Læknablaðið : fylgirit - 01.05.1978, Page 56

Anna-Liisa Makela
Department of Paediatrics, Turku University
Hospital, Turku, Finland.
In a long term double-blind crossover study
the effect of naproxen was compared to that of
acetosalicylic acid in 15 patients with juvenile
rheumatoid arthritis.
The salicylate preparation employed in this
test was MagnesylR, (ACO Lakemedel AB).
The age of the children with JRA varied
from 7 to 15 years. There were 13 girls and
2 boys. The duration of the disease was six
years, on an average, the range being from 1
to 10 years.
(Table 1) The dose of naproxen was 80 mg
twice daily, the mean daily dose per kg of body
weight being 6,5 mg (range from 4 to 10 mg/kg).
The noon dose was á placebo.
The dose of acetosalicylic acid was 500 mg
three times daily, the mean daily dose being
62 mg/kg of body weight (range 35-95 mg/kg).
Each of the two drugs were outlined to be
given during 8 weeks the duration of the whole
trial being designed as 4 months.
The patients were evaluated for drug efficacy
and toxicity every second week at the out-patient
department. At every visit the following
measurements were made: the number of active
inflammed joints, the range of joint movements,
TABLE 1.
DOSAGE OF THE DRUGS:
NAPROXEN 2 x 80 mg/day
Mean daily dose : 6 , 5 mg/kg
of body weight : (range 4-10 mg/kg/day)
MAGNESYL^) : 3 x 500 mg
Mean daily dose : 62 mg/kg i
of body weight (range 35 - 95 mg/kg/day)
A DOUBLE-BLIND CROSS-OVER
STUDY OF NAPROXEN AND
ASPIRIN IN PATIENTS WITH
JUVENILE RHEUMATOID
ARTHRITIS
the duration of morning stiffness, fever, and the
possible side effects. Sedimentation rate, Hb,
WBC and urine analysis were controlled at each
visit. Serum transaminases, protrombin test
and bleeding time were controlled in the beginning
and after 8 and 16 weeks.
The results of the clinical evaluation are seen
in Table 2.
The average pre-trial figures are compared
with those at the end of the naproxen-phase and
correspondingly with those at the end of the
salicylate-phase.
As compared with the corresponding pre-trial
figure, the mean number of actively inflamed
joints is clearly decreased at the end of the
naproxen-phase. During salicylate treatment
this number is even increased.
These differences are favourable to naproxen,
though no statistical significance could be found
owing to great deviations.
After the period with salicylate treatment,
there were more new inflamed joints than after
the naproxen-period.
The average duration of morning stiffness was
clearly shorter in both groups, naproxen- and
salicylate, than before the test.
The average sedimentation rate and Hb showed
no significant differences between the two groups
or the pre-trial values.
The final drug preferences expressed by each
patient, and as judged by the investigator are
shown in Tabel 3. Eight patients preferred
naproxen, 3 preferred Magnesyl, and one evalu-
ated the drugs as equally efficient. In the final
clinical evaluation naproxen was best in 10
patients, Magnesyl in one and in one patient
there were no definite differences between the
two drugs.
Three patients dropped out of the study due to
the highly active rheumatic disease. Two of
these patients discontinued both periods of the
tests already after a few days owing to the poor
control of joint symptoms.
One patient, who previously had been treated
with naproxen, showed a clear relapse, when
naproxen treatment was replaced by Magnesyl.
The trial was discontinued, and the patient
clearly improved, when naproxen treatment was
resumed.
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