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J Fernández,1 MJ
Torres,2 J Campos,3 F
Arribas-Poves,3 M Blanca,2 on
behalf of the DAP-Diater group* |
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1Allergy Section, General
University Hospital, UMH, Alicante, Spain
2Allergy Service, Carlos Haya Hospital,
Málaga, Spain
3Research Unit, Diater laboratory, Madrid,
Spain
*V Soriano, P Gamboa, A Vega, T Lobera, S
Millán, L Sánchez, MI Montañez, C Martínez, E Moreno, J
Quiralte, N Blanca-López, R González, MT Audícana, MA
Padial, MJ Barasona, C Colas, M Boquete, B García, and
MC García-Aviles |
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Abstract |
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Background:
Allergy to
penicillin is the
most commonly
reported type of
drug
hypersensitivity.
Diagnosis is
currently confirmed
using skin tests
with
benzylpenicillin
reagents, ie,
penicilloyl-polylysine
(PPL) as the major
determinant of
benzylpenicillin and
benzylpenicillin,
benzylpenicilloate
and benzylpenilloate
as a minor
determinant mixture
(MDM).
Objective: To
synthesize and
assess the
diagnostic capacity
of 2 new
benzylpenicillin
reagents in patients
with immediate
hypersensitivity
reactions to ß-lactams:
benzylpenicilloyl
octa-L-lysine (BP-OL)
as the major
determinant and
benzylpenilloate (penilloate)
as the minor
determinant.
Methods:
Prospective
multicenter clinical
trial performed in
18 Spanish centers.
Efficacy was
assessed by
detection of
positive skin test
results in an
allergic population
and negative skin
test results in a
nonallergic,
drug-exposed
population.
Sensitivity,
specificity, and
negative and
positive predictive
values were
determined.
Results: The
study sample
comprised 94
allergic patients:
31 (35.23%)
presented
anaphylaxis, 4
(4.55%) anaphylactic
shock, 51 (58.04%)
urticaria, and 2
(2.27%) no specific
condition. The
culprit ß-lactams
were amoxicillin in
63 cases (71.60%),
benzypencillin in 14
cases (15.89%),
cephalosporins in 2
cases (2.27%), other
drugs in 3 cases
(3.42%), and
unidentified agents
in 6 cases (6.82%).
The results of
testing with BP-OL
were positive in 46
cases (52.3%); the
results of testing
with penilloate were
positive in 33 cases
(37.5%). When both
reagents were taken
into consideration,
sensitivity reached
61.36% and
specificity 100%.
Skin testing with
penilloate was
significantly more
often negative when
the interval between
the reaction and the
study was longer.
Conclusions:
The sensitivity of
BP-OL and penilloate
was 61%. Considering
that amoxicillin was
the culprit drug in
71% of reactions,
these results
indicate that most
patients were
allergic to the
whole group of
penicillins. These
data support the use
of benzylpenicillin
determinants in the
diagnosis of allergy
to ß-lactams, even
in predominantly
amoxicillin-allergic
populations.
Key words:
Hypersensitivity. ß-Lactams.
Penicillin
determinants. Skin
tests. Clinical
trial. |
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