重组白细胞介素－2（rIL－2）的免疫放射分析及人体药代动力学研究

Immunoradiometric Assay and Pharmacokinetics Analysis For Recombinant Interleukin-2

用免疫放射分析（ＩＲＭＡ）检测接受白细胞介素－２（ｒＩＬ－２）治疗的肿瘤病人血清标本中ＩＬ－２活性。该法采用双抗体夹心模式，灵敏度＜２．１Ｕ／ｍｌ，（２９０ｎｇ／ｍｌ），平均批内和批间变异系数分别为１．９８％和５．２７％，方法特异、灵敏、快速。用此法检测两组皮下注射不同剂量ｒＩＬ－２的１６例本院肿瘤病人血清浓度，并对部分病例进行药代动力学研究，其血药浓度变化曲线属二室模型。消除半衰期（ｔ１／２β）为１８ｈ，达峰时间为２．５ｈ。

Using two different monoclonal antibodies to human recombinant IL-2 (rIL-2), we developed a sandwish type immunoradiometric assay (IRMA) for quantitation of IL-2 in serum samples. This assay was more specific, sensitive and less time-consuming than other tests. The detection limit was below 2.1 U/ml (290ng/ml), the within-batch and between-batch CV were 1. 98% and 5. 27%, respectively. IL-2 levels in 16 serum samples from rIL-2-treated cancer patients were measured with present assay and its pharmacokinetics was analysed. The blood concentration change curve was of bicameral model and t1/2β was 18h and Tmax 2. 5h.