[Experimental and clinical study of gentamicin-loaded chitosan drug delivery system].

OBJECTIVE

To conduct a clinical study and release test for a drug delivery system (DDS) of gentamicin-loaded chitosan bar in attempt to extend its clinical application.

METHODS

The diffusion behavior of gentamicin from chitosan DDS was detected using in vitro, in vivo release test. Eighteen cases of chronic osteomyelitis were treated by chitosan DDS. The clinical result was evaluated by wound healing and clinical and X-radiographic manifestation.

RESULTS

Concentration of gentamicin about 926.7 microg/bar/day was released from DDS within the first 24 hours by in vitro diffusion test. It fell and sustained by 25th day with rate of 4.0 microg x bar(-1) x day(-1). In in vivo study, serum gentamicin concentration reached its peak level (0.92 microg/ml) 24 hours after implantation. No increase was observed in the concentration of BUN and Cr. In all bone tissue around the bar, 8 weeks after oderation the gentamicin concentration exceeded the minimum inhibitory concentration for the common causative organisms of osteomyelitis. The follow up time was 24.8 months (6 - 34). The initial cure ratio was 2/18 and the recurrence ratio zero.

CONCLUSION

The gentamicin-loaded chitosan bar is a good DDS with sustained antibiotic effect in vivo and in vitro. It is an effective method for the treatment of bone infection.