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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(rh EPO)初始剂量为100~150 U/(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1 g,每日3次;对照组患者口服琥珀酸亚铁片0.2 g,每日3次。两组疗程均为16周。治疗过程中每月调整1次rh EPO的用量,使血红蛋白(Hb)为100~120 g/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),rh EPO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、Hb、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rh EPO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(P<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rh EPO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 and Shengxuening in treating renal anemia in diabetic nephropathy peritoneal dialysis (CAPD) patients. Methods: Sixty-four diabetic nephropathy patients with CAPD renal anemia were randomly divided into observation group (32 cases) and control group (32 cases). All patients were given insulin subcutaneous injection of blood glucose control (according to the amount of insulin to adjust the blood glucose level before meals), hypertension positive control of blood pressure, correct acid-base, electrolyte imbalance, oral folic acid and vitamin B12, while continuing ambulatory CAPD, subcutaneous injection Recombinant human erythropoietin (rh EPO) initial dose of 100 ~ 150 U / (kg · weeks), 2 to 3 times the routine treatment. On this basis, the observation group patients oral Shengxuening 1 g, 3 times a day; the control group patients oral administration of ferrous succinate 0.2 g, 3 times a day. The two groups of treatment were 16 weeks. The amount of rh EPO was adjusted once a month during treatment so that hemoglobin (Hb) was 100-120 g / L. The clinical efficacy, serum iron, serum ferritin, total iron binding capacity and transferrin saturation before and after treatment were compared before and after treatment. Hb, hematocrit (Hct) at 4, 8, High-sensitivity C-reactive protein (hs-CRP), rh EPO dosage and adverse reactions. Results: There was no significant difference in the total effective rate between the two groups (P> 0.05). After treatment, serum iron, total iron binding capacity, transferrin saturation, Hb, Hct in both groups were significantly higher than those before treatment, and gradually increased with the prolongation of treatment time. Serum ferritin and hs-CRP were significantly increased (P <0.05), but there was no significant difference between the two groups in the same period (P> 0.05). In the observation group, the dosage of rh EPO after 8 weeks, 12 weeks, 16 weeks and 8 weeks of treatment in the control group were significantly lower than those in the same group after treatment for 4 weeks, and the observation group was 12 weeks and 16 weeks later, The differences were statistically significant (P <0.05). The incidence of adverse reactions in observation group was significantly lower than that in control group, the difference was statistically significant (P <0.05). Conclusion: On the basis of routine treatment, the efficacy of adjuvant ferrous succinate and Shengxuening in treating diabetic nephropathy with CAPD renal anemia are better, both can improve anemia and iron metabolism in patients, but in improving micro-inflammatory state, reducing rh EPO Dosage and safety of blood rather than ferrous succinate.