ABSTRACT
Background: Iron deficiency anemia (IDA) is a public health problem worldwide. Shengxuening Tablet (SXN) has been used for the treatment of various types of anemia, attaining high efficacy. Objective: To evaluate the safety of SXN as well as its preventive and therapeutic efficacy against IDA across different population groups. Methods: PubMed, Embase, Web of Science, the Cochrane Library, the China Knowledge Network, the China Biomedical Literature Database, the Wanfang Data Knowledge Service Platform, and the China Science and Technology Journal Database was searched for relevant clinical trials through June 2022 and a systematic review and meta-analysis of the identified studies was undertaken. Results: A total of 39 trials involving 4,562 cases were included in the meta-analysis. The total efficiency of SXN was superior than the control group in improving red blood cell (RBC) count [SMD = 1.31, 95% CI (0.7, 1.91), p < 0.0001], hemoglobin (Hb) [SMD = 1.11, 95% CI (0.75, 1.46), p < 0.00001], mean corpuscular volume (MCV) [SMD = 0.5, 95% CI (0.33, 0.68), p < 0.00001], total serum iron (SI) levels [SMD = 1.87, 95% CI (1.3, 2.44), p < 0.00001], and transferrin saturation (TSAT) levels [SMD = 2.07, 95% CI (1.86, 2.27), p < 0.00001]. Besides, the total effects of SXN to improve mean corpuscular hemoglobin (MCH) [SMD = 0.12, 95% CI (-0.16, 0.4), p = 0.41], mean corpuscular hemoglobin concentration (MCHC) [SMD = 0.03, 95% CI (-0.18, 0.24), p = 0.77], hematocrit (HCT) [SMD = 0.65, 95% CI (-0.25, 1.55), p = 0.16], and serum ferritin (SF) levels [SMD = 0.59, 95% CI (-0.67, 1.85), p = 0.36] and reduce the total iron binding capacity (TIBC) [SMD = 0.34, 95% CI (-0.07, 0.74), p = 0.1] was comparable to that of iron supplementation. SXN significantly raised the total effective rates of IDA [risk ratio (RR) = 1.06, 95% CI (1.02, 1.09), p = 0.0005] and was associated with fewer adverse events [RR = 0.24, 95% CI (0.18, 0.31), p < 0.00001], fewer adverse pregnancy outcomes [RR = 0.34, 95% CI (0.2, 0.57), p < 0.0001], and lower anemia recurrence rates during pregnancy [RR = 0.29, 95% CI (0.1, 0.84), p = 0.02]. Regarding prevention, the effects of SXN to maintain the RBC count, Hb level and other IDA-related parameters were comparable to that of control group and SXN reduced the risk of IDA incidence during pregnancy. Conclusion: SXN demonstrated promising efficacy in the treatment and prevention of IDA and outperformed routine iron formulations in terms of safety, thus rendering SXN a reliable treatment option for IDA. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier: CRD42022353247.
ABSTRACT
The aim of the present study was to investigate the clinical effects of Shengxuening tablet (silkworm excrement) combined with recombinant human erythropoietin (rHuEPO) for the treatment of renal anemia of maintenance hemodialysis (MHD) patients. Seventy-two MHD patients with renal anemia were included in the study and randomly divided into the control (n=34) and observation (n=38) groups. Patients in the control group were treated by hypodermic injection of 100-150 U/(kg·w) rHuEPO and patients in the observation group were treated by rHuEPO + 1.0 g t.i.d. p.o. Shengxuening tablet. The two groups were assisted by conventional treatments including iron, folic acid, vitamin B12 and L-carnitine. After 3 and 6 months, improvement of anemia was compared. After 3 months, the hemoglobin, hematocrit, serum ferritin and transferrin saturation levels of the observation group were significantly higher than those of the control group (p<0.05). In addition, C-reactive protein and superoxide dismutase levels of the observation group were significantly lower than those of the control group (p<0.05). After 6 months, indices of the observation group were ameliorated while the improvement of control group was not obvious, and indices of the observation group were significantly higher than those of the control group (p<0.05). Consumption of rHuEPO in the observation group was significantly less than that of the control group, and the total effective rate was significantly higher than that of the control group (p<0.05). In conclusion, Shengxuening tablet combined with rHuEPO was safe and effective for the treatment of renal anemia of MHD patients.
ABSTRACT
OBJECTIVE:To compare therapeutic efficacies of Shengxuening tablet and Iron sucrose injection for anemia in maintenance hemodialysis(MHD)patients,and their effects on oxidative stress and micro-inflammation state. METHODS:80 pa-tients who had received MHD over half year were assigned into shengxuening group and iron sucrose group with 40 cases in each group. Both groups received MHD 3 times a week,4 h/time,blood flow of 200~300 ml/min;erythropoietin(EPO)was used at a dose of 10 000 IU/time hypodermically in each group. Shengxuening group was additionally given Shengxuening tablet orally,0.5 g/time,tid. Iron sucrose group was given Iron sucrose injection 100 mg 2 h intravenously via dialyser after the beginning of hemo-dialysis,twice a week,received iron treatment every one week until complete the total dose of 1 000 mg,to maintain ferritin be-tween 100~300 μg/L. The levels of Hb,Hct,SF,TSAT,hs-CRP,IL-6,TNF-α,MDA,SOD and GSH-Px were tested in 2 groups before and 12 weeks after the treatment. RESULTS:After 12 weeks of treatment,the levels of Hb,Hct,SF and TSAT in 2 groups were significantly increased,with statistical significance (P0.05). Compared with before treatment,the levels of hs-CRP,IL-6,TNF-α and MDA increased significantly in iron sucrose group,while SOD and GSH-Px levels declined significantly,with statistical significance (P<0.01). Above indicators of shengxuening group had no significant change,compared with before treatment;there was statistical significance between 2 groups after treatment(P<0.01). No obvious ADR was found in 2 groups. CONCLUSIONS:Therapeutic efficacy of shengxuening is simi-lar to that of iron sucrose in improving the anemia and iron deficiency status of MHD patients,but doesn't aggravate oxidative stress and micro-inflammation state. It is an safe and effective oral iron supplement drugs.
