Efficacy of Roxadustat in the Maintenance Hemodialysis of HIV/AIDS Patients Resistant to EPO
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摘要:
目的 观察罗沙司他治疗促红细胞生成素(erythropoietin,EPO)抵抗的维持性血透HIV/AIDS患者的临床疗效和安全性。 方法 将2022年7月至2023年12月在昆明市第三人民医院血液净化中心行维持性血透治疗的HIV/AIDS合并EPO抵抗患者60例,根据患者意愿分为继续使用重组促红细胞生成素(EPO)治疗的对照组30例,使用罗沙司他治疗的观察组30例,治疗8周。记录比较2组治疗前后患者的血红蛋白(HGB)、铁蛋白(SF)、血清铁(SI)、总铁结合力(TIBC)、超敏C反应蛋白(hs-CRP)、细胞因子(IL-1β、IL-6、IL-8、IL-10、TNF-α、IFN-γ、IFN-α)指标,并监测药物不良反应发生情况。 结果 观察组患者治疗8周后血红蛋白(HGB)、血清铁(SI)、总铁结合力(TIBC)水平均显著升高,差异均有统计学意义(均P < 0.05),铁蛋白(SF)、IL-1β、IL-6、IL-10、TNF-α水平均显著下降,差异均有统计学意义(均P < 0.05);2组组间比较,观察组患者血红蛋白(HGB)、总铁结合力(TIBC)水平均高于对照组,差异均有统计学意义(均P < 0.05),观察组铁蛋白(SF)、IL-1β、IL-6、IL-10、TNF-α水平均低于对照组,差异均有统计学意义(P < 0.05)。2组均无严重不良反应发生。 结论 对EPO抵抗的维持性血透HIV/AIDS患者使用罗沙司他安全有效,可明显改善患者血红蛋白及铁代谢水平,可以改善患者的微炎症状态。 Abstract:Objective To study the clinical efficacy and safety of Roxadustat in the maintenance hemodialysis of HIV/AIDS patients with EPO resistance. Methods 60 cases of HIV/AIDS patients with EPO resistance undergoing maintenance hemodialysis treatment at the Blood Purification Center of the Third People's Hospital of Kunming from July 2022 to December 2023 were divided based on patient preference into a control group of 30 cases continuing Erythropoietin (EPO) treatment and an observation group of 30 cases treated with Roxadustat for 8 weeks. Changes in patients' hemoglobin (HGB), serum ferritin (SF), serum iron (SI), total iron binding capacity (TIBC), high-sensitivity C-reactive protein (hs-CRP), cytokines (IL-1β, IL-6, IL-8, IL-10, TNF-α, IFN-γ, IFN-α) were recorded and compared before and after treatment in the two groups, along with monitoring the occurrence of adverse drug reactions. Results After 8 weeks of treatment, the levels of hemoglobin (HGB), serum iron (SI) and total iron binding capacity (TIBC) in observation group were significantly increased, and the differences were statistically significant (all P < 0.05), while the levels of serum ferritin (SF), IL-1β, IL-6, IL-10 and TNF-α were significantly decreased, with statistically significant (all P < 0.05). In the comparison between the two groups, the levels of hemoglobin (HGB) and total iron binding capacity (TIBC) in the observation group were higher than those in the control group, with statistically significant differences (all P < 0.05). The levels of serum iron (SF), IL-1β, IL-6, IL-10, and TNF-α in the observation group were lower than those in the control group, with statistically significant differences (P < 0.05). There were no serious adverse reactions in either group. Conclusion The use of Roxadustat in maintenance hemodialysis patients resistant to EPO and living with HIV/AIDS is safe and effective, significantly improving the patients' hemoglobin and iron metabolism levels, and can improve the patients' state of micro-inflammation. -
Key words:
- Roxadustat /
- EPO resistance /
- AIDS /
- Maintenance hemodialysis /
- Renal anemia
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表 1 2组患者治疗前的临床一般资料比较[n(%)/($\bar x \pm s $)/ M(Q1,Q3)]
Table 1. Comparison of general clinical data before treatment between the two groups [n(%)/($\bar x \pm s $)/ M(Q1,Q3)]
组别 男性 年龄(岁) 透析龄(月) 原发病HIV/AIDS相关性肾病 糖尿病肾病 高血压肾病 慢性肾小球肾炎 观察组(n = 30) 18(60.00) 49.40 ± 8.78 19.50 (14.25) 12(40.00) 5(16.67) 3(10.00) 10(33.33) 对照组(n = 30) 16(53.33) 49.87 ± 7.12 21.00(22.50) 9(30.00) 7(23.33) 5(16.67) 9(30.00) t/Z/χ2 0.271 −0.226 −0.481 0.659 0.417 0.144 0.077 P 0.602 0.822 0.630 0.417 0.519 0.704 0.781 表 2 组患者用药前后血红蛋白和铁代谢对比($\bar x \pm s $)
Table 2. Comparison of hemoglobin and iron metabolism between the two groups before and after treatment($\bar x \pm s $)
组别 HGB(g/L) 铁蛋白(ng/mL) 血清铁(μmol/L) 总铁结合力(μmol/L) 0周 8周 0周 8周 0周 8周 0周 8周 观察组(n = 30) 89.53 ± 7.84 97.53 ± 7.77* 124.31 ± 74.85 93.96 ± 52.96* 8.70 ± 3.51 10.40 ± 4.25* 42.89 ± 13.01 51.25 ± 12.75* 对照组(n = 30) 86.40 ± 6.02 91.57 ± 6.13* 128.38 ± 55.06 125.49 ± 53.98 9.88 ± 3.64 10.24 ± 3.81 42.91 ± 9.62 44.79 ± 9.96* t 1.736 3.303 −0.240 −2.284 −1.279 0.154 −0.006 2.187 P 0.088 0.002△ 0.811 0.026△ 0.206 0.878 0.996 0.033△ 2组用药后比较,△P < 0.05;同组用药后比较,*P < 0.05。 表 3 2组患者用药前后细胞因子比较($ \bar x \pm s $)
Table 3. Comparison of cytokines before and after treatment between the two groups($ \bar x \pm s $)
指标 时段 观察组(n = 30) 对照组(n = 30) t P IL-1β(pg/mL) 0周 2.95 ± 1.28 2.40 ± 1.14 1.763 0.083 8周 1.68 ± 1.01 2.36 ± 1.08 −2.529 0.014△ t 6.686 0.154 P < 0.001* 0.878 IL-6(pg/mL) 0周 9.54 ± 3.19 8.38 ± 3.27 1.393 0.169 8周 6.57 ± 2.48 8.09 ± 3.07 −2.115 0.039△ t 5.975 1.215 P < 0.001* 0.234 IL-8(pg/mL) 0周 31.16 ± 16.34 24.98 ± 10.77 1.728 0.090 8周 26.57 ± 13.68 23.89 ± 10.28 0.858 0.395 t 1.468 1.402 P 0.153 0.171 IL-10(pg/mL) 0周 8.66 ± 3.62 8.35 ± 3.29 0.344 0.732 8周 5.17 ± 2.87 7.74 ± 3.50 −3.108 0.003△ t 4.107 0.790 P < 0.001* 0.436 IFN-γ(pg/mL) 0周 6.23 ± 2.46 5.66 ± 2.25 0.921 0.361 8周 5.14 ± 2.67 5.62 ± 1.63 −0.841 0.405 t 1.818 0.104 P 0.079 0.918 IFN-α(pg/mL) 0周 4.41 ± 1.76 4.24 ± 1.65 0.366 0.716 8周 4.26 ± 1.93 3.65 ± 1.53 1.360 0.179 t 0.317 1.412 P 0.753 0.169 TNF-α(pg/mL) 0周 3.92 ± 1.73 4.56 ± 1.81 −1.392 0.169 8周 2.40 ± 1.01 4.06 ± 1.84 −4.350 < 0.001△ t 4.294 1.255 P < 0.001* 0.219 hs-CRP(mg/L) 0周 3.67 ± 1.54 3.10 ± 1.41 1.512 0.136 8周 3.24 ± 1.37 2.89 ± 1.40 0.978 0.332 t 1.243 1.136 P 0.224 0.265 2组用药后比较,△P < 0.05;同组用药后比较,*P < 0.05。 表 4 2组患者不良反应发生情况[n(%)]
Table 4. The occurrence of adverse reactions in two groups[n(%)]
组别 血压升高 血栓形成 过敏反应 胃肠道反应 不良反应 观察组(n = 30) 0(0) 2(6.67) 0 2(6.67) 4(13.33) 对照组(n = 30) 2(6.67) 3(10) 0 0 5(16.67) χ2 0.517 0.000 − 0.517 0.000 P 0.472 1.000 − 0.472 1.000 -
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