目的  对比2 h与4 h血液灌流联合血液透析(hemoperfusion combined with hemodialysis，HP+HD)模式治疗维持性血液透析(maintenance hemodialysis，MHD)患者的临床疗效及安全性，为优化MHD患者毒素清除方案提供临床依据。 方法  采用前瞻性开放随机对照研究，选择2025年1—12月在上海健康医学院附属周浦医院血液净化中心规律MHD患者，按随机数字表法(比例1:1)分为2 h HP+HD组和4 h HP+HD组。2组均采用SR150型血液灌流器与HD串联，HP 频率1次/2周，连续治疗12周。比较2组单次治疗后毒素及炎症因子清除率，治疗12周后中大分子毒素、蛋白结合毒素、炎症因子、透析充分性及安全性指标，记录不良事件及灌流器凝血情况。 结果  4 h HP+HD组与2 h HP+HD组各入组52例患者。单次HP+HD治疗后，4 h组硫酸吲哚酚(indoxyl sulfate，IS)、β2-微球蛋白(β2-microglobulin，β2-MG)、全段甲状旁腺激素(intact parathyroid hormone，iPTH)、血磷、肿瘤坏死因子-α(tumor necrosis factor-α，TNF-α)、白细胞介素-6(interleukin-6，IL-6)和白细胞介素-1β(interleukin-1β，IL-1β)清除率高于2 h组(Z=-1.928，P=0.047；Z=2.583，P=0.020；Z=2.505，P＜0.001；t=-2.726，  P=0.009；Z=-2.931，P=0.003；Z=-2.112，P=0.044；Z=-2.844，P=0.004)。治疗12周后，4 h组IS、β2-MG、iPTH、TNF-α、IL-6、和IL-1β水平均低于2 h组(t=-4.145，P＜0.001；t=-2.532，P=0.013；t=-3.312，  P=0.030；t=-2.711，P=0.008；t=-6.858，P＜0.001；t=-4.823，P＜0.001)。安全性方面：2组治疗后血红蛋白、红细胞、白细胞、血小板、白蛋白比较，组间差异无统计学意义(t=1.635，P=0.105；t=0.062，P=0.951； t=1.225，P=0.224；t=-0.063，P=0.548；t=0.062，P=0.951)；灌流器凝血发生率(χ²=0.188，P=0.665)组间比较差异无统计学意义。 结论  4 h HP+HD模式能更高效清除MHD患者中大分子毒素及蛋白结合毒素(protein-bound uremic toxins，PBUTs)，改善微炎症状态，且安全性良好、操作可行，可作为MHD患者的优化治疗方案。

Objective To compare the clinical efficacy and safety of 2-hour and 4-hour hemoperfusion combined with hemodialysis (HP+HD) in the treatment of patients undergoing maintenance hemodialysis (MHD), and to provide clinical evidence for optimizing toxin clearance strategies in this population. Methods A prospective open-label randomized controlled trial was conducted. Patients receiving MHD at the Blood Purification Center of Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences from January to December 2025 were enrolled. They were randomly divided into the 2-hour HP+HD group and the 4-hour HP+HD group at a ratio of 1:1 using a random number table. Both groups were treated with SR150 hemoperfusion cartridge in series with HD, with a HP frequency of once every 2 weeks for a continuous 12-week course. The clearance rates of toxins and inflammatory cytokines after a single session, as well as levels of middle-molecular-weight toxins, protein-bound uremic toxins (PBUTs), inflammatory cytokines, dialysis adequacy, and safety parameters after 12 weeks of treatment, were compared between the two groups. Adverse events and cartridge clotting were also recorded. Results Each group enrolled 52 patients. After a single HP+HD session, the 4-hour group showed significantly higher clearance rates than the 2-hour group for indoxyl sulfate (IS) (Z=-1.928, P=0.047), β2‑microglobulin (β2-MG) (Z=2.583, P=0.020), intact parathyroid hormone (iPTH) (Z=2.505, P<0.001), phosphorus (t=-2.726, P=0.009), tumor necrosis factor-α (TNF-α) (Z=-2.931, P=0.003), interleukin-6 (IL-6) (Z=-2.112, P=0.044), and interleukin-1β (IL-1β) (Z=-2.844, P=0.004). After 12 weeks of treatment, the 4-hour group had significantly lower levels of IS,  β2-MG,  iPTH,  TNF-α, IL-6, and IL-1β than the 2-hour group (t=-4.145, P<0.001; t=-2.532, P=0.013; t=-3.312, P=0.030; t=-2.711, P=0.008;  t=-6.858, P<0.001; t=-4.823, P<0.001, respectively). Regarding safety, no statistically significant differences were found between the two groups in post-treatment hemoglobin, red blood cell count, white blood cell count, platelet count, or albumin (t=1.635, P=0.105; t=0.062, P=0.951; t=1.225, P=0.224; t=-0.063, P=0.548; t=0.062, P=0.951). The incidence of cartridge clotting also did not differ significantly between the groups (χ²=0.188, P=0.665).  Conclusion  The 4-hour HP+HD regimen is more effective in clearing middle-and large-molecular-weight toxins and PBUTs in MHD patients, with a favorable safety profile and feasible operation. It may serve as an optimized treatment option for MHD patients.