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分析台湾地区使用的静脉注射免疫球蛋白中针对细菌和病毒抗原以及细菌类毒素的抗体滴度。

Analyzing titers of antibodies against bacterial and viral antigens, and bacterial toxoids in the intravenous immunoglobulins utilized in Taiwan.

作者信息

Wu Chi-Yu, Wang Hsiu-Chi, Wang Kun-Teng, Yang-Chih Shih Daniel, Lo Chi-Fang, Wang Der-Yuan

机构信息

Section of Biologics & Advanced Therapeutic Product Analysis, Division of Research and Analysis, Food and Drug Administration, Department of Health, Executive Yuan, Taiwan, ROC.

出版信息

Biologicals. 2013 Mar;41(2):88-92. doi: 10.1016/j.biologicals.2012.10.003. Epub 2012 Nov 11.

Abstract

Intravenous immunoglobulin (IVIG) manufactured from human plasma contains IgG as the primary ingredient, and is used for indications such as immunodeficiency syndrome. Available IVIGs in Taiwan are either manufactured from Taiwanese or North American plasma. The effectiveness of the national immunization program of Taiwan can be evaluated by analyzing and comparing IVIG antibody titers that are induced through the corresponding vaccines (tetanus, diphtheria, and pertussis, measles, rubella, hepatitis A, hepatitis B and varicella). Both enzyme-linked immunosorbent assay (ELISA) and the in vitro neutralization test demonstrated that all IVIGs provide adequate clinical protection against diphtheria and tetanus toxins. ELISA results further revealed that plasma of Taiwanese subjects contains higher levels of pertussis toxin and filamentous hemagglutinin antibodies, when compared to foreign IVIGs. This may be related to the later adoption of acellular pertussis vaccine in Taiwan. Antibodies titers against measles, rubella, hepatitis A, and varicella-zoster virus were otherwise low. Low titers of hepatitis B surface antigen antibodies are present in Taiwanese plasma IVIG, indicating immune memory decline or loss. In conclusion, our results show that Taiwanese IVIG contains varying titers of vaccine-induced antibodies, and serves as a guide for future amendments to Taiwan's immunization program.

摘要

由人血浆制成的静脉注射免疫球蛋白(IVIG)以IgG作为主要成分,用于免疫缺陷综合征等适应症。台湾现有的IVIG是由台湾或北美血浆制成的。通过分析和比较通过相应疫苗(破伤风、白喉、百日咳、麻疹、风疹、甲型肝炎、乙型肝炎和水痘)诱导产生的IVIG抗体滴度,可以评估台湾国家免疫规划的有效性。酶联免疫吸附测定(ELISA)和体外中和试验均表明,所有IVIG均能提供足够的临床保护以抵御白喉和破伤风毒素。ELISA结果进一步显示,与国外IVIG相比,台湾受试者的血浆中百日咳毒素和丝状血凝素抗体水平更高。这可能与台湾较晚采用无细胞百日咳疫苗有关。否则,针对麻疹、风疹、甲型肝炎和水痘-带状疱疹病毒的抗体滴度较低。台湾血浆IVIG中乙型肝炎表面抗原抗体滴度较低,表明免疫记忆下降或丧失。总之,我们的结果表明,台湾IVIG含有不同滴度的疫苗诱导抗体,并为台湾免疫规划的未来修订提供了指导。

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