罗沙司他联合多糖铁复合物、生血宁治疗重组人促红素效果不佳的维持性血液透析肾性贫血患者的临床研究

Efficacy of roxallistat combined with polysaccharide iron complex and Shengxuening in the treatment of maintenance hemodialysis renal anemia with poor recombinant human erythropoietin

目的探讨罗沙司他联合多糖铁复合物、生血宁治疗重组人促红素效果不佳的维持性血液透析肾性贫血患者的临床疗效。方法将重组人促红素效果不佳的维持性血液透析肾性贫血患者以随机数字表法分成对照组与试验组。对照组口服罗沙司他,体质量>60 kg,每次120 mg,每周3次,体质量45~60 kg,每次100 mg,每周3次;口服多糖铁复合物,每次300 mg,每天1次。试验组在对照组基础上口服生血宁,每次0.25~0.50 g,每天3次。2组均治疗3个月。对比2组临床疗效、炎症因子、铁代谢、肾功能、贫血指标、中医证候评分及药物不良反应发生情况。结果对照组入组34例,脱落1例,最终33例纳入分析;试验组入组35例,脱落1例,最终34例纳入分析。试验组和对照组治疗后的总有效率分别为97.06%(33例/34例)和81.82%(27例/33例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的核转录因子-κB(NF-κB)分别为(24.09±3.06)和(35.23±4.11)ng·L^(-1),干扰素γ(IFN-γ)分别为(41.39±4.13)和(50.10±5.27)ng·L^(-1),转铁蛋白饱和度(TAST)分别为(38.62±5.91)%和(31.16±4.73)%,血清铁蛋白(SF)分别为(28.13±5.77)和(22.47±4.65)μmol·L^(-1),血清铁(SI)分别为(15.66±3.76)和(13.19±2.94)μmol·L^(-1),24 h尿蛋白排泄率(24 h UPE)分别为(1.85±0.41)和(2.91±0.62)g·24 h^(-1),血尿素氮(BUN)分别为(5.16±0.67)和(6.89±0.97)mmol·L^(-1),血红蛋白(Hb)分别为(91.38±11.23)和(83.19±8.54)g·L^(-1),血细胞比容(Hct)分别为(29.01±7.40)%和(24.56±5.69)%,主症评分分别为(5.29±1.05)和(7.15±1.53)分,次症评分分别为(3.11±0.46)和(4.98±0.77)分,总评分分别为(8.40±1.49)和(12.13±2.30)分,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应总发生率分别为14.71%和9.09%,在统计学上差异无统计学意义(P>0.05)。结论罗沙司他联合多糖铁复合物、生血宁治疗重组人促红素效果不佳的维持性血液透析肾性贫血患者的疗效好,可减轻炎症反应,调节铁代谢,改善肾功能,且药物不良反应少。

Objective To investigate the efficacy of roxallistat combined with polysaccharide iron complex and Shengxuening in the treatment of maintenance hemodialysis renal anemia with poor recombinant human erythropoiesis.Methods Maintenance hemodialysis renal anemia patients with poor recombinant human erythropoietin effect were divided into control group and treatment group according to random number table method.The control group took roxallistat orally with a body weight of>60 kg,120 mg each time,3 times a week,and 45-60 kg with 100 mg each time,3 times a week;oral polysaccharide iron complex,300 mg each time,once a day.The treatment group was given Shengxuening orally based on the control group,0.25-0.50 g each time,3 times a day.Both groups were treated for 3 months.The clinical efficacy,inflammatory factors,iron metabolism,renal function,anemia index,traditional Chinese medicine symptom score and adverse drug reaction were compared between the two groups.Results In the control group,34 cases were enrolled,1 case fell off,and finally 33 cases were included in the analysis.In the treatment group,35 cases were enrolled,1 case was shed,and 34 cases were finally included in the analysis.After treatment,the total effective rate of treatment group and control group was 97.06%(33 cases/34 cases)and 81.82%(27 cases/33 cases),respectively,and the difference was statistically significant(P<0.05).After treatment,the nuclear transcription factor kappa B(NK-κB)in treatment group and control group were(24.09±3.06)and(35.23±4.11)ng·L^(-1);interferon gamma(IFN-γ)were(41.39±4.13)and(50.10±5.27)ng·L^(-1);transferrin saturation(TAST)were(38.62±5.91)%and(31.16±4.73)%;serum ferritin(SF)were(28.13±5.77)and(22.47±4.65)μmol·L^(-1);serum iron(SI)were(15.66±3.76)and(13.19±2.94)μmol·L^(-1);urinary protein excretion rate(24 h UPE)were(1.85±0.41)and(2.91±0.62)g·24 h^(-1);blood urea nitrogen(BUN)were(5.16±0.67)and(6.89±0.97)mmol·L^(-1);hemoglobin(Hb)were(91.38±11.23)and(83.19±8.54)g·L^(-1);hematocrit(Hct)were(29.01±7.40)%and(24.56±5.69)%;main disease score were(5.29±1.05)and(7.15±1.53)scores;the secondary scores were(3.11±0.46)and(4.98±0.77)scores;the total scores were(8.40±1.49)and(12.13±2.30)scores,with statistical significance(all P<0.05).The total incidence of adverse drug reactions in treatment group and control group were 14.71%and 9.09%,with no statistical significance(P>0.05).Conclusion Roxallistat combined with polysaccharide and iron complex and Shengxuening have good therapeutic effect in the treatment of maintenance hemodialysis renal anemia with poor recombinant human erythropoietin effect;it can reduce inflammation,regulate iron metabolism,improve renal function,and reduce adverse drug reactions.