UA104249U - A method for treating exacerbations of chronic hepatitis c - Google Patents

Abstract

A method of treating exacerbations of chronic viral hepatitis C involves the use in the treatment of these patients with pegylated IFN and ribavirin. White coal enterosorbent is additionally introduced. It is taken 3-4 tablets inside 30-40 minutes before meals or medication 1-2 times daily for 10-12 days in a row.

Description

A useful model belongs to the field of medicine, namely to methods of treating infectious diseases.

The relevance of the problem is due to the fact that, according to epidemiological studies, the epidemic situation regarding hepatitis C in Ukraine is assessed as unfavorable. At the same time, it was established that non-bilious and subclinical forms of viral hepatitis C (HCV) prevail among the population of Ukraine, mainly in the form of a chronic infectious process, that is, chronic HCV (HCV). At the same time, according to our research, in the presence of a chronic infectious process occurring in the liver and insufficient perfection of the existing methods of treating patients with this pathology, further optimization of treatment methods is required.

There is a method of treating patients with HCV, which includes the administration of pegylated interferons (IFN) and ribavirin (I.M. Skrypnyk. Clinical hepatology: educational manual / I.M. Skrypnyk, T.V.

Melnyk, M.M. Potyazhenko - Poltava: Dyvosvit, 2007. - 424 p.).

The disadvantages of this method include the fact that when using this method, only in 45-55 95 cases of HCV, the achievement of a stable virological response is noted, in the remaining patients, resistance to interferon therapy is gradually formed or shortly after the end of IFN administration, a relapse of HCV occurs, which is associated with a low the level of endogenous IFN and a decrease in its production precisely as a result of long-term administration of large doses of exogenous IFN.

Therefore, it was suggested that in addition to genetically engineered recombinant IFNs, the hepatoprotective drug glutargin (Glutargin - pharmacological action and clinical application: monograph / O.Ya. Babak, V.M. Frolov, N.V. Kharchenko. - Kh., Luhansk:

Zlton-2, 2005. - 455 p.).

This method is the most effective of the existing ones and therefore was chosen as a prototype.

Among the shortcomings of the prototype is the fact that some patients with HCV have long-term preservation of excessive activity of lipoperoxidation processes and accumulation of products of distorted metabolism in the blood in the form of so-called "medium molecules" (SM), which clinically causes a long course of exacerbation of this pathology. Therefore, the known prototype method needs further improvement.

The purpose of the useful model was to increase the effectiveness of the known method of treating patients with HCV, namely, to shorten the duration of treatment, improve the results of treatment and

From the normalization of the activity of lipoperoxidation processes.

The task is solved by introducing su to such patients against the background of CP by additional introduction of enterosorbent "White coal".

Enterosorbent "White coal" is a preparation based on silicon oxide. Promotes adsorption from the gastrointestinal tract and removal from the body of exo- and endogenous toxic substances of various origins. "White coal" contributes to reducing the manifestations of toxic-allergic reactions, restoring the course of metabolic reactions, reducing the metabolic load on detoxification organs, primarily on the liver and kidneys.

The proposed method is used as follows. A patient with HCV is prescribed pegylated IFN and ribavirin, and 3-4 tablets of "White coal" enterosorbent are also administered orally 30-40 minutes before meals or medication 1-2 times a day for 10-12 days in a row.

During the development of the proposed method of treatment for HCV, 50 patients with this diagnosis who had clinical and laboratory signs of exacerbation of hepatitis were examined, who made up the main group and received treatment according to the proposed method of treatment, and 48 patients with the same diagnosis, who made up the group comparison, which was treated, according to the prototype method. Age, gender composition and total duration of the disease in both groups were similar.

Conducting clinical supervision and laboratory examination made it possible to establish that the proposed method has significant advantages over the prototype method.

During a biochemical study before the start of treatment in examined patients with

In HCV patients of both groups, shifts in LPO indicators were found, which were characterized by an increase in the blood content of LPO products - MDA and DC, which indicated a significant activation of lipoperoxidation processes in such patients (Table 1).

Table 1

Levels of POL in the blood of patients with HCV before the start of treatment (Mat)

Biochemical indicators norm Z Daily (lyo) insertion of VI 1

Note: in the table 1-4, the probability of the difference in indicators is calculated between the group indicator and the norm at Р«е0.05 - и; Р«0.01 - их and Р«е0.001 - и column P reflects the probability of the difference between the indicators of the main group and the comparison group

During this period, the concentration of MDA in the patients of the main group averaged (7,750.16) μmol/l, that is, it was 2.4 times higher than the norm (P-0.001), in the patients of the comparison group, the concentration of the final metabolite of POL was equal to (7.4- 40.18) μmol/l, which was 2.3 times higher than normal values (P<0.001). The content of intermediate products of lipoperoxidation - DK - was also increased in the vast majority of examined patients with HCV and amounted to an average of (18.1:50.3) μmol/l in the subjects of the main group, which was 1.88 times higher than the norm (P -0.001), and in patients of the comparison group - (17.8:.-0.24) μmol/l, that is, it was 1.85 times higher than the norm (P-0.001). In order to study the influence of lipid peroxidation processes on the state of erythrocyte biomembranes, the severity of erythrocyte peroxide resistance was also analyzed according to the PGE indicator, which in the patients of the main group was equal to (9,320,8)95, which was 3.0 times higher than the norm on average (Р- 0.001), and in the comparison group - (9.020.6)95, which exceeded normal values by 2.9 times (Р«0.001).

Repeated study of biochemical indicators of lipoperoxidation activity was carried out after completion of the treatment course: in the main group - according to the declared method, in the comparison group - according to the prototype method. At the same time, it was established that in the main group of patients with

In HCV patients, during the indicated period, almost complete normalization of the studied indicators was noted, while in patients of the comparison group, despite some tendency to improvement, the values of these indicators at the time of completion of treatment differed significantly from the indicators of the norm and the main group (Table 2).

Table 2

Levels of POL in the blood of patients with HCV after completion of treatment (Met)

Bositytianny ene G stntvy I

The concentration of MDA in the subjects of the main group decreased relative to the initial value by an average of 2.1 times, that is, to (3.6-0.1) μmol/l, which corresponded to the upper limit of the norm (Р»0.05). In the comparison group, this indicator decreased to (4.9:0.08) μmol/l, i.e. 1.5 times relative to the initial value, but remained above the norm by an average of 1.53 times (Р«0.05).

As for the level of DC, in patients of the main group at the end of treatment, it was (9.8:20.12) μmol/l, which probably did not differ from the norm (Р»0.05); in the comparison group, this indicator decreased during treatment to (12.8240.3) μmol/l, which was lower than the initial value of this indicator by an average of 1.4 times, but still remained probably higher than the norm by 1.33 times (Р«е0.05) and a similar indicator in the main group also by an average of 1.3 times (Р«0.05). The PGE indicator also decreased after the treatment in both the main and comparison groups, while its dynamics depended on the nature of the treatment. Thus, in the main group there was a decrease in its level to the upper limit of the norm (3,730,1 90). In general, PGE decreased in this group relative to the initial level by an average of 2.6 times (P<0.01). In the comparison group, these changes were less pronounced, although the PGE indicator decreased relative to the initial value by 1.9 times, it exceeded both the norm by 1.55 times (Р«0.05) and the corresponding indicator in the main group by 1, 33 times (Р«0.05).

The conditional economic effect associated with the acceleration of the achievement of stable long-term clinical and biochemical remission and, in connection with this, the increase in the working capacity of patients, amounts to 526 hryvnias. per 1 patient.

Therefore, the proposed method is useful, as it helps to accelerate the achievement of stable long-term clinical and biochemical remission in HCV against the background of CP. It is based on the use of domestic drugs, does not require scarce or very expensive drugs, and therefore can be recommended for widespread use in the conditions of infectious disease departments and hospitals in the treatment of exacerbations of HCV against the background of CP.

The given data can be supported by the following specific examples of using the proposed method.

Example 1.

Patient P., 33 years old, a nurse, has been suffering from HCV on the background of CP for the past 4 years, exacerbations are noted mainly 2 times a year. Previously, she received only pathogenetic therapy. She was examined for another exacerbation of HCV on the background of CP. She complained of general weakness, malaise, moderate headache, decreased appetite, heaviness in the right hypochondrium, significant decrease in work capacity, darkening of urine. On examination: the general condition of the patient is moderately severe, moderate scleral jaundice, subicteric skin is noted. The liver is enlarged, protrudes by 3-4 cm from the edge of the costal arch, the spleen by 1-2 cm in the position on the right side. The edge of the liver is sensitive to palpation.

Laboratory examination: Er. - 3.971012/l, Hr-138 g/l, L. - 5.17109/l, 6.-1, p. -4, 6 - 52, l - 30, m - 4; SOE - 7 mm/h. Urine analysis - bile pigments, urobilin. Biochemical indicators: total bilirubin - 52.3 μmol/l, direct - 29.1 μmol/l, indirect - 23.2 μmol/l; AlAT - 2.86 mmol/l, ASAT - 2.23 mmol/l, thymol test - 8.2 units, GGTP - 3126 nmol/l, Lf - 4.9 mmol/l, A/G - 0.8 .

Diagnosis: HCV on the background of CP, moderately severe course, confirmed by the duration of the disease (about 4 years), the presence in the anamnesis of surgical intervention, blood transfusion and course injections 5-6 years ago, the presence of clinical symptoms at the time of examination

Due to the general toxic and hepatic nature, increased activity of aminotransferases and shifts in other functional tests of the liver, as well as detection by the ELISA method in the blood of a patient of api-

NOM Id (Cs-M), in the absence of markers of hepatitis A and B. After clarifying the diagnosis, the patient was prescribed treatment according to the proposed method, which included the introduction of pegylated

IFN and ribavirin and additionally enterosorbent "White coal" on 3 tablets orally 30-40 minutes before taking food or medicine once a day for 102 days in a row.

Under the influence of treatment, the general condition of the patient significantly improved. Jaundice of the sclera disappeared on the 5th day from the start of treatment, subicteric skin and sclera - on the 10th day, urine was light already on the 4th day of treatment. General weakness and malaise disappeared on the 8th day from the start of treatment, appetite appeared on the 7th day, heaviness in the right hypochondrium disappeared on the 6th day. The sensitivity of the edge of the liver during palpation was eliminated on the fifth day, the size of the liver decreased on the 14th day from the start of treatment, the spleen - on the 10th day. On the tenth day, the patient's ability to work normalized.

A repeated biochemical examination on the 30th day after the start of treatment allowed establishing the normalization of biochemical indicators. Indeed, the level of total bilirubin decreased to 14.2 μmol/l, direct - to 3.6 μmol/l, ALT activity - to 0.55 mmol/l, AST - to 0.41 mmol/l, thymol test indicator - to 4.4 units, GHTP activity - up to 2011 nmol/l, Lf - up to 1.2 mmol/g. The A/G ratio increased to 1.1.

Thus, a full-fledged clinical and biochemical remission of HCV was achieved against the background of CP in patient P. Dispensary supervision for 2 years made it possible to establish the duration of the achieved remission. There were no relapses or exacerbations of the disease during the entire period of dispensary examination, the patient's working capacity was preserved.

Example 2.

Patient L, 53 years old, a packer, has been suffering from HCV on the background of CP for 5 years, exacerbations of the pathological process are noted 1-2 times a year. Previously received only pathogenetic therapy. He was examined for another exacerbation of HCV on the background of CP. He complained of general weakness, malaise, headache, decreased appetite, darkening of urine, moderate jaundice of the skin and sclera, reduced work capacity, heaviness in the right hypochondrium. During the examination, the presence of moderate jaundice of the skin and sclera, hepatomegaly (-3-4 cm), splenomegaly (12 cm), sensitivity of the edge of the liver during palpation, darkening of urine was established.

A biochemical examination revealed the presence of hyperbilirubinemia (56.6 μmol/l), an increase in the content of the direct (bound) bilirubin fraction (30.2 μmol/l), the activity of ALT (3.06 mmol/g) and AST (2 .56 mmol/g"l), GGTP (3260 nmol/l) and Lf (4.9 mmol/g"l), an increase in the thymol test index (8.1 units), a decrease in the A/G ratio (0.81 ).

Diagnosis: HCV on the background of CP, moderate course, established on the basis of the duration of the disease (about 5 years), the presence in the history of blood transfusion and course injections 6 years ago, the detection of a characteristic clinical and biochemical picture at the time of examination, as well as markers of HCV in of the patient's blood - api-NOSM Id (Cs--M) by the ELISA method in the absence of hepatitis A and B markers in the patient's blood.

After clarifying the diagnosis, the patient was prescribed treatment according to the proposed method, namely pegylated IFN and ribavirin and additionally enterosorbent "White coal" 4 tablets orally 30-40 minutes before taking food or medicine 2 times a day for 12 consecutive days.

Under the influence of the treatment, the general condition of the patient and his well-being significantly improved. Jaundice disappeared on the sixth day from the start of treatment, subicteric sclera - on the tenth day, darkening of urine - on the sixth day, general weakness and malaise - on the 10th day of treatment, heaviness in the right hypochondrium - on the 6th day. Hepatomegaly was eliminated on the 14th day of treatment, splenomegaly on the 10th day, reduced work capacity on the 10th day.

When the biochemical parameters were re-examined on the 30th day from the start of the treatment, a clearly expressed positive trend was established. The level of total bilirubin decreased to 16.8 μmol/l, direct - to 3.5 μmol/l, ALT activity - to 0.62 mmol/l,

ASAT - up to 0.42 mmol/l, thymol test - up to 4.8 units, GHTP activity - up to 19860 nmol/l, Lf - up to 1.1 mmol/l. A/G ratio increased to 1.08 So, a full-fledged clinical and biochemical remission of cytoflavin was achieved after 3 tablets orally 3 times a day for 25 days in a row.

Dispensary supervision for 2 years made it possible to establish the duration of the achieved remission.

There were no relapses and exacerbations of the disease during the entire period of dispensary examination, the patient's working capacity was preserved.

Thus, the proposed method has significant advantages over the existing one and can be recommended for widespread use in the practice of infectious disease departments and

From hospitals.

Claims (2)

USEFUL MODEL FORMULA 1. The method of treatment of exacerbations of chronic viral hepatitis C, which includes the use of pegylated IFN and ribavirin in the therapy of these patients, which is distinguished by the fact that the enterosorbent "White coal" is additionally administered. 2. The method according to claim 1, which differs in that the enterosorbent "White coal" is taken 3-4 tablets internally 30-40 minutes before taking food or medicine 1-2 times a day for 10-12 days in a row.