scholarly journals Thromboembolic and Hemorrhagic Risks After Vaccination Against SARS-CoV-2: a Systematic Review and Meta-analysis of Randomized Controlled Trials

Author(s):  
Noppacharn Uaprasert ◽  
Krissana Panrong ◽  
Ponlapat Rojnuckarin ◽  
Thita Chiasakul

Abstract Background: Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whether SARS-CoV-2 vaccines increase the risks of thromboembolism and hemorrhage. Methods: We performed a literature search using PubMed, EMBASE, Cochrane, medRxiv databases, and reference lists of relevant articles to identify RCTs that reported thromboembolic and hemorrhagic events and thromboembolism/hemorrhage-related death after SARS-CoV-2 vaccination. The primary aim of this systematic review and meta-analysis was to estimate the pooled thromboembolic risk related to SARS-CoV-2 vaccines compared to placebo. The secondary outcomes included estimating the risks of arterial thromboembolism (ATE), venous thromboembolisms (VTE), hemorrhage, and thromboembolism/hemorrhage-related death. Results: Eight RCTs of 4 vaccine platforms comprised of 195,196 participants were retrieved. SARS-CoV-2 vaccines were not associated with an increased risk of overall thromboembolism (risk ratio [RR], 1.14; 95%CI [confidence interval], 0.61-2.14; I2 = 35%), ATE (RR, 0.97; 95%CI, 0.46-2.06; I2 = 21%), VTE (RR, 1.47; 95%CI, 0.72-2.99; I2 = 0%), hemorrhage (RR, 0.97; 95%CI, 0.35-2.68; I2 = 0), and thromboembolism/hemorrhage-related death (RR, 0.53; 95%CI, 0.16-1.79; I2 = 0). Compared to the baseline estimated risk of these outcomes in participants administered placebos, the risk differences with vaccines were very small and not statistically significant. These findings were consistent in the subgroup analysis across 4 vaccine platforms. Conclusion: Vaccines against SARS-CoV-2 are not associated with an increased risk of thromboembolism, hemorrhage, and thromboembolism/hemorrhage-related death.

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Noppacharn Uaprasert ◽  
Krissana Panrong ◽  
Ponlapat Rojnuckarin ◽  
Thita Chiasakul

Abstract Background Thromboembolic and bleeding events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are major public concerns leading to vaccine hesitancy. Due to low incidence, an individual randomized controlled trial (RCT) is underpowered to determine whether SARS-CoV-2 vaccines increase the risks of thromboembolism and hemorrhage. Methods We performed a literature search using PubMed, EMBASE, Cochrane, medRxiv databases, and reference lists of relevant articles to identify RCTs that reported thromboembolic, hemorrhagic events, and thromboembolism/hemorrhage-related death after SARS-CoV-2 vaccination. The primary aim of this systematic review and meta-analysis was to estimate the pooled thromboembolic risk related to SARS-CoV-2 vaccines compared to placebo. The secondary outcomes included estimating the risks of arterial thromboembolism (ATE), venous thromboembolisms (VTE), hemorrhage, thrombocytopenia, and thromboembolism/hemorrhage-related death. Results Eight RCTs of 4 vaccine platforms comprised of 195,196 participants were retrieved. SARS-CoV-2 vaccines were not associated with an increased risk of overall thromboembolism (risk ratio [RR], 1.14; 95% CI [confidence interval], 0.61–2.14; I2 = 35%), ATE (RR, 0.97; 95% CI, 0.46–2.06; I2 = 21%), VTE (RR, 1.47; 95% CI, 0.72–2.99; I2 = 0%), hemorrhage (RR, 0.97; 95% CI, 0.35–2.68; I2 = 0), and thromboembolism/hemorrhage-related death (RR, 0.53; 95% CI, 0.16–1.79; I2 = 0). Compared to the baseline estimated risk of these outcomes in participants administered placebos, the risk differences with vaccines were very small and not statistically significant. These findings were consistent in the subgroup analysis across 4 vaccine platforms. Conclusion Vaccines against SARS-CoV-2 are not associated with an increased risk of thromboembolism, hemorrhage, and thromboembolism/hemorrhage-related death.


2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Saad Alhumaid ◽  
Abbas Al Mutair ◽  
Zainab Al Alawi ◽  
Ali A. Rabaan ◽  
Raghavendra Tirupathi ◽  
...  

Abstract Background Currently there is no systematic review and meta-analysis of the global incidence rates of anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines in the general adult population. Objectives To estimate the incidence rates of anaphylactic and nonanaphylactic reactions after COVID-19 vaccines and describe the demographic and clinical characteristics, triggers, presenting signs and symptoms, treatment and clinical course of confirmed cases. Design A systematic review and meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] statement was followed. Methods Electronic databases (Proquest, Medline, Embase, Pubmed, CINAHL, Wiley online library, and Nature) were searched from 1 December 2020 to 31 May 2021 in the English language using the following keywords alone or in combination: anaphylaxis, non-anaphylaxis, anaphylactic reaction, nonanaphylactic reaction, anaphylactic/anaphylactoid shock, hypersensitivity, allergy reaction, allergic reaction, immunology reaction, immunologic reaction, angioedema, loss of consciousness, generalized erythema, urticaria, urticarial rash, cyanosis, grunting, stridor, tachypnoea, wheezing, tachycardia, abdominal pain, diarrhea, nausea, vomiting and tryptase. We included studies in adults of all ages in all healthcare settings. Effect sizes of prevalence were pooled with 95% confidence intervals (CIs). To minimize heterogeneity, we performed sub-group analyses. Results Of the 1,734 papers that were identified, 26 articles were included in the systematic review (8 case report, 5 cohort, 4 case series, 2 randomized controlled trial and 1 randomized cross-sectional studies) and 14 articles (1 cohort, 2 case series, 1 randomized controlled trial and 1 randomized cross-sectional studies) were included in meta-analysis. Studies involving 26,337,421 vaccine recipients [Pfizer-BioNTech (n = 14,505,399) and Moderna (n = 11,831,488)] were analyzed. The overall pooled prevalence estimate of anaphylaxis to both vaccines was 5.0 (95% CI 2.9 to 7.2, I2 = 81%, p =  < 0.0001), while the overall pooled prevalence estimate of nonanaphylactic reactions to both vaccines was 53.9 (95% CI 0.0 to 116.1, I2 = 99%, p =  < 0.0001). Vaccination with Pfizer-BioNTech resulted in higher anaphylactic reactions compared to Moderna (8.0, 95% CI 0.0 to 11.3, I2 = 85% versus 2.8, 95% CI 0.0 to 5.7, I2 = 59%). However, lower incidence of nonanaphylactic reactions was associated with Pfizer-BioNTech compared to Moderna (43.9, 95% CI 0.0 to 131.9, I2 = 99% versus 63.8, 95% CI 0.0 to 151.8, I2 = 98%). The funnel plots for possible publication bias for the pooled effect sizes to determine the incidence of anaphylaxis and nonanaphylactic reactions associated with mRNA COVID-19 immunization based on mRNA vaccine type appeared asymmetrical on visual inspection, and Egger’s tests confirmed asymmetry by producing p values < 0.05. Across the included studies, the most commonly identified risk factors for anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines were female sex and personal history of atopy. The key triggers to anaphylactic and nonanaphylactic reactions identified in these studies included foods, medications, stinging insects or jellyfish, contrast media, cosmetics and detergents, household products, and latex. Previous history of anaphylaxis; and comorbidities such as asthma, allergic rhinitis, atopic and contact eczema/dermatitis and psoriasis and cholinergic urticaria were also found to be important. Conclusion The prevalence of COVID-19 mRNA vaccine-associated anaphylaxis is very low; and nonanaphylactic reactions occur at higher rate, however, cutaneous reactions are largely self-limited. Both anaphylactic and nonanaphylactic reactions should not discourage vaccination.


2022 ◽  
Vol 6 (3) ◽  
pp. 1446-1454
Author(s):  
Burhannudin Ichsan ◽  
Nining Lestari ◽  
Sulistyani

Background. Infantile colic, defined as paroxysmal, excessive, and consolable crying without an identifiable cause. It is common in the first 3 months of life. There have been many RCT studies conducted. A systematic synthesis is required to summarize the results of these RCTs. This study was aimed to systematically analyze the benefits of Lactobacillus reuteri DSM 17938 for infantile colic. Methods. This systematic review and meta-analysis used keywords: (“infantile colic” OR “abdominal cramps” OR “abdominal cramp” OR “infant colic”) AND “lactobacillus reuteri” AND (placebo OR placebos) AND (“randomized controlled trial” OR RCT). The databases used were: pubmed, science direct, and google scholar. Meta-analysis was conducted to combine the articles. The eligibility criteria were: patient with infantile colic, intervention with L. reuteri DSM 17938, control was placebo, RCT study design, outcome with dichotomous scale, all races, all ethnicities, all countries, all genders, in English, and not limited by year. Results. The search resulted in 800 articles. After reducing duplication, the number of articles was 747. Screening with titles and abstracts resulted in 13 full teks articles. Six articles fitted the eligibility criteria. The results of the meta-analysis were as follows. The forest plot showed that the combined effect of the six articles showed an RR of 0.47 and was statistically significant (p <0.001). Conclusion. Based on the results of this meta-analysis, L. reuteri DSM 17938 is recommended for infants with infantile colic. There were no significant side effects with the use of L. reuteri DSM 17938 on infantile colic.


2020 ◽  
Vol 11 ◽  
Author(s):  
Jinjin Wang ◽  
Ailin Zhao ◽  
Hui Zhou ◽  
Jinbing Zhu ◽  
Ting Niu

Background: Ibrutinib is an oral covalent Bruton’s tyrosine kinase inhibitor that has been approved for chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia and some other B-cell malignancies. Some studies have found an increased risk of bleeding with ibrutinib. Some studies, however, found no significant differences in the risk of major bleeding between patients treated with ibrutinib and those with other regimens. So, a systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to estimate the risk of bleeding associated with ibrutinib in patients with B-cell malignancies.Methods: A systematic search of PUBMED, EMBASE, Central Register of Controlled Trials, and ClinicalTrials.gov was conducted from January 2000 to February 2020 to identify RCTs by comparing ibrutinib with other agents or placebo in B-cell malignancies. The RevMan software (version 5.3) was used to carry out this analysis, and the analyzed data were represented by risk ratios (RR) and 95% confidence intervals (CI).Results: There were 11 eligible RCTs (4,288 patients). All studies reported major bleeding, and seven studies reported overall bleeding (any-grade bleeding). Ibrutinib was associated with a significantly increased risk of bleeding (overall bleeding and major bleeding) in patients with B-cell malignancies [RR = 2.56, 95% CI 1.68–3.90, p &lt; 0.0001 and RR = 2.08, 95% CI 1.36–3.16, p = 0.0006, respectively]. The bleeding (overall bleeding and major bleeding) risk in patients with CLL was more obvious [RR = 3.08, 95% CI 2.07–4.58, p &lt; 0.00001 and RR = 2.46, 95% CI 1.37–4.41, p = 0.003, respectively]. There were no statistically significant differences for risk of bleeding between the subgroups based on dose and treatment setting.Conclusion: Ibrutinib was associated with a significantly higher risk of bleeding (both overall bleeding and major bleeding) in patients with B-cell malignancies, especially in CLL.


2022 ◽  
Author(s):  
Barak Pertzov ◽  
Boris Krasulya ◽  
Karam Azem ◽  
Yael Shostak ◽  
Shimon Izhakian ◽  
...  

Abstract Background:Dexmedetomidine (DEX), is a highly selective alpha2 adrenoceptor (α2-AR) agonist, successfully used in various procedures including flexible bronchoscopy. Randomized controlled trials (RCTs) evaluating DEX sedation during bronchoscopy report equivocal results regarding respiratory and hemodynamic outcomes. Methods We conducted an RCT to evaluate the efficacy of dexmedetomidine compared to propofol for sedation during bronchoscopy. The primary outcome was desaturation events, secondary outcomes were transcutaneous Pco2 level, hemodynamic adverse events and physician and patient satisfaction. We have also conducted A systematic review and meta-analysis of all RCTs evaluating DEX sedation during flexible bronchoscopy, included current study results.ResultsOverall, 63 patients were included, 30 and 33 in the DEX and propofol groups, respectively. The number of desaturation events was similar between groups, median (IQR) 1 (0-1) and 1 (0-2) in the DEX and control groups, respectively (P=0.29). Median desaturation time was 1 (0-2) and 1 (0-3) minutes in the DEX and control groups, respectively (P=0.48). Adverse events included hypotension, 33% vs 21.1% in intervention and control groups, respectively (P=0.04), bradycardia, cough, and delayed recovery from sedation. Total adverse events were 22 and 7 in DEX and propofol groups, respectively (P=0.009). The pooled meta-analysis included 13 trials (1604 participants) showed a significantly lower rate of desaturation events in the DEX group (RR 0.67, 95% CI 0.57 to 0.79) with a significantly higher rate of hypotension and bradycardia events (RR 1.55, 95% CI 1.16 to 2.06 and RR 1.91, 95% CI 1.04 to 3.5, respectively)ConclusionDexmedetomidine sedation resulted in a significantly reduced rate of desaturation events in comparison to propofol, midazolam and fentanyl. However, it was also associated with a higher rate of hypotension and bradycardia.Trial registration : NCT04211298, registration date: 26/12/2019


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