静脉用蔗糖铁注射液治疗血液透析患者肾性贫血的临床研究

目的评价蔗糖铁注射液治疗维持性血液透析（血透）患者铁缺乏的有效性与安全性。方法159例维持性血透患者随机分为静脉组与口服组，分别采用静脉注射蔗糖铁及口服硫酸亚铁进行补铁治疗，总疗程50d。检测治疗前后血清铁指标、红细胞相关指标及生化指标，并对不良反应进行监测。结果①治疗50d时，静脉组Hb及Hct显著升高，分别上升（23．8±17．2）％和（27．8±20．2）％，幅度明显高于口服组（10．9±14．5）％和（15．2±20．9）％]，P〈0．001。②治疗50d后两组血清铁蛋白（sv）与转铁蛋白饱和度（TSAT）均较治疗前显著升高，且静脉组升高幅度SF（310．0±389．0）％，TSAT（88．2±96．3）％]明显高于口服组SF（150．3±433．8）％，TSAT（33．8±55．6）％]，P〈0．001。③治疗50d后静脉组血清白蛋白及血清钾较治疗前升高，白蛋白由（36．9±5．2）g/L升至（39．3±5．9）g／L，血清钾由（4．8±0．8）mmol／L升至（5．1±0．9）mmol／L，P〈0．01。两组治疗前后血WBC及其它生化指标均相近。④静脉组4例有不良反应，1例出现药物相关皮疹，停药后消失；1例轻微心悸；2例轻度胃肠道反应。口服组15例出现明显胃肠道症状，2例出现轻微药物性皮疹。静脉组总不良反应发生率（4／70，5．7％）明显低于口服组（17／66，25．8％），P〈0．005。结论静脉注射蔗糖铁可有效纠正维持性血透患者的铁缺乏，提高铁利用率及rHuEPO的治疗效果，且不良反应发发生率低、安全性良好。

Ferrous Saccharose Injection Treatment in Chronic Hemodialysis Multicenter Collaboration

Objective To investigate the safety and efficiency of Ferrous saecharose injection （FSI）in chronic hemodialysis patients. Methods One hundred and thirty - six patients on chronic hemodialysis were involved in recent 50 days with randomized, ontrolld, multicenter trial. Seventy patients received Ferrous saccharose injection and 66 received ferrous sulfate （FS）. Levels of serum ferritin （ SF）, transferrin saturation （ TSAT）, hemoglobin （Hb） and hematocrit （Hct） were tested before and after the treatment. Results After treatment, the levels of Hb, Hct, SF and TSAT were all significantly increased in FSI,which were also significantly higher than those in FS. The levels of serum albu- min and potassium elevated significantly in FSI, but no obvious changes of above both indexes were found in FS. One case in FSI presented rash during the treatment and recovered soon after drug withdrawal. Seventeen cases in FS showed adverse gastrointestinal effects. The rate of side - effect in FSI （5.7 % ）was significantly lower than that in FS （25.8% ,P 〈 0. 005 ）. Conclusion Ferrous saccharose injection can effectively increase serum iron parameters and hemoglobin levels in chronic hemodialysis patients ,with relatively high degree of safety.