罗沙司他对比rhEPO治疗腹膜透析贫血的随机对照研究：显著改善血红蛋白、减轻炎症反应并提升疗效

A Randomized Controlled Study of Roxadustat Versus RhEPO in the Treatment of Peritoneal Dialysis Anemia: Significantly Improving Hemoglobin, Reducing Inflammation, and Enhancing Efficacy

摘要: 目的：比较罗沙司他(roxadustat)与红细胞生成素(recombinant human Erythropoietin, rhEPO)治疗腹膜透析(peritoneal dialysis)患者贫血的疗效，重点评估其对血红蛋白水平、肾功能指标、炎症状态、营养状况及整体治疗效果的影响。方法：选取腹膜透析贫血患者54例，随机均分为对照组与实验组。对照组采用红细胞生成素(rhEPO)治疗，实验组采用罗沙司他治疗。统计2组治疗前、3个月及6个月血红蛋白(HGB)、血肌酐(Scr)、补体C1q、中性粒细胞绝对值/淋巴细胞绝对值(NLR)、血钾(K⁺)、视黄醇结合蛋白水平(RBP)、血清白蛋白(ALB)、预后营养指数(PNI = ALB + 5 × 外周血淋巴细胞总数)的水平变化。结果：治疗3个月后，2组HGB、C1q水平较治疗前均增高，且实验组高于对照组(t = −2.14, P < 0.05; t = −2.19, P < 0.05)；治疗3个月后2组NLR水平较治疗前降低(均P < 0.05)，且实验组低于对照组(t = −2.56, P < 0.05)；治疗6个月后2组Scr水平较治疗前均降低(均P < 0.05)，且实验组低于对照组(t = −2.449, P < 0.05)；两组间治疗前后不同时间点的ALB、K⁺、PNI、RBP水平差异均无统计学意义。相关性分析显示，▲NLR与BMI呈显著正相关(r = 0.196, P = 0.048)，与血钾(r = −0.227, P = 0.018)、PNI (r = −0.278, P = 0.026)呈显著负相关，而与HB、C1q等指标无显著关联。结论：罗沙司他治疗腹膜透析贫血，可以显著改善患者的贫血程度，减轻体内炎性反应，提升整体治疗效果。

Abstract: Objective: To compare the efficacy of roxadustat and recombinant human erythropoietin (recombinant human Erythropoietin, rhEPO) in the treatment of anemia in peritoneal dialysis patients, focusing on the effects of roxadustat on hemoglobin levels, renal function markers, inflammatory status, nutritional status and overall treatment effect. Methods: Fifty-four anemic PD patients were randomized equally to a control group (rhEPO) and an experimental group (roxadustat). Hemoglobin (HGB), Serum creatinine (Scr), complement C1q, Neutrophil-to-Lymphocyte Ratio (NLR), serum potassium (K⁺), Retinol-Binding Protein (RBP), serum Albumin (ALB), and prognostic nutritional index (PNI = ALB + 5 × total lymphocytes) were measured at baseline, 3 months, and 6 months. Results: At 3 months, HGB and C1q increased significantly from baseline in both groups (all P < 0.05), with higher levels in the experimental group (HGB: t = −2.14, P < 0.05; C1q: t = −2.19, P < 0.05). NLR decreased significantly at 3 months in both groups (both P < 0.05), with lower values in the experimental group (t = −2.56, P < 0.05). At 6 months, Scr decreased significantly from baseline in both groups (both P < 0.05), with lower levels in the experimental group (t = −2.449, P < 0.05). No significant intergroup differences occurred in ALB, K⁺, PNI, or RBP at any timepoint. Correlation analysis showed that ▲NLR was significantly positively correlated with BMI (r = 0.196, P = 0.048), and significantly negatively correlated with serum potassium (r = −0.227, P = 0.018) and PNI (r = −0.278, P = 0.026), while no significant correlation was observed between ▲NLR and HB, C1q, or other indicators. Conclusion: Roxadustat significantly improves anemia, reduces systemic inflammation, and enhances clinical efficacy in PD patients.