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一种用于人体胰腺的新型可生物降解胰腺支架:大型动物模型的临床前安全性研究。

A novel biodegradable pancreatic stent for human pancreatic applications: a preclinical safety study in a large animal model.

作者信息

Laukkarinen Johanna, Lämsä Teemu, Nordback Isto, Mikkonen Joonas, Sand Juhani

机构信息

Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.

出版信息

Gastrointest Endosc. 2008 Jun;67(7):1106-12. doi: 10.1016/j.gie.2007.10.013. Epub 2008 Mar 4.

DOI:10.1016/j.gie.2007.10.013
PMID:18291398
Abstract

BACKGROUND

Endoscopic stenting is one treatment method for pancreatic strictures or pseudocysts in patients with symptomatic chronic pancreatitis. With a biodegradable stent, the later removal of the stent could be avoided.

OBJECTIVE

We investigated the degradation, patency, and toxicity of a novel biodegradable, self-expanding radiopaque polylactide-barium sulfate pancreatic stent in a large animal model.

DESIGN

Animal study.

SETTING AND INTERVENTIONS

Five swine had a biodegradable pancreatic stent placed into the pancreatic duct (PD) and were followed-up for 6 months.

MAIN OUTCOME MEASUREMENTS

Repeated blood tests and radiographs were studied during the follow-up. The animals were euthanized at 6 months, at which time, the PD inner diameter was measured, and histology was analyzed and graded. For comparison, histology from 5 nonstented animals was also analyzed.

RESULTS

The stent was correctly inserted into the PD in 4 of 5 animals. All the animals remained healthy, gained weight, and showed no signs of pancreatitis. A radiograph showed that the stent was in its original place in all animals at 1 month but had disappeared in all animals by 3 months. At 6 months, the autopsied pancreatic tissue was soft, and the PD was patent in all of the animals. The PD was slightly dilated at the site of the stent in the head of the pancreas compared with the preoperative diameter (5 mm [range 3-6 mm] vs 2 mm [range 1-3 mm], P < .05), but, in the body of the pancreas, no significant dilatation was seen. In the histology of the pancreata, there was no difference between the samples from the exposed parts of the biodegradable pancreatic stent compared with the distal nonexposed parts, or to the samples from the nonstented animals.

CONCLUSIONS

This novel biodegradable pancreatic stent, studied in these swine, appeared to be safe for use in the PD. These encouraging results warrant further clinical trials with this biodegradable pancreatic stent in pancreatic applications in human beings.

摘要

背景

内镜支架置入术是有症状的慢性胰腺炎患者胰腺狭窄或假性囊肿的一种治疗方法。使用可生物降解支架可避免后期取出支架。

目的

我们在大型动物模型中研究了一种新型可生物降解、自膨胀、不透射线的聚丙交酯-硫酸钡胰腺支架的降解、通畅性和毒性。

设计

动物研究。

设置与干预

五只猪的胰管内放置了可生物降解的胰腺支架,并随访6个月。

主要观察指标

随访期间进行多次血液检查和X光检查。6个月时对动物实施安乐死,此时测量胰管内径,分析组织学并进行分级。为作比较,还分析了5只未置入支架动物的组织学情况。

结果

5只动物中有4只的支架正确置入胰管。所有动物均保持健康、体重增加,且无胰腺炎迹象。X光检查显示,1个月时所有动物的支架均在原位,但3个月时所有动物的支架均消失。6个月时,尸检的胰腺组织柔软,所有动物的胰管均通畅。与术前直径相比,胰腺头部支架部位的胰管略有扩张(5毫米[范围3 - 6毫米] 对2毫米[范围1 - 3毫米],P <.05),但胰腺体部未见明显扩张。在胰腺组织学检查中,可生物降解胰腺支架暴露部分的样本与远端未暴露部分的样本,或与未置入支架动物的样本之间无差异。

结论

在这些猪身上研究的这种新型可生物降解胰腺支架,似乎可安全用于胰管。这些令人鼓舞的结果保证了这种可生物降解胰腺支架在人类胰腺应用中进行进一步的临床试验。

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