静注人免疫球蛋白(pH 4)中肠道病毒71型中和抗体效价的筛查  

Screening of neutralizing antibody titers against enterovirus 71 in human intravenous immunoglobulin(pH 4)

作　　者：王敏力[1] 王威[1] 孙思才 丁勇 侯继锋[1] 

机构地区：[1]中国食品药品检定研究院血液制品室,北京100050 [2]同路生物制药股份有限公司研发部,合肥230022

出　　处：《中国生物制品学杂志》2012年第7期869-872,共4页Chinese Journal of Biologicals

基　　金：国家科技支撑计划课题(2008BAI54B08)

摘　　要：目的对目前市售静注人免疫球蛋白(Human intravenous immunoglobulin,简称IVIG)(pH 4)以及静注肠道病毒71型(Enterovirus 71,EV71)免疫球蛋白试验品中的EV71中和抗体效价进行筛查,为手足口病(Hand-foot-mouth disease,HFMD)的被动免疫治疗提供参考。方法采用微量细胞病变法,在2个实验室,采用2个毒株检测国内IVIG产品以及经原料血浆筛查后制备的静注EV71免疫球蛋白试验品的EV71抗体效价。结果实验室A采用毒株-01检测国内17个企业55批IVIG的EV71中和抗体效价范围为104～256,其中效价≥239的占23.64%(13/55),效价≥256的占12.73%(7/55),检测3批静注EV71免疫球蛋白试验品GMT为1 203。NIFDC实验室采用毒株-01检测国内8个企业12批IVIG的GMTs为335;检测3批静注EV71免疫球蛋白试验品的GMT为1 402,显著高于12批IVIG(P<0.05);采用毒株-02检测国内12个企业16批IVIG的EV71 GMT为332,与毒株-01检测结果差异无统计学意义(P>0.05)。结论来自全国各企业的IVIG中EV71中和抗体效价均为阳性,效价分布于104～630之间。经血浆筛查后投浆制备的静注EV71免疫球蛋白具有显著高于普通IVIG的EV71中和效价。Objective To screen the neutralizing antibody titers against enterovirus 71 （EV71） in commercial human intravenous immunoglobulin （IVIG）（pH 4） and experimental intravenous EV71 immunoglobulin, and provide a basis for further passive immunotherapy of hand-foot-mouth disease （HFMD）. Methods The neutralizing antibody titers against EV71 in domestic IVIG （pH 4） and in experimental intravenous EV71 immunoglobulin prepared with screened raw plasma were determined by microcytopathic effect （micro-CPE） method with two virus strains in two laboratories. Results The neutralizing antibody titers of 55 batches of domestic IVIG manufactured by 17 manufacturers determined with strain-01 in laboratory A were 104 - 256, of which 23.64% （13/55） were not less than 239, 12. 73% （7/55） were not less than 256, while the GMTs of neutralizing antibodies of 3 batches of experimental intravenous EV71 immunoglobulin were 1 203. However, the GMTs of neutralizing antibody against EV71 in 3 batches of experimental intravenous EV71 immunogiobulin （1 402） determined with strain-01 in NIFDC laboratory were significantly higher than those of 12 batches of IVIG manufactured by 8 manufacturers （P 〈 0. 05）. The GMTs of neutralizing antibody against EV71 in 16 batches of IVIG manufactured by 12 manufacturers determined with strain-02 were 332, which showed no significant difference with those determined with strain-01 （P 〉 0. 05 ）. Conclusion All the neutralizing antibody against EV71 in domestic IVIG manufactured by various manufacturers were positive, of which the titers ranged from 104 to 630. However, the neutralizing antibody titers against EV71 in intravenous EV71 immunoglobulin prepared with the screened plasma were significantly higher than those in IVIG.

关 键 词：静注入抗体免疫球蛋白 中和抗体 肠道病毒A型 人 手足口病 微量细胞病变 

分 类 号：R373.2[医药卫生—病原生物学] R392-33[医药卫生—基础医学]