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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 evaluate the efficacy and safety of EV71 neutralizing antibody titers in the currently marketed human intravenous immunoglobulin (IVIG) (pH 4) and enterovirus 71 (EV71) immunoglobulin test Screening for passive immunotherapy for Hand-foot-mouth disease (HFMD) provides a reference. Methods The titer of EV71 antibody in domestic IVIG and intravenous EV71 immunoglobulin was determined by using the method of microcytopathology in two laboratories. Results In laboratory A, the EV71 neutralizing antibody titer of 55 batches of IVIG from 17 domestic enterprises was between 104 and 256 with 23.64% (13/55) of the titer≥239 and the titer ≥256 Accounting for 12.73% (7/55). The GMT of three groups of intravenous EV71 immunoglobulin test products was 1 203. The GMTs of 12 batches of IVIG in NIFDC laboratory using strain-01 were 335; the GMT of 3 batches of EV71 immunoglobulin test was 1 402, significantly higher than 12 batches of IVIG (P <0.05); Using strain-02 to detect the EV71 GMT of 16 batches of IVIGs in 12 domestic enterprises, there was no significant difference with strain-01 (P> 0.05). CONCLUSION: The neutralizing antibody titer of EV71 in IVIG from all the enterprises in the country is positive and the titer is between 104 and 630. The intravenous EV71 immunoglobulin prepared by plasmapheresising had significantly higher EV71 neutralizing titers than the normal IVIG.