3+ 4/2002 - Společnost pro pojivové tkáně

Demographic and baseline characteristics
(Tabs. 1 and 2): An evaluation of the
demographic data upon entry showed only
negligible differences under studied groups.
Patients groups are comparable with respect
to demographic characteristics and
also with respect to disease characteristics
except for a slight under representation of
patients with gonarthrosis in PCH group
and an overrepresentation of patients with
more than 12 month of previous therapy in
DCF group (Tab. 3).
Treatment efficacy assessment: The
efficacy of treatment was evaluated according
to the functional status of the patients
in their daily lives using n algofunctional
Lequesne Index in the three point scale
(none, moderate, severe) (Lequesne et al.,
1987) as well as by specialized laboratory
tests – urinary pyridinoline (UPD) and
deoxypyridinoline (UDPD), serum bone
alkaline phosphatase (BAP), serum chondrex.
It occurred at screening, baseline
(visit 1), at weeks 4 (visit 2), 8 (visit 3), 12
(visit 4), followed by assessments at week
20 (visit 5) representing post-treatment follow-up
and according to specialised biochemical
tests. Pyridinoline (UPD) and
deoxypyridinoline (UDPD) were determined
in the fasting urine by HPLC (Špaček
et al., 1997), serum bone alkaline phosphatase
(BAP) by ELISA, and the levels of
serum chondrex (YLK 40) (both by kits
from Metra,CA,USA) also by ELISA. In some
patients also serum level of TNFá, Il-1a, Il-8.
Medication: Patients were randomly allocated
to either pharmaceutical collagen
hydrolysate (PCH) (10g a day) – 15 patients,
or to diclofenac (DFC) (75 mg a day) – 13
patients, or to the combination of both the
substances i.e. PCH (10 g a day) and DFC (75
mg a day) – 16 patients. PCH was product of
DGF Stoess, Eberbach, Germany. Double-
blind treatment was carried out for 12 weeks
from visit 2 to visit 5 with one sachet containing
either from the three tested medications
daily for 12 months and followed by an
eight week post-treatment washout.
Efficacy assessment occurred at screening
(baseline visit 1), at weeks 4 (visit 2), 8,
12 (visit 4), followed by assessments at
week 24 (visit 5) representing post-treatment
follow-up. The efficacy of treatment
was evaluated according to the functional
status of the patients in their daily lives
using Lequesne's Index (LI) in the three
point scale (none, moderate, intense) and
according to specialized biochemical tests.
Pyridinoline (UPD) and deoxypyridinoline
(UDPD) were measured in the fasting
urine by HPLC, bone alkaline phosphatase
(BAP) in serum by ELISA, and serum levels
of chondrex (YLK 40) also by ELISA.
Specialised biochemical test: both the
pyridinolines were determined in fasting
urine after hydrolysis and microgranular
cellulose CC31 prefractionation and fluorescence
detection after strong action
HPLC (Špaček et al., 1997). Serum bone
alkaline and chondrex were measured
using specific antibodies (Metra, CA, USA)
by ELISA.
Paracetamol consumption: During the
16 months study patients were allowed to
take paracetamol as rescue medication.
Statistical evaluation of the data was
performed by an independent AAI Deutschland
GmbH, Neu Ulm, Germany in compliance
with Good Statistical Practices
RESULTS
There was an evident difference in early
effect (visit 2) between DFC and PCH
groups according to Lequesne Index (LI) in
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