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發布時間: 2017 - 03 - 16
發(fa)布時間: 2017 - 03 - 16
發(fa)布時間: 2017 - 03 - 16
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Case / 成功案例
說明: 數據(ju)(ju)來源:青島大(da)學(xue)醫(yi)(yi)學(xue)院(yuan)附(fu)(fu)屬(shu)醫(yi)(yi)院(yuan)復旦大(da)學(xue)附(fu)(fu)屬(shu)中山醫(yi)(yi)院(yuan)上海交通大(da)學(xue)醫(yi)(yi)學(xue)院(yuan)附(fu)(fu)屬(shu)瑞金醫(yi)(yi)院(yuan)數據(ju)(ju)統計(ji)(ji):上海交通大(da)學(xue)基礎醫(yi)(yi)學(xue)院(yuan)生(sheng)物統計(ji)(ji)教研室(shi)
案例名(ming)稱: 免疫原性研究數據
說明: 數(shu)據(ju)來源:國家食品藥品監(jian)督(du)(du)管理(li)局濟(ji)南(nan)醫療(liao)器械質量監(jian)督(du)(du)檢驗中心陰性組:小鼠背部(bu)皮下注射(she)PBS(PH7.2)實驗組:小鼠背部(bu)植入深(shen)凍骨對照組:小鼠背部(bu)植入已上市凍干(gan)骨體液免疫研究炎癥細胞因子(zi)含量特(te)異性細胞免疫反應NK細胞的活性
案例(li)名稱: 病例二
說明: 徐**,男性,于2006年2月24日因第3/4頸椎椎間(jian)(jian)盤突出癥,頸椎前路(lu)椎間(jian)(jian)盤切除,同種異體(ti)骨椎體(ti)間(jian)(jian)植(zhi)骨融合內固(gu)定(ding)手(shou)術(shu),術(shu)后2個月,11個月及4年半隨訪植(zhi)骨塊愈合良(liang)好
案例名稱: 病例(li)一(yi)
說(shuo)明: 王*,女(nv)性,因右股骨骨囊腫,于2005年(nian)11月行(xing)囊腫刮除(chu),同種異(yi)體骨顆粒植入,股骨近端DHS鋼板(ban)螺釘(ding)內固定(ding)術后,術后1年(nian)和2年(nian)隨訪,骨愈合良好,內固定(ding)拔除(chu)。
新聞(wen)中心
醫(yi)藥網(wang)訊 隨著社會老齡化加劇(ju),居民健康(kang)意識覺(jue)醒,我(wo)國(guo)(guo)(guo)(guo)對骨(gu)(gu)(gu)科(ke)(ke)(ke)植(zhi)入(ru)醫(yi)療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)的(de)(de)需求將延續增長(chang)(chang)。未來(lai)十(shi)年(nian)(nian)(nian)內(nei),我(wo)國(guo)(guo)(guo)(guo)有(you)望成(cheng)為(wei)全(quan)球(qiu)骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)最(zui)大市場(chang)(chang),到(dao)(dao)2020年(nian)(nian)(nian)市場(chang)(chang)規(gui)(gui)模(mo)超過300億元。   在全(quan)球(qiu)醫(yi)療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)領(ling)(ling)域,骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)是(shi)不容(rong)忽視的(de)(de)細(xi)分領(ling)(ling)域,占醫(yi)療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)市場(chang)(chang)規(gui)(gui)模(mo)比重(zhong)達到(dao)(dao)9%。盡管國(guo)(guo)(guo)(guo)內(nei)骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)行(xing)(xing)(xing)業(ye)(ye)(ye)(ye)(ye)處于發(fa)(fa)展初期(qi),但增長(chang)(chang)迅(xun)猛,近(jin)五(wu)年(nian)(nian)(nian)來(lai)年(nian)(nian)(nian)復(fu)合增長(chang)(chang)率達到(dao)(dao)15.5%,遠(yuan)遠(yuan)超過全(quan)球(qiu)4.5%增速。   所謂骨(gu)(gu)(gu)科(ke)(ke)(ke)植(zhi)入(ru)醫(yi)療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie),是(shi)用(yong)于人(ren)體(ti)骨(gu)(gu)(gu)骼替代、支(zhi)撐、修補、填充的(de)(de)臨床骨(gu)(gu)(gu)科(ke)(ke)(ke)用(yong)醫(yi)療(liao)(liao)材料。從(cong)類別上可分四(si)大類,即創(chuang)(chuang)傷、關節(jie)(jie)、脊(ji)柱和(he)其他。其中(zhong)(zhong),創(chuang)(chuang)傷、關節(jie)(jie)和(he)脊(ji)柱類在骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)中(zhong)(zhong)份額超過八(ba)成(cheng)。   我(wo)國(guo)(guo)(guo)(guo)骨(gu)(gu)(gu)科(ke)(ke)(ke)醫(yi)療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)行(xing)(xing)(xing)業(ye)(ye)(ye)(ye)(ye)始于上個世紀八(ba)十(shi)年(nian)(nian)(nian)代,經過20余(yu)年(nian)(nian)(nian)發(fa)(fa)展,已培(pei)育出一(yi)批具有(you)較強競(jing)爭力的(de)(de)本土企(qi)業(ye)(ye)(ye)(ye)(ye),但與國(guo)(guo)(guo)(guo)際領(ling)(ling)先(xian)企(qi)業(ye)(ye)(ye)(ye)(ye)相比,還(huan)有(you)較大差距。   總體(ti)來(lai)看,國(guo)(guo)(guo)(guo)內(nei)骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)行(xing)(xing)(xing)業(ye)(ye)(ye)(ye)(ye)整體(ti)滲透(tou)率低,集中(zhong)(zhong)在中(zhong)(zhong)低端市場(chang)(chang),企(qi)業(ye)(ye)(ye)(ye)(ye)規(gui)(gui)模(mo)小、生(sheng)產線單一(yi),存在研(yan)發(fa)(fa)能力薄弱、創(chuang)(chuang)新能力不足(zu)等(deng)問題。另一(yi)角度來(lai)說,這也表(biao)明我(wo)國(guo)(guo)(guo)(guo)骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)還(huan)有(you)很大增長(chang)(chang)空間與發(fa)(fa)展潛(qian)力。   我(wo)國(guo)(guo)(guo)(guo)骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)行(xing)(xing)(xing)業(ye)(ye)(ye)(ye)(ye)正(zheng)處于快(kuai)速增長(chang)(chang)期(qi),在多重(zhong)因素作用(yong)下,未來(lai)五(wu)年(nian)(nian)(nian)有(you)望迎來(lai)蓬勃(bo)發(fa)(fa)展。據前瞻產業(ye)(ye)(ye)(ye)(ye)研(yan)究(jiu)院提供(gong)的(de)(de)《中(zhong)(zhong)國(guo)(guo)(guo)(guo)骨(gu)(gu)(gu)科(ke)(ke)(ke)植(zhi)入(ru)醫(yi)療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)行(xing)(xing)(xing)業(ye)(ye)(ye)(ye)(ye)投資戰略規(gui)(gui)劃分析報(bao)告(gao)》數(shu)據,2015年(nian)(nian)(nian),中(zhong)(zhong)國(guo)(guo)(guo)(guo)骨(gu)(gu)(gu)科(ke)(ke)(ke)器(qi)(qi)械(xie)(xie)(xie)行(xing)(xing)(xing)業(ye)(ye)(ye)(ye)(ye)規(gui)(gui)模(mo)為(wei)175億元,預計到(dao)(dao)2020年(nian)(nian)(nian)行(xing)(xing)(xing)業(ye)(ye)(ye)(ye)(ye)規(gui)(gui)模(mo)將達到(dao)(dao)310億元,五(wu)年(nian)(nian)(nian)復(fu)合增速為(wei)12%。&#...
發(fa)布時間: 2017 - 05 - 04
瀏(liu)覽次數:365
摘要(yao)  合(he)成材(cai)料(liao)組(zu)(zu)織(zhi)工(gong)(gong)程(cheng)骨(gu)(gu)(gu)(gu)(gu)移(yi)(yi)植(zhi)物是(shi)(shi)(shi)(shi)當(dang)前(qian)骨(gu)(gu)(gu)(gu)(gu)移(yi)(yi)植(zhi)材(cai)料(liao)研發(fa)重點,發(fa)展迅速,但是(shi)(shi)(shi)(shi),目(mu)前(qian)研發(fa)的(de)各類支架材(cai)料(liao)性(xing)能(neng)(neng)(neng)(neng)存(cun)(cun)在(zai)(zai)缺(que)陷(xian),還(huan)不(bu)(bu)能(neng)(neng)(neng)(neng)完全(quan)滿足臨(lin)床(chuang)(chuang)(chuang)要(yao)求(qiu);細胞(bao)(bao)(bao)(bao)體(ti)(ti)外(wai)篩選(xuan)、擴增、分化(hua)和(he)為能(neng)(neng)(neng)(neng)在(zai)(zai)局部持(chi)續釋放細胞(bao)(bao)(bao)(bao)因(yin)子而采用的(de)轉基因(yin)細胞(bao)(bao)(bao)(bao)移(yi)(yi)植(zhi)或腺病(bing)(bing)毒轉染(ran)(ran)局部細胞(bao)(bao)(bao)(bao)等(deng)技術還(huan)存(cun)(cun)在(zai)(zai)安(an)全(quan)隱(yin)患(huan),回(hui)植(zhi)體(ti)(ti)內后不(bu)(bu)能(neng)(neng)(neng)(neng)保證細胞(bao)(bao)(bao)(bao)活性(xing),細胞(bao)(bao)(bao)(bao)骨(gu)(gu)(gu)(gu)(gu)組(zu)(zu)織(zhi)工(gong)(gong)程(cheng)種(zhong)植(zhi)體(ti)(ti)構建質(zhi)量(liang)、及時性(xing),儲(chu)存(cun)(cun)、運輸等(deng)方(fang)面還(huan)不(bu)(bu)具臨(lin)床(chuang)(chuang)(chuang)規(gui)模化(hua)應用的(de)可(ke)行(xing)性(xing)。目(mu)前(qian),無細胞(bao)(bao)(bao)(bao)人工(gong)(gong)合(he)成材(cai)料(liao)在(zai)(zai)臨(lin)床(chuang)(chuang)(chuang)上(shang)脊柱(zhu)融合(he)、良(liang)性(xing)骨(gu)(gu)(gu)(gu)(gu)腫瘤刮(gua)除后填充等(deng)方(fang)面應用較(jiao)普(pu)遍,細胞(bao)(bao)(bao)(bao)骨(gu)(gu)(gu)(gu)(gu)組(zu)(zu)織(zhi)工(gong)(gong)程(cheng)移(yi)(yi)植(zhi)物應用僅見(jian)于散(san)在(zai)(zai)病(bing)(bing)例報道。關(guan)鍵詞  骨(gu)(gu)(gu)(gu)(gu)組(zu)(zu)織(zhi)工(gong)(gong)程(cheng);支架;干細胞(bao)(bao)(bao)(bao);細胞(bao)(bao)(bao)(bao)因(yin)子;臨(lin)床(chuang)(chuang)(chuang)上(shang)嚴重創傷、腫瘤切除、骨(gu)(gu)(gu)(gu)(gu)感染(ran)(ran)、骨(gu)(gu)(gu)(gu)(gu)壞死等(deng)原因(yin)導(dao)(dao)致的(de)的(de)骨(gu)(gu)(gu)(gu)(gu)缺(que)損(sun)、骨(gu)(gu)(gu)(gu)(gu)折不(bu)(bu)愈(yu)合(he)以(yi)及人工(gong)(gong)假體(ti)(ti)置換及翻(fan)修(xiu)、脊柱(zhu)、關(guan)節(jie)融合(he)等(deng)十分常見(jian),自體(ti)(ti)皮質(zhi)-松質(zhi)骨(gu)(gu)(gu)(gu)(gu)移(yi)(yi)植(zhi)仍是(shi)(shi)(shi)(shi)無法(fa)被替(ti)代(dai)的(de)“金標準”,但是(shi)(shi)(shi)(shi),存(cun)(cun)在(zai)(zai)諸如供區新的(de)創傷、感染(ran)(ran)、疼痛(tong)等(deng)并(bing)發(fa)癥,特別(bie)是(shi)(shi)(shi)(shi),來源有限不(bu)(bu)能(neng)(neng)(neng)(neng)滿足臨(lin)床(chuang)(chuang)(chuang)需要(yao),因(yin)此,同種(zhong)異(yi)體(ti)(ti)骨(gu)(gu)(gu)(gu)(gu)以(yi)較(jiao)好的(de)骨(gu)(gu)(gu)(gu)(gu)傳導(dao)(dao)、誘導(dao)(dao)性(xing),成為繼自體(ti)(ti)骨(gu)(gu)(gu)(gu)(gu)移(yi)(yi)植(zhi)之(zhi)后的(de)首選(xuan)[1],但是(shi)(shi)(shi)(shi),來源仍然有限,其他(ta)缺(que)陷(xian)如:新鮮異(yi)體(ti)(ti)移(yi)(yi)植(zhi)存(cun)(cun)在(zai)(zai)疾病(bing)(bing)傳播、免(mian)疫排斥和(he)難以(yi)保存(cun)(cun)等(deng)問題;深低(di)溫或凍干處理可(ke)降低(di)免(mian)疫原性(xing)和(he)疾病(bing)(bing)傳染(ran)(ran),但成骨(gu)(gu)(gu)(gu)(gu)誘導(dao)(dao)性(xing)能(neng)(neng)(neng)(neng)降低(di);異(yi)體(ti)(ti)脫鈣骨(gu)(gu)(gu)(gu)(gu)(demineralized bone matrix ,DBM)的(de)骨(gu)(gu)(gu)(gu)(gu)誘導(dao)(dao)性(xing)也(ye)較(jiao)差,并(bing)受加工(gong)(gong)方(fang)法(fa)和(he)供體(ti)(ti)年齡等(deng)因(yin)素的(de)影(ying)響等(deng)。在(zai)(zai)自體(ti)(ti)和(he)異(yi)體(ti)(ti)骨(gu)(gu)(gu)(gu)(gu)越來越不(bu)(bu)能(neng)(neng)(neng)(neng)滿足臨(lin)床(chuang)(chuang)(chuang)需要(yao)的(de)的(de)情況下(xia)...
發布時間(jian): 2017 - 05 - 04
瀏覽次數:362
大段骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)缺損是(shi)矯(jiao)形外科較普遍又棘手(shou)的(de)問題,由于(yu)自體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)來源有(you)(you)限,人工假體(ti)無(wu)生(sheng)(sheng)(sheng)物學活性(xing)(xing),易發(fa)(fa)生(sheng)(sheng)(sheng)松動(dong)和疲(pi)勞斷裂等(deng)并(bing)發(fa)(fa)癥(zheng),而(er)異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)來源豐(feng)富,形狀大小不(bu)受限制,并(bing)具有(you)(you)生(sheng)(sheng)(sheng)物學活性(xing)(xing),有(you)(you)較好的(de)應用前景。臨(lin)床長期隨訪結果常發(fa)(fa)生(sheng)(sheng)(sheng)異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折并(bing)發(fa)(fa)癥(zheng)〔1,2〕,影(ying)響手(shou)術(shu)效(xiao)果。為(wei)(wei)此本文(wen)著重闡述骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)腫瘤保肢術(shu)后發(fa)(fa)生(sheng)(sheng)(sheng)異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折的(de)臨(lin)床特點(dian)(dian)及預(yu)防措施,以提高保肢手(shou)術(shu)質量。  1 同(tong)種異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折的(de)臨(lin)床與(yu)(yu)(yu)(yu)(yu)(yu)治療  1.1 臨(lin)床特點(dian)(dian) 保肢術(shu)后異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折的(de)發(fa)(fa)生(sheng)(sheng)(sheng)率占(zhan)16.6%~19%〔1~3〕,多見于(yu)術(shu)后6~100個(ge)月(yue),高峰位于(yu)術(shu)后6~18個(ge)月(yue),2年(nian)內(nei)發(fa)(fa)生(sheng)(sheng)(sheng)率占(zhan)53%以上,3年(nian)內(nei)所(suo)(suo)占(zhan)比例超過70%〔1〕。術(shu)后是(shi)否存在宿主與(yu)(yu)(yu)(yu)(yu)(yu)供體(ti)結合部(bu)(bu)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)不(bu)連與(yu)(yu)(yu)(yu)(yu)(yu)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折無(wu)關,擔骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折發(fa)(fa)生(sheng)(sheng)(sheng)后,受供體(ti)結合部(bu)(bu)愈合率有(you)(you)所(suo)(suo)減低〔1,4〕。  1.2 分類 1990年(nian)Berrey等(deng)〔1〕將骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折分為(wei)(wei)三型(xing)。Ⅰ型(xing)——不(bu)是(shi)由于(yu)感染、腫痛復發(fa)(fa)而(er)導致的(de)迅速、幾乎完全的(de)移植骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)溶(rong)解、病(bing)理性(xing)(xing)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折。可能與(yu)(yu)(yu)(yu)(yu)(yu)少見的(de)免疫(yi)反(fan)應有(you)(you)關〔5〕。Ⅱ型(xing)——異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)干(gan)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折,多見于(yu)術(shu)后12~100個(ge)月(yue),平均27.6個(ge)月(yue),男性(xing)(xing)多見。主要與(yu)(yu)(yu)(yu)(yu)(yu)異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)內(nei)固定方式和應力集中有(you)(you)關〔6〕。Ⅲ型(xing)——異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)遠端關節表(biao)面的(de)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折或(huo)溶(rong)解,發(fa)(fa)生(sheng)(sheng)(sheng)時(shi)(shi)間(jian)較晚,平均31.6個(ge)月(yue),女(nv)性(xing)(xing)多見。與(yu)(yu)(yu)(yu)(yu)(yu)異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)遠端再血管(guan)化時(shi)(shi)間(jian)晚,遲發(fa)(fa)免疫(yi)反(fan)應有(you)(you)關〔1〕。  1.3 治療與(yu)(yu)(yu)(yu)(yu)(yu)療效(xiao) 治療方案主要根據骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折類型(xing)決定〔1〕,同(tong)時(shi)(shi)還有(you)(you)考(kao)慮到(dao)異(yi)(yi)(yi)(yi)體(ti)骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)的(de)條(tiao)件(jian)、骨(gu)(gu)(gu)(gu)(gu)(gu)(gu)折部(bu)(bu)位、原有(you)(you)疾病(bing)、患者...
發布(bu)時間(jian): 2017 - 05 - 04
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