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Clinical study of the efficacy
of and tolerance to seaprose S in inflammatory venous disease.
Controlled study versus serratio-peptidase
Bracale G, Selvetella L.
Minerva Cardioangiol. 1996 Oct;44(10):515-24.
Divisione di Chirurgia Vascolare, Universita degli Studi
di Napoli, Federico II. |
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This study was designed to compare the efficacy and safety
of seaprose S and serratio-peptidase in the treatment of
venous inflammatory disease. Forty patients entered the study
(11 males, 29 females), mean age 54.3 years (range 30-77),
mean weight 74.8 kg (range 51-96), with superficial thrombophlebitis.
The trial was conducted following a controlled, between patients,
randomized experimental design. Seaprose S was administered
as 30 mg tablets at a daily dosage of 90 mg (one tab t.i.d.),
and serratio-peptidase as 5 mg tablets, at a dose of 30 mg
per day (two tabs t.i.d.), both orally, for 14 days. Twenty
patients received seaprose S and 20 serratio-peptidase. The
findings indicate that seaprose S was more effective and
better tolerated than serratio-peptidase. Although the group
of patients assigned to seaprose S had considerably more
severe initial symptoms, by the end of treatment spontaneous
pain was reduced 68.7% from the baseline mean score (from
3.2 to 1.0), as compared with a 63.3% reduction in the serratio-peptidase
group (from 3.0 to 1.1). Pain on pressure was reduced 61.1%
with seaprose S (from 3.6 to 1.4), compared to 57.6% with
the reference treatment (from 3.3 to 1.4). Edema was reduced
respectively 75% (from 1.6 to 0.4) and 56.2% (from 1.6 to
0.7); erythema diminished 72.4% (from 2.9 to 0.8) and 58.3%
(from 2.4 to 1.0); nighttime cramps were 61.1% less (from
1.8 to 0.7) compared with 52.9% (from 1.7 to 0.8); hemorrhagic
suffusion was 53.3% less (from 1.5 to 0.7) compared with
41.7% (from 1.2 to 0.7); cutaneous dystrophy was reduced
by 11.1% (from 1.8 to 1.6) and 7.7% (from 1.3 to 1.2). At
the end of the treatment with seaprose S efficacy was assessed
as good or excellent in 85% of the cases, compared with 65%
for serratio-peptidase. Seaprose S caused no adverse reactions.
During serratio-peptidase treatment one patient reported
diarrhea, requiring temporary dosage reduction and specific
treatment. It can thus be confirmed that seaprose S was effective
and well tolerated in patients with inflammatory venous diseases.
Publication Types:
• Clinical Trial
• Randomized Controlled Trial |
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