Clinical Analysis Of 65 Patients With Severe Adverse Drug Reactions

ObjectiveTo analyse the clinical characteristics,treatment and outcome of hospitalized patients with severe adverse drug reactions(SADRs),in order to provide an objective basis for the future diagnosis and treatment of SADRs,and to provide reference ideas for the prevention of SADRs.MethodsThe clinical data of patients with SADRs admitted to Hospital of Shandong Province from January 1,2018 to December 31,2021 were retrospectively analyzed,including disease category,disease age and gender,previous drug allergy history,underlying diseases,suspected allergenic drugs,clinical presentation,laboratory tests,treatment regimen,and prognosis.Results1.Baseline data:Among the 65 SADRs,there were 15 cases of drug reaction with eosinophilia and systemic symptoms(DRESS),12 cases of toxic epidermal necrolysis(TEN),7 cases of severe erythema multiforme(SJS),23 cases of acute generalized exanthematous pustulosis(AGEP),and 8 cases of exfoliative dermatitis(ED).There were 25 male patients and 40 female patients,which with a male to female ratio of 0.38:1.The onset of the SADRs covered the age range of 12-82 years,with a mean age of 48.2±16.8 years.42 patients had a history of underlying disease prior to the onset of the disease.2.Allergenic drugs:A total of 47 patients took single allergenic drugs before onset of the disease,including antibacterial drugs(18.5%),antiepileptic drugs(12.3%),Chinese patent medicines(10.8%),antipyretic and analgesic drugs(9.2%),Chinese herbal medicine(4.6%),other drugs(15.4%),and 18 patients took more than one medicine.3.Incubation period:The incubation period could last from a few hours to a few days.The incubation periods of SADRs subtypes were DRESS(30.1±13.3)days,TEN(9.0±10.3)days,SJS(11.7±9.9)days,AGEP(8.6±12.6)days and ED(7.0±9.7)days respectively,with DRESS patients had a longer incubation period than TEN,AGEP and ED patients,the difference was statistically significant(P<0.05).4.Clinical manifestations:Besides skin damage,more than half of the patients also had hypoproteinemia(70.8%)and hyperthermia(61.5%).There were liver function damage(44.6%),mucosal damage(30.8%)mostly in TEN and SJS patients,infection with skin breaks(26.2%)mostly in TEN and AGEP patients,and lymph node enlargement(20.0%)mostly in DRESS patients.5.Treatment:Patients were divided into 5 groups;Group 1 patients were treated with conventional glucocorticosteroids alone;Group 2 patients were given glucocorticosteroids combined with TNF-α antagonists if they were not effective with glucocorticosteroids alone or could not tolerate the side effects of hormones;Group 3 patients had rapid progression and severe symptoms and were given glucocorticosteroids combined with TNF-α antagonists and IVIG.Group 4 and 5 had milder disease and were treated with TNF-α antagonist or cyclosporine alone.The average duration of skin lesion control for all patients was 8.8±3.0 days and the average length of stay was 16.8±4.4 days.The time to control skin lesions(7.4±1.3 days)and hospital stay(15.6±2.6 days)were lower in group 3 than in group 2(9.5±2.6 days),(18.1 ±5.5 days)(P<0.05).6.There were 58 patients(92.0%)who were cured,3 patients(4.8%)who were not cured,and 2 patients(3.1%)who died.Conclusions1.AGEP is the most common of the serious adverse drug reactions,occurring mainly in patients aged 40 years and above.There are more common female patients than male patients.2.The types of allergenic drugs are varied,with antibacterial drugs accounting for the largest proportion of single allergenic drugs.3.The incubation period varies,with a mean incubation period of 13.5±14.4 days,with DRESS patients having the longest incubation period.4.The clinical manifestations are varied and the common concomitant symptoms include hypoproteinaemia,hyperthermia,liver function damage,mucosal damage,skin infection and lymph node enlargement,with hypoproteinaemia being the most common.5.Glucocorticoids combined with TNF-α antagonists and IVIG are more effective.