scholarly journals A Retrospective Analysis of the Clinical Studies of a Drug "Flakozid" in the Treatment of Diseases of the Hepatobiliary System

2021 ◽  
Vol 10 (3) ◽  
pp. 100-104
Author(s):  
V. V. Bortnikova ◽  
V. V. Karabaeva ◽  
L. V. Krepkova ◽  
P. G. Mizina ◽  
A. N. Babenko ◽  
...  

Introduction. The medicine "Flakozid" with hepatoprotective effect has been developed at the VILAR. The drug is presented in dosage form-tablets of 0.1 g for oral drug administrationAim. To analyze the clinical efficacy and safety of "Flakozid" therapy according to clinical laboratory methods, as well as the motility of the gallbladder and bile ducts in patients with diseases of the hepatobiliary system.Materials and methods. The results of clinical studies of "Flakozid" (0.1 g tablets) were analyzed in 99 patients with chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy, conducted in 2 clinical institutions: Perm State Medical University. Academician E. A. Wagner of the Ministry of Health of Russia and the Central Research Institute of Gastroenterology. "Flakozid" was prescribed against the background of a therapeutic diet (Table No. 5) of 0.1-0.2 g 3 times a day after meals for 32 days and repeated courses (3-5) for 6-12 months. Analysis of the efficacy and safety of "Flakozid" was carried out on the basis of the results of clinical and laboratory studies: general and biochemical blood analysis, general urinalysis, electrocardiogram. To study the motility of the gallbladder and biliary tract, the method of multifractional duodenal probing was used to determine the functional state of the sphincter apparatus of the gallbladder and biliary tract. In cystic and hepatic bile, its biochemical composition was determined. All patients underwent X-ray examination of the gastrointestinal tract, liver scanning and hepatography with iodine-131-bengal-roz.Results and discussion. In chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy the use of "Flakozid" orally in daily doses of 0.3-0.6 g for 25-45 days led to an improvement in the General condition of patients, a decrease in pain in the right hypochondrium, a decrease in dyspeptic disorders, and an improvement in appetite. According to cholecystography, the indicators of concentration and contractility of the gallbladder improved. In terms of the severity of the therapeutic effect, "Flakozid" was not inferior to silibor and carsil, and in some indicators (improvement of the motility of the gallbladder and biliary tract) significantly exceeded them.Conclusions. Treatment of "Flakozid" improved functional state of the liver, reducing the syndrome of cytolysis and cholestasis. "Flakozid" is recommended in clinical practice in the complex treatment of diseases of the hepatobiliary system, such as chronic active hepatitis, chronic stone-free cholecystitis and fatty liver dystrophy.

Author(s):  
Qing Gou ◽  
Lingeng Wu ◽  
Wei Cui ◽  
Zhiqiang Mo ◽  
Dejin Zeng ◽  
...  

Abstract Objective To evaluate the efficacy and safety of stent placement combined with intraluminal radiofrequency ablation (intra-RFA) and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced biliary tract cancers (Ad-BTCs) and biliary obstruction (BO). Methods We retrospectively reviewed data for patients with Ad-BTCs and BO who underwent stent placement with or without intra-RFA and HAIC in three centres between November 2013 and November 2018. The stent patency time (SPT), overall survival (OS), and adverse events (AEs) were analysed. Results Of the 135 enrolled patients, 64 underwent stent placement combined with intra-RFA and HAIC, while 71 underwent only stent placement. The median SPT was significantly longer in the combination group (8.2 months, 95% confidence interval [CI]: 7.1–9.3) than in the control group (4.3 months, 95% CI: 3.6–5.0; p < 0.001). A similar result was observed for OS (combination: 13.2 months, 95% CI: 11.1–16.5; control: 8.5 months, 95% CI: 7.6–9.6; p < 0.001). The incidence of AEs related to biliary tract operation was not significantly different between the two groups (p > 0.05). The most common AE and serious AE related to HAIC were alanine aminotransferase elevation (24/64; 37.5%) and thrombocytopenia (8/64; 12.5%), respectively. All AEs were tolerable, and there was no death from AEs. Conclusions Stent placement combined with intra-RFA and HAIC may be a safe, potential treatment strategy for patients with Ad-BTCs and BO. Key Points • Advanced biliary cancers (Ad-BTCs) with biliary obstruction (BO) can rapidly result in liver failure and cachexia with an extremely poor prognosis. • Stent placement combined with intraluminal radiofrequency ablation and hepatic arterial infusion chemotherapy may be safe and effective for patients with Ad-BTCs and BO. • The long-term efficacy and safety of the combined treatment is promising.


1985 ◽  
Vol 66 (5) ◽  
pp. 342-343
Author(s):  
N. A. Cherkasova ◽  
V. P. Bulatov ◽  
M. V. Voitsekhovich

The question of the influence of lesions of the hepatobiliary system on the activity of the heart in childhood is not sufficiently covered in the literature.


2021 ◽  
Vol 100 (9) ◽  
pp. 943-946
Author(s):  
Marina V. Sheenkova ◽  
Oksana P. Rushkevich ◽  
Irina V. Yatsyna

Ntroduction. The article is devoted to the study of the features of the metabolic pathology of the liver under the influence of harmful industrial factors. The relevance of the study of nonalcoholic fatty liver disease of workers in contact with industrial aerosols is due to the high prevalence of the disease among the working-age population, the polyethological nature of the pathology, including the pathogenetic relationship with external household and occupational toxic effects. Materials and methods. The were examined two hundred four industrial production workers, divided into four groups according to the composition of the affected aerosol: copper-nickel ore dust, welding aerosol, quartz-containing dust, carbon-based dust. The survey was conducted using the AUDIT questionnaire, examination of patients, anthropometry, ultrasound examination of the abdominal organs, biochemical blood analysis, determination of viral hepatitis B and C markers, and serum immunoglobulins. Results. The frequency of detection of ultrasonic signs of liver damage in the examined patients who came into contact with copper-nickel aerosol dust significantly exceeds the same indicator of the studied patients who came into contact with quartz-containing dust (p<0.05) and also exceeds the frequency of detection in the group working under the influence of carbon-based and welding aerosol (p>0.05). Most often, an increase in the activity of liver enzymes was noted among those working in contact with copper-nickel ore dust. Significant differences were found between groups 1 and 3; 1 and 4 (p<0.05). There were no significant differences between the groups in the frequency of lipid and carbohydrate metabolism disorders and biliary tract pathology. Discussion. The results of the study may be related to the toxic effects of the copper-nickel aerosol but may also be associated with the climatogeographic features of the workers ‘ habitat. Conclusion. The prevalence of liver diseases in the group that came into contact with copper-nickel dust was established. The revealed changes do not depend on lipid and carbohydrate metabolism features, pathology of the biliary tract. For a detailed study of liver damage in industrial workers, it is necessary to conduct an in-depth study.


2021 ◽  
Vol 13 (3) ◽  
pp. 200-210
Author(s):  
A. G. Prityko ◽  
K. V. Osipova ◽  
P. L. Sokolov ◽  
E. A. Ezhova ◽  
I. G. Kotel’nikova ◽  
...  

Objective: to prove the therapeutic equivalence and similar safety profile of “Sibazon, rectal solution” (international nonproprietary name: diazepam) and “Sibazon, solution for intravenous and intramuscular administration” in children with primary generalized and bilateral tonic, clonic and tonic-clonic seizures.Material and methods. An open-label, randomized clinical trial on efficacy and safety was conducted in 20 patients suffering from epilepsy with generalized seizures aged 1 to 17 years. Clinical blood and urine tests, biochemical blood analysis were used for diagnostics (glucose, total protein, albumin, total bilirubin, cholesterol, aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, creatinine, urea, creatinine clearance), as well as data on electrocardiographic (ECG) and electroencephalographic (EEG) studies. The patients were divided into two groups: in Group 1 (n=8), a rectal solution was used, in Group 2 (n=12) – a solution for intravenous and intramuscular administration.Results. The number of cases in which seizures were completed within 10 minutes after using the drug without resuming within subsequent 60 minutes, in Group 1 was 7 (87.5%), and in Group 2 – 9 (75.0%) (Fisher exact test (FET): p=0.617). Repeated primary generalized or bilateral tonic/clonic/tonic-clonic seizures within 24 hours after drug administration, in Group 1 were absent in 5 (62.5%) patients, in Group 2 – in 6 (50%) (FET: p=0.670); within 48 hours after drug administration – in 5 (62.5%) and 7 (58.3%) children, respectively (FET: p=1.00). Physical examination revealed no pathology in all patients at the final visit. While comparing ECG and EEG data at the final visit, no inter-group differences were found by the number of children with deviations from the norm. The results of laboratory studies confirmed that using the studied drugs had no negative effect on the main indicators of clinical and biochemical blood tests as well as clinical urine analysis.Conclusion. The effectiveness of the rectal form of Sibazon in relieving pediatric generalized epileptic seizures is comparable to that of Sibazon for intramuscular administration. The drug rectal form, due to easy-to-use administration, is preferable for outpatient practice. “Sibazon, rectal solution” is safe and has good tolerability.


Author(s):  
Yu. V. Kulezneva ◽  
L. V. Bondar ◽  
E. A. Vasina ◽  
M. B. Boboeva ◽  
P. M. Cholak ◽  
...  

Aim. To identify diagnostic value of hepatocholescintigraphy for evaluation of functional state of biliodigestive anastomoses (BDA).Material and methods. 99mTc-IDA hepatocholescintigraphy was applied in 52 patients to evaluate function of biliodigestive anastomoses.Results. Scintigraphic signs of “bowel-anastomosis” and/or “BDA-intrahepatic bile ducts” reflux were revealed in 14 (27%) cases. Obstruction of biliodigestive anastomosis occurred in 3 (5.7%) patients. Normal bile flow through BDA was observed in 10 (19.2%) patients, impaired passage – in 21 (40.3%) cases. Tracer delay in intrahepatic bile ducts was noted in 21 (25.0%) cases, signs of adhesive process near deferent bowel – in 3 (3.8%) cases.Conclusion. Hepatocholescintigraphy is highly effective method to assess biliary tract in patients after Roux-en-Y biliodigestive anastomoses formation.


2021 ◽  
Vol 76 (6) ◽  
pp. 595-603
Author(s):  
Igor V. Maev ◽  
Alexey O. Bueverov ◽  
Artem V. Volnukhin

Background. Drug treatment of non-alcoholic fatty and alcoholic liver disease remains an urgent, unsolved problem. Due to the commonality of many pathogenetic mechanisms and predictors of progression, a universal approach to the search for a therapeutic agent can be considered. Aims pooled analysis of the results of two multicenter, randomized, double-blind, placebo-controlled studies of a fixed combination of glycyrrhizic acid and essential phospholipids in two dosage forms to study its efficacy and safety in non-alcoholic fatty and alcoholic liver disease, in the presence and absence of predictors of disease progression. Methods. The pooled analysis included 180 patients with non-alcoholic fatty liver disease (Gepard study) and 120 patients with alcoholic liver disease (Jaguar study). Patients of the main group received a fixed combination of 5.0 g intravenous jet 3 times a week for the first 2 weeks; then 2 capsules 3 times a day for the next 10 weeks. Patients in the control group received placebo according to the same scheme. The total duration of treatment was 12 weeks in the Gepard study (1 course of stepwise therapy) and 24 weeks in the Jaguar study (2 courses of stepwise therapy). A comparative analysis of the efficacy and safety of a fixed combination and a placebo was carried out, in the presence and absence of predictors of progression, separately for each nosology and in a mixed sample. Results. In patients with non-alcoholic fatty and alcoholic liver disease who received the fixed combination, in contrast to the placebo group, there was a statistically more significant decrease in the level of biochemical markers of inflammation alanine aminotransferase, aspartate aminotransferase, adiponectin, and the value of the AktiTest index. There was no negative trend in the NAFLD fibrosis score; more significant positive dynamics of FibroTest is shown. Predictors of disease progression hyperglycemia, hyperlipidemia, age did not have a negative impact on the results in the study group. The efficacy of the study drug was noted in patients with non-alcoholic fatty liver disease and normal body weight; data were obtained indicating its possible effectiveness with a high activity of the inflammatory process associated with alcoholic liver damage. The frequency of adverse events in the study and control groups was comparable. Conclusions. Based on a generalized analysis of the results of two studies, promising directions for the study and use of a fixed combination of glycyrrhizic acid and essential phospholipids were identified: non-alcoholic fatty liver disease without obesity, alcoholic steatohepatitis of high activity (as an adjuvant); steatohepatitis of non-alcoholic and alcoholic etiology, combined with hyperglycemia and hyperlipidemia.


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