红细胞洗涤机制备洗涤红细胞临床输注的随机双盲对照研究

摘要

目的 评价WG-XDJ-1型红细胞洗涤机制备洗涤红细胞临床输注的安全性和有效性.方法 采用随机双盲对照的临床试验设计,将患者随机分为实验组(55例)与对照组(54例),2组分别输注WG-XDJ-1型红细胞洗涤机和ACP215型洗涤机制备的洗涤红细胞2单位,记录患者输血前后临床症状及体征变化,并在输血前后检查血常规、肝功能和肾功能.输血有效率分别以意向性分析(ITT)和方案分析(PP)进行评估;2组洗涤前红细胞保存期、输血不良反应比较采用χ2检验;同时比较实验组输血前后肝肾功能.结果 按ITT分析,实验组和对照组输血有效率分别为78.94%和71.93%,2组比较差异无统计学意义(P>0.05);按PP分析,实验组和对照组输血有效率分别为81.81%和75.93%,2组比较差异无统计学意义(P>0.05).实验组和对照组洗涤前红细胞保存期(d)分别为7.037±0.823和7.204±0.877,2组比较差异无统计学意义(P>0.05).实验组和对照组输血不良反应发生率分别是0和1.85%,2组比较差异无统计学意义(P>0.05).实验组患者输血前后肝肾功能的差异无统计学意义(P>0.05).结论 WG-XDJ-1型红细胞洗涤机制备洗涤红细胞输血疗效确切,患者耐受性良好.%Objective This study was designed to evaluate the efficacy and safety of washed RBCs by WG-XDJ-1 RBC washer in the transfusion treatment.Methods A randomized double blind control trial was conducted.Individuals were randomly divided trial group (55 cases) and control group (54 cases). The two groups were treated with washed RBCs 2 units prepared by WG-XDJ-1 RBC washer and ACP215 RBC washer respectively. Before and after blood transfusion, we recorded the patients' changes about clinical symptoms and physical signs and also examined blood routine,hepatic and renal functions.The effective rates of blood transfusion was evaluated by intention-to-treat (ITT)analysis and per-protocol (PP) analysis,using χ2test; The adverse transfusion reaction of the 2 groups were compared by χ2test;The preservation period of RBCs of the 2 groups before washing were compared by independent samples t test; Wilcoxon rank sum test was used to compare the liver and kidney function before and after blood transfusion in the experimental group.Results According to ITT analysis,the effective rates of trial and control groups were 78.94%,71.93% and there was no difference between trial and control groups (P>0.05); According to PP analysis,the effective rates of trial and control groups were 81.81%, 75.93% and there was no difference between trial and control groups (P>0.05).The preservation period of RBCs of trial and control groups were 7.037±0.823 days and 7.204±0.877 days and there was no difference between trial and control groups (P>0.05).The incidences of adverse transfusion reaction were 0.00% and 1.85% for trial and control groups.There was no difference between trial and control groups (P>0.05).There was no difference in hepatic and renal functions before and after blood transfusion in the trial group(P>0.05).Conclusion The transfusion treatment with washed RBCs prepared by WG-XDJ-1 RBC washer was effective and well tolerated.