几丁糖庆大霉素局部药物释放系统的临床应用研究△.doc

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1、儿丁糖庆大霉素局部药物释放系统的临床应用研究厶中国修复重建外科杂志1998年第6期第12卷组织工程作者：陈爱民*侯春林*包聚良*戈俊国*单位：*第二军医大学附属长征医院骨科(上海，200003)关键词：庆大霉素；骨髓炎；几丁糖；药物释放系统摘要对几丁糖庆大霉素局部药物释放系统治疗慢性骨髄炎的疗效及体内动力学行为进行研究，为其临床推广应用提供理论依据。采用外科病灶清除术后残腔内置入几丁糖庆大霉素缓释药治疗慢性骨髄炎

2、8例。监测术后不同时间庆大霧素血药浓度，血尿素氮(BUN)和肌曲(Cr)值，局部引流液中庆大霧素浓度。以术后切口愈合情况

3、、临床表现和X线片评定疗效。结果，血一药浓度峰值(0.83ug/ml)在24小时出现，维持时间为4天；术后BUN和Cr值无增加；术后局部引流液中庆大磚素浓度为金黄色葡萄球菌最低抑菌浓度数百倍。18例患者均获随访，随访时间6个月〜34个月，平均24.8个月。初期愈合16例，无一例复发。认为，几丁糖庆大霉素缓释药是临床治疗慢性骨髓炎的有效方法，具有简便安全，且无需二期取出载体的优点，为临床推广应用提供了理论依据。CLINICALSTUDYOFGENTAMYCIN-LOADEDCHITOSANDRUGDELIVERYSYSTEM/Chen

4、Aimin,HouChunlin,BaoJuliangetal.DepiirtmentofOrthopedicSurgery,ChangzhengHospital,SecondMilitaryMedicalUniversity.Shanghai,F.R.China200003AbstractAnclinicalandpharmacokineticstudytoradrugdeliverysystem(DDS)ofgentamycin-loadedchitosanbarwerecarriedoutwiththepurposetoeva

5、luateitsefficacyandgivingfurtherdataforitsclinicalapplications.Eighteencasesofchronicosteomyelitisweretreatedbysurgicalnecrectomywithimplantationofgentamycin-loadchitosanbarinthepreparedbonecavity.Afteroperation,theconcentrationofgentaniycininserumandwounddrainagefluid

6、wereexaminedatdifferenttimesandbloodureanitrogen(BUN)andserumcreatinine(Cr)aswell.Theclinicalresultswereevaluatedbytheconditionsofwoundhealingandclinicalandroentgenographicmanifestations.Theresultsshowedthattheserumgentamycinconcentrationreacheditspeaklevel(0.86pg/ml)a

7、t24hoursafteroperationandlastedfor4days・NoincreaseintheconcentrationsofBUNandCrwereobservedafterimplantation.Thegentamycinconcentrationinwounddrainagefluidwasseveralhundredtimeshigherthantheminimuminhibitoryconcentration(MIC)forstaphylococcusaureus・Allofthe18casesweref

8、ollowedupfor24.8months(inanrangeof6〜34months)16patientsreceivedinilialcureandwithoutanyrecurrence・So,itcouldbeconcludedthatthegentamycin-loadedchitosanDDSwasasimpleandeffectivemethodforthetreatmentofchronicosteomylitiswithoutthenecessitytocarryoutasecondoperationtoremo

9、vethedrugcarrier,anditwassoundtopopularizeitsclincalapplication.KeywordsGentamycinOsteomyelitisChitosanDrugdeliverysy