scholarly journals Clinical efficacy of Heptrong in patients with non-alcoholic liver disease in real clinical practice (pilot study)

Author(s):  
I. Yu. Pirogova ◽  
S. P. Sinitsyn ◽  
V. S. Chulkov

The purpose of the study: to assess clinical efficacy, dynamics of liver steatosis, effect on insulin resistance and hypolipidemic, ammonia level, systemic inflammation of the Heptrong in patients with non-alcoholic fatty liver disease (NAFLD) and dyslipidemia with obesity.Materials and methods. The study included 40 patients (23 men), age Me 48 (41–53) years, BMI Me 30.5 (28–34) kg / sqm. Inclusion criterion: presence of fatty hepatosis in ultrasound and the ALT level is more than 1.5 norms. Asthenia (AVS) was detected in 78% of patients, abdominal pain in 65% (hepatomegaly, chronic cholecystitis), flatulence in 26%, dyspepsia in 32%. In 36% of patients there was arterial hypertension, in 54% of cases — insulin resistance, in 72% of cases — dyslipidemia with hypertriglyceridemia. Before therapy, patients had an increase in the level of ALT up to 1.9 norms, AST up to 2.1 norms, GGTP up to 1.8 norms, total bilirubin — 1.4 norms, glycated hemoglobin — 1.2 norms, HOMA index up to 1,3 norms, total cholesterol up to 1.3 norms, triglycerides up to 1.4 norms, CRP up to 1.2 norms and ferritin up to 1.3 norms, combined with an increase in CRP and leukocytes up to 1.2 norms. According to the results of liver FIBROSCAN, hepatic steatosis was detected in all patients, Me CAP 295 (254–343), liver fibrosis was detected in 32% of cases (Me 6.4 (5.4–7.6) kPa). The level of ammonia in the peripheral blood on an empty stomach was Me 72 (42–91) mmol / l (with a norm of up to 54 mmol / l). Heptrong was prescribed in the form of 3 courses of 10 intramuscular injections according to the scheme 3.0 ml-3 ml-6.0 ml-6.0 ml-9.0 ml-9.0 ml-6.0 ml-6.0 ml-3.0 ml-3.0 ml for 3 months.Resaults. After 1 month of Heptrong therapy according to the scheme, there was a significant decrease (p≤0.05 according to the Wilcoxon criterion) in the frequency of AVS, pain and dyspeptic syndrome, the level of bilirubin, ALT, CRP, ferritin, ammonia, GGTP. After 3 courses of therapy, the examined patients showed further regression of clinical syndromes. During examination and communication, a positive trend was noted on the scales of quality of life and level of anxiety. Revealed a decrease in Me ALT by 31% (p <0.05); decrease in AST by 28% (p <0.05); GGTP — by 33% (p <0.05); glycated HB — by 15% (p <0.05); CRP — by 10% (p <0.03) ; ferritin — by 11% (p <0.05), ammonia — by24% (p <0.05); HOMA — index by 15% (p <0.04); total cholesterol — by 12% (p <0.05); triglycerides — by 20% (p <0.05); LDL — by 19% (p <0.05); HDL + 18% (p <0.05); Liver steatosis (dВ / m²) –26% (p <0.05); Liver fibrosis — reduction of 1 stage (Metavir) in 28% of patients. A positive response to therapy correlated (r> 0.3) with the patient’s age, male gender, BMI, Homa index, LDL, CRP, ammonia, ferritin.Conclusions. During the course of treatment with Heptrong, patients with NAFLD experience regression of clinical symptoms, stigma of systemic and local inflammation, correction of metabolic disorders, and improvement in the quality of life.

Antioxidants ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. 1125
Author(s):  
Diego Martinez-Urbistondo ◽  
Rafael Suarez del Villar ◽  
Josepmaria Argemí ◽  
Lidia Daimiel ◽  
Omar Ramos-López ◽  
...  

The assessment of liver fibrosis has gained importance since the progression of non-alcoholic fatty liver disease (NAFLD). Indeed, the description of the association between undetected liver fibrosis and lifestyle in terms of antioxidant habits, comorbidity and quality of life (QoL) domains may help in the characterization of subjects with NAFLD. A cross-sectional evaluation of (n = 116) consecutive patients from an Internal Medicine ambulatory evaluation was performed. Demographic data, lifestyle, co-morbidity, QoL (according to the SF-36 index) and analytical values to calculate the oxidative related Fibrosis-4 (FIB-4) index were recorded. The association between FIB-4 and co-morbidity, antioxidant habits in QoL was assessed in univariate analysis (p < 0.05) and confirmed in multivariable analysis for 4 of the 8 SF-36 categories: Physical QoL, Physical role, Social QoL and General QoL, as well as in the Physical summary of SF-36 (p < 0.05). Finally, interactions were assessed between co-morbidity, FIB-4 and antioxidant habits showed in the prediction of mean SF-36 (p < 0.01). Liver fibrosis assessed by the oxidative surrogate index FIB-4 is associated with the interaction between antioxidant lifestyle, co-morbidity and physical, social and general aspects of QoL in apparent liver disease-free individuals, generating a proof of concept for health empowerment and personalized medicine.


2019 ◽  
pp. 52-57
Author(s):  
O. N. Minushkin ◽  
L. V. Maslovsky ◽  
M. I. Bulanova ◽  
O. F. Shaposhnikovа

A study of the clinical efficacy and safety of the drug Samelix (ademetionine, manufacturer – JSC «Canonfarma production», Russia) in 30 patients with chronic alcoholic liver disease (steatohepatitis mild to moderate currents, cirrhosis of the liver grade a ChildPugh) with the syndrome of cholestasis. Purpose of the study: evaluate the clinical efficacy and safety of Samelix (ademetionine) in 30 patients with chronic alcoholic liver disease. Objectives of the study: evaluate the effect of the drug on biochemical parameters, evaluate the effect of the drug on the clinical manifestation of the disease based on the individual diary data during the course therapy, assess the quality of life through the SF-36 questionnaire before and after treatment; report adverse events. The results of the study showed that therapy with this drug leads to a significant positive dynamics of biochemical parameters, regression of clinical manifestations of the disease, a significant increase in the quality of life. Good and excellent results of therapy were observed in 76.7% of cases. The drug is safe and well tolerated.


2020 ◽  
Vol 14 (5) ◽  
pp. 817-827
Author(s):  
Jorge Luis Poo ◽  
Aldo Torre ◽  
Juan Ramón Aguilar-Ramírez ◽  
Mauricio Cruz ◽  
Luis Mejía-Cuán ◽  
...  

Abstract Background and aims Pirfenidone (PFD), an oral antifibrotic drug, has been authorized by the EMA and FDA for treatment of idiopathic pulmonary fibrosis. Few studies have addressed its use in advanced liver fibrosis (ALF). We evaluated a prolonged-release formulation (PR-PFD) plus standard of care on disease progression in ALF. Methods 281 ALF patients from 12 centers receiving PR-PFD (600 mg bid) were screened; 122 completed 1 year of treatment. Additionally, 74 patients received only standard of care regimen. Average age was 64 ± 12 years, 58% female. 43.5% had fatty liver disease (NAFLD), 22.5% viral hepatitis C (VHC), 17% autoimmune hepatitis (AIH), and 17% alcoholic liver disease (ALD). Baseline fibrosis was F4 in 74% and F3 in 26%. Antifibrotic effects were assessed by transient elastography (Fibroscan®) and Fibro Test® (FT); Cytokines and PFD plasma levels were tracked and quality of life evaluated. Results We found a significant reduction in fibrosis in 35% of PR-PFD patients and only in 4.1% in non PR-PFD patients. Child–Pugh score improved in 29.7%. Biochemical values remained stable; 40.6% and 43.3% decreased ALT or AST, respectively. TGFβ1 (pg/mL) levels were lower in PFD-treated patients. PFD serum concentration (µg/mL) was higher (8.2 ± 1.7) in fibrosis regression profile (FRP) patients compared to fibrosis progression profile (FPP) patients (4.7 ± 0.3 µg/mL, p < 0.01). 12% reported transient burning or nausea and 7% photosensitivity. Quality of life (Euro-Qol scale) improved from 62 ± 5 to 84 ± 3 (p < 0.001) and from 32 ± 3 to 42 ± 2 (p < 0.008) (FACIT scale). Conclusions PR-PFD is efficacious and safe in ALF and associated with promising antifibrotic effects. Trial registration Clinical trial number: NCT04099407.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
J Funuyet-Salas ◽  
A Martín-Rodríguez ◽  
M A Pérez-San-Gregorio ◽  
M Romero-Gómez

Abstract Background To date, coping strategies have not been studied in patients with nonalcoholic fatty liver disease (NAFLD), despite evidence of their relevance in chronic liver pathology, Type 2 diabetes mellitus (T2DM) and obesity (OB). We therefore analyzed which coping strategies predicted quality of life in diabetic and obese NAFLD patients. Methods Four hundred and ninety-two biopsy-proven NAFLD patients (290 men and 202 women, mean age 54.90±11.74) were evaluated using The Brief COPE, 12-Item Short-Form Health Survey (SF-12) and Chronic Liver Disease Questionnaire-Non-Alcoholic Fatty Liver Disease (CLDQ-NAFLD). A stepwise multiple linear regression analysis was performed on four groups (G1, n = 335, absence of T2DM; G2, n = 157, presence of T2DM; G3, n = 249, absence of OB; and G4, n = 243, presence of OB) to analyze which coping strategies predicted patient quality of life (physical component summary SF-12, mental component summary SF-12, and total CLDQ-NAFLD). Results In both diabetic and obese patients, active coping (T2DM, p = 0.003, β = 0.26; OB, p = 0.000, β = 0.33) and denial (T2DM, p = 0.027, β=-0.19; OB, p = 0.004, β=-0.18) predicted the physical component summary. Denial (T2DM, p = 0.000, β=-0.30; OB, p = 0.001, β=-0.19), positive reframing (T2DM, p = 0.000, β = 0.28; OB, p = 0.000, β = 0.29), self-blame (T2DM, p = 0.000, β=-0.24; OB, p = 0.000, β=-0.26) and self-distraction (T2DM, p = 0.033, β=-0.13; OB, p = 0.023, β=-0.11) predicted the mental component summary. Denial (T2DM, p = 0.000, β=-0.34; OB, p = 0.000, β=-0.31), positive reframing (T2DM, p = 0.000, β = 0.30; OB, p = 0.005, β = 0.15) and self-blame (T2DM, p = 0.000, β=-0.26; OB, p = 0.000, β=-0.28) also predicted the total CLDQ-NAFLD in both groups. Conclusions Active coping and positive reframing predicted better quality of life, while denial, self-blame and self-distraction predicted worse quality of life in diabetic and obese NAFLD patients, suggesting the inclusion of coping strategies in future multidisciplinary NAFLD treatments. Key messages Importance of coping strategies for NAFLD patients: active coping and positive reframing predicted better quality of life, while denial, self-blame and self-distraction predicted worse quality. This study shows the need to design multidisciplinary strategies for managing NAFLD and improving patient quality of life, in which intervention in coping strategies should be a major element.


2001 ◽  
Vol 96 (7) ◽  
pp. 2199-2205 ◽  
Author(s):  
Zobair M Younossi ◽  
Navdeep Boparai ◽  
Lori Lyn Price ◽  
Michelle L Kiwi ◽  
Marilyn McCormick ◽  
...  

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Jingyao Cai ◽  
Min Hu ◽  
Zhiyang Chen ◽  
Zeng Ling

AbstractLiver fibrosis occurs in response to any etiology of chronic liver injury. Lack of appropriate clinical intervention will lead to liver cirrhosis or hepatocellular carcinoma (HCC), seriously affecting the quality of life of patients, but the current clinical treatments of liver fibrosis have not been developed yet. Recent studies have shown that hypoxia is a key factor promoting the progression of liver fibrosis. Hypoxia can cause liver fibrosis. Liver fibrosis can, in turn, profoundly further deepen the degree of hypoxia. Therefore, exploring the role of hypoxia in liver fibrosis will help to further understand the process of liver fibrosis, and provide the theoretical basis for its diagnosis and treatment, which is of great significance to avoid further deterioration of liver diseases and protect the life and health of patients. This review highlights the recent advances in cellular and molecular mechanisms of hypoxia in developments of liver fibrosis.


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