Acute Allergic Reactions Research Articles

Anaphylactic shock with methylprednisolone sodium succinate in a child with short bowel syndrome and cow\u2019s milk allergy

BackgroundMedications with methyl-prednisolone sodium succinate containing lactose, which potentially contains traces of cow’s milk proteins (CMP), could cause allergic reactions or compromise treatment of acute allergic reactions in sensitized patients.Case presentationWe describe the unusual case of a one-year-old child affected by short bowel syndrome and history of severe cow’s milk allergy (CMA) and anaphylactic reaction due to intravenous administration of methyl-prednisolone sodium succinate (Solu-Medrol 40 mg, Pfizer). He was admitted to our hospital for severe respiratory failure and was initially treated with methyl-prednisolone (Urbason 40 mg, Sanofi Aventis), then with methyl-prednisolone sodium succinate (Solu-Medrol 40 mg, Pfizer). After the intravenous administration of second steroid, immediate anaphylaxis was recorded and treatment was stopped. Antihistamine and epinephrine were required and symptom resolution occurred.ConclusionChildren who are highly sensitive to milk may have severe allergic reactions also after exposure to CMP through a different administration route than the oral one. Patients who have food allergies need to pay particular attention to the prescription of drugs and their formulation.

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Approximately two-thirds of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) need long-term intravenous immunoglobulin. Subcutaneous immunoglobulin (SCIg) is an alternative option for immunoglobulin delivery, but has not previously been investigated in a large trial of CIDP. The PATH study compared relapse rates in patients given SCIg versus placebo. Between March 12, 2012, and Sept 20, 2016, we studied patients from 69 neuromuscular centres in North America, Europe, Israel, Australia, and Japan. Adults with definite or probable CIDP who responded to intravenous immunoglobulin treatment were eligible. We randomly allocated participants to 0·2 g/kg or 0·4 g/kg of a 20% SCIg solution (IgPro20) weekly versus placebo (2% human albumin solution) for maintenance treatment for 24 weeks. We did randomisation in a 1:1:1 ratio with an interactive voice and web response system with a block size of six, stratified by region (Japan or non-Japan). The primary outcome was the proportion of patients with a CIDP relapse or who were withdrawn for any other reason during 24 weeks of treatment. Patients, caregivers, and study personnel, including those assessing outcomes, were masked to treatment assignment. Analyses were done in the intention-to-treat and per-protocol sets. This trial is registered with ClinicalTrials.gov, number NCT01545076. In this randomised, double-blind, placebo-controlled trial, we randomly allocated 172 patients: 57 (33%) to the placebo group, 57 (33%) to the low-dose group, and 58 (34%) to the high-dose group. In the intention-to-treat set, 36 (63% [95% CI 50-74]) patients on placebo, 22 (39% [27-52]) on low-dose SCIg, and 19 (33% [22-46]) on high-dose SCIg had a relapse or were withdrawn from the study for other reasons (p=0·0007). Absolute risk reductions were 25% (95% CI 6-41) for low-dose versus placebo (p=0·007), 30% (12-46) for high-dose versus placebo (p=0·001), and 6% (-11 to 23) for high-dose versus low-dose (p=0·32). Causally related adverse events occurred in 47 (27%) patients (ten [18%] in the placebo group, 17 [30%] in the low-dose group, and 20 [34%] in the high-dose group). Six (3%) patients had 11 serious adverse events: one (2%) patient in the placebo group, three (5%) in the low-dose group, and two (3%) in the high-dose group; only one (an acute allergic skin reaction in the low-dose group) was assessed to be causally related. This study, which is to our knowledge, the largest trial of CIDP to date and the first to study two administrations of immunoglobulins and two doses, showed that both doses of SCIg IgPro20 were efficacious and well tolerated, suggesting that SCIg can be used as a maintenance treatment for CIDP. CSL Behring.

Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study

BackgroundRecent studies show that near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has the potential to improve the performance of sentinel lymph node (SLN) mapping. The current cohort study was designed to assess the value of the combination of ICG and methylene blue (MB) dye in patients undergoing SLN biopsy.MethodsA prospective self-controlled trial was designed to detect the difference in the detection efficacies of ICG, MB, and combined ICG and MB (ICG + MB) navigation methods. Between 2010 and 2013, 198 consecutive early breast cancer patients eligible for sentinel lymph node biopsy were enrolled and 200 biopsy procedures were performed by injection of both ICG and MB. SLNs were searched and removed under the guidance of fluorescence and/or blue dye. The mapping characteristics, the detection rate of SLNs and positive SLNs, and the number of SLNs of ICG, MB, and ICG + MB were compared. Injection safety of ICG and MB was evaluated.ResultsFluorescence imaging of lymphatic flow, which is helpful to locate the incision site, could be seen in 184 of 200 procedures. The nodal detection rate of ICG, MB, and ICG + MB samples was 97, 89, and 99.5% (χ2 = 26.2, p < 0.001), respectively, with the combination method yielding a superior identification result. The addition of ICG to the MB method resulted in the identification of more lymph nodes (median 3 versus 2) and more positive axillas (22.7% involved axillas were discovered by fluorescence only) than either method alone. No acute or chronic allergic reaction was observed in this study. However, 23 patients (23/82) who received breast-conserving therapy reported temporary skin staining, and 5 patients had permanent tattooing. Palpable subcutaneous nodules at the injection sites were reported in nine patients. There were no reports of skin necrosis.ConclusionsThe lymphatic navigation by ICG fluorescence detects SLNs at a high detection rate and improves the mapping performance when added to the MB method. The novel ICG + MB dual tracing modality, without involvement of radioactive isotopes, exhibits great potential as an alternative to traditional standard mapping methods.Trial registrationACTRN12612000109808. Retrospectively registered on 23 January 2012.

Risk factors for severe anaphylaxis in the United States

BackgroundAnaphylaxis is an acute systemic allergic reaction and may be life-threatening. ObjectiveTo assess risk factors associated with severe and near-fatal anaphylaxis in a large observational cohort study. MethodsWe analyzed administrative claims data from Medicare Advantage and privately insured enrollees in the United States from 2005 to 2014. Severe anaphylaxis was defined as anaphylaxis resulting in hospital or intensive care unit (ICU) admission, requiring endotracheal intubation, or meeting criteria for near-fatal anaphylaxis. ResultsOf 38,695 patients seen in the emergency department for anaphylaxis during the study period, 4,431 (11.5%) required hospitalization, 2,057 (5.3%) were admitted to the ICU, 567 (1.5%) required endotracheal intubation, and 174 (0.45%) were classified as having a near-fatal episode. Multivariable analysis revealed that medication-related anaphylaxis (odds ratio [OR], 1.50; 95% confidence interval [CI], 1.38–1.63; P < .001), age of 65 years or older (OR, 3.15; 95% CI, 2.88–3.44; P < .001), and the presence of cardiac disease (OR, 1.56; 95% CI, 1.50–1.63; P < .001) or lung disease (OR, 1.23; 95% CI, 1.16–1.30; P < .001) were associated with increased odds of severe anaphylaxis requiring any hospital admission, ICU admission, or intubation or being a near-fatal reaction. ConclusionIn this large contemporary cohort study, 11.6% of patients had severe anaphylaxis. Age of 65 years or older, medication as a trigger, and presence of comorbid conditions (specifically cardiac and lung disease) were associated with significantly higher odds of severe anaphylaxis. Additional studies examining risk factors for severe anaphylaxis are needed to define risk assessment strategies and establish a framework for management.

Epinephrine Autoinjectors: New Data, New Problems

Epinephrine is the first-line treatment for anaphylaxis. Despite this, there have been identified gaps in the management of anaphylaxis including infrequent or delayed use of epinephrine for acute allergic reactions, as well as inadequate epinephrine autoinjector (EAI) training, and prescription rates of these devices for patients at risk. This paper reviews new data, and new problems in recently published literature on EAIs. A database search was conducted for publications between January 2015 and February 2017 using keywords related to EAIs including their functionality and features, carriage, prescription rates, barriers, and side effects. Eligibility criteria included patients at risk for anaphylaxis, caregivers, and health care professionals. Experimental studies and observational studies were included. Of 1,737 potentially relevant articles, 19 were used for analysis. These articles addressed specific aspects of an EAI, including (1) information on features and functionality; (2) prescriptions; (3) training on their use; and (4) carriage and use at the time of reaction by patients, schools, camps, emergency departments, and paramedics. Our review highlights that existing gaps in anaphylaxis management remain unaddressed. Patient needs are largely unmet, and very few studies are being designed to clarify and instill best practice, and to determine how to increase adherence to existing anaphylaxis guidelines through integrated knowledge translation strategies.

Oral Immunotherapy for Food Allergy.

Food allergy is a potentially life-threatening condition with no approved therapies apart from avoidance and injectable epinephrine for treatment of acute allergic reactions. Oral immunotherapy (OIT) is an experimental treatment in which patients consume gradually increasing quantities of the food to which they are allergic in an attempt to induce some level of desensitization. While desensitization is possible in most patients, OIT carries significant risks for allergic reactions, and the ability to induce longer-term tolerance has not yet been established. This review focuses on selected studies of OIT for the treatment of common food allergies such as cow's milk, hen's egg, and peanut.

Evaluating the Cost and Utility of Mandating Schools to Stock Epinephrine Auto-injectors

Background: The Michigan Legislature mandated that all public schools stock epinephrine auto-injectors (EAIs). A minimal amount is known regarding the incremental value of EAIs in schools. Our primary objective was to describe the frequency of administration of epinephrine for EMS patients with acute allergic reactions in public schools. Our secondary objective was to estimate the cost of mandating public schools to stock EAIs. Methods: We performed a retrospective cohort study of EMS cases with an impression of allergic reaction and who received epinephrine recorded in the 2014 Michigan EMS Information System (MI-EMSIS). We abstracted patient demographics, incident location by address to identify public schools, source of epinephrine given, and suspected allergen if known. We calculated advanced life support (ALS) response times to assess temporal impact of school EAIs in communities with ALS systems. We estimated the unsubsidized annual procurement cost of this mandate for Michigan public schools (N = 4,039), using range of costs for the required 2 EAIs (adult and pediatric) as estimated by the legislature ($140/each) and recently reported costs for commercial sources ($1,200). Training costs were not included. Descriptive statistics are reported. Results: During this period, there were 1,550,009 EMS cases in the state with 631 receiving non-cardiac arrest epinephrine for presumed anaphylaxis, of which 23 cases were in public schools. Reported allergens were most often food 12 (51.2%), insect stings 4(22.2%) or unknown 7(30.4%). Among these patients, the source for epinephrine used was from the student, 7 (30.4%), EMS 7 (30.4%), school 7(30.4%), and unknown 2(8.7%). A majority (21, 91.3%) of the public school cases occurred in communities with ALS systems and ALS response was relatively rapid (median response 6 minutes, 90 percentile, 13 minutes). The unsubsidized annual cost of Michigan public schools to stock EAIs ranges from $565,460 to $4,846,800. Conclusion: In this study, few public school patients received epinephrine for anaphylaxis and the vast majority occurred in communities with rapid ALS response. The direct annual supply cost of the school EAI mandate is substantial.

Changes in Emergency Department Concordance with Guidelines for the Management of Insect Sting-Induced Anaphylaxis: 1999-2001 Versus 2013-2015

Background Awareness about food allergy and food-induced anaphylaxis (FIA) has increased dramatically over the past decade. It remains unclear, however, whether concordance with guidelines for FIA management has improved over time. Objective Our objective was to describe changes in emergency department (ED) concordance with guidelines for FIA management. Methods We analyzed data from 2 multicenter retrospective studies of patients with food-related acute allergic reactions seen in 1 of 17 EDs during 2 time periods: 1999 to 2001 and 2013 to 2015. Visits were identified similarly across years—for example, using International Classification of Diseases, Ninth Revision, Clinical Modification codes 693.1, 995.60, 995.61-995.69, 995.0, and 995.3. Anaphylaxis was defined as an acute allergic reaction with involvement of 2+ organ systems or hypotension. We compared concordance between time periods for 4 guideline recommendations: (1) treatment with epinephrine, (2) discharge prescription for an epinephrine autoinjector (EAI), (3) referral to an allergist/immunologist, and (4) instructions to avoid offending allergen. Results We compared 290 patients with FIA during 1999 to 2001 and 459 during 2013 to 2015. Any treatment with epinephrine (pre-ED or in the ED) for patients with FIA increased over time (38% vs 56%; P Conclusions Over the nearly 15-year study interval, we observed clinically and statistically significant increases in ED concordance with epinephrine-related guidelines for FIA. Management gaps remain and interventions to standardize care still appear warranted.

Extensively hydrolyzed casein formula alone or with L. rhamnosus GG reduces β-lactoglobulin sensitization in mice.

Extensively hydrolyzed casein formula (EHCF) has been proposed for the prevention and is commonly used for the treatment of cow's milk allergy (CMA). The addition of the probiotic Lactobacillus rhamnosus GG (LGG) to EHCF may induce faster acquisition of tolerance to cow's milk. The mechanisms underlying this effect are largely unexplored. We investigated the effects of EHCF alone or in combination with LGG on β-lactoglobulin (BLG) sensitization in mice. Three-week-old C3H/HeOuJ mice were sensitized by oral administration of BLG using cholera toxin as adjuvant at weekly intervals for 5 weeks (sensitization period). Two experimental phases were conducted: (i) EHCF or EHCF+LGG given daily, starting 2 weeks before the sensitization period and then given daily for 5 weeks and (ii) EHCF or EHCF+LGG given daily for 4 weeks, starting 1 week after the sensitization period. Diet free of cow's milk protein was used as control. Acute allergic skin response, anaphylactic symptom score, body temperature, intestinal permeability, anti-BLG serum IgE, and interleukin (IL)-4, IL-5, IL-10, IL-13, IFN-γ mRNA expression were analyzed. Peptide fractions of EHCF were characterized by reversed-phase (RP)-HPLC, MALDI-TOF mass spectrometry, and nano-HPLC/ESI-MS/MS. Extensively hydrolyzed casein formula administration before or after BLG-induced sensitization significantly reduced acute allergic skin reaction, anaphylactic symptom score, body temperature decrease, intestinal permeability increase, IL-4, IL-5, IL-13, and anti-BLG IgE production. EHCF increased expression of IFN-γ and IL-10. Many of these effects were significantly enhanced by LGG supplementation. The peptide panels were similar between the two study formulas and contained sequences that could have immunoregulatory activities. The data support dietary intervention with EHCF for CMA prevention and treatment through a favorable immunomodulatory action. The observed effects are significantly enhanced by LGG supplementation.

Mucociliary Clearance: Measures and Therapies

Mucociliary Clearance can be measured clinically with the Saccharine Test in the sino-nasal system. When clearance is slow, treat mucus viscosity and slow ciliary beat frequency. Chronic sinusitis and bronchitis are often due to poor MCC. Therapy to upper or lower respiratory system benefits both. Therapy for Mucociliary Clearance includes proteolytic enzymes to reduce mucus viscosity, vibrations for improving ciliary beat frequency, irrigation with Locke-Ringer's solution for cilia frequency, glucosteroids and surfactants. Use of the Saccharine Test can help determine toxic effects of chromium, Sulphur Dioxide, benzines and other toxic products. In acute allergy, mucociliary clearance speeds up; but sinusitis may follow when mucociliary clearnace slows down later. In slow mucociliary clearance, bacteria remain in place and are able to multiply. This is a significant factor for recurrent sinus infections and indicates a method of treatment that includes restoring normal mucociliary clearance (MCC). Measuring MCC in the lower respiratory tract is complex and includes inhalation of radioactive particles. Clinically, the results of the Saccharine test of the nasal system may be an indicator of the MCC in the lower respiratory system.

Integrative transcriptomic analysis reveals key drivers of acute peanut allergic reactions

Integrative transcriptomic analysis reveals key drivers of acute peanut allergic reactions

Occurrence of Kounis syndrome under anesthesia.

Occurrence of Kounis syndrome under anesthesia.

The transforming power of proximity food challenges

In recent years, food allergy has become a problem that affects the physical health and emotional well-being of individuals and their families. As many as 15 million people in the United States have food allergies, with nearly 6 million of them being children. [1] Clark S. Espinola J. Rudders S.A. Banerji A. Camargo Jr., C.A. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy Clin Immunol. 2011; 127: 682-683 Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar Both medical and lay publications (www.foodallergy.org) reiterate the prevalence and effect of food allergy and attempt to educate practitioners and patients on appropriate management. 2 Boyce J.A. Assa'ad A. Burks A.W. et al. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. J Allergy Clin Immunol. 2010; 126: 1105-1118 Abstract Full Text Full Text PDF PubMed Scopus (1176) Google Scholar , 3 Simonte S.J. Ma S. Mofidi S. Sicherer S.H. Relevance of casual contact with peanut butter in children with peanut allergy. J Allergy Clin Immunol. 2003; 112: 180-182 Abstract Full Text Full Text PDF PubMed Scopus (134) Google Scholar Patients and families are informed that every 3 minutes a food allergy reaction sends someone to the emergency department and every 6 minutes the reaction is anaphylactic. [1] Clark S. Espinola J. Rudders S.A. Banerji A. Camargo Jr., C.A. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy Clin Immunol. 2011; 127: 682-683 Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar They learn that more than 15% of school aged children with food allergies have a reaction at school, [4] Sicherer S.H. Furlong T.J. DeSimone J. Sampson H.A. The US Peanut and Tree Nut Allergy Registry: characteristics of reactions in schools and day care. J Pediatr. 2001; 138: 560-565 Abstract Full Text Full Text PDF PubMed Scopus (156) Google Scholar that almost half of fatal food allergy reactions are triggered by food consumed outside the home, [5] Bock S.A. Munoz-Furlong A. Sampson H.A. Further fatalities caused by anaphylactic reactions to food, 2001-2006. J Allergy Clin Immunol. 2007; 119: 1016-1018 Abstract Full Text Full Text PDF PubMed Scopus (782) Google Scholar and that, of the food allergens, peanuts are most commonly associated with severe allergic reactions. [6] Yu J.W. Kagan R. Verreault N. et al. Accidental ingestions in children with peanut allergy. J Allergy Clin Immunol. 2006; 118: 466-472 Abstract Full Text Full Text PDF PubMed Scopus (148) Google Scholar They are educated that failure to promptly treat food anaphylaxis with epinephrine is a risk factor for fatalities. 2 Boyce J.A. Assa'ad A. Burks A.W. et al. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. J Allergy Clin Immunol. 2010; 126: 1105-1118 Abstract Full Text Full Text PDF PubMed Scopus (1176) Google Scholar , 5 Bock S.A. Munoz-Furlong A. Sampson H.A. Further fatalities caused by anaphylactic reactions to food, 2001-2006. J Allergy Clin Immunol. 2007; 119: 1016-1018 Abstract Full Text Full Text PDF PubMed Scopus (782) Google Scholar

Parent-reported prevalence of food allergy in Mexican schoolchildren: A population-based study

BackgroundFood allergy (FA) prevalence is well documented in developed countries and appears to be increasing, but remains unknown in most Latin American countries. We aimed to evaluate on a population basis the parent-reported prevalence of FA and its clinical characteristics in Mexican schoolchildren. MethodsA validated Spanish version of a structured written questionnaire was administered to parents of schoolchildren aged 5–13 years old from Culiacan, Mexico. ResultsA total of 1049 parents responded to the survey (response rate, 84%). The estimated prevalence rates (95% CI) were: adverse food reactions 10.0% (8.3–11.9), “perceived FA, ever” 5.5% (4.3–7.0), “physician-diagnosed FA, ever” 4.9% (3.7–6.3), “immediate-type FA, ever” 4.4% (3.3–5.8), “immediate-type FA, current” 3.5% (2.6–4.8), and anaphylaxis 1.2% (0.72–2.1). Immediate hypersensitivity reactions were mainly triggered by the consumption of shrimp (1.3%), other shellfish (0.7%), strawberry (0.6%), chocolate (0.5%), and egg (0.4%). Schoolchildren with “immediate-type FA, current” had more atopic dermatitis and allergic rhinitis (p<0.05), but not asthma or drug allergy (p>0.05) than children without FA. All cases of anaphylaxis sought medical attention, but only one child had physician-diagnosed anaphylaxis and was advised to acquire an epinephrine autoinjector. ConclusionsThe prevalence of “immediate-type FA, current” to any food is 3.5% in Mexican schoolchildren. The poor recognition of anaphylaxis and the low frequency of prescription of epinephrine autoinjectors suggest that acute food-induced allergic reactions are not optimally managed in Mexico.

Postmortem serum levels of total IgE.

The first aim of this study was to assess whether non-allergic deaths in non-atopic individuals with increasing postmortem intervals are characterized by progressively greater concentrations of total IgE in postmortem serum from femoral blood. Our second goal was to determine whether traumatic deaths with different survival times, septic deaths, and deaths in individuals suffering from diseases with significant systemic inflammation are systematically characterized by increased concentrations of total IgE in postmortem serum from femoral blood. Four study groups were prospectively and retrospectively formed (non-allergic deaths in non-atopic individuals with increasing postmortem intervals, traumatic deaths in non-atopic individuals with different survival times, deaths possibly related to sepsis in non-atopic individuals, and deaths occurring in non-atopic individuals with disseminated malignancies at autopsy). Unenhanced computed tomography, autopsy, histology, and biochemistry were performed in all cases. First results indicate that increasing postmortem intervals are not associated with progressively increasing postmortem serum IgE levels. Moreover, the obtained results do not reveal that severe trauma, bacterial sepsis, and disseminated malignancies are systematically associated with increased postmortem serum IgE levels, irrespective of survival time duration. Though the usefulness of increased total IgE concentrations in postmortem samples to assess any underlying atopic disposition or death preceded by acute IgE-mediated allergic reaction remains questionable, measurements of total IgE are possible in postmortem serum samples.

Repeated FcεRI triggering reveals modified mast cell function related to chronic allergic responses in tissue

Activation of mast cells through FcεRI plays an important role in acute allergic reactions. However, little is known about the function of mast cells in patients with chronic allergic inflammation or the effect of repeated FcεRI triggering occurring in such responses. We aimed to identify changes in mast cell function after repeated FcεRI triggering and to correlate these changes to chronic allergic responses in tissue. Human cord blood-derived mast cells were treated for 2weeks with anti-IgE. The function of naive or treated mast cells was analyzed by means of RNA sequencing, quantitative RT-PCR, flow cytometry, and functional assays. Protein secretion was measured with ELISAs and multiplex assays. We observed several changes in mast cell function after repeated anti-IgE triggering. Although the acute response was dampened, we identified 289 genes significantly upregulated after repeated anti-IgE. Most of these genes (84%) were not upregulated after a single anti-IgE stimulus, indicating a significantly different response mode characterized by increased antigen presentation, response to bacteria, and chemotaxis. Changes in mast cell function were related to changes in expression of the transcription factors RXRA and BATF and others. Importantly, we found a substantial overlap between genes upregulated after repeated anti-IgE triggering and genes upregulated in tissue from patients with chronic allergy, in particular those of patients with chronic rhinosinusitis. Our study provides evidence for intrinsic modulation of mast cell function on repeated FcεRI-mediated activation. The overlap with gene expression in tissues is suggestive of a direct link between repeated IgE-mediated activation of mast cells and chronic allergy.

Basophil activation test: food challenge in a test tube or specialist research tool?

Oral food challenge (OFC) is the gold-standard to diagnose food allergy; however, it is a labour and resource-intensive procedure with the risk of causing an acute allergic reaction, which is potentially severe. Therefore, OFC are reserved for cases where the clinical history and the results of skin prick test and/or specific IgE do not confirm or exclude the diagnosis of food allergy. This is a significant proportion of patients seen in Allergy clinics and results in a high demand for OFC. The basophil activation test (BAT) has emerged as a new diagnostic test for food allergy. With high diagnostic accuracy, it can be particularly helpful in the cases where skin prick test and specific IgE are equivocal and may allow reducing the need for OFC. BAT has high specificity, which confers a high degree of certainty in confirming the diagnosis of food allergy and allows deferring the performance of OFC in patients with a positive BAT. The diagnostic utility of BAT is allergen-specific and needs to be validated for different allergens and in specific patient populations. Standardisation of the laboratory methodology and of the data analyses would help to enable a wider clinical application of BAT.

Allergy-Like Immediate Reactions with Herbal Medicines: A Retrospective Study Using Data from VigiBase®.

Herbal medicines are used worldwide and with an increasing popularity in Western countries. Although often perceived as 'naturally safe', herbals may cause severe adverse drug reactions (ADRs), with immediate allergic reactions being particularly life threatening. The aim of this study was to analyse immediate allergy-like ADRs to herbals documented in VigiBase®, the WHO international pharmacovigilance database. The documentation of all suspected ADRs in association with herbal exposure reported to VigiBase® from 1969 to August 2014 was retrieved. Among all reports in which WHO-ART reaction terms were indicative of acute allergic reactions, those classified as 'suspect' with a documented causality assessment and latency time of ≤1 day were selected. For the most frequent specific herbal-ADR combinations, the information component (IC) as a measure of disproportionality based on Bayesian statistics was calculated. We identified 757 reports out of 1039 ADRs. Products with mixed herbals (36.0 %) as well as those administered orally (63.2 %) were predominant. The most frequent reactions were urticaria and rash (49.2 %). Anaphylactic reactions accounted for 9.5 %. Disproportionally frequent reporting of mouth edema (IC = 1.81) and anaphylactic reactions (IC = 1.24) to Phleum pretense were noted. Our findings indicate that herbal medicines for oral use carry a risk of causing immediate allergy-like ADRs. Studies using the Vigibase® database can identify specific combinations of particular herbs and adverse reactions. Healthcare professionals and patients should be aware of these risks and report any serious adverse experiences.

Cyclosporine A in Reperfused Myocardial Infarction: The Multicenter, Controlled, Open-Label CYCLE Trial

BackgroundWhether cyclosporine A (CsA) has beneficial effects in reperfused myocardial infarction (MI) is debated. ObjectivesThis study investigated whether CsA improved ST-segment resolution in a randomized, multicenter phase II study. MethodsThe authors randomly assigned 410 patients from 31 cardiac care units, age 63 ± 12 years, with large ST-segment elevation MI within 6 h of symptom onset, Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 to 1 in the infarct-related artery, and committed to primary percutaneous coronary intervention, to 2.5 mg/kg intravenous CsA (n = 207) or control (n = 203) groups. The primary endpoint was incidence of ≥70% ST-segment resolution 60 min after TIMI flow grade 3. Secondary endpoints included high-sensitivity cardiac troponin T (hs-cTnT) on day 4, left ventricular (LV) remodeling, and clinical events at 6-month follow-up. ResultsTime from symptom onset to first antegrade flow was 180 ± 67 min; a median of 5 electrocardiography leads showed ST-segment deviation (quartile [Q]1 to Q3: 4 to 6); 49.8% of MIs were anterior. ST-segment resolution ≥70% was found in 52.0% of CsA patients and 49.0% of controls (p = 0.55). Median hs-cTnT on day 4 was 2,160 (Q1 to Q3: 1,087 to 3,274) ng/l in CsA and 2,068 (1,117 to 3,690) ng/l in controls (p = 0.85). The 2 groups did not differ in LV ejection fraction on day 4 and at 6 months. Infarct site did not influence CsA efficacy. There were no acute allergic reactions or nonsignificant excesses of 6-month mortality (5.7% CsA vs. 3.2% controls, p = 0.17) or cardiogenic shock (2.4% CsA vs. 1.5% controls, p = 0.33). ConclusionsIn the CYCLE (CYCLosporinE A in Reperfused Acute Myocardial Infarction) trial, a single intravenous CsA bolus just before primary percutaneous coronary intervention had no effect on ST-segment resolution or hs-cTnT, and did not improve clinical outcomes or LV remodeling up to 6 months. (CYCLosporinE A in Reperfused Acute Myocardial Infarction [CYCLE]; NCT01650662; EudraCT number 2011-002876-18)

Red blood cell distribution width and haemoglobin are associated with hospital admission in patients with acute allergic reactions

Introduction: Red blood cell distribution width (RDW) is significantly associated with a variety of human disorders. This study aimed to investigate whether RDW value at admission may predict the need of hospitalisation in patients presenting to the emergency department (ED) with acute allergic reactions.Materials and Methods: The study population consisted of adult patients (aged > 17) admitted to the ED for acute allergic reactions.Results: One hundred and thirty-two subjects were included, 12 of whom (9%) required hospital admission for severity of symptoms. Patients who needed hospital admission displayed significantly lower values of haemoglobin and significantly higher values of RDW-coefficient of variation (RDW-CV). In multivariate analysis, haemoglobin and RDW-CV were found to be independent predictors of hospital admission. The area under the curve (AUC), sensitivity and specificity for predicting hospital admission were 0.72, 0.88 and 0.42 for haemoglobin and 0.73, 0.88 and 0.50 for RDW-CV, respectively. The combination of these tests (both positive) was characterised by 0.76 AUC, 0.83 sensitivity, 0.67 specificity, 0.96 negative predictive value and 0.30 positive predictive.Discussion: The results of this study suggest that two common and inexpensive parameters such as haemoglobin and RDW are independent predictors of hospital admission in patients presenting to the ED with acute allergic reactions.