Predictors Of Adverse Reactions Research Articles

Prevalence and Predictors of Adverse Reactions to COVID-19 AstraZeneca Vaccine among Healthcare Staff of General Hospital Ilorin, North-Central, Nigeria

Background: Vaccines are crucial for an effective global pandemic response. Despite the proven efficacy and safety of the COVID-19 AstraZeneca vaccine by the World Health Organization, some adverse effects have been reported. Aim: This was to determine the prevalence of adverse reactions to COVID-19 vaccine among the healthcare workers, to assess the time of onset of symptoms after vaccination, to determine the total duration of persistent of symptoms after vaccination among respondents and to determine the socio-demographic and clinical predictors of adverse reactions among the participants. Materials and Method: This study was a hospital-based descriptive cross-sectional study, and it was conducted at the General Hospital Ilorin (GHI), Kwara State. The study population consists of 121 health workers at GHI who received the first dose of COVID-19 vaccine. Interviewers’ administered questionnaires were used to obtain socio-demographic and some clinical information from the participants. Clinical measurements were done using weighing scale, stadiometer, stethoscope, and sphygmomanometer. Results: The mean age of the participants was 39.5±8.9. The most commonly reported adverse drug reactions (ADRs) among the participants were site tenderness (51.2%), site pain (51.2%), fatigue (25.6%), and myalgia (24%). There was no report of blood clotting problems among them (0%). The majority of the ADRs started within 30 minutes to about 24 hours after the respondents received their COVID-19 vaccine jabs except for arthralgia which developed after 24 hours in the majority of the respondents who had it (61.5%). Most of the ADRs resolved completely within 24 hours to 72 hours except for chills that lasted for less than 24 hours among the majority of the participants who had it (53.3%), and also myalgia that lasted for more than 72 hours among the highest percentage of participants who reported having it (41.4%). The results of the multiple logistic regression analysis revealed no statistically significant predictors for the reactions (All reported P-values for all the regression coefficients were greater than 0.05). Conclusion: This study reported the prevalence, time of onset and duration of ARs to the first dose of AstraZeneca vaccine among health workers in Ilorin. The prevalence and pattern of the ARs reported is similar to those from other countries and continents. No report of severe anaphylactic reactions or blood clotting problems among the respondents. The time of onset and duration of most ARs were between 30 minutes to 24 hours, and less than 3 days respectively. The study also reported that no socio-demographic or clinical factors studied could significantly predict the occurrence of ARs among the participants.

Body Composition as a Predictor of Toxicity and Prognosis in Patients with Diffuse Large B-Cell Lymphoma Receiving R-CHOP Immunochemotherapy.

Background: Our study measured the body composition of Diffuse large B-cell lymphoma (DLBCL) patients receiving rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) regimen by computed tomographic (CT) and assessed their correlation with treatment-related toxicity and other adverse outcomes. Methods: We retrospectively analyzed 201 DLBCL patients who underwent pre-treatment abdominal CT examination. CT images were used to assess body composition metrics at the third lumbar vertebrae including fat tissues and muscle. Based on the skeletal muscle area (SMA) and density (SMD), skeletal muscle index (SMI), skeletal muscle gauge (SMG = SMI × SMD) and lean body mass (LBM) were calculated. Also analyzed were the toxicity, adverse events and survival. Results: We found that SMG, SMD, SMI and LBM were correlated with any grade 3–4 toxicity, dose reduction, hospitalization or termination of the treatment due to immunochemotherapy and worse survival. However, multivariate analysis demonstrated SMG [progression-free survival (PFS): hazard ratio (HR), 2.889; 95% CI, 1.401–5.959; p = 0.004; overall survival (OS): HR, 2.655; 95% CI, 1.218–5.787; p = 0.014] was the best predictor of poor prognosis. Conclusions: SMG, SMD, SMI and LBM were identified as predictors of adverse reactions and poor survival. SMG was an innovative and valuable indicator of immunochemotherapy toxicity and other adverse outcomes. Additionally, it can be used to individualize antineoplastic drug dosing.

Predictors of adverse reactions among children undergoing oral food challenges

Predictors of adverse reactions among children undergoing oral food challenges

Prevalence and predictors of adverse reactions in plateletpheresis donors with the perspective of donor safety in a tertiary care hospital of Northern India.

BACKGROUND:Plateletpheresis procedures are generally safe and associated with low adverse reactions. Although donor reactions and injuries are self-limited events, they may discourage donors from future platelet donations.AIM:The purpose of this study was to determine the prevalence and predictors of adverse donor reactions in plateletpheresis donors, which could serve as targets for interventions to reduce reactions.MATERIALS AND METHODS:The study included 106 platelet donors over a period of 2 years. The demographic, biometric, and clinical parameters were noted. The data were analyzed for predictors of adverse donor reactions.STATISTICAL ANALYSIS USED:The data were analyzed using independent sample t-test to correlate donor variables such as gender. To correlate other variables such as age, weight, and whole blood processed, Chi-square test was used.RESULTS:A total of 106 plateletpheresis donations were performed and 13.2% of vasovagal reactions were observed. The significant predictive factors for reactions were young female donors with low body weight in which more than 2.5 L volume of whole blood was processed and more than 250 ml of acid, citrate, and dextrose-A was infused and with single venous access procedures.CONCLUSIONS:The results of this study are encouraging and helpful in identifying donors at risk for developing adverse reactions during plateletpheresis so that proper and close observation during and after donation as well as timely intervention can prevent most of the unpleasant events of plateletpheresis donors.

The REQUITE project: Validating predictive models and biomarkers of radiotherapy toxicity to reduce side effects.

276 Background: Recently the first replicated genetic associations for adverse reactions to radiotherapy (RT) have been reported. These will help to build predictive statistical models for optimising RT delivery or interventions to alleviate the side effects. It is now timely to start a project that aims to validate known predictors of adverse reactions and develop the statistical models to become clinically useful. REQUITE is a European Union funded FP7 project that aims to do this. Methods: REQUITE’s objectives: (1.) Perform a multi-centre, cohort study collecting: blood samples, epidemiology and treatment data, longitudinal side-effect and QOL data (before and after treatment, yrs 1 and 2). (2.) Produce a centralised biobank of DNA from 5,300 patients and a centralised data management system. (3.) Validate published biomarkers of radiosensitivity. (4.) Validate clinical predictors of RT toxicity in breast, prostate, and lung cancer and incorporate biomarker data. (5.) Design interventional trials to reduce long-term side effects. (6.) Provide a resource for dissemination and exploitation to the RT community. Results: REQUITE is funded for 60 mos and organised into 7 work packages. Overall management and scientific oversight is run by Manchester. The central activity of the project is a multi-centre, observational study. Enrolment will proceed for 2 yrs in 9 clinical centres, with 2 yrs follow-up. The primary endpoints are change in breast appearance; rectal bleeding (prostate); pneumonitis (lung). Blood samples will be collected before radiotherapy. Tracking, biobanking, DNA preparation and validation of biomarkers (genetic markers and apoptosis assays) as predictive factors will be carried out in WP3-4. Some clinical factors have suggested predictive value for RT side-effects, but there is no consensus. Validation of published models in existing cohorts will be performed, leading to replicated models that can be validated using the REQUITE cohorts. Conclusions: The predictive models will be used to design clinical interventional trials and produce protocols that seek to lower RT side-effects in those individuals at high risk of developing them without affecting tumour control. Dissemination will follow.

Differences among allelic variants of human glutathione transferase A2-2 in the activation of azathioprine

Azathioprine has been clinically used for decades in connection with organ transplantation, autoimmune disease, and treatment of cancer. Toxic side-reactions are common and have been linked to the liberation of excessively high concentrations of 6-mercaptopurine and corresponding toxic metabolites. An allelic variant of thiopurine methyltransferase with low activity is associated with elevated concentrations of 6-mercaptopurine. However, other genetic markers remain to be identified in order to fully account for adverse reactions and efficacy failure. In the present study, we studied the five known allelic variants of human glutathione transferase A2-2 (GST A2-2) (EC 2.5.1.18), abundantly expressed in liver and efficiently catalyzing the bioactivation of azathioprine to release 6-mercaptopurine. All five variants exhibited high activity with azathioprine, but allelic variant E of GST A2-2 displayed a 3–4-fold elevated catalytic efficiency compared to the other variants. High GST activity can lead to overproduction of 6-mercaptopurine, and the nature of the multiple forms of GSTs in a patient will obviously affect the metabolism of azathioprine. In addition to GST A2-2, the polymorphic GST M1-1 is also highly active with azathioprine. Considering our findings, it appears that the genotypic and phenotypic variations in the GST complement may influence the presentation of adverse reactions in patients treated with azathioprine. Clinical trials will be required to clarify the impact of the GST expression in comparison with the established biomarker thiopurine methyltransferase as predictors of adverse reactions.

Predictors of Adverse Reactions to Chiropractic Treatment of Neck Pain

Predictors of Adverse Reactions to Chiropractic Treatment of Neck Pain

The safety of intravenous iron dextran in hemodialysis patients

The treatment of anemia in hemodialysis patients is frequently hindered by the presence of suboptimal iron stores. Intravenous iron dextran is in common use to maintain iron stores in this population, but there are little published data regarding the incidence and type of adverse events. The purpose of this study was to evaluate the safety of this medication. Charts from four hemodialysis centers of all 573 patients treated with intravenous iron dextran (INFeD; Schein Pharmaceutical, Inc, Florham Park, NJ) between July 1, 1993, and June 30, 1995, were studied. Twenty-seven patients (4.7%) had adverse reactions that were related to iron dextran. Four patients (0.7%) had reactions classified as serious (one cardiac arrest; three others required hospitalization). Ten patients (1.7%) had reactions classified as anaphylactoid. No patients died or developed permanent disability as a result of reactions. The most common adverse reactions included itching (1.5% of patients) and dyspnea or wheezing (1.5%); others included chest pain (1.0%), nausea (0.5%%), hypotension (0.5%), swelling (0.5%), dyspepsia (0.5%), diarrhea (0.5%), skin flushing (0.3%), headache (0.3%), cardiac arrest (0.2%), and myalgias (0.2%). Five of all the reactions occurred during a test dose; four of these were anaphylactoid. Several factors were studied as possible predictors of adverse reactions. A positive history of drug allergy (odds ratio, 2.4; P = 0.03) and history of multiple drug allergy (odds ratio, 5.5; P = 0.0004) were significant predictors of reactions. In summary, we found serious adverse reactions to be uncommon in hemodialysis patients treated with intravenous iron dextran. Future prospective studies will help confirm this finding.