PHARMACOEPIDEMIOLOGY AND DRUG SAFETY药物流行病学与药物安全
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY(英文缩写 PHARMACOEPIDEM DR S),ISSN 1053-8569,eISSN 1099-1557,中文译名:药物流行病学与药物安全 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-11-01 至 2026-10-31，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 2.732 | Q3 |
| 2022 | 2.600 | Q3 |
| 2023 | 2.400 | Q2 |
| 2024 | 2.400 | Q2 |
| 2025 | 2.600 | Q2 |
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 最新收录文献
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1. Post-Discharge Antiseizure Medication Use and Poststroke Survival: An Emulated Target Trial in Older Adults.
1. 出院后抗癫痫药物使用与卒中后生存：一项针对老年人的模拟目标试验PMID:日期:2026-09-30Levetiracetam is commonly prescribed for seizure prophylaxis after acute ischemic stroke (AIS) and often continued beyond discharge. While its short-term effectiveness for preventing poststroke seizures is established, it is unclear whether prolonged use improves survival, particularly in older adults. We estimated the effect of continued levetiracetam use on 90-day mortality among Medicare beneficiaries after AIS. Using Traditional Medicare claims data (2008-2021), we identified beneficiaries aged ≥ 65 years hospitalized for AIS who initiated outpatient levetiracetam within 90 days of discharge. After 1 month of continued poststroke levetiracetam use (start of follow-up), we compared 90-day mortality between patients with a new levetiracetam dispensation within a 14-day grace period post-follow-up and those without one. We performed cloning, censoring, and weighting to address immortal-time bias and estimated standardized mortality risks, risk differences, and 95% confidence intervals (CIs). Among 3212 eligible beneficiaries, 1779 (55.4%) received a new levetiracetam dispensation within the 14-day grace period. After adjustment for demographics, hospitalization characteristics, timing of initiation, and comorbidities, continued use was associated with lower 90-day mortality than discontinuation (53 vs. 62 deaths per 1000; risk difference -9 per 1000; 95% CI: -12, -5). Among older Medicare beneficiaries who initiated levetiracetam after AIS, continued outpatient use was associated with lower short-term 90-day mortality, particularly among patients aged ≥ 75 years. These findings should not be interpreted as support for routine or indefinite continuation, because the claims-based design cannot assess seizure recurrence, functional outcomes, quality of life, treatment indication, or potential neuropsychiatric harms.
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2. Validation of Claims-Based Algorithms for Intussusception Identification in Japanese Hospitals: A Multicenter Analysis From the CLEAR Study.
2. 日本医院中基于理赔的肠套叠识别算法的验证：CLEAR研究的多中心分析PMID:日期:2026-09-29Intussusception is a serious condition and a rare adverse event of rotavirus vaccination. While health insurance claims data are increasingly used for epidemiological research, claims-based algorithms for identifying intussusception have not been validated in Japan. This study aimed to validate multiple claims-based algorithms for intussusception identification against ultrasound findings as the reference standard. This validation study used claims data and ultrasound findings from three Japanese hospitals between 2011 and 2024. The study population comprised all patients who received care during each hospital's data period. We developed 10 algorithms combining an intussusception diagnostic code (ICD-10: K56.1), hospitalization status, ultrasound imaging codes, and surgery codes. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each algorithm. Age- and sex-stratified analyses were also performed. Among 701 263 patients (mean age: 41.8 years; 52.0% female), 79 true intussusception cases (mean age: 8.3 years; 41.8% female) were identified (prevalence: 0.0113%). While sensitivity (54.4%-77.2%) and PPV (8.9%-28.1%) varied according to definition stringency, all algorithms achieved near-perfect specificity and NPV (≥ 99.9%). The algorithm that only used the diagnostic code yielded the highest sensitivity, while the algorithm that incorporated all four criteria achieved the highest PPV. Algorithm validity varied by age, with higher sensitivity and PPV for children aged ≤ 5 years. The algorithms demonstrated a trade-off between sensitivity and PPV, and researchers should select algorithms according to their study objectives. Our findings provide a robust foundation to guide algorithm selection for intussusception research using Japanese claims data.
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3. CodeMergeR: A Shiny-Based Application for Codelist Integration.
3. CodeMergeR：一个基于Shiny的代码列表集成应用PMID:日期:2026-09-29To describe CodeMergeR, an open-source R shiny application developed within the VAC4EU network for the standardization, cleaning, and integration of individual concept codelists into a master file for real-world evidence (RWE) studies. CodeMergeR was designed to process codelists exported by CodeMapper v1.0. The application includes two modules: (1) Conformance and Coherence, which checks file naming conventions, metadata consistency, and structural integrity; and (2) Cleaning and Standardization, which removes duplicates, corrects formatting issues where a valid match is available, flags and excludes uncorrectable codes (e.g., scientific notation, dashes). Functional and performance testing were conducted using real-world library metadata and codelists from the VAC4EU library, including manually introduced errors to assess detection capabilities. The CodeMergeR identified a wide range of structural and semantic issues, achieving an overall error detection rate of 96.8% (61/63 errors). Depending on the issue type, detected errors were either automatically corrected (e.g., rounding, when a validated code was found), flagged and excluded from the master codelist if unresolved (e.g., scientific notation, dashes), or flagged for manual review (e.g., metadata mismatches, missing concepts). Processing of 50 clinical concept folders and 10 Algorithms completed in under 1 min during performance testing. CodeMergeR detected structural and formatting errors with an accuracy of 96.8%, supporting its use as a quality-check step prior to deploying codelists in analytical pipelines. In contrast to existing, CodeMergeR fills a distinct quality assurance role in codelist generation and transparency. CodeMergeR contributes to improved reproducibility, scalability, and transparency in codelist management in RWE studies.
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4. Pregnancy Outcome After First-Trimester Exposure to Statins: Study Results Based on the Embryotox Cohort.
4. 孕早期暴露于他汀类药物后的妊娠结局：基于Embryotox队列的研究结果PMID:日期:2026-09-28This observational cohort study aimed to assess the risk of adverse pregnancy and neonatal outcomes in pregnancies exposed to statins during the first trimester, given that the use of statins during pregnancy remains controversial. The primary study endpoints were the rates of spontaneous abortion and major birth defects. In total, 188 pregnancies exposed to statins in the first trimester were compared with a cohort of 564 pregnancies without the study medication, which were recorded at the Embryotox Centre between January 2000 and June 2021. The effect of statin exposure on pregnancy outcome was estimated using Cox proportional hazards regression models. Log-binomial regression was used to evaluate the risk of major birth defects. Major birth defects were observed in 10 of 135 (7.4%) infants in the statin cohort and in 12 of 501 (2.4%) infants in the comparison cohort (RR 3.09, 95% CI 1.37-7.00). After adjustment for relevant baseline covariates and additional maternal disease factors, the difference substantially attenuated (RRadj 2.16; 95% CI 0.88-5.31). The cumulative incidence of spontaneous abortion was 26.8% in the statin-exposed versus 15.0% in the comparison cohort (HR 1.86, 95% CI 1.13-3.04; HRadj 1.66, 95% CI 0.99-2.78). Current evidence suggests that statins are not major teratogens. The observed associations between statin exposure and birth defects, as well as unfavourable pregnancy outcomes, are presumably influenced by confounding factors such as underlying maternal disease. Our study results lend support to this assumption. However, they should be interpreted cautiously due to the limited cohort size.
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5. Brain Penetrant Calcium Channel Blockers Were Not Associated With Reduced Alcohol Consumption: Converging Results From Two Large Independent Cohort Studies Using Electronic Health Records.
5. 脑穿透性钙通道阻滞剂与酒精消费量降低无关：两项使用电子健康记录的大型独立队列研究得出一致结果PMID:日期:2026-09-27Alcohol use disorder (AUD) remains a major public health problem, with few effective treatments. L-type calcium channel blockers (LTCCBs) have genetic and preclinical support as potential treatments for AUD. We evaluated whether brain penetrant (BP)-LTCCBs are associated with reduced alcohol consumption in two preregistered observational cohort studies using electronic health records from the US Department of Veterans Affairs (VA) and Kaiser Permanente Northern California (KPNC). New users of BP-LTCCBs (nifedipine or felodipine) were compared with new users of a non-BP-LTCCB (amlodipine) and with unexposed patients from the same clinics, requiring a 180-day washout and ≥ 60 days' supply. Propensity score matching was performed across all exposure contrasts. The primary outcome was change in drinks per week from pre-index to end of follow-up using difference-in-differences (DiD) models, with prespecified subgroup analyses by AUD diagnosis, drinking level, and sex. Across both health systems, BP-LTCCB initiation was not associated with greater reductions in drinks per week than either comparator, with broadly consistent findings across all subgroups; though some subgroups were small and imprecise. In the VA, the DiD comparing BP-LTCCB with non-BP-LTCCB was 0.14 drinks/week (95% CI -0.06, 0.34), and versus unexposed was 0.00 (95% CI -0.18, 0.19). Similar results were observed in KPNC (BP-LTCCB vs. non-BP-LTCCB: 0.31, 95% CI -0.48, 1.11; BP-LTCCB vs. unexposed: 0.16, 95% CI -0.67, 0.99). In two large, preregistered EHR-based cohorts, we found no evidence that BP-LTCCBs were associated with reduced drinking relative to comparators. Despite compelling genetic and preclinical evidence, these findings do not support repurposing BP-LTCCBs for AUD and instead prioritize alternative pharmacologic targets.
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6. Trends and Gender Disparities in Medical Narcotics Utilization in South Korea: A Nationwide Population-Based Study, 2019-2023.
6. 韩国医疗麻醉药品使用趋势与性别差异：一项基于全国人群的研究，2019-2023年PMID:日期:2026-09-25In South Korea, a substantial volume of prescription psychotropics is dispensed outside the national health insurance reimbursement system, creating a pharmacovigilance blind spot. We investigated nationwide utilization patterns of medical narcotics to identify potential safety signals using the Narcotics Information Management System (NIMS) database. This population-based descriptive study analyzed NIMS data covering all controlled substances dispensed in South Korea from January 2019 to May 2023. We examined overall trends and stratified patterns for anorexiants and ADHD medications. Prescription volumes were expressed as estimated dispensing units (EDU) per 1000 persons per month using resident registration population data as denominators. Among 3.1 million dispensing cases, anorexiants exhibited a stark gender disparity. Women at primary care clinics received approximately 440 EDUs per 1000 women per month-approximately 15 times the volume dispensed to men-concentrated among women aged 30-49, suggesting widespread prescribing outside approved indications for aesthetic weight management. ADHD medications were predominantly dispensed to males, with the largest gender gap observed in adolescents aged 10-19 and a progressively narrowing disparity in older age groups. Dispensing rates for both drug classes increased steadily over the study period, with the most pronounced rise in ADHD medications observed after the resumption of in-person schooling following COVID-19 disruptions. This study provides the first population-level analysis of medical narcotics utilization in South Korea's non-reimbursed sector. The disproportionate exposure of young women to psychotropic anorexiants constitutes a compelling pharmacovigilance signal. Addressing this requires not only an integrated data infrastructure linking NIMS with national health insurance records, but also the restoration of meaningful professional oversight over prescribing outside the reimbursement system.
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7. Incremental Propensity Score Interventions: A Primer for Pharmacoepidemiologists.
7. 增量倾向评分干预：药物流行病学家的入门指南PMID:日期:2026-09-25In observational pharmacoepidemiology, estimating average treatment effects (ATEs) is often challenging due to a lack of practical positivity. In highly selective clinical settings, certain patients almost always or never receive treatment, causing ATE estimators to rely on unstable extrapolation. Incremental propensity score interventions (IPSIs) offer a stochastic alternative by shifting each patient's probability of treatment, providing a more clinically realistic framework that circumvents positivity violations. We illustrate the IPSI approach, including key identification results and inferential procedures. Using observational data from a cohort of 996 patients undergoing percutaneous coronary intervention (PCI), we evaluated the effect of shifting each patient's probability of receiving abciximab by a predetermined amount on six-month mortality. Propensity scores (PSs) and outcome predictions were estimated using a machine learning ensemble (Super Learner) with 10-fold sample splitting. The ATE estimate suggested that abciximab administration reduced the 6-month mortality risk by 5.9 percentage points compared with PCI alone (risk difference = -0.059, 95% CI: -0.104 to -0.015). However, the practical interpretability of the ATE estimate may be limited because it implicitly assumes that patients with a near-certain probability of treatment could realistically be assigned to withhold abciximab. In contrast, shifting each patient's treatment propensity by odds ratios ranging from 0.1 to 10 showed that 6-month mortality would be significantly reduced under a strong treatment policy promoting abciximab administration. IPSIs provide a robust and practical alternative to conventional causal inference methods in pharmacoepidemiology settings where treatment assignment is highly selective and the strict positivity is violated.
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8. Updated Estimates of Agreement Between Dispensed Medications and Forensic Toxicology in Sweden.
8. 瑞典配发药物与法医毒理学一致性的更新估计PMID:日期:2026-09-24To present updated estimates from a nationwide Swedish study comparing dispensed medications with forensic toxicological findings (2006-2013), following re-evaluation of the toxicology dataset to address periods with non-uniform analytical detection and inconsistent testing. Observations from time periods with non-uniform detection or inconsistent testing were excluded. Analyses were repeated using the PRE2DUP method to model drug exposure. Agreement between PRE2DUP-modelled exposure and post-mortem toxicology was assessed using sensitivity, specificity, predicted adherence, and Cohen's κ. After exclusion of inconsistent testing periods, the number of individuals for affected substances was reduced (10 060 vs. 18 627). Proportional changes in sensitivity and specificity were negligible. In contrast, predicted adherence and Cohen's κ improved across several substances. Moderate to substantial proportional increases were observed for selected medications but translated into only small group-level effects (approximately 2%-7%). The largest improvements were observed for cardiovascular drugs, beta-blockers, for which Cohen's κ and predicted adherence increased substantially (approximately 40%-55%) at the class level; notably, only for these substances did Cohen's κ shift interpretation (from fair to moderate agreement). Overall, proportional improvements across all substances were moderate (approximately 10%-15%). Despite these changes, overall agreement patterns remained comparable to the original results. After exclusion of periods with non-uniform or incomplete toxicological testing, agreement between PRE2DUP-modelled exposure and forensic toxicology improved overall. Moderate increases observed for a few individual medications translated into only small effects at the group level, except for cardiovascular drugs, for which improvements were substantial. These updates do not materially alter the original interpretation but strengthen the validity of register-based drug exposure modelling.
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9. Use of Ibuprofen Before and in Early Pregnancy Among Women With and Without Chronic Medical Diseases. A Cross-Sectional Study.
9. 患有与未患有慢性内科疾病的女性在孕前及孕早期使用布洛芬的情况。一项横断面研究PMID:日期:2026-09-23While having a chronic medical disease (CMD) increases use of analgesics and anti-inflammatory drugs, sufficient knowledge regarding patterns of use during pregnancy is lacking. We aimed to describe ibuprofen use before and in early pregnancy among women with and without CMD, and to assess the associations between CMD and ibuprofen use before and in early pregnancy. We used self-reported data from 24 018 pregnancies from the Copenhagen Pregnancy Cohort (2013-2019) to compare ibuprofen use between women with and without CMD. Descriptive statistics and multivariable logistic regression models were applied. Women with CMD reported higher ibuprofen use before and in early pregnancy. However, use was markedly reduced from before to early pregnancy in both groups: from 19.8% to 0.61% among women with CMD (p < 0.001), and from 16.9% to 0.27% among women without. Before pregnancy, women with CMD more often reported frequent (daily or 1-2 times per week) ibuprofen use compared with women without (aOR 2.40, 95% CI 1.96-2.94), and in early pregnancy more often any use (aOR 2.08, 95% CI 1.31-3.32). Especially endometrioses, rheumatological, and neurological diseases were associated with frequent use before pregnancy (aOR 4.85, 95% CI 2.14-10.99; aOR 4.57, 95% CI 2.92-7.16; and aOR 3.55, 95% CI 2.09-6.04, respectively). Similar analyses of specific diseases in early pregnancy were precluded due to low numbers. Use of ibuprofen was markedly reduced in early pregnancy, among both women with and without CMD. Having CMD was associated with increased ibuprofen use before and in early pregnancy.
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10. High Risk of Metabolic Side Effects Among New Paediatric Antipsychotic Users in Sweden-A Register-Based Study.
10. 瑞典新使用抗精神病药物的儿童患者代谢副作用风险高——一项基于登记的研究PMID:日期:2026-09-22This study aims to assess the risk of metabolic side effects among paediatric new users of antipsychotics in Sweden, focusing on differences between substances and sexes. Children aged 5-17 years, who were new users of antipsychotics between 2014 and 2021, were identified using Swedish national health registers. Cox' models were fitted for children during first treatment with an antipsychotic, excluding those with eating disorders, yielding hazard ratios (HRs) for metabolic side effects with 95% confidence intervals (CIs). A total of 5441 children were new users of antipsychotics. Of these, 399 (7.3%; 42% girls) received a new diagnosis or new treatment indicating a metabolic side effect, of which 139 cases during first-line treatment and without an eating disorder diagnosis. Obesity was the most common metabolic side effect, accounting for 69% of the cases. In girls, significantly increased risks were observed for aripiprazole (HR 3.52, 95% CI 1.58-7.80), olanzapine (HR 6.99, 95% CI 2.34-20.93) and quetiapine (HR 4.87, 95% CI 1.97-12.04), compared with risperidone. Younger girls had higher risks. In boys, a significantly increased risk was found for aripiprazole (HR 2.21, 95% CI 1.37-3.56). The overall risk of metabolic side effects is considerable, with higher relative risks in girls, especially younger girls. These findings highlight the need for carefully considered treatment and attentive monitoring when initiating antipsychotics in children.