【摘要】 目的 综合评价马破伤风免疫球蛋白F（ab’）₂用于预防破伤风梭菌感染的短期被动免疫的临床价值。方法 采用定性与定量相结合的评价方法，基于循证医学、流行病学、临床医学、临床药学、药物经济学等方法学，通过公开资料、临床试验数据及文献二次评价，从安全性、有效性、经济性、创新性、适宜性、可及性六个维度进行系统评估。结果 马破伤风免疫球蛋白F（ab’）₂作为传统破伤风抗毒素（TAT）的升级换代产品，经柱色谱纯化工艺制备，去除可结晶区域（Fc）段，显著降低免疫原性。临床前急毒、长毒试验未见明显毒性反应；Ⅲ期临床试验显示，其皮试阳性率仅为3.1%，过敏反应发生率低于1%，显著优于TAT。药效学研究表明，其中和抗体效价≥2 000 IU/mL，用药后6 h破伤风抗体水平扣除基线大于10 IU/L的比例达93.2%，保护效果持续至7 d。药物经济学评价显示，与TAT相比，其增量成本效果比（ICER）为-434.1元，具有经济性优势。产品已获36项专利，纳入国家医保乙类目录，全国24个省市挂网，覆盖1 500余家医疗机构，疗程费用占人均可支配收入比例低，可及性良好。结论 马破伤风免疫球蛋白F（ab’）₂用于预防破伤风梭菌感染的短期被动免疫，临床价值证据充足，结果确定。更多还原

【Abstract】 Objective To comprehensively evaluate the clinical value of tetanus immunoglobulin F（ab’）₂, equine for short-term passive immunization against Clostridium tetani infection. Methods A combination of qualitative and quantitative evaluation methods was employed. Based on methodologies including evidence-based medicine, epidemiology, clinical medicine, clinical pharmacy, and pharmacoeconomics, a systematic assessment was conducted across six dimensions: safety, efficacy, economy, innovation, suitability, and accessibility, utilizing publicly available information, clinical trial data, and secondary literature evaluation. Results As an upgraded product replacing traditional tetanus antitoxin（TAT）, tetanus immunoglobulin F（ab’）₂, equine was prepared via column chromatography purification process, which removed the Fc fragment, significantly reducing immunogenicity. Preclinical acute and long-term toxicity tests showed no significant toxic reactions. Phase Ⅲ clinical trials demonstrated a skin test positive rate of only 3.1% and an allergic reaction incidence of less than 1%, significantly superior to TAT. Pharmacodynamic studies indicated a neutralizing antibody titer ≥ 2 000 IU/mL; The proportion of subjects achieving a tetanus antibody level increase of > 10 IU/L above baseline at 6 hours post-administration reached 93.2%, with the protective effect lasting up to 7 days. Pharmacoeconomic evaluation showed an incremental cost-effectiveness ratio（ICER） of-434.1 RMB compared to TAT, indicating an economic advantage. The product had obtained 36 patents, was included in the National Reimbursement Drug List（Category B）, was listed on procurement platforms in 24 provinces and municipalities, and covered more than 1 500 medical institutions. The course of treatment cost accounted for a low proportion of the per capita disposable income, indicating good accessibility. Conclusion Tetanus immunoglobulin F（ab’）₂, equine, used for short-term passive immunization against Clostridium tetani infection, has substantial and conclusive evidence supporting its clinical value.更多还原