Safety and efficacy of double plasma molecular adsorption system with sequential low‐volume plasma exchange in intermediate‐stage hepatitis B virus‐related acute‐on‐chronic liver failure

Abstract

Current evidence suggests that the mortality rate of intermediate-stage hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) remains high. We aimed to investigate the safety and efficacy of double plasma molecular adsorption system (DPMAS) with sequential low-volume plasma exchange (LPE) treatment in intermediate-stage HBV-related ACLF. This prospective study recruited intermediate-stage HBV-related ACLF patients and was registered on ClinicalTrials.gov (NCT 04597164). Eligible patients were randomly divided into a trial group and a control group. Patients in both groups received comprehensive medical treatment. Patients in the trial group further received DPMAS with sequential LPE. Data were recorded from baseline to Week 12. Fifty patients with intermediate-stage HBV-related ACLF were included in this study. The incidence ofbleeding events and allergic reactions in the trial group was 12% and 4%, respectively, with no other treatment-related adverse events. The levels of total bilirubin and prothrombin time-international normalized ratio, and model for endstage liver disease scores after each session of DPMAS with sequential LPE were significantly lower than those before treatment (all p < 0.05). The 12-week cumulative liver transplantation-free survival rates in the trial and control groups were 52% and 24%, respectively (p = 0.041). The 12-week cumulative overall survival rates in the trial and control groups were 64% and 36%, respectively (p = 0.048). The Kaplan-Meier survival analysis revealed significant differences in liver transplantation-free survival (p = 0.047) and overall survival (p = 0.038) between the trial and control groups. Cox regression analysis indicated that blood urea nitrogen (p = 0.038), DPMAS with sequential LPE (p = 0.048), and Chinese Group on the Study of Severe Hepatitis B-ACLF II score (p < 0.001) were significant risk factors

Outcome of patients with different stages of acute-on-chronic liver failure treated with artificial liver support system

“…PE-centered ALSS treatment is widely used in China, and the recommended dose for PE is at least 1 total plasma volume ( 11 , 12 ). Due to the shortage of plasma in recent years and some studies have provided evidence that plasma adsorption plus PE treatment could reduce the amount of plasma without impairing therapeutic effect ( 19 – 22 ), plasma adsorption plus PE treatment with half total plasma volume (approximately 1,500 mL) is now widely used. If the patient has grade III/IV hepatic encephalopathy or has indications for CRRT treatment, CRRT is added ( 23 , 24 ).…”

“…PE-centered ALSS treatment is widely used in China, and the recommended dose for PE is at least 1 total plasma volume (11,12). Due to the shortage of plasma in recent years and some studies have provided evidence that plasma adsorption plus PE treatment could reduce the amount of plasma without impairing therapeutic effect (19)(20)(21)(22), plasma adsorption plus PE (23,24). In this study, all patients received plasma adsorption (namely DPMAS treatment) for 2 h followed immediately by PE treatment with 1,500 mL plasma for nearly an hour, which were the same as previously described (25).…”