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一种新的高纯热处理马狂犬病免疫球蛋白(PHT-Erig)F(ab′)2制剂已在泰国和菲律宾进行临床评价,因为狂犬病为该两国的地方病。最初前瞻性、随机对照实验(研究1)是比较注射PHT-Erig或一种商品采用的马狂犬病免疫球蛋白(Erig PMC)后的安全性和药物动力学(狂犬病抗体的血清浓度)。第二次实验(研究2)是使用一种参考细胞培养疫苗,纯Vero-细胞狂犬病疫苗(PVRV)或者与Erig PMC或与PHT-Erig联合注射,模拟暴露后狂犬病的预防。研究1:27例健康人。泰国成人通过
A new high-purity heat-treated horse’s rabies immunoglobulin (PHT-Erig) F (ab ’) 2 formulation has been clinically evaluated in Thailand and the Philippines because rabies is endemic in both countries. The initial prospective, randomized, controlled trial (Study 1) compared the safety and pharmacokinetics (rabies antibody serum concentrations) following injection of PHT-Erig or a commercial Erin’s PMC. The second experiment (Study 2) was the use of a reference cell culture vaccine, a pure Vero-cell rabies vaccine (PVRV) or a combination with Erig PMC or with PHT-Erig to simulate the prophylaxis of rabies after exposure. Study 1:27 healthy people. Thai adults pass