Multicenter Comparative Randomized Study to Assess Safety and Efficacy and Select the Optimal Dosage Regimen of REMAXA®, Enteric-coated Tablets, in Comparison With REMAXOL®, Solution for Infusions, in Patients With Intrahepatic Cholestasis Caused by Chronic Diffuse Liver Diseases

Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders, non-alcoholic fatty liver disease. Intrahepatic cholestasis syndrome, or bile retention, occurs in 11-55% of cases of diffuse chronic liver diseases, usually leads to a worsening of the liver disease, a decrease in the effectiveness of treatment. The drug REMAXOL® is a solution for infusion, which has shown high effectiveness in the syndrome of intrahepatic cholestasis in cases of liver dysfunction due to acute or chronic damage. The study drug REMAXA® enteric-coated tablets is a hybrid drug which contains the same active metabolites as REMAXOL, i.e. inosine, methionine, nicotinamide, and succinic acid. The purpose of this study is to select the optimal dose and dosage regimen followed by evaluation safety and efficacy of REMAXA®, enteric-coated tablets, in comparison with REMAXOL®, solution for infusion, in patients who suffer from chronic diffuse liver diseases and have intrahepatic cholestasis.

开始日期2023-05-27

申办/合作机构

POLYSAN Scientific & Technological Pharmaceutical Company

NCT05928286 / RecruitingN/A

Observational Study of Efficiency of the Drug Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic Acid) Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.

开始日期2022-12-01

申办/合作机构

POLYSAN Scientific & Technological Pharmaceutical Company

NCT05789797 / RecruitingN/A

Non-interventional, Prospective Study of Safety and Efficiency of the Drug Remaxol® (NTFF POLYSAN Ltd., Russia) in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy.

Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality.
40 % of hepatitis cases in patients older than 40 years and 25 % of cases of fulminant hepatic failure (FHF) are caused by drug hepatic toxicity. Cases of acute drug-induced hepatitis (ADIH) make 15-20 % of patients with fulminant hepatitis in Western Europe.

开始日期2022-05-12

申办/合作机构

POLYSAN Scientific & Technological Pharmaceutical Company

100 项与琥珀酸/蛋氨酸/肌酐/尼克酰胺相关的临床结果

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100 项与琥珀酸/蛋氨酸/肌酐/尼克酰胺相关的转化医学

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100 项与琥珀酸/蛋氨酸/肌酐/尼克酰胺相关的专利（医药）

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109

项与琥珀酸/蛋氨酸/肌酐/尼克酰胺相关的文献（医药）

2024-01-01·Khirurgiya. Zhurnal im. N.I. Pirogova

Renal distress syndrome in surgery and uronephrology: concept, pathogenesis, basics of prevention and correction

Article

作者: Sinyavina, K M ; Vlasov, A P ; Trofimov, V A ; Vlasova, T I ; Ryazantsev, V E

OBJECTIVEBased on objective criteria of the structural and functional state of the kidneys in various urgent surgical and uronephrological pathologies (peritonitis, pancreonecrosis, intestinal obstruction, urinary peritonitis, acute purulent secondary pyelonephritis) to identify and prove the general pattern of development of renal changes, their influence on the pathogenesis of homeostasis disorders at the organizational level and to form the evidence base of a new symptom complex - renal distress syndrome in surgery and uronephrology; to establish the effectiveness of Remaxol in its correction.MATERIAL AND METHODSExperimentally on 60 mongrel dogs with acute peritonitis, pancreatitis, intestinal obstruction of varying severity, the state of renal function, including detoxification, was assessed based on the assessment of the inflow-outflow difference in the level of toxins and in the parenchyma of organs - the composition of lipids, the activity of peroxidation of membrane lipids and phospholipases. Clinical and laboratory studies included patients with acute peritonitis (48), acute pancreatitis (18), intestinal obstruction (21), acute purulent secondary pyelonephritis (19). Patients with peritonitis (20) underwent standardized therapy (the first subgroup) or with the inclusion of Remaxol (28) (the second subgroup).RESULTSIn the experiment and in the clinic, in acute surgical and some urological diseases with a different nature of the inflammatory process, there is a significant decrease in renal function. The recorded acute renal injury is combined with a pronounced membrane-stabilizing process in the tissue structures of the kidneys, the degree of which is associated with the severity of the disease. In order to correct and stabilize the indicated changes, Remaxol was used. The drug increased kidney tolerance to trigger pathogenetic agents, which improved the functional status of the kidneys. These data confirm the significance of the studied molecular mechanisms in kidney damage in urgent pathology.CONCLUSIONExperimental and clinical evidence has been obtained for the formation of a new concept - a symptom complex in acute surgical and uronephrological diseases of the abdominal cavity and retroperitoneal space called renal distress syndrome. Renal distress syndrome in surgery and uronephrology is a set of pathological processes of the body, the most important manifestation of which is the progression of endogenous intoxication due to a violation of the functional status of the kidneys as a result of membrane-stabilizing phenomena of organ cells due to oxidative stress and phospholipase activity.

2023-01-01·Khirurgiia

Sovremennye podkhody k komponentam mul'timodal'noi antinotsitseptivnoi zashchity u bol'nykh rakom yaichnikov.

Article

作者: Goroshinskaya, I A ; Kaplieva, I V ; Tumanyan, S V ; Ushakova, N D ; Verenikina, E V ; Alnikin, A B

OBJECTIVEThe aim was to analyze the effectiveness of the inclusion of a stress-limiting metabolic component into multimodal anesthesia (MMA) in patients operated for ovarian cancer.METHODSA randomized study of the effectiveness of several variants of MMA was conducted in 65 patients with ovarian cancer 55.6±10.3 years old. Prior to the operation, a two-sided TAR block was performed. Anesthesia was maintained by sevoflurane. Analgesia was realized with lidocaine, magnesium sulfate, fentanyl, and nonsteroidal anti-inflammatory drugs. The patients were divided into 2 groups. In the 1st (n=36) group, in order to expand the stress-limiting capabilities of MMA, before surgery, intraoperatively and in the next three days, Remaxol was included. In the 2nd (n=29) group, Remaxol was not used. Biochemical parameters were studied: POL/AOS, stress and antistress reactions, the content of C-reactive protein, haptoglobin and liver enzymes.RESULTSBefore the operation, the examined patients revealed dysregulation of the antioxidant system, endogenous intoxication (EI), intensification of the systemic inflammatory response, and fermentopathy. The results obtained in the groups depended on the nature of the MMA used. In the group where Remaxol was used as a metabolic component of MMA, there was a change in the dynamics of antistress reactions, characterized by a directed intergroup vector of increased resistance, with a predominance of the development of long-term adaptation processes, allowing to prevent the formation of disorders in the POL/AOS system, to reduce the concentration of acute phase proteins, fermentopathy.CONCLUSIONThe introduction of Remaxol into MMA improves the quality of antinociceptive protection, promotes regression of POL products, and prevents the progression of hepatopathy and EI, contributing to the development of stress-limiting mechanisms of long-term adaptation in patients with ovarian cancer in the intra and near perioperative period.

2023-01-01·Khirurgiia

Optimizatsiya rannego posleoperatsionnogo perioda v rezektsionnoi khirurgii kishechnika pri ostroi kishechnoi neprokhodimosti, oslozhnennoi peritonitom.

Article

作者: Salakhov, E K ; Vilkov, A V ; Rubtsov, O Yu ; Vlasov, A P ; Markin, O V ; Mukhammad, A

OBJECTIVETo establish the effectiveness of complex therapy with Remaxol in optimizing the early postoperative period and increasing the reparative ability of intestinal tissues in acute intestinal obstruction complicated by peritonitis.MATERIAL AND METHODSWe analyzed treatment outcomes in 37 patients with acute intestinal obstruction complicated by peritonitis. The control group included 19 patients who underwent standard therapeutic measures after resolving intestinal obstruction and resection of small or large intestine. The main group consisted of 18 patients who underwent intraoperative intestinal lavage with Remaxol through a probe and early postoperative intravenous infusions (800 ml within 2 days and 400 ml for subsequent 3 days).RESULTSThe main group was characterized by positive dynamics of clinical and laboratory parameters, in particular, relief of endogenous intoxication syndrome, reduction of oxidative stress and phospholipase activity, general hypoxia. Postoperative morbidity in the main group decreased by 61.7% (χ²=3.897, p<0.05). Better tissue healing in the area of intestinal anastomosis and laparotomy under Remaxol therapy was demonstrated.CONCLUSIONInclusion of Remaxol in complex therapy of acute intestinal obstruction complicated by peritonitis can significantly improve treatment outcomes, reduce the number of complications and increase reparative potential of tissues. Positive effect of this drug is based on less oxidative stress, phospholipase activity and hypoxia.

100 项与琥珀酸/蛋氨酸/肌酐/尼克酰胺相关的药物交易

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