左卡尼汀注射液联合生血宁片治疗糖尿病肾病腹膜透析伴肾性贫血的临床研究

Clinical trial of levocarnitine injection combined with Shengxuening tablets in the treatment of diabetic nephropathy peritoneal dialysis patients with renal anemia

目的观察左卡尼汀注射液联合生血宁片治疗糖尿病肾病腹膜透析伴肾性贫血的临床疗效及安全性。方法将30例糖尿病肾病腹膜透析伴肾性贫血患者随机分为对照组15例和试验组15例。对照组予以重组人红细胞生成素注射液每次100~150 U·kg^(-1),每周3次,皮下注射;试验组在对照组治疗的基础上,予以左卡尼汀每次1.0 g,每周3次,静脉推注+生血宁片每次0.5 g,tid,口服。2组患者均治疗3个月。比较2组患者的临床疗效、血清铁蛋白(SF)、转铁蛋白饱和度(TSAT)、丙二醛(MDA)、超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶(GSH-Px)、血细胞比容(HCT)、血红蛋白(Hb)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为93.33%(14例/15例)和60.00%(9例/15例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的SF分别为(471.26±43.46)和(352.45±33.27)ng·m L^(-1),TSAT分别为(34.75±3.86)%和(27.12±2.89)%,MDA分别为(9.47±1.02)和(12.37±1.04)nmol·L^(-1),SOD分别为(73.05±5.37)和(62.12±6.45)μg·m L^(-1),GSH-Px分别为(60.85±5.48)和(54.34±5.39)U·L^(-1),HCT分别为(32.87±2.74)%和(25.63±2.46)%,Hb分别为(110.42±11.23)和(92.14±10.04)g·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有腹痛、发热、恶心呕吐,对照组的药物不良反应主要有发热、恶心呕吐。试验组和对照组的总药物不良反应发生率分别为20.00%和13.33%,差异无统计学意义(P>0.05)。结论左卡尼汀注射液联合生血宁片治疗糖尿病肾病腹膜透析伴肾性贫血的临床疗效显著,其能明显地提高患者的血清SF、TSAT水平和抗氧化能力,减轻氧化应激反应,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of levocarnitine injection combined with Shengxuening tablets in the treatment of diabetic nephropathy peritoneal dialysis patients with renal anemia. Methods A total of 30 diabetic neplropathy peritoneal dialysis patients with renal anemia were randomly divided into control group and treatment group with 15 cases per group. Control group was given recom- binant human erythropoietin injection 100 - 150 U ·kg-1 per time, 3 times a week, subcutaneous injection. Treatment group was given levoc- arnitine 1.0 g per time,3 times a week, intravenous injection ＋ Sheng- xuening tablets 0. 5 g per time, tid, orally, on the basis of control group. Two groups were treated for 3 months. The clinical efficacy,the levels ofserum ferritin （SF）, transferrin saturation （TSAT）, malondialdehyde （MDA）, superoxide dismutase （SOD）, gluta- thione peroxidase （GSH -Px） , hematokrit （HCT） and hemoglobin （Hb） , and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates in treatment and control groups were 93.33% （ 14 cases/15 cases） and 60. 00% （9 cases/15 cases） with significant difference （P 〈 0. 05 ）. After treatment, the main indexes in treatment and control groups were compared： SF were （471.26 ± 43.46）, （352.45 ± 33.27） ng · mL-1; TSAT were （34. 75 ±3. 86）%, （27. 12 ±2. 89）% ; MDA were （9.47 ± 1.02）, （ 12. 37± 1.04） nmol · L-1 ; SOD were （73.05 ±5.37）, （62. 12 ±6.45） μg · mL-1 ; GSH -Px were （60.85 ±5.48）, （54.34±5.39）U ± L-1 ; HCTwere （32.87±2.74）%, （25.63±2.46）%; Hbwere （110.42±11.23）, （92.14±10.04）μ L-l, all with significant difference（ all P 〈 0.05）. The adverse drug reactions in treatment group were abdominal pain, fever, nausea and vomiting, which in control group were fever, nausea and vomiting. The incidences of adverse drug reactions in treatment and control groups were 20. 00% and 13.33% without significant difference （ P 〉 0. 05 ）. Conclusion Levocarnitine injection combined with Shengxuening tablets has a definitive clinical eflqcacy in the treatment of diabetic nephropathy peritoneal dialysis patients with renal anemia, which can significantly improve the levels of serum SF and TSAT and the antioxidant capacity,and reduce oxidative stress, without increasing the incidence of adverse drug reactions.