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Carsil®
CLINICAL USE OF CARSIL
Carsil is appropriate in patients with liver steatosis, chronic hepatitis,
hepatic cirrhosis, toxic metabolic liver damage, liver adipose
degeneration, but also as a hepatoprotective agent in case of
administration of liver-loading substances.
The judgment of the effect of the liver therapeutic agents is rather
problematic. On the one hand due to the substantial spontaneous
inter-individual fluctuations of the course of the disease, and on the
other - because the comparisons among the cohorts of patients are
difficult, as the same clinical and histological picture may be the result
of totally different ethiopathogenetic prerequisites.
CARSIL IN CHRONIC LIVER DISEASES (CLD)
H. Brailsky et al performed a comparative clinical study of Carsil and
Legalon.
The study was carried out as an open clinical trial on inpatients and
outpatients. After a preliminary diagnostic appraisal based on clinical,
laboratory-biochemical and instrumental methods, the patients were
assigned to the respective groups, as follows:
First group: mild liver damage - chronic persisting hepatitis (CPH) and
liver steatosis (LS):
Second group: chronic active hepatitis (CAH):
Third group: hepatic cirrhosis (HC).
The definite assignment of the patients to the individual groups was done
on the basis of the results of the histomorphological investigation and
the laparoscopy. The patients were randomly assigned to the groups with
Carsil and Legalon therapy, after the diagnostic clarification and the
order of admission to the clinic.
Table A indicates the data about the effect on the
clinical symptoms in the aggregate group of chronic liver diseases (CLD)
treated with Carsil. Table B shows the data about
the effect on the clinical symptoms in the aggregate group of chronic
liver diseases (CLD) treated with Legalon.
|
Symptom
|
Table A
Effect on the clinical symptoms in patients with CLD, after Carsil
therapy
(% of patients with effect)
|
Table B
Effect on the clinical symptoms in patients with CLD, after
Legalon therapy
(% of patients with effect)
|
| Pain |
|
|
| Feeling of weight |
|
|
| Upper dyspeptic syndrome |
|
|
| Lower dyspeptic syndrome |
|
|
| Pruritus |
|
|
| Dark urine |
|
|
| Raspberry tongue |
|
|
| Coated tongue |
|
|
| Icterus |
|
|
| Palmar erythema |
|
|
| Telangiectases |
|
|
| Hepatomegaly |
|
|
| Splenomegaly |
|
|
| Acholia |
|
|
| Weight loss |
|
|
| Impotence |
|
|
Table A and B indicate that the subjective
symptoms of pain and weight in the right hypochondrium, the upper and
lower dyspeptic syndrome, the pruritus and dark urine were best influenced
after Carsil and Legalon therapy. Some of the above symptoms improved in
more than half of the patients. The icterus was less affected. A week or
no change of the incidence of the objective signs, such as liver raspberry
tongue, telangiectasis, hepato-, and splenomegaly, occurred after both
drugs. The reduction in terms of the degree of the hepato- and
splenomegaly under the influence of the therapy deserves attention.
- The administration of Carsil is indicated
in liver damage of mild and moderate degree: liver steatosis and
chronic persisting hepatitis.
- No contraindications for administration of
Carsil exist also in advanced liver damage, where it can be included
as a basic medication.
In 1977 Z. Krustev at al. performed a comparative clinical trial of
Carsil and Legalon on CLD patients in order to study the change in the
clinical, morphological and laboratory parameters.
An open trial was carried out to compare the Bulgarian Carsil brand
with the Legalon brand of Madaus (Germany). Initially, the inpatients
received 210 mg Carsil or Legalon each for 20-25 days (bed regimen and
liver diet prescribed). They continued the therapy as outpatients until
the third month, with various labor regiments assigned according to the
severity of the liver disease. No other hepatoprotective agents or
immunostimulants were given to the patients. Administration of antibiotics
(4 cases), antihypertensive agents (7 cases) and other symptomatic
medication was necessary in some of the cases. An active selection was
done of 18 patients pairs with the same clinical diagnosis, liver disease
etiology, analogous degree of the liver damage judged by a primary blind
diagnostic liver biopsy. A relative selection was also done, according to
comorbid diseases, sex and age.
The feeling of pain and weight in the right hypohondrium, the change of
the urine color, the upper and the lower dyspeptic complaints, the
cutaneous signs of liver damage, the icterus and the menstrual disorders
were recorded in order to evaluate the clinical effect of the therapy. In
3 out of the 18 patients, no detectable base-line clinical signs of liver
damage were recorded, with the exception of the hepatomegaly (evaluated
ultrasonographically). Therefore, the results of the clinical effect in 15
patient pairs only are reported. No negative dynamics of the above
clinical signs was observed in any of the patients. A good clinical effect
was recorded in half of the patients treated with Carsil and Legalon for 3
months. A better clinical effect of the Legalon therapy was observed in 5
pairs, and of the Carsil therapy - in 3 pairs, while in 7 pairs
(p>0.10) the effect had the same direction. No effect of the therapy
was observed predominantly in patients with a more severe liver damage.
In the group of the chronic liver disease patients, no significant
differences between both drugs were found in terms of the clinical signs
of liver damage (Table 1). The ultrasonography-detected
liver changes (Figure 1), the parameters of protein
synthesis (Table 2), of cytolysis (Table 3),
of cholestasis and immune response (Table 4), as well as
in terms of the histological findings of a parenchymal and mezenchymal
liver damage (Table 5).
|
Table 1 Clinical
effect of the therapy with Carsil and Legalon
|
|
Drug
|
Patients
|
| |
Improved
|
No change
|
Aggravated
|
| |
20 days
|
90 days
|
20 days
|
90 days
|
20 days
|
90 days
|
| Carsil |
7
|
8
|
8
|
7
|
0
|
0
|
| Legalon |
9
|
9
|
6
|
6
|
0
|
0
|
|
p >0.10
|
Figure 1
Ultrasonographic dynamic examination of the liver and spleen of
patients on Carsil and Legalon (3 months)
|
|
10
|
|
|
9
|
|
Legalon
|
|
|
8
|
|
Carsil
|
|
|
7
|
|
|
|
6
|
Carsil
|
Legalon
|
|
|
5
|
|
|
4
|
Carsil
|
|
|
3
|
Legalon
|
|
2
|
|
1
|
| |
1st
group of patients - Improved
|
2nd
group patients - Unchanged
|
3rd
group of patients - Aggravated
|
|
Table 2 Change of the
protein synthesis parameters - 90th day
|
|
Parameter
|
Product
|
t-test for paired data
|
| |
|
n
|
xd ±Sxd
|
t
|
p<
|
p=
|
| Albumin g/l |
C
|
18
|
-0.56 ±1.32
|
0.42
|
|
0.30
|
|
L
|
18
|
3.13 ± 1.56
|
2.01
|
0.10
|
0.10
|
| SChE U/L |
C
|
12
|
67 ± 346
|
0.19
|
|
0.62
|
|
L
|
12
|
191 ± 369
|
0.52
|
|
0.27
|
| Cholesterol mmol/L |
C
|
18
|
0.34 ± 0.34
|
0.99
|
|
0.50
|
|
L
|
18
|
0.52 ± 0.53
|
0.98
|
|
0.19
|
| Prothrombin consumption index |
C
|
18
|
1.86 ± 1.79
|
1.04
|
|
0.27
|
|
L
|
18
|
4.43 ± 4.50
|
0.98
|
|
0.15
|
|
C - Carsil; L - Legalon
|
|
Table 3 Change of the
cytolysis parameters - 90th day
|
|
Parameter
|
Product
|
t-test for paided data
|
| |
|
n
|
xd ±Sxd
|
t
|
p<
|
p=
|
| ASAT U/L |
C
|
18
|
-19.11 ± 11.82
|
1.62
|
|
0.15
|
|
L
|
18
|
-17.81 ± 8.44
|
2.099
|
0.10
|
0.046
|
| ALAT U/L |
C
|
12
|
-19.17 ± 10.42
|
1.84
|
0.10
|
0.09
|
|
L
|
12
|
-19.83 ± 7.48
|
2.59
|
0.02
|
0.01
|
|
C - Carsil; L - Legalon
|
|
Table 4 Change of the
cholestasis parameters - 20th day
|
|
Parameter
|
Product
|
t-test for paided data
|
| |
|
n
|
xd ±Sxd
|
t
|
p=
|
| Total bilirubin |
C
|
6
|
2
|
9
|
0.145
|
|
L
|
11
|
5
|
2
|
0.105
|
| Conjugated bilirubin |
C
|
10
|
4
|
3
|
0.09
|
|
L
|
11
|
3
|
4
|
0.029
|
| ALP |
C
|
8
|
2
|
6
|
0.55
|
|
L
|
5
|
3
|
9
|
0.363
|
| Gamma - GTP |
C
|
9
|
2
|
5
|
0.033
|
|
L
|
7
|
4
|
7
|
0.274
|
|
C - Carsil ; L - Legalon
|
|
Table 5 Change of
histology picture after Carsil and Legalon therapy
|
|
Parameter
|
Product
|
Improved
|
Unchanged
|
Worsened
|
Patients total
|
| Parenchyma |
C
|
3
|
7
|
4
|
14
|
|
L
|
4
|
1
|
4
|
9
|
| Mesenchyma |
C
|
5
|
9
|
0
|
14
|
|
L
|
1
|
7
|
1
|
9
|
| Total |
C
|
6
|
6
|
2
|
14
|
|
L
|
4
|
1
|
4
|
9
|
|
C - Carsil; L - Legalon
|
|