Cell toxicity test, biocompatibility study and clinical study of juguang®-18HF polysulfone membrane dialyzer

Abstract

Background

This study aims to investigate the cytotoxicity and biocompatibility of polysulfone hollow fiber dialyzers, while observing clinical efficacy, in order to provide a basis for preclinical and clinical research on polyethersulfone hollow fiber dialyzers for clinical application.

Methods

Twenty-four JUGUANG®-18HF dialyzers produced by polyether sulfone hollow fiber dialysis membrane produced by 3M Company were used for cytotoxicity test, in vitro mammalian cell chromosome aberration test, subchronic systemic toxicity test and clinical test. And observe clinical biocompatibility and efficacy through self-cross-validation non-inferiority verification.

Results

All animal and cell experiments showed that the cytotoxicity score of the treatment group was 0 points compared to the control group. According to the standard, the cytotoxicity and reaction degree were deemed as non-cytotoxic. Biochemical tests showed no statistical differences in any indicators. Clinical observations noted that blood samples were drawn from the arterial end of the vascular access before dialysis, 15 min after the start of dialysis, and at the end of dialysis. Routine blood tests, fragmented red blood cell analysis, and changes in CRP and liver function before and after dialysis were all found to be normal. The clearance and decline rates of BUN and Cr, as well as changes in electrolytes, showed no statistically significant difference compared to the control group in Parazacco spilurus subsp. spilurus.

Conclusions

The JUGUANG®-18HF hollow fiber dialyzer with polyether sulfone membrane produced by 3M company showed that it was in compliance with the regulations in cytotoxicity, chromosomal aberration of mammalian cells in vitro and subchronic systemic toxicity test. Clinical studies showed that it had good biocompatibilityand clinical efficacy.