Aplicación de colágeno inyectable en gonartrosis

1. PHYSIOLOGICAL REGULATING MEDICINE 2012
37
OBJECTIVE
This study has been planned to investigate the effectiveness of
collagen injections of GUNA MD-KNEE + GUNA MD-MATRIX
on pain and daily functioning in symptomatic knee osteoarthri-
tis III-IV X-ray stages by Kellgren.
High frequencyultrasonographyis an approved imagingtechnique
for diagnosis of joint swelling and monitoring of the therapy.
METHODS
We studied 25 patients aged between 62 and 79.
Inclusion and exclusion criteria are presented in TAB. 1.
were performed. All patients had sonographic examination of
both knees with Mindray M5 (China) scanner with multi-fre-
quency linear transducer (7.5-10 MHz) at beginning and 30
days after completion of the treatment. We applied a combina-
tion of GUNA MD-Knee and GUNA MD-Matrix periarticu-
larly, 10 ampoules in the following scheme: during the first 2
weeks - 2 applications per week; during the next 6 weeks - 1
application per week in a single course of treatment 8 weeks.
STATISTICAL ANALYSIS
For the statistical processing of data and building graphics it
was used the package IBM SPSS Statistics 19.
We used descriptive statistics and analysis with repeated obser-
vations (Repeated Measures Analysis).
RESULTS
– 10-point VAS
Theaveragescorefor pain at rest decreased threefold at theend
of treatment course /60 day/, the effect is maintained after
treatment (FIG. 1). The mean score for pain on movement
decreased almost twice at the end of treatment and continued
to decrease 30 days after completion of the course (FIG. 2).
All patients are clinically evaluated by joint assessment, as well
as by standard X-Ray and Ultrasonography of the knee.
Questionnaires completed by the patients before treatment,
60th and 90th day evaluation of pain at rest using a 10-point
visual analog scale /VAS/,pain assessment during movement of
the knee in 10-point VAS, assessment of the Lequesne Index on
Gonarthrosis /algo-functional index/ and evaluation of the effi-
cacy of the treatment according to the patient and the physician
R. Nestorova, R. Rashkov,
V. Reshkova, N. Kapandjieva
EFFICIENCY OF COLLAGEN INJECTIONS OF
GUNA MD IN PATIENTS WITH GONARTHROSIS,
ASSESSED CLINICALLY AND BY ULTRASOUNDS
SHORTCOMMUNICATION
INCLUSION CRITERIA
1. Gonarthrosis III-IV X-ray of
Kellgren
2. Joint swelling,
sonographically proven
3. VAS of pain > 25 mm
4. AFI of Lequesne > 7
EXCLUSION CRITERIA
1. Inflammatory joint diseases
2. Аutoimmune diseases
3. Gout
4. Malignant diseases
5. Previous trauma or surgical
intervention of the knee
6. Concomitant
chondroprotectives
7. Supporting physiotherapy
Avaragescore(1-10)
Pain at rest
,0
1,0
visit 1 visit 2 visit 3
2,0
3,0
4,0
3,28
1,44
1,16
Avaragescore(1-10)
Pain movement
,0
2,0
visit 1 visit 2 visit 3
4,0
6,0
8,0
7,32
4,32
3,0
FIG. 1
TAB. 1
FIG. 2
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2. 38
PHYSIOLOGICAL REGULATING MEDICINE 2012
– Algo-functional index of Lequesne
We observed improvements in all indicators of the index, but
most significant are as follows:
– Morning stiffness decreased more than twice at the end of
the course and the effect remained 30 days after therapy (FIG. 3).
– Average score of pain on standing was reduced threefold in
the third visit - 90 days from the beginning (FIG. 4).
– The mean assess for pain during walking decreased 1.5
times at the third visit compared with baseline (FIG. 5).
– The average score for the maximum walking distance was
reduced 1.5 times at the third visit compared with baseline.
This means that the actual distance that the patient can walk,
thanks to GUNA MD-Knee and GUNA MD-Matrix, increased
about 1.5 times (FIG. 6).
– There were no side effects of application of collagen
injections.
– Joint swelling, sonographically assessed:
We present some of the sonographic images of the knee prior
to treatment with GUNA MD-Knee and GUNA MD-Matrix
and 30 days thereafter (FIGG. 7a, b; 8a, b).
Sonographic evaluation of swelling of the knee joint 30 days
after treatment with the combination GUNA MD-Knee and
GUNA MD-Matrix shows that 60% of the patients were with-
out edema, and 30%were with reduction of swelling (FIG.9).
Avaragescore(0-2)
Morning stiffness
,0
,2
,4
visit 1 visit 2 visit 3
,6
1,0
,8
1,2
1,08
,56
,44
FIG. 3
Avaragescore(0-1)
Pain on standing
,0
,2
visit 1 visit 2 visit 3
,4
,6
,8 ,76
,44
,24
FIG. 4
Avaragescore(0-2)
Pain during walking
,0
,5
visit 1 visit 2 visit 3
1,0
1,5
2,0
1,76
1,24
1,08
FIG.5
Maximum walking distance
,0
10
visit 1 visit 2 visit 3
3,0
5,0
4,0
2,0
6,0
5,32
3,88
3,56
Avaragescore(0-8)
FIG. 6
Visit 3 - efficacy (patient)
,0
10,0
20,0
30,0
40,0
Percent
40,0%
28,0%
24,0%
8,0%
Very good Good Medium No efficacy
FIG.10
Visit 3 - efficacy (doctor)
,0
10,0
Very good Good Medium No efficacy
20,0
30,0
40,0
Percent
40,0%
32,0%
20,0%
8,0%
FIG. 11
Fig. 7 a
Suprapatellar
bursa was
enlarged and
swollen before
treatment.
Fig. 7 b
Marked
reduction of
swelling after
treatment.
Fig. 8 a
Swelling of
the joint
space /lateral
access/ prior to
treatment.
Fig. 8 b
Lack of edema
after treatment.
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3. 39
PHYSIOLOGICAL REGULATING MEDICINE 2012
Efficacy of treatment according to patient and physician
Assessment of the patient and the physician of the efficacy of
treatment with injectablecollagen GUNA MDs on the60th and
90th day matches, with the highest percentage is the highest
rating, namely “very good”.
FIG.10 and FIG.11 showthe effect of treatment at visit 3 /90 day/.
68%of the evaluations of patients and 72%of doctors’ assess-
ments of the efficacy of treatment are “very good” and “good”.
CONCLUSIONS
1. Periarticular administration of GUNA MD-Knee and
GUNA MD-Matrix in Gonarthrosis III-IV X-Ray stage
improves the status of the knee and thus improves the qual-
ity of life of patients due to:
* Statistically significant reduction in pain at rest and pain
on movement.
*Statistically significant improvement in all indicators of the
algo-functional Index of Lequesne.
* Improvement in swollen syndrome in 90%, sonographi-
cally proven.
2. The effectiveness of GUNA MDs continues after stopping
treatment.
3. The products have a very good safety profile.
4. 68% of the evaluations of patients and 72% of the evalua-
tions of physicians on efficacy of the treatment have been
defined as “very good” and “good”.
5. Arthrosonography remains a proven technique for joint
swelling assessment and monitoring of the therapy. í
Abstract presented at the
9th
Central European Congress of Rheumatology (CECR 2012)
3rd
Annual Meeting of the Polish Rheumatologists
1st
- 3rd
September 2012, Kracow - Poland
First author
Dr. R. Nestorova, MD
– Rheumatology Centre St. Irina
Sofia, Bulgaria
60%
30%
10%
Without edema
With reduction
No change
FIG. 9
Influence of joint
swelling
estimated by
ultrasounds.
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