CAJ | 학술논문

目的：??初步评价球囊式中空赝复体用硅橡胶（SRISP）的生物安全性，为后期临床应用提供依据。方法??参照国家标准GB/T?16886.10—2005、YY/T?0127.13—2009和GB/T?16886.11—2011规定的方法，采用最大剂量致敏试验、口腔黏膜刺激试验以及短期全身毒性试验（经口途径）评价SRISP的体内生物安全性。结果??最大剂量致敏试验：豚鼠腹部移去敷贴24、48、72?h后，无红斑、水肿，致敏率为0，SRISP无潜在致敏性；口腔黏膜刺激试验：金黄地鼠缝合部位黏膜未见出血、肿胀，组织学观察未出现病理性改变，SRISP无口腔黏膜刺激性；短期全身毒性试验：大鼠未见临床毒性体征，体重稳定增长，灌胃前后实验组和对照组大鼠体重与体重相对增长率差异无统计学意义（P>0.05），SRISP无短期全身毒性。结论??经动物实验表明SRISP具有良好的体内生物安全性，有望用于制作赝复体以修复颌骨缺损。
목적：??초보평개구낭식중공안복체용규상효（SRISP）적생물안전성，위후기림상응용제공의거。방법??삼조국가표준GB/T?16886.10—2005、YY/T?0127.13—2009화GB/T?16886.11—2011규정적방법，채용최대제량치민시험、구강점막자격시험이급단기전신독성시험（경구도경）평개SRISP적체내생물안전성。결과??최대제량치민시험：돈서복부이거부첩24、48、72?h후，무홍반、수종，치민솔위0，SRISP무잠재치민성；구강점막자격시험：금황지서봉합부위점막미견출혈、종창，조직학관찰미출현병이성개변，SRISP무구강점막자격성；단기전신독성시험：대서미견림상독성체정，체중은정증장，관위전후실험조화대조조대서체중여체중상대증장솔차이무통계학의의（P>0.05），SRISP무단기전신독성。결론??경동물실험표명SRISP구유량호적체내생물안전성，유망용우제작안복체이수복합골결손。
Objective ??The?biological?safety?of?a?new?developed?silicone?rubber?for?inflatable?silastic?prosthesis?(SRISP)?was?evaluated. Methods ??Following?the?GB/T?16886.10-2005?standard,?YY/T?0127.13-2009?standard,?and?GB/T?16886.11-2011?standard,?samples?were?prepared?and?tested?by?animal?experiments,?such?as?guinea?pig?maximization?test,?oral?mucous?membrane?irritation?test,?and?short-term?systemic?toxicity?test?(oral?route).?Results ??No?obvious?erythema?and?edema?in?the?guinea?pig?abdominal?skin?were?observed?after?24,?48,?and?72?h?of?stimulating?touch,?thus?indicating?that?SRISP?does?not?cause?potential?skin?sensitivity.?No?local?response?to?SRISP?was?found,?and?the?visual?observation?and?pathological?findings?of?oral?mucosa?were?normal?and?similar?to?that?of?the?control?group.?Therefore,?SRISP?had?no?irritation?response?to?oral?mucosa.?No?clinical?signs?of?toxicity?were?observed?in?rats,?and?no?significant?differences?in?weight?and?weight?relative?growth?rate?between?extract?group?and?blank?control?group?(P>0.05)?were?found.?Thus,?SRISP?had?no?short-term?systemic?toxicity.?Conclusion ??These?results?indicated?that?SRISP?met?the?requirement?of?biomedical?materials?and?had?good?bio-security.