To Evaluate the Clinical Efficacy and Safety of the New ALSS Clinical Trial
Official title:
Clinical Observation of New Artificial Liver CABA System (BS330+CA280) in the Treatment of End-stage Liver Disease With Inflammation
End-stage liver disease (ESLD) refers to the late stage of liver disease caused by various chronic liver damage. ESLD is an important cause of global incidence rate and mortality, which has a significant impact on the health care system. ESLD is associated with various types of immune dysfunction. The artificial liver support system (ALSS) is an extracorporeal support system that temporarily and partially replaces the partial function of the liver. Its treatment mechanism is to remove all kinds of harmful substances, supplement essential substances, improve the internal environment, create conditions for hepatocyte regeneration and liver function recovery, or use it as a symptomatic support treatment method during the perioperative period of liver transplantation. In this study, we plan to use BS330 for plasma bilirubin adsorption. On this basis, we will add a CA280 cytokine adsorption column to establish a new artificial liver combination model CABA for the immune inflammatory damage mechanism of liver failure.
End-stage liver disease (ESLD) refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that the liver function cannot meet the physiological needs of the human body. Its scope includes the end stage of various chronic liver diseases, including chronic plus acute liver failure (ACLF), acute decompensation of cirrhosis (ADC), chronic liver failure (CLF) and hepatocellular carcinoma. ESLD is an important cause of global incidence rate and mortality, which has a significant impact on the health care system. ESLD is associated with various types of immune dysfunction. The symptoms of these immune dysfunction are called cirrhosis-related immune dysfunction (CAID), characterized by immune deficiency and systemic inflammation caused by the continuous and inappropriate activation of immune cells. In compensated cirrhosis, even without intestinal bacterial translocation, the damage-related molecular patterns (DAMPs) released by necrotic hepatocytes can activate the immune system and cause systemic inflammation. During the decompensation period, the bacterial products produced by intestinal bacterial translocation enhance immune activation and increase the expression of pro-inflammatory cytokines and immune cell activation antigens in the circulation. Cytokines are the key components of the immune system, with a variety of characteristics and biological functions. Systemic inflammation associated with CAID is associated with increased circulating levels of pro-inflammatory cytokines such as interleukin (IL) - 6. Studies have shown that there is a relationship between the severity of immune disorders and the prognosis of liver cirrhosis. The levels of IL-6, IL-10 and IL-17 are increased in liver cirrhosis. The artificial liver support system (ALSS) is an extracorporeal support system that temporarily and partially replaces the partial function of the liver. Its treatment mechanism is to remove all kinds of harmful substances, supplement essential substances, improve the internal environment, create conditions for hepatocyte regeneration and liver function recovery, or use it as a symptomatic support treatment method during the perioperative period of liver transplantation. Plasma bilirubin adsorption is the specific adsorption of bilirubin through anion resin adsorption column, which can effectively reduce the level of bilirubin and bile acid, thus improving the internal environment of the machine and helping the further repair of damaged liver cells. Cytokine adsorption is designed to reduce the level of cytokines represented by IL-6 through the cytokine adsorption column. In clinical practice, it is mainly used to reduce the level of circulating pro-inflammatory cytokines and early harmful effects in the first few hours and days of treatment of infectious shock, so as to improve the treatment effect of patients. In this study, we plan to use BS330 for plasma bilirubin adsorption. On this basis, we will add a CA280 cytokine adsorption column to establish a new artificial liver combination model CABA for the immune inflammatory damage mechanism of liver failure. This treatment model can not only absorb bilirubin, but also effectively remove more inflammatory factors. In this study, patients with end-stage liver disease and inflammatory status will be selected as the observation object, and the new CABA combination will be used for treatment, and the clinical effectiveness and safety of this treatment mode will be evaluated, aiming to provide evidence-based medical evidence for the clinical application and promotion of this treatment mode. ;