Rheumatoid Arthritis
|
As you may know, rheumatoid
arthritis (often called RA) is a chronic systemic
inflammatory disorder that primarily attacks the joints –
although other tissues may be inflamed as well. Rheumatoid
arthritis is an autoimmune disease, so it is often treated
with high dosages of steroid hormones or other powerful
drugs like methotrexate, or gold salts, or high dosage
NSAIDs. Because rheumatoid arthritis is an autoimmune disease there are increased amounts antibodies, such as Rheumatoid Factor and IgG-RF. This can result in increased circulating immune complexes, which, as we mentioned earlier, are quite pro-inflammatory. We also see increased levels of proinflammatory cytokines such as TFN-alpha (tissue necrosis factor – which, as the name implies, promotes destruction of tissue).As you would expect, there are also increased levels of C-reactive protein. In contrast to osteoarthritis – which is a degenerative process, rheumatoid arthritis is an actively destructive process. From FREQUENTLY ASKED QUESTIONS, with answers by Joseph J Collins, RN, ND Read the special section: JOINT PAIN & WOBENZYM® |
What the literature says about Systemic Enzyme Support and:
Wobenzym in therapy of rheumatoid arthritis
Guseinov N.I. Wobenzym in therapy of rheumatoid arthritis.
International Journal on Immunorehabilitation 2001, Vol. 3, No. 2,
pp. 73-74.
By
now there are no precise indication to select basic preparations
while treating rheumatoid arthritis (RA). The basic treatment of RA
is limited by the risk of adverse drug reactions. There are no
non-toxic basic preparations for this purpose except of polyenzyme
preparations.
74
patients with RA underwent ínvestigation. Group I (n=40) received
Wobenzym 30 tablets daily during the first month, then 15 tablets
daily for a long-term treatment. Group II (n=34) received Tauredon
as basic therapy in a standard way: 1 week, 10 mg/day; 2 week, 20
mg/day, 3 week, 50 mg/day, 4 week till the 20 week 50 mg/day. In
both groups, non-steroid anti-inflammatory drugs were administered
additionally as basic therapy (150-200 mg/day). Both groups were
comparatively equal in clinical-laboratory characteristics. The
influence of basic therapy on the evolution of joint syndrome was
studied in the dynamics of clinical and laboratory indicators. Our
results showed that the defínite signs of RA remission appear at the
end of the first month in t group 1 and in the group II at the 3-4
months. The dose of non-steroid anti-inflammatory drugs was reduced,
respectively. This confirms the literature data on the basic
properties of Wobenzym therapy.
Poster Reference Number 66.
The
results of long-term use of Wobenzym in complex management of
rheumatoid arthritis.
Shalamberidze L., Kartvelishvili E., Astvatsaturova T. The results
of long-term use of Wobenzym in complex management of rheumatoid
arthritis. International congress "Advances in Immunology and
Allergology at the Treshold of the XXI Century" May 3-6, 2000, Eilat,
Israel. [Czech]
Open controlled one year study of 60 patients with confirmed
diagnosis of rheumatoid arthritis was conducted. Of those 30
received 7 tablets of Wobenzym (Mucos Pharma, Germany) three times a
day (group 1), another 30 patients received a weekly dose of 7.5 mg
of Methotrexate (group2) (control). The both groups were matched by
sex, age, clinical and laboratory data. The majority of the patients
in both groups also received Diclofenac (100-150 mg/day), while some
patients received the daily dose of 7.5-10 mg Prednisolone. The
universally accepted clinical and laboratory indices were assessed
before the treatment 3, 6, 9 months after the beginning and on
completion of the therapy.
The
onset of therapeutic effect (diminishing of the pain intensity,
morning rigidity, Ritchi's index, inflammatory and immune activity
etc.) in cases of complex management with Wobenzym was observed as
early as 1-2 months after the beginning of the therapy, while in the
control group the same effect was observed only after 3-4 months. In
the course of the study the medicine was withdrawn in 8 patients
(26.6%) of the group 1 and in 7 patients (23.3%) of the control
group because of its inefficiency. Besides, in 4 patients of the
control group Methotrexate was withdrawn due to side effects. In the
majority of patients of the both groups who endured the one year
course of therapy no X-ray and ultrasonographically confirmed
progress of the above pathology was observed.
Poster Reference Number 67.
The
Efficacy of Systemic Enzyme Therapy in the Treatment of Rheumatoid
Arthritis.
Mazourov V.I., Lila A.M., Klimko N.N., Raimuev K.V, Makulova T.G.
The Efficacy of Systemic Enzyme Therapy in the Treatment of
Rheumatoid Arthritis. Inter. Journal of Immunotherapy 1997, Vol.
XIII, No. 3/4, pp. 85-91.
Summary
A
total of 156 patients with rheumatoid arthritis were enrolled in a
clinical study on safety and efficacy of oral enzyme therapy in a
treatment involving methotrexate and NSAID. One group (n=65)
received methotrexate at a dose of 7.5-10 mg/week and NSAID, while
the second group (n=91) additionally received an oral enzyme
combination preparation (Wobenzym®) in a daily dosage of 15-30
dragées. The group taking enzymes showed superior efficacy in the
therapy with regard to Ritchie Index (improvement: 10.7 points in
group one versus 14.4 points in group two), morning stiffness
(improvement: 49.6 minutes in group one versus 92.0 minutes in group
two), and Lee Index (improvement: 4.2 points in group one versus 5.7
in group two). Laboratory findings showed a decrease in circulating
immune complexes by 30.3 % in group one and 42.2% in group two at
the end of therapy. These beneficial effects of combining oral
enzyme therapy with standard therapy in rheumatoid arthritis are
supported by several findings in the immunological laboratory. The
serum concentrations of interferons were reduced after 6 months of
therapy in the enzyme group to almost normal values as compared to
two to three times higher values in the control group. The
stimulated interferon production was about 70% (IFN-a), and 90%
(IFN-g) increased after treatment in the enzyme group (about 20% and
30% respectively in the control group).
In
addition, serum levels of proinflammatory cytokines (IL-1b and
TNF-a) were significantly more reduced in the enzyme group than in
the control group (control versus enzyme group IL-1b: -4.1 pg/ml
versus -10.3 pg/ml; TNF-a: -75.1 pg/ml versus -179.5 pg/ml).
Poster Reference Number 68.
Pain Reduction in Rheumatic Diseases by Oral Therapy with Enzymes.
Klein G., Kullich W. Pain Reduction in Rheumatic Diseases by Oral
Therapy with Enzymes. Wien. Med. Wschr. 1999, 149, pp. 577-580.
Summary
Proteolytic enzymes have analgesic effects, besides the well known
antiinflammatory and edema-reducing properties. These analgesic
effects are based on the inhibition of inflammation and in addition
to that on direct influences on the nociceptors. All that explains
the therapeutical effects of such enzymes in degenerative-rheumatic
and soft tissue rheumatic diseases in which inflammatory or
immunologic processes are not in the forefront. In recent years a
significant reduction of pain in various rheumatic diseases,
concerning these aspects, was shown in several clinical studies. The
clinical trial in patients with periarthritis of shoulder showed
statistical equivalence of pain reduction, whether they were treated
with Phlogenzym or diclofenac. Likewise in the trial of patients
suffering from painful osteoarthritis of the knee, there was a
statistical equivalence of the pain-scores, comparing diclofenac and
enzymes. The study of painful vertebral-syndromes again resulted in
equivalence of the treatment with NSAIDs compared to therapy with
enzymes.
Our
experience with Wobenzym in the treatment of patients with
rheumatoid and psoriatic arthritis.
Szilasiová A., Macejová Ž., Jautová J., Pundová L. Our experience
with Wobenzym in the treatment of patients with rheumatoid and
psoriatic arthritis. Prakt. Lékař 1998, Vol. 78, No. 7, pp.
366-368.
Summary
The
objective of the uncontrolled trial was to assess the tolerance and
safety of the preparation Wobenzym in patients with rheumatoid and
psoriatic arthritis who had other concurrent anti-inflammatory
treatment and to evaluate its position in combined treatment of RA
and PsA. The authors added Wobenzym, 9 to 15 enterosolvent pills per
day to anti-inflammatory antirheumatic treatment in 23 patients with
RA and 4 patients with PsA because of persisting clinical and
laboratory activity. Treatment lasted 16 weeks and more. The
evaluation of the effectiveness of Wobenzym by the physician was as
follows: very good 33.3 %, good 54.3 % and unsatisfactory 12.4 %.
The evaluation of physical capacity by the patients was as follows:
18 patients (75 %) reported a better physical capacity after
Wobenzym and only 25 % (6) had the same physical capacity. There was
no case of deterioration. When evaluating clinical parameters, the
authors found after four months of treatment a decline of the
morning stiffness (p < 0.01) and a better grip strength (p < 0.05),
reduced articular index and index of incapacity according to HAQ,
which however was not statistically significant. The authors
recorded a decline of FW the CRP and CIK concentration (p < 0.01).
The concentration of alpha-2 macroglobulin, alpha-1 antitrypsin,
haemoglobin and amylase values did not change significantly during
treatment. The trial confirmed the favourable effect of Wobenzym on
the rheumatic process, good tolerance and safety of treatment in
patients with rheumatoid diseases even in case of polytherapy.
Clinical and immunological criteria of activity of different
rheumatic arthritis courses and their treatment by Wobenzym.
Siziakina L.P., Artemenko N.A. Clinical and immunological criteria
of activity of different rheumatic arthritis courses and their
treatment by Wobenzym. III. Internat. Congress on
Immunorehabilitation and Rehabilitation in Medicine, Eilat, Israel,
1997.
Rheumatic arthritis (RA) is a chronical disease, its pathogenesity
includes deep immune system disorders with a disbalance of
qualitative and quantitative composition of immunocompetent cells
including functional and cell cooperation disorders (8). Joint
damage is the most obvious syndrom of rheumatic arthritis. But other
symptoms than joint damage mostly determine an aggressivity of the
disease and its prognosis. Role and place of different components of
inflammation immune complex in a rheumatic arthritis process
development is beeing currently discussed. A progresive character of
the disease with a formation of irreversible joint and inner organ
damage, an early invalidity of patients, and a decrease of working
ability define a medical and social importance of this problem as
well as a necessity of continuing study of clinical-pathogenetic
peculiarities of rheumatic arthritis and a search for optimal
treatment program.
An
important role in a rheumatic arthritis diagnosis plays a
determination of IgG-RF (rheumatic factor) which seems to be an
autoantibody against IgG fragment (6). Both an existence of serum
negative variant of rheumatic factor and its detection in other
rheumatic and nonrheumatic diseases determine a necessity to
investigate RA serological markers, for example antibodies against
cardiolipins (aCL), associated with thromboses during rheumatic
diseases, and antibody against native DNA (n-DNA) determining a
formation of immunopathological component.
In
many cases a rheumatic arthritis course is complicated by systemic
symptoms which cause a development of pathological process (3, 13).
Various changes in rheological properties of blood during rheumatic
arthritis cause damages of microcirculation and seem to be one of
the factors which make the disease become chronic (2, 20).
Despite of different clinical symptoms of thrombohemorragical
syndrom and expression of damages of rheological, coagulational, and
fibrinolytical properties of blood (2, 3, 7), the most important way
to diagnose changes in microcirculation is the use of immunological
methods.
Such methods include determination of antigen factor van Billebrand
(FB) in blood plasma. FB is a macromolecular protein synthesized by
the vascular endothelium cells which define a function of
thrombocytes (TC) and an activity of VIII. coagulating factor
structural part of which FB makes (7).
Except this, investigation of new pathogenetic mechanisms of a
rheumatic arthritis formation, insufficient efficacy of existing
preparations for treatment, and serious side effects (treatment by
corticosteroids, nonsteroidal antirheumatic substances, cytostatics)
show a need for new treatment methods of different types of
rheumatic arthritis.
45
patients (9 men, 36 women) with reliable rheumatic arthritis
(criteria of American Rheumatological Association, 1987) were
observed. An average age was 46.9 (from 23 to 76) years. 38 patients
were serum positive on IgM-RF and 7 were serum negative. 5 patients
showed activity of rheumatic arthritis corresponding to degree I, 24
patients to degree II and 16 patients to degree III.
Confirmation of diagnosis by X-ray for all patients is available
(Table 1).
In
28 patients syndroms such as fever, rheumatic nodes, amiotrophic
syndrom, damage of cardiovascular system, digestive system and
others occured.In some cases concomitant diseases appeared:
tuberculosis - 1, malignant tumors - 1, diabetes - 1, periodical
illness - 1.
During clinical observations of patients joint index, oedema index,
joint sum (by Richi), functional test by Li and an intensity of hand
clasp (mm.rt.st) were followed.
All
patients were subjected to a general clinical observation and also
basic signs of immunological statute (9) were observed. Using IFA a
titer of antibody against n-DNA was determined. IgM-RF and a
presence of antibody against cardiolipins and antigen factor von
Billebrand (FB) were determined in patients’ serum (test of the
“AGAB” system, Moscow).
Wobenzym (Mucos Pharma) was administred together with methotrexate
15mg on Sunday; 10 dragees three times a day, 40 minutes before
meals - 15 days, then 7 dragees three times a day - 15 days,
followed by 5 dragees three times a day - 30 days. To observe an
efficacy of the preparation, a group of 8 people (serum positive,
joint form) was established. Control group included 9 people treated
with nonsteroidal antirheumatic substances and methotrexate (15 mg).
Results were evaluated statistically using nonparametrical criterium
by Mann-Whitney.Observed group included 38 patients (84.4%),
positive on IgM-RF, and 7 (15.6%) serum negative patients.
Comparison of clinical signs in both groups showed an absence of
significant differences (Table II). In serum negative group
dominated patients with inner organ damage 85.7%, in serum positive
group inner organ damage occured in 57.9% patients.
Presence of antibodies against cardiolipins was tested in serum
positive group.
A
positive result was obtained in 24 patients (63.2%). In 17 patients
(70.8%) inner organ damage developed and only in 7 patients (29.2%)
joint form of rheumatic arthritis was diagnosed.
| Signs | Number of serum positive patients |
Number of serum negative patients |
Total number of patients |
|
Sex M F |
8 30 |
1 6 |
9 36 |
|
Age 0-40 40-60 more than 60 |
14 17 7 |
1 4 2 |
15 21 9 |
|
Degree of activity I II III |
5 19 14 |
- 5 2 |
5 24 16 |
|
Functional I insufficiency II of joints III IV |
14 17 7 - |
- 4 3 - |
14 21 10 - |
|
X-ray stadium I II III IV |
4 23 5 6 |
- 2 4 1 |
4 25 9 7 |
|
Form joint with inner organ damage |
16 22 |
1 6 |
17 28 |
Table II Basic clinical signs of joint syndrome
| Signs | Serum positive patients | Serum negative patients |
| Joint index by Richi | 25.9 + 0.12* | 24 + 0.69* |
| Joint sum by Richi | 25.9 + 0.13* | 24.1 + 0.7* |
| Oedema index by Richi | 26.2 + 0.13 | 26.6 + 0.74 |
| Functional index by Li | 13.4 + 0.10* | 16.4 + 0.58* |
| Intensity of a hand clasp R (mm.rt.st.) L |
97.5 + 0.26* 85.7 + 0.24* |
85.0 + 1.32* 66.4 + 1.16* |
* -
statistically significant differences p< 0.05 as compared to control
A
degree of autoimmune process activity can be derived from a titer of
antibody against n-DNA. Among serum positive patients antibody
against n-DNA was detected in 22 patients (57.9%) - 8 (36.4%) with
the joint form and 14 (63.6%) with the inner organ damage.
In
the serum negative group aCL were detected in 85.7% of patients
(83.3% with the inner organ damage and only 16.7% of patients with
the joint form of rheumatic arthritis).
Among observed patients antibody against n-DNA was detected in 4
patients (57.1%). Interestingly, all of them had a rheumatic
arthritis with inner organ damage (Table III).
| Groups | Signs of immunological statute | |||
|---|---|---|---|---|
|
Sedimentation mm/hour |
CIC |
Titer of antibody against n-DNA, lg |
aCL % |
|
|
Serum positive (IgM - RF (+)) |
28.8 + 0.14* | 119.2 + 0.29* | 1.68 | 63.16 |
|
Serum negative (IgM - RF (-)) |
33.0 + 0.82* | 81.0 + 1.29* | 1.34 | 85.7 |
* - statistically significant differences p< 0.05
From obtained results it can be concluded that aCL occur in
rheumatic arthritis patients sufficiantly frequently - in 66.7% of
cases. In patients with inner organ damage aCL were detected more
often - in 73.3%. In the groups of serum negative and serum positive
patients on IgM -RF, aCL occured with the same frequency - in 83.3%
and 70.8%, respectively (Figure 1).
Figure 1: Frequency of an aCL occurance in patients with rheumatic
arthritis with different courses.
Serum negativity on IgM-RF does not presume a favourable course of
rheumatic arthritis with a high titer of antibody against n-DNA,
high value of CIC and a presence of aCL. Additionally, in such cases
a positivity on IgG or IgA-RF is possible.
Clinical sign analysis of rheumatic arthritis patients, administred
with methotrexate and Wobenzym, gave following results. In patients
treated with Wobenzym a faster reduction of joint swelling,
reduction of a degree of morning tightness and a lessening of Li
index was observed compared to a control group (Figure 2).
Analysis of immunological statute signs showed that in patients
treated with Wobenzym a more significant lessening of IgM level
occured as well as a faster normalization of sedimentation.
CIC
degree remained higher ( Figure 2).
A
faster clinical and immunological remission in patients treated with
Wobenzym and methotrexate enabled to lessen a dosage of methotrexate
to 7.5 mg. Two patients voluntarily gave up on methotrexate. During
next three months an activation of pathological process did not
occur. In the case of one patient an effect of Wobenzym treatment
was negligible, glucocorticoids were therefore administred.
Comparison of a treatment efficacy in Wobenzym group and a control
group is shown in Figure 3.
Figure 2: Signs of immunological statute in RA patients treated with
and without Wobenzym.
Figure 3: Effect of Wobenzym in the rheumatic arthritis treatment.
With regard to a higher CIC values after Wobenzym administration it
is necessary to include a plasmapheresis during first month of
treatment.Based on all above mentioned facts it can be concluded
that a presence of antibodies against cardiolipins and n-DNA is
associated with inner organ damage at IgM-RF serum positive and
serum negative rheumatic arthritis. Rheumatic arthritis with inner
organ damage, accompanied with an increased titer of antibody
against n-DNA, CIC level and a presence of an antibody against
cardiolipins, is considered a unfavourable course which needs a
therapy improvement.
An
increase of n-DNA antibody titer, CIC level and a presence of
antibodies against cardiolipins appear to be a more informative
signs of an autoimmune process activity in comparison to general
clinical observations. Therefore, it is suggested to use these
immunological tests for prognosis of a disease course and for
control of the therapy efficacy.
Poster Reference Number 71.
New
possibilities of basic therapy in patients with rheumatoid arthritis
on the basis of systemic enzyme therapy.
Kovalenko V.M., Golovkov Y.Z. New possibilities of basic therapy in
patients with rheumatoid arthritis on the basis of systemic enzyme
therapy. Reumatologia 1998, Suppl Vol. XXXVI, Warsaw 1998, Lectures
No. 212, pp 110-111
Wobenzym (Mucos Pharma, Germany) and NSAIDs (Diclofenac-Sodium) were
used in the 2 years-treatment of 15 rheumatoid arthritis (RA)
patients, aged 20-55 years, all of them with III disease activity
grade, X-ray stage II (Wobenzym group). The average duration of the
disease was 1 to 10 years. 8 patients have been earlier treated by
different medication. However, this treatment was found ineffective
and further intake of this medication was, therefore,
stopped.Control group included 20 patients which received a gold
derivate Tauredon as a basic medication (intramuscularly, usual
administration scheme). Both groups were comparable by the age, sex,
and the main clinical and laboratory parameters.
At
the beginning of the treatment corticosteroid hormones at the dose
of 60-120 mg were intravenously administered (3-6 injections) to the
patients in both groups with high grades of the disease activity.
Patients received Wobenzym at the dose of 7-10 tablets 3x daily for
2-4 weeks and 150-200 mg of Diclofenac-Sodium daily at the beginning
of the treatment. When a clear disease activity decrease was
observed, the dose level of Diclofenac was reduced to 75-100 mg a
day, while that of Wobenzym to 5 tablets 3 times a day. After the
achievement of apparent clinical remission, patients continued a
supporting treatment by Wobenzym at the dose of 25-75 mg daily.
Widely used criteria of RA patient's clinical and laboratory state
were analyzed.
First clear signs of RA remission appeared in the first (Wobenzym)
group after 2-3 months in comparison to 3-4 months in control group.
By the 6th month of treatment the apparent clinical remission was
achieved in 80% of patients in Wobenzym group and in about 70% of
patients in control group. During second year of observation, an
exacerbation of the disease was seen in 2 patients. They were,
therefore, additionally treated with Methotrexate.
As
evidenced by the data presented, Wobenzym can be successfully used
in the treatment of RA. Systemic enzyme therapy can be combined with
corticosteroids, cytostatic immunosuppressors, gold derivates, and
NSAIDs.
Wogenzym® in the Treatment of Patients with Juvenile Chronic
Arthritis.
Shaivok A.V., Movsisyan G.R., Stolyarova A.V. Wogenzym® in the
Treatment of Patients with Juvenile Chronic Arthritis. INt. J.
Immunotherapy XIII(3/4) 93-96 (1997).
Summary: Ten children (five boys and five girls, aged 2 through 15)
suffering from juvenile chronic arthritis (JCA) were enrolled in the
study. All patients received oral Wobenzym® in an open six-month
trial. Articular signs and extra-articular manifestations improved
in the majority of the children. The experimental drug revealed its
therapeutic potential beginning with 4-5 months of treatment. Enzyme
therapy appears to be able to limit the use of corticosteroids in
some JCA patients. No side effects were observed. Only two children
experienced a relapse in the more than 2 years of follow-up exams.
Using of systemic enzymotherapy for treatment of rheumatoid
arthritis.
We
applied the drug WOBENZYM (MUCOS Pharma Gmbh & Co., Germany) in the
complex treatment of 25 rheumatoid arthritis (RA) patients (mean age
62,1+4,4 years), which formed the basic group (BG), parallel with
NSAIDs. In 27 patients of the control group (CG) there were used
only NSAIDs. The both groups were comparable by the age, severity of
their disease, and accompanying diseases.
The
WOBENZYM was given during 30 days, at the dose of 10 tablets 3 times
a day.
The
treatment efficacy was estimated by the data of clinical, laboratory
and instrumental findings.
The
intensity of pain syndrome (by 10-scale) reduced in pts of BG from
6,85±0,28 to 2,80+0,19 units /u./ (p<0,01), while in pts of CG from
7,04±0,26 to 3,87±0,24 (p<0,01), but this reduction was more
pronounced in pts of BG (p<0,01).
Pain reduction by 50% was observed in 85% of BG but only in 39,1% of
CG pts (p<0,05). Patient self-evaluation of treatment efficacy
coincided with physician evaluation in 87,5% of BG pts, while in CG
-68% (p<0,05). There was observed positive dynamics of Stanford form
indices: from 31,2±3,5 to 22,1±3,4 in the BG (p<0,05), while in the
CG changes were insignificant. Also we have observed increase of
hand strength in BG and CG by 4,52±0,86 kg and 2,27±0,51 kg,
accordingly (p<0,05). We have not observed adverse reactions in BG,
while in 20% of CG pts (p<0,01). By infrared thermography data
resumption of inflammatory process, or its essential reduction was
stated, ESR also decreased (p<0,05).
Thus WOBENZYM application in complex treatment of RA pts permits to
get effective curative results at absence of indesirable effects.
Poster Reference Number 74.
Summary
The
objective of the uncontrolled trial was to assess the tolerance and
safety of the preparation Wobenzym in patients with rheumatoid and
psoriatic arthritis who had other concurrent anti-inflammatory
treatment and to evaluate its position in combined treatment of RA
and PsA. The authors added Wobenzym, 9 to 15 enterosolvent pills per
day to anti-inflammatory antirheumatic treatment in 23 patients with
RA and 4 patients with PsA because of persisting clinical and
laboratory activity. Treatment lasted 16 weeks and more. The
evaluation of the effectiveness of Wobenzym by the physician was as
follows: very good 33.3 %, good 54.3 % and unsatisfactory 12.4 %.
The evaluation of physical capacity by the patients was as follows:
18 patients (75 %) reported a better physical capacity after
Wobenzym and only 25 % (6) had the same physical capacity. There was
no case of deterioration. When evaluating clinical parameters, the
authors found after four months of treatment a decline of the
morning stiffness (p < 0.01) and a better grip strength (p < 0.05),
reduced articular index and index of incapacity according to HAQ,
which however was not statistically significant.
The
authors recorded a decline of FW the CRP and CIK concentration (p <
0.01).
The
concentration of alpha-2 macroglobulin, alpha-1 antitrypsin,
haemoglobin and amylase values did not change significantly during
treatment. The trial confirmed the favourable effect of Wobenzym on
the rheumatic process, good tolerance and safety of treatment in
patients with rheumatoid diseases even in case of polytherapy.
Basic treatment of rheumatoid arthritis: new approaches.
Kovalenko V.N., Golovkov Y. Z. Basic treatment of rheumatoid
arthritis: new approaches. Revmatology in Europe 1997, Vol. 26,
Suppl. 2, Abst. 446.
Abstract
We
applied the drug WOBENZYM® (MUCOS Pharma GmbH & Co., Germany) in the
complex treatment of 21 rheumatoid arthritis (RA) patients (mean age
41,1 ± 6,4 years), which formed the basic group (BG), parallel with
NSAIDs. In 27 patients of the control group (CG) there were used
only NSAIDs.
The
both groups were comparable by the age, severity of their disease,
and accompanying diseases.
The
WOBENZYM was given during 1 year, at the dose of 15 tablets a day.
The treatment efficacy was estimated by the data of clinical,
laboratory and instrumental findings, every month. The intensity of
pain syndrome reduced in pts of BG from 6,85 ± 0,28 to 2,8 ± 0,19
/points/ (p<0,01), while in pts of CG from 7,04 ± 0,26 to 3,87 ±
0,24 /points/ (p<0,01), but this reduction was more pronounced in
pts of BG (p<0,01).
Pain reduction by 50 % was observed in 85 % of BG but only in 39,1 %
of CG pts.
(p<0,05). Patient self-evaluation of treatment efficacy coincided
with physician evalutation in 87,5 % of BG pts, while in CG – 68 %
(p<0,05). There was observed positive dynamics of Stanford form
indices: from 31,2 ± 3,5 (units) to 22,1 ± 3,4 in the BG (p<0,05),
while in the CG changes were insignificant. Also we have observed
increase of hand strength in BG and CG by 4,52 ± 0,86 kg and 2,27 ±
0,51 kg accordingly (p<0,05). We have not observed adverse reactions
in BG, while in 20 % of CG pts. (p<0,01). By infrared thermography
data resumption of inflammatory process, or its essential reduction
was stated, ESR also decreased (p<0,05).
As
evidenced by the data presented, WOBENZYM® application in treatment
of RA pts permits to effective curative results at absence of
adverse reactions.
Poster Reference Number 76.