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).
Conclusions: 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.
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。
Keywords: Qingshen Granules; hepcidine; inflammation; iron metabolism; renal anemia.