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The Effectiveness and Adverse Events of Cannabidiol and Tetrahydrocannabinol Used in the Treatment of Anxiety Disorders in a PTSD Subpopulation: An Interim Analysis of an Observational Study. 大麻二酚和四氢大麻酚治疗PTSD亚群焦虑症的有效性和不良事件:一项观察性研究的中期分析。
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-08-01 DOI: 10.1177/87551225231180796
Sophie K Stack, Nial J Wheate, Niamh C Moloney, Sarah V Abelev, John W Barlow, Elise A Schubert

Background: Anxiety is a condition for which current treatments are often limited by adverse events (AEs). Components of medicinal cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC), have been proposed as potential treatments for anxiety disorders, specifically posttraumatic stress disorder (PTSD). Objective: To evaluate quality-of-life outcomes after treatment with various cannabis formulations to determine the effectiveness and associated AEs. Methods: An interim analysis of data collected between September 2018 and June 2021 from the CA Clinics Observational Study. Patient-Reported Outcomes Measurement Information System-29 survey scores of 198 participants with an anxiety disorder were compared at baseline and after treatment with medicinal cannabis. The data of 568 anxiety participants were also analyzed to examine the AEs they experienced by the Medical Dictionary for Regulatory Activities organ system class. Results: The median doses taken were 50.0 mg/day for CBD and 4.4 mg/day for THC. The total participant sample reported significantly improved anxiety, depression, fatigue, and ability to take part in social roles and activities. Those who were diagnosed with PTSD (n = 57) reported significantly improved anxiety, depression, fatigue, and social abilities. The most common AEs reported across the whole participant cohort were dry mouth (32.6%), somnolence (31.3%), and fatigue (18.5%), but incidence varied with different cannabis formulations. The inclusion of THC in a formulation was significantly associated with experiencing gastrointestinal AEs; specifically dry mouth and nausea. Conclusions: Formulations of cannabis significantly improved anxiety, depression, fatigue, and the ability to participate in social activities in participants with anxiety disorders. The AEs experienced by participants are consistent with those in other studies.

背景:焦虑是一种疾病,目前的治疗往往受到不良事件(ae)的限制。药用大麻的成分,大麻二酚(CBD)和四氢大麻酚(THC),已被提出作为治疗焦虑症,特别是创伤后应激障碍(PTSD)的潜在治疗方法。目的:评价各种大麻制剂治疗后的生活质量结果,以确定有效性和相关的ae。方法:对2018年9月至2021年6月CA诊所观察性研究收集的数据进行中期分析。患者报告的结果测量信息系统-29对198名患有焦虑症的参与者的调查得分进行了基线和药用大麻治疗后的比较。对568名焦虑参与者的数据进行分析,以检查他们在调节活动医学词典器官系统类中经历的ae。结果:CBD的中位剂量为50.0 mg/天,四氢大麻酚的中位剂量为4.4 mg/天。总的参与者样本报告说,焦虑、抑郁、疲劳以及参与社会角色和活动的能力都得到了显著改善。那些被诊断患有创伤后应激障碍的人(n = 57)报告焦虑、抑郁、疲劳和社交能力显著改善。在整个参与者队列中报告的最常见ae是口干(32.6%),嗜睡(31.3%)和疲劳(18.5%),但发病率因不同的大麻配方而异。在配方中加入四氢大麻酚与胃肠道不良反应显著相关;尤其是口干和恶心。结论:大麻制剂可显著改善焦虑障碍患者的焦虑、抑郁、疲劳和参与社交活动的能力。参与者所经历的不良事件与其他研究一致。
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引用次数: 2
Acute Kidney Injury Incidence With Bayesian Dosing Software Versus 2-Level First-Order Area Under the Curve-Based Dosing of Vancomycin With Piperacillin-Tazobactam. 贝叶斯剂量软件与基于万古霉素与哌拉西林-他唑巴坦曲线下面积的两级一阶剂量相比的急性肾损伤发生率。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-08-01 Epub Date: 2023-06-27 DOI: 10.1177/87551225231182542
Ashton Bellamy, Elizabeth W Covington

Background: Two methods of area under the curve (AUC) dosing are recommended in vancomycin consensus guidelines: first-order calculations utilizing 2 vancomycin concentrations or a Bayesian approach. It is unknown if there is a difference in acute kidney injury (AKI) between the 2 dosing strategies for patients receiving concomitant piperacillin-tazobactam and vancomycin (VPT). Objective: The objective of this study was to compare incidence of AKI in patients being administered VPT with first-order calculations versus model-informed precision dosing (MIPD)/Bayesian dosing. Methods: This was a single-center, retrospective, observational study at a community hospital. Patients who received VPT therapy for at least 48 hours were included. The primary outcome was overall incidence of AKI. Secondary outcomes included percentage target attainment with initial regimen, average serum creatinine increase, time to AKI, usable vancomycin levels, and need for temporary dialysis or intensive care unit admission. Results: There were 100 patients included (50 in the first-order group and 50 in the MIPD/Bayesian group). The overall incidence of AKI was lower in the MIPD/Bayesian group (12% vs 28%, P = 0.046). There was no difference in average serum creatinine increase, time to AKI, need for temporary dialysis, or intensive care unit admission. Patients in the MIPD/Bayesian group had a higher percentage of target attainment (46% vs 18%, P = 0.003) and usable vancomycin levels (98% vs 60%, P < 0.001). Conclusion and Relevance: In patients receiving VPT, model-informed precision dosing with Bayesian modeling resulted in a lower rate of AKI, higher target attainment, and more usable vancomycin levels compared with first-order AUC dosing. The small sample and retrospective nature of this study reinforces the need for additional data.

背景:万古霉素共识指南推荐了两种曲线下面积(AUC)给药方法:利用两种万古霉素浓度的一阶计算法或贝叶斯法。对于同时接受哌拉西林-他唑巴坦和万古霉素(VPT)治疗的患者,这两种给药策略在急性肾损伤(AKI)方面是否存在差异尚不清楚。研究目的本研究旨在比较采用一阶计算方法和模型信息精确配药(MIPD)/贝叶斯配药方法给药的 VPT 患者的急性肾损伤(AKI)发生率。方法:这是一项在社区医院进行的单中心、回顾性、观察性研究。研究纳入了接受 VPT 治疗至少 48 小时的患者。主要结果是 AKI 的总体发生率。次要结果包括初始方案达标率、平均血清肌酐升高率、发生 AKI 的时间、可用万古霉素水平以及临时透析或入住重症监护室的需求。结果:共纳入 100 名患者(一阶组 50 人,MIPD/贝叶斯组 50 人)。MIPD/Bayesian 组的 AKI 总发生率较低(12% 对 28%,P = 0.046)。在平均血清肌酐升高、发生 AKI 的时间、临时透析需求或入住重症监护室方面没有差异。MIPD/Bayesian 组患者的达标率更高(46% vs 18%,P = 0.003),可用万古霉素水平更高(98% vs 60%,P < 0.001)。结论与意义:在接受 VPT 治疗的患者中,与一阶 AUC 剂量相比,采用贝叶斯模型的精准剂量可降低 AKI 发生率、提高达标率和可用万古霉素水平。这项研究的样本较少且具有回顾性,因此需要更多的数据。
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引用次数: 0
Impact of Abrupt Interruption of Home Psychotropic Medications at ICU Admission. 入住重症监护室时中断家庭精神药物治疗的影响。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-08-01 Epub Date: 2023-06-30 DOI: 10.1177/87551225231182286
Jennifer Atherton, Maryam Abdrabbo, Hagar Kassab

Background: Abrupt discontinuation of home psychotropic medications is common among critically ill patients but may precipitate clinically significant withdrawal. Objective: To determine the percent of patients with interruptions in home psychotropic medications upon intensive care unit (ICU) admission and to identify outcomes associated with these interruptions. Methods: This was an institutional review board-approved, single-center, retrospective study of critically ill patients with a history of mental illness taking an antipsychotic or antidepressant medication. The primary outcome was the percent of patients with interruption in at least one home psychotropic medication for ≥24 hours upon ICU admission. Secondary outcomes included time to psychotropic re-initiation, percent of home psychotropic medications restarted in the ICU, ICU length of stay (LOS), delirium, withdrawal-related complications, need for acute antipsychotics or benzodiazepines, and reasons for psychotropic interruption. Results: Among 183 patients, 93 (50.8%) had interruptions in home psychotropic therapy for ≥24 hours upon ICU admission. Mean time to reinitiation of at least one psychotropic agent was 1.4 days, and 16.4% of patients did not have any home psychotropics restarted. Patients with psychotropic interruption had a longer ICU LOS (P = 0.01) and greater incidence of ICU delirium (P < 0.01). Withdrawal-related complications were similar between groups. Acute antipsychotic use was greater in patients with psychotropic interruption (P < 0.01). Acute benzodiazepine use was not different between groups (P = 0.87). Most patients did not have a documented reason for therapy interruption. Conclusion and Relevance: Unless contraindicated, clinicians should attempt to restart home psychotropic medications as soon as possible in critically ill patients.

背景:突然停用家庭精神药物在重症患者中很常见,但可能会导致临床上严重的戒断。目的:确定重症监护患者中断家庭精神药物治疗的百分比:确定重症监护病房(ICU)入院时中断家庭精神药物治疗的患者比例,并确定与这些中断治疗相关的结果。研究方法:这是一项由机构审查委员会申请的研究:这是一项经机构审查委员会批准的单中心回顾性研究,研究对象是有精神病史且正在服用抗精神病药或抗抑郁药的重症患者。研究的主要结果是患者入住重症监护室时至少一种家庭精神药物中断用药时间≥24小时的百分比。次要结果包括重新开始服用精神药物的时间、在重症监护室重新开始服用家庭精神药物的百分比、重症监护室住院时间(LOS)、谵妄、戒断相关并发症、急性抗精神病药物或苯二氮卓药物的需求以及精神药物中断的原因。研究结果在183名患者中,93人(50.8%)在入住重症监护室时中断家庭精神药物治疗≥24小时。重新开始使用至少一种精神药物的平均时间为1.4天,16.4%的患者没有重新开始使用任何家用精神药物。中断精神药物治疗的患者在重症监护室的住院时间更长(P = 0.01),重症监护室谵妄的发生率更高(P < 0.01)。各组间与停药相关的并发症相似。精神药物治疗中断患者的急性抗精神病药物用量更大(P < 0.01)。急性苯二氮卓类药物的使用在组间没有差异(P = 0.87)。大多数患者没有中断治疗的记录原因。结论与意义:除非有禁忌症,否则临床医生应尝试尽快为重症患者重新启动家庭精神药物治疗。
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引用次数: 0
Performance of Methicillin-Resistant Staphylococcus aureus Polymerase Chain Reaction Nasal Screening for Ruling Out MRSA Pneumonia in Hospitalized, Immunocompromised Patients. 耐甲氧西林金黄色葡萄球菌聚合酶链式反应鼻腔筛查在排除住院免疫力低下患者 MRSA 肺炎方面的性能。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-08-01 Epub Date: 2023-06-27 DOI: 10.1177/87551225231182876
Hui Lin, Daniel T Anderson, Amber Clemmons, Joshua Eudy, Brittny Nutt, Caroline Stevens, Sydney White, Christy Forehand

Background: Recent literature demonstrates support for using methicillin-resistant Staphylococcus aureus (MRSA) nasal swab polymerase chain reaction (NaPCR) screening as an antimicrobial stewardship tool aiding early de-escalation of anti-MRSA antimicrobials. However, immunocompromised patients have been underrepresented in previous studies despite increased risk of morbidity and mortality from multidrug-resistant organisms (MDRO). Objective: The purpose of this study was to determine the negative predictive value (NPV) of the MRSA NaPCR in hospitalized, immunocompromised adult patients with suspected pneumonia. Methods: A single-center, retrospective, observational review was conducted of hospitalized, immunocompromised adult patients that had an MRSA NaPCR obtained between March 1, 2020 and January 10, 2021. For inclusion, bacterial cultures must have been collected within 2 weeks after MRSA NaPCR. The primary outcome was the NPV of MRSA NaPCR in hospitalized, immunocompromised patients with suspected pneumonia. Secondary outcomes include NPV in other infections. Results: Between March 1, 2020 and January 10, 2021, 59 patients with 78 unique cultures, including 28 respiratory cultures, were included in the study. The NPV of the MRSA NaPCR for pneumonia was 91.7%. The NPV for bloodstream infections was 100% and for urinary tract infections was 100%, but interpretation of these results should be cautioned due to the small sample sizes. Conclusion: The NPV of MRSA NaPCR in pneumonia remains high in this study. The MRSA NaPCR has utility as a de-escalation tool in hospitalized, immunocompromised adult patients, but larger studies are warranted to evaluate all immunocompromised patient populations.

背景:最近的文献表明,耐甲氧西林金黄色葡萄球菌(MRSA)鼻拭子聚合酶链反应(NaPCR)筛查是一种抗菌药物管理工具,可帮助早期降低抗 MRSA 抗菌药物的使用剂量。然而,尽管耐多药生物(MDRO)导致发病和死亡的风险增加,但免疫力低下的患者在以往的研究中却没有得到足够的重视。研究目的本研究旨在确定 MRSA NaPCR 在疑似肺炎的住院免疫功能低下成人患者中的阴性预测值 (NPV)。研究方法:对 2020 年 3 月 1 日至 2021 年 1 月 10 日期间获得 MRSA NaPCR 的住院免疫功能低下成人患者进行单中心回顾性观察。纳入患者时,必须在 MRSA NaPCR 后 2 周内采集细菌培养。主要结果是住院的疑似肺炎免疫功能低下患者中 MRSA NaPCR 的 NPV。次要结果包括其他感染的 NPV。结果:2020 年 3 月 1 日至 2021 年 1 月 10 日期间,59 名患者共进行了 78 次培养,其中包括 28 次呼吸道培养。MRSA NaPCR 对肺炎的 NPV 为 91.7%。血流感染的 NPV 为 100%,尿路感染的 NPV 为 100%,但由于样本量较小,在解释这些结果时应谨慎。结论在本研究中,MRSA NaPCR 在肺炎中的 NPV 仍然很高。MRSA NaPCR 可作为免疫力低下的住院成人患者的降级工具,但需要进行更大规模的研究来评估所有免疫力低下的患者群体。
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引用次数: 0
Impact of a Co-curricular Poverty Simulation on Pharmacy Students' Socioeconomic and Patient Advocacy Attitudes and Beliefs. 联合课程模拟贫困对药学专业学生的社会经济及患者权益维护态度和信念的影响。
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-01 Epub Date: 2023-04-22 DOI: 10.1177/87551225231167294
Michael P Kelsch, Sara Thompson, Elizabeth Skoy

Background: Pharmacists are well-positioned to assist patients facing poverty with financial and well-being resource navigation. Pharmacy educators must find avenues for students that foster awareness of applicable challenges encountered by economically disadvantaged patients. Objective: This study examines the impact of a poverty simulation on pharmacy students' socioeconomic and patient advocacy attitudes and beliefs. Methods: Third year professional pharmacy students participated in the Community Action Poverty Simulation (CAPS). Students were asked to voluntarily complete a survey prior to and following their participation. The survey was based upon a combination of 3 previously validated survey tools: Attitudes Toward Poverty (ATP) scale, Medical Student Attitudes Toward the Underserved (MSATU), and the Locus of Control Scale (LCS). Students also responded to open-ended questions postsimulation. Results: Forty of the 74 students completed both the presimulation and postsimulation surveys. Significant changes were seen in a matched sample analysis for 17 of 49 survey questions. Prominent differences (decreasing agreement) came from the statements: "An able-bodied person collecting welfare is ripping off the system" and "Welfare makes people lazy"; and increasing agreement that "I feel personally responsible for providing medical care to the needy." Open-ended survey responses reflected a greater understanding of time and effort needed to locate and navigate available resources, and challenges such as adhering to medication regimens due to inability to pay. Conclusion: A poverty simulation, such as CAPS, is an effective method to encourage pharmacy students to reflect on their future impact toward patients facing the challenges of poverty. The shift in students' attitudes and beliefs on various measures revealed that the simulation had an impact on altering perceptions for those with low socioeconomic status.

背景:药剂师完全有能力帮助面临贫困的患者进行经济和福利资源导航。药剂学教育者必须为学生寻找途径,培养他们对经济困难患者所面临的挑战的认识。目标:本研究探讨了贫困模拟对药剂学学生的社会经济及患者权益维护态度和信念的影响。方法:三年级药学专业学生参加了贫困模拟项目:药学专业三年级学生参加了社区行动贫困模拟(CAPS)。学生们被要求在参与之前和之后自愿填写一份调查问卷。该调查基于 3 种先前已验证的调查工具的组合:贫困态度量表 (ATP)、医学生对未得到服务者的态度量表 (MSATU) 和控制感量表 (LCS)。学生们还在模拟后回答了开放式问题。结果:74 名学生中有 40 人完成了模拟前和模拟后调查。在 49 个调查问题中,有 17 个问题在匹配样本分析中出现了显著变化。明显的差异(同意率下降)来自以下陈述:"身体健康的人领取福利是对福利制度的践踏 "和 "福利使人变得懒惰";对 "我觉得自己有责任为有需要的人提供医疗服务 "的认同度有所提高。开放式调查反馈反映出,人们更加了解寻找和利用可用资源所需的时间和精力,以及由于无力支付而无法坚持用药等挑战。结论贫困模拟(如 CAPS)是一种有效的方法,可以鼓励药剂学学生思考他们未来对面临贫困挑战的病人的影响。学生们在各种衡量标准上的态度和信念转变表明,模拟活动对改变人们对社会经济地位低下者的看法产生了影响。
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引用次数: 0
A Retrospective Analysis of Sacubitril/Valsartan in Heart Failure and Chronic Kidney Disease. 萨库比特利/缬沙坦治疗心力衰竭和慢性肾病的回顾性分析
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-01 Epub Date: 2023-05-03 DOI: 10.1177/87551225231168543
Kayla L McFarland, Erica A Sheridan

Background: Sacubitril/valsartan has demonstrated benefit for patients with heart failure (HF); however, patients with advanced stages of chronic kidney disease (CKD) as defined by the National Kidney Foundation have historically been underrepresented in landmark HF trials. Objective: The goal of this study is to examine the safety and efficacy of sacubitril/valsartan in patients with HF and concomitant CKD stages III to V. Methods: This multicenter, retrospective, observational study included adult patients with HF and CKD stages III to V prescribed sacubitril/valsartan during hospital admission or upon discharge from January 2017 through March 2022. The primary outcome was the comparison of estimated glomerular filtration rate (eGFR) from baseline to 90 days. Key secondary outcomes included the comparison of the ejection fraction (EF) at 180 days, the rate of all-cause- and HF-related readmissions within 30 days, and adverse events. Results: Fifty patients were included in the analysis, with most patients (56%) having CKD stage IIIa. There was no difference in eGFR between baseline and 90 days (45.3 (11.2) mL/min/1.73 m2 vs 45.5 (18.6) mL/min/1.73 m2; P = 0.91). EF improved between baseline and 180 days (median 22.5% [17.5-27.5] vs 30.0% [22.5-42.5]; P < 0.001). Three patients (6%) were rehospitalized within 30 days for HF-related causes. There were 6 episodes (12%) of hyperkalemia greater than 5.0 milliequivalents per liter (mEq/L), and 2 episodes (4%) greater than 5.5 mEq/L. Conclusion: There was no significant difference in eGFR from baseline to 90 days in patients with HF and CKD prescribed sacubitril/valsartan during hospitalization, though there was an observed increase in EF.

背景:萨库比特利/缬沙坦已证明对心力衰竭(HF)患者有益;然而,根据美国国家肾脏基金会的定义,慢性肾脏病(CKD)晚期患者在具有里程碑意义的 HF 试验中历来代表性不足。研究目的本研究的目的是探讨沙库比特利/缬沙坦治疗高血压合并 CKD III 至 V 期患者的安全性和疗效:这项多中心、回顾性、观察性研究纳入了 2017 年 1 月至 2022 年 3 月期间入院或出院时被处方沙库比妥/缬沙坦的高血压合并 CKD III 至 V 期的成年患者。主要结果是比较从基线到90天的估计肾小球滤过率(eGFR)。主要次要结果包括 180 天时射血分数 (EF) 的比较、30 天内全因和 HF 相关再住院率以及不良事件。结果:分析共纳入了 50 名患者,其中大多数患者(56%)为 CKD IIIa 期。eGFR 在基线和 90 天之间没有差异(45.3 (11.2) mL/min/1.73 m2 vs 45.5 (18.6) mL/min/1.73 m2; P = 0.91)。在基线和 180 天之间,EF 有所改善(中位 22.5% [17.5-27.5] vs 30.0% [22.5-42.5];P < 0.001)。三名患者(6%)在 30 天内因心房颤动相关原因再次入院。有 6 例(12%)高钾血症超过 5.0 毫当量/升(mEq/L),2 例(4%)超过 5.5 毫当量/升。结论住院期间服用沙库比妥/缬沙坦的高血压和慢性肾功能衰竭患者从基线到90天的eGFR没有明显差异,但观察到EF有所增加。
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引用次数: 0
Comparison of Tertiary Drug Information Resources With the CDC Guideline for Oxycodone Dosing: Are Patients at Risk? 三级药物信息资源与CDC羟考酮给药指南的比较:患者是否有风险?
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-01 DOI: 10.1177/87551225231164897
Allyson Ellsworth, Michael A Veronin

Background: Inappropriate prescribing of opioids is thought to play a central role in the ongoing opioid health crisis. Tertiary information resources are commonly used by clinicians for obtaining opioid dosing information. To assist health care providers in pain management, the Centers for Disease Control and Prevention (CDC) developed a guideline for prescribing opioids. Objective: To identify discrepancies for dosing information on oxycodone between commonly used tertiary drug information resources and the CDC Guideline. Methods: Searches of the tertiary drug information resources were conducted in the following order: Facts and Comparisons, Lexicomp, Medscape, and Micromedex. The term "oxycodone" was entered in the search box in the tertiary resources' applications. Drug information items retrieved were organized in tabular format. In the Google Chrome version 106.0.5249.119 search box, the term "CDC guideline for opioid dosing" was entered to retrieve current information on the CDC Guideline. Results: Searches produced drug information on oxycodone for available formulations, dosing regimens, recommended dosing, and maximum daily dose (MDD). Searches revealed discrepancies in dosing recommendations for oxycodone among tertiary drug resources and between tertiary drug resources and the CDC Guideline. Conclusions: When considering maximum daily dosing information for oxycodone from the selected tertiary drug information resources, the potential exists for patients to be at risk of addiction, overdose, and perhaps death. Improving the way opioids are prescribed through the CDC Clinical Practice Guideline can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse or overdose from inappropriate dosing information.

背景:阿片类药物处方不当被认为在持续的阿片类药物健康危机中发挥核心作用。三级信息资源通常被临床医生用于获取阿片类药物给药信息。为了帮助医疗保健提供者进行疼痛管理,疾病控制和预防中心(CDC)制定了阿片类药物处方指南。目的:确定常用三级药物信息资源与CDC指南中羟考酮剂量信息的差异。方法:按照Facts and comparison、Lexicomp、Medscape、Micromedex的顺序进行三级药物信息资源检索。在三级资源应用程序的搜索框中输入“羟考酮”。检索到的药品信息项目以表格形式组织。在Google Chrome版本106.0.5249.119搜索框中,输入“CDC指南阿片类药物剂量”一词,检索CDC指南的当前信息。结果:搜索产生了羟考酮的药物信息,包括可用的配方、给药方案、推荐给药和最大日剂量(MDD)。搜索结果显示,三级药物资源之间以及三级药物资源与CDC指南之间的羟考酮剂量建议存在差异。结论:当考虑从选定的三级药物信息资源中获得的羟考酮的最大日剂量信息时,可能存在患者成瘾、过量用药甚至死亡的风险。通过CDC临床实践指南改进阿片类药物的处方方式,可以确保患者获得更安全、更有效的慢性疼痛治疗,同时减少因不适当的剂量信息而误用或过量使用阿片类药物的人数。
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引用次数: 0
Vonoprazan: A New Potassium-Competitive Acid Blocker. Vonoprazan:一种新型钾竞争性酸阻滞剂
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-01 Epub Date: 2023-04-22 DOI: 10.1177/87551225231166531
Erin St Onge, Bradley Phillips

Objective: To review the safety, efficacy, and tolerability of vonoprazan for the treatment of Helicobacter pylori infection in adults. Data Sources: A literature search was performed through PubMed using the following key terms: vonoprazan, Voquezna, TAK-438, potassium-competitive acid blocker, H pylori, and gastrointestinal. Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacology, pharmacokinetics, efficacy, safety, or tolerability of vonoprazan. Data Synthesis: Vonoprazan works by competing with potassium on the proton pump to inhibit gastric acid secretion. Phase 3 clinical trials have shown that vonoprazan is noninferior to proton pump inhibitors (PPIs) as a component of H pylori eradication regimens. Vonoprazan has also shown promise in duodenal ulcer-healing rates and in reducing symptoms of heartburn. Common adverse effects associated with vonoprazan include nasopharyngitis, diarrhea, constipation, flatulence, dyspepsia, headache, and abdominal pain. Conclusion: Clinical practice guidelines recommend PPIs as the antisecretory agent of choice in H pylori eradication regimens with histamine-2 receptor antagonists (H2RAs) as potential alternatives. However, the use of either class of medications may be limited by adverse effects, drug interactions, and tolerability. Potassium-competitive acid blockers (P-CABs), like vonoprazan, may be safe and effective alternative antisecretory agents for H pylori eradication regimens, as well as other gastrointestinal disorders.

目的研究vonoprazan治疗成人幽门螺旋杆菌感染的安全性、有效性和耐受性。数据来源:PubMed使用以下关键词在 PubMed 上进行文献检索:vonoprazan、Voquezna、TAK-438、钾竞争性酸阻断剂、幽门螺杆菌和胃肠道。研究选择和数据提取:所选文章包括对vonoprazan的药理学、药代动力学、疗效、安全性或耐受性进行临床研究的文章。数据综合:沃诺普拉赞通过与质子泵上的钾竞争来抑制胃酸分泌。三期临床试验表明,作为根除幽门螺杆菌疗法的一种成分,Vonoprazan的疗效并不亚于质子泵抑制剂(PPIs)。在十二指肠溃疡愈合率和减轻胃灼热症状方面,沃诺普拉赞也显示出良好的前景。沃诺普拉赞常见的不良反应包括鼻咽炎、腹泻、便秘、胀气、消化不良、头痛和腹痛。结论临床实践指南建议将 PPIs 作为根除幽门螺杆菌方案中的首选抗幽门螺杆菌药物,组胺-2 受体拮抗剂 (H2RAs) 可作为潜在的替代药物。但是,这两类药物的使用都可能受到不良反应、药物相互作用和耐受性的限制。钾竞争性酸阻滞剂(P-CABs),如vonoprazan,可能是根除幽门螺杆菌方案以及其他胃肠道疾病的安全有效的替代抗分泌药物。
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引用次数: 0
Use of Sodium-Glucose Cotransporter-2 Inhibitor for Diabetes Management in Patients Following Kidney Transplantation. 使用钠-葡萄糖转运体 2 抑制剂控制肾移植患者的糖尿病。
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-01 Epub Date: 2023-05-05 DOI: 10.1177/87551225231169620
Erica F Crannage, Katherine L Nguyen, Morgan D Ellebrecht, Laura M Challen, Andrew J Crannage

Objective: To evaluate data sources pertaining to the safety and efficacy of sodium-glucose cotransporter-2 (SGLT2) inhibitor use for diabetes management in patients following kidney transplantation. Data Sources: A literature search was conducted through PubMed (1966-January 2023), EMBASE (1973-January 2023), and clinicaltrials.gov databases using the search terms kidney transplantation, diabetes mellitus, and SGLT2 inhibitor or empagliflozin, dapagliflozin, and canagliflozin. Study Selection and Data Extraction: Studies evaluating human kidney transplant recipients (KTR) receiving SGLT2 inhibitors treatment and published in the English language were included. Eight case series or retrospective analyses, 4 prospective observational studies, and 1 randomized controlled trial were identified. Data Synthesis: Available literature provides evidence that the addition of SGLT2 inhibitors may provide modest benefits on glycemic control, body weight, and serum uric acid levels in certain KTR. Various studies and case reports found that incidence of urinary tract infections was low, but still present. Overall, there are limited data on mortality and graft survival; however, one study reported a benefit of SGLT2 inhibitor use in KTR relative to these outcomes. Conclusions: The current literature evaluated demonstrates that there may be benefit to the addition of SGLT2 inhibitors for diabetes management in select KTR. However, the limited evidence within a large diverse population and extended duration of treatment makes it difficult to definitively identify the true efficacy and safety of SGLT2 inhibitor use in this population.

目的评估有关肾移植术后患者使用钠-葡萄糖共转运体-2 (SGLT2) 抑制剂治疗糖尿病的安全性和有效性的数据来源。数据来源:通过 PubMed(1966 年至 2023 年 1 月)、EMBASE(1973 年至 2023 年 1 月)和 clinicaltrials.gov 数据库进行文献检索,检索词为肾移植、糖尿病和 SGLT2 抑制剂或 empagliflozin、dapagliflozin 和 canagliflozin。研究选择和数据提取:纳入评估接受 SGLT2 抑制剂治疗的人类肾移植受者(KTR)的研究,这些研究均以英文发表。确定了 8 项系列病例或回顾性分析、4 项前瞻性观察研究和 1 项随机对照试验。数据综合:现有文献提供的证据表明,对某些 KTR 患者而言,添加 SGLT2 抑制剂可能会在血糖控制、体重和血清尿酸水平方面带来适度的益处。多项研究和病例报告发现,尿路感染的发生率较低,但仍然存在。总体而言,有关死亡率和移植物存活率的数据有限;但有一项研究报告称,在 KTR 中使用 SGLT2 抑制剂对这些结果有益。结论:目前评估的文献表明,在选定的 KTR 中添加 SGLT2 抑制剂进行糖尿病管理可能有好处。然而,由于在大量不同人群中的证据有限,且治疗时间较长,因此很难明确确定在该人群中使用 SGLT2 抑制剂的真正疗效和安全性。
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引用次数: 0
A Quasi-Experimental Evaluation of Single Trough-Based Area Under the Curve Guided Dosing on the Incidence of Vancomycin Associated Nephrotoxicity in Veteran Patients. 基于单通道曲线下面积指导用药对退伍军人万古霉素相关肾毒性发生率的准实验性评估
IF 1 Q3 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-01 Epub Date: 2023-05-22 DOI: 10.1177/87551225231172349
Tanvi Patil, Stacey N Zysk, Meghan E Akridge, Rebecca W McCraven, Shikha S Vasudeva

Background: Two common dosing strategies for vancomycin are trough-based and area under the curve (AUC)-based dosing. Objective: To compare the incidence of nephrotoxicity in trough-based dosing group with the single trough-based AUC dosing at the Salem VA Medical Center. Methods: This retrospective study included patients who received trough-based dosing of vancomycin between January 1, 2017, and January 1, 2019 (preimplementation group) and AUC-based dosing (postimplementation) between October 1, 2019, and October 1, 2021, at the Salem VA Medical Center. The primary outcome was nephrotoxicity at 96 hours, 7 days, and entire hospital length of stay (LOS). Secondary outcomes included 30-day readmission and all-cause mortality rates, cumulative doses at 24, 48, and 72 hours, and percentage of patients considered at goal (AUC 400-600 or trough between 10 and 20 mg/L). Propensity score (PS) matching was utilized to adjust for confounding. Results: After PS matching 100 patients were included in preimplementation and 95 patients in the postimplementation group. The average study patient was a 68-year-old white male. There was significant reduction in the risk of nephrotoxicity in postimplementation cohort at 96 hours (adjusted (a)HR: 0.28, 95% CI (0.12-0.66); 7 days (aHR: 0.39, 95% CI (0.18-0.85); and entire hospital LOS (aHR: 0.46, 95% CI (0.22-0.95). Secondary outcomes showed no difference between the groups except significantly higher proportion of patients were considered at therapeutic goal in the postimplementation cohort compared with pre-implementation cohort. Conclusion: This hypothesis generating study shows that AUC-based dosing calculated using single trough concentration may result in reduced rate of nephrotoxicity than trough-based dosing.

背景:万古霉素的两种常用给药策略是基于谷值的给药和基于曲线下面积(AUC)的给药。目的比较塞勒姆退伍军人医疗中心基于谷值给药组与基于单一谷值 AUC 给药组的肾毒性发生率。研究方法这项回顾性研究纳入了塞勒姆退伍军人医疗中心在 2017 年 1 月 1 日至 2019 年 1 月 1 日期间(实施前组)接受万古霉素谷值给药和在 2019 年 10 月 1 日至 2021 年 10 月 1 日期间接受 AUC 给药(实施后)的患者。主要结果是96小时、7天和整个住院时间(LOS)的肾毒性。次要结果包括 30 天再入院率和全因死亡率、24、48 和 72 小时的累积剂量以及达到目标(AUC 400-600 或谷值在 10-20 mg/L 之间)的患者比例。采用倾向评分(PS)匹配来调整混杂因素。结果:经过倾向评分匹配后,100 名患者被纳入实施前组,95 名患者被纳入实施后组。研究患者平均为 68 岁的白人男性。实施后组群的肾毒性风险在 96 小时(调整后 (a)HR: 0.28, 95% CI (0.12-0.66))、7 天(aHR: 0.39, 95% CI (0.18-0.85))和整个住院时间(aHR: 0.46, 95% CI (0.22-0.95))均明显降低。次要结果显示,两组间无差异,但实施后组群中达到治疗目标的患者比例明显高于实施前组群。结论这项提出假设的研究表明,与基于谷浓度的剂量相比,基于单谷浓度计算的 AUC 剂量可能会降低肾毒性发生率。
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引用次数: 0
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Journal of Pharmacy Technology
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