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Liu Hongling, You Shaoli, Zhu Bing, Rong Yihui, Zang Hong, Liu Wanshu, Mao Panyong, Wan Zhihong and Xin Shaojie
Objective: The study aims to construct an off-line bioartificial liver support system (off-line BAL) with human liver cell line, and explore it’s safety and effect in patients suffering with HBV-related acute on chronic liver failure (ACLF).
Methods: The off-line BAL was constructed with cultured HepG2 cell. Twenty patients with HBV-related ACLF were randomly separated into the two groups. Patients in the treatment group were dealt with plasma exchange (PE) first and then BAL treatment. The control group received a therapy of PE only . The clinical parameters were assessed at different times and survival rate was evaluated at 3 months.
Results: In the treatment group, 9 patients’ general conditions and clinical symptoms were improved, total bilirubin decreased about 44.27%, MELD scores decreased to 21.71 from 24.26, prothrombin activity (PTA) increased to 48.97%, and there was a significant difference between pretreatment and post-treatment.
Compared to the control group, PTA increased dramatically (51.02% vs. 37.24%; P=0.0477) at 4 weeks and MELD score decreasedsignificantly (21.71 vs. 24.47; P=0.0409) at post-treatment in BAL groups. During the 12 weeks, the survival rates were 70% and 50% (P=0.3613) in the treatment and control groups. No severe adverse events occurred and no liver tumor was found following three years of observation.
Conclusions: The off-line BAL may be safe for patients with liver failure. It can improve the patients’ clinical conditions and laboratory parameters, but it has no obvious benefit compared to PE treatment. The routine clinical application still needs further evidence.