Local Side Effects Research Articles

Intraductal Delivery and X-ray Visualization of Ethanol-Based Ablative Solution for Prevention and Local Treatment of Breast Cancer in Mouse Models

Breast cancer is the most prevalent cancer and the second-leading cause of cancer-related death for women in the USA. For high-risk women, prophylactic mastectomy is the most effective primary prevention strategy. Prophylactic mastectomy is an aggressive surgical procedure that completely removes the mammary epithelial cells from which breast cancer arises along with the surrounding tissue. We seek to develop a minimally invasive intraductal procedure as an alternative to prophylactic mastectomy to locally ablate the mammary epithelial cells before they can become malignant. We and others have developed an intraductal delivery procedure to reach and treat these epithelial cells in rodent models of breast cancer. While the mouse mammary gland with a single non-anastomosed ductal tree opening at the nipple has a much less complex and tortuous architecture than the human breast, chemically induced and genetically engineered mouse models of breast cancer are valuable to produce proof-of-concept studies of new preventative strategies. Here, we describe a procedure for intraductal delivery of an ethanol-based ablative solution containing micro-CT/X-ray tantalum-based contrast agent within the mouse mammary ductal tree for the therapeutic purpose of primary prevention of breast cancer. Intraductal delivery of aqueous reagents (e.g., cytotoxic compounds, siRNAs, AdCre) has been previously described in mouse models. Thus, we focus our protocol description on methodological modifications and unique experimental considerations for optimizing delivery of ethanol, for minimizing local and systemic side effects of ethanol administration, and for in vivo visualization of ductal tree filling via micro-CT/fluoroscopy imaging. Visualization of the ductal tree immediately after injection of a contrast-containing solution allows for confirmation of complete filling or unsuccessful outcomes such as underfilling or overfilling. This procedure can be applied for delivery and imaging of other ablative compounds aimed at either preventing tumor formation or locally treating early-stage tumors accessible via the ductal tree.

Intraductal Delivery and X-ray Visualization of Ethanol-Based Ablative Solution for Prevention and Local Treatment of Breast Cancer in Mouse Models.

Breast cancer is the most prevalent cancer and the second-leading cause of cancer-related death for women in the USA. For high-risk women, prophylactic mastectomy is the most effective primary prevention strategy. Prophylactic mastectomy is an aggressive surgical procedure that completely removes the mammary epithelial cells from which breast cancer arises along with the surrounding tissue. We seek to develop a minimally invasive intraductal procedure as an alternative to prophylactic mastectomy to locally ablate the mammary epithelial cells before they can become malignant. We and others have developed an intraductal delivery procedure to reach and treat these epithelial cells in rodent models of breast cancer. While the mouse mammary gland with a single non-anastomosed ductal tree opening at the nipple has a much less complex and tortuous architecture than the human breast, chemically induced and genetically engineered mouse models of breast cancer are valuable to produce proof-of-concept studies of new preventative strategies. Here, we describe a procedure for intraductal delivery of an ethanol-based ablative solution containing micro-CT/X-ray tantalum-based contrast agent within the mouse mammary ductal tree for the therapeutic purpose of primary prevention of breast cancer. Intraductal delivery of aqueous reagents (e.g., cytotoxic compounds, siRNAs, AdCre) has been previously described in mouse models. Thus, we focus our protocol description on methodological modifications and unique experimental considerations for optimizing delivery of ethanol, for minimizing local and systemic side effects of ethanol administration, and for in vivo visualization of ductal tree filling via micro-CT/fluoroscopy imaging. Visualization of the ductal tree immediately after injection of a contrast-containing solution allows for confirmation of complete filling or unsuccessful outcomes such as underfilling or overfilling. This procedure can be applied for delivery and imaging of other ablative compounds aimed at either preventing tumor formation or locally treating early-stage tumors accessible via the ductal tree.

Clinical effectiveness and local side effects of topical 0.05% cyclosporine in treatment of children with severe vernal keratoconjunctivitis

Purpose: To evaluate the therapeutic response of topical cyclosporine (CyS-A) in patients with vernal keratoconjunctivitis (VKC), resistant to topical mast cell stabilizer (MCS) and anti-histamine therapy. Study Design: Quasi experimental study. Place and Duration of Study: Qazi Hussain Ahmad Medical Complex, Nowshera, from April 2019 to August 2019. Methods: Forty patients, 30 males and 10 females, less than 18 years of age and diagnosed with Vernal Keratoconjunctivitis were enrolled in the study. All participants were graded based upon severity of the disease at presentation with a score of 0 for normal, 1 for mild, 2 for moderate and 3 for severe, for both symptoms and signs. Each patient received topical CyS-A 0.05%in QID regimen in addition to lubricating tear substitute. Followup was done for 04 months. Results: Clinical scoring was done at baseline and at the 1st, 2nd and 4th month following therapy. After 4 months of topical application, not only the patients improved symptomatically but their clinical signs also improved, which achieved a level of statistical significance (p < 0.05). All participants completed the follow-up duration of therapy. Although Horner Tranta’s dot showed improvement, but comparison of baseline with 1st month values were statistically non-significant (p = 0.048). However, during 2nd and 4th month, the improvement achieved statistical significance (p = 0.013 and p = 0.006 respectively). None of the participants reported any bothersome local side effect. Conclusion: Topical cyclosporine 0.05% is effective in alleviating the symptoms and signs without any local side effects in resistant VKC. Key Words: Vernal keratoconjunctivitis, Cyclosporine, Cobblestone Papillae.

Humoral response and safety of BNT162b2 mRNA vaccine in children with rheumatic diseases.

ObjectivesThe coronavirus disease 2019 (COVID-19) vaccine represents a cornerstone in tackling the pandemic and with the approval of the BNT162b2 mRNA vaccine in December 2020, it has become a beacon of hope for people around the world, including children. This study aimed to present the data on the humoral response and safety of vaccine in a cohort of patients with paediatric rheumatic diseases receiving immunomodulatory treatments.MethodsForty-one children with paediatric rheumatic diseases were included and were vaccinated with the BNT162b2 mRNA vaccine (two doses of 30 µg administered 3–4 weeks apart). To assess the humoral response, IgG antibodies developed against the S1/Receptor-binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein at baseline and 3–4 weeks after the second dose were measured. The possible local and systemic side effects and disease activity scores were evaluated during the study period.ResultsAfter the second dose of vaccine, markedly elevated anti-RBD IgG titres were observed in all patients with a median titre of 20 474 AU/ml [interquartile range (IQR) 6534–36 151] with a good safety profile. The median disease duration was 4.3 (IQR 3.5–5.6) years. In the cohort, 14 (34.1%) received conventional DMARDs (cDMARDs), 16 (39%) received biologic DMARDs (bDMARDs) and 11 (26.8%) received a combined therapy (cDMARDs and bDMARDs). Patients treated with combined therapy [median 4695 (IQR 2764–26 491)] had significantly lower median titres of anti-RBD IgG than those receiving only cDMARDs.ConclusionPaediatric rheumatic diseases patients receiving immunomodulatory treatments were able to mount an effective humoral response after two dose regimens of BNT162b2 mRNA vaccine safely without interrupting their current treatments.

Evaluation of efficacy and safety of subcutaneous acetaminophen in geriatrics and palliative care (APAPSUBQ)

IntroductionSubcutaneous infusion (SC) or hypodermoclysis is an old perfusion technique that is often used off-label although it has been shown to be effective. Acetaminophen (paracetamol) subcutaneous injection is performed in some centers despite the lack of conclusive evidence on its effectiveness. This study aims to evaluate the efficacy of subcutaneous infusion of Acetaminophen in the treatment of pain and fever in geriatrics and in palliative care and to determine its safety profile and possible side effects.Material and methodsThis experimental study was conducted between 2018 and 2019 on adult patients in palliative care or in geriatrics in several hospitals and nursing homes in Lebanon. Primary outcomes were change in temperature; change in pain score on the numerical rating scale (NS) or on the Algoplus scale after 60 min from the start of the infusion; and the appearance of local side effects at the infusion site. Changes in the various parameters at 30 min and 180 min were also evaluated as secondary outcomes.ResultsThirty-one patients were included in the study, with a total of 120 doses of acetaminophen. At 60 min, the mean decrease in pain on the NS was 5.35 points, while the mean decrease in temperature was 0.79 degrees Celsius. At 60 min, 75%, CI = [47.62-92.73] of the patients who received acetaminophen for pain and 66.67%, CI = [38.38-88.17] of those who received it for fever had clinically significant improvement. The overall effect of subcutaneous acetaminophen, defined as any clinically significant effect on pain or fever, was 70.97%, CI = [51.96-85.78]. The overall effect at 30 min and at 180 min was 23.33%, CI = [9.93-42.28] and 87.10%, CI = [70.17-96.37], respectively. The side effects reported 30 min after the injection and observed after at least one of the doses were: local edema in 16 patients (51.61%), induration in one patient (3.23%), local pain in one patient (3.23%) and local heat in one patient (3.23%). At 180 min, only 2 patients (6.45%) still had edema at the infusion site.ConclusionSubcutaneous administration of acetaminophen is effective and well tolerated in geriatric and palliative care patients. It is appropriate when no other route is available, especially for home-based care. Comparative studies are needed to allow the expansion of this practice.

ChAdOx1 nCoV-19 Vaccine Side Effects among Healthcare Workers in Trinidad and Tobago.

Vaccine hesitancy due to safety concerns is a hindrance to the success of vaccination campaigns. In February 2021, Trinidad and Tobago commenced its National COVID-19 Vaccination Program. Healthcare workers were among the first group to receive the ChAdOx1 nCoV-19 (Oxford–AstraZeneca (Covishield, Serum Institute of India, Pune, India), the first COVID-19 vaccine available nationally. This study examined the safety of this vaccine in terms of the systemic and local adverse events following immunization reported by healthcare worker recipients. A cross-sectional study was conducted via a telephone questionnaire. Data concerning demographics, medical and COVID-19-related anamneses, and local and systemic side effects experienced within the first 48 h after receiving the first and second dose of this vaccine, respectively, were gathered. Among the 687 participants (male = 275; female = 412), prevalence of fever, body pain, chills, nausea, myalgia, headache, malaise, fatigue, and other systemic symptoms declined significantly 48 h after administration of the second dose compared to the first dose. Chi-square test and multiple logistic regression demonstrated the greater likelihood of younger recipients to report systemic symptoms compared to older recipients. Multiple logistic regression indicated that females were more likely to report headache, fatigue, and discomfort, and were less likely to report no symptoms, compared to males, after both doses. On average, recipients reported less local and systemic side effects 48 h after receiving the second dose compared to the first dose. The reported rate of occurrence of side effects was <50% for most adverse events, which is consistent with the manufacturer’s claims that the vaccine is safe. This study adds data on the safety of this vaccine in a population that has not been previously studied. The findings can inform public health policy efforts to lower vaccine hesitancy based on safety concerns surrounding the ChAdOx1 nCoV-19 vaccine across various groups in society, including healthcare workers.

COVID-19 Vaccines Side Effects Among Iraqi people In Kurdistan Region: A cross-sectional study

Background: Communities around the world have expressed concern about the safety and side effects of SARS-CoV-2 vaccines. The adverse effects of the Covid-19 vaccines played a critical role in public trust in the vaccines. The current study aimed to provide evidence on the side effects of the BNT163b2 mRNA COVID-19 vaccine (Pfizer-BioNTech®); ChAdOx1 nCoV-19 vaccine (AstraZeneca®); BBIBP-CorVvaccine (Sinopharm®) COVID-19 vaccines. Material and Methods: A cross-sectional study design was performed from April 26th, 2021, to June 3rd, 2021. Convenience sampling was used to select respondents; face validity was performed to the mandatory multiple-choice items questionnaire to cover the respondent’s demographic characteristics, coronavirus-19 related anamneses, and the side effect duration of coronavirus-19 vaccines, the data were analyzed by using descriptive statistics. Results: The 588 participants enrolled in the current study. ChAdOx1 nCoV-19 vaccine received 49.7%, followed by BNT163b2 mRNA COVID-19 vaccine and BBIBP-CorV (39.5% and 10.9%). The most common complaint was headache (61.2%), followed by vaccine injection site discomfort (58.8%), fatigue (49.7%), fever (48.3%), muscle discomfort (42.9%), and approximately (10.5% and 10.2%) had injection site swelling and nausea, respectively. Most of those surveyed had post-vaccine symptoms for one to two days (25.2%), (41%), and only a small percentage (3.7%) experienced them for over one month. ChAdOx1 nCoV-19 vaccine handled 53% of the side effects, followed by BNT163b2 mRNA COVID-19 vaccine (42%) and BBIBP-CorV vaccines (5%). Conclusion: Prevalence of various local and systemic vaccines side effects, such as headache, fever, and pain at the injection site, was observed. Almost all participants had mild symptoms and were well-tolerated .AstraZeneca® vaccine has the most side effects, followed by the Pfizer® vaccine, and the Sinopharm® vaccine has the least. More independent studies on vaccination safety and public awareness are critical to improving public trust in vaccines.

Regional Scalp Blockade for Painless Removal ofIntracranial Pressure Bolts: Technical Note and Patient-Reported Outcomes

Elective insertion of intracranial pressure (ICP) monitoring bolts is useful for the diagnosis and treatment of disorders of cerebrospinal fluid dynamics. Patients typically report severe discomfort on bolt removal, which negatively impacts overall patient satisfaction of ICP monitoring. We assessed the efficacy and safety of using supratrochlear and supraorbital nerve block-a commonly used form of scalp anesthesia-alongside oral analgesia before bolt removal. We compared the efficacy and safety of regional scalp block anesthesia alongside oral analgesia versus oral analgesia alone in a cohort of 85 patients undergoing removal of diagnostic ICP bolts between June 2017 and April 2019 using retrospective patient questionnaires, as well as electronic admission documentation. We found that scalp block alongside oral analgesia improved bolt removal experience (4/5 vs. 3/5 on a 1-5 point Likert scale) and that a majority (70.6%) of patients would have preferred local anesthetic before removal in the oral analgesia-only group. Only 2 patients experienced mild and localized side effects: mild bruising and temporary facial and eyelid swelling following regional scalp block. We conclude that regional supraorbital and supratrochlear nerve block is a simple, safe, and effective adjunct to minimizing discomfort during bolt removal and improving overall patient satisfaction of ICP monitoring.

Safety Profile of COVID-19 Vaccines among Healthcare Workers in Poland.

The aim of the study was to compare the safety profiles (prevalence of both local and systemic side effects) of COVID-19 vaccines (Pfizer–BioNTech, Moderna, Oxford–AstraZeneca) among healthcare workers (doctors, nurses, and pharmacists) administered with a first and a second dose of the vaccines. Another goal of the research was to evaluate potential demographic and clinical risk factors for the frequency and intensity of side effects. A post-marketing, cross-sectional survey-based study was carried out on a sample of 971 respondents (323 doctors, 324 nurses, and 324 pharmacists), all more than 18 years old, who have taken two doses of the following SARS-CoV-2 vaccines: BNT162b2 (Pfizer–BioNTech) (group 1), mRNA-1273 (Moderna) (group 2), and ChAdOx1 nCoV-19 (Oxford–AstraZeneca) (group 3). A validated, self-administered questionnaire was developed and delivered online to the target population group of healthcare workers. The survey was conducted during the third wave of the COVID-19 (1 February 2021–1 July 2021) pandemic. It was based on the CAWI (computer-assisted web interview) method. Questionnaires were disseminated using selected social media. The BNT162b2 (Pfizer–BioNTech) vaccine was the most commonly administered COVID-19 vaccine among healthcare professionals in Poland (69.61%). Side effects following a SARS-CoV-2 vaccine were reported by 53.11% of respondents in group 1, 72% in group 2, and 67.59% in group 3. The following were the most common side effects regardless of the type of vaccine administered: pain at the injection site, headache, muscle pain, fever, chills, and fatigue. The number and intensity of reported side effects following administration of a BNT162b2 (Pfizer–BioNTech) vaccine were significantly lower than in the other two study groups (p < 0.00001). Risk factors for side effects following administration of one of the SARS-CoV-2 vaccines subject to the analysis included being female, young, and suffering from a diagnosed allergy. Our results clearly show that the short-term safety profiles of the eligible COVID-19 vaccines (Pfizer–BioNTech, Moderna, Oxford–AstraZeneca) are acceptable. Nevertheless, the two-dose COVID-19 vaccines available in Poland differ significantly in the frequency of both local and systemic side effects and their intensity. Women, young people, and patients diagnosed with allergies are particularly exposed to the risk of side effects. Further studies are needed to determine the long-term safety profile of COVID-19 vaccines.

Identification of the Risks of Giving the Covid 19 Vaccine on Other Health Workers at Dr Mohammad Hoesin Hospital Palembang

Corona Virus Disease 2019 (COVID-19) is a disease caused by the SARS-CoV-2 virus, this disease spreads faster and in a short time becomes a worldwide pandemic. In the context of controlling and preventing the spread of the COVID-19 virus, the COVID-19 vaccination is carried out. The main priority in administering the COVID 19 vaccination is health workers because they are at high risk of being exposed to the COVID 19 virus. Other Health Workers who are included in the Committee for other Health Workers at Dr Mohammad Hoesin Hospital Palembang also receive the COVID-19 vaccination which is carried out in 2 doses or 2 injections. The COVID-19 vaccination may pose a risk of local or systemic side effects. This study aims to identify the risks that arise after administering the COVID-19 vaccine to other health workers at Dr Mohammad Hoesin Hospital Palembang. The design of this study was quantitative using an analytical survey method through a retrospective approach. The population is 534 people consisting of 20 other health professions. Based on the data analysis, it can be concluded that the risks that arise after the administration of the COVID -19 I Vaccination are in the form of systemic side effects, namely drowsiness (67%) and local side effects are pain (58.5%), while after the second Covid 19 vaccination, the most common side effects are pain. Common side effects are local side effects, namely pain (77.3%) and systemic side effects are drowsiness (62.1%). occurred after the administration of the first Covid 19 vaccination (86.2%). After giving the COVID 19 vaccination, there were still 5 other Health Workers who were exposed to the Covid 19 virus (4.6%).

A Cohort Study on the Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (BBIBP-CorV) in Patients With Breast Cancer; Does Trastuzumab Interfere With the Outcome?

AimTo determine the efficacy and safety of inactivated SARS-CoV-2 vaccine (BBIBP-CorV) in patients with breast cancer.MethodsIn this multi- institutional cohort study, a total of 160 breast cancer patients (mean age of 50.01 ± 11.5 years old) were assessed for the SARS-CoV-2 Anti-Spike IgG and SARS-CoV2 Anti RBD IgG by ELISA after two doses of 0.5 mL inactivated, COVID-19 vaccine (BBIBP-CorV). All patients were followed up for three months for clinical COVID-19 infection based on either PCR results or imaging findings. Common Terminology Criteria for Adverse Events were used to assess the side effects.ResultsThe presence of SARS-CoV-2 anti-spike IgG, SARS-CoV2 anti-RBD IgG, or either of these antibodies was 85.7%, 87.4%, and 93.3%. The prevalence of COVID-19 infection after vaccination was 0.7%, 0% and 0% for the first, second and third months of the follow-up period. The most common local and systemic side-effects were injection site pain and fever which were presented in 22.3% and 24.3% of patients, respectively.DiscussionThe inactivated SARS-CoV-2 vaccine (BBIBP-CorV) is a tolerable and effective method to prevent COVID-19.

The systematic development of attributes and levels for a discrete choice experiment of HIV patient preferences for long-acting antiretroviral therapies in the United States

IntroductionPatient preferences for long-acting antiretroviral therapies (LA-ART) should inform development of regimens with optimal adherence and acceptability. We describe a systematic process used to identify attributes and levels for a discrete choice experiment (DCE) designed to elicit preferences for potential LA-ART options in the US.MethodsOur approach was conducted in four stages: data collection, data reduction, removing inappropriate attributes, and optimizing wording. We started with 8 attributes defining potential LA-ART products based on existing literature and knowledge of products in development. We conducted 12 key informant interviews with experts in HIV treatment. The list of attributes, the set of plausible levels for each attribute, and restrictions on combinations of attribute levels were updated iteratively.ResultsDespite uncertainty about which products will become available, key informant discussions converged on 4 delivery modes (infusions and patches were not considered immediately feasible) and 6 additional attributes. Treatment effectiveness and frequency of clinical monitoring were dropped. Oral lead-in therapy was split into two attributes: pre-treatment time undetectable and pre-treatment negative reaction testing. We omitted product-specific systemic and local side effects. In addition to mode, the final set of attributes included: frequency of dosing; location of treatment; pain; pre-treatment time undetectable; pre-treatment negative reaction testing; and late-dose leeway.ConclusionsA systematic process successfully captured elements that are both feasible and relevant to evaluating the acceptability of potential LA-ART alternatives to patients.

Evaluation of Infants with Retinopathy of Prematurity Treated with Intravitreal Bevacizumab

Objective: To evaluate the systemic and local effects and side effects of intravitreal bevacizumab injection in preterm infants with aggressive posterior retinopathy of prematurity. Material and Methods: A total of 16 patients were included in this single-center observational cohort study between June 2020 and March 2021. The clinical, laboratory, and radiological findings before and after intravitreal injection of 0.3 mg bevacizumab were recorded for a total of 32 eyes. Results: The patients’ mean gestational age at birth was 25±0.38 weeks and their mean birth weight was 695±119.2 g. None of the patients developed complications such as local vitreous hemorrhage or endophthalmitis secondary to intravitreal injection administered at a postmenstrual age of 34 weeks, and none required repeated injections. There was no increase in the rate of intraventricular hemorrhage after injection. There was no statistically significant difference in the patients’ laboratory parameters, blood pressure values, or systemic findings before and after treatment. Conclusion: Although no systemic or local side effects were observed in patients treated with intravitreal bevacizumab injection in this study, patients should be monitored closely for systemic hypertension, intraventricular hemorrhage, and hypotension. More detailed studies are needed to evaluate later neurodevelopmental outcomes compared to other treatment options.

A practical guide to the safety of topical medications for the pediatric population

Prescribing topical therapy for a child could be a challenging matter. This is due to the higher susceptibility of children to local and systemic side effects of topical drugs than adults. Herein, we provide clinicians with a practical guide regarding the side effects, precautions, and lower age limit of commonly prescribed topical medications for the pediatric population.

Injectable In Situ Gelling System for Sustained Nicotine Delivery as a Replacement Therapy for Smoking Cessation.

Nicotine replacement therapy (NRT) is widely used to limit the withdrawal symptoms associated with cigarette smoking cessation. However, the available NRT formulations are limited by their short release profiles, requiring frequent administrations along with local side effects. Thus, the objective of this study is to develop an NRT formulation that offers prolonged, sustained nicotine release. Thermoresponsive in situ gelling systems containing nicotine were prepared using poloxamer 407 (P407) and poloxamer 188 (P188). The system was optimized using a three-factor, two-level full factorial design (23). A formulation composed of P407 (20% w/w), P188 (5% w/w), and loaded with nicotine (0.5% w/w) exhibited sol-to-gel transition at a suitable temperature close to physiological temperature (30 °C). The rheological analysis demonstrated a Newtonian-like flow at room temperature, suggesting ease of administration via injection, and semisolid gel status at physiological temperature. The optimized formulation successfully sustained nicotine in vitro release over 5 days following single administration. The findings suggest that poloxamer based in situ gelling systems are promising platforms to sustain the release of nicotine.

Clinical Experience of Use of Percutaneous Continuous Nervemonitoring in Robotic Bilateral Axillo-Breast Thyroid Surgery.

Introduction and ObjectiveThere is a need for a simplified technique for C-IONM in robotic surgery. The primary aim of this study was to describe our clinical experience with the use of percutaneous C-IONM in robotic bilateral axillary thyroid surgery.MethodsThis study prospectively enrolled 304 consecutive patients who underwent robotic thyroidectomy via the bilateral axillo-breast approach and standardized C-IONM via percutaneous probe stimulation.Results323 RLNs were analyzed. C-IONM with percutaneous probes was feasible in all cases. During this study, we did not record any cases of probe displacement, and no additional robotic maneuvers were required. The average stimulation intensity was 2 mA. There were no adverse local or systemic C-IONM side effects. The mean time required for probe positioning was 3 minutes. The EMG amplitude signal of 48 RLNs decreased significantly, < 50% from the original V1 signal. In these cases, the surgical procedure was modified.ConclusionThe proposed percutaneous C-IONM provides a simplification of the continuous monitoring procedure for robotics. The advantage of percutaneous C-IONM is that it does not require additional trocar space, repeated instrument changes, and unmodified cosmesis. To our knowledge, this is the first study on the application of percutaneous C-IONM in robotic thyroid surgery.

Prospective Evaluation of Side-Effects Following the First Dose of Oxford/AstraZeneca COVID-19 Vaccine among Healthcare Workers in Saudi Arabia.

Background: Several different types of vaccines have been developed for the prevention of coronavirus disease (COVID-19). Despite several local and systemic side-effects to COVID-19 vaccination reported, the vaccines are still considered the best intervention to tackle the spread of the virus and reduce the severity of COVID-19 infection. However, the reported side-effects continue to have a crucial role in public confidence in the vaccine and its acceptance. This study aimed to investigate the short-term side-effects reported by the healthcare workers (HCWs) in Saudi Arabia after receiving the first dose of the Oxford/AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccine. Methods: A prospective cohort study was conducted among HCWs in the Jazan region of southwestern Saudi Arabia. Healthcare workers who had received the first dose of the COVID-19 vaccine and agreed to participate in the study were followed up for 3 weeks post vaccination through a weekly online survey. Information was collected on local and/or systemic side-effects reported following vaccine administration. Participants’ general and demographic information was also collected. Results: A total of 57.2% (250/437) of the HCWs who participated in this study reported at least one side-effect. Injection site pain and redness (80.0%), fever (73.2%), whole-body pain/fatigue (56.4%), and headache (48.8%) were the most commonly reported side-effects. Moreover, 12.4% of the participants who reported side-effects needed to see a physician, and only one female participant was admitted to the hospital. Multivariate regression analyses revealed that nationality (Saudi, adjusted odds ratio (aOR) = 3.65; 95% CI = 2.40, 5.55) and residency (Jazan governorate, aOR = 0.38; 95% CI = 0.15, 0.95) were the significant factors associated with reporting COVID-19 post-vaccination side-effects, while the number of reported side-effects was found to be significantly influenced by occupation (medical, aOR = 0.42; 95% CI = 0.26, 0.66; p < 0.001) and gender (female, aOR = 0.61; 95% CI = 0.38, 0.97; p = 0.038). Conclusions: Findings of the present study support the safety of the Oxford/AstraZeneca COVID-19 vaccine among HCWs in Saudi Arabia. All the reported side-effects were mild-to-moderate side-effects. The findings may help convince vaccine-hesitant individuals and skeptics to accept the COVID-19 vaccine.

SBRT in Localized Renal Carcinoma: A Review of the Literature.

Stereotactic body radiotherapy (SBRT) allows high doses of radiation to be administered in a limited number of fractions. The high doses per session might allow the theoretical radioresistance of renal carcinoma to be overcome. SBRT may be a therapeutic alternative in inoperable patients with localized renal carcinoma. This review studied the available literature on the use of SBRT in inoperable localized renal carcinoma. The review including data from English-language studies was conducted in PubMed and MEDLINE between January 2010 and December 2020. Articles were included with data from patients with renal carcinoma treated with SBRT, their indications, simulation, dose and fractionation, local control, survival and side effects, comparison with other treatments, response assessment and radioimmunotherapy. The articles included were evaluated for content and validation. The immobilization systems were variable between studies. Doses and fractions were variable from 25-26 Gy in single fractions to 21-48 Gy in 3-5 fractions, with local control being around 90% with a low rate of side-effects. We review the state of the art in SBRT for renal cell carcinoma. More research is needed to determine optimal doses and fractionation, and to develop a reliable response assessment tool. The role of radioimmunotherapy in renal carcinoma is being studied.

Characterization of a novel non-steroidal glucocorticoid receptor agonist optimized for topical treatment

Glucocorticoids (GCs) are commonly used topical treatments for skin diseases but are associated with both local and systemic side effects. In this study, we describe a selective non-steroidal glucocorticoid receptor (GR) agonist for topical use, LEO 134310, which is rapidly deactivated in the blood resulting in low systemic exposure and a higher therapeutic index in the TPA-induced skin inflammation mouse model compared with betamethasone valerate (BMV) and clobetasol propionate (CP). Selectivity of LEO 134310 for GR was confirmed within a panel of nuclear receptors, including the mineralocorticoid receptor (MR), which has been associated with induction of skin atrophy. Topical treatment with LEO 134310 in minipigs did not result in any significant reduction in epidermal thickness in contrast to significant epidermal thinning induced by treatment with BMV and CP. Thus, the profile of LEO 134310 may potentially provide an effective and safer treatment option for skin diseases compared with currently used glucocorticoids.

Safety of the BNT162b2 mRNA COVID-19 vaccine in oncologic patients undergoing numerous cancer treatment options: A retrospective single-center study.

The COVID-19 pandemic, caused by the SARS-CoV2 virus, has infected millions worldwide with cancer patients demonstrating a higher prevalence for severe disease and poorer outcomes. Recently, the BNT162b2 mRNA COVID-19 vaccine was released as the primary means to combat COVID-19. The currently reported incidence of local and systemic side effects was 27% in the general public. The safety of the BNT162b2 mRNA COVID-19 vaccine has not been studied in patients with an active cancer diagnosis who are either ongoing or plan to undergo oncologic therapy.This single center study reviewed the charts of 210 patients with active cancer diagnoses that received both doses of the BNT162b2 mRNA COVID-19 vaccine. The development of side effects from the vaccine, hospitalizations or exacerbations from various oncologic treatment were documented. Type of oncologic treatment (immunotherapy, chemotherapy, hormonal, biologic, radiation or mixed) was documented to identify if side effects were related to treatment type. The time at which the vaccine was administered in relation to treatment onset (on long term therapy, within 1 month of therapy or prior to therapy) was also documented to identify any relationships.Sixty five (31%) participants experienced side effects from the BNT162b2 mRNA COVID-19 vaccine, however most were mild to moderate. Treatment protocol was not linked to the development of vaccine related side effects (P = .202), nor was immunotherapy (P = .942). The timing of vaccine administered in relation to treatment onset was also not related to vaccine related side effects (P = .653). Six (2.9%) participants were hospitalized and 4 (2%) died.The incidence of side effects in cancer patients is similar to what has been reported for the general public (31% vs 27%). Therefore, we believe that the BNT162b2 mRNA COVID-19 vaccine is safe in oncologic patients undergoing numerous cancer treatments.