Incidence Of Severe Reactions Research Articles

Polyurethane foam dressings ameliorating local adverse effects of azacitidine: a randomized controlled trial

This study investigated the use of polyurethane foam dressings to prevent local adverse reactions of subcutaneous azacitidine injection. Patients receiving a subcutaneous azacitidine injection were randomly divided into experimental and control groups. A total of 55 patients were included in each group. A polyurethane foam dressing was used to cover the injection site of patients in the experimental group. Conventional treatment was used in the control group. Injection site pain and local skin reactions were assessed after the intervention in both groups. The score and duration of pain, the incidence and duration of local skin adverse reactions, and the incidence of severe reactions in the experimental group were significantly lower than in the control group (p < 0.05). Polyurethane foam dressing can effectively reduce local adverse reactions of subcutaneous injection of azacitidine, relieve pain, shorten the duration of local pain and adverse reactions, and improve the quality of nursing.

Estudio de seguridad en inmunoterapia: práctica clínica en consulta de alergia

Immunotherapy with specific allergens is the only immune system-modifying treatment for allergic disease. To identify the prevalence of adverse reactions during the subcutaneous immunotherapy initiation phase in real-life conditions and possible associated risk factors. One-year retrospective, observational study. Epidemiological characteristics of 481 patients, type of immunotherapy used and adverse reactions were recorded. 16.8% of patients suffered atopic dermatitis, 8.9% food allergy, 4% drug allergy and 7.3 % had experienced idiopathic urticaria. Grass pollen was the main allergen. In polysensitized patients, the use of polymerized extracts that contained grasses in their composition was higher (89.2%) than that of native extracts (78.9%). A total of 1292 doses of specific immunotherapy were administered: 881 polymerized extracts and 411 depot extracts; 30 patients had an adverse reaction (6.2 %): 4.4% of those who received polymerized extract and 14.3 % of those who received a native one (OR = 3.657). In patients who received polymerized extracts, the adverse reaction was local in 82.4%, mild systemic in 11.8% and only in one it was serious systemic; 66.7 % of those who received native extract had local reactions, 25 % mild systemic and only one, serious systemic. Subcutaneous immunotherapy under real life conditions is not free of risk, but the incidence of severe reactions is very low, especially with polymerized extracts, even when grouped or ultra-rapid testing is used.

CLINICAL CHARACTERISTICS OF ADVERSE REACTION TO RADIOCONTRAST MEDIA IN CHILDREN: A SINGLE CENTER EXPERIENCE

Introduction Radiocontrast media are used widely in medical imaging to improve the diagnostic accuracy. However, studies on the adverse reaction of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocontrast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. Methods We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary university hospital. We selected data of children under the age of 19 from July 2011 to December 2017 and analyzed characteristics of them. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. Results During the period, a total of 88050 radiocontrast media-enhanced imaging studies were performed and 184 cases were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was 12.7±3.2 years. The incidence of radiocontrast media related adverse reactions was 0.09% and that of severe reactions was 0.002%. The most common features were skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). Conclusions The adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reaction is low. Most reactions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children awaiting imaging studies using radiocontrast media. Radiocontrast media are used widely in medical imaging to improve the diagnostic accuracy. However, studies on the adverse reaction of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocontrast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary university hospital. We selected data of children under the age of 19 from July 2011 to December 2017 and analyzed characteristics of them. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. During the period, a total of 88050 radiocontrast media-enhanced imaging studies were performed and 184 cases were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was 12.7±3.2 years. The incidence of radiocontrast media related adverse reactions was 0.09% and that of severe reactions was 0.002%. The most common features were skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). The adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reaction is low. Most reactions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children awaiting imaging studies using radiocontrast media.

Clinical characteristics of adverse reaction to radiocontrast media in children - A single center experience

Purpose: Radiocontrast media are widely used in medical imaging to improve diagnostic accuracy. However, studies on the adverse reactions of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocon trast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. Methods: We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary uni versity hospital. We selected data from children under the age of 19 from July 2011 to December 2017 and analyzed their character istics. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. Results: During the period, a total of 88,050 radiocontrast media-enhanced imaging studies were performed and 184 cases of ad verse reactions were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was 12.7±3.2 years. The incidence of radiocontrast media-related adverse reactions was 0.09% and severe reactions were 0.002%. The most common clinical feature was skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). Conclusion: Adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reactions is low. Most re actions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children scheduled for imaging studies using radiocontrast media. (Allergy Asthma Respir Dis 2018;6:315-321)

FRI0179 Infliximab infusion reactions in patients with rheumatoid arthritis and spondylarthropathies

BackgroundTherapies that target TNF have been successfully used for the treatment of patients with rheumatoid arthritis (RA) and spondylarthropathies (SpA). TNF-α blocking agents have been relatively safe, however intravenous administration...

Phase III Randomized, Double-Blind Study Comparing Single-Dose Intravenous Peramivir with Oral Oseltamivir in Patients with Seasonal Influenza Virus Infection

Antiviral medications with activity against influenza viruses are important in controlling influenza. We compared intravenous peramivir, a potent neuraminidase inhibitor, with oseltamivir in patients with seasonal influenza virus infection. In a multinational, multicenter, double-blind, double-dummy randomized controlled study, patients aged ≥ 20 years with influenza A or B virus infection were randomly assigned to receive either a single intravenous infusion of peramivir (300 or 600 mg) or oral administration of oseltamivir (75 mg twice a day [b.i.d.] for 5 days). To demonstrate the noninferiority of peramivir in reducing the time to alleviation of influenza symptoms with hazard model analysis and a noninferiority margin of 0.170, we planned to recruit 1,050 patients in South Korea, Japan, and Taiwan. A total of 1,091 patients (364 receiving 300 mg and 362 receiving 600 mg of peramivir; 365 receiving oseltamivir) were included in the intent-to-treat infected population. The median durations of influenza symptoms were 78.0, 81.0, and 81.8 h in the groups treated with 300 mg of peramivir, 600 mg of peramivir, and oseltamivir, respectively. The hazard ratios of the 300- and 600-mg-peramivir groups compared to the oseltamivir group were 0.946 (97.5% confidence interval [CI], 0.793, 1.129) and 0.970 (97.5% CI, 0.814, 1.157), respectively. Both peramivir groups were noninferior to the oseltamivir group (97.5% CI, <1.170). The overall incidence of adverse drug reactions was significantly lower in the 300-mg-peramivir group, but the incidence of severe reactions in either peramivir group was not different from that in the oseltamivir group. Thus, a single intravenous dose of peramivir may be an alternative to a 5-day oral dose of oseltamivir for patients with seasonal influenza virus infection.

Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial.

Envenoming from snakebites is most effectively treated by antivenom. However, the antivenom available in South Asian countries commonly causes acute allergic reactions, anaphylactic reactions being particularly serious. We investigated whether adrenaline, promethazine, and hydrocortisone prevent such reactions in secondary referral hospitals in Sri Lanka by conducting a randomised, double-blind placebo-controlled trial. In total, 1,007 patients were randomized, using a 2 × 2 × 2 factorial design, in a double-blind, placebo-controlled trial of adrenaline (0.25 ml of a 1∶1,000 solution subcutaneously), promethazine (25 mg intravenously), and hydrocortisone (200 mg intravenously), each alone and in all possible combinations. The interventions, or matching placebo, were given immediately before infusion of antivenom. Patients were monitored for mild, moderate, or severe adverse reactions for at least 96 h. The prespecified primary end point was the effect of the interventions on the incidence of severe reactions up to and including 48 h after antivenom administration. In total, 752 (75%) patients had acute reactions to antivenom: 9% mild, 48% moderate, and 43% severe; 89% of the reactions occurred within 1 h; and 40% of all patients were given rescue medication (adrenaline, promethazine, and hydrocortisone) during the first hour. Compared with placebo, adrenaline significantly reduced severe reactions to antivenom by 43% (95% CI 25-67) at 1 h and by 38% (95% CI 26-49) up to and including 48 h after antivenom administration; hydrocortisone and promethazine did not. Adding hydrocortisone negated the benefit of adrenaline. Pretreatment with low-dose adrenaline was safe and reduced the risk of acute severe reactions to snake antivenom. This may be of particular importance in countries where adverse reactions to antivenom are common, although the need to improve the quality of available antivenom cannot be overemphasized.

Severe food‐allergic reactions in children across the UK and Ireland, 1998–2000

. Colver A.F., Nevantaus H., Macdougall C.F. Cant A.J. ( 2005 ) , 94 , 689 – 695 . Aim Medical and lay concerns about food allergy are increasing. Whilst food allergy may be becoming more common, fatal reactions to food in childhood are very rare and their rate is not changing. We sought to establish how common severe reactions are.Methods Prospective survey, 1998–2000, of hospital admissions for food‐allergic reactions – conducted primarily through the British Paediatric Surveillance Unit, covering the 13 million children in the UK and Ireland.Results A total of 229 cases reported by 176 physicians in 133 departments, yielding a rate of 0.89 hospital admissions per 100 000 children per year. Sixty‐five per cent were male, 41% were under 4 years and 60% started at home. Main allergens were peanut (21%), tree nuts (16%), cow's milk (10%) and egg (7%). Main symptoms were facial swelling (76%), urticaria (69%), respiratory (66%), shock (13%), gastrointestinal (4%). Fifty‐eight cases were severe. Three were fatal, six near fatal, and 8 of these 9 had asthma with wheeze being the life‐threatening symptom. Three near‐fatal cases received excess intravenous epinephrine. None of the non‐fatal reactions resulted in mental or physical impairment. Seven of 171 non‐severe and 6/58 severe cases might have had a worse outcome if epinephrine auto‐injectors had been unavailable. Six of the severe cases might have benefited if auto‐injectors had been more widely prescribed.Conclusion In the UK and Ireland, the incidence of severe reactions is low. The study highlights that: (1) asthma is a strongly significant risk factor for a severe reaction and therefore warrants optimal management; (2) severe wheeze is a prominent feature of severe reactions and warrants optimal management; and (3) intravenous epinephrine should be used with great care if needed. Epinephrine auto‐injectors do not always prevent death, but our study design and data do not allow a definite statement about whether overall they are beneficial.

Severe food‐allergic reactions in children across the UK and Ireland, 1998–2000

Medical and lay concerns about food allergy are increasing. Whilst food allergy may be becoming more common, fatal reactions to food in childhood are very rare and their rate is not changing. We sought to establish how common severe reactions are. Prospective survey, 1998 to 2000, of hospital admissions for food-allergic reactions-conducted primarily through the British Paediatric Surveillance Unit, covering the 13 million children in the United Kingdom and Ireland. 229 cases reported by 176 physicians in 133 departments, yielding a rate of 0.89 hospital admissions per 100,000 children per year. Sixty-five per cent were male, 41% were under 4 y and 60% started at home. Main allergens were peanut (21%), tree nuts (16%), cow's milk (10%) and egg (7%). Main symptoms were facial swelling (76%), urticaria (69%), respiratory (66%), shock (13%), gastrointestinal (4%). Fifty-eight cases were severe. Three were fatal, six near fatal, and 8 of these 9 had asthma with wheeze being the life-threatening symptom. Three near-fatal cases received excess intravenous epinephrine. None of the non-fatal reactions resulted in mental or physical impairment. Seven of 171 non-severe and 6/58 severe cases might have had a worse outcome if epinephrine auto-injectors had been unavailable. Six of the severe cases might have benefited if auto-injectors had been more widely prescribed. In the United Kingdom and Ireland, the incidence of severe reactions is low. The study highlights that: asthma is a strongly significant risk factor for a severe reaction and therefore warrants optimal management; severe wheeze is a prominent feature of severe reactions and warrants optimal management; intravenous epinephrine should be used with great care if needed. Epinephrine auto-injectors do not always prevent death, but our study design and data do not allow a definite statement about whether overall they are beneficial.

Spontaneous movements, local reactions and pain on injection of rocuronium. A comparison between female and male patients.

We investigated the incidence of withdrawal, local reactions and pain on injection of rocuronium in 120 adult ASA I-II patients undergoing general anaesthesia (group A: 60 male patients, group B: 60 female patients). After induction of anaesthesia with propofol and remifentanil, rocuronium 0.6 mg kg(-1) was injected in a separate intravenous cannula on the opposite arm. The patient's response to the injection of rocuronium was graded using a four-point scale. The appearance of local signs (i.e. erythema, venous sequelae) on the arm where rocuronium had been injected was recorded at the end of the injection as well as 1 h and 24 h after recovery from anaesthesia. Moreover, patients were asked 24 h after recovery from anaesthesia whether they had recall of pain or movements in this arm during induction of anaesthesia. In 26 of the 120 patients (22%) included, withdrawal reactions after injection of rocuronium were observed. Of these 26 patients, 16 (13%) had severe movements. The overall incidence of withdrawal reactions after rocuronium as well as the incidence of severe reactions was significantly higher in female patients compared to male patients (overall incidence: 18 females (30%) vs. 8 males (13%), P<0.05; severe reaction: 13 females (22%) vs. 3 males (5%), P<0.05). No local reactions were observed and no patient remembered any pain or movements during induction of anaesthesia. The incidence and the degree of withdrawal reactions in response to the injection of rocuronium were significantly higher in women than in men. This was not associated with adverse clinical consequences for the patient's outcome.

Editorial Comment

Editorial Comment

VACCINATIONS

Vaccines have prevented morbidity and death in millions of people throughout the world. It is because of the great success of many of these vaccines in eliminating diseases such as smallpox and polio that the side effects of the vaccine have become magnified and a focus of our concerns. There is always a small price to pay for such large benefits. Further, careful screening and prudence in administering these vaccines to high-risk patients such as egg-sensitive individuals, the immunocom-promised, or those with seizure disorders can help to decrease these unfortunate untoward effects. Finally, work toward safer (and more effective) vaccines is continuing and with these efforts, the incidence of severe reactions will eventually be reduced.

Safety of oral ciprofloxacin: An update based on clinical trial results

The safety of ciprofloxacin was established on a data base (compiled through the end of 1988) of 9,473 well-documented treatment courses worldwide. The daily dosages ranged between 200 and 2,000 mg orally. Thirty-eight percent of the patients received doses between 1 and 10 mg/kg body weight, 46 percent between 11 and 20 mg/kg, and the remaining 16 percent more than 20 mg/kg body weight daily. ciprofloxacin was administered to 4,214 women (45 percent) and 5,252 men (55 percent). The duration of treatment ranged from less than two days to more than 90 days. A 600-mg daily dose of ciprofloxacin was used mostly in Japan (2,341 patients). The daily dose of 1,000 mg was administered chiefly in the United States and Europe (2,288 patients). The age of the patients ranged from less than one year to 99 years (mean, 50.6 years). More than 38 percent were older than 60 years. According to COSTART terminology, the following drug-related side effects were observed in the different organ systems: digestive, 4.9 percent; metabolic-nutritional, 4.4 percent; central nervous system, 1.5 percent, skin, 1.1 percent; hemic and lymphatic, 0.9 percent; urogenital, 0.8 percent; body as a whole, 0.5 percent cardiovascular, 0.2 percent; special senses, 0.2 percent; musculoskeletal, 0.1 percent; and respiratory, 0.1 percent. Several patients had more than one reaction. The total incidence of side effects for the treated patients was 9.3 percent. The vast majority of adverse reactions were mild or moderate (94 percent). Serious side effects were reported for 55 patients (6 percent). Based on the 9,473 courses, the incidence of severe reactions was 0.6 percent. Ciprofloxacin treatment was discontinued due to side effects in 146 patients (1.5 percent), mostly due to gastrointestinal reactions (80 patients). The worldwide data from clinical trials with oral ciprofloxacin clearly demonstrate that the drug is relatively safe, and the side effects are usually mild or moderate in intensity and are reversible.

A Prospective Study of Dextran-induced Anaphylactoid Reactions in 5745 Patients

A prospective study of dextran-induced anaphylactoid reactions (DIAR) in 5745 gynaecological and obstetric patients who received dextran 70 solution intravenously while undergoing major surgery revealed 8 patients who had Grade I or II reactions and 7 patients who had Grade III or IV reactions. The incidence of severe reactions was 1:821 patients treated. The overall incidence of reactions per patient treated was 1:383. One neonatal death followed a dextran-induced cardiac arrest in a woman about to undergo caesarean section. The risks of dextran 70 treatment exceeded the risks of thromboembolism in these patients.

Epidemiologic study of insect allergy in children. II. Effect of accidental stings in allergic children

One hundred eighty-one children with non-life-threatening reactions to insect stings and positive venom skin tests were randomized to treatment (53) or no-treatment (128) groups and followed up clinically and immunologically for at least two years to assess the results of accidental stings. Twenty-eight stings in 17 treated patients and 74 stings in 47 untreated children occurred, leading to one mild reaction in a treated patient, and eight in the no-treatment group (P = NS). No reaction was more serious than the original. Based on IgE antibody changes and skin test results, 87% of the untreated children were stung by an insect to which they had clinical sensitivity by skin test. Vespid skin test sensitivity decreased 10-fold or more in both treated (72%) and untreated (44%) children. Of those with increased sensitivity, congruent to 70% had been stung. These data indicate that the incidence of severe reactions on resting is low in insect-allergic children, and that the majority show decreased skin test sensitivity over time.

The current status of reactions to intravenous contrast media.

A prospective 12-month survey in 272 United Kingdom hospitals was performed and data are presented on the incidence of adverse reactions following intravenous urography, contrast CT scanning, and intravenous cholangiography. Minor and intermediate reactions are commonest in young adults, but severe and fatal reactions predominate in the older age group. There is an increased risk of severe reactions in patients with a history of allergy or previous reaction to contrast media and in patients with heart disease. The risk of severe reaction is also increased in certain ethnic groups. There appears to be an association between the incidence of severe reactions and contrast medium dose. Etiology, prevention and treatment of reactions are briefly discussed.

Chemotherapeutic properties of prominent nitrofurans.

Nitrofurazone, nitrofurantoin and furazolidone are rather broad spectrum antimicrobial agents effective against both Gram-positive and Gram-negative bacteria. Nitrofurazone has been found to be effective also against certain trypanosomes and furazolidone against trichomonads and Giardia. Resistance to these nitrofurans develops rather slowly and is seldom complete. In practice, resistance development has not been a significant problem over the many years that these compounds have been in use. Cross-resistance with antibiotics and sulphonamides has not been observed and transferable resistance is at most a very rare phenomenon. The precise mode of action of the nitrofurans has not been elucidated, however, they are known to inhibit the actions of a number of bacterial enzymes. Adverse reactions to these compounds have been observed but the incidence of severe reactions is relatively low. At present nitrofurazone is used primarily as a topical agent, furazolidone as a gastrointestinal agent and nitrofurantoin for infections of the urinary tract. Of the three, nitrofurantoin is currently the one most extensively used in human medicine.

The lymphocyte transformation test and gold hypersensitivity.

TheEmpireRheumatism Council's controlled trial (1960) showedthatgoldsalts benefit patients withrheumatoid arthritis. However, side-effects still occurwiththis treatment despite regular blood counts andurineexaminations and,although the incidence ofsevere reactions hasprobably been reduced bycareful attention tothedoseandnumber ofinjections given, serious haematological complications arestill encountered (Saphir andNey,1966). Itiswidely believed thattoxicity fromgoldtherapy isimmunologically determined, butsofarthere has beenlittle convincing evidence toprovethisassumption. Blast transformation ofperipheral bloodlymphocytes after their exposure invitro toanantigen towhichthedonorhasbecomesensitized hasbeen usedasa testfordrughypersensitivity (Vischer, 1966; Sarkany, 1967). We report hereexperiments inwhichtheperipheral bloodlymphocytes of patients withseveregoldtoxicity responded to invitrochallenge withMyocrisin. Theresults provide direct evidence thatgoldhypersensitivity isimmunologically determined andsuggest apossible methodforpredicting thelikelihood oftoxicity occurring inindividual patients.

ELECTROSHOCK THERAPY WITH THE PHENOTHIAZINES AND RESERPINE: A SURVEY AND REPORT.

Some ten years ago reserpine and the phenothiazines, beginning with chlorpromazine, came into general use altering the structure of psychiatry; the treatment of the psychotic patients and the whole atmosphere of state hospitals undergoing perhaps the most marked changes. To many psychiatrists, particularly those in state hospitals who continue to bear the major responsibility for the treatment of severe psychotic illness, combination treatment with the phenothiazines and the older treatment method, electroshock, has seemed useful. This technique remains controversial. There are two questions at issue: 1) how effective is this combination of EST with the phenothiazines compared with the use of either alone? and 2) how safe is the use of this combination? There is at least the possibility that investigation of the former question is being hampered because of apprehension about the latter question. In 1955 Rogy( 1) reported on the combined use of thorazine and EST noting that there had been no untoward result of any kind. He also expressed the clinical impression that the combination of treatment methods was useful in shortening the duration of illness. Also in 1955 Foster and Gayle(2) in a paper on the combination of EST with reserpine noted a 10% incidence of severe reactions. One of their patients died, the others showing confusion, lethargy and a fall in blood pressure to shock levels which persisted for several hours. They reported that there was no correlation between the amount of reserpine given and the severity of the reaction. F. J. Ayd, Jr. (3) in 1956 reported on a series of 25 patients treated with combined chlorpromazine and EST. His conclusions were that chlorpromazine does not influence the intensity or

"Neurallergic" reaction to intravenous urography.

THIS report concerns a case of severe, nonfatal encephalopathy associated with a systemic allergic reaction occurring after the intravenous administration of sodium diatrizoate (Hypaque).The introduction of materials consisting of a triiodinated benzoic acid nucleus and one or more acylamino radicals was considered an advance in the search for safe contrast mediums.1 The group of compounds that includes acetrizoate (Urokon), diprotrizoate (Miokon) and diatrizoate (Hypaque) have high solubility and relatively low toxicity.2 3 4 5 6 7 However, it has been estimated that there is a 1:500 incidence of severe reactions regardless of which of the newer compounds is used.8 Pendergrass et al.9 reported that . . .