J Oncol Pharm Pract. 2023 Jun 8:10781552231180470. doi: 10.1177/10781552231180470. Online ahead of print.

ABSTRACT

INTRODUCTION: Azacitidine (AZA), a demethylating agent, is one of the mainstay treatments for patients with myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML) who are ineligible for curative allogeneic stem-cell transplantation and is recommended as first-line treatment in multiple countries. While arthralgia and myalgia have been commonly reported as side effects, the incidence of drug-induced reactive arthritis has only been reported twice so far.

CASE REPORT: We present a retrospective overview of a clinical case of a 71-year-old patient that developed new cytopenias on a background of Chronic Lymphocytic Leukaemia and was diagnosed with therapy-associated AML. His treatment included an indefinite course of AZA to induce remission and optimise long-term survival which resulted in a satisfactory haematological response. However, after his ninth AZA cycle, he presented to the emergency department with knee swelling and erythema and conjunctivitis.

MANAGEMENT AND OUTCOMES: Arthrocentesis of the knee revealed reactive arthritis with no crystal or organism growth. His symptoms were managed effectively with conservative management including NSAIDs, analgesia and temporary immobilization for joint rest. The adverse drug reaction probability score in our study was calculated as six and adverse drug reaction was thus assigned to the "probable" category.

CONCLUSION: We report a case that points to AZA as a probable cause of arthritis flares in MDS patients. The current limitation of this study is the lack of available data, future reviews and research will aid in providing stronger evidence of a correlation between arthritis and AZA treatment.

PMID:37291905 | DOI:10.1177/10781552231180470

Bioorg Med Chem Lett. 2023 Jun 6:129365. doi: 10.1016/j.bmcl.2023.129365. Online ahead of print.

ABSTRACT

The use of light to activate prodrugs offers a promising method for the precise control of drug release, reducing drug-related side effects and enhancing therapeutic effectiveness. We have created a novel prodrug system that utilizes a unique, heavy-atom-free photosensitizer to produce singlet oxygen, which then triggers the conversion of the prodrug into its active form. This system has been successfully demonstrated through the creation of "photo-unclick" prodrugs of paclitaxel (PTX), combretastatin A-4 (CA-4), and 10-hydroxy-7-ethylcamptothecin (SN-38). These prodrugs show decreased toxicity in the absence of light, but exhibit increased toxicity when exposed to red light.

PMID:37290494 | DOI:10.1016/j.bmcl.2023.129365

Rev Prat. 2023 Apr;73(4):421-429.

ABSTRACT

PRESERVING THE ORAL HEALTH OF PATIENTS ON ANTIRESORPTIVE DRUGS. For many years, antiresorptive medication have proven their effectiveness in reducing the risk of pathological fractures in osteoporotic or tumoral bone. However, bisphosphonates and denosumab may, in rare cases, induce osteonecrosis of the jaw, especially when prescribed for malignant disease (bone metastases or multiple myeloma). The presence of oral infections and the performance of invasive procedures, particularly dental avulsions, increase the risk of this complication. The management of osteonecrosis of the jaw is complex, and the prescribing physician and the dental surgeon must implement preventive measures. There are numerous recommendations published by national and international scientific societies that guide practitioners in the oral management of these patients. An oral check-up and oral cavity restoration are strongly recommended before treatment, as well as the implementation of rigorous oral hygiene and regular visits to the dental surgeon. During and after treatment with antiresorptive medication, oral care protocols are used to reduce the risk of osteonecrosis of the jaws and, when it occurs, to manage it.

PMID:37289162

EFORT Open Rev. 2023 Jun 8;8(6):482-488. doi: 10.1530/EOR-23-0016.

ABSTRACT

Convulsions are a neurological illness that has complexity. In clinical treatment, drug-induced convulsions appear from time to time. Drug-induced convulsions often begin as isolated acute seizures but may progress to persistent seizures. In orthopedics, topical administration of tranexamic acid is commonly used in conjunction with intravenous drip to achieve hemostasis during artificial joint replacement surgery. However, side effects induced by tranexamic acid accidental spinal administration should be taken seriously. We report a case of a middle-aged male treated with tranexamic acid locally in combination with intravenous drip for intraoperative hemostasis when undergoing spinal surgery. The patient had involuntary convulsions in both lower limbs after the operation. After symptomatic administration, the symptoms of convulsions gradually resolved. During the follow-up, the convulsions never occurred again. We reviewed the literature on cases with side effects of local tranexamic acid application in spinal surgery and discussed the mechanism of tranexamic acid-induced convulsions. Tranexamic acid is associated with an increased incidence of postoperative seizures. However, many clinicians are unaware that tranexamic acid causes seizures. This rare case summarized the risk factors and clinical features of these seizures. Moreover, it highlights several clinical and preclinical studies that offer mechanistic insights into the potential causes and treatments for tranexamic acid-associated seizures. A clear understanding of tranexamic acid-induced convulsions-related adverse reactions can help the first-line clinical screening of causes and adjustment of drug treatment. This review will aid the medical community by increasing awareness about tranexamic acid-associated seizures and translating scientific findings into therapeutic interventions for patients.

PMID:37289050 | DOI:10.1530/EOR-23-0016

Clin Infect Dis. 2023 Jun 8:ciad339. doi: 10.1093/cid/ciad339. Online ahead of print.

ABSTRACT

BACKGROUND: Integrase strand transfer inhibitor (INSTI)-based regimens are recommended for first-line therapy in HIV-2. Nonetheless, dolutegravir (DTG) clinical trial data is lacking.

METHODS: We conducted a phase II, single arm, open-label trial to evaluate the safety and efficacy of a triple therapy regimen including DTG, in persons with HIV-2 (PWHIV-2) in Portugal. Treatment-naïve adults were recruited to receive DTG in combination with two nucleoside reverse transcriptase inhibitors (NRTIs). Treatment efficacy was evaluated by the proportion of subjects achieving a plasma viral load (pVL) <40 copies/mL and/or by the change from baseline in CD4+T cell count and in CD4/CD8 ratio at week 48.

RESULTS: A total of 30 subjects were enrolled [22 women, median age 55 years-old]. At baseline, 17 (56.7%) individuals were viremic [median pVL 190 copies/mL; interquartile range (IQR): 99-445 copies/mL]. The median CD4 count was 438 cells/μL (IQR: 335-605) and CD4/CD8 ratio was 0.8. During follow-up, 3 subjects discontinued the study. At week 48, all participants (27) had pVL<40 copies/mL. No virological failures were observed. Mean changes of CD4 count and CD4/CD8 ratio at week 48 were of + 95.59 (95%CI: 28.05-163.14) cells/µL and +0.32 (95%CI: 0.19-0.46). The most common drug-related adverse events were headache and nausea. One participant discontinued due to central nervous system symptoms. No serious adverse events were reported.

CONCLUSIONS: DTG plus two NRTIs is safe and effective as first-line treatment for PWHIV-2 with a tolerability profile previously known. No virological failures were observed which suggest a high potency of DTG in HIV-2 as occurs in HIV-1.

PMID:37288954 | DOI:10.1093/cid/ciad339

Cureus. 2023 May 5;15(5):e38606. doi: 10.7759/cureus.38606. eCollection 2023 May.

ABSTRACT

Dual antiplatelet therapy (DAPT) with P2Y12 receptor inhibitors in conjunction with aspirin is the gold standard treatment for acute coronary syndrome (ACS) and to prevent stent thrombosis after percutaneous coronary intervention (PCI). While there have been reported allergic effects-particularly angioedema-linked to clopidogrel there is limited data on hypersensitivity reactions to ticagrelor. Here, we discuss a case of delayed-onset ticagrelor-induced angioedema in a patient, three weeks following initiation of DAPT with aspirin and ticagrelor status post-PCI with DES placement. The patient presented with acute onset tongue swelling and was successfully treated with epinephrine, steroids, and antihistamine. The C1 esterase inhibitor and tryptase levels were within normal limits. Ticagrelor was discontinued and the patient was transitioned to prasugrel for DAPT, without recurrence of symptoms. Given the few cases reported involving ticagrelor-induced angioedema, and the even rare, delayed onset cases such as those described above, it is imperative that clinicians be made aware of this adverse effect and its management.

PMID:37288188 | PMC:PMC10243224 | DOI:10.7759/cureus.38606

Sci Rep. 2023 Jun 7;13(1):9286. doi: 10.1038/s41598-023-35856-4.

ABSTRACT

It is well-known that chemotherapy brings about various adverse physical effects such as fatigue, nausea, or vomiting, and that it lowers mental well-being. It is less known that it desynchronizes patients with social environment. This study explores the temporal aspects and challenges of chemotherapy. Three groups equal in size and distinguished according to weekly, biweekly, and triweekly treatment schemes, each independently representative in terms of sex and age of the cancer population (total N = 440) were compared. The study found that chemotherapy sessions, regardless of their frequency, patients' age, and the overall length of treatment, have a very large effect on changing the felt pace of time from flying to dragging (Cohen's d = 1.6655). Most patients pay more attention to the passing of time than before treatment (59.3%), which has to do with the disease (77.4%). They also experience the loss of control over time, which they subsequently attempt to regain. The patients' actual activities before and after chemotherapy, however, are mostly the same. All these aspects create a unique 'chemo-rhythm', in which the significance of the type of cancer and demographic variables is negligible, and the mere rhythmic nature of treatment plays a central role. In conclusion, patients find the 'chemo-rhythm' stressful, unpleasant and difficult to control. It is vital to prepare them for it and help to reduce its adverse effects.

PMID:37286667 | PMC:PMC10246531 | DOI:10.1038/s41598-023-35856-4

BMJ Open. 2023 Jun 7;13(6):e070490. doi: 10.1136/bmjopen-2022-070490.

ABSTRACT

OBJECTIVE: Hepatitis C is an important risk factor for cirrhosis and liver cancer in the Taiwanese population. Domestic prisons reported a higher rate of hepatitis C infection than the national average. Efficient and effective treatment of patients with hepatitis C in prisons is required to decrease the number of infections. This study analysed the effectiveness of hepatitis C treatment and its side effects in prison patients.

DESIGN: This retrospective analysis included adult patients with hepatitis C who received direct-acting antiviral agents between 2018 and 2021.

SETTING: The special hepatitis C clinics in the two prisons were run by a medium-sized hepatitis C treatment hospital in Southern Taiwan. Three direct-acting antiviral agents, sofosbuvir/ledipasvir for 12 weeks, glecaprevir/pibrentasvir for 8 or 12 weeks and sofosbuvir/velpatasvir for 12 weeks, were adopted based on patient characteristics.

PARTICIPANTS: 470 patients were included.

OUTCOME MEASURE: The sustained virological response at 12 weeks after the end of treatment was compared between the different groups.

RESULTS: Most of the patients were men (70.0%) with a median age of 44 years. The most prevalent hepatitis C virus genotype was genotype 1 (44.26%). A total of 240 patients (51.06%) had a history of injectable drug use; 44 (9.36%) and 71 (15.11%) patients were coinfected with hepatitis B virus and HIV, respectively. Only 51 patients (10.85%) had liver cirrhosis. Most patients (98.30%) had normal renal function or no history of kidney disease. The patients had a sustained virological response achievement rate of 99.2%. The average incidence of adverse reactions during treatment was approximately 10%. Many of the adverse reactions were mild and resolved spontaneously.

CONCLUSION: Direct-acting antiviral agents are effective for treating hepatitis C in Taiwanese prisoners. These therapeutics were well-tolerated by the patient population.

PMID:37286314 | DOI:10.1136/bmjopen-2022-070490

Am Soc Clin Oncol Educ Book. 2023 Jun;43:e390876. doi: 10.1200/EDBK_390876.

ABSTRACT

The use of poly (ADP-ribose) polymerase (PARP) inhibitor therapy is standard care in the management of patients with various malignancies including ovarian, breast, prostate, and pancreatic cancers. PARP inhibitors have been approved in different settings for patients with specific hereditary pathogenic variants, most notably homologous recombination repair pathways such as BRCA1 and BRCA2 genes. The vast experience with PARP inhibitors (olaparib, niraparib, rucaparib) has been in the management of epithelial ovarian cancer. There have not been any head-to-head comparisons of PARP inhibitors in randomized trials, and we can only perform cross-comparison on the basis of the reported literature. The three approved PARP inhibitors share several common adverse effects because of a class effect including nausea, fatigue, and anemia, but there are notable differences likely because of variations in their poly-pharmacology and off-target effects. Finally, patients included in clinical trials are often younger with a good performance status and less comorbidities than the real-world population, and hence, the potential benefits and adverse effects may not be superimposable. In this review, we describe these differences and discuss strategies to mitigate and manage adverse side effects effectively.

PMID:37285556 | DOI:10.1200/EDBK_390876

Rev Soc Bras Med Trop. 2023 Jun 2;56:e0044. doi: 10.1590/0037-8682-0044-2023. eCollection 2023.

ABSTRACT

BACKGROUND: Safety and efficacy concerns regarding coronavirus disease 2019 (COVID-19) vaccines are common among the public and have a negative impact on their uptake. We aimed to report the adverse effects currently associated with the vaccine in Pakistan to build confidence among the population for its adoption.

METHODS: A cross-sectional study was conducted in five districts of the Punjab province of Pakistan between January and March 2022. The participants were recruited using convenience sampling. All data were analyzed using SPSS 22.

RESULTS: We recruited 1622 people with the majority aged between 25-45 years. Of these, 51% were female, including 27 pregnant women and 42 lactating mothers. Most participants had received the Sinopharm (62.6%) or Sinovac (17.8%) vaccines. The incidences of at least one side effect after the first (N = 1622), second (N = 1484), and booster doses (N = 219) of the COVID-19 vaccine were 16.5%, 20.1%, and 32%, respectively. Inflammation/erythema at the injection site, pain at the injection site, fever, and bone/muscle pain were common side effects of vaccination. No significant differences were observed in the adverse effect scores between all demographic variables except for pregnancy (P = 0.012) after the initial dose. No significant association was observed between any variable and the side effect scores of the second and booster doses of the vaccine.

CONCLUSIONS: Our study showed a 16-32% prevalence of self-reported side effects after the first, second, and booster COVID-19 vaccinations. Most adverse effects were mild and transient, indicating the safety of different COVID-19 vaccines.

PMID:37283345 | DOI:10.1590/0037-8682-0044-2023

Nat Commun. 2023 Jun 7;14(1):3332. doi: 10.1038/s41467-023-38032-4.

ABSTRACT

DESTINY-CRC01 (NCT03384940) was a multicenter, open-label, phase 2 trial assessing the efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-expressing metastatic colorectal cancer (mCRC) that progressed after ≥2 prior regimens; results of the primary analysis are published. Patients received T-DXd 6.4 mg/kg every 3 weeks and were assigned to either: cohort A (HER2-positive, immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+), cohort B (IHC 2+/ISH-), or cohort C (IHC 1+). Primary endpoint was objective response rate (ORR) by independent central review in cohort A. Secondary endpoints included ORR (cohorts B and C), duration of response, disease control rate, progression-free survival, overall survival, pharmacokinetics, and safety of T-DXd. 86 patients were enrolled (53 in cohort A, 15 in cohort B, and 18 in cohort C). Results of the primary analysis are published, reporting an ORR of 45.3% in cohort A. Here, we report the final results. No responses occurred in cohorts B or C. Median progression-free survival, overall survival, and duration of response were 6.9, 15.5, and 7.0 months, respectively. Overall serum exposure (cycle 1) of T-DXd, total anti-HER2 antibody, and DXd were similar regardless of HER2 status. Most common grade ≥3 treatment-emergent adverse events were decreased neutrophil count and anemia. Adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8 patients (9.3%). These findings support the continued exploration of T-DXd in HER2-positive mCRC.

PMID:37286557 | DOI:10.1038/s41467-023-38032-4

Eur J Hosp Pharm. 2023 Jun 7:ejhpharm-2023-003786. doi: 10.1136/ejhpharm-2023-003786. Online ahead of print.

ABSTRACT

Polymyxin B and colistin are considered the last therapeutic option to treat infections caused by highly drug-resistant bacteria. However, their administration may lead to various adverse effects such as nephrotoxicity, neurotoxicity, and allergic reactions. The current case report presents the clinical manifestation of polymyxin B-associated neurotoxicity in a female patient with no chronic illness history. The patient was rescued from under rubble during an earthquake. She was diagnosed with an intra-abdominal infection caused by Acinetobacter baumannii (A. baumannii) After the initiation of the polymyxin B infusion, the patient developed numbness and tingling sensations in her hands, face, and head. On discontinuing polymyxin B and starting colistimethate, the patient's symptoms improved. Therefore, healthcare professionals should be aware of the potential risk factors associated with neurotoxicity in patients receiving polymyxin B. On identifying such symptoms treatment should be discontinued promptly to prevent further neurological damage.

PMID:37286311 | DOI:10.1136/ejhpharm-2023-003786

Lancet Reg Health West Pac. 2023 Mar 15;34:100724. doi: 10.1016/j.lanwpc.2023.100724. eCollection 2023 May.

ABSTRACT

BACKGROUND: Therapeutic approaches to HIV-suppressed immunological non-responders (INRs) remain unsettled. We previously reported efficacy of Chinese herbal Tripterygium wilfordii Hook F in INRs. Its derivative (5R)-5-hydroxytriptolide (LLDT-8) on CD4 T cell recovery was assessed.

METHODS: The phase II, double-blind, randomized, placebo-controlled trial was conducted in adults patients with long-term suppressed HIV infection and suboptimal CD4 recovery, at nine hospitals in China. The patients were 1:1:1 assigned to receive oral LLDT-8 0.5 mg or 1 mg daily, or placebo combined with antiretroviral therapy for 48 weeks. All study staff and participants were masked. The primary endpoints include change of CD4 T cell counts and inflammatory markers at week 48. This study is registered on ClinicalTrials.gov (NCT04084444) and Chinese Clinical Trial Register (CTR20191397).

FINDINGS: A total of 149 patients were enrolled from Aug 30, 2019 and randomly allocated to receiving LLDT-8 0.5 mg daily (LT8, n = 51), 1 mg daily (HT8, n = 46), or placebo (PL, n = 52). The median baseline CD4 count was 248 cells/mm3, comparable among three groups. LLDT-8 was well-tolerated in all participants. At 48 weeks, change of CD4 counts was 49 cells/mm3 in LT8 group (95% confidence interval [CI]: 30, 68), 63 cells/mm3 in HT8 group (95% CI: 41, 85), compared to 32 cells/mm3 in placebo group (95% CI: 13, 51). LLDT-8 1 mg daily significantly increased CD4 count compared to placebo (p = 0.036), especially in participants over 45 years. The mean change of serum interferon-γ-induced protein 10 was -72.1 mg/L (95% CI -97.7, -46.5) in HT8 group at 48 weeks, markedly decreased compared to -22.8 mg/L (95% CI -47.1, 1.5, p = 0.007) in placebo group. Treatment-emergent adverse events (TEAEs) were reported in 41 of 46 (89.1%) participants in HT8 group, 43 of 51 (84.3%) in LT8, and 42 of 52 (80.7%) in PL group. No drug-related SAEs were reported.

INTERPRETATION: LLDT-8 enhanced CD4 recovery and alleviated inflammation in long-term suppressed INRs, providing them a potential therapeutic option.

FUNDINGS: Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, Shanghai Pharmaceuticals Holding Co., Ltd., and the National key technologies R&D program for the 13th five-year plan.

PMID:37283977 | PMC:PMC10240372 | DOI:10.1016/j.lanwpc.2023.100724

J Oncol Pharm Pract. 2023 Jun 6:10781552231180876. doi: 10.1177/10781552231180876. Online ahead of print.

ABSTRACT

INTRODUCTION: Combination treatment with atezolizumab and bevacizumab is the preferred first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma with a Child-Pugh Class A liver function. Reactivation of the antitumor immune response with atezolizumab can result in the development of immune-related adverse events including colitis, skin rash, endocrinopathies, pneumonitis, and nephritis with renal dysfunction. However, the occurrence of myositis with immune checkpoint inhibitors is rare.

CASE REPORT: We report on a 67-year-old male patient with an initial diagnosis of hepatocellular carcinoma, stage IV, unresectable with underlying cirrhosis who experienced atezolizumab-associated myositis.

MANAGEMENT AND OUTCOME: Utilization of the American Society of Clinical Oncology guideline on managing immune checkpoint inhibitors adverse events helped guide the ordering of pertinent labs for monitoring and pharmacologic treatment. In our case, atezolizumab-induced myositis was resolved via a combination of corticosteroids, intravenous immunoglobulins, and plasmapheresis.

DISCUSSION: Recognition of the signs and symptoms of atezolizumab-associated myositis is recommended and utilization of the American Society of Clinical Oncology guideline to guide management and treatment of associated symptoms.

PMID:37282559 | DOI:10.1177/10781552231180876

J Oncol Pharm Pract. 2023 Jun 6:10781552231180598. doi: 10.1177/10781552231180598. Online ahead of print.

ABSTRACT

INTRODUCTION: Apalutamide is an oral selective androgen receptor inhibitor, approved by the FDA for the treatment of patients with non-metastatic, castration-resistant prostate cancer (M0 CRPC) at high risk of developing metastases and for patients with metastatic castration-sensitive prostate (mHSPC) in association with androgen deprivation therapy (ADT). In the registration studies, skin reactions were reported among the most common side effects and as an adverse event of special interest.

CASE REPORT: Apalutamide-induced rash includes a wide spectrum of different types of skin reactions, but few cases reports and case series have described this adverse event. Here, we report an M0 CRPC patient who experienced a rare skin adverse event, a lichenoid reaction.

MANAGEMENT & OUTCOME: After 4 months of therapy with apalutamide, the patient reported dorsal pricking and dry skin. Lichenoid reaction was confirmed histologically and its correlation to the drug was demonstrated after pursuing a multidisciplinary approach.

DISCUSSION: To our knowledge, this is one of the first cases of Apalutamide-related lichenoid reaction and this clinical case showed the relevance of a multidisciplinary management when assessing drug-related adverse events. A broader knowledge of the spectrum of drug-related reactions would allow for a better diagnosis and therapy management by both physicians and patients.

PMID:37282554 | DOI:10.1177/10781552231180598

BMC Infect Dis. 2023 Jun 6;23(1):378. doi: 10.1186/s12879-023-08363-0.

ABSTRACT

On March 11th, 2020, the World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) a pandemic. To control the pandemic, billions of vaccine doses have been administered worldwide. Predictors of COVID-19 vaccine-related side effects are inconsistently described in the literature. This study aimed to identify the predictors of side effects' severity after COVID-19 vaccination among young adult students at Taif University (TU) in Saudi Arabia. An online, anonymous questionnaire was used. Descriptive statistics were calculated for numerical and categorical variables. Possible correlations with other characteristics were identified using the chi-square test. The study included 760 young adult participants from TU. Pain at the injection site (54.7%), headache (45.0%), lethargy and fatigue (43.3%), and fever (37.5%) were the most frequently reported COVID-19 vaccine-related side effects after the first dose. The most frequent side effects were reported among the 20-25-year-old age group for all doses of all vaccines. Females experienced remarkably more side effects after the second (p < 0.001) and third doses (p = 0.002). Moreover, ABO blood groups significantly correlated with vaccine-related side effects after the second dose (p = 0.020). The participants' general health status correlated with the side effects after the first and second doses (p < 0.001 and 0.022, respectively). The predictors of COVID-19 vaccine-related side effects in young, vaccinated people were blood group B, female gender, vaccine type, and poor health status.

PMID:37280542 | DOI:10.1186/s12879-023-08363-0

Sci Rep. 2023 Jun 6;13(1):9171. doi: 10.1038/s41598-023-36319-6.

ABSTRACT

Throughout the pandemic era, COVID-19 was one of the remarkable unexpected situations over the past few years, but with the decentralization and globalization of efforts and knowledge, a successful vaccine-based control strategy was efficiently designed and applied worldwide. On the other hand, excused confusion and hesitation have widely impacted public health. This paper aims to reduce COVID-19 vaccine hesitancy taking into consideration the patient's medical history. The dataset used in this study is the Vaccine Adverse Event Reporting System (VAERS) dataset which was created as a corporation between the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to gather reported side effects that may be caused by PFIEZER, JANSSEN, and MODERNA vaccines. In this paper, a Deep Learning (DL) model has been developed to identify the relationship between a certain type of COVID-19 vaccine (i.e. PFIEZER, JANSSEN, and MODERNA) and the adverse reactions that may occur in vaccinated patients. The adverse reactions under study are the recovery condition, possibility to be hospitalized, and death status. In the first phase of the proposed model, the dataset has been pre-proceesed, while in the second phase, the Pigeon swarm optimization algorithm is used to optimally select the most promising features that affect the performance of the proposed model. The patient's status after vaccination dataset is grouped into three target classes (Death, Hospitalized, and Recovered). In the third phase, Recurrent Neural Network (RNN) is implemented for both each vaccine type and each target class. The results show that the proposed model gives the highest accuracy scores which are 96.031% for the Death target class in the case of PFIEZER vaccination. While in JANSSEN vaccination, the Hospitalized target class has shown the highest performance with an accuracy of 94.7%. Finally, the model has the best performance for the Recovered target class in MODERNA vaccination with an accuracy of 97.794%. Based on the accuracy and the Wilcoxon Signed Rank test, we can conclude that the proposed model is promising for identifying the relationship between the side effects of COVID-19 vaccines and the patient's status after vaccination. The study displayed that certain side effects were increased in patients according to the type of COVID-19 vaccines. Side effects related to CNS and hemopoietic systems demonstrated high values in all studied COVID-19 vaccines. In the frame of precision medicine, these findings can support the medical staff to select the best COVID-19 vaccine based on the medical history of the patient.

PMID:37280253 | PMC:PMC10242606 | DOI:10.1038/s41598-023-36319-6

BMJ Open. 2023 Jun 6;13(6):e073777. doi: 10.1136/bmjopen-2023-073777.

ABSTRACT

OBJECTIVES: The purpose of this study was to assess the clinical and economic impact of adverse drug reactions (ADRs) among patients admitted to the University of Gondar Comprehensive Specialized Hospital (UoGCSH).

DESIGN AND SETTING: A prospective nested case-control study was conducted at the UoGCSH among admitted adult patients with (cases) and without ADRs (controls) between May and October 2022.

PARTICIPANTS: All eligible adult patients admitted in the medical ward of the UoGCSH during the study period were included in this study.

MAIN OUTCOME MEASURES: The outcome variables were the clinical and economic outcomes. Length of hospital stay, visits to intensive care units (ICU) and in-hospital mortality were used to measure and compare clinical outcomes in patients with and without ADRs. The economic outcome was also assessed using direct medical-related costs and compared for the two groups. Paired samples t-test and McNemar tests were used to compare measurable outcomes between the two groups. A p value <0.05 at the 95% CI was considered statistically significant.

RESULTS: Out of a total of 214 eligible enrolled patients, 206 (103 with and 103 without ADRs) with a 96.3% response rate were included in the cohort. The length of hospital stay was much longer in patients with ADRs than without ADRs (19.8 vs 15.2 days, p<0.001). Similarly, ICU visits (11.2% vs 6.8%, p<0.001) and in-hospital mortality (4.4% vs 1.9%, p=0.012) were significantly higher in patients with ADRs compared with those without ADRs. Patients with ADRs were significantly charged with higher direct medical costs compared with those without ADRs (6237.2 vs 5256.3 Ethiopian birr; p<0.001).

CONCLUSION: This study concluded that ADRs had a significant impact on patients' clinical and medical costs. Healthcare providers should strictly follow the patients to minimise ADR-related clinical and economic adverse outcomes.

PMID:37280017 | DOI:10.1136/bmjopen-2023-073777

J Infect Dev Ctries. 2023 May 31;17(5):583-587. doi: 10.3855/jidc.17167.

ABSTRACT

INTRODUCTION: Universal coverage of COVID-19 vaccines is of paramount importance for the prevention and control of the pandemic. World Health Organization (WHO) in 2019 declared vaccine hesitancy as one of the top ten global health threats. The study aims to find out the COVID-19 vaccine hesitancy among school children along with their parent's perspectives.

METHODOLOGY: A cross-sectional study was conducted among school children (aged 12-14 years) at two schools in Bhubaneswar, Odisha. Data were collected via web-based links using a semi-structured questionnaire among students and their parents.

RESULTS: Of 343 children, 79% (271) showed a strong willingness to get vaccinated. Around 91.8% (315) of parents agreed to get their children vaccinated. Fear of side effects (65.2%) was the most common reason for unwillingness.

CONCLUSIONS: With only 1/5th of the children not willing to get vaccinated, policymakers should create a multi-centric effort for the universal coverage of the COVID-19 vaccination.

PMID:37279412 | DOI:10.3855/jidc.17167

Radiology. 2023 Jun;307(5):e222321. doi: 10.1148/radiol.222321.

ABSTRACT

Background Diabetes mellitus may be associated with an increased likelihood of CT contrast material-induced acute kidney injury (CI-AKI), but this has not been studied in a large sample with and without kidney dysfunction. Purpose To investigate whether diabetic status and estimated glomerular filtration rate (eGFR) are associated with the likelihood of acute kidney injury (AKI) following CT contrast material administration. Materials and Methods This retrospective multicenter study included patients from two academic medical centers and three regional hospitals who underwent contrast-enhanced CT (CECT) or noncontrast CT between January 2012 and December 2019. Patients were stratified according to eGFR and diabetic status, and subgroup-specific propensity score analyses were performed. The association between contrast material exposure and CI-AKI was estimated with use of overlap propensity score-weighted generalized regression models. Results Among the 75 328 patients (mean age, 66 years ± 17 [SD]; 44 389 men; 41 277 CECT scans; 34 051 noncontrast CT scans), CI-AKI was more likely in patients with an eGFR of 30-44 mL/min/1.73 m2 (odds ratio [OR], 1.34; P < .001) or less than 30 mL/min/1.73 m2 (OR, 1.78; P < .001). Subgroup analyses revealed higher odds of CI-AKI among patients with an eGFR less than 30 mL/min/1.73 m2, with or without diabetes (OR, 2.12 and 1.62; P = .001 and .003, respectively), when they underwent CECT compared with noncontrast CT. Among patients with an eGFR of 30-44 mL/min/1.73 m2, the odds of CI-AKI were higher only in those with diabetes (OR, 1.83; P = .003). Patients with an eGFR less than 30 mL/min/1.73 m2 and diabetes had higher odds of 30-day dialysis (OR, 1.92; P = .005). Conclusion Compared with noncontrast CT, CECT was associated with higher odds of AKI in patients with an eGFR of less than 30 mL/min/1.73 m2 and in patients with diabetes with an eGFR of 30-44 mL/min/1.73 m2; higher odds of 30-day dialysis were observed only in patients with diabetes with an eGFR less than 30 mL/min/1.73 m2. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Davenport in this issue.

PMID:37278631 | DOI:10.1148/radiol.222321