本文選題：分離血漿　切入點(diǎn)：單采原料血漿　出處：《安徽醫(yī)科大學(xué)》2015年碩士論文　論文類型：學(xué)位論文

【摘要】：研究背景:隨著臨床用血管理的不斷規(guī)范,血液成分應(yīng)用的逐步普及,臨床用血漿開始出現(xiàn)富余,部分地區(qū)已開始出現(xiàn)過期報(bào)廢的現(xiàn)象,并呈逐步增加的趨勢(shì)。而另一方面,由于我國(guó)血液制品生產(chǎn)的原料血漿來源不足,臨床白蛋白、靜注丙球等血液制品供不應(yīng)求。因此,探討臨床用血漿用于血液制品生產(chǎn)的可行性有著重要的實(shí)用價(jià)值。目前,我國(guó)尚無血站分離血漿用于血液制品生產(chǎn)風(fēng)險(xiǎn)評(píng)估的相關(guān)研究數(shù)據(jù)。因此,開展經(jīng)輸血傳播輸血相關(guān)病原體在單采原料血漿和血站分離血漿中的風(fēng)險(xiǎn)評(píng)估,對(duì)血站分離血漿用于血液制品生產(chǎn)工作的可行性分析及保證血液制品的安全性具有重要意義。目的:評(píng)估單采原血漿和血站分離血漿中常規(guī)篩查病原體的殘余風(fēng)險(xiǎn)和未常規(guī)篩查病原體的風(fēng)險(xiǎn),并采用統(tǒng)計(jì)學(xué)方法比較和分析兩種不同來源血漿傳播輸血相關(guān)病原體的風(fēng)險(xiǎn),為分離血漿用于血液制品的生產(chǎn)提供數(shù)據(jù)支持。材料和方法:收集2013年1月1日至2013年12月31日期間四川地區(qū)九家合作血站/血液中心和蓉生藥業(yè)及其所屬漿站所有HBs Ag,HCV抗體和HIV抗體初篩反應(yīng)性的樣本及樣本信息,同時(shí)搜集同期所有獻(xiàn)血者和獻(xiàn)漿員的篩查信息;對(duì)于HBs Ag,HCV抗體和HIV抗體初篩反應(yīng)性樣本分別用中和試驗(yàn),重組免疫印跡試驗(yàn)和蛋白印跡試驗(yàn)進(jìn)行確證;并用改良的發(fā)病率-窗口期模型計(jì)算這兩種血漿中常規(guī)篩查病原體經(jīng)輸血傳播的殘余風(fēng)險(xiǎn);從初篩合格的樣本中各隨機(jī)抽取5000份左右樣本及捐獻(xiàn)者信息;分別用商用試劑盒檢測(cè)HEV RNA,HCMV DNA,WNV RNA,SFTSV RNA,HAV RNA和B19 DNA,并計(jì)算樣本陽性率,并用卡方檢驗(yàn)進(jìn)行比較分析;分別運(yùn)用泊松分布模型法和等效檢驗(yàn)法對(duì)單采原料血漿和血站分離血漿中這兩類經(jīng)輸血傳播病毒的殘余風(fēng)險(xiǎn)進(jìn)行分析比較。結(jié)果:1.2013年1月1日-2013年12月31日研究期間首次獻(xiàn)漿員為8200名,重復(fù)獻(xiàn)漿數(shù)為467388人次,重復(fù)獻(xiàn)漿員所獻(xiàn)血漿中經(jīng)ELISA篩查并確證HBs Ag、抗-HCV、抗-HIV陽性數(shù)分別為11、2和3例。重復(fù)獻(xiàn)漿員中HBV、HCV和HIV的殘余風(fēng)險(xiǎn)分別為4.73/100,000、3.18/100,000和1.59/100,000;首次獻(xiàn)漿員中HBV、HCV和HIV的殘余風(fēng)險(xiǎn)分別為618.29/100,000、0.97/100,000和126.47/100,000;經(jīng)計(jì)算HBV、HCV和HIV的總體殘余風(fēng)險(xiǎn)分別為73.78/100,000、2.81/100,000和1.08/100,000。2.2013年1月1日-2013年12月31日研究期間獻(xiàn)血者樣本106210例,其中重復(fù)獻(xiàn)血者為43759例,首次獻(xiàn)血者為62451例。有重復(fù)獻(xiàn)血者所獻(xiàn)血液經(jīng)ELISA篩查并確證HBs Ag、抗-HCV、抗-HIV陽性數(shù)分別為10例、4例和3例。重復(fù)獻(xiàn)血者中HBV、HCV和HIV的殘余風(fēng)險(xiǎn)分別為2.18/100,000、0.97/100,000和0.24/100,000;首次獻(xiàn)血者中HBV、HCV和HIV的殘余風(fēng)險(xiǎn)分別為6.08/100,000、3.59/100,000和1.05/100,000;HBV、HCV和HIV總的殘余風(fēng)險(xiǎn)分別為73.88/100,000、2.53/100,000和0.72/100,000。獻(xiàn)血者血漿放置一年后,HBV殘余風(fēng)險(xiǎn)為0.0590/100,000。3.對(duì)于未常規(guī)的病原體核酸檢測(cè)后,結(jié)果發(fā)現(xiàn)血站分離血漿樣本中有一份為B19DNA陽性,一份CMV Ig M陽性,一份HEV Ig M,核酸檢測(cè)陽性率為1.99/萬,血清學(xué)檢測(cè)陽性率為3.98/萬,總體陽性率為5.96/萬;單采原料血漿樣本中有2份為B19 DNA陽性,2份為HAV Ig M陽性,2份為HEV Ig M陽性,核酸檢測(cè)陽性率為3.97/萬,血清學(xué)檢測(cè)陽性率為7.94/萬,總體陽性率為11.90/萬。4.分別用泊松分布模型法和等效檢驗(yàn)兩種統(tǒng)計(jì)學(xué)方法對(duì)這兩種血漿中HBV、HCV和HIV的殘余風(fēng)險(xiǎn)進(jìn)行統(tǒng)計(jì)學(xué)分析,結(jié)果均無統(tǒng)計(jì)學(xué)差異。對(duì)兩種血漿中HAV、B19、WNV、SFTSV、HCMV、HEV的陽性率進(jìn)行統(tǒng)計(jì)學(xué)分析,結(jié)果均無統(tǒng)計(jì)學(xué)差異。結(jié)論:本研究表明單采原料血漿和血站分離血漿中常規(guī)篩查病原體殘余風(fēng)險(xiǎn)無統(tǒng)計(jì)學(xué)差異,未常規(guī)篩查病原體的總體陽性率也無統(tǒng)計(jì)學(xué)差異。故認(rèn)為血站分離血漿傳播經(jīng)血傳播病原體的風(fēng)險(xiǎn)并不高于單采血漿,血站分離血漿可以用于血液制品生產(chǎn)的需要。血站分離血漿放置一年后,傳播輸血相關(guān)病原體的風(fēng)險(xiǎn)低于單采血漿,建議血站分離血漿放置一年后,用于血液制品的生產(chǎn)。
[Abstract]:Background: with the clinical use of blood management continue to regulate the gradual popularization of blood components, the clinical use of plasma began to appear in some areas of surplus, has begun to appear overdue phenomenon, and was gradually increased. On the other hand, because the raw plasma source in our blood products production lack clinical albumin. Intravenous immunoglobulin and other blood products in short supply. Therefore, to explore the clinical feasibility of plasma for blood products has important practical value. At present, the relevant research data in China there is no blood plasma separation for blood products production risk assessment. Therefore, to carry out transfusion transmitted transfusion related pathogens in the apheresis plasma and risk assessment of raw materials the blood plasma separation, separation of the blood plasma for feasibility analysis of blood products production work and ensure the safety of blood products has important significance. The residual risk: risk assessment of apheresis plasma and blood routine screening of primary pathogens in plasma separation and routine screening of pathogens, and use statistical methods to compare and analyze the risk of two different sources of plasma transfusion related pathogens spread, provide data support for the production of blood products used for plasma separation. Materials and methods: collected during January 1, 2013 until December 31, 2013 nine / Sichuan province blood center blood bank cooperation and ronsen pharmaceuticals and their plasma station all HBs Ag, HCV antibody and HIV antibody reactivity of the sample and the sample information, we collected over the same period all blood donors and plasma donation staff screening information; for HBs Ag, HCV antibody and HIV antibody screening the reaction samples respectively by neutralization test, recombinant immunoblot assay and Western blot assay were confirmed; and with improved incidence - window model calculating the two kinds of Blood routine screening of pathogens by the residual risk of transfusion transmitted; from the screening were randomly selected each qualified sample of about 5000 copies of the sample and the donor information; using HEV RNA, detection of commercial kit HCMV DNA, WNV RNA, SFTSV RNA, HAV RNA and B19 DNA, and calculated the positive rate of the sample, and using the chi square test analysis; using Poisson distribution model and the equivalent test method of the two category of apheresis residual risk of transfusion transmitted virus in plasma and blood plasma separation in the raw materials of comparative analysis respectively. Results: 1.2013 years December 31st -2013 in January 1st for the first time during the plasma donation of 8200 employees, repeated plasma donation number for 467388 people. Repeat the plasma donation staff offered in plasma by ELISA screening and confirmation of HBs Ag, anti -HCV, anti -HIV positive numbers were 11,2 and 3 cases. Plasma donation staff in HBV, HCV and HIV of the residual risk were 4.73/100000,3.18 and 1.59 /100000 /100000; the first plasma donation staff in HBV, HCV and HIV of the residual risk were 618.29/100000,0.97/100000 and 126.47/100000; the calculation of HBV, HCV and HIV overall residual risk were -2013 in December 31st of January 1st 73.78/100000,2.81/100000 and 1.08/100000.2.2013 during the period of blood donor samples in 106210 cases, including 43759 cases of repeat blood donors for blood donors was 62451, for the first time cases. Repeat donors donated blood by ELISA screening and confirmation of HBs Ag, anti -HCV, anti -HIV positive were 10 cases, 4 cases and 3 cases. Repeat blood donors, HBV, HCV and HIV of the residual risk respectively for 2.18/100000,0.97/100000 and 0.24/100000 for the first time; blood donors, HBV, HCV and residual risk HIV were 6.08/100000,3.59/100000 and 1.05/100000; HBV, HCV and HIV of the total residual risk were 73.88/100000,2.53/100000 and 0.72/100000. blood donors for one year After HBV, the residual risk is 0.0590/100000.3. for pathogen nucleic acid detection routine not found after separation of blood plasma samples with a positive for B19DNA, a CMV Ig M a HEV Ig M positive, the positive rate of nucleic acid detection of 1.99/ million, the positive rate of serological detection of 3.98/ million, the total positive rate was 5.96/ 000; apheresis plasma samples of raw materials 2 samples were B19 DNA positive, 2 were HAV Ig M positive, 2 were HEV Ig M positive, the positive rate of nucleic acid detection of 3.97/ million, the positive rate of serological detection of 7.94/ million, the total positive rate was 11.90/ million.4. respectively with Poisson distribution model and the equivalent test two statistical methods for the two levels of HBV, HCV and HIV of the residual risk statistical analysis, the results were not statistically significant. The two levels of HAV, B19, WNV, SFTSV, HCMV, statistical analysis of the positive rate of HEV, the results were not statistically significant conclusion. This study shows that the residual risk of apheresis plasma and blood routine screening of pathogens in raw materials for plasma separation had no statistical difference, there was no statistically significant difference in the total positive rate of non routine screening of pathogens. So that the risk of blood plasma separation transmission of bloodborne pathogens is not higher than the single plasma, blood plasma separation can be used to the production of blood products. Blood separation of plasma placed after a year, the risk of transfusion transmitted pathogens is lower than that of single plasma, blood plasma separation that placed a year later, for the production of blood products.

【學(xué)位授予單位】：安徽醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R457.1

【參考文獻(xiàn)】

相關(guān)期刊論文 前4條

1 季陽;鄭忠偉;蔡輝;肖小璞;苑宇哲;;病毒血清學(xué)檢測(cè)與核酸檢測(cè)技術(shù)在輸血傳染病篩檢中的應(yīng)用[J];中國(guó)輸血雜志;2010年06期

2 周康鳳;姜立民;莊f 成;;西尼羅河病毒[J];國(guó)際病毒學(xué)雜志;2006年04期

3 王宋興;曾勁峰;楊愛蓮;古醒輝;;深圳地區(qū)無償獻(xiàn)血者HIV感染情況調(diào)查分析及輸血?dú)堄囡L(fēng)險(xiǎn)評(píng)估[J];中國(guó)輸血雜志;2012年07期

4 王婭;李長(zhǎng)清;楊匯川;劉忠;;國(guó)內(nèi)外血站分離血漿利用概況[J];中國(guó)輸血雜志;2014年10期

，

本文編號(hào)：1569480