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Adverse events in different administration routes of Edaravone: A pharmacovigilance study based on the FDA adverse event reporting system

by Deye Ge, Liyan Wu, Jingrong Yang, Jingxian Sun, Jinying Wang, Jingxin Wang, Huihui Song, Ran Wei, Zecheng Xu, Binbin Zhao, Rongfei Sun, Yifei Wang

The U.S. Food and Drug Administration (FDA) approved intravenous edaravone for the treatment of amyotrophic lateral sclerosis (ALS) in 2017, followed by the approval of the oral formulation in 2022. This study aims to utilize the FDA#39;s Adverse Event Reporting System (FAERS) to investigate the spectrum and timing of adverse events (AEs) associated with edaravone administration, employing repeatability analysis, the Reporting Odds Ratio (ROR) approach, Weibull distribution, and stratification methods. The investigation focuses on data collected from the first quarter of 2017 through the fourth quarter of 2024, aiming to identify adverse event signals and their temporal patterns related to both intravenous and oral edaravone administration. In total, 3,262 records of edaravone-related adverse reactions were identified; among these, 1,534 incidents were associated with intravenous administration, while 453 incidents pertained to oral administration. The analysis revealed distinct adverse reaction profiles for the two routes of administration. Notably, the spectrum of adverse reactions resulting from oral administration predominantly involved the respiratory system, digestive system, and skin damage. In contrast, intravenous administration was more frequently linked to complications associated with invasive procedures and local tissue damage. Furthermore, the timing of adverse reactions exhibited significant variability between the two routes. Weibull distribution analysis indicated that the median onset time for adverse reactions following intravenous administration was 35 days, whereas for oral administration, it was 27 days. Both analytical approaches identified early failure signals, suggesting that the risk of adverse events diminishes over time.

The Impact of Workplace Violence on Nursing Staff's Physical and Mental Health: A Cross‐Sectional Survey at a Teaching Hospital

ABSTRACT

Aims

To assess the current situation of nursing staff exposed to workplace violence in a teaching hospital in China, and analyze the relationship between workplace violence and their physical and mental health status, aiming to establish a foundation for enhancing the working conditions for nursing staff.

Design

Cross-sectional study.

Methods

In 2024, a cross-sectional survey was conducted at a teaching hospital in Hubei Province, China, involving 3681 nursing staff. Assessments included workplace violence experiences and health outcomes using validated scales such as the Depression Screening Scale, Anxiety Disorder Screening Scale, Perceived Stress Scale, Psychological Resilience Scale, and Self-rating Symptom Scale. Statistical analyses incorporated propensity score matching and logistic regression.

Results

Among the 3681 nursing staff surveyed, 33.4% (1228) reported experiencing workplace violence. Moreover, 53.6% (1974) reported symptoms of mild to severe depression, and 34.5% (1270) reported symptoms of mild to severe anxiety. Commonly reported physical health conditions included peptic ulcers (6.8%, 250), autoimmune diseases (6.6%, 241), hypertension (3.0%, 112), malignant tumors (2.0%, 73), and diabetes (1.5%, 54). Workplace violence exposure showed significant associations with gender, weekly working hours, professional roles, living situations, and alcohol consumption.

Conclusions

Workplace violence significantly increases the risk of both physical and psychological health problems among nursing staff. Relevant authorities should implement proactive prevention strategies to reduce the occurrence of workplace violence and thereby mitigate its associated adverse outcomes, including anxiety, depression, elevated stress levels, and chronic physical conditions.

Impact

This study found a high prevalence of workplace violence (33.4%) among nursing staff, linked to physical and mental health impairments. Screening for vulnerabilities and providing tailored psychological support can enhance resilience, reducing the frequency of violence and its detrimental impacts on staff well-being.

Reporting Method

This study adhered to the STROBE checklist for observational studies.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct, or reporting. The contribution of patients/members of the public was limited solely to data collection.

The mediating role of blood metabolites in the association between myocardial infarction and cancer risk: An observational and mendelian randomization analysis

by Jia Zhu, Xiaojun Xia, Haodong Jiang, Congying Wang, Yunpeng Jin

Background

Myocardial infarction (MI) and cancer are major global public health challenges. Research indicates that they share common risk factors and that physiological changes following MI may affect cancer incidence and progression. However, evidence defining the independent relationship between these conditions is still limited.

Methods

We analyzed data from the National Health and Nutrition Examination Survey (NHANES) (2011–2018) using multivariable weighted logistic regression to examine the association between myocardial infarction (MI) and cancer. Additionally, we utilized genome-wide association study (GWAS) summary statistics and conducted Mendelian randomization (MR) to assess potential causal relationships and explore underlying mechanisms. Sensitivity analyses were performed to ensure the robustness of our findings.

Results

A total of 20,859 participants were included in our observational study using NHANES data. Multivariable weighted logistic regression revealed no direct association between MI and cancer (OR=1.161, 95% CI [0.895–1.507], P = 0.261). Interestingly, MR analysis indicated that MI occurrence was associated with a reduced incidence of cancer (OR=0.9497, 95% CI [0.9223–0.9778], P = 0.0005). Furthermore, two-stage MR results suggested this reduction might be mediated by increased blood levels of metabolites that inhibit cancer development, such as dihomo-linoleate (20:2n6) (beta = −0.0050, 95% CI [−0.0027–0.0004], P  Conclusion

Our integrative analysis suggests that myocardial infarction may be associated with a reduced cancer incidence through potential alterations in blood metabolite profiles, including dihomo-γ-linolenic acid, alpha-tocopherol, and inosine. These findings provide preliminary evidence that warrants further large-scale studies to validate the observed associations and to elucidate the underlying mechanisms.

Effects of aromatherapy on agitation and aggression in cognitive impairment: A meta‐analysis

Abstract

Aims and objectives

To evaluate the effectiveness of aromatherapy on agitation and aggression in patients with cognitive impairment.

Background

The impact of aromatherapy on agitation and aggression has been evaluated in various studies, but there is uncertainty about their impact.

Design

A meta-analysis of randomised controlled trials was undertaken.

Methods

This meta-analysis was conducted under PRISMA guidelines. Following eight electronic literature databases were searched: Web of Science, PubMed, PsycINFO, Embase, Cochrane Library, Chinese Wanfang database, CNKI and VIP digital database from the inception of the databases up to 27 February 2021. Two reviewers assessed the risk of bias of the included studies independently using the Cochrane Collaboration tool. Overall, meta-analysis and three subgroup analyses regarding the type of aroma preparations, delivery mode and session length were performed using RevMan5.3 and stata14.0. Publication bias was assessed by visual inspection of the funnel plot asymmetry and Egger's regression test.

Results

Fifteen studies comprising 693 participants were included. The meta-analysis indicated that aromatherapy could ameliorate agitation and aggression for cognitive impairment. The subgroup analysis based on the type of aroma preparations showed that lavender oil could significantly improve agitation and aggression. Most delivery modes of aromatherapy, including smearing and inhalation, were effective. Moreover, less length (≤4 weeks) aromatherapy showed a better effect on agitation behaviour than aromatherapy more than 4 weeks.

Conclusions

Despite the meta-analysis indicating that aromatherapy could alleviate agitation and aggression especially short-term (≤4 weeks) aromatherapy inhalation in different conditions, further researches are needed to investigate the appropriate dosage of essential oils and the side effects. More well-designed randomised controlled trials containing participants from more countries are needed to verify our findings before we can make strong recommendations.

Relevance to clinical practice

This meta-analysis suggested that aromatherapy should be considered as a complementary programme for patients with cognitive impairment patients. Medical workers could apply aromatherapy into daily routine cares for cognitive impairment patients.

Clusters of Sleep Disturbance and Associated Factors in People With Systemic Lupus Erythematosus: A Latent Profile Analysis

ABSTRACT

Background

Individuals with systemic lupus erythematosus (SLE) often suffer from sleep disturbance, which exhibits heterogeneity. Whether it could be grouped into different clusters remains unknown, posing challenges to the development of personalised interventions to address sleep disturbance.

Aim

To examine clusters of sleep disturbance and associated factors in people with SLE.

Design

Cross-sectional design.

Methods

From November 2023 to January 2024, people diagnosed with SLE were recruited by a convenience sampling approach. Data were collected via an online platform Wenjuanxing. Sleep disturbance was evaluated by the Pittsburgh Sleep Quality Index (PSQI). Other information, such as disease activity, pain, fatigue, depression and anxiety was also collected using validated instruments. Latent profile analysis was performed to reveal the distinct clusters of sleep disturbance. Multiple logistic regression analysis was performed to investigate factors associated with the clusters.

Results

A total of 538 participants were included, with a response rate of 85.1% (538/632). Only those with sleep disturbance (PSQI > 5) were included in the final analyses. Participant mean age was 32.9 (SD = 8.4) years and 402 (92.6%) were females. All had sleep disturbance (PSQI > 5) and their mean PSQI was 8.8 (SD = 2.9). Three distinct clusters were identified: mild sleep disturbance with poor sleep quality, adequate sleep duration and good daytime functioning (50.7%), mild sleep disturbance with poor sleep quality, adequate sleep duration and poor daytime functioning (30.9%) and moderate sleep disturbance with poor sleep quality, inadequate sleep duration and impaired daytime functioning (18.4%). There are both overlaps and unique aspects in terms of factors associated with each cluster of sleep disturbance, including age, body mass index, cardiovascular system damage, musculoskeletal system damage, depression and anxiety.

Conclusions

Sleep disturbance in patients with SLE showed three distinct clusters, with each cluster having slightly different predisposing factors.

Implications for the Profession

In clinical practice, nurses are recommended to prioritise assessment and interventions for those at-risk subgroups. They could also use the above information to develop and provide personalised interventions to address the unique needs of each cluster of sleep disturbance.

Reporting Method

Checklist for reporting of survey studies.

Patient or Public Contribution

No patient or public contribution.

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