【摘要】 作者采用吸附破类(5Lf/0.5ml)对245名健康成人进行2～3针基础免疫,再肌注大剂量(36Lf/0.5ml)精破类加强免疫1针,可获得大量高效价免疫血浆。用低温乙醇法制备3批人 TIG,其破伤风抗体效价为240～330IU/ml,较原血浆的抗体浓缩13～18倍,各项生化及生物学指标均符合有关规程要求,制品的稳定性良好。临床验证中,第一阶段观察20名健康成人,肌注 TIG1ml(250IU)后无局部及全身反应。第二阶段观察156例急诊开放性外伤患者,肌注 TIG1ml 后对破伤风病的预防有效。血清学抗体检测也显示 TIG 优于TAT。对1例破伤风患者肌注5,000IU TIG 后,其血清抗体显著上升,症状消失,得以治愈。表明用 TIG预防和治疗破伤风感染是安全有效的。更多还原

【Abstract】 After 2-3 muscular iniections with adsorbed tetanus toxoid as basic immunjzation, the donors were further hyperimmunized with a big dose(36Lf/0.5ml)of thepurfied reranus toxoid.Accordinly,a plenty amount of immune plasma with high antibody titer was determined with ID techn que in vitro. From above pooling plasma we prepared three barches of TIG.The antibody titer of TIG was 260-330IU/ml which was concentrated 13-18 times compared witl poeling plasma.The stability of TIG was desirable as well. In first stage of clinical trial for 20 adults with 250IU/m1 TIG,all the persons have shown satisfactory startding to TIG without any Io al and all over rea tions.For second stage, the same dosage of TIG Was intected to 156 cases snffering from different open tratma.The resnlts has given significant evidence for prevention tetams with TIG.The level of antibodies in ser also indicated that TIG is better than TAT. Our results have demonstrated that TIG was effective,reliable and very safe for not only prevention but also therapy of tetanus disease.更多还原