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目的评价右旋糖酐氢氧化铁注射液治疗腹膜透析患者铁缺乏的有效性及安全性。方法选择第二军医大学附属长海医院肾内科59例长期不卧床腹膜透析(CAPD)患者,肾性贫血程度:血红蛋白(Hb)60～90g/L,或红细胞压积(Hct)0.18%～0.27%,随机分为静脉组与口服组,分别采用静脉注射右旋糖酐氢氧化铁及口服琥珀酸亚铁进行补铁治疗,总疗程8周。检测治疗前治疗后8周时血清铁指标、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共50例完成本临床研究,其中静脉组与口服组各25例,两组患者年龄、性别、贫血程度、血清铁指标及促红细胞生成素(EPO)用量相匹配。②治疗8周时,静脉组Hb及Hct显著升高,分别为(24.1±17.9)%和(27.2±19.7)%,幅度明显高于口服组[(12.1±16.5)%和(15.8±11.8)%],P<0.001。③治疗8周时,两组血清铁蛋白(SF)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(487.3±390.8)%,TSAT(93.1±87.0)%]明显高于口服组[SF(178.9±271.7)%,TSAT(38.9±41.7)%],P<0.001。④治疗8周时,静脉组血清白蛋白及血清钾较治疗前升高,白蛋白由(35.7±6.1)g/L升至(39.4±5.9)g/L,血清钾由(4.1±0.7)g/L升至(4.9±0.8)g/L,P<0.01。两组治疗前后血白细胞及其它生化指标均相近。⑤静脉组2例有不良反应,其中1例轻微心悸,1例轻度胃肠道反应。口服组7例出现明显胃肠道症状。静脉组总不良反应发生率(2/25,8.0%)明显低于口服组(7/25,28.0%),P<0.01。结论①静脉注射右旋糖酐氢氧化铁可有效纠正CAPD患者的铁缺乏、提高铁利用率及EPO的治疗效果。②静脉注射右旋糖酐氢氧化铁临床应用不良反应发生率低、安全性良好。
Objective To evaluate the efficacy and safety of dextran injection in the treatment of iron deficiency in peritoneal dialysis patients. Methods Fifty-nine patients with long-term ambulatory peritoneal dialysis (CAPD) were enrolled in Department of Nephrology, Changhai Hospital affiliated to Second Military Medical University. The levels of renal anemia were: hemoglobin (Hb) 60-90g / L, Hct 0.18% -0.27% , Were randomly divided into intravenous group and oral group, respectively, intravenous dextran iron hydroxide and oral ferrous succinate for iron treatment, the total duration of 8 weeks. Serum iron index, erythrocyte related index and biochemical index were detected 8 weeks after treatment, and the adverse reactions were monitored. Results ① A total of 50 patients completed the clinical study. Among them, 25 patients in the intravenous and oral groups, respectively, matched the age, gender, degree of anemia, serum iron index and EPO dosage. ② At 8 weeks of treatment, Hb and Hct were significantly increased in the venous group (24.1 ± 17.9%) and (27.2 ± 19.7)%, respectively, which were significantly higher than those in the oral group (12.1 ± 16.5% vs 15.8 ± 11.8% %], P <0.001. ③ After 8 weeks of treatment, the levels of serum ferritin (SF) and transferrin saturation (TSAT) in both groups were significantly higher than those before treatment (SF (487.3 ± 390.8)%, TSAT 87.0%)] was significantly higher than that of oral [SF (178.9 ± 271.7%), TSAT (38.9 ± 41.7%)], P <0.001. ④ After 8 weeks of treatment, serum albumin and serum potassium in venous group increased significantly from (35.7 ± 6.1) g / L to (39.4 ± 5.9) g / L and serum potassium increased from (4.1 ± 0.7) g / L to (4.9 ± 0.8) g / L, P <0.01. Before and after treatment, blood leukocytes and other biochemical indicators were similar. ⑤ venous group 2 cases had adverse reactions, including 1 case of mild palpitations, 1 case of mild gastrointestinal reactions. 7 cases of oral group showed obvious gastrointestinal symptoms. The incidence of adverse reactions in the intravenous group (2 / 25,8.0%) was significantly lower than that in the oral group (7 / 25,28.0%), P <0.01. Conclusion ① intravenous injection of dextran ferric hydroxide can effectively correct the iron deficiency in patients with CAPD, improve the utilization of iron and EPO treatment. ② intravenous dextran iron hydroxide clinical application of low incidence of adverse reactions, good safety.