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作者对生物合成(重组)α_2干扰素(RαIFN)治疗毛细胞白血病进行I/l期试验。附22例病人观察RaIFN毒性反应,并对其中17例观察骨髓反应。病人皮下注射Zxlo6IU/m.RaxFN,每周3次。20人在治疗前2~120个月(平均32个月)已施行脾切除术。进入试验的标准为持续性血细胞减少、有机会性惑染史或难以控制的血管炎病史。平均随访时间为6个月(2~7个月)。1例在治疗后1周死于脑血怜意外,他在试验前即患严重血小板减少症。20例均出现发热(39OC)、肌痛和疲劳。这些副作用均由RaIFN治疗前投用的醋氨酚所致。2例在试验过程中有细菌感染,其中l例在治疗的第2周发生下领下软组织感染,另l例在第18周发生大叶性肺炎,对他们静脉注射抗生素均有效,继续用RaIFN治疗。接受骨髓反应观察的17例病人在治疗后12周内,其外周血血红蛋白、粒细胞和血小板计数均明显改善。3个月后,17例病人的骨髓活检表明,毛细胞浸润率下降10~60帕(平均20听),正常造血细胞增加5一85呱(平均20肠),该结果与治疗前的数据有显著性差异。6个月治疗完成后,对7例病人进行第3次骨髓活检,发现毛细胞浸润率为50呱(30~80肠),而在治疗3个月时为70帕,治疗开始时为90肠,造血细胞分别为50帕、30肠和5肠。作者认为,机体对本试验所用RaIFN剂量能很好耐受,且RaIFN对毛细胞白血病的治疗十分有效。作者对生物合成(重组)吸
The authors conducted a phase I / l trial of biosynthesis (recombinant) alpha 2 interferon (RαIFN) in the treatment of hairy cell leukemia. Twenty-two patients were observed with RaIFN toxicity and 17 of them were observed bone marrow reaction. Patients were injected subcutaneously with Zxlo6IU / m.RaxFN three times per week. Twenty patients underwent splenectomy 2 to 120 months prior to treatment (mean, 32 months). The criteria for entering the trial were persistent cytopenias, a history of opportunistic infections or vasculitis that were difficult to control. The average follow-up time was 6 months (2 to 7 months). One patient died of cerebral hemorrhage 1 week after treatment, and he developed severe thrombocytopenia before the test. 20 cases were fever (39OC), muscle pain and fatigue. These side effects are caused by acetaminophen administered before RaIFN treatment. 2 cases of bacterial infection in the course of the trial, of which 1 cases occurred in the first 2 weeks of treatment under the collar of soft tissue infections, the other in the first 18 weeks of lobar pneumonia, intravenous antibiotics were effective for them continue to use RaIFN treatment. Seventeen patients who underwent bone marrow response observed a significant improvement in peripheral blood hemoglobin, granulocytes, and platelet counts within 12 weeks of treatment. Three months later, bone biopsy of 17 patients showed a decrease in hair cell infiltration rate of 10-60 angstroms (mean, 20 ears) and an increase of 5-18% in normal hematopoietic cells (an average of 20%), as compared with pretreatment data Significant difference. After 6 months of treatment, a third bone marrow biopsy was performed on 7 patients and found that the rate of hair cell infiltration was 50 ng (30 to 80 bowel) and 70 bar at 3 months of treatment, 90 at the beginning of treatment , Hematopoietic cells were 50 Pa, 30 intestine and 5 intestine. The authors believe that the body can be well tolerated with the RaIFN dose used in this study and that RaIFN is very effective in the treatment of hairy cell leukemia. The author of biosynthesis (recombinant) suction