Drug Hypersensitivity Quality of Life Questionnaire: validation procedures and first results of the Portuguese version.

BACKGROUND: Hypersensitivity reactions to drugs are unpredictable and can be very complex and severe, even life threatening. Assess its impact on patient's health related quality of life (HRQoL) is crucial. The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the only validated disease-specific HRQoL questionnaire. We aimed to translate and cross-cultural validate the DrHy-Q to the Portuguese population. It was also our purpose to determine the impact of drug hypersensitivity on patients' HRQoL. METHODS: The translation and cross-cultural adaptation of the DrHy-Q to Portuguese was performed according to standards. Reliability of the DrHy-Q Portuguese version was assessed in terms of internal consistency and test-retest reliability. Structural validity, divergent validity (with a generic health related QoLQ-PGWBI) and discriminant validity were also evaluated. Forty patients accepted to participate in the validation phase. The Portuguese version of the DrHy-Q was applied to 260 consecutively adult patients, studied in our Department for suspected drug hypersensitivity. RESULTS: The Portuguese DrHy-Q showed adequate internal consistency (Cronbach's ɑ = 0.938), good test-retest reliability [ICC = 0.713 (95% CI 0.488-0.850] and one-dimensional structure. No significant correlation was found between the DrHy-Q and the PGWBI total scores (r = - 0.010, p = 0.957). Two hundred of patients completed the study: 78.5% female; mean age = 44 ± 15 years. Mean DrHy-Q score was 36.8 ± 12.6. Two clinical factors significantly predict DrHy-Q total score: clinical manifestations and number of suspected drugs. Patients with anaphylaxis (ß = 11.005; 95% CI 5.523; 16.487), urticaria/angioedema (ß = 7.770; 95% CI 2.600; 12.940) and other manifestations (ß = 7.948; 95% CI 1.933; 13.962) are more likely to have higher DrHy-Q total score than patients with maculopapular exanthema. Patients with ≥ 2 suspected drugs are also more likely to have worse QoL (ß = 7.927; 95% CI 3.687; 12.166). CONCLUSION: The Portuguese version of DrHy-Q revealed adequate validity and reliability, indicating that it is appropriate to assess the impact of drug hypersensitivity on patients' HRQoL, providing data for a better comprehension and management of our patients. Moreover, our results highlight that the severity of the drug hypersensitivity reaction and the number of suspected drugs have impact on patient's DrHy-QoL.

Allergy to beta-lactam antibiotics in children: Risk factors for a positive diagnostic work-up

BACKGROUND: Allergy to beta-lactam (BetaL) antibiotics is highly reported in children, but rarely confirmed. Risk factors for a positive diagnostic work-up are scarce. The primary aim was to characterize the cases of children with confirmed BetaL allergy, investigating potential risk factors. Secondary aims were to assess the prevalence of allergy to BetaL in this population and to confirm the safety of less extensive diagnostic protocols for milder reactions. METHODS: We reviewed the clinical data from all children evaluated in our Department for suspected BetaL allergy, over a six-year period. RESULTS: Two hundred and twenty children (53% females) with a mean age of 6.5 ± 4.2 years were evaluated. Cutaneous manifestations were the most frequently reported (96.9%), mainly maculopapular exanthema (MPE). The reactions were non-immediate in 59.5% of the cases. Only 23 children (10.5%) were diagnosed with allergy to βL. The likelihood of BetaL allergy was significantly higher in children with a family history of drug allergy (p < 0.001) and in those with a smaller time period between the reaction and the study (p = 0.046). The probability of not confirming BetaL allergy is greater in children reporting less severe reactions (p < 0.001) and MPE (p < 0.001). We found the less extensive diagnostic protocol in milder reactions safe, since only 4.2% of the children presented a positive provocation test (similar reaction as the index reaction). CONCLUSION: This study highlights family history of drug allergy as a risk factor for a positive diagnostic work-up. Larger series are required, particularly genetic studies to accurately determine future risk for BetaL allergy in children

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Allergy to beta-lactam antibiotics in children: Risk factors for a positive diagnostic work-up.

BACKGROUND: Allergy to beta-lactam (ßL) antibiotics is highly reported in children, but rarely confirmed. Risk factors for a positive diagnostic work-up are scarce. The primary aim was to characterize the cases of children with confirmed ßL allergy, investigating potential risk factors. Secondary aims were to assess the prevalence of allergy to ßL in this population and to confirm the safety of less extensive diagnostic protocols for milder reactions. METHODS: We reviewed the clinical data from all children evaluated in our Department for suspected ßL allergy, over a six-year period. RESULTS: Two hundred and twenty children (53% females) with a mean age of 6.5±4.2 years were evaluated. Cutaneous manifestations were the most frequently reported (96.9%), mainly maculopapular exanthema (MPE). The reactions were non-immediate in 59.5% of the cases. Only 23 children (10.5%) were diagnosed with allergy to ßL. The likelihood of ßL allergy was significantly higher in children with a family history of drug allergy (p<0.001) and in those with a smaller time period between the reaction and the study (p=0.046). The probability of not confirming ßL allergy is greater in children reporting less severe reactions (p<0.001) and MPE (p<0.001). We found the less extensive diagnostic protocol in milder reactions safe, since only 4.2% of the children presented a positive provocation test (similar reaction as the index reaction). CONCLUSION: This study highlights family history of drug allergy as a risk factor for a positive diagnostic work-up. Larger series are required, particularly genetic studies to accurately determine future risk for ßL allergy in children.

An unusual case of delayed-type hypersensitivity to ceftriaxone and meropenem.

Recent studies have demonstrated a low cross-reactivity between ß-lactam antibiotics and carbapenems in IgE-mediated reactions. There are no studies on cross-reactivity of meropenem in patients with non-immediate hypersensitivity to cephalosporins. We describe a case of a 13-year-old male, admitted in Neurosurgery with a severe extradural empyema complicating frontal sinusitis, submitted to an emergent bifrontal craniotomy. A generalized maculopapular exanthema, fever and malaise, appeared by the 7th day of meningeal doses of ceftriaxone, clindamycin and vancomycin. Those were replaced by meropenem, with posterior worsening of the reaction and mucosal involvement. A new scheme with amikacin, metronidazole and linezolid was done with improvement. Skin prick, intradermal and patch tests to penicillins, ceftriaxone and meropenem were negative. Lymphocyte transformation test was positive to ceftriaxone and negative to meropenem.Non-immediate T cell mechanism seems to be involved. Diagnosis work-up couldn't exclude cross-reactivity between ceftriaxone and meropenem.