琥珀酸亚铁对比生血宁辅助治疗糖尿病肾病腹膜透析患者肾性贫血的临床观察

Clinical Observation of Ferrous Succinate versus Shengxuening in the Adjuvant Treatment of Renal Anemia in Patients with Diabetic Nephropathy Peritoneal Dialysis

目的：比较琥珀酸亚铁与生血宁辅助治疗糖尿病肾病腹膜透析（CAPD）患者肾性贫血的疗效和安全性。方法：64例糖尿病肾病CAPD肾性贫血患者随机分为观察组（32例）和对照组（32例）。所有患者均给予皮下注射胰岛素控制血糖（根据餐前血糖水平调节胰岛素用量），高血压者积极控制血压，纠正酸碱、电解质平衡紊乱，口服叶酸和维生素B12,同时持续非卧床CAPD，后皮下注射重组人促红细胞生成素（rhEPO）初始剂量为100～150U／（kg·周），分2～3次等常规治疗。在此基础上，观察组患者口服生血宁片1g，每日3次；对照组患者口服琥珀酸亚铁片0．2g，每日3次。两组疗程均为16周。治疗过程中每月调整1次rhEPO的用量，使血红蛋白（Hb）为100～120g／L。比较两组患者的临床疗效，治疗前后血清铁、血清铁蛋白、总铁结合力、转铁蛋白饱和度，治疗前、治疗第4、8、12、16周Hb、血细胞比容（Hct）、超敏C反应蛋白（hs．CRP），rhEPO用量及不良反应发生情况。结果：两组患者总有效率比较差异无统计学意义（P〉0．05）。治疗后，两组患者血清铁、总铁结合力、转铁蛋白饱和度、Fib、Hct均显著高于同组治疗前，且随治疗时间延长逐渐升高，血清铁蛋白、hs．CRP均显著低于同组治疗前，且随治疗时间延长逐渐降低，差异均有统计学意义（P〈0.05），但组间同期比较差异无统计学意义（P〉0．05）。观察组患者治疗8周、12周、16周后及对照组治疗8周后的rhEPO用量均显著低于同组治疗4周后，且观察组治疗12周、16周后低于对照组，差异均有统计学意义（尸〈0.05）。观察组患者不良反应发生率显著低于对照组，差异有统计学意义（P〈0．05）。结论：在常规治疗的基础上，琥珀酸亚铁与生血宁辅助治疗糖尿病肾病CAPD肾性贫血的疗效均较好，均能改善患者贫血及铁代谢情况，但在改善微炎症状态、减少rhEPO用量和安全性方面生血宁优于琥珀酸亚铁。

OBJECTIVE ： To compare the efficacy and safety of ferrous succinate or Shengxuening in the adjuvant treatment of renal anemia in patients with diabetic nephropathy peritoneal dialysis （CAPD）. METHODS： 64 diatetic nephropathy CAPD pa- tients with renal anemia were randomly divided into observation group （32 cases） and control group （32 cases）. All patients re- ceived subcutaneous injection of insulin for blood glucose control （adjusted the insulin dosage based on fasting blood glucose lev- els）, hypertension patients actively controlled blood pressure, corrected acid-base and electrolyte balance disorders, orally received fo- lic acid and vitamin Bt2, ambulant CAPD, then rhEPO was subcutaneously injected with initial dose of 100-150 U/（kg. week） for 2-3 times and other conventional treatment. Based on it, observation group received 1 g of Shengxuening tablet, 3 times a day; control group received 0.2 g Ferrous succinate tablet, 3 times a day. The treatment course for both groups was 16 weeks. The rhEPO dose was monthly adjusted to make Hb 100-120 g/L. Clinical efficacy, serum iron, serum ferritin, total iron binding capacity, transfer- tin saturation before and after treatment, Hb, Hct, hs-CRP, rhEPO dose before treatment and after 4, 8, 12 and 16 weeks of treat- ment, and the incidence of adverse reactions in 2 groups were observed. RESULTS： There was no significant difference in the total effective rate between 2 groups （P〉0.05）. After treatment, serumiron, total iron binding capacity, transferrin saturation, Hb and Hct in 2 groups were significantly higher than before, and it gradually increased by treatment time, serum ferritin, hs-CRP was sig- nificantly lower than before, and it gradually decreased by treatment time, the differences were statistically significant （P〈0.05） ; but there was no significant difference between 2 groups （P〉0.05）. The rhRPO dose in observation group 8, 16 and 16 weeks af- ter treatment and in control group 8 weeks after treatment were significantly lower than 4 weeks after treatment, and 12 and 16 weeks after treatment in observation group were lower than control group, the differences were statistically significant （P〈0.05）. The incidence of adverse reactions in observation group was significantly lower than control group, the difference was statistically significant （P〈0.05）. CONCLUSIONS： Based on conventional treatment, both ferrous succinate and Shengxuening show good ef- ficacy in the adjuvant treatment of renal anemia with diabetic nephropathy CAPD, both can improve anemia and iron metabolism, while Shengxuening is superior to ferrous succinate in terms of improving microinflammatory state and reducing rhEPO dose, withbetter safety.