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BMJ Open Jun 2023To summarise the available evidence on the risk of myocarditis and/or pericarditis following mRNA COVID-19 vaccination, compared with the risk among unvaccinated... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To summarise the available evidence on the risk of myocarditis and/or pericarditis following mRNA COVID-19 vaccination, compared with the risk among unvaccinated individuals in the absence of COVID-19 infection.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Electronic databases (Medline, Embase, Web of Science and WHO Global Literature on Coronavirus Disease), preprint repositories (medRxiv and bioRxiv), reference lists and grey literature were searched from 1 December 2020 until 31 October 2022.
STUDY SELECTION
Epidemiological studies of individuals of any age who received at least one dose of an mRNA COVID-19 vaccine, reported a risk of myo/pericarditis and compared the risk of myo/pericarditis to individuals who did not receive any dose of an mRNA COVID-19 vaccine.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently conducted screening and data extraction. The rate of myo/pericarditis among vaccinated and unvaccinated groups was recorded, and the rate ratios were calculated. Additionally, the total number of individuals, case ascertainment criteria, percentage of males and history of SARS-CoV-2 infection were extracted for each study. Meta-analysis was done using a random-effects model.
RESULTS
Seven studies met the inclusion criteria, of which six were included in the quantitative synthesis. Our meta-analysis indicates that within 30-day follow-up period, vaccinated individuals were twice as likely to develop myo/pericarditis in the absence of SARS-CoV-2 infection compared to unvaccinated individuals, with a rate ratio of 2.05 (95% CI 1.49-2.82).
CONCLUSION
Although the absolute number of observed myo/pericarditis cases remains quite low, a higher risk was detected in those who received mRNA COVID-19 vaccinations compared with unvaccinated individuals in the absence of SARS-CoV-2 infection. Given the effectiveness of mRNA COVID-19 vaccines in preventing severe illnesses, hospitalisations and deaths, future research should focus on accurately determining the rates of myo/pericarditis linked to mRNA COVID-19 vaccines, understanding the biological mechanisms behind these rare cardiac events and identifying those most at risk.
Topics: Humans; Male; COVID-19; COVID-19 Vaccines; Myocarditis; Pericarditis; RNA, Messenger; SARS-CoV-2; Vaccination
PubMed: 37339840
DOI: 10.1136/bmjopen-2022-065687 -
Tropical Medicine and Infectious Disease Oct 2022The World Health Organization (WHO) recommended coronavirus disease 2019 (COVID-19) booster dose vaccination after completing the primary vaccination series for... (Review)
Review
The World Health Organization (WHO) recommended coronavirus disease 2019 (COVID-19) booster dose vaccination after completing the primary vaccination series for individuals ≥18 years and most-at-risk populations. This study aimed to estimate the pooled proportion of COVID-19 vaccine booster dose uptake and intention to get the booster dose among general populations and healthcare workers (HCWs). We searched PsycINFO, Scopus, EBSCO, MEDLINE Central/PubMed, ProQuest, SciELO, SAGE, Web of Science, Google Scholar, and ScienceDirect according to PRISMA guidelines. From a total of 1079 screened records, 50 studies were extracted. Meta-analysis was conducted using 48 high-quality studies according to the Newcastle-Ottawa Scale quality assessment tool. Using the 48 included studies, the pooled proportion of COVID-19 vaccine booster dose acceptance among 198,831 subjects was 81% (95% confidence interval (CI): 75-85%, = 100%). The actual uptake of the booster dose in eight studies involving 12,995 subjects was 31% (95% CI: 19-46%, = 100%), while the intention to have the booster dose of the vaccine was 79% (95% CI: 72-85%, = 100%). The acceptance of the booster dose of COVID-19 vaccines among HCWs was 66% (95% CI: 58-74%), = 99%). Meta-regression revealed that previous COVID-19 infection was associated with a lower intention to have the booster dose. Conversely, previous COVID-19 infection was associated with a significantly higher level of booster dose actual uptake. The pooled booster dose acceptance in the WHO region of the Americas, which did not include any actual vaccination, was 77% (95% CI: 66-85%, = 100%). The pooled acceptance of the booster dose in the Western Pacific was 89% (95% CI: 84-92%, = 100), followed by the European region: 86% (95% CI: 81-90%, = 99%), the Eastern Mediterranean region: 59% (95% CI: 46-71%, = 99%), and the Southeast Asian region: 52% (95% CI: 43-61%, = 95). Having chronic disease and trust in the vaccine effectiveness were the significant predictors of booster dose COVID-19 vaccine acceptance. The global acceptance rate of COVID-19 booster vaccine is high, but the rates vary by region. To achieve herd immunity for the disease, a high level of vaccination acceptance is required. Intensive vaccination campaigns and programs are still needed around the world to raise public awareness regarding the importance of accepting COVID-19 vaccines needed for proper control of the pandemic.
PubMed: 36288039
DOI: 10.3390/tropicalmed7100298 -
Tidsskrift For Den Norske Laegeforening... Mar 2015Prostate cancer is a radiosensitive type of cancer for which radiotherapy is used for both curative and palliative purposes. Low-dose-rate brachytherapy is an internal... (Review)
Review
BACKGROUND
Prostate cancer is a radiosensitive type of cancer for which radiotherapy is used for both curative and palliative purposes. Low-dose-rate brachytherapy is an internal radiotherapy technique which allows high doses of radiation to be delivered to a tumour at short range and with a high degree of precision. We have conducted a systematic review of the evidence base for this treatment. The method is not established in Norway.
METHOD
This review is based on systematic review articles and publications on treatment, outcomes, adverse effects and health economics considerations found by searching the databases Cochrane Library, Current Controlled Trials, Medline, Embase and NICE (National Institute of Clinical Excellence).
RESULTS
Subsequent to long-term observations of the efficacy, adverse effects and costs presented in 43 selected studies, including one randomised, controlled trial, there is still uncertainty as to which of the three methods low-dose brachytherapy, external radiotherapy and radical prostatectomy is optimal. The reason for this is the methodological differences in patient selection and in endpoints such as biochemical disease-free interval and cause-specific survival. The evidence base appears to suggest that low-dose-rate brachytherapy causes more frequent grade 2 and 3 doctor-reported urogenital adverse effects than prostatectomy, but better patient-reported sexual functions and fewer patients with urinary incontinence than after surgery. Low-dose-rate brachytherapy appears to be socioeconomically cost-effective.
INTERPRETATION
The evidence base with respect to therapeutic effect and toxicity in men with low-risk prostate cancer treated with low-dose brachytherapy is regarded as solidly documented. However, there are no good prospective randomised multi-centre trials with overall survival as an endpoint.
Topics: Brachytherapy; Cost-Benefit Analysis; Disease-Free Survival; Erectile Dysfunction; Humans; Male; Prostatic Neoplasms; Treatment Outcome; Urinary Incontinence
PubMed: 25806763
DOI: 10.4045/tidsskr.13.1404 -
British Journal of Clinical Pharmacology Apr 2023Standard doses of daptomycin at 4 and 6 mg/kg were used for the treatment of skin and soft tissue for infections and bacteraemia, respectively. However, increased doses... (Meta-Analysis)
Meta-Analysis Review
AIMS
Standard doses of daptomycin at 4 and 6 mg/kg were used for the treatment of skin and soft tissue for infections and bacteraemia, respectively. However, increased doses of daptomycin are recommended for complicated infections by Gram-positive organisms.
METHODS
A systematic review was conducted using 4 databases. We compared treatment success between standard-dose (SD, 4-6 mg/kg) and high-dose (HD, >6 mg/kg) daptomycin in patients with all-cause bacteraemia, complicated bacteraemia, infective endocarditis, osteomyelitis and foreign body/prosthetic infection as the primary outcome. We also compared the success between SD and HD2 (≥8 mg/kg) daptomycin treatments in patients with these diseases as the secondary outcome. The incidence of creatine phosphokinase (CPK) elevation was evaluated as safety.
RESULTS
In patients with complicated bacteraemia and infective endocarditis, the treatment success was significantly lower in the SD group than in the HD group (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.30-0.76 and OR 0.50, 95% CI 0.30-0.82) and HD2 group (OR 0.38, 95% CI 0.21-0.69 and OR 0.30, 95% CI 0.15-0.60), respectively. A significant difference was demonstrated only in the HD2 group in patients with bacteraemia, including simple infection. SD did not decrease the success rate for the treatment of osteomyelitis and foreign body/prosthetic infection. The incidence of elevated CPK was significantly lower in SD group than in HD group.
CONCLUSION
SD daptomycin was associated with significantly lower treatment success than HD in patients with complicated bacteraemia/infective endocarditis. The CPK elevation should be considered in patients treated with high daptomycin doses.
Topics: Humans; Daptomycin; Anti-Bacterial Agents; Bacteremia; Osteomyelitis; Endocarditis; Treatment Outcome; Retrospective Studies
PubMed: 36693240
DOI: 10.1111/bcp.15671 -
Neurosurgery Jun 2023Stereotactic radiosurgery (SRS) is one of the main treatment options in the management of small to medium size vestibular schwannomas (VSs), because of high tumor... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Stereotactic radiosurgery (SRS) is one of the main treatment options in the management of small to medium size vestibular schwannomas (VSs), because of high tumor control rate and low cranial nerves morbidity. Series reporting long-term hearing outcome (>3 years) are scarce.
OBJECTIVE
To perform a systematic review of the literature and meta-analysis, with the aim of focusing on long-term hearing preservation after SRS.
METHODS
Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we reviewed articles published between January 1990 and October 2020 and referenced in PubMed or Embase. Inclusion criteria were peer-reviewed clinical study or case series of VSs treated with SRS (single dose), reporting hearing outcome after SRS with a median or mean audiometric follow-up of at least 5 years. Hearing preservation, cranial nerves outcomes, and tumor control were evaluated.
RESULTS
Twenty-three studies were included. Hearing preservation was found in 59.4% of cases (median follow-up 6.7 years, 1409 patients). Main favorable prognostic factors were young age, good hearing status, early treatment after diagnosis, small tumor volume, low marginal irradiation dose, and maximal dose to the cochlea. Tumor control was achieved in 96.1%. Facial nerve deficit and trigeminal neuropathy were found in 1.3% and 3.2% of patients, respectively, both significantly higher in Linear Accelerator series than Gamma Knife series ( P < .05).
CONCLUSION
Long-term hearing preservation remains one of the main issues after SRS, with a major impact on health-related quality of life. Our meta-analysis suggests that hearing preservation can be achieved in almost 60% of patients after a median follow-up of 6.7 years, irrespective of the technique.
Topics: Humans; Neuroma, Acoustic; Radiosurgery; Treatment Outcome; Quality of Life; Hearing; Follow-Up Studies; Retrospective Studies
PubMed: 36735500
DOI: 10.1227/neu.0000000000002354 -
Vaccines Jan 2023Once the COVID-19 pandemic was declared, the world was waiting for the clue that would be able to cut down the progression of the disease. Vaccines play a crucial role... (Review)
Review
INTRODUCTION
Once the COVID-19 pandemic was declared, the world was waiting for the clue that would be able to cut down the progression of the disease. Vaccines play a crucial role in reducing the disease and saving many people worldwide. However, there are several side effects of these vaccines, like pain, fatigue, fever, and neurological defects like Bell's palsy. In this systematic review, we presented evidence about the occurrence of Bell's palsy followed by COVID-19 vaccination.
METHODS
We searched PubMed, SCOPUS, EBSCO, and Web of Science (WOS) from inception till October 2022. The quality assessment was conducted using the Joanna Briggs Institute, National Institute of Health, and Newcastle-Ottawa. The analysis was conducted on SPSS.
RESULTS
Thirty-five records were involved in our study. The results of our cases revealed that most of the patients (62.8%) experienced unilateral facial paralysis. Also, the majority of the cases were reported after the first dose, and most cases were after Pfizer, AstraZeneca, and Sputnik V vaccines, respectively. The patients who were treated with corticosteroids, IVIG, and anti-viral drugs, showed marked recovery afterward.
CONCLUSION
The rate ratio of Bell's palsy after COVID-19 vaccination was 25.3 per 1,000,000. The ratio was higher after the first dose compared to the second dose and was higher among those who took Oxford/AstraZeneca vaccine compared to other vaccines. However, this condition was reported in a small number of cases among a large number of vaccinated people worldwide. It is important to note that the benefits of getting vaccinated far outweigh any potential risks.
PubMed: 36851114
DOI: 10.3390/vaccines11020236 -
OncoTargets and Therapy 2019The present standard dose of gemcitabine (Gem), a pyrimidine antimetabolite, is 1,000-1,250 mg/m, and the infusion time is 30 min. However, pharmacological studies have... (Review)
Review
BACKGROUND
The present standard dose of gemcitabine (Gem), a pyrimidine antimetabolite, is 1,000-1,250 mg/m, and the infusion time is 30 min. However, pharmacological studies have demonstrated that Gem with prolonged infusion could attain a better accumulation rate of Gem triphosphate (active metabolites of Gem), indicating that Gem with prolonged infusion is superior to 30-min infusion. Thus, this systematic review aims to provide some references for Gem administered as a prolonged infusion.
METHODS
We searched electronic databases, including PubMed, EMBASE, Cochrane Library, and CNKI, for trials. Keywords were "Gem," "prolonged infusion," and "low-dose." In addition, we used the Cochrane Handbook V5.1.0 and methodological index for non-randomized studies to evaluate the quality of randomized controlled trials (RCTs) and non-RCTs, respectively. Furthermore, Cochrane Collaboration guidelines and the PRISMA statement were adopted.
RESULTS
We systematically reviewed 19 studies (5 RCTs and 14 non-RCTs). All studies assessed the efficacy and safety of Gem administered as a prolonged low-dose infusion (P-LDI) and reported that Gem administered as P-LDI was effective and well tolerated.
CONCLUSION
Gem administered as P-LDI is effective, safe, and economical, especially suited for patients with poor performance status or without good economic condition.
PubMed: 31417283
DOI: 10.2147/OTT.S210117 -
Brachytherapy 2014To review and analyze the published data on high-dose-rate brachytherapy as monotherapy in the treatment of prostate cancer. (Review)
Review
PURPOSE
To review and analyze the published data on high-dose-rate brachytherapy as monotherapy in the treatment of prostate cancer.
METHODS
A literature search and a systematic review of the high-dose-rate (HDR) brachytherapy (monotherapy) prostate literature were performed on PubMed using "high-dose-rate, brachytherapy, prostate, monotherapy" as search terms. More than 80 articles and abstracts published between 1990 and 2013 were identified. Data tables were generated and summary descriptions created. Commentary and opinion was formulated through discussion and consensus based on the critical review of the literature and the author's combined personal experience and knowledge.
RESULTS
Thirteen articles reported clinical outcome and toxicity with followup ranging from 1.5 to 8.0 years. Results were available for all risk groups. A variety of dose and fractionation schedules were described. Prostate-specific antigen progression-free survival ranged from 79% to 100% and local control from 97% to 100%. The toxicity rates were low. Genitourinary toxicity, mainly frequency/urgency, was 0-16% (Grade 3). Gastrointestinal toxicity was 0-2% (Grade 3). Erectile function preservation was 67-89%. The radiobiological, clinical, and technical features of HDR brachytherapy were reviewed and discussed.
CONCLUSIONS
Consistently high local tumor control and low complications rates are reported with HDR monotherapy. It provides reproducible high-quality dosimetry, it has an advantage from a radiobiology perspective, and it has a good radiation safety profile. HDR brachytherapy is a safe and effective local treatment modality for prostate cancer.
Topics: Brachytherapy; Disease-Free Survival; Humans; Male; Prostate-Specific Antigen; Prostatic Neoplasms; Radiotherapy Dosage; Tomography, X-Ray Computed
PubMed: 25085454
DOI: 10.1016/j.brachy.2014.03.002 -
The Cochrane Database of Systematic... Oct 2014This is an updated version of the original Cochrane review published in 2010 (Issue 7).Carcinoma of the uterine cervix is the second most common cancer and the third... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an updated version of the original Cochrane review published in 2010 (Issue 7).Carcinoma of the uterine cervix is the second most common cancer and the third leading cause of cancer death among women. Radiotherapy has been used successfully to treat cervical cancer for nearly a century. The combination of external beam radiotherapy (EBRT) and intracavity brachytherapy (ICBT) has become a standard treatment for cervical cancer. Whether high dose rate (HDR) or low dose rate (LDR) brachytherapy improves outcomes in terms of local control rates, survival and complications for women with cervical cancer remains controversial.
OBJECTIVES
To assess the efficacy and safety of HDR versus LDR ICBT in combination with EBRT for women with uterine cervical cancer.
SEARCH METHODS
We searched the Cochrane Gynaecological Cancer Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 1), MEDLINE (1966 to March 2014), EMBASE (1974 to March 2014), and the Chinese Biomedical Literature Database (CBM) (1978 to March 2014) for relevant original, published trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-RCTs that compared HDR with LDR ICBT, combined with EBRT, for women with locally advanced uterine cervical cancer.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted the data using standardised forms. Primary outcome measures included overall survival (OS), relapse-free survival (RFS) and pelvic control rate, while secondary outcomes included rates of recurrence and complications.
MAIN RESULTS
Four studies involving 1265 women met the inclusion criteria. In our meta-analysis to compare HDR and LDR ICBT, the pooled risk ratios (RRs) were 0.95 (95% confidence interval (CI) 0.79 to 1.15), 0.93 (95% CI 0.84 to 1.04) and 0.79 (95% CI 0.52 to 1.20) for 3-, 5- and 10-year overall survival rates respectively; and 0.95 (95% CI 0.84 to 1.07) and 1.02 (0.88 to 1.19) for 5- and 10-year disease-specific survival (DSS) rates respectively. The RR for RFS was 1.04 (95% CI 0.71 to 1.52) and 0.96 (95% CI 0.81 to 1.14) at 3- and 5- years. For local control rates the RR was 0.95 (95% CI 0.86 to 1.05) and 0.95 (95% CI 0.87 to 1.05) at 3- and 5- years; with a RR of 1.09 (95% CI 0.83 to 1.43) for locoregional recurrence, 0.79 (95% CI 0.40 to 1.53) for local and distant recurrence, 2.23 (95% CI 0.78 to 6.34) for para-aortic lymph node metastasis, and 0.99 (95% CI 0.72 to 1.35) for distance metastasis. For bladder, rectosigmoid and small bowel complications, the RR was 1.33 (95% CI 0.53 to 3.34), 1.00 (95% CI 0.52 to 1.91) and 3.37 (95% CI 1.06 to 10.72) respectively. These results indicated that there were no significant differences except for increased small bowel complications with HDRs (P = 0.04).
AUTHORS' CONCLUSIONS
Since the last version of this review, no new studies were identified for inclusion in this review to provide additional information. This review showed no significant differences between HDR and LDR ICBT when considering OS, DSS, RFS, local control rate, recurrence, metastasis and treatment related complications for women with cervical carcinoma. Due to some potential advantages of HDR ICBT (rigid immobilization, outpatient treatment, patient convenience, accuracy of source and applicator positioning, individualized treatment) we recommend the use of HDR ICBT for all clinical stages of cervix cancer. The overall risk of bias was high for the included studies as many of the items were either of high or unclear risk. The GRADE assessment of the quality of the evidence was low to moderate.
Topics: Brachytherapy; Female; Humans; Neoplasm Recurrence, Local; Neoplasm Staging; Radiotherapy Dosage; Randomized Controlled Trials as Topic; Uterine Cervical Neoplasms
PubMed: 25300170
DOI: 10.1002/14651858.CD007563.pub3 -
BJGP Open Sep 2022Tablet splitting can provide dose flexibility and cost savings; however, pharmaceutical representatives typically discourage the practice.
BACKGROUND
Tablet splitting can provide dose flexibility and cost savings; however, pharmaceutical representatives typically discourage the practice.
AIM
To identify and summarise all published concerns related to tablet splitting and to present the experimental evidence that investigates those concerns.
DESIGN & SETTING
Systematic review and qualitative synthesis of tablet-splitting concerns and evidence.
METHOD
Medline and EMBASE databases were searched over all years of publication for articles in English discussing the splitting of tablets. Eligible articles included original research, narrative reviews, systematic reviews, and expert opinion.
RESULTS
After removing duplicates, 1837 potentially relevant articles underwent dual review, whereupon 1612 articles were excluded based on title and abstract. After examination of 225 full texts, 138 articles were included (one systematic review, four narrative reviews, 101 original research articles, and 32 opinion articles). The described concerns included difficulty breaking tablets, loss of mass, weight variability, chemical instability, overly rapid dosing if sustained-release medications are split, non-compliance, and patient confusion resulting in medication errors. No substantive evidence was found to support concerns regarding loss of mass, weight variability, chemical instability, or non-compliance. Evidence does support some older adults struggling to split tablets without tablet splitters, and the inappropriateness of splitting sustained-release preparations, given the potential for alteration of the rate of drug release for some products.
CONCLUSION
With the exception of sustained-release tablets, which should not be split, and excepting those older people who may struggle to split tablets based on physical limitations, there is little evidence to support tablet-splitting concerns.
PubMed: 35193886
DOI: 10.3399/BJGPO.2022.0001