南方医科大学学报

南方医科大学学报 ›› 2019, Vol. 39 ›› Issue (10): 1155-.doi: 10.12122/j.issn.1673-4254.2019.10.04

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清肾颗粒对肾性贫血患者炎症/铁调素轴及铁代谢的干预机制：单中心前瞻性随机对照研究

张磊，王亿平，金华，王东，魏玲，任克军，茅燕萍   

  • 出版日期:2019-10-20 发布日期:2019-10-20

Effect of Qingshen Granules on inflammation/hepcidin axis and iron metabolism in patients with renal anemia: a single-center, randomized controlled trial

  • Online:2019-10-20 Published:2019-10-20

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摘要： 目的基于炎症/铁调素轴探讨清肾颗粒对肾性贫血湿热证患者的治疗效果和铁代谢的干预机制。方法符合纳入标准的 60例慢性肾衰竭湿热证患者，随机分为治疗组和对照组各30例。两组均予以西医基础治疗，治疗组在对照组治疗基础上，加用 清肾颗粒1包/次，3次/d。两组疗程均为12周。观察两组患者治疗前后中医证候积分值变化情况及血肌酐、肾小球滤过率、血红 蛋白、红细胞压积、红细胞水平、白介素-6、超敏C反应蛋白、铁调素、生长分化因子-15水平以及血清铁、总铁结合力、转铁蛋白饱 和度、可溶性转铁蛋白受体和铁蛋白水平。结果治疗后，治疗组患者中医证候积分与治疗前比较明显改善，并优于同期对照组 （P=0.000）；两组患者血肌酐、肾小球滤过率与治疗前比较均明显改善。两组患者血红蛋白、红细胞压积、红细胞水平均较治疗 前改善，且治疗组优于对照组（P=0.002，P=0.002，P=0.017）；两组患者白介素-6、超敏C反应蛋白、铁调素、生长分化因子-15水平均 较治疗前下降，且治疗组较对照组下降明显（均P=0.000）。两组患者血清铁、转铁蛋白饱和度水平均较治疗前上升，总铁结合力、 可溶性转铁蛋白受体、铁蛋白较治疗前，可溶性转铁蛋白受体下降水平治疗组优于对照组（P=0.000）。结论在肾性贫血湿热证患 者贫血治疗过程中联合清肾颗粒口服可以有效改善贫血状态，其机制可能是通过减轻患者炎症状态，下调铁调素水平改善患者 铁代谢实现的。

Abstract: Objective To evaluate the therapeutic effect of Qingshen Granules on renal anemia in patients with damp-heat syndrome and explore the mechanisms in light of inflammation/hepcidin axis and iron metabolism. Methods Sixty patients with renal anemia and dampness-heat syndrome were randomized into control group (n=30) and treatment group (n=30). All the patients were given routine treatment, and the patients in the treatment group received additional treatment with Qingshen Granules (3 times a day). After 12 weeks of treatments, the patients were examined for changes in the integral value of TCM syndrome, serum creatinine (Scr), glomerular filtration rate (eGFR), hemoglobin (HGB), hematocrit (HCT), red blood cell (RBC) count, interleukin-6 (IL-6), hypersensitive C-reactive protein (hs-CRP), ferritin, growth differentiation factor-15 (GDF-15), serum iron (SI), total iron binding capacity (TIBC), transferrin saturation (TAST), soluble transferrin receptor (sTfR) and ferritin levels. Results After the treatment, the scores of TCM syndrome were significantly improved in the treatment group and were better than those in the control group (P=0.000). Scr and eGFR were improved in both groups after the treatment. The levels of HGB, HCT and RBC were all improved in the two groups after treatment, and the improvements were more obvious in the treatment group (P=0.002, 0.002, and 0.017, respectively). The levels of IL-6, hs-CRP, hepcidine and GDF-15 were all lowered in the two groups after the treatment, and they were all significantly lower in the treatment group than in the control group (all P=0.000). The treatments increased the levels of SI and TAST in both of the groups, and compared with those in control group, the levels of TIBC, sTfR and ferritin were significantly lowered in the treatment group after the 12-week treatment (P=0.000). Conclusion Qingshen granules can effectively improve renal anemia in patients with damp-heat syndrome possibly by improving iron metabolism through alleviation of inflammation and reduction of hepcidine level.