| 中文摘要 |
臺灣位於亞熱帶地區，蛇類種類繁多，臨床上常見毒蛇咬傷種類為百步蛇、赤尾鮐、龜殼花、雨傘節、飯匙倩與鎖鏈蛇等六大毒蛇，目前最有效治療方法仍為施打抗蛇毒血清。衛生福利部疾病管制署為目前國內唯一且具有抗雨傘節及飯匙倩蛇毒血清凍晶注射劑、抗龜殼花及赤尾鮐蛇毒血清凍晶注射劑、抗百步蛇毒血清凍晶注射劑以及抗鎖鏈蛇毒血清凍晶注射劑等4種抗蛇毒血清凍晶注射劑藥證，供應全國人民所需產品，數十年來已拯救無數病患生命。
衛生福利部疾病管制署自日據時代起，進行抗蛇毒血清製造迄今已逾70年，期間為尋得合適之免疫馬場進行抗蛇毒血漿產製而屢次搬遷，後於2009年，開始建造我國第一座符合國際醫藥品稽查協約組織(Pharmaceutical Inspection Co-operation Scheme, PIC/S)藥品優良製造規範(Good Manufacturing Practice, GMP)精神之國家免疫馬匹畜牧場，於2017年試運行、2019年全面啟用，將抗蛇毒血漿製程作業，包含蛇毒抗原配製、馬匹免疫、馬匹採血、血漿採集等程序納入，目前4種抗蛇毒血漿生產量可充足供應國內抗蛇毒血清凍晶注射劑產製所需。近年著手優化馬匹免疫用蛇毒抗原配方，成功提高抗龜殼花及赤尾鮐蛇毒血漿效價至少4倍，且產能顯著提升約36倍，同時降低龜殼花蛇毒使用量約90%，得以減少實驗動物、蛇毒生物材料等使用量，並促進馬匹健康，使其保持於良好狀態，未來將持續精進抗蛇毒血漿製造相關技術及研究並積極優化血漿採集製程，以提高血漿品質，保障國人用藥安全。 |
| 英文摘要 |
In Taiwan, there are six clinically significant vipers, including Deinagkistrodon acutus, Trimeresurus stejnegeri, Protobothrops mucrosquamatus, Daboia russelii siamensis, Bungarus multicinctus and Naja atra. To save people from envenoming, Taiwan Centers for Disease Control produces and supplies four antivenoms for six vipers from hyperimmune horse. To find a suitable horse facility, the farm was moved several times and finally settled down at the national immunization horse farm in 2019, with Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Good Manufacturing Practice, (GMP) designation. Consequently, the following processes can comply with regulations, including antigen preparation, immunization, blood collection, plasma collection, and reinfusion.
Recently we overcame the obstacle of low success rate and low titers for hyperimmune plasma of Trimeresurus stejnegeri, and the production capacity increased by approximately 36 times. Meanwhile, we also reduced and refined the use of venom in horses, which led to decreasing the quantity of horses used and the side effects of immunization on horses.
In the future, we will further improve the production capacity for other hyperimmune plasma and establish plasmapheresis on plasma production to ensure the health and safety of people with snakebites envenoming in Taiwan. |
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