国际医药卫生导报
國際醫藥衛生導報
국제의약위생도보
INTERNATIONAL MEDICINE & HEALTH GUIDANCE NEWS
2014年
12期
1683-1686
,共4页
亚甲蓝光化学疗法%病毒灭活%血浆%疗效性%安全性
亞甲藍光化學療法%病毒滅活%血漿%療效性%安全性
아갑람광화학요법%병독멸활%혈장%료효성%안전성
Methylene blue photochemical therapy%Virus inactivation%Plasma%Efficacy%Security
目的 根据2012年颁发的GB 18469-2012《全血及成分血质量要求》中对病毒灭活新鲜冰冻血浆质量控制项目和要求,分析亚甲蓝光化学疗法血浆病毒灭活技术在血浆灭活过程中对血液成分和功能的影响,探讨亚甲蓝光化学疗法血浆病毒灭活技术的疗效及安全性,为进一步广泛推广应用提供临床参考依据.方法 采用称重法、双缩脲法、磁珠法、比色法、荧光定量PCR检测方法检测亚甲蓝光化学疗法病毒灭活前后的血浆量、血浆蛋白含量、凝血因子Ⅷ含量、亚甲蓝残留量、病毒灭活效果的变化.结果 新鲜血浆病毒灭活前后血浆容量分别为(235±15.51)g、(230±14.17)g;Ⅷ因子含量为(1.084±0.045)IU/ml、(0.826±0.029)IU/ml;血浆蛋白含量为(83.71±3.24)g/L、(79.09±3.21)g/L;凝血因子Ⅷ含量灭活前后差异有统计学意义(P＜0.01);血浆容量和血浆蛋白在灭活前后无统计学意义(P＞0.05),亚甲蓝的残留率为(0.0638±0.013)μmol/L;标本病毒灭活后血浆HBV-DNA及HCV-RNA载量均为＜1000 copies/ml.结论 利用亚甲蓝光化学疗法血浆病毒灭活技术对血浆成分有一定的影响,但均达到GB 18469-2012《全血及成分血质量要求》对病毒灭活新鲜冰冻血浆的质量要求.亚甲蓝光化学疗法简便、无毒、能最大程度的减少新鲜冰冻血浆病毒等显著特点,可有效消除临床输血带来的安全隐患.
目的 根據2012年頒髮的GB 18469-2012《全血及成分血質量要求》中對病毒滅活新鮮冰凍血漿質量控製項目和要求,分析亞甲藍光化學療法血漿病毒滅活技術在血漿滅活過程中對血液成分和功能的影響,探討亞甲藍光化學療法血漿病毒滅活技術的療效及安全性,為進一步廣汎推廣應用提供臨床參攷依據.方法 採用稱重法、雙縮脲法、磁珠法、比色法、熒光定量PCR檢測方法檢測亞甲藍光化學療法病毒滅活前後的血漿量、血漿蛋白含量、凝血因子Ⅷ含量、亞甲藍殘留量、病毒滅活效果的變化.結果 新鮮血漿病毒滅活前後血漿容量分彆為(235±15.51)g、(230±14.17)g;Ⅷ因子含量為(1.084±0.045)IU/ml、(0.826±0.029)IU/ml;血漿蛋白含量為(83.71±3.24)g/L、(79.09±3.21)g/L;凝血因子Ⅷ含量滅活前後差異有統計學意義(P＜0.01);血漿容量和血漿蛋白在滅活前後無統計學意義(P＞0.05),亞甲藍的殘留率為(0.0638±0.013)μmol/L;標本病毒滅活後血漿HBV-DNA及HCV-RNA載量均為＜1000 copies/ml.結論 利用亞甲藍光化學療法血漿病毒滅活技術對血漿成分有一定的影響,但均達到GB 18469-2012《全血及成分血質量要求》對病毒滅活新鮮冰凍血漿的質量要求.亞甲藍光化學療法簡便、無毒、能最大程度的減少新鮮冰凍血漿病毒等顯著特點,可有效消除臨床輸血帶來的安全隱患.
목적 근거2012년반발적GB 18469-2012《전혈급성분혈질량요구》중대병독멸활신선빙동혈장질량공제항목화요구,분석아갑람광화학요법혈장병독멸활기술재혈장멸활과정중대혈액성분화공능적영향,탐토아갑람광화학요법혈장병독멸활기술적료효급안전성,위진일보엄범추엄응용제공림상삼고의거.방법 채용칭중법、쌍축뇨법、자주법、비색법、형광정량PCR검측방법검측아갑람광화학요법병독멸활전후적혈장량、혈장단백함량、응혈인자Ⅷ함량、아갑람잔류량、병독멸활효과적변화.결과 신선혈장병독멸활전후혈장용량분별위(235±15.51)g、(230±14.17)g;Ⅷ인자함량위(1.084±0.045)IU/ml、(0.826±0.029)IU/ml;혈장단백함량위(83.71±3.24)g/L、(79.09±3.21)g/L;응혈인자Ⅷ함량멸활전후차이유통계학의의(P＜0.01);혈장용량화혈장단백재멸활전후무통계학의의(P＞0.05),아갑람적잔류솔위(0.0638±0.013)μmol/L;표본병독멸활후혈장HBV-DNA급HCV-RNA재량균위＜1000 copies/ml.결론 이용아갑람광화학요법혈장병독멸활기술대혈장성분유일정적영향,단균체도GB 18469-2012《전혈급성분혈질량요구》대병독멸활신선빙동혈장적질량요구.아갑람광화학요법간편、무독、능최대정도적감소신선빙동혈장병독등현저특점,가유효소제림상수혈대래적안전은환.
Objective Virus inactivation of plasma could be achieved by methylene blue (MB) photochemical method as Whole Blood and Blood Components Quality Requirements,2012 issue (GB 18469-2012) had advised.To investigate the safety and effectiveness of the method and the effect on biochemical functions of plasma components,we designed this experiment.Methods The virus inactivation method was performed on single donor plasma,then gravimetric method,biuret method,beads method,colorimetry,fluorescence quantitative PCR method were used to study the virus inactivation efficacy and the quality of plasma components by MB photochemical methods.Results The volume of fresh plasma before and after virus inactivation were (235 ± 15.51) g and (230-± 14.17) g respectively,without statistically significant difference (P ＞ 0.05); the activities of the factor Ⅷ before and after virus inactivation were (1.084 ± 0.045) IU/ml and (0.826 ± 0.029) IU/ml,with statistically significant difference (P ＜ 0.01); the content of plasma protein before and after virus inactivation were (83.71 ± 3.24) g/L and (79.09 ± 3.21) g/L,without statistically significant difference (P ＞ 0.05).Residual methylene blue was (0.0638 ± 0.013) μ mol/L.HBV-DNA and HCV-RNA load were both lower than 1000 copies/ml after virus inactivation.Conclusions Methylene blue photochemical therapy plasma virus inactivation technology has a certain effect on plasma components,but reaches GB 18469-2012 Whole Blood and Blood Components Quality Requirements for virus inactivation of fresh frozen plasma quality requirements,with efficacy and safety.Methylene blue photochemical therapy is simple and non-toxic,can reduce fresh frozen plasma virus at the greatest extent and effectively eliminate potential safety hazard caused by clinical blood transfusion.
