Pharmacoepidemiology最新文献

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1604 Comparative Risks of Infection with Belimumab versus Oral Immunosuppressants in Patients with Non-Renal Systemic Lupus Erythematosus 1604 Belimumab与口服免疫抑制剂在非肾系统性红斑狼疮患者中感染的风险比较

Pharmacoepidemiology

Pub Date : 2022-12-01 DOI: 10.1136/lupus-2022-lupus21century.99

A. Jorge, E. Materne, Hyon-Min Choi, Baijun Zhou, K. Costenbader, Yuqing Zhang

引用次数: 0

Evaluation of the Effectiveness of Buprenorphine-Naloxone on Opioid Overdose and Death among Insured Patients with Opioid Use Disorder in the United States. 丁丙诺啡-纳洛酮对美国参保阿片类药物使用障碍患者阿片类药物过量和死亡的疗效评价

Pharmacoepidemiology

Pub Date : 2022-12-01 DOI: 10.3390/pharma1030010

Tianyu Sun, Natallia Katenka, Stephen Kogut, Jeffrey Bratberg, Josiah Rich, Ashley Buchanan

Opioid use disorder (OUD) is a chronic disease requiring long-term treatment and is associated with opioid overdose and increased risk of mortality. However, existing randomized clinical trials focused on short-term treatment engagement and detoxification rather than overdose or mortality risk due to limited follow-up time and ethical considerations. We used a hypothetical trial framework to conduct a retrospective cohort study to assess the effectiveness of time-varying buprenorphine-naloxone on opioid overdose and death. We identified 58,835 insured adult patients with OUD diagnosis in the US, 2010-2017. We fit a marginal structural model using inverse probability weighting methods to account for measured baseline and time-varying confounders, as well as selection bias due to possibly differential loss-to-follow-up. We found that receipt of buprenorphine-naloxone was associated with reduced risk of opioid overdose (hazard ratio (HR) = 0.66, 95% confidence interval (CI): 0.49, 0.91), death (HR = 0.24, 95% CI: 0.08, 0.75), and overdose or death (HR = 0.58, 95% CI: 0.40, 0.84). The E-value for death was 7.8, which was larger than the upper 95% CI of the association between each measured baseline variable and all-cause death, which implies that the unmeasured confounding itself may not explain away the estimated effect of treatment on the endpoint of all-cause mortality.

阿片类药物使用障碍(OUD)是一种需要长期治疗的慢性病，与阿片类药物过量和死亡风险增加有关。然而，由于随访时间有限和伦理考虑，现有的随机临床试验侧重于短期治疗参与和解毒，而不是过量或死亡风险。我们采用假设的试验框架进行回顾性队列研究，以评估时变丁丙诺啡-纳洛酮对阿片类药物过量和死亡的有效性。2010-2017年，我们在美国确定了58,835名患有OUD诊断的参保成年患者。我们使用逆概率加权方法拟合一个边际结构模型，以考虑测量的基线和时变混杂因素，以及可能由于差异损失而导致的选择偏差。我们发现丁丙诺啡-纳洛酮与阿片类药物过量(HR = 0.66, 95%可信区间(CI): 0.49, 0.91)、死亡(HR = 0.24, 95% CI: 0.08, 0.75)和过量或死亡(HR = 0.58, 95% CI: 0.40, 0.84)的风险降低相关。死亡的e值为7.8，大于每个测量的基线变量与全因死亡之间关联的95% CI上限，这意味着未测量的混杂因素本身可能无法解释治疗对全因死亡率终点的估计影响。

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引用次数: 0

1701 Improving completion rates of routine mental health screening for depression and anxiety in paediatric lupus outpatient clinic to enhance patient mental health care 1701提高儿科狼疮门诊抑郁和焦虑常规心理健康筛查完成率，加强患者心理健康护理

Pharmacoepidemiology

Pub Date : 2022-12-01 DOI: 10.1136/lupus-2022-lupus21century.100

T. Tal, A. Longmore, A. A. Mutairi, Audrea Chen, H. Convery, D. Finkelstein, L. Hiraki, Chetana Kulkarni, J. Ledochowski, Neely Lerman, K. Leslie, Deborah M Levy, Sharon Lorber, J. Macmahon, J. McColl, Sarah I Mossad, O. Mwizerwa, L. Ng, Luana F Pereira, Vandana Rawal, Alaa M. Shehab, Amani Al Bijadi, E. Smith, Alène Toulany, A. Knight

引用次数: 0

Spironolactone Utilization among Patients with Reduced and Preserved Ejection Fraction Heart Failure 射血分数降低和维持性心力衰竭患者对螺内酯的利用

Pharmacoepidemiology

Pub Date : 2022-10-20 DOI: 10.3390/pharma1030009

E. Eworuke, Austin Cosgrove, Q. Her, Jennifer G. Lyons, David Martin, S. Adimadhyam

Background: Spironolactone is a mineralocorticoid receptor antagonist indicated for the management of heart failure with reduced ejection fraction (HFrEF). In a previous clinical trial, spironolactone significantly lowered the incidence of heart failure (HF) hospitalizations among HF patients with preserved ejection fraction (HFpEF). Real world utilization of spironolactone in HFrEF and HFpEF is unknown. Methods: We conducted a retrospective cohort study using data from FDA’s Sentinel System. We identified patients with HFrEF or HFpEF using diagnosis and procedure codes from a previously validated algorithm. We required patients to be continuously enrolled in the 183 days prior to HF diagnosis. Follow-up started on the day of HF diagnosis and ended at the earliest occurrence of a spironolactone dispensing, disenrollment, death, or end of data. We calculated the proportion of spironolactone utilization, and for those initiating treatment, we estimated the dose and duration of the first continuous treatment episode. Results: Among 2,009,529 HFrEF patients, 57.8% were male, and mean age was 73.8 ± 12.1 years. Among 9,257,514 HFpEF patients, 42.7% were male, and mean age was 73.0 ± 12.1 years. The proportion of spironolactone utilization following HFrEF diagnosis was 20.7% versus 7.6% after HFpEF. The median time (days) to initiation of spironolactone after HFrEF diagnosis was 90 (IQR: 19–385) versus 286 (IQR: 57–851) after HFpEF diagnosis. The median duration (days) of first treatment episode in HFrEF patients was 120 (IQR: 44–321) and 114 (IQR: 32–301) for HFpEF patients. The median dose was similar (25 mg/day) for both HF cohorts. Conclusion: Findings of low real-world utilization of spironolactone from our large, geographically, and demographically diverse multi-site study in the US are consistent with reports from smaller studies in the literature. Similar spironolactone dosing and duration were observed in both the HFpEF and HFrEF cohorts. Future research characterizing spironolactone treated and untreated HFpEF cohorts will be needed to identify treatment gaps.

背景:螺内酯是一种矿皮质激素受体拮抗剂，用于治疗心力衰竭伴射血分数降低(HFrEF)。在之前的一项临床试验中，螺内酯显著降低了保留射血分数(HFpEF)的心力衰竭(HF)患者的住院率。螺内酯在HFrEF和HFpEF中的实际应用尚不清楚。方法:我们使用FDA哨兵系统的数据进行了一项回顾性队列研究。我们使用先前验证过的算法中的诊断和程序代码来确定HFrEF或HFpEF患者。我们要求患者在HF诊断前183天连续入组。随访开始于HF诊断当天，并在最早发生螺内酯配药、退组、死亡或数据结束时结束。我们计算了使用螺内酯的比例，对于那些开始治疗的患者，我们估计了第一次连续治疗的剂量和持续时间。结果:2,009,529例HFrEF患者中，男性占57.8%，平均年龄73.8±12.1岁。9257514例HFpEF患者中，男性占42.7%，平均年龄73.0±12.1岁。HFrEF诊断后使用螺内酯的比例为20.7%，而HFpEF后为7.6%。HFrEF诊断后开始使用螺内酯的中位时间(天)为90 (IQR: 19-385)，而HFpEF诊断后为286 (IQR: 57-851)。HFrEF患者首次治疗的中位持续时间(天)为120 (IQR: 44-321)， HFpEF患者为114 (IQR: 32-301)。两个心衰组的中位剂量相似(25mg /天)。结论:我们在美国进行的大型、地理位置和人口分布多样化的多地点研究发现，螺内酯的实际使用率较低，这与文献中较小的研究报告一致。在HFpEF组和HFrEF组中观察到相似的螺内酯剂量和持续时间。需要进一步研究螺内酯治疗和未治疗的HFpEF队列，以确定治疗差距。

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引用次数: 0

Medication Use among Immigrants from Syria Living in Western Norway: A Cross-Sectional Study 生活在挪威西部的叙利亚移民的药物使用:一项横断面研究

Pharmacoepidemiology

Pub Date : 2022-09-01 DOI: 10.3390/pharma1020008

George Deeb, E. Diaz, S. Haavik, A. Lupattelli

This cross-sectional study sought to quantify medication use and change in use of prescription-only medications purchased in the past in Syria without medical prescription versus today in Norway in an adult population originating from Syria and living in western Norway. Data on adults born in Syria and living in Norway during December 2019–January 2020 were collected via a self-administrated questionnaire in Arabic. Participants were recruited at a community pharmacy and at a refugee center. We included 148 participants (mean age 36.4 years; 38.5% females and 60.8% males) of whom 62.6% had lived in Norway for 4–6 years. Most participants had low (45.9%) or medium (39.2%) health literacy. Painkillers and analgesics were the most widely used medications, in both Norway (69.6%) and Syria (78.4%). Use of antibiotics declined significantly in Norway (31.1%) relative to Syria (65.5%); 70.9% participants used prescription-only medications in both countries, while 6.1% and 13.5%, respectively, did so only in Norway or only in Syria. This study reports a relatively high rate of medication use, particularly painkillers and analgesics both in Syria and in Norway. Participants with low health literacy reported greater use of antibiotics than those with high level in Syria but not in Norway. Use of antibiotics decreased substantially in Norway relative to the past in Syria, reaching a comparable prevalence with that in the host community. Although uncommon, prescription-only medication use only in Norway was reported by some participants.

这项横断面研究试图量化来自叙利亚并居住在挪威西部的成年人口的药物使用情况和过去在叙利亚购买的处方药使用情况的变化，而不是现在在挪威。2019年12月至2020年1月期间出生在叙利亚并居住在挪威的成年人的数据是通过阿拉伯语的自我管理问卷收集的。参与者是在社区药房和难民中心招募的。我们纳入了148名参与者（平均年龄36.4岁；38.5%的女性和60.8%的男性），其中62.6%的人在挪威生活了4-6年。大多数参与者的健康素养较低（45.9%）或中等（39.2%）。止痛药和止痛药是使用最广泛的药物，在挪威（69.6%）和叙利亚（78.4%）。相对于叙利亚（65.5%），挪威（31.1%）的抗生素使用量显著下降；在这两个国家，70.9%的参与者只使用处方药，而分别有6.1%和13.5%的参与者只在挪威或叙利亚使用。这项研究报告称，叙利亚和挪威的药物使用率相对较高，尤其是止痛药和止痛药。叙利亚健康知识水平低的参与者报告说，他们比健康知识水平高的参与者使用了更多的抗生素，但挪威没有。与过去叙利亚相比，挪威的抗生素使用量大幅下降，与宿主社区的流行率相当。一些参与者报告说，尽管不常见，但仅在挪威使用处方药。

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引用次数: 0

The Complexity in the Diagnosis and Treatment of Symptoms in Electronic Cigarette Users during the COVID-19 Pandemic 新冠肺炎大流行期间电子烟使用者症状诊断和治疗的复杂性

Pharmacoepidemiology

Pub Date : 2022-07-12 DOI: 10.3390/pharma1020006

A. Ahmed, M. Ahmed

The issue with the overlapping clinical symptoms from an electronic cigarette (e-cigarette) or vaping product use-associated lung injury (EVALI) and coronavirus disease 2019 (COVID-19) sometimes leads to incorrect diagnosis and, consequently, wrong treatment regimen. The purpose of this review is to study the burden of vaping-associated health consequences on the diagnosis and treatment of COVID-19 in young adults and adolescents with a misconception of e-cigarettes as a safer alternative to smoking. The online reference databases, including PubMed, Google Scholar, Web of Science, Medline, and Centers for Disease Control and Prevention (CDC), were used in the literature search, as we analyzed the complexity of timely diagnosis and treatment in the current COVID-19 era with the use of e-cigarettes. This study briefly describes the dysbiosis of the oral microbiome in e-cigarette users that could potentially aggravate the COVID-19 symptoms and lead to the complexity of timely diagnosis and treatment. Additionally, the patient case reports with a history of vaping and symptoms similar to COVID-19 disease are reviewed.

电子烟或电子烟产品使用相关肺损伤(EVALI)和2019冠状病毒病(COVID-19)的临床症状重叠的问题有时会导致错误的诊断，从而导致错误的治疗方案。本综述的目的是研究电子烟相关健康后果对年轻成人和青少年COVID-19诊断和治疗的负担，这些年轻人和青少年错误地认为电子烟是吸烟更安全的替代品。文献检索使用PubMed、谷歌Scholar、Web of Science、Medline、Centers for Disease Control and Prevention (CDC)等在线参考数据库，分析当前COVID-19时代使用电子烟进行及时诊断和治疗的复杂性。本研究简要描述了电子烟使用者口腔微生物群的失调，这可能会加剧COVID-19症状，并导致及时诊断和治疗的复杂性。此外，还回顾了有电子烟史和症状类似于COVID-19疾病的患者病例报告。

引用次数: 1

Welcome to Pharmacoepidemiology—An Open Access Journal 欢迎来到《药物流行病学——开放获取期刊》

Pharmacoepidemiology

Pub Date : 2022-05-13 DOI: 10.3390/pharma1010004

C. Bosetti

We are very proud to launch this new, international, peer-reviewed, open access journal [...]

我们很自豪能推出这本新的、国际性的、同行评审的、开放获取的期刊[…]

引用次数: 0

Multimedication in Family Doctor Practices: The German Evidence-Based Guidelines on Multimedication 家庭医生实践中的多重用药:德国多重用药循证指南

Pharmacoepidemiology

Pub Date : 2022-05-13 DOI: 10.3390/pharma1010005

I. Schubert, J. Fessler, Sebastian Harder, T. Dinh, Maria-Sophie Brueckle, C. Muth

Patients with multimorbidity and multimedication require special attention from their treating physicians, as the risks of drug interactions and negative effects on adherence increase with the number of drugs. Most guidelines aim for the treatment of a single disease and do not take potential problems due to multimedication into account. In 2021, updates and evidence-based upgrades of the first version (2012) of the German Guidelines on Multimedication were issued. The aim of the article is to introduce the framework of these evidence-based guidelines, which follows the medication process in six steps: (1) inventory and medication assessment; (2) coordination with the patient; (3) prescription proposal and communication; (4) dispensing of medicines; (5) medication application and self-management; and (6) monitoring. For each step, recommendations and practice tips are presented. The central feature is a structured medication review. The target group is patients with multimorbidity and the concurrent use of five or more drugs. The Medication Appropriateness Index has been modified, and the guiding questions are recommended as guidance for the structured medication review. Overuse and undertreatment are taken into account. The guidelines were consented to in a formal process with 15 medical societies, a patient representative, and experts, as well as piloted in general practices.

由于药物相互作用的风险和对依从性的负面影响随着药物数量的增加而增加，患有多种疾病和多种药物的患者需要其治疗医生的特别关注。大多数指南的目标是治疗单一疾病，而没有考虑到多种药物治疗带来的潜在问题。2021年，发布了第一版(2012年)《德国多种药物指南》的更新和循证升级。本文旨在介绍这些循证指南的框架，该指南遵循用药过程的六个步骤:(1)清单和用药评估;(2)与患者的协调;(3)处方建议与沟通;(四)调剂药品;(5)用药及自我管理;(6)监测。对于每个步骤，都给出了建议和练习技巧。中心特征是结构化的药物回顾。目标人群是同时使用五种或五种以上药物的多病患者。用药适宜性指数已被修改，并建议将指导性问题作为结构化用药审查的指导。过度使用和治疗不足也被考虑在内。这些准则经15个医学协会、一名患者代表和专家的正式程序同意，并在一般做法中试行。

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引用次数: 2

Risk of Obstructive Sleep Apnea in Adults with Resistant Hypertension 成人顽固性高血压患者阻塞性睡眠呼吸暂停的风险

Pharmacoepidemiology

Pub Date : 2022-05-12 DOI: 10.3390/pharma1010003

Raj Desai, Haesuk Park, Joshua D. Brown, Steven M. Smith

The risk of obstructive sleep apnea (OSA) in patients with resistant hypertension (RH) has not been well-quantified. We sought to evaluate the risk of OSA in patients with RH compared to those with treated but non-resistant hypertension (non-RH) using a time-dependent-exposure analysis. We conducted a retrospective cohort study of patients with treated hypertension (hypertension diagnosis + ≥2 antihypertensive drug claims within 1 year) using the IBM MarketScan® commercial claims database from January 2008 to December 2019. We excluded patients without 12 months of continuous enrollment before the second antihypertensive fill date (index date of cohort entry) and those having the outcome (OSA) in the 12-month pre-index period. We employed Cox proportional hazard regression with OSA as the dependent variable, and time-dependent exposure (non-RH vs. RH) and baseline covariates as independent variables. Of the 1,375,055 patients with treated hypertension, 13,584 patients were categorized as exposed to RH. In the multivariable Cox proportional hazards model, exposure with RH was associated with a 60% increased risk of OSA (adjusted hazard ratio (aHR): 1.60; 95% CI, 1.52–1.68) compared to non-RH exposure. Findings of the study suggest that exposure with RH, compared to non-RH, is associated with a higher risk of incident OSA.

抵抗性高血压（RH）患者发生阻塞性睡眠呼吸暂停（OSA）的风险尚未得到很好的量化。我们试图通过时间依赖性暴露分析来评估RH患者与接受治疗但无耐药性高血压（非RH）患者发生OSA的风险。2008年1月至2019年12月，我们使用IBM MarketScan®商业索赔数据库对接受治疗的高血压患者（1年内高血压诊断+≥2例降压药索赔）进行了一项回顾性队列研究。我们排除了在第二个降压药填充日期（队列输入的指标日期）之前没有连续入组12个月的患者和在指标前12个月内有结果（OSA）的患者。我们采用Cox比例风险回归，OSA为因变量，时间依赖性暴露（非RH与RH）和基线协变量为自变量。在1375055名接受治疗的高血压患者中，13584名患者被归类为暴露于RH。在多变量Cox比例风险模型中，暴露于RH与OSA风险增加60%相关（调整后的风险比（aHR）：1.60；95%CI，1.52–1.68）。研究结果表明，与非RH相比，暴露于RH与OSA发生的风险更高。

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引用次数: 1

Multimedication Guidelines: Assessment of the Size of the Target Group for Medication Review and Description of the Frequency of Their Potential Drug Safety Problems with Routine Data 多用药指南：评估药物审查目标人群的规模，并用常规数据描述其潜在药物安全问题的频率

Pharmacoepidemiology

Pub Date : 2022-04-15 DOI: 10.3390/pharma1010002

V. Lappe, T. Dinh, S. Harder, Maria-Sophie Brueckle, J. Fessler, U. Marschall, C. Muth, I. Schubert

(1) Background: About 10 years ago, several guidelines for the better management of patients with polypharmacy were issued. A central issue is the definition of the target group. The primary aim of this study is therefore to assess the size of the target group, applying the criteria of the German guidelines. A further aim is to describe the frequency of occurrence of medication safety issues for patients of the target group. (2) Methods: The study is based on administrative data of one large statutory health insurer in Germany (n = 9,012,523). (3) Results: The criteria of multimorbidity (at least three chronic diseases) and utilization of five or more concurrent drugs over at least 91 days is fulfilled by 14.1% of the insured patients, or almost 1.3 million persons. About 5% of this multimorbid and poly-medicated population fulfilled at least three of out of five additional occasion-related criteria. Medication safety issues occur frequently: treatment prevalence with potentially inadequate medication, QT-drugs, benzodiazepine or Z-drugs and proton pump inhibitors was 30.4%, 28.9%, 11.1% and 52.4%, respectively. (4) Conclusions: The analysis shows the scope of patients eligible for a structured medication review and demonstrates the relevance for counselling based on the high percentage potentially at risk due to medication therapy safety problems.

（1）背景：大约10年前，发布了几项关于更好地管理多药患者的指南。一个核心问题是目标群体的定义。因此，本研究的主要目的是应用德国指南的标准来评估目标群体的规模。另一个目的是描述目标群体患者药物安全问题的发生频率。（2）方法：本研究基于德国一家大型法定健康保险公司（n=9012523）的管理数据。（3）结果：14.1%的参保患者，即近130万人，符合多发病（至少三种慢性病）和在至少91天内同时使用五种或五种以上药物的标准。大约5%的多发病和多药人群至少满足了五分之三的额外场合相关标准。药物安全问题经常发生：潜在药物不足、QT药物、苯二氮卓类或Z类药物以及质子泵抑制剂的治疗发生率分别为30.4%、28.9%、11.1%和52.4%。（4）结论：该分析显示了有资格进行结构化药物审查的患者的范围，并证明了基于药物治疗安全问题潜在风险的高百分比的咨询的相关性。

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引用次数: 5

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