A potentially improved approach to methylene blue virus inactivation of plasma: the Maco Pharma Maco-Tronic system

Plasma was subjected to methylene blue (MB) photochemical virus inactivation using the Maco Pharma Maco-Tronic system which allows three units to be illuminated together, thus reducing processing time. The plasma bag system used incorporates an integral membrane plasma filter and a dry MB pill which dissolves in the plasma to give a 1-microM concentration. There is computer-controlled processing and datalogging. In an assessment of 10 pools of Group A plasma, the losses of coagulation factors, following MB/light treatment, were 23% fibrinogen, 10% FV, 26% FVIII, 11% FIX and 13% FXI. Group O, Group B and Group AB plasmas were not tested. Von Willebrand factor (vWf) multimers showed no substantial change when treated with MB, and no losses were seen for antithrombin III (ATIII), protein C and vWf:Ag. Measurements of C3a, C5a, prothrombin fragment 1+2 and FXIIa indicated that there was no activation as a result of filtration.     

亚甲蓝/光化学法对血浆中IgG的影响

目的　探讨亚甲蓝 /光化学法对血浆中IgG的影响 ,评价含SARS抗体的病毒灭活血浆临床应用的可行性。方法　将不同浓度的亚甲蓝分别加入人血浆中 ,经JY I型血浆病毒灭活仪处理后 ,用Native PAGE和SDS PAGE测定IgG含量、亚基数目和分子量 ,用Western blot检测其抗原性。 结果　经亚甲蓝 /光化学法处理后血浆的IgG含量、亚基数目、分子量和抗原性均未见变化。 结论　亚甲蓝 /光化学法对血浆中IgG的影响较小 ,含SARS抗体的病毒灭活血浆应用于临床是可行的     

FFP经亚甲蓝光化学法灭活病毒并直接冻干于血袋的冻干血浆研制

目的探索制备冻干血浆的新工艺,研制适合在艰苦环境下储运和方便使用的新型冻干血浆。方法采用亚甲蓝光化学技术对新鲜冰冻血浆(FFP)做病毒灭活处理,再将FFP直接冻干于血袋中,观察不同条件下的保存效果。结果亚甲蓝光化学技术(终浓度为1μmol/L)能有效灭活血浆中的Sindbis病毒、PRV和VSV等指示病毒,处理30min后灭活效果>4.75LgTCID50,经细胞3代盲传证明灭活病毒效果可靠。新型冻干血浆外观成淡黄色疏松体,残水量为2.2%—2.5%,室温下<2min完全溶解;储存稳定性试验表明,新型冻干血浆中的FⅡ、FⅤ、FⅧ、FⅨ和FⅪ在25℃和4℃比较稳定,高温(40℃)保存对其活性有一定影响。结论采用亚甲蓝光化学灭活病毒技术和袋装血浆冻干技术制备新型冻干血浆是可行的。     

病毒灭活血浆中亚甲蓝残留量超标原因的研究

目的探讨亚甲蓝光化学法病毒灭活后亚甲蓝残留量结果范围及其原因。方法采用固相萃取法,检测不同规格的病毒灭活血浆中亚甲蓝残留量,并分析亚甲蓝残留量超标的原因。结果统计分析不同规格病毒灭活血浆中亚甲蓝残留量,结果有差异。结论根据亚甲蓝残留量超标存在的原因采取相应措施,加强制备过程中关键控制点的监测,减少亚甲蓝残留量超标现象,保证输血安全。     

病毒灭活血浆残余亚甲蓝对人外周血单个核细胞免疫功能影响的体外研究

目的利用人外周血单个核细胞(PBMC)研究用于血浆病毒灭活后残余的亚甲蓝是否对人体免疫细胞功能产生影响。方法采用Ficoll-Hypaque密度梯度离心法分离PBMC,在T细胞特异性刺激因子Anti-CD3/CD28存在的条件下,加或者不加不同浓度的亚甲蓝共培养,培养至72h,收集培养上清液,采用酶联免疫吸附试验(ELISA)检测细胞因子分泌情况;培养66h后,加入CCK-8染料继续培养4~6h,于A_(450)处测定细胞增殖情况。结果高浓度剂量亚甲蓝(1.25、2.5、5μmol/L组)对AntiCD3/28刺激PBMC的增殖均有明显抑制作用(P0.01),其OD值由0.897±0.385分别降至0.632±0.334、0.524±0.254、0.445±0.287,呈一定的剂量依赖效应。高浓度亚甲蓝(1.25、2.5、5μmol/L组)可下调Anti-CD3/28诱导PBMC分泌细胞因子白细胞介素(IL)-17a、IL-10、γ-干扰素(IFN)-γ,且呈剂量依赖效应。1.25、2.5、5μmol/L的亚甲蓝影响PBMC分泌IL-17a,IL-17a水平由(406±57)pg/mL分别降至(276±38)、(192±31)、(134±24)pg/mL;影响PBMC分泌IL-10,IL-10水平由(184±15)pg/mL分别降至(132±13)、(110±12)、(42±8)pg/mL;影响PBMC分泌IFN-γ,IFN-γ水平由(4 512±187)pg/mL分别降至(2 876±143)、(2 234±153)、(1 988±112)pg/mL。结论高浓度亚甲蓝(≥1.25μmol/L)对人PBMC的增殖以及分泌细胞因子功能有显著抑制作用,换而言之,血浆病毒灭活后残余浓度(≤0.33μmol/L)的亚甲蓝对PBMC免疫功能无明显影响,但该浓度的亚甲蓝对人纯T细胞免疫功能是否有影响需要进一步评估研究。     

分离白膜后血浆制备冷沉淀的质量评价

目的对采用22℃手工制备富含血小板白膜后分离的血浆制备冷沉淀的质量进行评价。方法 2013年11月—2014年6月,共随机选取22℃手工制备富含血小板白膜后分离的血浆70例,将其作为原料血浆制成冷沉淀后留样(即A组)。同时另随机选取4℃常规制备新鲜冰冻血浆90例,将其作为原料血浆制成冷沉淀后留样(即B组)。用全自动血凝分析仪检测冷沉淀中Ⅷ因子、纤维蛋白原含量,运用统计学方法对比分析2组有无统计学差异。结果 A组、B组Ⅷ因子含量分别为(136.96±59.32)IU、(163.53±77.33)IU(P0.05),合格率分别为97%、99%(P0.05)。A组、B组纤维蛋白原含量为(165.68±25.73)mg/袋、(164.11±17.54)mg/袋(P0.05),合格率分别为91%和98%(P0.05)。结论本文试验数据显示,22℃手工制备富含血小板白膜后分离的血浆可以用于制备冷沉淀。     

联合应用滤除白细胞和亚甲蓝光化学病毒灭活对新鲜血浆成分的影响

目的探讨联合应用滤除白细胞和亚甲蓝光化学病毒灭活处理后血浆主要成分的生物活性变化。方法应用去白细胞四联血袋采集全血分离制备成滤除白细胞的新鲜血浆10袋(100 ml/袋),加入1μmol/L亚甲蓝并放置2~6℃,光照度为30 000 Lux的可见光下左右摆动照射30 min。留取白细胞滤过前和亚甲蓝光照处理后新鲜血浆各5 ml,分别计数白细胞并检测血浆中部分凝血因子活性,血浆蛋白含量和补体水平变化。结果 2种方法处理后的新鲜血浆白细胞滤除率>99.91%,APTT,FⅧ∶C、FⅨ∶C水平与处理前比较t值分别为3.041、8.039、3.617,P<0.05。FⅧ∶C,FⅨ∶C回收率均>81%。PT,FⅡ∶C Fib较处理前无统计学意义,P>0.05。血浆白蛋白,IgG、IgM、IgA以及补体C3,C4水平较处理前变化不大。结论联合应用滤除白细胞和亚甲蓝光化学灭活病毒法对新鲜血浆处理前后的主要成分和生化指标影响不大。     

亚甲蓝光化学灭活对血浆丙型肝炎病毒基因组核酸降解的研究

目的研究丙型肝炎病毒(HCV)基因组核酸在亚甲蓝光化学法(methelene blue photochemistry,MB-P)灭活病毒前后的变化,在全基因组水平分析MB-P对基因组各结构区段的降解作用。方法含HCV的血浆中加入终浓度为1.0μmol/L的MB,经约30000Lux强度的荧光照射后,在不同作用时间点取样;将HCV全基因组序列分为互相重叠的8个区段,分别进行RT-PCR,分析基因组核酸的完整性;同时运用实时定量PCR(real time-PCR,RT-PCR)技术观察核酸降解的动力学变化。结果基因组各区段RT-PCR结果发现,经过不同的光照时间,HCV基因组各区段的稳定性不同,第2、4、5、6区段对MB-P作用较敏感,基因组5’端区段和3’端区段经MB-P作用后的稳定性高于基因组其它区段;RT-PCR结果显示,随着光照时间延长,可被检测到的病毒核酸拷贝数逐渐下降。结论MB-P灭活过程中HCV基因组核酸被降解,而且基因组不同区段对光化学作用的反应性不同,提示RNA降解可能是病毒灭活的重要机制;检测病毒核酸稳定性以监测病毒灭活具有一定临床实用价值。     

硬膜外注入亚甲蓝对腰椎脊髓及脊神经节结构的影响

背景：亚甲蓝可阻碍感觉神经的异常疼痛传导,其机制是阻断缓激肽诱导的痛觉过敏,消除局部组织炎症引起的痛觉过敏反应。目的：观察亚甲蓝溶液对大鼠腰椎脊髓及脊神经节功能的影响,明确亚甲蓝治疗椎间盘源性腰痛的安全性。方法：将120只Wistar大鼠随机分为5组,每组24只。暴露大鼠腰节段硬膜,亚甲蓝0.2 mL组、亚甲蓝1 mL组、亚甲蓝2 mL组分别于大鼠硬膜外注入相应量的亚甲蓝;生理盐水组大鼠硬膜外注入1 mL生理盐水;空白对照组不进行此步操作。分别在注入后30 min,2 h,24 h,72 h每组分别随机对6只大鼠进行灌流固定,并切除相应节段脊髓及神经节,行苏木精-伊红染色,在光镜下观察对比组织结构改变。结果与结论：亚甲蓝各组大鼠注入后30 min,2 h,24 h,72 h时间脊髓及神经根苏木精-伊红染色,显示脊髓背侧面结构完整,白质与灰质分界清晰,白质中神经纤维致密,纤维间有圆形或卵圆形的神经胶质细胞核;灰质后角神经纤维致密;神经元细胞,胞核圆形染色浅,核仁明显;细胞群间有成束的神经纤维。亚甲蓝各组大鼠腰椎脊髓及脊神经节与生理盐水组及空白对照组比较均无明显的组织结构变化。结果表明硬膜外注入1%亚甲蓝对脊髓及脊神经结构无明显影响。     

亚甲兰光化学法对FFP中凝血因子及总蛋白含量的影响

目的探讨亚甲蓝光化学法(MB-P)对新鲜冰冻血浆(FFP)中Fg、FⅡ∶C、FⅤ∶C、FⅧ∶C、FⅩ∶C、FⅫ∶C及总蛋白含量的影响,为制定病毒灭活血浆标准及其临床应用提供数据参考。方法随机抽取88份FFP分成灭活组(n=40)及过滤组(n=48),分别对2组样本处理前后的FⅡ∶C、FⅤ∶C、FⅧ∶C、FⅩ∶C、FⅫ∶C、Fg及总蛋白含量进行检测。结果灭活组FⅤ∶C、FⅧ∶C处理后含量显著低于灭活前(分别为t=3.40,P<0.01;t=2.57,P<0.01),但Fg、FⅡ∶C、FⅩ∶C、FⅫ∶C及总蛋白灭活前后的含量无明显差异(P>0.05),过滤组处理前后FⅤ∶C、FⅧ∶C无明显差异(P>0.05)。结论 MB-P对FFP中不稳定的凝血因子FⅤ∶C和FⅧ∶C含量有明显影响,均在可接受的范围内,对其他凝血因子及总蛋白的含量无影响。     

Changes in functional activities of plasma fibrinogen after treatment with methylene blue and red light

BACKGROUND: Methylene blue (MB) plus light treatment used for virus inactivation of human plasma units may lead to changes in the functional activities of fibrinogen. STUDY DESIGN AND METHODS: Single-donor units of fresh plasma were treated with 1.0 microM MB and a red light dose of 48 J per cm2. The effects of MB plus red light treatment on fibrinogen clottability, fibrin polymerization and gelation, clot stabilization, and fibrinolysis were studied. RESULTS: The concentration of clottable fibrinogen was unchanged during MB plus red light treatment, but a light-dose-dependent decrease of the concentration of functional fibrinogen was found. The initial release rate of fibrinopeptide A was slightly increased after MB plus red light treatment. Turbidity measurements of fibrin gel showed prolonged clotting time, lower fibrin fiber mass-to-length ratio, and slightly smaller fiber diameter. At a given clotting time, a gel with lower fibrin fiber mass-to-length ratio was produced. Clot stability and fibrinolysis remained normal. l-Histidine added to plasma before MB plus red light treatment normalized the thrombin-induced coagulation time in a dose-dependent way. CONCLUSION: MB plus red light treatment affected the polymerization and gelation phase of fibrin. A tighter fibrin gel structure was formed. No effect on stabilization of fibrin clot or fibrinolysis was found.     

亚甲兰光化学法红细胞病毒灭活的初步探讨

目的　探讨择定条件下亚甲兰光化学方法对红细胞悬液的病毒灭活效果及其对红细胞质量指标的影响。　方法　在国产 PVC储血袋内的 GMA红细胞悬液中预置 VSV和 Sindbis病毒 ,加入终浓度为 5μmol/L的亚甲兰后用380 0 0 lx荧光照射 60分钟 ,测定处理后红细胞悬液及其匀浆中的病毒滴度及保存 2 1天内各时间段的红细胞 ATP、2 ,3-DPG、上清 K+ 和游离血红蛋白等质量指标。　结果　经上述方法处理后 ,红细胞悬液上清和红细胞匀浆中的 VSV病毒滴度分别降低 8.87± 0 .4 2 lg TCID50 和 7.79± 0 .90 lg TCID50 ;Sindbis病毒滴度则分别降低 6.5 8± 1 .67lg TCID50 和 5 .0 8±1 .4 2 lg TCID50 :处理后保存 2 1天内的各时间段红细胞主要质量指标未发生明显不良变化。　结论　亚甲兰光化学方法能有效灭活红细胞悬液及红细胞匀浆中与细胞相关的脂质包膜模型病毒 ,对红细胞体外质量指标无明显不良影响     

利用动物模型评估亚甲蓝光化学法红细胞病毒灭活效果

目的　评估亚甲蓝光化学法 (MB P) (亚甲蓝浓度 5 μmol/L ,光照时间 1h ,光照强度 380 0 0lux)红细胞病毒灭活的安全性、有效性。方法　①建立Beagle犬急性失血性贫血模型 ,观察经MB P处理的Beagle犬自体纠正贫血的效果、体内溶血情况及对肝肾功能的影响 ;②将含不同基因组拷贝数的鸭乙肝病毒 (DHBV)的人红细胞经静脉感染 1日龄雏鸭。采用同位素核酸杂交法检测鸭血清中DHBVDNA ,计算病毒灭活前后人红细胞中DHBV的半数致死量 (ID50 ) )。结果　①经MB P处理的犬自体红细胞输入Beagle犬体内未发生溶血 ,输血前后谷丙转氨酶 (ALT)、谷草转氨酶 (AST)、尿素、肌酐等与输血前比较无明显差异 ;②经MB P灭活处理后 ,含DHBV红细胞的ID50 由 1 0 3 .3 5变为 1 0 8.3 5拷贝。结论　红细胞MB P病毒灭活是安全有效的。     

Elevated plasma fibrinogen γ'' concentration is associated with myocardial infarction: effects of variation in fibrinogen genes and environmental factors

BACKGROUND: Fibrinogen gamma', a fibrinogen gamma-chain variant generated via alternative mRNA processing, has been associated with susceptibility to thrombotic disease. OBJECTIVE: The present case-control study searched for potential determinants of the plasma fibrinogen gamma' concentration and examined the relationship between this variant and risk of myocardial infarction (MI). PATIENTS AND METHODS: The Stockholm Coronary Artery Risk Factor study, comprising 387 postinfarction patients and 387 healthy individuals, was employed. The fibrinogen gamma (FGG) 9340T > C [rs1049636], fibrinogen alpha (FGA) 2224G > A [rs2070011] and fibrinogen beta (FGB) 1038G > A [rs1800791] polymorphisms were determined. The plasma fibrinogen gamma' concentration was measured by enzyme-linked immunosorbent assay. The multifactor dimensionality reduction method was used for interaction analyses on risk of MI. RESULTS: The FGG 9340T > C and FGA 2224G > A polymorphisms, total plasma concentrations of fibrinogen, insulin and high-density lipoprotein, and gender appeared to be independent determinants of plasma fibrinogen gamma' concentration in patients, and the corresponding determinants in controls included FGG 9340T > C and FGA 2224G > A polymorphisms and plasma fibrinogen concentration. An elevated plasma fibrinogen gamma' concentration proved to be an independent predictor of MI [adjusted odds ratio (OR) (95% CI): 1.24 (1.01, 1.52)]. The plasma fibrinogen gamma' concentration was involved in a high-order interaction with total plasma fibrinogen and the FGG 9340T > C and FGA 2224G > A polymorphisms, associated with a further increased risk of MI [OR (95% CI): 3.22 (2.35, 4.39)]. CONCLUSIONS: Plasma fibrinogen gamma' concentration influences the risk of MI, and this relationship seems to be strengthened by the presence of an elevated total plasma fibrinogen concentration and the FGG 9340T and FGA 2224G alleles.     

Inactivation of SARS-CoV-2 infectivity in platelet concentrates or plasma following treatment with ultraviolet C light or with methylene blue combined with visible light

Background

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unlikely to be a major transfusion-transmitted pathogen; however, convalescent plasma is a treatment option used in some regions. The risk of transfusion-transmitted infections can be minimized by implementing Pathogen Inactivation (PI), such as THERAFLEX MB-plasma and THERAFLEX UV-Platelets systems. Here we examined the capability of these PI systems to inactivate SARS-CoV-2.

Study Design and Methods

SARS-CoV-2 spiked plasma units were treated using the THERAFLEX MB-Plasma system in the presence of methylene blue (~0.8 μmol/L; visible light doses: 20, 40, 60, and 120 [standard] J/cm²). SARS-CoV-2 spiked platelet concentrates (PCs) were treated using the THERAFLEX UV-platelets system (UVC doses: 0.05, 0.10, 0.15, and 0.20 [standard] J/cm²). Samples were taken prior to the first and after each illumination dose, and viral infectivity was assessed using an immunoplaque assay.

Results

Treatment of spiked plasma with the THERAFLEX MB-Plasma system resulted in an average ≥5.03 log₁₀ reduction in SARS-CoV-2 infectivity at one third (40 J/cm²) of the standard visible light dose. For the platelet concentrates (PCs), treatment with the THERAFLEX UV-Platelets system resulted in an average ≥5.18 log₁₀ reduction in SARS-CoV-2 infectivity at the standard UVC dose (0.2 J/cm²).

Conclusions

SARS-CoV-2 infectivity was reduced in plasma and platelets following treatment with the THERAFLEX MB-Plasma and THERAFLEX UV-Platelets systems, to the limit of detection, respectively. These PI technologies could therefore be an effective option to reduce the risk of transfusion-transmitted emerging pathogens.     

亚甲蓝体内抗氧化特性的临床研究

目的：利用静脉普鲁卡因复合麻醉（IPA）致体内氧自由基（OFR）含量增高的内环境变化，观察亚甲蓝（MB）在体内的抗氧化特性。方法：40例择期手术患者，根据麻醉方法不同随机分为观察组（IPA，n=20)和对照组（芬太尼，n=20)。分别观察麻醉诱导前（T0）、麻醉120min(T1)、麻醉180min(T2)以及静脉注射MB（1－2mg/kg)后30min(T3)时患者血内一氧化氮（NO）、OFR、脂质过氧化物（LPO）、高铁血红蛋白（MHb)的含量以及红细胞（RBC）、超氧化物歧化酶（SOD）、过氧化氢酶（CAT）、还原型辅酶1－细胞色素b5还原酶（NADH－cyt b5-R)活性的变化。结果：IPA组T1、T2与T0相比：NO、OFR、LPO、MHb均有显著性升高。SOD、CAT、NADH－cyt b5-R均有显著性降低。经MB治疗后30min,NO等7项指标均恢复至正常水平。芬太尼麻醉期间（T0－T3）各指标无显著性变化。结论：普鲁卡因在体内的代谢产物具有强氧化剂特性，通过产生过量的NO：ONOO－介导RBC过氧化损伤。临床治疗剂量的MB在人体内具有直接清除NO：ONOO－特性，对组织细胞可提供多途径的保护作用。     

Revisiting the physiological effects of methylene blue as a treatment of cyanide intoxication

Background: Although methylene blue (MB) had long been proposed to counteract the effects of cyanide (CN) intoxication, research on its mechanisms of action and efficacy has been abandoned for decades. Recent studies on the benefits of MB in post-anoxic injuries have prompted us to reexamine the relevance of this historical observation.

Methods: Our study was performed in adult male Sprague–Dawley rats and on HEK293T epithelial cells. First, the effects and toxicity of MB (0–80?mg/kg) on circulation and metabolism were established in four urethane-anesthetized rats. Then nine rats received a lethal infusion of a solution of KCN (0.75?mg/kg/min) and were treated by either saline or MB, at 20?mg/kg, a dose that we found to be innocuous in rat and to correspond to a dose of about 4?mg/kg in humans. MB was also administered 5?min after the end of a sub-lethal exposure to CN in a separate group of 10 rats. In addition, ATP/ADP ratio, ROS production, mitochondrial membrane potential (Δψm) and cellular O₂ consumption rate (OCR) were determined in HEK293T cells exposed to toxic levels of CN (200?µM for 10?min) before and after applying a solution containing MB (1–100?µM for 10?min).

Results: Methylene blue was found to be innocuous up to 50?mg/kg. KCN infusion (0.75?mg/kg/min) killed all animals within 7–8?min. MB (20?mg/kg) administered at the same time restored blood pressure, cardiac contractility and limited O₂ deficit, allowing all the animals to survive, without any significant methemoglobinemia. When administered 5?min after a non-lethal CN intoxication, MB sped up the recovery of lactate and O₂ deficit. Finally, MB was able to decrease the production of ROS and restore the ATP/ADP ratio, Δψm as well as OCR of epithelial cells intoxicated by CN.

Conclusions: The present observations should make us consider the potential interest of MB in the treatment of CN intoxication. The mechanisms of the antidotal properties of MB cannot be accounted for by the creation of a cyanomethemoglobinemia, rather its protective effects appears to be related to the unique properties of this redox dye, which, depending on the dose, could directly oppose some of the consequences of the metabolic depression produced by CN at the cellular level.     

首发精神分裂症患者血浆D-二聚体和纤维蛋白原水平的临床研究

目的研究首发精神分裂症患者急性期D-二聚体(D-D)和纤维蛋白原(Fib)水平及其临床意义。方法选择2014年3月至2016年12月该院收治的首发精神分裂症患者83例为研究组,另选择同期无精神疾病和重大躯体疾病的健康体检者58例为对照组。空腹采集两组研究对象的枸橼酸钠抗凝血浆,检测D-D和Fib水平。结果首发精神分裂症组血浆D-D水平为(240.42±245.78)μg/L,显著高于对照组(76.53±71.25)μg/L,且差异具有统计学意义(P0.05),而血浆Fib水平(2.62±0.49)g/L显著低于对照组(2.87±0.65)g/L,且差异具有统计学意义(P0.05)。精神分裂症患者D-D水平的增高和Fib水平的降低与性别无关。结论首发精神分裂症患者发病急性期可能存在高凝状态和继发性纤溶功能亢进。     

全血手工制备浓缩血小板后的血浆再制备冷沉淀的质量评价

目的评价室温新鲜全血白膜法制备浓缩血小板后的血浆再制备冷沉淀的质量。方法实验组为24例,新鲜全血(400 mL)置室温于<8 h用白膜法制备浓缩血小板后所得的血浆,冰冻保存。对照组1为12例,常规制备新鲜冰冻血浆,冰冻保存。对照组2为12例,新鲜冰冻单采血浆,血浆单采完毕分装为200 mL/袋并立即冰冻保存。3组血浆按常规制备冷沉淀,评价其质量:外观、凝血因子FⅧ及Fib的含量;血细胞残留量。结果 3组冷沉淀外观均正常;WBC含量在3组间无统计学意义。与对照组1比较:实验组凝血因子FⅧ(81.76±34.07)IU较低,Fib(202.63±48.58)mg及Plt(7.81±5.81)×109均较高。与对照组2比较:实验组凝血因子FⅧ含量相当,Fib(202.63±48.58)mg较高、Plt(7.81±5.81)×109较低。结论全血来源的制备浓缩血小板后的冰冻血浆还可以用于冷沉淀的制备,其质量符合国家标准。