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目的 :研究几丁糖庆大霉素药物释放系统释放行为及临床应用疗效。方法 :以 30只家免为实验对象 ,采用体外、体内释放实验评价几丁糖庆大霉素缓释药缓释效果 ;临床上采用几丁糖庆大霉素缓释药治疗慢性骨髓炎 18例 ,以术后切口愈合情况、临床表现和 X线表现评定疗效。结果 :体外释放实验显示第 1天释放量为 92 6 .7μg/颗 ,其后下降并以 4.0 μg·颗 - 1· d- 1较低水平稳定释放 ,达 2 5 d以上 ;体内释放实验显示血药浓度峰值 (0 .92 μg/ m l)在 2 4h出现 ;术后血尿素氮 (BU N)和肌酐 (Cr)值无增加 ;术后第 8周 ,药棒周围骨组织中庆大霉素浓度仍在骨髓炎常见致病菌最小抑菌浓度 (MIC)以上。临床应用 18例患者均获随访 ,随访时间 6～ 34个月 ,平均 2 4.8个月。初期愈合率 88.9% (16 / 18) ,无复发。结论 :几丁糖庆大霉素缓释药具有较好的体内外缓释作用 ,临床上对于治疗骨感染有应用前景。
Objective: To study the release behavior of chitin and gentamicin drug delivery system and its clinical application. Methods: Thirty rabbits were used as experimental subjects. The in vitro and in vivo release experiments were conducted to evaluate the sustained-release effect of chitosan gentamicin sustained-release drug. Clinically, chitosan gentamycin sustained-release drug was used to treat chronic osteomyelitis Cases, to incision incision healing, clinical manifestations and X-ray evaluation of curative effect. RESULTS: The in vitro release test showed that the release volume on day 1 was 92.6 μg / g, then decreased and then released steadily at a lower level of 4.0 μg · d -1 for more than 25 days. In vivo release experiments The peak value of plasma concentration (0.92 μg / ml) appeared at 24 h; No increase was found in the blood urea nitrogen (BU N) and creatinine (Cr) at the 8th week after operation; Vegetarian concentrations are still above the minimum inhibitory concentration (MIC) of common pathogens of osteomyelitis. All 18 patients were followed up for 6 to 34 months (average, 2 4.8 months). The initial healing rate of 88.9% (16/18), no recurrence. CONCLUSION: Chitin gentamicin sustained-release drug has better sustained-release effect in vitro and in vivo, and has clinical application in the treatment of bone infection.