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作者设计了白细胞介素-6(IL-6)在对免疫抑制剂治疗无反应或复发的AA病人的Ⅰ期研究,并评定了rhIL-6的安全性、耐受性和它对周围血象、出血合并症和输血需要的影响。 在Ⅰ/Ⅱ期研究中,11例骨髓衰竭病人(10例获得性AA,1例全血细胞减少的先天性AA;男6例,女5例;严重AA8例,非严重AA3例)接受rhIL-6治疗,rhIL-6皮下注射每天一次共28天,剂量0.5～5μg/kg,2周观察期后,5例病人接受第2个疗程治疗。 结果 仅1例病人(IL-6剂量为0.5μg/kg·d)有血小板持续增加(从18000/μl～72000/μl),4例病人发生出血,致使3个病人提前终止治疗。9例病人贫血加重。在第1疗程没有发现白细胞数的改变。第2疗程周
The authors designed a phase I study of interleukin-6 (IL-6) in patients with AA who did not respond or relapse to immunosuppressive therapy and assessed the safety, tolerability and efficacy of rhIL-6 in peripheral blood, Bleeding complications and effects of transfusion needs. In the phase I / II study, eleven patients with bone marrow failure (10 acquired AA, 1 congenital pancytopenia AA; 6 males and 5 females; severe AA8 and non-severe AA3) received rhIL- 6 treatment, rhIL-6 subcutaneous injection once a day for a total of 28 days, a dose of 0.5 ~ 5μg / kg, 2 weeks after the observation period, 5 patients received the second course of treatment. Results Only one patient (IL-6 at a dose of 0.5 μg / kg · d) had a sustained increase of platelets (from 18000 / μl to 72000 / μl) and bleeding occurred in 4 patients, resulting in early termination of treatment in 3 patients. Nine patients had anemia. In the first course of treatment did not find the number of white blood cell changes. Week 2 of treatment