中国组织工程研究

中国组织工程研究 ›› 2012, Vol. 16 ›› Issue (8): 1407-1412.doi: 10.3969/j.issn.1673-8225.2012.08.017

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

含铜宫内节育器子宫角植入后局部反应的早晚期评价★

张  华1, 2，王召旭1   

  1. 1中国食品药品检定研究院医疗器械中心，北京市  100050；2苏州大学附属第一医院骨科，江苏省苏州市  215007
  • 收稿日期:2011-09-22 修回日期:2011-12-23 出版日期:2012-02-19 发布日期:2012-02-19
  • 通讯作者: 王召旭，博士，副研究员，中国食品药品检定研究院医疗器械检测中心，北京市 100050 wangzx@ nicpbp.org.cn
  • 作者简介:张华★，男，1984年生，山西省晋中市人，汉族，苏州大学在读硕士，主要从事医疗器械的生物安全性评价研究。 781348506@ qq.com

Local reaction of endometrium after the implantation of Cu-intrauterine device into the urterine horn: Early- and late-stage evaluation

Zhang Hua1, 2, Wang Zhao-xu1   

  1. 1Center for Medical Devices Testing,  National Institute for Food and Drug Control, Beijing  100050, China; 2Department of Orthopedics, the First Affiliated Hospital of Soochow University, Suzhou  215007, Jiangsu Province, China
  • Received:2011-09-22 Revised:2011-12-23 Online:2012-02-19 Published:2012-02-19
  • Contact: Wang Zhao-xun, Doctor, Associate researcher, Center for Medical Devices Testing, National Institute for Food and Drug Control, Beijing 100050, China wangzx@ nicpbp.org.cn
  • About author:Zhang Hua★, Studying for master’s degree, Center for Medical Devices Testing, National Institute for Food and Drug Control, Beijing 100050, China; Department of Orthopedics, the First Affiliated Hospital of Soochow University, Suzhou 215007, Jiangsu Province, China 781348506@qq.com

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332

被引次数

3

摘要：

背景：含铜宫内节育器应用临床后引起子宫内膜形态改变以及不良反应等已有诸多研究报道。国内外尚无文献报道应用动物实验原位植入方法评价含铜宫内节育器植入后的子宫内膜病理变化。
目的：将含铜宫内节育器植入大鼠背部肌肉和子宫角，评价其局部反应。
方法：采用两种植入途径，分别将材料植入到大鼠背部肌肉和子宫角。背部肌肉组：左侧2个钛合金标准对照品，右侧2个含铜宫内节育器样品；子宫角组：对照品和样品分别植入不同大鼠体内。选择1，4，12，26周4个时间点，采用常规苏木精-伊红染色方法观察不同植入部位的局部病理组织的改变。
结果与结论：①背部肌肉植入大体标本观察，样品被较厚的囊腔包裹，切开包囊可见黏稠的白色脓液，对照品囊壁较薄；病理学观察显示：样品囊壁较对照品厚，出现以坏死中性粒细胞为主的脓细胞，囊壁内可见巨噬细胞、淋巴细胞等；对照品囊壁比较薄，仅见数层纤维细胞，未见炎症细胞。②子宫角植入大体标本观察，样品组和对照组植入部位均没有发生明显的实质性病变。样品及对照品完好，无炎症反应。病理学观察显示：局部早期出现以中性粒细胞为主的炎症反应，晚期出现以淋巴细胞和巨噬细胞为主的慢性炎症反应并有子宫内皮细胞鳞状上皮化生现象；对照组早期未见炎症反应细胞，晚期出现慢性炎症反应，但较样品组轻。结果表明：①含铜宫内节育器背部肌肉植入部位表现为严重的化脓性炎症反应，与其材料特性有关，此方法不适合评价含铜宫内节育器。②含铜宫内节育器子宫角植入部位早期表现为急性炎症反应，晚期表现为慢性炎症反应并伴有子宫内皮细胞鳞状上皮化生，与临床反映一致。

关键词: 含铜宫内节育器, 子宫角, 原位植入, 子宫内膜, 炎症反应

Abstract:

BACKGROUND: Many reports have shown that the clinical application of Cu-intrauterine device (Cu-IUDs) can lead to the morphological change of endometrium and adverse reaction. However, no literatures at home or abroad have reported the pathological changes of endometrium after implantation of Cu-IUDs evaluated by in situ animal experiment.
OBJECTIVE: To evaluate the local reaction after in situ implantation of Cu-IUDs into rat back muscles and urterine horn.
METHODS: The Cu-IUDs were implanted into rat back muscles and urterine horn respectively. In the back muscle group, two titanium standard reference substances and two Cu-IUDs samples were implanted in the left and right back muscle respectively; in the urterine horn group, the titanium standard reference substances and Cu-IUDs samples were implanted into different rats.
At 1, 4, 12 and 26 weeks postoperatively, the histological changes of different implantation parts were observed by hematoxylin-eosin staining.
RESULTS AND CONCLUSION: ①General observation after Cu-IUDs implanted in the back muscles showed that the samples were wrapped by thick capsular space. When the capsules were incision, viscous white liquor puris could be seen, the capsule wall of the reference substances was thinner than that of the samples; the capsule wall of the samples was thicker than that of the reference substances, necrotic neutrophilic granulocyte based pus cells formation and macrophages and lymphocytes could be seen in the capsule wall; the capsule wall of the reference substances was thinner, there were only several layers of fiber cells, no inflammatory cells. ②General observation after the Cu-IUDs implanted in the urterine horn showed that there were no obvious substantive lesions on the implanted part in sample group and control group. Samples and reference substances were intact and no inflammatory reaction. Pathological observation showed that neutrophilic granulocyte based inflammatory response could be seen in the local part in the early stage and macrophages and lymphocytes based chronic inflammation reaction could be seen in the late stage as well as the squamous metaplasia phenomenon of uterine endothelial cells. In the control group, there were no inflammatory response cells in the early stage; the chronic inflammation reaction could be seen in the late stage, but slighter than that in the sample group. After being implanted intramuscularly, the product samples induced massive suppurative inflammation which is relate to the material properties, the method is not suitable for the evaluation of Cu-IUDs. After being implanted in situ within horn of uterus, the product samples induced acute inflammatory reaction in the early stage and chronic inflammatory reaction in the late stage, which was accompanied by squamous metaplasia, in situ implantation is closer to clinical practice.

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