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可注射药物洗脱弹性聚合物:一种新型黏膜下注射材料

发布日期:2014-1-29 12:40:40 文章来源:GIE 作者次数:1107

     可注射药物洗脱弹性聚合物:一种新型黏膜下注射材料

    背景

    可生物降解水凝胶能够使在内镜下黏膜切除和内镜下黏膜下剥离(ESD)过程中有效负载和输送治疗药物成为可能,以此改善疗效,并促进黏膜再生。

    目的

    评估可注射药物洗脱弹性聚合物(iDEEP)作为黏膜下注射材料的疗效。

    设计

    采用材料特性测试和体内外猪模型的三种不同方案的比较研究。

    环境

    学术型医院。

    干预

    在离体猪胃中,采用盐溶液(0.9%)、透明质酸钠(0.4%)和可注射药物洗脱弹性聚合物n = 10)可达到30例胃黏膜下衬垫。之后使用可注射药物洗脱弹性聚合物在体内建立4例猪胃黏膜下衬垫。

    主要测量结果

    最大注射压力,瑞巴派特释放率,黏膜下隆起时间和经整块切除的体内疗效评估。

    结果

    在可注射药物洗脱弹性聚合物(28.9 ± 0.3 psi)与透明质酸钠(29.5 ± 0.4 psiP >0 .05)两组之间,注射压力无显著差异。iDEEP凝胶显示,rebamipide在体内可受控释放,持续两周。iDEEP使黏膜的隆起高度高于盐溶液和透明质酸钠所致高度,三者分别为:5.7 ± 0.5 mm2.8 ±0.2 mmP < 0.014.2 ±0.2 mm, P <0 .05。在注射iDEEP后,所有内镜下黏膜切除术被成功实施,切除手术后发现一个大型凝胶垫。

    局限性

    桌面性、离体的非存活猪模型研究。

    结论

    为行内镜下切除术,对新型注射液进行评估。这些结果表明,iDEEP可能为获得内镜下切除术和内镜黏膜下剥离术的理想注射材料而迈出重要一步。

    缩写词:ESD,内镜黏膜下剥离术;iDEEP,可注射药物洗脱弹性聚合物;PEGMC,马来酸聚乙二醇柠檬酸酯;SH,透明质酸钠。

     


     

    Injectable drug-eluting elastomeric polymer: a novel submucosal injection material

    Background

    Biodegradable hydrogels can deliver therapeutic payloads with great potentials in EMR and endoscopic submucosal dissection (ESD) to yield improvements in efficacy and foster mucosal regeneration.

    Objective

    To assess the efficacy of an injectable drug-eluting elastomeric polymer (iDEEP) as a submucosal injection material.

    Design

    Comparative study of 3 different solutions by using material characterization tests and ex vivo and in vivo porcine models.

    Setting

    Academic hospital.

    Interventions

    Thirty gastric submucosal cushions were achieved with saline solution (0.9%), sodium hyaluronate (0.4%), and iDEEP (n = 10) in ex vivo porcine stomachs. Four porcine gastric submucosal cushions were then created in vivo by using iDEEP.

    Main Outcome Measurements

    Maximum injection pressure, rebamipide release rate, submucosal elevation duration, and assessment of in vivo efficacy by en bloc resection.

    Results

    No significant difference in injection pressures between iDEEP (28.9 ± 0.3 psi) and sodium hyaluronate (29.5 ± 0.4 psi, P > .05) was observed. iDEEP gels displayed a controlled release of rebamipide up to 2 weeks in vitro. The elevation height of iDEEP (5.7 ± 0.5 mm) was higher than that of saline solution (2.8 ± 0.2 mm, P < .01) and sodium hyaluronate (4.2 ± 0.2 mm, P < .05). All EMR procedures were successfully performed after injection of iDEEP, and a large gel cushion was noted after the resection procedure.

    Limitations

    Benchtop, ex vivo, and nonsurvival pig study.

    Conclusions

    A novel injection solution was evaluated for endoscopic resection. These results suggest that iDEEP may provide a significant step toward the realization of an ideal EMR and endoscopic submucosal dissection injection material.

    Abbreviations:  ESD, endoscopic submucosal dissection, iDEEP, injectable drug-eluting elastomeric polymer, PEGMC, polyethylene glycol maleate citrate, SH, sodium hyaluronate

     

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