Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy最新文献

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Characterization and Management of Patients with Heroin versus Nonheroin Opioid Overdoses: Experience at an Academic Medical Center 海洛因与非海洛因阿片类药物过量患者的特征和管理:在学术医疗中心的经验

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-07-01 DOI: 10.1002/phar.1902

Kate Morizio, R. Baum, A. Dugan, Julia Martin, Abby M. Bailey

To characterize the differences between patients who had heroin and nonheroin opioid overdoses and to determine whether there were any significant differences in their management with regard to the naloxone use.

描述海洛因和非海洛因阿片类药物过量患者之间的差异，并确定他们在纳洛酮使用方面的管理是否存在显著差异。

引用次数: 19

Analysis of the Appropriateness of Off‐Label Antipsychotic Use for Mental Health Indications in a Veteran Population 退伍军人心理健康适应症使用标签外抗精神病药物的适宜性分析

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 DOI: 10.1002/phar.1910

J. Painter, R. Owen, K. Henderson, M. Bauer, D. Mittal, T. Hudson

A substantial proportion of antipsychotic (AP) use in veterans is for nonapproved indications (i.e., off‐label prescribing). Not all off‐label use is necessarily detrimental to patients, however, and in certain situations, off‐label prescribing could be considered justifiable. The objective of this study was to determine the extent to which off‐label AP prescribing in a veteran population was potentially appropriate.

在退伍军人中，相当大比例的抗精神病药物(AP)用于未经批准的适应症(即标签外处方)。然而，并非所有说明书外用药都必然对患者有害，在某些情况下，说明书外用药可以被认为是合理的。本研究的目的是确定退伍军人人群中标签外AP处方的潜在适宜程度。

引用次数: 12

Comparison of the Safety and Effectiveness of Apixaban versus Warfarin in Patients with Severe Renal Impairment 阿哌沙班与华法林在严重肾功能损害患者中的安全性和有效性比较

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 DOI: 10.1002/phar.1905

Brooke E. Stanton, Naomi S Barasch, K. Tellor

The U.S. Food and Drug Administration approval of the use of apixaban in patients with a creatinine clearance (CrCl) of < 15 ml/minute or in those receiving dialysis is based only on pharmacokinetic data as clinical trials of apixaban excluded patients with a CrCl of < 25 ml/minute or a serum creatinine concentration (SCr) of > 2.5 mg/dl. Thus, the objective of this study was to evaluate the safety and effectiveness of apixaban versus warfarin in patients with severe renal impairment.

美国食品和药物管理局批准阿哌沙班用于肌酐清除率(CrCl) < 15ml /分钟或接受透析的患者，仅基于药代动力学数据，因为阿哌沙班的临床试验排除了CrCl < 25ml /分钟或血清肌酐浓度(SCr)为bb0 2.5 mg/dl的患者。因此，本研究的目的是评估阿哌沙班与华法林在严重肾功能损害患者中的安全性和有效性。

引用次数: 99

Higher Maximum Doses and Infusion Rates Compared with Standard Unfractionated Heparin Therapy Are Associated with Adequate Anticoagulation without Increased Bleeding in Both Obese and Nonobese Patients with Cardiovascular Indications 与标准的无分级肝素治疗相比，更高的最大剂量和输注速率与有心血管适应症的肥胖和非肥胖患者的充分抗凝而不增加出血相关

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 DOI: 10.1002/phar.1904

C. Floroff, N. Palm, D. Steinberg, E. Powers, B. Wiggins

To evaluate the time to achieve therapeutic activated partial thromboplastin time (aPTT) values and occurrence of bleeding based on standard unfractionated heparin (UFH) weight‐based dosing recommendations compared with an aggressive weight‐based UFH dosing strategy using higher maximum doses and infusion rates in both obese and nonobese patients who presented with non–ST‐segment elevation myocardial infarction or unstable angina (NSTEMI/UA) or atrial fibrillation.

评估在非st段抬高型心肌梗死或不稳定型心绞痛(NSTEMI/UA)或房颤的肥胖和非肥胖患者中，基于标准未分级肝素(UFH)体重给药建议与采用更高最大剂量和输注速率的积极分级肝素给药策略相比，达到治疗性活化部分血栓活素时间(aPTT)值的时间和出血发生率。

引用次数: 4

Valproate Protein Binding Is Highly Variable in ICU Patients and Not Predicted by Total Serum Concentrations: A Case Series and Literature Review 丙戊酸蛋白结合在ICU患者中是高度可变的，不能由总血清浓度预测:病例系列和文献回顾

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 DOI: 10.1002/phar.1912

R. Riker, David J. Gagnon, C. Hatton, Teresa L. May, David B. Seder, Katie Stokem, G. Fraser

The free fraction of valproate (the pharmacologically active moiety, normally 5–10%) may vary significantly in critically ill patients, but this topic is understudied, with only four prior intensive care unit (ICU) case reports. The objective of this study was to evaluate the range of valproate plasma protein binding in ICU patients.

丙戊酸的游离部分(药理学活性部分，通常为5-10%)在危重患者中可能有显著差异，但这一主题尚未得到充分研究，只有4例重症监护病房(ICU)病例报告。本研究的目的是评估ICU患者丙戊酸血浆蛋白结合的范围。

引用次数: 27

Systematic Review and Meta-Analysis of Patiromer and Sodium Zirconium Cyclosilicate: A New Armamentarium for the Treatment of Hyperkalemia. 帕替洛尔和环硅酸锆钠的系统回顾和元分析：治疗高钾血症的新武器。

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 Epub Date: 2017-03-10 DOI: 10.1002/phar.1906

Calvin J Meaney, Mario V Beccari, Yang Yang, Jiwei Zhao

Objective: To compare and contrast the efficacy and safety of patiromer and sodium zirconium cyclosilicate (ZS-9) in the treatment of hyperkalemia.

Design: A systematic review and meta-analysis of phase II and III clinical trial data was completed.

Patients or participants: Eight studies (two phase II and four phase III trials with two subgroup analyses) were included in the qualitative analysis, and six studies (two phase II and four phase III trials) were included in the meta-analysis.

Measurements and results: Significant heterogeneity was found in the meta-analysis with an I² value ranging from 80.6-99.6%. A random-effects meta-analysis was applied for all end points. Each clinical trial stratified results by hyperkalemia severity and dosing; therefore, these were considered separate treatment groups in the meta-analysis. For patiromer, a significant -0.70 mEq/L (95% confidence interval [CI] -0.48 to -0.91 mEq/L) change was noted in potassium at 4 weeks. At day 3 of patiromer treatment, potassium change was -0.36 mEq/L (range of standard deviation 0.07-0.30). The primary end point for ZS-9-change in potassium at 48 hours-was -0.67 mEq/L (95% CI -0.45 to -0.89 mEq/L). By 1 hour after ZS-9 administration, change in potassium was -0.17 mEq/L (95% CI -0.05 to -0.30). Analysis of pooled adverse effects from these trials indicates that patiromer was associated with more gastrointestinal upset (7.6% constipation, 4.5% diarrhea) and electrolyte depletion (7.1% hypomagnesemia), whereas ZS-9 was associated with the adverse effects of urinary tract infections (1.1%) and edema (0.9%).

Conclusion: Patiromer and ZS-9 represent significant pharmacologic advancements in the treatment of hyperkalemia. Both agents exhibited statistically and clinically significant reductions in potassium for the primary end point of this meta-analysis. Given the adverse effect profile and the observed time-dependent effects, ZS-9 may play more of a role in treating acute hyperkalemia.

目的比较和对比帕替洛尔和环硅酸锆钠（ZS-9）治疗高钾血症的疗效和安全性：设计：对 II 期和 III 期临床试验数据进行系统回顾和荟萃分析：定性分析包括 8 项研究（2 项 II 期临床试验和 4 项 III 期临床试验以及 2 项亚组分析），荟萃分析包括 6 项研究（2 项 II 期临床试验和 4 项 III 期临床试验）：在荟萃分析中发现了明显的异质性，I2 值介于 80.6-99.6% 之间。所有终点均采用随机效应荟萃分析。每项临床试验都根据高钾血症的严重程度和剂量对结果进行了分层；因此，在荟萃分析中，这些试验被视为不同的治疗组。对于帕替洛尔，4周时血钾的变化幅度为-0.70 mEq/L（95% 置信区间 [CI] -0.48 至 -0.91 mEq/L）。在帕替洛尔治疗的第 3 天，血钾变化为-0.36 mEq/L（标准偏差范围为 0.07-0.30）。ZS-9的主要终点--48小时的血钾变化为-0.67毫升/升（95% CI -0.45 至 -0.89毫升/升）。服用 ZS-9 1 小时后，血钾变化为 -0.17 mEq/L（95% CI -0.05 至 -0.30）。对这些试验的不良反应汇总分析表明，帕替洛尔与更多的胃肠道不适（7.6%便秘、4.5%腹泻）和电解质消耗（7.1%低镁血症）有关，而ZS-9与尿路感染（1.1%）和水肿（0.9%）的不良反应有关：结论：帕替洛尔和ZS-9是治疗高钾血症的重大药理进步。在这项荟萃分析的主要终点上，两种药物都能在统计学和临床上显著降低血钾。考虑到不良反应情况和观察到的时间依赖性效应，ZS-9 在治疗急性高钾血症方面可能会发挥更大的作用。

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引用次数: 0

Advances in the Treatment of Duchenne Muscular Dystrophy: New and Emerging Pharmacotherapies 杜氏肌营养不良症的治疗进展:新的和新兴的药物疗法

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 DOI: 10.1002/phar.1909

A. Reinig, S. Mirzaei, Daniel J. Berlau

Duchenne muscular dystrophy (DMD) is a genetic neuromuscular disease that primarily affects young males. Patients with DMD are unable to produce dystrophin, a crucial protein found in myocytes, leading to a loss of muscle support and integrity. Corticosteroids are the standard supportive treatment for DMD; however, there is a high demand to expand the number of safe, effective pharmacologic options. Recently a surge of new therapeutics for DMD is offering hope to patients. A variety of these new medications, such as stop codon readthrough agents, exon‐skipping agents, and utrophin modulators, aim to replace dystrophin in myocytes. Other new therapeutics aim to prevent or repair muscle damage caused by the absence of dystrophin. This review provides an update on the medications being investigated in DMD.

杜氏肌营养不良症(DMD)是一种主要影响年轻男性的遗传性神经肌肉疾病。患有DMD的患者无法产生肌营养不良蛋白，这是一种在肌细胞中发现的关键蛋白质，导致肌肉支持和完整性的丧失。皮质类固醇是DMD的标准支持治疗;然而，有一个高需求，以扩大安全，有效的药物选择的数量。最近，一大批治疗DMD的新疗法给患者带来了希望。各种各样的新药物，如停止密码子解读剂、外显子跳跃剂和肌营养蛋白调节剂，旨在取代肌细胞中的肌营养不良蛋白。其他新的治疗方法旨在预防或修复由肌营养不良蛋白缺失引起的肌肉损伤。这篇综述提供了DMD中正在研究的药物的最新进展。

引用次数: 66

Effect of Plasmapheresis on the Anti–Factor Xa Activity of Enoxaparin in an Obese Adolescent Patient 血浆置换对肥胖青少年依诺肝素抗Xa因子活性的影响

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 DOI: 10.1002/phar.1907

Kassim W. Rahawi, Kristi L Higgins, C. Noda, Jeremy S. Stultz

To our knowledge, the effect of plasmapheresis on the anti–factor Xa activity of enoxaparin has never been reported. We describe a 13‐year‐old, obese (92‐kg) girl who was treated with enoxaparin for a pulmonary embolism while receiving plasmapheresis for suspected autoimmune encephalitis and who experienced clinically significant reductions in anti–factor Xa activity after plasmapheresis. She received five courses of plasmapheresis, with the final two administered during treatment with enoxaparin. Her anti–factor Xa concentrations were highly variable, and we hypothesized that plasmapheresis was affecting these levels. To test this hypothesis, anti–factor Xa concentrations were measured before and immediately after the patient's last plasmapheresis treatment, and then again 2 days after plasmapheresis. The rate of anti–factor Xa activity decline was 0.28 IU/mL/hour with plasmapheresis and only 0.088 IU/mL/hour on the day without plasmapheresis, representing a greater than 3‐fold difference. The changes in anti–factor Xa activity due to plasmapheresis altered the final enoxaparin dosage required to remain in the therapeutic range of 0.5–1 IU/mL (0.98 mg/kg/dose while receiving plasmapheresis vs 0.69 mg/kg/dose without plasmapheresis). Our patient's data suggest that plasmapheresis can significantly alter enoxaparin's anticoagulant effect as measured by anti–factor Xa concentrations, which could cause a decreased anticoagulant effect during plasmapheresis and an increased risk of bleeding on plasmapheresis discontinuation. If concurrent enoxaparin‐based anticoagulation and plasmapheresis are necessary, close monitoring of anti–factor Xa levels is advisable. Dose escalations and reductions of enoxaparin may be necessary when initiating and discontinuing plasmapheresis, respectively.

据我们所知，血浆置换对依诺肝素抗Xa因子活性的影响尚未见报道。我们描述了一个13岁的肥胖(92公斤)女孩，她在接受怀疑自身免疫性脑炎的血浆置换术时接受依诺肝素治疗肺栓塞，血浆置换后抗Xa因子活性显著降低。她接受了5个疗程的血浆置换，最后2个疗程在依诺肝素治疗期间进行。她的抗Xa因子浓度变化很大，我们假设血浆置换影响了这些水平。为了验证这一假设，在患者最后一次血浆置换治疗之前和之后立即测量抗Xa因子浓度，然后在血浆置换治疗后2天再次测量。血浆置换组抗Xa因子活性下降率为0.28 IU/mL/h，未血浆置换组仅为0.088 IU/mL/h，差异大于3倍。血浆置换引起的抗Xa因子活性的变化改变了维持在0.5-1 IU/mL治疗范围所需的最终依诺肝素剂量(接受血浆置换时0.98 mg/kg/剂量vs未接受血浆置换时0.69 mg/kg/剂量)。我们的患者数据表明，血浆置换可以显著改变依诺肝素的抗凝作用(通过抗Xa因子浓度测量)，这可能导致血浆置换期间抗凝作用降低，血浆置换停止后出血风险增加。如果需要同时进行依诺肝素抗凝和血浆置换，建议密切监测抗Xa因子水平。开始血浆置换和停止血浆置换时，依诺肝素的剂量增加和减少可能是必要的。

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引用次数: 6

Comparison of Generic‐to‐Brand Switchback Rates Between Generic and Authorized Generic Drugs 仿制药和授权仿制药之间仿制药到品牌切换率的比较

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-04-01 DOI: 10.1002/phar.1908

R. Hansen, J. Qian, R. Berg, J. Linneman, E. Seoane-Vazquez, S. Dutcher, S. Raofi, C. D. Page, P. Peissig

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic‐to‐brand switchback rates between generic and AGs.

仿制药含有与相应品牌药相同的活性成分，具有药学等效和生物等效性，而授权仿制药(AGs)含有与相应品牌药相同的活性成分和非活性成分，但作为仿制药销售。本研究比较了仿制药和AGs之间仿制药到品牌的切换率。

引用次数: 19

Comparison of Rates of Nephrotoxicity Associated with Vancomycin in Combination with Piperacillin‐Tazobactam Administered as an Extended versus Standard Infusion 万古霉素联合哌拉西林-他唑巴坦长期输注与标准输注肾毒性的比较

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

Pub Date : 2017-03-01 DOI: 10.1002/phar.1901

Mariam Mousavi, Tanya Zapolskaya, Marco R Scipione, E. Louie, J. Papadopoulos, Yanina Dubrovskaya

Despite recent reports of relatively high rates (16–37%) of acute kidney injury (AKI) in patients receiving the combination of intravenous piperacillin‐tazobactam (PTZ) and vancomycin, data are limited evaluating the impact of PTZ infusion strategy on the occurrence of nephrotoxicity. The objective of this study was to compare the rates of nephrotoxicity in patients receiving vancomycin in combination with PTZ administered as an extended infusion (EI) versus a standard infusion (SI).

尽管最近有报道称，在接受静脉注射哌拉西林-他唑巴坦(PTZ)和万古霉素联合治疗的患者中，急性肾损伤(AKI)发生率相对较高(16-37%)，但评估PTZ输注策略对肾毒性发生的影响的数据有限。本研究的目的是比较接受万古霉素联合PTZ作为延长输注(EI)与标准输注(SI)的患者肾毒性发生率。

引用次数: 13

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Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy

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