Evaluation of safety, efficacy and economy of equine tetanus immunoglobulin F(ab′)2
10.13200/j.cnki.cjb.004673
- VernacularTitle:马破伤风免疫球蛋白F(ab')2的安全性、有效性和经济性评价
- Author:
Hui LV
1
Author Information
1. Department of Emergency Critical Care Medicine, Shanghai General Hospital, Shanghai 201600, China
- Publication Type:Journal Article
- Keywords:
Equine tetanus immunoglobulin F (ab′) 2;
Tetanus;
Allergic reaction;
Safety;
Efficacy;
Economy
- From:
Chinese Journal of Biologicals
2026;39(03):309-313+325
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the safety, efficacy and economy of equine tetanus immunoglobulin F(ab')_2, so as to provide reference for its clinical application.MethodsPatients who were admitted to six research centers for trauma from November 23, 2021 to October 31, 2022 and required a tetanus immunoglobulin injection were selected as the research subjects to observe the positive rate of skin sensitization test of equine tetanus immunoglobulin F(ab')_2 and the incidence of adverse events(AEs) after injection. In addition, one of the study centers was selected to evaluate the incidence of tetanus in patients receiving equine tetanus immune globulin F(ab')_2 injection in this center. Meanwhile, a pharmacoeconomic model per 10 000 patients was constructed to compare the difference in drug costs of switching to human tetanus immunoglobulin(TIG) due to a positive skin sensitization test when patients preferred tetanus antitoxin(TAT) or equine tetanus immunoglobulin F(ab')_2.ResultsA total of 422 patients were enrolled in the study, of whom 419 underwent an equine tetanus immunoglobulin F(ab')_2 skin sensitization test and 416 received a test result, with a positive skin sensitization test rate of 5. 05%(21/416). Among the 395 patients who had a negative skin sensitization test and completed equine tetanus immunoglobulin F(ab')_2 injection, five(1. 27%) patients developed AEs related to equine tetanus immunoglobulin F(ab')_2, mainly including rash and pruritus, and two(0. 51%) patients had grade ≥ 3 AEs related to equine tetanus immunoglobulin F(ab')_2, including one case of immediate anaphylaxis and one case of pruritus. None of the patients developed anaphylactic shock or death related to equine tetanus immunoglobulin F(ab')_2. None of the patients in the selected research center developed tetanus after administration of equine tetanus immunoglobulin F(ab')_2. In addition, the pharmacoeconomic evaluation model showed that equine tetanus immunoglobulin F(ab')_2 had a higher drug economic value compared to TAT and TIG.Conclusion Equine tetanus immunoglobulin F(ab')_2 has shown good efficacy and safety in preventing tetanus in the real world with high pharmacoeconomic value.
