Page 71 - 2023-06-中国全科医学

·712· http: //www.chinagp.net E-mail: zgqkyx@chinagp.net.cn February 2023, Vol.26 No.6

clinically treated with moderate-dose rHuEPO，but there is a lack of research on the safety of single and divided administration of
moderate-dose rHuEPO. Objective To compare the safety between weekly single and divided administration of moderate-dose
rHuEPO for renal anemia in maintenance hemodialysis patients. Methods This study was designed as a randomized，parallel-
group controlled，non-inferiority clinical trial. Eighty-eight patients with renal anemia who underwent maintenance hemodialysis
at the Hemodialysis Room，Tongzhou Branch，Dongzhimen Hospital，Beijing University of Chinese Medicine from January 2019
to May 2021 were selected and randomly divided into an experimental group and a control group with 44 in each. For comparing the
safety and efficacy of weekly single and divided administration of moderate-dose rHuEPO，29 cases（experimental subgroup 1）
and other 15 cases（experimental subgroup 2） in the experimental group received an rHuEPO dose of 6 000 U，and an rHuEPO
dose of 4 000 U，once a week，respectively；30 cases（control subgroup 1） in the control group received a single rHuEPO
dose of 2 000 U，three times a week（6 000 U per week in total），and other 14 cases（control subgroup 2） received a single
rHuEPO dose of 2 000 U，twice a week（4 000 U per week in total）. Results Safety analysis：two-factor repeated-measures
ANOVA showed that the type of intervention scheme and duration had no interaction effects on systolic blood pressure，diastolic
blood pressure，mean arterial pressure，and pre-dialysis serum potassium between experimental subgroup 1 and control subgroup
1，and between experimental subgroup 2 and control subgroup 2（P>0.05），and produced no main effects on systolic blood
pressure，diastolic blood pressure，mean arterial pressure，and pre-dialysis serum potassium in experimental subgroup 1 and
control subgroup 1，and between experimental subgroup 2 and control subgroup 2（P>0.05）. The serum levels of AST，ALT
and TBiL were similar between experimental subgroup 1 and control subgroup 1 at baseline and 12 weeks of treatment（P>0.05）.
Likewise，they were similar between experimental subgroup 2 and control subgroup 2 at baseline and 12 weeks of treatment
（P>0.05）. No thromboembolic，cardiovascular or cerebrovascular events and gastrointestinal reactions related to rHuEPO
occurred in any of the subgroups during the 12-week treatment. Efficacy analysis：the hemoglobin level（reference range was
110-130 g/L） in experimental subgroup 1 〔65.5%（19/29）〕was similar to that in control subgroup 1 〔73.3%（22/30）〕
2
at 12 weeks of treatment（χ =0.425，P=0.514）. The serum levels of hemoglobin were similar between experimental subgroup
2 and control subgroup 2 at 12 weeks of treatment（P>0.05）. The levels of red blood cell count，hematocrit，percentage and
absolute number of reticulocytes，ferritin and transferrin saturation did not vary between experimental subgroup 1 and control
subgroup 1，and between experimental subgroup 2 and control subgroup 2 either at baseline or 12 weeks of treatment（P>0.05）.
Conclusion Weekly single and divided administration of moderate-dose erythropoietin had no significant difference in
medication safety in the treatment of renal anemia in maintenance hemodialysis patients.
【Key words】 Renali insufficiency，chronic；Renal dialysis；Erythropoietin；Renal anemia；Administration
frequency；Equivalence trial

重组人促红素注射液（rHuEPO）上市 30 余年来， 京中医药大学东直门医院通州院区血透室进行维持性血
已被证实在慢性肾脏病（CKD）患者中纠正贫血、改善 液透析治疗的合并肾性贫血患者 88 例。本研究经北京
生活质量、减少输血等方面是有效的 ［1-3］ 。部分研究 中医药大学东直门医院医学伦理委员会批准（DZMEC-
结果表明在同等总剂量的情况下，rHuEPO 给药频率不 KY-2019-111），患者均自愿参加研究且签署知情同意书。
影响治疗效果，每周单次给药与分次给药疗效无显著差 1.2 分组 采用随机数字表法分为两组，每组 44 例，
异 ［4-6］ 。而在同等疗效的情况下，rHuEPO 每周单次给 试验组为 rHuEPO 每周单次给药，对照组为 rHuEPO 每
药具有增加患者依从性、减少医疗费用等优势。对于 周分次给药。其中试验组男 34 例、女 10 例，平均年龄
rHuEPO 每周单次给药的安全性研究较少，每周单次给 （57.8±11.8）岁，平均透析时间（67.5±50.8）个月；
药与分次给药相比较，增加了单次给药剂量是否会增加 对照组男 28 例、女 16 例，平均年龄（58.3±11.3）岁，
患者的不良反应发生率，是临床研究需要探讨的问题。 平均透析时间（71.6±45.9）个月。
由于实际临床中维持性血液透析患者病情相对平稳， 1.3 纳入标准 （1）规律血液透析 3 个月以上（３次
血色素相对稳定，大部分患者使用的 rHuEPO 周剂量为 / 周，4 h/ 次），病情稳定者；（2）入组时血红蛋白
4 000~6 000 U 的中等剂量。因此，本研究对中等剂量 （Hb）为 100~130 g/L；（3）年龄 18~80 岁；（4）接
rHuEPO 每周单次与分次给药治疗维持性血液透析肾性 受 rHuEPO 稳定治疗 3 个月以上者；（5）4 周内检查血
贫血的安全性进行探讨。 清铁蛋白（SF）≥ 100 μg/L，转铁蛋白饱和度（TSAT）
1 对象与方法 ≥ 10%；（6）自愿受试。
1.1 研究对象 选取 2019 年 1 月至 2021 年 5 月于北 1.4 排除标准 （1）合并有未控制的重度高血压