Real-world effectiveness and safety of Baloxavir Marboxil or Oseltamivir in outpatients with uncomplicated influenza A: an ambispective, observational, multi-center study.

Introduction: Baloxavir Marboxil is a per oral small-molecule antiviral for the treatment of influenza. While the efficacy and safety of Baloxavir Marboxil have been thoroughly characterized across an extensive clinical trial, studies on the effectiveness of Baloxavir Marboxil in a real-world setting are still scarce. Methods: We conducted an ambispective, observational, multi-center study that enrolled uncomplicated in-fluenza outpatients treated with Baloxavir Marboxil or Oseltamivir in East China. The primary endpoint was time from treatment to alleviation of all influenza symptoms (TTAIS). The secondary endpoints included time from treatment to alleviation of fever (TTAF) and household transmission during the duration of influenza. Results: A total of 509 patients were enrolled. The median TTAIS in the Baloxavir Marboxil group and the Oseltamivir group was 28.0 h (IQR, 20.0 to 50.0) and 48.0 h (IQR, 30.0 to 67.0), respectively. The median TTAF in the Baloxavir Marboxil group and the Oseltamivir group was 18 h (IQR, 10.0-24.0) and 30.0 h (IQR, 19.0-48.0). In the COX multivariable analysis, Baloxavir Marboxil reduced the duration of influenza symptoms (HR = 1.36 [95%CI:1.12-1.64], p = 0.002) and the duration of fever (HR = 1.93 [95%CI:1.48-2.52], p < 0.001) compared to Oseltamivir. When antiviral drugs were given within 12-48 h after symptom onset, the Baloxavir Marboxil group had a significantly shorter TTAIS compared to the Oseltamivir group. There was no significant difference in the rate of adverse events between the two group (p = 0.555). Discussion: Baloxavir Marboxil was superior to Oseltamivir in alleviating influenza symptoms in outpatients with uncomplicated influenza. Our findings suggested that compared to Oseltamivir, Baloxavir Marboxil might be more appropriate for patients with influenza 12- 48 h after symptom onset.

A retrospective pharmacovigilance study of post-marketing safety concerns with cefuroxime.

Background: Cefuroxime has played a crucial role in the prevention and treatment of bacterial infections. However, the differences in adverse events across formulations and routes remain unclear. Objectives: This study aimed to investigate the post-marketing safety of cefuroxime, particularly concerning formulations and routes. Design: A retrospective pharmacovigilance study of cefuroxime was conducted using the data from Food and Drug Administration Adverse Event Reporting System database. Methods: The clinical characteristics and concomitant drugs reported with cefuroxime were investigated. Adverse event signals of cefuroxime were identified based on four disproportionality algorithms. The signal differences of cefuroxime across formulations and routes were further examined. Results: A total of 1810 adverse event reports associated with cefuroxime were identified, and 181 cefuroxime-associated signals were detected. Compared with tablets, injections were more likely to cause preferred terms 'blood pressure decreased' and 'anaphylactic shock'. In addition, system organ class 'eye disorders' significantly increased when cefuroxime was administered intraocularly, underscoring the importance of exercising caution regarding ocular toxicity. Conclusion: The adverse events associated with cefuroxime were significantly different across formulations and routes, which deserve special attention in clinical use.

Background: Cefuroxime is a commonly used antibiotic. This study investigated the safety of cefuroxime using Food and Drug Administration Adverse Event Reporting System database. Research design and methods: We analyzed the clinical characteristics and concomitant drugs reported with cefuroxime. Then, we detected the signals of cefuroxime. We further examined the signal differences of cefuroxime across formulations and routes. Results: We retrieved 1810 reports and identified 181 signals associated with cefuroxime. In comparison to tablets, injections had a higher likelihood of causing decreased blood pressure and anaphylactic shock. Furthermore, the administration of cefuroxime intraocularly increased the possibility of experiencing eye disorders. Conclusion: The signals associated with cefuroxime were significantly different across formulations and routes, which deserve special attention in clinical use.

Post-marketing safety concerns with cefuroxime.

A real-world pharmacovigilance study of FDA adverse event reporting system events for Capmatinib.

Capmatinib is a potent selective mesenchymal-epithelial transition inhibitor approved in 2020 for the treatment of metastatic non-small cell lung cancer. As real-world evidence is very limited, this study evaluated capmatinib-induced adverse events through data mining of the FDA Adverse Event Reporting System database. Four disproportionality analysis methods were employed to quantify the signals of capmatinib-related adverse events. The difference in capmatinib-associated adverse event signals was further investigated with respect to sex, age, weight, dose, onset time, continent, and concomitant drug. A total of 1518 reports and 4278 adverse events induced by capmatinib were identified. New significant adverse event signals emerged, such as dysphagia, dehydration, deafness, vocal cord paralysis, muscle disorder, and oesophageal stenosis. Notably, higher risk of alanine aminotransferase and aspartate aminotransferase increases were observed in females, especially when capmatinib was combined with immune checkpoint inhibitors. Compared with Europeans and Asians, Americans were more likely to experience peripheral swelling, especially in people > 65 years of age. Renal impairment and increased blood creatinine were more likely to occur with single doses above 400 mg and in Asians. This study improves the understanding of safety profile of capmatinib.

Is pitolisant safe for clinical use? A retrospective pharmacovigilance study focus on the post-marketing safety.

Pitolisant, a novel histamine H3-receptor antagonist, holds significant promise for treating narcolepsy. However, a petition, which highlighted that pitolisant was associated with deaths during clinical trials, has propelled it into the spotlight of widespread societal attention on April 3, 2023. Till now, the clinical safety of pitolisant remains a heatedly debated topic. This study aimed to offer a comprehensive assessment of the safety profile of pitolisant in real-world clinical settings. Adverse event reports where pitolisant was the primary suspect drug were extracted from the FDA Adverse Event Reporting System database. The clinical characteristics and concomitant drugs of the pitolisant-associated adverse events were analyzed. The potential adverse event signals of pitolisant were explored using four disproportionality analysis methods. Furthermore, the difference in pitolisant-associated adverse event signals was investigated concerning sex, age, weight, and dose. A total of 526 reports and 1695 adverse events with pitolisant as the primary suspected drug were identified. The most significant adverse event signals were generally mild and of short duration. The concomitant drugs of pitolisant were highly intricate, mainly included drugs for treating narcolepsy as well as antidepressants. Seven new significant adverse event signals emerged. The safety profile of pitolisant exhibited no significant differences across age and dose groups, although slight variations were observed in relation to sex and weight. The findings from reports of death and life-threatening outcomes underscore the importance of enhanced monitoring for cardiac and respiratory adverse reactions when utilizing pitolisant. This study provided a broader understanding of the safety profile of pitolisant.

Pre-service EFL teacher's perceptions of foreign language writing anxiety and some associated factors.

Researchers have been striving to investigate the causes and consequences associated with writing anxiety experienced by students of foreign languages. This study aimed to investigate the level and nature of writing anxiety experienced by learners of foreign languages, considering gender as a variable. The study's second goal was to uncover the learners' perspectives on writing anxiety and the factors that contribute to it. The convenience sample method was used to choose seventy-six students to participate in the English language teacher training course. Second Language Writing Anxiety Reasons Inventory (SLWARI) and Second Language Writing Anxiety Inventory (SLWAI) (Cheng, 2004; Kara, 2013) [1,2] were used in order to determine the levels and types of anxiety that are associated with learners' foreign language writing. Both inventories were used to determine what causes learners' foreign language writing. In order to gain a comprehensive understanding of how students perceive the level of anxiety they feel when writing, a semi-structured interview was conducted with each participant. The data showed that there was no difference when taking into account learners' gender concerning their anxiety levels and kinds. The vast majority of individuals reported feeling a significant amount of anxiety. The subjects exhibited cognitive anxiety symptoms, although there were no indications of gender effect. The responses to the interview questions highlighted a deficiency in both writing practice and linguistic expertise as critical contributors to anxious sentiments.

An investigation of foreign language writing anxiety and its reasons among pre-service EFL teachers in Pakistan.

Psychologically complicated by nature, anxiety refers to feelings of worry, fear, or apprehension. Several research studies have been devoted to exploring anxiety's effects on language skills, including writing. Since foreign language anxiety directly influences a learner's motivation and determination to learn that language, it is imperative to study the findings and reasons behind these anxious feelings. One-third of foreign language learners have been experiencing at least a moderate level of anxiety. Researchers have attempted to investigate the causes of anxiety among foreign language pre-service teachers. The present study objectifies two goals to determine the extent of writing anxiety, followed by reasons and references to the role of gender. Seventy-two pre-service teachers of the English language training department from the University of Education, Multan, Pakistan, were selected for the study using convenience sampling. Second language writing anxiety inventory (SLWAI) and second language writing anxiety reasons inventory (SLWARI) were used to collect data, and semi-structured interviews were taken with students. The findings presented no difference in anxiety levels between genders, whereas cognitive anxiety type was distinctive in results. Most of the participants experienced high and medium levels of anxiety.

[Impact of liver steatosis on antiviral effects of pegylated interferon-alpha in patients with chronic hepatitis B].

OBJECTIVE: To investigate the impact of hepatic steatosis on virologic response in chronic hepatitis B (CHB) patients treated with pegylated interferon-alpha (PEG-IFNa). METHODS: Ninety-six naive patients positive for hepatitis B e antigen (HBeAg) and with biopsy-proven CHB were administered PEG-IFNa-2a or PEG-IFNa-2b for 48 weeks. Virologic response (HBeAg clearance and hepatitis B virus (HBV) DNA less than 5 log10 copies/ml) and biochemical response (alanine transaminase (ALT) normalization) were compared between patients with (n=34) and without (n=62) steatosis. RESULTS: The HBV DNA titer in the steatosis group was significantly lower than that of the non-steatosis group (6.961.27 vs. 7.541.28 log10 copies/ml; t=2.161, P=0.033). After 48 weeks of PEG-IFNa treatments, there was no significant difference in HBeAg seroconversion or the percentage of undetectable HBV DNA (less than 3 log10 copies/ml) between steatosis and non-steatosis patients. However, the steatosis patients presented with a significantly lower complete response rate (virologic response plus biochemical response) compared to non-steatosis patients (26.5% vs. 48.4%; x² =4.373, P=0.037). Of the 45 CHB patients with undetectable HBV DNA after 48 weeks of treatment, seven did not achieve ALT normalization. The rate of patients with non-biochemical response was significantly higher in the steatosis group than in the non-steatosis group (33.3% vs. 6.67%; P=0.032). CONCLUSION: Hepatic steatosis does not affect the virologic response, but does affect the biochemical response in CHB patients treated with PEG-IFNa for 48 weeks.

[Three-year efficacy and side effect of adefovir dipivoxil for the treatment of the old patients with chronic hepatitis B virus infection].

OBJECTIVE: To investigate 3-year antiviral efficacy and side effect of adefovir dipivoxil (ADV) on the old patients with hepatitis B chronic infection. METHODS: 31 HBeAg-negative chronic hepatitis B virus infected old patients (include 8 patients with chronic hepatitis B and 23 patients with liver cirrhosis) with serum HBV DNA levels > 1000 copies/ml, and ALT > 2 times the upper limit of normal, without company with other liver diseases, cancer, renal dysfunction, and autoimmune disease. All the patients were treated with ADV orally (10 mg once daily) for 36 months. HBV DNA and biochemical and blood routine indexes were checked after treated. RESULT: Serum total bilirubin, direct bilirubin, alamine aminotransferase, aspartate aminotransferase and load of HBV DNA decrease significantly after therapy (P < 0. 001). Other biochemical indexs and blood routine are no significant changes (P > 0.05). CONCLUSION: The way to treat with ADV is safe and effective for old patients with chronic hepatitis B virus infection.