bullos pemphigoid
TRANSCRIPT
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JOURNAL READING
By : Vera Septia Nalurita (2008730129)
Preceptor : dr. Bowo Wahyudi, SpKK
RSUD KOTA BANJAR
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Background
Bullous pemphigus is a chronicdisease characterized by tense bullae
walled, often accompanied by
erythema Bullous pemphigus blistering skin
disease most common in adults
Parents have a low tolerance for oralcorticosteroid regimen
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Purpose
Is topical corticosteroid therapyeffective for both moderate and severe
bullous pemphigoid, and for better oral
corticosteroid therapy for extensivedisease?
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Method
A total of 341 patients with bullouspemphigoid were enrolled in arandomized, multicenter trial andstratified according to the severity of their
disease (moderate or extensive). Patients were randomly assigned to
receive either topical clobetasolpropionate cream (40 g per day) or oral
prednisone (0.5 mg per kilogram of bodyweight per day for those with moderatedisease and 1 mg per kilogram per dayfor those with extensive disease).
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Inclusion criteria
patients with newly diagnosed bullous pemphigoid
were eligible for entry if the following criteria weremet :
Clinical features suggestive of bullous pemphigoid
subepidermal blister on skin biopsy;
and linear deposits of IgG and C3 along thebasement-membrane zone
Exclusion criteria
Exclusion criteria were predominant or exclusivemucosal involvement
Treatment with oral or topical corticosteroids,dapsone, or immunosuppressive drugs during the
previous six months.
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Study Design
This randomized, nonblinded studycompared two parallel groups of patients
treated with topical or oral corticosteroids.
Randomization was stratified according tothe clinical center and the severity of
disease, which was determined on the
basis of the mean number of new bullae
that had appeared daily during the three
previous days
moderate disease was defined by 10 new
bullae daily
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The initial dose was maintained for 15 days
after control of the disease had beenattained. Thereafter, the dose was reducedby 15 percent every 3 weeks. Treatment wasstopped after 12 months
patients who were assigned to receive topicalcorticosteroids received a daily dose of 40 gof clobetasol propionate that was appliedtwice daily on the entire surface of the bodyuntil 15 days after control of the disease had
been attained. The doses were then gradually reduced to
20 g daily for one month, 10 g daily for twomonths, 10 g every other day for four months,
and finally 10 g twice a week for four months
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Statical Analysis
The primary end point was overallsurvival during the first year after theonset of bullous pemphigoid
Secondary end points were control ofthe disease at day 21 :the absence of new bullae for three
consecutive days
no severe side effects occur during thefirst year
cumulative hospital days (including theinitial hospitalization plus all
rehospitalizations).
R lt
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Result
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Among both patients with moderate bullous pemp higoid and patients with
extensive bullous pemphigoid, no significant differences were observed between
patients assigned to receive topical applications of clobetasol propionate cream
and those assigned to receive oral prednisone
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Result
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The corresponding figures among the patients with extensive disease were
44 of the 95 patients in the oral-prednisone group (46 percent; 95 percent
confidence interval, 36 to 56 percent) after a mean interval of 210133 days
and 34 of the 93 patients in the topical-corticosteroid group (37 percent; 95
percent confidence interval, 27 to 46 percent) after a mean interval of187118 days
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Result
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only cases of diabetes requiring insulin were included in the analysis of
severe (grade 3) or life-threatening (grade 4) adverse events.
Data include both clinically apparent fractures and vertebral fractures visible
on radiography
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Result
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Students t-test was used to compare the mean durations of
hospitalization
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Discussion
Systemic corticosteroids have beenconsidered the mainstay of treatment
for bullous pemphigoid for 40 years.
The present study confirms the poorprognosis of patients with bullous
pemphigoid who are treated with 1 mg
of prednisone per kilogram per day,among whom the one-year mortality
rate was 41 percent
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The present study was designed totest the hypothesis that topical
corticosteroids could be an effective
alternative treatment for patients withbullous pemphigoid and would result
in a decrease in the incidence of
severe adverse events Our results clearly demonstrate the
efficacy of clobetasol propionate
cream
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Topical treatments have lower toxicitythan the 1 mg of prednisone per
kilogram per day
Topical corticosteroids should beconsidered as a standard treatment
for patients with extensive bullous
pempigous
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Conclusion
Topical corticosteroid therapy is
effective for both moderate and
severe bullous pemphigoid andis superior to oral corticosteroid
therapy for extensive disease
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