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Allergy Jan 2023For persons with immediate allergic reactions to mRNA COVID-19 vaccines, skin testing (ST) to the vaccine/excipients (polyethylene glycol[PEG] and polysorbate 80 [PS])... (Meta-Analysis)
Meta-Analysis
For persons with immediate allergic reactions to mRNA COVID-19 vaccines, skin testing (ST) to the vaccine/excipients (polyethylene glycol[PEG] and polysorbate 80 [PS]) has been recommended, but has unknown accuracy. To assess vaccine/excipient ST accuracy in predicting all-severity immediate allergic reactions upon re-vaccination, systematic review was performed searching Medline, EMBASE, Web of Science, and the WHO global coronavirus database (inception-Oct 4, 2021) for studies addressing immediate (≤4 h post-vaccination) all-severity allergic reactions to 2nd mRNA COVID-19 vaccination in persons with 1st dose immediate allergic reactions. Cases evaluating delayed reactions, change of vaccine platform, or revaccination without vaccine/excipient ST were excluded. Meta-analysis of diagnostic testing accuracy was performed using Bayesian methods. The GRADE approach evaluated certainty of the evidence, and QUADAS-2 assessed risk of bias. Among 20 studies of mRNA COVID-19 first dose vaccine reactions, 317 individuals underwent 578 ST to any one or combination of vaccine, PEG, or PS, and were re-vaccinated with the same vaccine. Test sensitivity for either mRNA vaccine was 0.2 (95%CrI 0.01-0.52) and specificity 0.97 (95%CrI 0.9-1). PEG test sensitivity was 0.02 (95%CrI 0.00-0.07) and specificity 0.99 (95%CrI 0.96-1). PS test sensitivity was 0.03 (95%CrI 0.00-0.0.11) and specificity 0.97 (95%CrI 0.91-1). Combined for use of any of the 3 testing agents, sensitivity was 0.03 (95%CrI 0.00-0.08) and specificity was 0.98 (95%CrI 0.95-1.00). Certainty of evidence was moderate. ST has low sensitivity but high specificity in predicting all-severity repeat immediate allergic reactions to the same agent, among persons with 1st dose immediate allergic reactions to mRNA COVID-19 vaccines. mRNA COVID-19 vaccine or excipient ST has limited risk assessment utility.
Topics: Humans; Bayes Theorem; COVID-19; COVID-19 Vaccines; Excipients; Hypersensitivity; Hypersensitivity, Immediate; Polysorbates; Vaccine Excipients; Vaccines
PubMed: 36321821
DOI: 10.1111/all.15571 -
Clinical and Translational Science Mar 2023Experimental exposure of healthy volunteers to the T-cell dependent neoantigen keyhole limpet hemocyanin (KLH) permits the evaluation of immunomodulatory investigational... (Review)
Review
Experimental exposure of healthy volunteers to the T-cell dependent neoantigen keyhole limpet hemocyanin (KLH) permits the evaluation of immunomodulatory investigational medicinal product (IMP) pharmacology prior to the recruitment of patient populations. Despite widespread use, no standardized approach to the design and conduct of such studies has been agreed. The objective of this systematic review was to survey the published literature where KLH was used as a challenge agent, describing methodology, therapeutic targets addressed, and pharmacodynamic outcome measures. We searched MEDLINE, EMBASE, clinicaltrials.gov, and Cochrane CENTRAL for studies using KLH challenge in humans between January 1, 1994, and April 1, 2022. We described key study features, including KLH formulation, dose, use of adjuvants, route of administration, co-administered IMPs, and end points. Of 2421 titles and abstracts screened, 46 met the inclusion criteria, including 14 (31%) early phase trials of IMP, of which 10 (71%) targeted T-cell co-stimulation. IMPs with diverse mechanisms demonstrated modulation of the humoral response to KLH, suggesting limited specificity of this end point. Two early phase IMP studies (14%) described the response to intradermal re-challenge (delayed type hypersensitivity). Challenge regimens for IMP assessment were often incompletely described, and exhibited marked heterogeneity, including primary KLH dose (25-fold variation: 100-2500 mcg), KLH formulation, and co-administration with adjuvants. Methodological heterogeneity and failure to exploit the access to tissue-level mechanism-relevant end points afforded by KLH challenge has impaired the translational utility of this paradigm to date. Future standardization, characterization, and methodological development is required to permit tailored, appropriately powered, mechanism-dependent study design to optimize drug development decisions.
Topics: Humans; Pharmaceutical Preparations; T-Lymphocytes; Hemocyanins; Adjuvants, Immunologic
PubMed: 36420645
DOI: 10.1111/cts.13457 -
Journal of Interventional Cardiac... Aug 2020Cardiac sarcoidosis is a multisystem inflammatory disorder characterized by ventricular arrhythmias. Implantable cardioverter defibrillator (ICD) is used to prevent... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Cardiac sarcoidosis is a multisystem inflammatory disorder characterized by ventricular arrhythmias. Implantable cardioverter defibrillator (ICD) is used to prevent sudden cardiac death.
METHODS
We performed literature search for studies that addressed the outcome and complications of ICD in Cardiac Sarcoidosis (CS). Multiple search sites were reviewed from January 1, 2000 until December 1, 2018. We then performed a meta-analysis using a random effects model. Two investigators independently extracted the data and assessed studies' quality.
RESULTS
Ten studies with 585 patients qualified for the analysis. In the pooled analysis, 57% were male with mean left ventricular ejection fraction (LVEF) of 38.4%. Appropriate and inappropriate ICD treatments (AT and IAT) were reported in 39% and 15% of patients respectively over mean follow-up period of 25 months and mortality rate of 8%. A sub-analysis of four studies indicated that patients with appropriate therapy did not differ from the rest of CS population in LVEF% (mean difference (MD) = - 7.37%, 95% confidence interval (CI) - 16.89 to 2.15, p = 0.12), age (MD = - 3.87 years, 95% CI - 10.19 to 2.46, p = 0.23), primary prevention (range difference (RD) = - 0.11, 95% CI - 0.31 to 0.10, p = 0.31) or secondary prevention indication (RD = 0.09, 95% CI - 0.12 to 0.3, p = 0.37). High degree AV block was more common in patients with AT (RD = 0.07, 95% CI 0.00 to 0.14 p = 0.05).
CONCLUSIONS
ICD placement in CS is associated with high incidence of both appropriate and inappropriate therapy. High degree AV block appears to be predictive of appropriate ICD therapy.
Topics: Death, Sudden, Cardiac; Defibrillators, Implantable; Humans; Infant, Newborn; Male; Risk Factors; Sarcoidosis; Stroke Volume; Treatment Outcome; Ventricular Function, Left
PubMed: 32062788
DOI: 10.1007/s10840-020-00705-1 -
Contact Dermatitis Feb 2023The burden of occupational hand eczema in hairdressers is high, and (partly strong) allergens abound in the hair cosmetic products they use. (Review)
Review
BACKGROUND
The burden of occupational hand eczema in hairdressers is high, and (partly strong) allergens abound in the hair cosmetic products they use.
OBJECTIVES
To systematically review published evidence concerning contact allergy to an indicative list of active ingredients of hair cosmetics, namely, p-phenylenediamine (PPD), toluene-2,5-diamine (PTD), persulfates, mostly ammonium persulfate (APS), glyceryl thioglycolate (GMTG), and ammonium thioglycolate (ATG), concerning the prevalence of sensitization, particularly in terms of a comparison (relative risk; RR) between hairdressers and non-hairdressers.
METHODS
Following a PROSPERO-registered and published protocol, eligible literature published from 2000 to February 2021 was identified, yielding 322 publications, and extracted in standardized publication record forms, also considering risk of bias.
RESULTS
Based on 141 publications, the contact allergy prevalence to PPD was 4.3% (95% CI: 3.8-4.9%) in consecutively patch tested patients. Other ingredients were mostly tested in an aimed fashion, yielding variable, and partly high contact allergy prevalences. Where possible, the RR was calculated, yielding an average increased sensitization risk in hairdressers of between 5.4 (PPD) and 3.4 (ATG). Additional evidence related to immediate-type hypersensitivity, experimental results, exposures, and information from case reports was qualitatively synthesized.
CONCLUSIONS
An excess risk of contact allergy is clearly evident from the pooled published evidence from the last 20 years. This should prompt an improvement in working conditions and product safety.
Topics: Humans; Dermatitis, Allergic Contact; Dermatitis, Occupational; Drug-Related Side Effects and Adverse Reactions; Hair Dyes; Hair Preparations; Hypersensitivity, Immediate; Occupational Exposure; Patch Tests; Hand Dermatoses; Beauty Culture
PubMed: 36254351
DOI: 10.1111/cod.14236 -
Journal of Clinical Pharmacy and... Dec 2022Acute generalized exanthematous pustulosis (AGEP) is a serious and rare adverse reaction of cephalosporins. We aimed to describe the clinical features of...
WHAT IS KNOWN AND OBJECTIVE
Acute generalized exanthematous pustulosis (AGEP) is a serious and rare adverse reaction of cephalosporins. We aimed to describe the clinical features of cephalosporin-induced AGEP and provide a reference for rational clinical use of cephalosporins.
METHODS
We systematically searched Chinese and English databases for cephalosporin-induced TGEP-related case reports, retrospective studies, clinical studies, and review articles published before May 2022.
RESULTS AND DISCUSSION
A total of 43 patients from 35 articles were eligible, of which 28 (65.1%) were female, with a median age of 69 years. A total of 11 cephalosporins were suspected, the most commonly involved were ceftriaxone (41.9%), cephalexin (16.3%), and cefepime (9.3%). AEGP erupted primarily within 14 days after administration, manifested as nonfollicular pustules on an erythematous base, distributed favourably to the extremities (44.2%), trunk (23.3%), face (23.3%), and could involve the oral mucosa (11.6%). During AGEP resolution, the affected area had desquamation (39.5%). The acute phase of the disease may be accompanied by fever (>38.0°C) and elevated neutrophil count (>7500/mm ). Histology of AGEP showed subcorneal pustules (56.3%), intraepidermal cavernous pustules (37.5%), with papillary dermal edema (37.5%), containing neutrophils and eosinophilic infiltration (71.9%). After drug discontinuation, the median time to resolution of AGEP symptoms was 10 days (range 2, 90).
WHAT IS NEW AND CONCLUSION
Cephalosporin-induced AGEP is rare and should be properly diagnosed. This serious cutaneous adverse reaction is self-limiting and has a favourable prognosis, usually resolves with drug interruption, and may require additional interventions, such as topical steroids.
Topics: Humans; Female; Aged; Male; Acute Generalized Exanthematous Pustulosis; Cephalosporins; Retrospective Studies; Ceftriaxone; Exanthema; Monobactams
PubMed: 35909299
DOI: 10.1111/jcpt.13738 -
Dermatitis : Contact, Atopic,...
Topics: Dermatitis, Allergic Contact; Humans; Patch Tests
PubMed: 35849692
DOI: 10.1097/DER.0000000000000918 -
The American Journal of Cardiology Jul 2022Cardiac sarcoidosis (CS) frequently leads to ventricular tachycardia (VT), which is often refractory to antiarrhythmic and/or immunosuppressive medications and requires... (Meta-Analysis)
Meta-Analysis
Cardiac sarcoidosis (CS) frequently leads to ventricular tachycardia (VT), which is often refractory to antiarrhythmic and/or immunosuppressive medications and requires catheter ablation. We conducted a systematic review and meta-analysis to evaluate the role of catheter ablation in patients with refractory VT undergoing catheter ablation. We searched PubMed, Embase, and Scopus databases from their inception to December 31, 2021 with search terms "cardiac sarcoidosis" AND "electrophysiological studies OR ablation." Fifteen studies were ultimately included for evaluation. Patient demographics, VT mapping, and acute and long-term procedural outcomes were extracted. A total of 15 studies were included in our meta-analysis, with a total of 401 patients, of whom 66% were male, with ages ranging from 39 to 64 years. A total of 95% of patients were on antiarrhythmics and 79% of patients were on immunosuppressants. Left ventricular ejection fraction ranged from 35% to 49% and procedure duration ranged from 269 to 462 minutes. Ablation was reported using both irrigated and nonirrigated catheter tips. A total of 25% of patients (84/339) underwent repeat ablation. Acute procedural success was achieved in 57% (161/285). Procedure complications occurred in 5.7% (17/297) procedures. VT recurrence after first ablation was 55% (confidence interval 48% to 63%, 213/401); VT recurrence after multiple ablations was 37% (81/220). The composite end point of death, heart transplant, and left ventricular assist device implantation was 21% (confidence interval 14% to 30%, 55/297). In conclusion, catheter ablation is a useful modality in patients with CS with refractory VT. However, patients with CS presenting with refractory VT after undergoing VT ablation carry a poor prognosis.
Topics: Adult; Anti-Arrhythmia Agents; Catheter Ablation; Female; Humans; Male; Middle Aged; Myocarditis; Recurrence; Sarcoidosis; Stroke Volume; Tachycardia, Ventricular; Treatment Outcome; Ventricular Function, Left
PubMed: 35504741
DOI: 10.1016/j.amjcard.2022.03.038 -
Clinical Research in Cardiology :... Feb 2022Heart transplantation (HTx) is a valid therapeutic option for end-stage heart failure secondary to cardiac sarcoidosis (CS) or giant-cell myocarditis (GCM). However,... (Meta-Analysis)
Meta-Analysis
Heart transplantation (HTx) is a valid therapeutic option for end-stage heart failure secondary to cardiac sarcoidosis (CS) or giant-cell myocarditis (GCM). However, post-HTx outcomes in patients with inflammatory cardiomyopathy (ICM) have been poorly investigated. We searched PubMed, Scopus, Science Citation Index, EMBASE, and Google Scholar, screened the gray literature, and contacted experts in the field. We included studies comparing post-HTx survival, acute cellular rejection, and disease recurrence in patients with and without ICM. Data were synthesized by a random-effects meta-analysis. We screened 11,933 articles, of which 14 were considered eligible. In a pooled analysis, post-HTx survival was higher in CS than non-CS patients after 1 year (risk ratio [RR] 0.88, 95% confidence interval [CI] 0.60-1.17; I = 0%) and 5 years (RR 0.72, 95% CI 0.52-0.91; I = 0%), but statistically significant only after 5 years. During the first-year post-HTx, the risk of acute cellular rejection was similar for patients with and without CS, but after 5 years, it was lower in those with CS (RR 0.38, 95% CI 0.03-0.72; I = 0%). No difference in post-HTx survival was observed between patients with and without GCM after 1 year (RR 1.16, 95% CI 0.05-2.28; I = 0%) or 5 years (RR 0.98, 95% CI 0.42-1.54; I = 0%). During post-HTx follow-up, recurrence of CS and GCM occurred in 5% and 8% of patients, respectively. Post-HTx outcomes in patients with CS and GCM are comparable with cardiac recipients with other heart failure etiologies. Patients with ICM should not be disqualified from HTx.
Topics: Cardiomyopathies; Female; Heart Transplantation; Humans; Male; Middle Aged; Myocarditis; Sarcoidosis; Time; Treatment Outcome
PubMed: 34402927
DOI: 10.1007/s00392-021-01920-0 -
The Australasian Journal of Dermatology Mar 2024Toxic epidermal necrolysis (TEN) involves extensive mucocutaneous loss, and care is supportive. The approach to wound care includes surgical debridement or using... (Meta-Analysis)
Meta-Analysis Review
Toxic epidermal necrolysis (TEN) involves extensive mucocutaneous loss, and care is supportive. The approach to wound care includes surgical debridement or using dressings while leaving the epidermis intact. Robust evidence for either approach is lacking. We compared surgical debridement to the use of dressings while leaving the epidermis in situ (referred to hereon as dressings) in adult patients with TEN. The primary outcome assessed was mortality. The secondary outcome was time to re-epithelialisation. The impact of medications was evaluated. An individual patient data (IPD) systematic review and meta-analysis was undertaken. A random effects meta-analysis and survival analysis for IPD data examined mortality, re-epithelisation time and the effect of systemic medications. The quality of evidence was rated per the Grading of Recommendations Assessment, Development and Evaluation (GRADE). PROSPERO: CRD42021266611 Fifty-four studies involving 227 patients were included in the systematic review and meta-analysis, with a GRADE from very low to moderate. There was no difference in survival in patients who had surgical debridement or dressings (univariate: p = 0.91, multivariate: p = 0.31). Patients who received dressings re-epithelialised faster than patients who underwent debridement (multivariate HR: 1.96 [1.09-3.51], p = 0.023). Intravenous immunoglobulin (univariate HR: 0.21 [0.09-0.45], p < 0.001; multivariate HR: 0.22 [0.09-0.53], p < 0.001) and cyclosporin significantly reduced mortality (univariate HR: 0.09 [0.01-0.96], p = 0.046; multivariate HR: 0.06 [0.01-0.73], p = 0.028) irrespective of the wound care. This study supports the expert consensus of the dermatology hospitalists, that wound care in patients with TEN should be supportive with the epidermis left intact and supported with dressings, which leads to faster re-epithelialisation.
Topics: Adult; Humans; Stevens-Johnson Syndrome; Bandages; Cyclosporine; Immunoglobulins, Intravenous
PubMed: 38063272
DOI: 10.1111/ajd.14193 -
PloS One 2022The existing evidence demonstrates that survivors of SJS/TEN have reported long-lasting psychological effects of their condition. Burns patients experience similar...
Psychotherapeutic interventions for burns patients and the potential use with Stevens-Johnson syndrome and toxic epidermal necrolysis patients: A systematic integrative review.
BACKGROUND
The existing evidence demonstrates that survivors of SJS/TEN have reported long-lasting psychological effects of their condition. Burns patients experience similar psychological effects. It is important to look at ways to help allay the psychological complications of SJS/TEN. As there is an absence of evidence on SJS/TEN psychotherapeutic interventions, it was judged to be beneficial to determine the evidence underpinning psychotherapeutic interventions used with burns patients.
AIMS AND OBJECTIVES
The aim of this systematic integrative review was to synthesize the evidence relating to psychotherapeutic interventions used with adult burns patients and patients with SJS/TEN.
METHOD
The systematic review was guided by Whittemore and Knafl's integrative review process and the PRISMA guidelines. Nine databases were searched for English and French language papers published January 2008 to January 2021. The protocol for the review was registered with PROSPERO.
RESULTS
Following a screening process, 17 studies were included in the review. Two themes were identified using content analysis, (i) Empirically supported psychotherapeutic treatments, (ii) Alternative psychotherapeutic treatments. This review revealed no evidence on specific psychotherapeutic interventions for patients with SJS/TEN. Some of the interventions used with burns patients, viz. relaxation therapy, hypnosis and cognitive behavioral therapy showed some significant benefits. However, the evidence for burns patients is mainly focused on pain and pain anxiety as outcomes.
CONCLUSION
Following further research, some of the interventions deployed in burns patients may be applicable to SJS/TEN patients, particularly stress reduction techniques. In addition, the caring behaviours such as compassion, respect, and getting to know the patient as a person are important components to psychological care.
Topics: Adult; Burns; Databases, Factual; Humans; Pain; Retrospective Studies; Stevens-Johnson Syndrome
PubMed: 35759493
DOI: 10.1371/journal.pone.0270424