- 期刊
國人使用人免疫球蛋白製劑抗體保護力價之評估研究
Evaluation of Protective Titers of Human Immunoglobulin Products in Taiwan
摘要
由人血漿、血清等精製而得之免疫球蛋白製劑，主要為丙種球蛋白之無菌製劑，多用於原發性免疫球蛋白缺乏症、小兒HIV感染、川崎氏病及骨髓移植等病症之臨床治療。因免疫球蛋白製劑內含多種高力價抗體，故臨床上亦常用作對抗多種感染症之藥品。本研究係為六年長程計畫，主要評估國內外不同血源之人免疫球蛋白製劑所含抗體力價之差異，以及台灣血源之人免疫球蛋白製劑其抗體力價是否可呈現歷年來國內預防接種之免疫狀態與近年來國內特定流行病學之免疫特徵，以期作為臨床治療上製劑選擇之參考。 98年度係延續97年計畫內容，以96-98年間國內使用之3種國外血源與台灣血源（96年始供應）之人免疫球蛋白製劑各3-4批次為標的，持續以酵素連結免疫吸附分析套組(ELISA kits)進行後續批次之白喉毒素、破傷風毒素及百日咳FHA抗原之抗體保護力價分析，並於98年新增百日咳毒素做為評估指標。 國人使用之人免疫球蛋白製劑各種抗體力價範圍如下。白喉：2.05-6.26 IU/mL；破傷風：13.71-43.75 IU/mL；百日咳FHA:167-1,927 U anti-FHA/mL；百日咳毒素：7,235-46,660 FDA-U/mL。其中百日咳FHA抗體力價之結果顯示，台灣血源之人免疫球蛋白製劑其百日咳FHA抗體力價較國外血源高，約為2至11.5倍，而其餘抗體力價則與國外製劑相近。本研究係為市售人免疫球蛋白製劑之保護力價分析報告，期提供國人在使用人免疫球蛋白製劑於預防及治療特定病毒及細菌感染症上提供進一步之參考。
並列摘要
Intravenous immunoglobulin (IVIG) is made from concentrated human plasma and serum and contains immunoglobulin G (IgG) as the main active ingredient. It is used in treating clinical diseases such as immunodeficiency, infant HIV infections, Kawasaki disease and bone marrow transplant, and is thus frequently selected as a treatment for various infectious diseases. This proposed six-year project was aimed to assess the antibody protection titer of IVIGs manufactured from Taiwan and foreign blood sources, the status of Taiwan's immunization regimen, and the trends of recent disease epidemics. The results could aid the selection of a treatment plan in clinical therapies. This year continues the work of 2008, in which we have investigated 3 to 4 lots of IVIGs produced from local and foreign blood sources released between 2007 and 2008, and adopted enzyme-linked immunosorbent assay (ELISA) to examine the protective titer against diphtheria and tetanus toxins, and pertussis FHA antigen. Pertussis toxin was added to the testing list in 2009. The antibody titers against specific diseases for IVIG produced with local blood source are as follows: diphtheria 2.05-6.26 IU/ml, tetanus 13.71-43.75 IU/ml, pertussis FHA 167-1927 U anti-FHA/ml, pertussis toxin 7235-46660 FDA-U/ml. Furthermore, according to the ELISA result, IVIGs made from Taiwan blood source contain higher antibody titer against pertussis FHA than foreign sources, ranging from 2 to 11.5 times; however, the remaining antibody titres are similar for both blood sources. The investigation into the protective titers of commercial IVIGs could provide the information to evaluate their potentials as biological preparations that prevent and treat specific bacterial infections.