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Geptrong – clinical trials results and experimental data - Продолжение

Table 5

Dynamics of normalization of level of the common bilirubin (increasing result) in patients with viral hepatitis during treatment

Acute viral A hepatitis

Acute viral B hepatitis

Chronic viral B hepatitis

Chronic viral C hepatitis

Study
group
(n=6)

Control group
(n=6)

Study
group
(n=26)

Control group
(n=26)

Study
group
(n=38)

Control group
(n=38)

Study
group
(n=24)

Control group
(n=24)

1 day

1 (16.7)

-

-

-

8 (33.3)*

2 (5.3)

9 (37.5)*

3 (12.5)

21 day

3 (33.3)

1 (16.7)

4 (15.4)*

1 (3.8)

14 (36.8)

6 (15.8)

9 (37.5)*

2 (8.3)

Discharge

5 (83.3)*

2 (33.3)

11 (42.3)*

4 (15.4)

17 (44.7)

11 (28.9)

16 (66.7)*

6 (25.0)

* - distinctions with control group are statistically authentic (р>0.05)

Table 6

Dynamics of normalization of AP activity (alkaline phosphatase) (increasing result) in patients with viral hepatitis during treatment

* - distinctions with control group are statistically authentic (р > 0.05)

Thus, assessment of level of the common bilirubin and activity AP in all groups of patients with viral hepatitis revealed faster and significant dynamics of normalization of cholestasis parameters on a background of study treatment.

Acute viral A hepatitis

Acute viral B hepatitis

Chronic viral B hepatitis

Chronic viral C hepatitis

Study
group
(n=6)

Control group
(n=6)

Study
group
(n=26)

Control group (n=26)

Study
group
(n=38)

Control group
(n=38)

Study
group
(n=24)

Control group
(n=24)

1 day

5 (83.3)

3 (50.0)

19 (73.1)*

6 (23.1)

12 (31.6)

13 (34.2)

12 (50.0)

7 (29.2)

21 day

6 (100.0)*

3 (50.0)

26 (100.0)*

6 (23.1)

28 (73.7)*

16 (42.1)

24 (100.0)*

13 (54.2)

Discharge

(100.0)

6 (100.0)

26 (100.0)

16 (61.5)

31 (81.6)

25 (65.8)

23 (95.8)

22 (91.7)

Assessment of viral efficiency of study therapy in patients with viral hepatitis

For assessment of viral activity as additional criterion of efficiency, PCR before the beginning of therapy and by the moment of the termination of treatment has been presented.


Table 7

Dynamics of polymerase chain reaction at patients with viral hepatitis during treatment

Acute viral B hepatitis

Chronic viral B hepatitis

Chronic viral C hepatits

Study group (n=26)

Control group (n=26)

Study group (n=38)

Control group (n=38)

Study group (n=24)

Control group (n=24)

Before treatment

24 (92.3)

23 (88.5)

38 (100.0)

37 (97.4)

24 (100.0)

24 (100.0)

After treatment

2 (7.7)*

7 (26.9)

32 (84.2)

36 (94.7)

17 (70)

24 (100.0)

* * - distinctions with control group are statistically authentic (р > 0.05)

Thus, during study treatment in patients with viral hepatitis reduction of percent of chronization has been observed in acute process and achievement of seroconversion in 16 % of patients CVBH and 30 % CVCH that gives new prospects of use of this preparation in patients with the mentioned nosology.


Morphological activity and stage of fibrous changes in liver in patients with CH.

Morphological activity of inflammatory process in liver was assessed according to research of tissue samplings. The estimation of activity and stage of fibrous process in liver was estimated by scales Knodell and Desmet.

Tissue samplings of liver have been sent, prepared and investigated in laboratory of Gastroenterology of Institute of the Grippe of Russian Academy of Medical Science (Saint Petersburg): in 36 patients with CVBH and in 22 patients with CVCH.


Table 8

Dynamics of activity of pathological process in patients with chronic viral hepatitis C according to morphological research

Study group

Control group

Before treatment (n=11)

After treatment (n=11)

Before treatment (n=11)

After treatment (n=11)

Minimal

6 (54,5)

8 (72,7)

7 (63,6)

7 (63,6)

Mild

4 (36,4)

3 (27,3)

3 (27,3)

3 (27,3)

Moderate

1 (9,1)

-

1 (9,1)

1 (9,1)

Expressed

-

-

-

-


Table 9

Dynamics of activity of pathological process in patients with chronic viral hepatitis B according to morphological research

Study group

Control group

Before treatment (n=19)

After treatment (n=19)

Before treatment (n=17)

After treatment (n=17)

Minimal

5 (26,3)

10 (52,6)

5 (29,4)

6 (35,3)

Mild

10 (52,6)

7 (36,9)

9 (52,9)

8 (47,0)

Moderate

3 (15,8)

2 (10,5)

2 (11,8)

2 (11,8)

Expressed

1 (5,3)

-

1 (5,9)

1 (5,9)

In study group after the treatment patients with moderate activity has not been revealed, the quantity of patients with weak activity has decreased up to 3 (27.3%), and with minimal activity has increased up to 8 (72.7%) the person. At the same time in control group dynamics of morphological activity of pathological process in liver was absent.


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