The International journal of risk & safety in medicine最新文献_第2页

Strengthening pharmacovigilance for herbal medicines in Nigeria: An urgent health systems challenge. 加强尼日利亚草药药物警戒：卫生系统面临的紧迫挑战。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-03-04 DOI: 10.1177/09246479261432851

David Ololade Atanda, Oluwabukunmi Deborah Ayoola, Esther Oluwasemipe Adegunloye, Oluwatoyosi Moyinoluwa Aladelo

引用次数: 0

Batch-dependent safety signal: Nationwide analysis of suspected adverse events following COVID-19 vaccination in Germany. 批次依赖的安全信号：德国COVID-19疫苗接种后疑似不良事件的全国分析。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-05-19 DOI: 10.1177/09246479261453789

Vibeke Manniche, Vít Karásek, Max Schmeling, Jonathan D Gilthorpe, Tomáš Fürst, Peter Riis Hansen

{"title":"Batch-dependent safety signal: Nationwide analysis of suspected adverse events following COVID-19 vaccination in Germany.","authors":"Vibeke Manniche, Vít Karásek, Max Schmeling, Jonathan D Gilthorpe, Tomáš Fürst, Peter Riis Hansen","doi":"10.1177/09246479261453789","DOIUrl":"10.1177/09246479261453789","url":null,"abstract":"BackgroundPreliminary reports have suggested a batch-dependent safety signal for COVID-19 vaccines. It is important to establish if these findings can be replicated.MethodsWe used publicly available nationwide data from Germany spanning the first 3.5 years of the vaccination campaign to calculate weekly rates of spontaneously reported suspected adverse events (SAEs) per 1000 administered vaccine doses.ResultsSAE rates ranged between 2.2 and 22.8 per 1000 doses and women accounted for 72% of all SAEs. Crucially, SAE rates for Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), and Vaxzevria (AstraZeneca) were very high in the initial phase of vaccination rollout and hereafter declined precipitously. For example, SAE rates in weeks 1-4 of 2021 were 8.2, 50.8, and 620.9 per 1000 doses of Comirnaty, Spikevax, and Vaxzevria, respectively, but fell to 4.4, 11.6, and 7.4 per 1000 doses in weeks 12-16 of 2021.ConclusionsSAE rates in Germany were highly elevated in the initial phase of COVID-19 vaccination rollout and then fell precipitously, a pattern compatible with a batch-dependent safety signal. Furthermore, there was a considerable overrepresentation of women with SAEs. These preliminary results call for more definitive studies of batch-dependent COVID-19 vaccine safety.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"458-462"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147978642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of hematological adverse reactions in patients with epilepsy on monotherapy versus polytherapy. 癫痫患者单药治疗与多药治疗血液学不良反应的比较。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-04-20 DOI: 10.1177/09246479261444923

Ogunjimi Luqman, Ogunjimi Olabisi, Kasali Adeola, Oyenuga Ibironke, Ogungbe Oluwatosin, Adegoke Joshua, Mudashiru Olajumoke, Odusoga Oluwatosin, Adubi Opeoluwa, Akindolani Precious, Omotayo Adedire, Abeeb Taofeekat, Sonde James, Doyin-Bello Adedoyinsola, Kuye Testimony, Osalusi Bamidele

{"title":"Comparison of hematological adverse reactions in patients with epilepsy on monotherapy versus polytherapy.","authors":"Ogunjimi Luqman, Ogunjimi Olabisi, Kasali Adeola, Oyenuga Ibironke, Ogungbe Oluwatosin, Adegoke Joshua, Mudashiru Olajumoke, Odusoga Oluwatosin, Adubi Opeoluwa, Akindolani Precious, Omotayo Adedire, Abeeb Taofeekat, Sonde James, Doyin-Bello Adedoyinsola, Kuye Testimony, Osalusi Bamidele","doi":"10.1177/09246479261444923","DOIUrl":"10.1177/09246479261444923","url":null,"abstract":"BackgroundThis study compared the effects of anti-seizure medication (ASM) monotherapy and polytherapy on hematological parameters in patients with epilepsy (PWE).ObjectiveTo compare hematological parameters and derived inflammatory indices in patients with epilepsy receiving ASM monotherapy versus polytherapy and determine independent predictors and discriminatory performance of these parameters.MethodsA hospital-based cross-sectional study was conducted between January and June 2024 at the Neurology Clinic of Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria. Two hundred adult PWE were enrolled and classified into monotherapy or polytherapy groups. Sociodemographic and clinical data were collected. Venous blood samples were analyzed using the Sysmex XN-1000 hematology analyzer. Statistical analyses included independent t-tests, chi-square tests, logistic regression, and receiver operating characteristic (ROC) analysis (p < 0.05).ResultsMales predominated in the monotherapy group (58.8%), while females predominated in the polytherapy group (84.1%; p < 0.001). Monotherapy showed significantly higher neutrophils, hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin concentration, and neutrophil-lymphocyte ratio, but lower mean platelet volume. Neutrophils, hemoglobin, MCV, MCHC, and MPV independently predicted treatment pattern. ROC analysis showed moderate discrimination for MPV, while others performed poorly.ConclusionASM polytherapy is associated with greater hematological alterations. Monotherapy should be prioritized when feasible, with routine hematological monitoring recommended.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"390-398"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147725479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Preventable in-body hydrogen explosions from high-concentration H₂ inhalers in Japan-Switch to safe, low-concentration hydrogen therapy. 防止高浓度氢气吸入器引起的体内氢气爆炸——转向安全的低浓度氢气疗法。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-01-05 DOI: 10.1177/09246479251414573

Yusuke Ichikawa, Bunpei Sato, Yoshiyasu Takefuji, Fumitake Satoh

{"title":"Preventable in-body hydrogen explosions from high-concentration H2 inhalers in Japan-Switch to safe, low-concentration hydrogen therapy.","authors":"Yusuke Ichikawa, Bunpei Sato, Yoshiyasu Takefuji, Fumitake Satoh","doi":"10.1177/09246479251414573","DOIUrl":"10.1177/09246479251414573","url":null,"abstract":"BackgroundWith the growing recognition of the medical applications of hydrogen, hydrogen gas inhalers are increasingly used in clinics and other healthcare settings. However, hydrogen is highly explosive, and numerous explosion incidents involving these inhalers have been reported.ObjectivesThis study evaluates the safety risks of high-concentration hydrogen inhalers (67%-99.99% v/v H2) following multiple device explosions and a documented pulmonary explosion case, and to determine an optimal concentration balancing safety and efficacy.MethodsWe analyzed device explosion incidents recorded by the Consumer Affairs Agency of Japan and an in-body hydrogen explosion case reported in a 2024 scientific paper, and subsequently discussed the factors contributing to these accidents based on the explosive properties of hydrogen gas.ResultsHigh-concentration inhalers (>10% v/v H2) pose a substantial explosion risk, as confirmed by multiple device failures reported by Japan's Consumer Affairs Agency and a 2024 in-vivo pulmonary explosion case. Limiting hydrogen to ≤10% v/v maintains efficacy for intracellular hydroxyl radical scavenging while staying below the lower explosive limit.ConclusionTwo critical preventable hazards exist with high-concentration hydrogen therapy: external device explosion and internal airway detonation. Immediate transition to low-concentration (≤10% v/v H2) inhalers is strongly recommended, as they provide effective concentration while eliminating life-threatening risks, ensuring patient safety without compromising clinical outcomes.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"425-431"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145902237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A case of delayed-onset Stevens-Johnson syndrome following co-amoxiclav administration in a 98-year-old female. 一名98岁女性在阿莫昔拉夫联合用药后出现迟发性史蒂文斯-约翰逊综合征。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-02-17 DOI: 10.1177/09246479261426749

Gabriella Baldacchino, Francesca Farrugia, Godfrey Baldacchino

{"title":"A case of delayed-onset Stevens-Johnson syndrome following co-amoxiclav administration in a 98-year-old female.","authors":"Gabriella Baldacchino, Francesca Farrugia, Godfrey Baldacchino","doi":"10.1177/09246479261426749","DOIUrl":"10.1177/09246479261426749","url":null,"abstract":"BackgroundStevens-Johnson Syndrome is a type IV hypersensitivity mucocutaneous reaction characterised by a widespread desquamating rash, and is considered to be an emergency due to its potentially fatal complications. Drugs account for 50-80% of Stevens-Jonson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) cases, with anticonvulsants, antibiotics, analgesics and allopurinol being the most common causative agents. Co-amoxiclav contains amoxicillin (a penicillin) and clavulanic acid (a beta-lactamase inhibitor) and is widely used in healthcare settings for treatment of common infections due to its relatively broad spectrum and good safety profile. However, few publications have attributed SJS/TEN to co-amoxiclav administration.CaseWe describe the insidious development of Stevens-Johnson Syndrome in a 98-year-old female after receiving intravenous and oral co-amoxiclav (amoxicillin/clavulanic acid). The patient had received co-amoxiclav in prior hospital admissions with no reported complications.OutcomeThis was successfully treated with immunosuppressive therapies. The patient's frailty, as well as the exposed areas of skin and immunosuppression made her susceptible to a serious urinary tract infection and fall, which complicated her hospital stay.ConclusionCo-amoxiclav, while generally a well-tolerated antibiotic, should be a recognised cause of Stevens-Johnson syndrome, and care should be taken to prevent complications, especially in the elderly population.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"463-470"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146215516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Expression of concern: Trend analysis of adverse drug reactions to sedative-hypnotics among residents in Jiangsu Province of China, 2011-2019. 关注表达：2011-2019年江苏省居民镇静催眠药物不良反应趋势分析。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-01-07 DOI: 10.1177/09246479251413093

引用次数: 0

The causes of Australian excess deaths in 2021, and beyond: An ecological study considering COVID-19, the lockdowns, and the vaccines. 2021年及以后澳大利亚超额死亡的原因：一项考虑COVID-19、封锁和疫苗的生态学研究。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-02-14 DOI: 10.1177/09246479261426743

Raphael Lataster

{"title":"The causes of Australian excess deaths in 2021, and beyond: An ecological study considering COVID-19, the lockdowns, and the vaccines.","authors":"Raphael Lataster","doi":"10.1177/09246479261426743","DOIUrl":"10.1177/09246479261426743","url":null,"abstract":"BackgroundNumerous concerns have been raised about excess mortality persisting beyond the COVID-19 pandemic. COVID-19 and the lockdowns are typically offered as explanantia, with some suggesting that COVID-19 vaccines could be contributing. With its relative isolation it is prudent to pay attention to Australia, which provides a unique opportunity to consider what effectively became a large-scale vaccine safety trial.ObjectiveThe purpose of this study is to determine the plausibility of COVID-19 vaccination contributing to Australia's excess mortality.MethodsVarious regions of Australia displaying excess mortality were identified, and then the plausibility of three explanantia were considered in turn: COVID-19, the lockdowns, and COVID-19 vaccines.FindingsI found that in 4 of Australia's 8 major regions excess mortality was present, correlating with rapid and thorough COVID-19 vaccination programs, before mass exposure to COVID-19, and in the absence of lengthy and highly restrictive lockdowns.ConclusionsCombined with increasing evidence that the efficacy/effectiveness and safety of COVID-19 vaccines have been greatly exaggerated, including acknowledgements from the Australian and American governments that several deaths have been caused by the vaccines, these findings make it a near-certainty that COVID-19 vaccines have been - and continue to be - contributing to excess mortality.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"338-351"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146195718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Chronic venlafaxine ingestion inducing bluish oral hyperpigmentation with dysgeusia and dysphagia: A case report. 慢性文拉法辛摄入诱发蓝色口腔色素沉着伴发音困难和吞咽困难1例。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-04-10 DOI: 10.1177/09246479261441855

Yamini Ajmera, Karandeep Paul, Prasun Chatterjee

{"title":"Chronic venlafaxine ingestion inducing bluish oral hyperpigmentation with dysgeusia and dysphagia: A case report.","authors":"Yamini Ajmera, Karandeep Paul, Prasun Chatterjee","doi":"10.1177/09246479261441855","DOIUrl":"10.1177/09246479261441855","url":null,"abstract":"BackgroundMedication-induced oral hyperpigmentation represents an adverse drug reaction characterized by variable latency and unclear mechanism. Diagnosis is particularly challenging in older adults due to non-specific symptoms, multiple comorbidities and polypharmacy.Case reportWe present the first documented case of a woman in her 80s experiencing patchy, bluish hyperpigmentation of dorsum of tongue and buccal mucosa with altered taste sensation and swallowing difficulty, in association with chronic venlafaxine ingestion that remained undiagnosed for many years. To establish the current diagnosis, a comprehensive history taking, clinical examination, blood investigations and imaging studies were utilized to rule out the endogenous causes. Following discontinuation of venlafaxine, at 1 month follow-up, there was complete resolution of oral hyperpigmentation together with significant improvement in dysphagia and dysgeusia indicating a probable association with the drug.ConclusionThis report highlights the need for the healthcare professionals to be aware of the medications linked to oral hyperpigmentation to facilitate timely diagnosis, patient reassurance and optimize management.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"471-475"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147655620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Medical science and the madness of crowds; context for our COVID pandemic years. 医学科学与人群的疯狂；COVID大流行年份的背景。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-05-27 DOI: 10.1177/09246479261456462

Peter Rhodes

{"title":"Medical science and the madness of crowds; context for our COVID pandemic years.","authors":"Peter Rhodes","doi":"10.1177/09246479261456462","DOIUrl":"10.1177/09246479261456462","url":null,"abstract":"Individual autonomy is fragile.We must ask whether we have been swept up with ' a crowd '; perhaps trapped within a ' thought window ', carried by mass narrative, or entranced by the certainty of the totalitarised mind.Loss of the individual to the group can occur on any scale, from ' group-think ' cognitive bias, through the eager madness of a literal crowd, to the modern global reach of propaganda and technocratic totalitarianism.Milgram electrocution experiments show potential for the mind to be rapidly totalitarised - the hypnotic, focal enthusiasm of ' engaged followers '.This work was performed at the time Hannah Arendt coined the term ' banality of evil ' and described a new form of criminal, the bureaucrat.Totalitarianism is an ever present under current in society and the scientific community is not exempt from the dangers. Strictly enforced bed rest for patients is one of the best known medical mass narratives, responsible for the loss of many lives.Responses to the COVID pandemic years echo the ideologies of history.Healthy curiosity, dissent from the main stream and open debate are essential to progress in science and must be welcome at all times.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"443-445"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13428813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148045426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Mitigating risk in psychiatric hospital care for older adults by identifying adverse events with Global Trigger Tool for psychiatric patients. 通过识别精神病人的全球触发工具的不良事件，降低老年人精神病院护理的风险。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-01-11 DOI: 10.1177/09246479251409028

Arne Okkenhaug, Eivind Aakhus, Guro F Giskeødegård, Bodil J Landstad, Ellen T Deilkås

{"title":"Mitigating risk in psychiatric hospital care for older adults by identifying adverse events with Global Trigger Tool for psychiatric patients.","authors":"Arne Okkenhaug, Eivind Aakhus, Guro F Giskeødegård, Bodil J Landstad, Ellen T Deilkås","doi":"10.1177/09246479251409028","DOIUrl":"10.1177/09246479251409028","url":null,"abstract":"BackgroundOlder adults receiving psychiatric care are at greater risk of adverse events (AEs) than younger patients. This reflects broader vulnerabilities, including marginalization, complex health needs, and frequent transitions between care settings. It is therefore necessary to investigate AE risk in this population and to validate a previous version of the Global Trigger Tool - Psychiatry (GTT-P), originally developed for the general psychiatric population, for use with older psychiatric patients.ObjectiveTo apply the Norwegian version of GTT-P in psychiatric care for older adults, to identify the prevalence of AEs in this subpopulation.MethodsA retrospective cohort study was conducted by reviewing medical records of 184 patients aged 65+ admitted to a psychiatric hospital between 2022 and 2023. All patients who did not opt out were included.ResultsAEs were identified in 10.9% of patients. Triggers related to compulsory treatment and medication significantly increased AE risk. No AEs occurred without associated triggers. Of the AEs identified, 63% were considered avoidable.ConclusionsThis study demonstrates the utility of GTT-P in detecting AEs in older psychiatric patients. Specific clinical triggers were significantly associated with AEs. Preventive strategies and improved care coordination are essential to reduce avoidable harm and enhance patient safety in psychiatric care.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"328-337"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13428814/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145954898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0