Common Adverse Effects Research Articles

Adverse effects of COVID-19 vaccines in university students

Background Existing data on adverse effects of coronavirus disease 2019 (COVID-19) vaccines among university students are limited. This study aimed to investigate the characteristics of adverse effects that may arise from administering COVID-19 vaccines to university students in Thailand. Methods An online survey study was conducted among students from 12 Health Sciences faculties, and from 16 non-Health Sciences faculties of two universities from October 2021 to January 2022 to assess types and adverse effects of COVID-19 vaccines received by the students. Results There were 1,439 participating students; 522 (36%) were from Health Sciences faculties, and 917 (64%) were from 16 non-Health Sciences faculties. The types of the first-dose vaccine received were inactivated (49%), viral vector (46%), and mRNA (5%), while the types of the second-dose vaccine received were viral vector (53%), inactivated (40%) and mRNA (7%). The first-dose vaccines’ most common adverse effects of inactivated, viral vector, and mRNA vaccines were muscle pain (47%, 82%, and 58%, respectively). The second-dose vaccines’ most common adverse effects were cough (47%) for inactivated vaccines and muscle pain (49% for viral vector vaccines and 56% for mRNA vaccines). Viral vector vaccines were more likely to cause fever, muscle pain, diarrhoea, headache, and rashes than the others. The mRNA vaccines caused injection site pain more than inactivated vaccines. The majority of adverse effects occurred 24-48 hours after vaccination (68%), were more severe with the first dose compared with the second dose, and resolved spontaneously without any treatment at a hospital. Conclusions The adverse effects experienced by the students were various according to the types and number of doses of COVID-19 vaccines. The adverse effects were mostly non-severe and occurred less for the second dose compared with the first dose.

Evaluation of colitis induced by immune-checkpoint inhibitors therapy in melanoma patients by an overall grading scale.

Colitis was the third most common immune-related adverse effect in melanoma patients treated with immune-checkpoint inhibitor (ICI). With the limitation of real-world data in the UK population, this study was conducted in a UK hospital where a fresh colitis guidance was introduced to evaluate the overall grading (OG) to assess colitis severity and guide the treatment. This study aimed to investigate colitis severity by Common Terminology Criteria for Adverse Events (CTCAE) grade and overall grade at time of presentation. Colitis treatment and outcome were evaluated to compare the impact of these two categories. A single-center, retrospective observational study was performed in melanoma patient developing colitis symptoms. A total of 44 advanced melanoma patient with colitis symptoms were included. Median time to colitis onset was 67 days (range 4-890). Majority of patients developed G1/ G2 of CTCAE scale (70.4%) but moderate or severe overall grade (84.1%). There were 65.9% of patients treated with steroids, and 38.2% with infliximab and 4.5% with vedolizumab. The median time of colitis resolution was 28 days (range 0-282). Both treatment modality and time to resolution were associated with severity of colitis assessed by complete OG(p<0.0001) rather than CTCAE grading (p>0.05). This study provided a comprehensive description about ICI-induced colitis management in a single center of the UK. The more completed OG was proposed to stratify colitis patient and guide the investigation and treatment decision at presenting time, replacing the old CTCAE grading.

A retrospective cohort study describing chemotherapy-induced peripheral neuropathy in Non-Hodgkin lymphoma patients treated with EPOCH ± R: does HIV status matter?

The frontline immuno-chemotherapy regimen for HIV-associated non-Hodgkin Lymphoma is dose-adjusted EPOCH ± R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab). Chemotherapy-induced peripheral neuropathy (CIPN), caused by vincristine, is a common adverse effect of EPOCH ± R, negatively impacting long-term patient outcomes. The primary objective of this study was to determine the incidence of CIPN, stratified by HIV status, in patients treated with EPOCH ± R. A retrospective cohort study at a tertiary referral comprehensive cancer center evaluated patients treated with EPOCH ± R from 2011 to 2018. The final sample included 27 patients with HIV compared to 279 without HIV (total n = 306). Overall, the incidence of CIPN was 29.4% (n = 90), including 5 with HIV (18.5%) and 85 without HIV (30.5%). Propensity scores were used to match patients by HIV status. Although no relationship was found between HIV status and neuropathy, CIPN affects too many undergoing treatments for lymphoma, supporting future investigations to minimize toxicities.

Anti-PD-1 antibody in combination with radiotherapy as first-line therapy for unresectable intrahepatic cholangiocarcinoma

BackgroundUnresectable intrahepatic cholangiocarcinoma (iCCA) has a poor prognosis despite treatment with standard combination chemotherapy. We aimed to evaluate the efficacy and safety of radiotherapy in combination with an anti-PD-1 antibody in unresectable iCCA without distant metastases.MethodsIn this phase II study, patients with histopathologically confirmed unresectable primary or postoperative recurrent iCCA without distant metastases were enrolled. Patients received external radiotherapy with a dose of ≥45 Gy (2-2.5 Gy per fraction), followed by anti-PD-1 immunotherapy (camrelizumab 200 mg once, every 3 weeks) initiated within 7 days after completion of radiotherapy as first-line therapy. The primary endpoint was 1-year progression-free survival (PFS) rate. The secondary end points included safety, objective response rate (ORR), disease control rate (DCR), and overall survival (OS).ResultsFrom December 2019 to March 2021, 36 patients completed radiotherapy and at least one cycle of immunotherapy and were included in efficacy and safety analyses. The median follow-up was 19.0 months (IQR 12.0-24.0), and the one-year PFS rate was 44.4% (95% CI, 30.8-64.0). The median PFS was 12.0 months (95% CI, 7.5-not estimable); the median OS was 22.0 months (95% CI, 15.0-not estimable). The ORR was 61.1% and the DCR was 86.1%. Seventeen of 36 (47.2%) patients experienced treatment-related adverse effects (AEs) of any grade. The most common AE was reactive cutaneous capillary endothelial proliferation (25.0%). Five (13.9%) patients experienced grade ≥3 treatment-related AEs, including decreased lymphocyte (5.6%), bullous dermatitis (2.8%), decreased platelet count (2.8%), and deep-vein thrombosis (2.8%).ConclusionsExternal radiotherapy plus camrelizumab, as first-line therapy, met its primary endpoint and showed antitumor activity and low toxicity levels in patients with unresectable iCCA without distant metastases, warranting further investigation.Trial registrationNCT03898895. Registered 2 April 2019.

The Epidemiology of Newly Recognized Causes of Drug-Induced Liver Injury: An Update.

The incidence and prevalence of drug-induced liver injury appear to be increasing globally, for example, with the introduction of checkpoint inhibitors. Several reviews have been published in the last decade on the epidemiology of DILI, both among hospitalized patients and in the general population, as well as from retrospective and prospective studies on DILI. Most of these reviews have not focused on newly recognized agents that have recently changed the landscape of DILI. Apart from liver injury associated with antibiotics, oncological agents, particularly checkpoint inhibitors, are increasingly being recognized as causing liver injury. The type of liver injury associated with these agents is not idiosyncratic but rather an indirect type of injury. Furthermore, recently, COVID-19 vaccines and green tea extract have been found to lead to liver injury. Checkpoint inhibitors have revolutionized the treatment of many malignancies, such as malignant melanoma, lung cancer, and renal cancer. Via the activation of T cells, they can increase immune activity against malignant cells, but at the same time, they can decrease immune tolerance and therefore lead to immune-related adverse effects in many organs. The most common adverse effect in clinical practice is liver injury. A recent prospective study demonstrated an 8% frequency of DILI due to the use of checkpoint inhibitors among patients with malignant melanoma and renal cancer. This rate is much higher than observed with drugs, leading to idiosyncratic liver injury. Shortly after the implementation of the worldwide vaccination program against COVID-19, several case reports were published on suspected vaccination-induced autoimmune-like hepatitis occurring shortly after the vaccination. At first, these reports were met with skepticism, but currently, around 100 reports have been published, and cases of positive recurrence have been reported. The clinical, biochemical, immunological, and histological features are indistinguishable from classic autoimmune hepatitis (AIH). These reactions are very similar to drug-induced autoimmune-like hepatitis (DI-ALH) due to drugs such as nitrofurantoin, minocycline, and infliximab, which do not relapse after a short course of corticosteroids, which is the general rule in classic autoimmune hepatitis (AIH). Green tea extract has been found to be a well-documented cause of acute hepatocellular liver injury with jaundice. A strong HLA association has been reported, showing a high prevalence of HLA-B*35:01 among patients suffering from green tea-induced liver injury. Overall, 3% of patients recruited in the DILIN study were supplemented with green tea extract as one of the ingredients. In a prospective population-based study from Iceland, green tea was implicated in approximately 8% of patients with DILI.

Polymorphisms in ERBB4 and TACR1 associated with dry mouth in clozapine-treated patients.

Sialorrhea is a common and uncomfortable adverse effect of clozapine, and its severity varies between patients. The aim of the study was to select broadly genes related to the regulation of salivation and study associations between sialorrhea and dry mouth and polymorphisms in the selected genes. The study population consists of 237 clozapine-treated patients, of which 172 were genotyped. Associations between sialorrhea and dry mouth with age, sex, BMI, smoking, clozapine dose, clozapine and norclozapine serum levels, and other comedication were studied. Genetic associations were analyzed with linear and logistic regression models explaining sialorrhea and dry mouth with each SNP added separately to the model as coefficients. Clozapine dose, clozapine or norclozapine concentration and their ratio were not associated with sialorrhea or dryness of mouth. Valproate use (p = 0.013) and use of other antipsychotics (p = 0.015) combined with clozapine were associated with excessive salivation. No associations were found between studied polymorphisms and sialorrhea. In analyses explaining dry mouth with logistic regression with age and sex as coefficients, two proxy-SNPs were associated with dry mouth: epidermal growth factor receptor 4 (ERBB4) rs3942465 (adjusted p = 0.025) and tachykinin receptor 1 (TACR1) rs58933792 (adjusted p = 0.029). Use of valproate or antipsychotic polypharmacy may increase the risk of sialorrhea. Genetic variations in ERBB4 and TACR1 might contribute to experienced dryness of mouth among patients treated with clozapine.

Metabolic control in type 2 diabetic patients treated with empagliflozin: A case series.

Type 2 diabetes mellitus is a highly prevalent disease and is associated with increased morbidity and mortality. Due to the low percentage of adequate glycemic control, new strategies for the treatment of type 2 diabetes mellitus have been sought, including sodium-glucose cotransporter type 2 inhibitorss. To describe the evolution of patients with type 2 diabetes mellitus with insulin requirements treated with empagliflozin at the Peñaflor Hospital. The primary objective was to evaluate the efficacy of the medication regarding glycosylated hemoglobin A1c (HbA1c). The secondary objectives were: 1) achievement of HbA1c equal to or less than 7.5% according to survival analysis. 2) Change in glomerular filtration rate and urinary albumin excretion post treatment. Review of clinical records of all patients treated with empagliflozin from November 2019 to June 2023. Average follow-up of 19 (16.3 to 40) months. To compare HbA1c values according to follow-up ranges, the paired T test or Wilcoxon test was used. We included 58 patients, 15 men and 43 women (74.1%), with an average age of 58.5 ± 9.2 years, ranging from 35 to 75 years. Baseline HbA1c of 10.3 ± 1.6% and 8.98% ± 2.2 in a follow-up of 18 to 24 months post-treatment, resulted in a decrease of 1.27% (p = 0.002; confidence interval 95%: 0.5 to 2.03). The most common adverse effect was urinary tract infection. Patients with type 2 diabetes mellitus with insulin requirements treated with empagliflozin at the Peñaflor Hospital achieved better glycemic control with few adverse effects.

Arthralgia and myalgia associated with aromatase inhibitors: frequency and characterization in real-life patients.

Adjuvant treatment with aromatase inhibitors (AI) in oestrogen receptor-positive and/or progesterone receptor-positive breast cancer (BC) has been shown to increase overall survival. However, arthralgias and myalgias are common adverse effects in patients treated with AI. To evaluate the frequency and characteristics of arthralgias and myalgias in patients with early BC-treated adjuvantly with AI in the Mastology Unit of the Oncology Service of the Hospital de Clínicas and the Departmental Hospital of Soriano. A prospective, cross-sectional and descriptive study was performed. A questionnaire was administered to patients to assess the presence and characteristics of arthralgias and myalgias associated with AI. 'Age' was described with measures of central tendency and dispersion. Qualitative variables were presented in absolute and relative frequencies. Logistic models were used to evaluate the association between patient characteristics, tumour characteristics, treatment characteristics and the presence of pain. Results were presented by odds ratio and p-value, using R software (version 4.1.2) with a significance threshold of 5%. 83 patients were included, with a median age of 69 years. 75.9% presented arthralgias and/or myalgias related to treatment, with an average intensity of 5-7. 80.9% received non-steroidal anti-inflammatory drugs (NSAIDs), achieving satisfactory analgesia. The presence of arthralgias and myalgias was significantly associated with age and time since the last menstrual period (LMP), being more frequent in patients older than 50 years and those with more than 5 years since the LMP. Approximately 70% of the patients presented arthralgias or myalgias. These findings suggest a possible role of oestrogen withdrawal in its mechanism of development. Multidisciplinary and translational research is crucial to evaluate the ethology and therapeutic options for patients with AI-related arthralgia.

Janus kinase inhibitors and the changing landscape of vitiligo management: a scoping review.

Vitiligo is a chronic skin condition caused by an autoimmune response that results in the progressive loss of melanocytes and recent studies have suggested that Janus kinase inhibitors (JAKi) are emerging as a promising new treatment modality. Therefore, to assess and understand the extent of knowledge in the emerging field of JAKi use in vitiligo, a scoping review of the literature was undertaken. The reviewed articles explored a wide variety of JAKi administered either orally or topically for vitiligo. There were no injectable JAKi studied. Tofacitinib was the most commonly studied oral JAKi in 16 of the 35 studies selected for review, followed by baricitinib (n = 3), and one study each with ritlecitinib, ruxolitinib, and upadacitinib. Ruxolitinib (n = 6) and tofacitinib (n = 6) were the most often studied topical JAKi, followed by delgocitinib (n = 1). Potential benefits may vary between JAKi based on their receptor selectivity profile and coexistent autoimmune diseases. A topical JAKi would be advantageous in limited body area involvement and in adolescents. Concurrent use of JAKi with phototherapy or sun exposure appears beneficial. Most studies permitted the use of other topical agents. Acne-related events, though frequent yet mild, were reported with both oral and topical JAKi. Nasopharyngitis, upper respiratory tract infections, and headaches were the most common adverse effects seen in the larger trials with JAKi. No serious or clinically meaningful hematology or thromboembolic events were detected. Treatment of vitiligo with oral or topical JAKi seems to be promising and the growing evidence shows a favorable risk-benefit profile.

Endoscopic ultrasound-guided radiofrequency ablation of pancreatic tumors.

Surgery is a cornerstone in the management of pancreatic cancer and precancerous pancreatic lesions. However, many patients are not suitable candidates for surgery at the time of diagnosis for various reasons. Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) appears to be a promising treatment option for patients who are ineligible for surgery for management of pancreatic adenocarcinoma (PDAC), and pancreatic neuroendocrine tumors (PNETs), and pancreatic cystic lesions (PCLs). EUS-RFA may serve as an adjunct to chemotherapy or palliative measures for inoperable cases of PDAC. Given its feasibility and efficacy, EUS-RFA has an evolving niche as a minimally invasive and potentially definitive treatment for PNETs and high-risk PCLs such as intraductal papillary mucinous neoplasms (IPMNs). EUS-RFA is a generally well tolerated procedure, with abdominal pain and acute pancreatitis being the most common adverse effects, though the risk can be mitigated through prophylactic measures. There is an increasing body of evidence to support the use of EUS-RFA in managing pancreatic lesions, either as definitive, adjunctive, or palliative treatment, depending on lesion type.

The Role of Etanercept in Controlling Clinical and Radiological Progression in Rheumatoid Arthritis: A Systematic Review.

Etanercept (ETN) is a disease-modifyinganti-rheumatic drug (DMARD) used in the treatment of rheumatoid arthritis (RA) that works as a tumor necrosis factor inhibitor (TNF inhibitor) by blocking the effects of naturally occurring TNF. This review will evaluate the effect of ETN as a monotherapy or combination therapy with methotrexate (MTX) in the treatment of RA. This systematic review was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 guidelines. A systematic search was done on PubMed and Google Scholar from 1999 to 2023. Predefined eligibility criteria were set for selected studies, which include: free full-text articles published; randomized control trials (RCTs); systematic reviews and meta-analyses; and observational studies in a patient with RA treated with ETN as initial therapy or as an add-on to conventional disease-modified therapy. Hence, the data had been extracted, and a quality assessment of each study was done by two individual authors. When comparing patients who received 15-25 mg of MTX with those who also received 25 mg of ETN in combination, 71% achieved American College of Rheumatology 20 (ACR20) by 24 weeks, compared to 27% in the MTX and placebo groups (p<0.001), and 39% achieved American College of Rheumatology 50 (ACR50), compared to 3% in the placebo + MTX group (p<0.001). Low disease activity (DAS 28)was more common in patients who had both MTX and ETN (64.5% with DAS <2.4 and 56.3% with DAS 28 <3.2) compared to patients who received only one medication (44.4% with DAS <2.4 and 33.2% with DAS 28 <3.2 for ETN and 38.6% with DAS <2.4 and 28.5% with DAS 28 <3.2 for MTX, with P<0.01). ETN demonstrated smaller changes from baseline in the modified Sharp score (TSS) and erosion scores (ES) at 12 months and two years, as well as a decreased change in the ES score at one year (with a trend of P value = 0.06 for the TSS score), in comparison to those receiving DMARD. Reactions at the injection site (42% vs. 7%, P<0.001) were the only events that occurred significantly more frequently in the ETN plus-MTX group. Combining ETN and MTX appears to help control RA symptoms by decreasing the American College of Rheumatology (ACR) response and DAS score, as well as halting the disease's progression on X-rays. The most common adverse effects were reactions to ETN administered alone at the injection site, likely because of patient awareness of the treatment received. There was also concern about tuberculosis and malignancy, but no recent data is available. Therefore, a larger clinical trial with longer follow-up is required to ascertain long-term safety and benefits.

Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia

There has been increased interest in low-dose oral minoxidil for androgenetic alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be evaluated in comparative therapeutic trials. To compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA. This double-blind, placebo-controlled randomized clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged 18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and randomized. Data were collected from January to December 2021, and data were analyzed from September 2022 to February 2023. Participants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for 24 weeks. The primary outcome was change in terminal hair density on the frontal and vertex regions of the scalp. The secondary outcomes were change in total hair density and photographic evaluation. Among 90 enrolled participants, 68 completed the study; of these, the mean (SD) age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group and 35 in the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. For the frontal area, the mean change from baseline to week 24 between groups was 3.1 hairs per cm2 (95% CI, -18.2 to 21.5; P = .27) for terminal hair density and 2.6 hairs per cm2 (95% CI, -10.3 to 15.8; P = .32) for total hair density. For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm2 (95% CI, -0.3 to 43.0; P = .09) for terminal density and 5.5 hairs per cm2 (95% CI, -12.5 to 23.5; P = .32) for total hair density. According to the photographic analysis, oral minoxidil was superior to topical minoxidil on the vertex (24%; 95% CI, 0 to 48; P = .04) but not on the frontal scalp (12%; 95% CI, -12 to 36; P = .24). The most common adverse effects in the oral minoxidil group were hypertrichosis (22 of 45 [49%]) and headache (6 of 45 [14%]). In this study, oral minoxidil, 5 mg, once per day for 24 weeks did not demonstrate superiority over topical minoxidil, 5%, twice per day in men with AGA. Brazilian Registry of Clinical Trials Identifier: RBR-252w9r.

Current understanding of the molecular mechanisms of chemotherapy-induced peripheral neuropathy.

Chemotherapy-induced peripheral neuropathy (CIPN) is the most common off-target adverse effects caused by various chemotherapeutic agents, such as cisplatin, oxaliplatin, paclitaxel, vincristine and bortezomib. CIPN is characterized by a substantial loss of primary afferent sensory axonal fibers leading to sensory disturbances in patients. An estimated of 19-85% of patients developed CIPN during the course of chemotherapy. The lack of preventive measures and limited treatment options often require a dose reduction or even early termination of life-saving chemotherapy, impacting treatment efficacy and patient survival. In this Review, we summarized the current understanding on the pathogenesis of CIPN. One prominent change induced by chemotherapeutic agents involves the disruption of neuronal cytoskeletal architecture and axonal transport dynamics largely influenced by the interference of microtubule stability in peripheral neurons. Due to an ineffective blood-nerve barrier in our peripheral nervous system, exposure to some chemotherapeutic agents causes mitochondrial swelling in peripheral nerves, which lead to the opening of mitochondrial permeability transition pore and cytochrome c release resulting in degeneration of primary afferent sensory fibers. The exacerbated nociceptive signaling and pain transmission in CIPN patients is often linked the increased neuronal excitability largely due to the elevated expression of various ion channels in the dorsal root ganglion neurons. Another important contributing factor of CIPN is the neuroinflammation caused by an increased infiltration of immune cells and production of inflammatory cytokines. In the central nervous system, chemotherapeutic agents also induce neuronal hyperexcitability in the spinal dorsal horn and anterior cingulate cortex leading to the development of central sensitization that causes CIPN. Emerging evidence suggests that the change in the composition and diversity of gut microbiota (dysbiosis) could have direct impact on the development and progression of CIPN. Collectively, all these aspects contribute to the pathogenesis of CIPN. Recent advances in RNA-sequencing offer solid platform for in silico drug screening which enable the identification of novel therapeutic agents or repurpose existing drugs to alleviate CIPN, holding immense promises for enhancing the quality of life for cancer patients who undergo chemotherapy and improve their overall treatment outcomes.

Post-radiation middle ear effusion in NPC patients: Analysis of patient, tumour, and radiation factors.

The purpose of this study was to investigate whether patient, tumour and radiation therapy factors are associated with development of middle ear effusion (MEE) in nasopharyngeal carcinoma (NPC) patients. A retrospective review of NPC patients treated between January 2000 and June 2018 at Rabin Medical Center. Patient factors, tumour factors, radiation doses, and radiation fields were collected and outlined if needed (middle ear, eustachian tube [ET], tensor veli palatini [TVP], and levator palatini [LVP] muscles), then analysed and compared between patients with MEE and those without and between sides in patients with unilateral MEE. Seventy-three patients were enrolled. Most were males (71.2%) with advanced-stage diseases (78%). At the time of diagnosis 14 patients (19.2%) presented with MEE. Following radiation, 18 patients, with no evidence of MEE at presentation, developed MEE. Tumour stage, histology, and laterality were not associated with development of MEE. Comparison of mean radiation field dosages including-gross target volume, clinical target volume, and patient target volume showed no association with post-radiation MEE. In addition, no difference was found in the radiation doses to the middle ear, ET or the LVP nor the TVP between ears with and without MEE. Post-irradiation MEE remains a common adverse effect in NPC patients. Surprisingly, tumour stage, tumour laterality, and histology were not associated with MEE. Similar findings were observed for total radiation doses and specific doses to the middle ear, ET, and ET muscles.

Pattern of Inappropriate use of Topical Corticosteroid and Cutaneous Adverse Effects at a Tertiary Level Hospital in Kathmandu

Introduction: Topical corticosteroids are anti-inflammatory, immunosuppressive, and anti-proliferative drugs with profound efficacy. As it provides rapid relief, it is used for a wide spectrum of dermatological conditions. Rampant use of topical corticosteroids due to their easy availability gives rise to difficult-to-treat cutaneous adverse effects. Objectives: To determine the pattern of inappropriate use of topical corticosteroids and cutaneous adverse effects Materials and Methods: This was a hospital based cross-sectional prospective study conducted among 84 participants in the Department of Dermatology, Tribhuvan University Teaching Hospital, Kathmandu, from October 2020 to September 2021. Ethical clearance was obtained from the Institutional Review Committee. The participants fulfilling the inclusion criteria were included in the study. Results: Out of 84 cases, 59.5% were females and 40.5% were males. The mean age of participants was 30.4±9.1years. Dermatophytoses (71.4%) were the most common cause of inappropriate use of topical corticosteroids. The most common adverse effect was tinea incognito (23.8%). The most potent class (60%) of topical corticosteroids were misused. Most of the participants used topical steroids either for the duration of 1 week to 1 month ( 23.8%) or for more than 12 months (23.8%). Conclusion: Inappropriate topical corticosteroid use is a common problem due to its easy accessibility, resulting in several difficult-to-treat cutaneous adverse effects. So, awareness-raising activities regarding the proper use of corticosteroids have to be conducted.

Vaccines for Respiratory Syncytial Virus Prevention in Older Adults.

This review evaluates the efficacy and safety of novel respiratory syncytial virus (RSV) vaccines approved for adults aged 60 years and older. A literature search through February 27, 2024 was conducted using search terms, such as RSV, viral respiratory illness, vaccine, RSVpreF, RSVpreF3, Prefusion F, Abrysvo, and Arexvy. Data from primary literature and vaccine prescribing information were reviewed, encompassing evaluations of clinical pharmacology, efficacy, safety, adverse events, warnings, and precautions. The literature review process resulted in 10 articles included within this article's scope, including the results of 2 major phase III trials presented in detail. Two RSV vaccines, Respiratory Syncytial Virus Vaccine (recombinant [adjuvanted]; RSVpreF3-ASO1E, Arexvy) and Respiratory Syncytial Virus Vaccine (recombinant; RSVpreF, Abrysvo), approved for preventing RSV-associated lower respiratory tract disease (LRTD) in adults aged 60 years or older in the United States are discussed. Results from Phase III trials have demonstrated the efficacy of 1 dose of these vaccines in preventing RSV-associated LRTD across 2 RSV seasons. The Advisory Committee on Immunization Practices currently recommends use of these vaccines under shared clinical decision-making for adults aged 60 years or older. Most common adverse effects include injection site reactions (eg, site pain, redness, and swelling). Administration requires a single intramuscular injection of 0.5 mL, reconstituted prior to administration. The RSVpreF3-ASO1E and RSVpreF vaccines effectively prevent RSV-associated LRTD in adults aged 60 years and older.

Tolerability of intranasal esketamine, a case series of 15 patients

IntroductionIntranasal esketamine has recently been approved for the treatment of treatment-resistant depression in adults, with different studies showing its efficacy and tolerability. However, the real-world tolerability of this treatment is still unclear.ObjectivesEvaluate the tolerability of intranasal esketamine in a case series of 15 patients.MethodsOur case series includes 15 patients, who received treatment with intranasal esketamine during 2022-2023. In order to evaluate the tolerability of intranasal esketamine, patients were asked to complete the TSQM and a side effect questionnaire on different moments of the treatment (one week, six weeks and six months after the beginning of the treatment).ResultsThe most common adverse effects were dissociation, dizziness, and somnolence, which resolved within the hours following the administration. All of them were mild or moderate in severity, having a minor impact on the patient, so none of the patients discontinued the treatment due to adverse effects. Other adverse effects noticed were: transitory increment of blood pressure in several patients, and worsening of obsessions in a patient with previous obsessive-compulsive symptoms.Conclusions Our data suggests that intranasal esketamine is well tolerated, with transient and mild adverse effects. In all cases the risk-benefit ratio must be evaluated, but until more studies are done, it seems to be a safe treatment for treatment-resistant depression.Disclosure of InterestNone Declared

Treatment resistant FEP (first episode of psycosis) with neuroanatomical findings

IntroductionPresentantion of the first psychotic episode of a young man and the investigation of the efficacy of treatment with olanzapine and after cariprazine.ObjectivesAssessing the response to treatment of cariprazine in a psychotic patient with relevant neuroanatomical findings.MethodsA 25-year old man was admitted to the psychiatric intensive care due to his agggressive behavior and verbal abuse, threatening to kill them both. His medical history included long periods of negatively affected mood, social isolation and talking to himself according to his familyResultsWhent the patient was admitted he was very anxious, alert and extremely aggressive. During the interview he admitted auditory and visual hallucinations alongside delusional ideation with a particular aggression towards his father.Upon admission his PANSS score was 121. positive scale score was 23.The patient was treated initially with monotherapy olanzapine, gradually increased up to 20mg OD. Olanzapine caused asymptomatic transaminasemia, a relatively common adverse effect. At this point a change in medication was made and olanzapine was stopped and cariprazine was added gradually increasing its dose from 1,5mg to 6mg OD.Interestingly the medical investigations (brain CT scan) indicated a calcification in falx cerebri.After a period of 48 days since admission the patient was clinically improved and was discharged. His PANSS score was 72. Positive scale was 10.ConclusionsThe use of cariprazine as a treatment for a first psychotic episode of a young male improved his PANSS score after a 22-day treatment. According to the literature neuroanatomical findings have been associated with poor prognosis regarding the course of the illness. There needs to be further investigation on the efficacy of the long term treatment for this patient.Disclosure of InterestNone Declared

COVID-19 Booster Vaccination Adverse Effects and Willingness to Receive a Yearly Booster Dose among Members of Health Sciences Faculties: A Descriptive Cross-Sectional Study

ABSTRACT Background: New severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and waning vaccine efficacy led to the administration of booster doses. Healthcare workers (HCWs) are vulnerable to contract the infection, and vaccination hesitancy in this group may have an impact on vaccine uptake among the general public. Aims: This study aimed to (1) assess the prevalence of self-reported adverse effects (AEs) after the first booster dose vaccine, (2) evaluate the AEs between the homologous and heterologous booster vaccines, and (3) evaluate the willingness to receive a hypothetical yearly booster dose. Materials and Methods: An online, cross-sectional, self-administered, structured questionnaire was distributed to members of the health sciences faculties (HSFs), XXXX University, Malaysia. Convenience sampling was adopted, and descriptive statistics was used to interpret the results. Results: About 67.1% of participants experienced systemic or local AEs. The common AEs were pain at the site of injection (60.2%), fatigue (45.7%), headache (31.6%), and fever (24.7%). About 64% of our participants believed that the booster dose provided extra immunity against the coronavirus disease 2019 (COVID-19) infection and 57.7% of participants expressed concern over the “mix–match” of vaccination. About 78% of the participants were keen to receive the hypothetical yearly booster dose. The severity of AEs between the booster dose and the primary dose was statistically insignificant (P &lt; 0.159). Conclusion: Booster vaccination AEs were similar to the primary dose. However, a higher severity of AEs occurring in heterologous vaccine receivers was noted in our study.

480 Effect of Chronic DBS on Ventral Capsule Ventral Striatum-Specific Circadian Rhythm in Refractory Obsessive-Compulsive Disorder

INTRODUCTION: Deep brain stimulation (DBS) of the ventral capsule/ventral striatum (VC/VS) improves symptoms in ∼66% of patients with treatment-resistant obsessive-compulsive disorder (OCD). However, a common adverse effect of VC/VS DBS is hypomania, marked by decreased need for sleep and increased risk-taking behaviors. Modern DBS devices have enabled 24-hour collection of neural data, allowing for tracking of circadian rhythms reflected by VC/VS local field potentials (LFPs). METHODS: We implanted six patients with treatment-resistant OCD with a DBS device configured for constant VC/VS stimulation and recording. Spectral power in the 9 ± 2.5 Hz band was estimated onboard the device every 10 minutes for a median of 249 days (range 77-608). We assessed the rhythmicity of power in this spectral band by fitting 7-day retrospective rolling windows of per-day normalized LFP power to cosine functions using least-squared regression. Output metrics included acrophase (time of peak activity), amplitude, and fit significance. We quantified trends in acrophase over time using Pearson correlation. RESULTS: All six patients demonstrated consistent 24-hour cyclic LFP activity bilaterally. Two of the six had diurnal peaks which shifted significantly earlier across the study period. The remaining four patients had nocturnal peaks, all shifting significantly later over time. Notably, a patient in the latter group experienced three days of hypomania after DBS initiation associated with circadian disruptions even after clinical symptom resolution. Only after clinical DBS adjustment 2 weeks later did circadian rhythm rapidly return to pre-hypomanic levels. CONCLUSIONS: Study patients demonstrated evolving circadian VC/VS LFP activity across the course of DBS therapy, usually independent of cyclic whole-brain activity (i.e. sleep). Conversely, disruptions to these circadian patterns, as observed here during hypomania, may serve as biomarkers of region-specific stimulation side effects.