular dimensions in heart failure secondary to idiopathic dilated cardiomyopathy or to mitral or aortic regurgitation

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AMERICAN JOURNAL OF CARDIOLOGY 1999年第1期83卷 123-+页

作者： Tomoda, H Tokai Univ Hosp Dept Cardiol Isehara Kanagawa 25911 Japan

This study suggests that the short-term administration of a small dosage of anabolic steroids may have a beneficial effect on the deteriorated myocardium, although long-standing exposure to a larger dosage of anabolic... 详细信息

关键词：同化剂/投药和剂量同化剂/药理学主动脉瓣关闭不全/并发症主动脉瓣关闭不全/病理学主动脉瓣关闭不全/病理生理学心肌病扩张型/并发症心肌病扩张型/病理学心肌病扩张型/病理生理学用药计划表心室/药物作用心室/病理学二尖瓣闭锁不全/并发症二尖瓣闭锁不全/病理学二尖瓣闭锁不全/病理生理学羟甲烯龙/投药和剂量羟甲烯龙/药理学心室功能左/药物作用老年人人类男(雄)性中年人

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Neoral dose monitoring with cyclosporine 2-hour postdose levels in heart transplant patients receiving anti-thymocyte globulin induction

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TRANSPLANTATION PROCEEDINGS 2000年第2期32卷 446-448页

作者： Cantarovich, M Quantz, M Elstein, E Ergina, P Magnan, C de Varennes, B McGill Univ Royal Victoria Hosp Dept Med Ctr HlthDiv Transplantat Montreal PQ H3A 1A1 Canada

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INADEQUACIES IN PHARMACOLOGIC MANAGEMENT OF AMBULATORY CHILDREN

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JOURNAL OF PEDIATRICS 1975年第1期87卷 137-141页

作者： MATTAR, ME MARKELLO, J YAFFE, SJ SUNY SCH MED DEPT PEDIAT BUFFALO NY USA CHILDRENS HOSP DIV PHARMACOL 219 BRYANT ST BUFFALO NY 14222 USA

The compliance with treatment of acute otitis media in 300 pediatric outpatients was evaluated. Complete compliance in taking prescribed antibiotics was noted in 7.3% of the patients. Pharmacists dispensed less than prescribed amounts of antibiotics to 15% of patients. Bottles were incorrectly labeled 3% of the time. Volumes of 130 “teaspoons” examined varied from 2 to 9 ml. Parental understanding of the illness and of the effects of medication was inadequate and erroneous in many instances. Parents gave fewer than the prescribed number of doses in 36% of cases, and therapy was discontinued early in 37%. Recommendations for improving the quality of therapy for ambulatory pediatric patients are outlined.

关键词：剂型用药计划表药物相互作用药物标签/标准中耳炎/药物疗法中耳炎/遗传学中耳炎/护理双亲药学服务/标准维生素类/投药和剂量儿童儿童学龄前人类婴儿

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Prescribing practice for antibiotic prophylaxis for cesarean section in a teaching hospital in Brazil

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AMERICAN JOURNAL OF INFECTION CONTROL 2002年第6期30卷 341-345页

作者： Heineck, I Ferreira, MBC Schenkel, EP Univ Fed Rio Grande do Sul Fac Farm BR-90610000 Porto Alegre RS Brazil Univ Fed Rio Grande do Sul Dept Farmacol ICBS BR-90610000 Porto Alegre RS Brazil

Background: The contribution of antibiotic prophylaxis to reduce surgical wound infection and endometritis after cesarean section is well-known. Despite the knowledge about the effectiveness of antibiotic prophylaxis with this procedure, the administrative regimens are often inappropriate. Methods: The use of antibiotic prophylaxis in cesarean section was evaluated in a reference school hospital. Data were collected from medical records, and they correspond to the 9-month observation during 1995 and 1996. Results: The cesarean section rate was 26.4% in this period. The total procedures observed was 587. Antibiotic prophylaxis was prescribed in 358 procedures (61%). Cephalothin was the most prescribed drug (98.6%), with a regimen of 2 g intravenously after clamping of the umbilical cord and 2 more doses of 1g every 6 hours. Antibiotic prophylaxis was indicated more frequently in patients younger than 30 years and in those with rupture of membranes for more than 6 hours;such differences were significant (P < .05 and P < .00001, respectively). Conclusion: The prescribers met the hospital guidelines for antibiotic prophylaxis in only 37.1% of the cesarean sections performed.

关键词：抗菌药/投药和剂量抗生素预防/利用细菌感染/预防和控制巴西剖宫产术/统计学和数值数据用药计划表药物利用/统计学和数值数据医院教学医师诊疗模式/统计学和数值数据诊疗准则(主题) 外科伤口感染/预防和控制成年人女(雌)性人类妊娠

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COMPLICATIONS OF SMALL DOSE PROPHYLACTIC HEPARINIZATION

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AMERICAN JOURNAL OF SURGERY 1975年第5期130卷 570-574页

作者： STRING, ST BARCIA, PJ MONCRIEF ARMY HOSP DEPT SURGFT JACKSONSC

The observations reported herein on the use of prophylactic small dose heparinization are in no way intended to diminish its value but are reported and reviewed so that certain precautions may be exercised in its use. In fact, the apparent difference in the incidence of pulmonary emboli in the controls and heparinized patients may lend credence to its value. The large controlled series now being studied at various medical centers will help to confirm or deny the value of this factor in the prevention of emboli. Careful preoperative scrutiny of the patient and meticulous intraoperative hemostasis remain important factors when a patient is receiving small dose heparin therapy. Other factors such as concomitant medications, weight of the patient, frequency and technic of administration, and dosage must be considered. Additionally, monitoring the hemostatic mechanism with serial hematocrit determinations and laboratory coagulation tests appears to be an important adjunct in small dose prophylactic heparinization.

关键词：血液凝固/药物作用用药计划表胃肠出血/化学诱导血细胞比容血肿/化学诱导肝素/投药和剂量手术后并发症/化学诱导手术前护理/方法肺栓塞/预防和控制成年人女(雌)性人类男(雄)性

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Cardiac dimension and function in patients with childhood onset growth hormone deficiency, before and after growth hormone retreatment in adult age

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AMERICAN HEART JOURNAL 2003年第3期145卷 549-553页

作者： Feinberg, MS Scheinowitz, M Laron, Z Chaim Sheba Med Ctr Inst Heart IL-52621 Tel Hashomer Israel Chaim Sheba Med Ctr Neufeld Cardiac Res Inst IL-52621 Tel Hashomer Israel Tel Aviv Univ Sackler Sch Med Schneider Childrens Med Ctr Endocrinol & Diabet Res Unit IL-69978 Tel Aviv Israel

Background Growth hormone (GH) replacement during childhood has been shown to increase stature;however, there is little information on its long-term effect on the heart is not yet clear. The aim of this study was to assess cardiac size and function in patients with childhood-onset GH deficiency in whom GH treatment had been stopped at the achievement of final height and the effect of a second course of GH replacement in adult age. Methods Cardiac dimensions and function, obtained with echocardiography, of 21 patients (5 women and 16 men, mean age 28 8 years), all of whom were treated during childhood, were compared with 21 age- and sex-matched healthy control subjects. Eight of these patients (2 women and 6 men, mean age 28 +/- 8 years) were given a second course of GH replacement therapy for 15 3 months. Results The stature and all cardiac dimensions of patients with GH deficiency who were treated during childhood were significantly smaller than those of the control subjects. After the second course of GH in adulthood, the only significant change observed was an increase in left ventricular (LV) mass (93 +/- 21 vs 106 +/- 24 g, P = .007) and LV mass index (59 +/- 12 vs 66 +/- 13 g/body surface area, P = .005). Conclusion The stature and cardiac dimensions of patients with childhood-onset GH deficiency measured in adult age were smaller than those of control subjects, despite long-term GH replacement therapy during childhood. A second course of GH treatment during adulthood caused a significant increase in the estimated LV mass index in patients with both isolated and multiple pituitary hormone deficiency.

关键词：发病年龄身高/药物作用剂量效应关系药物用药计划表超声心动描记术生长/药物作用生长障碍/药物疗法心脏/药物作用心脏/生长和发育心脏/生理学激素替代疗法/方法人生长激素/缺乏人生长激素/药理学人生长激素/治疗应用重组蛋白质类/药理学重组蛋白质类/治疗应用治疗结果青少年成年人儿童女(雌)性人类男(雄)性

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