Effect of Sheng Xue Ning Tablets on Renal Anemia in Patients Subject to Maintenance Hemodialysis and Safety Evaluation: A Multi-setting Prospective Randomized Study

Abstract

This study compared Sheng Xue Ning (SXN) tablets with ferrous succinate (FS) tablets in terms of their efficacy for the treatment of iron-deficient renal anemia and safety in patients subject to maintenance hemodialysis (MHD). A total of 94 patients undergoing MHD were randomly assigned to an experiment group (receiving oral SXN tablets, SXN group) and a control group (orally given FS tablets, FS group) and followed up for 12 weeks. Erythropoietin (EPO) was used in both groups. The efficacy was assessed by detecting the subsequent changes in hemoglobin (Hb), serum iron (SI), SF and transferrin saturation (TSAT). At the 12th week, Hb and TSAT levels in both groups were significantly increased compared to those in the screening period (P<0.05). However, no significant difference in Hb and TSAT was found between the two groups. The average weekly EPO dosage used was lower in SXN group than in FS group (P<0.05) at the 10th week and the 12th week. Our study showed that SXN tablets can effectively ameliorate renal anemia and keep iron metabolism stable in MHD patients, and its efficacy is virtually close to that of FS tablets. Meanwhile, SXN tablets can reduce the dosage of EPO and have a good safety profile.

Keywords

hemodialysis / renal anemia / oral iron supplements

References

[1] StaufferME, FanT. Prevalence of anemia in chronic kidney disease in the United States. PLoS One, 2014, 9(1): e84943

[2] ZuoL, WangM, HouF, et al.. Anemia management in the China dialysis outcomes and practice patterns study. Blood Purif, 2016, 42(1): 33-43

[3] LocatelliF, PisoniRL, AkizawaT, et al.. Anemia management for hemodialysis patients: Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines and Dialysis Outcomes and Practice Patterns Study (DOPPS) findings. Am J Kidney Dis, 2004, 44(Suppl2): 27-33

[4] Kidney Disease. Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int, 2012, 2: 279-335

[5] ŁukaszykE, ŁukaszykM, Koc-ŻórawskaE, et al.. Iron Status and Inflammation in Early Stages of Chronic Kidney Disease. Kidney Blood Press Res, 2015, 40(4): 366-373

[6] LiH, WangSX. Iron metabolism state in maintenance hemodialysis patients. Chin J Blood Purification (Chinese), 2010, 9(9): 482-485

[7] ParkJH, LeeDY, YunP, et al.. Flavonoids from silkworm droppings and their promotional activities on heme oxygenase-1. J Asian Natural Products Res, 2011, 13(4): 377-382

[8] ZhangL, ZhangWJ, JinH. A Comparative Systematic Review of the Efficacy and Safety of Shengxuening (SXN) for anemia in chronic kidney disease. J Clin Nephrol, 2015, 15(6): 353-358

[9] ZhangWJ, ChenJW, YuFB, et al.. Clinical observation of Shengxuening tablets in maintenance hemodialysis patients with renal anemia and improve iron metabolism of blood. J Clin Nephrol, 2016, 16(2): 110-113

[10] LiuYB, HuDJ. Clinical Observation of Shengxuening Tablets Reducing the risk of microinflammation in maintenance hemodialysis with Renal Anemia. China Pharmacy, 2016, 27(8): 1096-1098

[11] BansalA, SandhuG, GuptaI, et al.. Effect of aggressively driven intravenous iron therapy on infectious complications in end-stage renal disease patients on maintenance hemodialysis. Am J Ther, 2014, 21(4): 250-253

[12] AkarsuS, DemirH, SelekS, et al.. Iron deficiency anemia and levels of oxidative stress induced by treatment modality. Pediatr Int, 2013, 55(3): 289-295

[13] Rozen-ZviB, Gafter-GviliA, PaulM, et al.. Intravenous versus oral iron supplementation for the treatment of anemia in CKD: systematic review and meta-analysis. Am J Kidney Dis, 2008, 52(5): 897-906

[14] Martinez-VeaA, MarcasL, BardajíA, et al.. Role of oxidative stress in cardiovascular effects of anemia treatment with erythropoietin in predialysis patients with chronic kidney disease. Clin Nephrol, 2012, 77(3): 171-181

[15] TolkienZ, StecherL, ManderAP, et al.. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One, 2015, 10(2): e0117383

[16] KortmanGAM, ReijndersD, SwinkelsDW. Oral iron supplementation: Potential implications for the gut microbiome and metabolome in patients with CKD. Hemodial Int, 2017, 21(Suppl1): S28-S36

[17] ZhangL, ZhangWJ, JinH. A Comparative Systematic Review of the Efficacy and Safety of Shengxuening (SXN) for anemia in chronic kidney disease. J Clin Nephrol, 2015, 15(6): 353-358

[18] LiJ, LinN, DuG. Prevention an d Treatment of Shengxuening on renal anemia and chronic renal injury of iron overload in mice. J Henan Univ (Natural Sci, Chinese), 2017, 47(2): 170-176

[19] YuJW, YoonSS, YangR. Iron chlorin e6 scavenges hydroxyl radical and protects human endothelial cells against hydrogen peroxide toxicity. Biol Pharm Bull, 2001, 24(9): 1053-1059

[20] KumarSS, ShankarB, SainisKB. Effect of chlorophyllin against oxidative stress in splenic lymphocytes in vitro and in vivo. Biochim Biophys Acta, 2004, 1672(2): 100-111

[21] LiuXL, ChenK, ShiH. Effect of sodium iron chlorophyllin (SIC) on CFU-E and CFU-GM yields of normal and anemic animal models. Chin J Hematol, 1997, 18(5): 234-236

[22] MiretS, TasciogluS v d, BurgM, et al.. In vitro bioavailability of iron from the heme analogue sodium iron chlorophyllin. J Agric Food Chem, 2010, 58(2): 1327-1332

[23] DingL, XuL, JinY, et al.. Efficacy of SXN in the Treatment of Iron Deficiency Anemia: A Phase IV Clinical Trial. Evid Based Complement Alternat Med, 2019, 2019: 8796234