CAJ | 학술논문

目的观察广泛使用条件下受试药物乙肝免疫球蛋白的疗效和不良反应.方法采用推荐的静注乙肝人免疫球蛋白使用剂量、多中心临床研究方法,在13家医院对525例乙肝相关性肝移植患者进行了(22.1±8.8)个月的防治乙肝复发临床的效果与药物相关不良反应观察.结果观察期内所有研究对象均未发现存在可能或肯定相关类型的药物不良反应;术后6个月内采用≥推荐药物剂量时,观察期内的再感染率低于4％;＜推荐药物剂量时,再感染率大于12％.结论受试药物的剂量与疗效存在明显的量效关系,药物的安全性及推荐用药方法的合理性再次得到了验证.
목적 관찰엄범사용조건하수시약물을간면역구단백적료효화불량반응.방법 채용추천적정주을간인면역구단백사용제량、다중심림상연구방법,재13가의원대525례을간상관성간이식환자진행료(22.1±8.8)개월적방치을간복발림상적효과여약물상관불량반응관찰.결과 관찰기내소유연구대상균미발현존재가능혹긍정상관류형적약물불량반응;술후6개월내채용≥추천약물제량시,관찰기내적재감염솔저우4％;＜추천약물제량시,재감염솔대우12％.결론 수시약물적제량여료효존재명현적량효관계,약물적안전성급추천용약방법적합이성재차득도료험증.
Objective To observe the efficacy and adverse reaction of the test drug hepatitis B immunoglobin on the post market.Method Employed by the methods of multiple center's clinical trials and using the recommended dosage of hepatitis B immunoglobulin for intravenous administration,the clinical efficacy of either prevention or treatment for hepatitis B recurrence and drug related adverse reactions were observed.This consisted of 22.1 months,13 hospitals,and 525 patients with hepatitis B related liver transplantation.Result The results showed a contrasting probability of adverse reactions for different doses among the observation period.Within 6 months postoperatively with a greater or equal to recommended drug dose,the infection rate was less than 4％.In contrast,the infection rate was greater than 12％ in the group with less than the recommended drug dose.Conclusion There was an obvious dose effect relationship,and the drug safety and recommended treatment rationality were verified.