健脾生血片与多糖铁复合物胶囊治疗非透析肾性贫血的疗效及安全性比较

Comparison of Therapeutic Efficacy and Safety of Jianpi Shengxue Tablets and Iron Polysaccharide Complex Capsules in the Treatment of Nondialysis Renal Anemia

目的:比较健脾生血片与多糖铁复合物胶囊治疗非透析肾性贫血的疗效及安全性。方法:选择2016年3月-2017年3月我院非透析肾性贫血患者60例,根据随机生成的数字,按入组顺序采用随机分配隐藏方法分为对照组(30例)和观察组(30例)。两组患者均给予重组人促红素注射液(CHO细胞)、叶酸片、维生素B_(12)片等常规治疗。在此基础上,对照组患者给予多糖铁复合物胶囊0.15 g,口服,每日1次;观察组患者给予健脾生血片1.8 g,口服,每日3次。两组患者疗程均为12周。比较两组患者的临床疗效,治疗前及治疗后第2、4、8、12周的血红蛋白(Hb)水平、红细胞计数(RBC)、红细胞比容(HCT)、网织红细胞百分比(Ret%),治疗前及治疗后第8、12周的血清铁(SI)、血清铁蛋白(SF)水平和转铁蛋白饱和度(TS),并记录不良反应发生情况。结果:两组患者均完成治疗。观察组患者总有效率(86.67%)显著高于对照组(63.33%),差异有统计学意义(P<0.05)。治疗前,两组患者Hb、RBC、HCT、Ret%、SI、SF、TS比较,差异均无统计学意义(P>0.05)。治疗后,两组患者上述指标均显著高于同组治疗前,且观察组显著高于对照组(除治疗后第8周Ret%外),差异均有统计学意义(P<0.05)。观察组患者黑便、铁锈色便发生例数显著少于对照组,牙齿黑染发生例数显著多于对照组,差异均有统计学意义(P<0.05)。结论:健脾生血片治疗非透析肾性贫血的疗效显著优于多糖铁复合物胶囊,可显著改善患者的铁元素储备与贫血状态,但健脾生血片引起的牙齿黑染率较高。

OBJECTIVE：To compare the clinical efficacy and safety of Jianpi shengxue tablets and Iron polysaccharidecomplex capsules in the treatment of nondialysis renal anemia. METHODS：A total of 60 nondialysis renal anemia patients in ourhospital during Mar. 2016 to Mar. 2017 were divided into control group（30 cases）and observation group（30 cases）with randomallocation concealment method according to random number and admission order. Both groups received routine treatment as rhEPOinjection,Folic acid tablets,Vitamin B12 tablets. Based on it,control group was given Iron polysaccharide complex capsules 0.15 gorally,once a day;observation group was given Jianpi shengxue tablets 1.8 g orally,3 times a day. Both groups were treated for12 weeks. Clinical efficacies were compared between 2 groups. The levels of Hb,RBC,HCT and Ret% were observed beforetreatment and 2,4,8,12 weeks after treatment;the levels of SI,SF and TS were also observed before treatment and 8,12 weeksafter treatment. The occurrence of ADR was recorded. RESULTS：Both groups completed the treatment. The total effective rate ofobservation group（86.67%）was significantly higher than control group（63.33%）,with statistical significance（P〈0.05）. Beforetreatment,there was no statistical significance in the levels of Hb,RBC,HCT,Ret% ,SI,SF or TS between 2 groups（P〈0.05）. After treatment,the levels of above indexes in 2 groups were significantly higher than before treatment,and observationgroup was significantly higher than control group（except for Ret% at 8th week）,with statistical significance（P〈0.05）. The casenumber of black stool and rust colored stool in observation group were significantly lower than control group,while the incidenceof black-dyed teeth in observation group was significantly higher than control group,with statistical significance （P〈0.05）.CONCLUSIONS：Therapeutic efficacy of Jianpi shengxue tablets are significantly better than Polysaccharide iron complex capsulesin the treatment of nondialysis renal anemia,and can significantly improve iron reserve and anaemia. But Jianpi shengxue tabletscauses high incidence of black-dyed teeth.