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Trospium 60 mg once daily (QD) for overactive bladder syndrome: Results from a placebo-controlled interventional study

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UROLOGY 2008年第3期71卷 449-454页

作者： Dmochowski, Roger R. Sand, Peter K. Zinner, Norman R. Staskin, David R. Vanderbilt Univ Sch Med Dept Urol Med Ctr N Nashville TN 37232 USA Northwestern Univ Feinberg Sch Med Evanston Continence Ctr Div Urogynecol & Reconstruct Pelv Surg Evanston IL USA Western Clin Res Torrance CA USA Weill Cornell Med Coll New York Presbyterian Hosp Dept Urol New York NY USA

OBJECTIVES A once-daily (QD) formulation of trospium chloride has been developed for the management of overactive bladder syndrome (OAB). This randomized controlled trial evaluated the efficacy and tolerability of this new extended-re lease formulation, trospium chloride 60 mg QD. METHODS Adults with OAB with urinary urgency, frequency, and urgency urinary incontinence (UUI) were eligible for inclusion. Subjects received trospium 60 mg QD or placebo for 12 weeks. Change in the mean number of toilet voids per day and UUI episodes per day were the primary outcome variables. Changes in urgency severity were also assessed and adverse events (AEs) were recorded. RESULTS Overall, 564 subjects participated in the study (trospium QD 280;placebo 284). Trospium QD demonstrated significant improvement in both primary outcome variables. The mean number of toilet voids per day was reduced from approximately 13 at baseline to 10.3 for trospium QD versus 11.1 for placebo (P < 0.001) at week 12, whereas the number of UUI episodes per day was reduced from approximately 4 at baseline to 1.7 at week 12 with trospium QD versus 2.4 for placebo (P < 0.001). Trospium QD also reduced urgency severity (P < 0.001) and increased voided volume (P < 0.01) compared with placebo. Benefits over placebo were apparent within the first week of treatment. Trospium QD was well tolerated;the most frequent AEs being dry Mouth (trospium QD 12.9%;placebo 4.6%) and constipation (7.5% versus 1.8%, respectively). Central nervous system side effects were rarely observed and were comparable between groups. CONCLUSIONS Trospium QD represents a convenient, effective, and well-tolerated treatment option for OAB.

关键词： Double-Blind Method Drug Administration Schedule Female Humans Male 双盲法用药计划表去甲托烷类前瞻性研究 trospium chloride outcome variable quadrant depression Double-Blind Method overactive bladder Placebos Drug Administration Schedule Urinary Urgency

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Effect of renal impairment on the pharmacokinetics of cilostazol and its metabolites

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CLINICAL PHARMACOKINETICS 1999年第2-Sup期37卷 33-40页

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

Objective: The pharmacokinetics of cilostazol were studied in patients with mild, moderate and severe renal impairment and in healthy volunteers after administration of 50mg single and multiple doses of cilostazol. Design: This was an open-label, single and multiple dose study administering 50mg cilostazol every 12 hours to healthy volunteers and patients with varying degrees of renal impairment. Participants: 6 normal volunteers [creatinine clearance (CLCR) greater than or equal to 90 ml/min];6 patients with mild (CLCR 50 to 89 ml/min), 5 with moderate (CLCR 26 to 49 ml/min) and 6 with severe (CLCR 5 to 25 ml/min) renal impairment. Outcome Measures: Noncompartmental pharmacokinetic parameters were determined for each study participant. Results: At steady state, in the severe renal disease group, cilostazol and OPC-13015 peak concentrations (C-max) were 24 and 41% lower and the areas under the concentration-time curve over the dosage interval (AUC(tau)) 39 and 47% lower than in the healthy volunteers. C-max and AUC(tau) of OPC-13213 were significantly higher, 173 and 209%, respectively, than those in the healthy volunteers. The accumulation ratios were not significantly different between the various renal function groups for cilostazol and its metabolites. The estimated pharmacological activity of cilostazol and its metabolites was similar between the normal volunteers and those with severe renal impairment. Conclusions: A dosage reduction in renally impaired patients is not supported by the pharmacokinetics of cilostazol and its metabolites in this patient group.

关键词：投药口服方差分析曲线下面积色谱法高压液相肌酸酐/代谢用药计划表半衰期代谢清除率参考值肾功能不全/分类肾功能不全/代谢疾病严重程度指数四唑类/投药和剂量四唑类/血液四唑类/代谢四唑类/药代动力学血管舒张药/投药和剂量血管舒张药/血液血管舒张药/代谢血管舒张药/药代动力学女(雌)性人类男(雄)性中年人

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Continuous antegrade infusion of adriamycin as adjuvant therapy for upper tract urothelial malignancies

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UROLOGY 2000年第2期56卷 216-222页

作者： See, WA Med Coll Wisconsin Div Urol Milwaukee WI 53226 USA

Objectives. To evaluate the feasibility, efficacy, and toxicity of antegrade chemotherapy delivered continuously as adjuvant treatment for patients with upper tract transitional cell carcinoma. Methods. During a 6-year interval, 12 patients with upper tract transitional cell malignancies underwent continuous antegrade intraluminal infusion chemotherapy (CAIIC) with adriamycin. After placement of percutaneous access and surgical treatment of the primary lesion, patients received 5-day cycles of CAIIC, Patients received between two and four treatment cycles at 2-week intervals. After therapy, patients with no evidence of residual disease were then monitored long-term with retrograde pyelography and upper tract cytology. Results. Twelve patients underwent a total of 35 5-day cycles of CAIIC. No patient experienced hematologic and/or local/regional toxicity during or after drug infusion, Three patients were treated for upper tract carcinoma in situ, and 9 patients had discrete exophytic tumors. Two patients died (treatment unrelated) before a final assessment of therapeutic outcome, leaving 10 patients available for evaluation of the therapeutic response. One patient with carcinoma in situ and 5 of 7 patients with discrete upper tract tumors remained disease free after surgery and adjuvant therapy. Both patients with discrete tumors in whom therapy failed had residual gross disease after primary surgical treatment. Conclusions. CAIIC using adriamycin was well tolerated for periods of up to 5 days over multiple cycles. Early data suggest a limited efficacy in treating;patients with gross residual disease. The efficacy of this approach in preventing the recurrence of upper tract disease after surgical ablation awaits further assessment. UROLOGY 56: 216-222, 2000. Published by Elsevier Science Inc.

关键词：抗肿瘤药/投药和剂量抗肿瘤药/治疗应用癌移行细胞/药物疗法癌移行细胞/外科学化学疗法辅助多柔比星/投药和剂量多柔比星/治疗应用用药计划表电外科手术滴注药物激光疗法肾造口术经皮治疗结果泌尿系肿瘤/药物疗法泌尿系肿瘤/外科学老年人女(雌)性人类男(雄)性

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The effects of DCG-IV and L-CCG-1 upon phencyclidine (PCP)-induced locomotion and behavioral changes in mice

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NEUROBIOLOGICAL MECHANISMS OF DRUGS OF ABUSE: COCAINE, IBOGAINE, AND SUBSTITUTED AMPHETAMINES 2000年第1期914卷 284-291页

作者： Tomita, N Murata, M Watanabe, H Ichikawa, T Washiyama, K Kumanishi, T Takahashi, Y Niigata Univ Brain Res Inst Dept Mol Neuropathol Niigata 9518585 Japan Natl Saigata Hosp Niigata 9493193 Japan

The behavioral changes of mice induced by acute and repeated ip injection of phencyclidine (PCP) were observed by measuring locomotor activity and stereotyped behavior. Then, the effects of metabotropic glutamate receptor (mGluR) agonists, DCG-IV and L-CCG-1, on the above behavioral changes induced by PCP were found. The effects of DCG-IV were very strong and completely depressed the PCP-induced hyperlocomotion. The effects of LCCG-1 were not so strong. Repeated injection of PCP for 20 days into mice induced lower locomotor activity than that in acutely injected mice. These behavioral changes may be related with the negative symptoms of schizophrenia. In order to examine some molecular mechanisms of PCP-induced behavioral changes, Northern blot analysis of total RNA from prefrontal cortical tissues of mice treated with PCP, DCG-IV, and L-CCG-1 was carried out.

关键词：氨基酸类二羧酸/药理学抗惊厥药/药理学行为动物/药物作用印迹法 RNA/方法环丙烷类/药理学剂量效应关系药物用药计划表药物相互作用兴奋性氨基酸激动剂/药理学基因表达调控/药物作用谷氨酸脱羧酶/遗传学谷氨酸脱羧酶/代谢甘氨酸/类似物和衍生物甘氨酸/药理学小鼠近交ICR 运动活动/药物作用多环化合物/投药和剂量额叶前皮质/药物作用额叶前皮质/代谢动物男(雄)性小鼠

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Continuity of antibiotic therapy in patients admitted from the emergency department

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ANNALS OF EMERGENCY MEDICINE 2003年第1期42卷 117-123页

作者： Shah, MN Schmit, J Croley, WC Meltzer, D Univ Rochester Sch Med & Dent Dept Emergency Med Rochester NY 14642 USA Univ Chicago Robert Wood Johnson Clin Scholars Program Chicago IL USA Univ Chicago Dept Med Chicago IL 60637 USA

Study objective: We describe discontinuities in antibiotic therapy in patients with community-acquired pneumonia admitted from the emergency department (ED) to an inpatient unit. Methods: We performed a retrospective cohort study of patients with community-acquired pneumonia admitted from the ED to the internal medicine service at an academic tertiary care hospital between July 1997 and June 1999. We characterized the frequency of antibiotic delays after arrival on the inpatient unit in relation to antibiotic dosing intervals. We performed paired analysis on the patients treated both with an antibiotic dosed every 6 hours and an antibiotic dosed every 24 hours. Results: Three hundred seventy-five patients were identified. The mean age was 61 years. Sixty-two percent were female. Five hundred fifty-one antibiotic doses were started in the ED and continued on the inpatient unit, with 177 ordered every 6 hours, and 351 ordered every 24 hours. Seventy-five percent of the antibiotics dosed every 6 hours and 19% of the antibiotics dosed every 24 hours were delayed more than 30 minutes (P<.001). Analysis of the 146 patients receiving both an antibiotic dosed every 6 and 24 hours showed that the first inpatient dose of antibiotics administered every 6 hours were 10 times more likely to be delayed than antibiotics dosed every 24 hours (95% confidence interval 5.0 to 23). The median delay for antibiotics dosed every 6 hours was 258 minutes (range 45 to 3,360 minutes), and the median delay for antibiotics dosed every 24 hours was 192 minutes (range 32 to 2,124 minutes). Conclusion: Discontinuous therapy, represented through a delayed first inpatient antibiotic dose, is common in patients with community-acquired pneumonia admitted from the ED. Although the effect on outcome is unknown, theoretical concerns should lead emergency physicians to consider using longer-acting antibiotics to minimize delayed therapy.

关键词：抗菌药/投药和剂量抗菌药/治疗应用社区获得性感染/药物疗法病人医护连续性用药计划表急诊室医院/统计学和数值数据保险健康病人转诊肺炎/药物疗法回顾性研究时间因素女(雌)性人类男(雄)性中年人

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Effect of d-amphetamine and sydnocarb on the extracellular level of dopamine, 3,4-dihydroxyphenylacetic acid, and hydroxyl radicals generation in rat striatum

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NEUROBIOLOGICAL MECHANISMS OF DRUGS OF ABUSE: COCAINE, IBOGAINE, AND SUBSTITUTED AMPHETAMINES 2000年第1期914卷 137-145页

作者： Anderzhanova, EA Afanas'ev, II Kudrin, VS Rayevsky, KS Russian Acad Med Sci Inst Pharmacol Lab Neurochem Pharmacol Moscow 125315 Russia

d-AMPH and its congeners are able to produce several neurotoxic effects, including behavioral evidences of dopaminergic dysfunction, enhanced generation of reactive oxygen species, and depletion of endogenous DA. As has been shown, Sydnocarb produces a slow and gradual increase of the parameters of dopaminergic dysfunction. Present investigations report that Sydnocarb, the original Russian psychostimulant, at a dose of 23.8 mg/kg (equimolar to 5 mg/kg d-AMPH) elicited a moderate increase in the extracellular level of DA. We found that Sydnocarb increased OH generation in less degree than that by d-AMPH. Sydnocarb was also able to elicit stereotyped behavior, but to a less extent than d-AMPH. Differences between the mode of action of this drug were previously observed. In our study, the DOPAC extracellular level was significantly decreased after the fourth injection of Sydnocarb, unlike with d-AMPH treatment. Taken together, this finding probably reflects less neurotoxic potential of the novel, original psychostimulant Sydnocarb with good clinical efficaciousness in comparison to the amphetamine.

关键词： 3 4-二羟苯酰乙酸/代谢苯丙胺/投药和剂量中枢神经系统刺激剂/投药和剂量纹状体/药物作用纹状体/代谢多巴胺/代谢用药计划表细胞外间隙/药物作用羟自由基/代谢大鼠 Wistar 斯德酮类/投药和剂量时间因素动物男(雄)性大鼠

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In vivo and in vitro induction of human cytochrome P4503A4 by dexamethasone

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CLINICAL PHARMACOLOGY & THERAPEUTICS 2000年第4期68卷 356-366页

作者： McCune, JS Hawke, RL LeCluyse, EL Gillenwater, HH Hamilton, G Ritchie, J Lindley, C Univ N Carolina Div Pharmacotherapy Chapel Hill NC 27599 USA Univ Washington Seattle WA 98195 USA Emory Univ Atlanta GA 30322 USA

Purpose: The aims of these experiments were to determine the effect of a therapeutic regimen of dexamethasone on cytochrome P4503A4 (CYP3A4) activity in healthy volunteers;and the concentration-effect relationship between dexamethasone and CYP3A4 activity in primary human hepatocyte cultures. Methods: The effect of dexamethasone (8 mg administered by mouth two times a day for 5 days) on CYP3A4 activity in 12 healthy volunteers was assessed with the erythromycin breath test and urinary ratio of dextromethorphan to 3-methoxymorphinan. Concentration-effect of dexamethasone on CYP3A4-dependent testosterone 6-beta -hydroxylation was determined in human hepatocytes treated with 2 to 250 mu mol/L dexamethasone. Results: The percent of erythromycin metabolized per hour increased from 2.20% +/- 0.60% (mean +/- SD) at baseline to 2.67% +/- 0.55% on day 5 of dexamethasone (mean increase in hepatic CYP3A4 activity 25.7% +/- 24.6%;P = .004). The mean urinary ratio of dextromethorphan to 3-methoxymorphinan was 28 (4.8 to 109) and 7 (1 to 23) at baseline and on day 5 of dexamethasone (mean decrease = 49%;P = .06). Substantial intersubject variability was observed in the extent of CYP3A4 induction. The extent of CYP3A4 induction was inversely correlated with baseline erythromycin breath test (r(2) = 0.58). In hepatocytes, dexamethasone 2 to 250 mu mol/L resulted in an average 1.7-fold to 6.9-fold increase in CYP3A4 activity respectively. The extent of CYP3A4 induction with dexamethasone in hepatocyte preparations was inversely correlated with baseline activity (r(2) = 0.59). Conclusions: These data demonstrate that dexamethasone at doses used clinically increased CYP3A4 activity with extensive intersubject variability and that the extent of CYP3A4 induction was, in part, predicted by the baseline activity of CYP3A4 in both healthy volunteers and human hepatocyte cultures.

关键词：投药口服消炎药/药理学呼吸试验/方法细胞培养的细胞色素P-450CYP3A 细胞色素P450酶系统/生物合成地塞米松/投药和剂量地塞米松/血液地塞米松/药理学右美沙芬/类似物和衍生物右美沙芬/尿剂量效应关系药物用药计划表酶诱导/药物作用红霉素/分析糖皮质激素类/投药和剂量糖皮质激素类/血液糖皮质激素类/药理学肝细胞/药物作用肝细胞/酶学羟基化/药物作用混合功能氧化酶类/生物合成试验预期值参考值睾酮/代谢成年人女(雌)性人类男(雄)性

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The effectiveness and timing of elective pharmacological cardioversion for paroxysmal atrial fibrillation

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EUROPEAN HEART JOURNAL 1999年第24期20卷 1768-1769页

作者： Shah, DC Hop Cardiol Haut Leveq Bordeaux France

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Hydrochlorothiazide reduces loss of cortical bone in normal postmenopausal women: A randomized controlled trial

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AMERICAN JOURNAL OF MEDICINE 2000年第5期109卷 362-370页

作者： Reid, IR Ames, RW Orr-Walker, BJ Clearwater, JM Horne, AM Evans, MC Murray, MAF McNeil, AR Gamble, GD Univ Auckland Dept Med Auckland New Zealand

PURPOSE: Thiazide diuretics reduce urine calcium excretion and might therefore reduce postmenopausal bone loss. In some, but not all, case-control studies, their use has been associated with a reduced incidence of hip fractures. We studied the effects of hydrochlorothiazide on bone loss in normal postmenopausal women. SUBJECTS AND METHODS: We performed a randomized, double-blind, 2-year trial of the effects of hydrochlorothiazide (50 mg per day) and placebo on bone mineral density in normal postmenopausal women. Participants were not required to have either low bone mineral density or hypertension. Bone mineral density was measured using dual-energy x-ray absorptiometry. RESULTS: One hundred eighty-five women entered the study, of whom 138 completed 2 years of follow-up. In an intention-to-treat analysis, hydrochlorothiazide produced significant benefits on bone mineral density of the total body (between-group difference at 2 years of 0.8%, 95% confidence interval [CI]: 0.3% to 1.3%, P < 0.0001), legs (0.9%, 95% CI: 0.2% to 1.7%, P < 0.0001), mid-forearm (1.2%, 95% CI: 0.2% to 2.2%, P = 0.02), and ultradistal forearm (1.7%, 95% CI: 0.1% to 3.2%, P = 0.04). There was no effect in the lumbar spine (0.5%, 95% CI: -0.5% to 1.6%) or femoral neck (0.2%, 95% CI: 1.3% to 1.7%). The between-group changes tended to be greatest during the first 6 months, except in the mid-forearm where there appeared to be a progressive divergence. An as-treated analysis produced similar results. Urine calcium excretion and indices of bone turnover decreased in the thiazide group, but parathyroid hormone concentrations did not differ between the groups. Treatment was tolerated well. CONCLUSIONS: Hydrochlorothiazide (50 mg per day) slows cortical bone loss in normal postmenopausal women. It may act directly on bone as well as on the renal tubule. The small size of the effect suggests that thiazides may have a role in the prevention of postmenopausal bone loss, but that they are not an appropria

关键词：骨密度/药物作用钙/代谢利尿药双盲法用药计划表股骨颈/代谢氢氯噻嗪/投药和剂量氢氯噻嗪/药理学腰椎/代谢绝经期/代谢骨质疏松绝经后/代谢骨质疏松绝经后/预防和控制参考值钠氯同向转运体抑制剂/投药和剂量钠氯同向转运体抑制剂/药理学时间因素治疗结果老年人女(雌)性人类中年人

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INVITRO AND INVIVO AVAILABILITY OF COMMERCIAL PREDNISONE TABLETS

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JOURNAL OF PHARMACEUTICAL SCIENCES 1975年第10期64卷 1723-1725页

作者： SULLIVAN, TJ SAKMAR, E ALBERT, KS BLAIR, DC WAGNER, JG UNIV MICHIGAN UPJOHN CTR CLIN PHARMACOLANN ARBORMI 48104 UNIV MICHIGAN COLL PHARMANN ARBORMI 48104

A three-way crossover bioavailability study was performed using nine adult male volunteers with three different commercial prednisone tablets. Plasma samples were assayed for prednisolone, the active metabolite of prednisone, by a radioimmunoassay method. Statistical analysis showed significant differences in the rate of appearance of prednisolone in plasma but not in the amount converted to prednisolone. The results suggest that differences in in vivo rates of appearance of prednisolone in plasma correlate with in vitro rates of dissolution.

关键词：生物利用度临床试验(主题) 地塞米松/代谢用药计划表动力学泼尼松龙/血液泼尼松/投药和剂量泼尼松/血液泼尼松/代谢溶解度片剂时间因素成年人人类男(雄)性

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