Sasaki Y, Inoue T, Oriuchi N, Mitsuhashi N, Nagai T, Igarashi H, Tsujino D, Takahashi T, Sakaki T, Okazaki A
Department of Nuclear Medicine, Gunma University, School of Medicine.
Kaku Igaku. 1990 Apr;27(4):349-62.
The clinical trials of immunoscintigraphy with a cocktail of 131I anti CEA monoclonal antibody F(ab')2 and 131I anti CA 19-9 monoclonal antibody F(ab')2 (IMACIS-1) were performed to evaluate the safety and clinical usefulness. Thirty-five patients with proven cancer in six hospitals were examined in the phase two study. No significant changes of the heart rates, temperature, blood pressure, respiratory rates and clinical laboratory data were observed after i.v. IMACIS-1. Significant elevation of HAMA and IgE values in serum were not shown. Positive scintigrams which were interpreted by each hospital were obtained in 31/35 (89%) patients and in 39/53 (74%) lesions. The safety and clinical usefulness of immunoscintigraphy with IMACIS-1 were proven in the phase two study.
开展了一项使用¹³¹I抗癌胚抗原单克隆抗体F(ab')₂和¹³¹I抗CA 19-9单克隆抗体F(ab')₂混合物进行免疫闪烁显像的临床试验（IMACIS-1），以评估其安全性和临床实用性。在六家医院对35例确诊癌症患者进行了二期研究。静脉注射IMACIS-1后，未观察到心率、体温、血压、呼吸频率和临床实验室数据有显著变化。血清中HAMA和IgE值未出现显著升高。各医院解读的阳性闪烁显像在31/35（89%）的患者和39/53（74%）的病灶中获得。二期研究证实了IMACIS-1免疫闪烁显像的安全性和临床实用性。
