Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia:A Prospective,Randomized,Open,Parallel Controlled and Multicenter Clinical Study

Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

Thin Layer Identification of Jiedu Shengxue Granules and Determination of Notoginsenoside R1 Content

[Objectives]To establish the quality standard of hospital preparation Jiedu Shengxue granules.[Methods]Scleromitrion diffusum and Prunella vulgaris in Jiedu Shengxue granules were qualitatively identified by thin layer chromatography(TLC).A high performance liquid chromatography(HPLC)was established to determine the content of notoginsenoside R1 in the granule.[Results]The traditional Chinese medicinal materials in Jiedu Shengxue granules could be identified by TLC,and the characteristic spots were stable and clear.Notoginsenoside R1 had a good linear relationship in the range of 10.45-104.5μg/mL,with an average recovery of 98.52%and RSD=2.36%.[Conclusions]TLC and HPLC,as the quality control methods of Jiedu Shengxue granules,have high accuracy and good repeatability,which lays a foundation for the quality control of this mixture.

Study on Quality Standard of Lujing Yiqi Shengxue Pills

[Objectives]This study was conducted to establish the quality standard for Lujing Yiqi Shengxue Pills to provide a basis for its quality control.[Methods]According to the quality requirements in the 2020 edition of Chinese Pharmacopoeia,the quality of Lujing Yiqi Shengxue Pills was evaluated from the aspects of properties,identification,inspection and content determination.Radix Astragali,Radix Angelicae Sinensis,Macrocephalae Rhizoma stir-fried with bran and Radix Paeoniae Alba in the preparation were identified and studied by thin layer chromatography(TLC).A high performance liquid chromatography(HPLC)method was established to determine the content of paeoniflorin in the preparation.[Results]The thin layer spots of Radix Astragali,Radix Angelicae Sinensis,Macrocephalae Rhizoma and Radix Paeoniae Alba were clear and round,and the negative preparations had no interference.The properties,moisture,weight difference,loading difference,dissolution time limit and microbial limit all met the requirements.The regression formula for the quantitative analysis of paeoniflorin in the concentration range of 4.86-194.40μg/ml was:Y=12.0241X+0.8797,R^(2)=0.9999;and the average recovery was 98.9%,and the RSD was 1.7%.[Conclusions]The method has good repeatability,and is stable,feasible,simple and convenient in operation and suitable for quality control of Lujing Yiqi Shengxue Pills.

Retrospective Analysis and Summary on Efficacy of Jianpi Shengxue Tablet in the Treatment of Iron Deficiency Anemia

[Objectives]The research aimed to make a retrospective analysis and summary on the efficacy of Jianpi Shengxue Tablet in the treatment of iron deficiency anemia.[Methods]A total of 200 patients with iron deficiency anemia who were treated at outpatient in Tongzhou District of Dongzhimen Hospital of Beijing University of Chinese Medicine from January 1,2017 to October 30,2020 were selected as the research objects.All these patients were given treatment with Jianpi Shengxue Tablet for the first time.Results of blood routine examination,serum iron concentration,total iron binding capacity and ferritin were compared before and after treatment at different dates.Subjective symptoms and adverse reactions were also described.Jianpi Shengxue Tablet was given orally after meals,3 tablets each time,3 times a day.[Results]Hemoglobin level was(83.58±15.81)g/L(M±SD,n=200)before treatment,and(103.40±12.60)g/L(n=74)after 2 week's treatment,with a 24.3%increase(P=0.0047).Hemoglobin concentration was(111.9±19.4)g/L(n=47)at the 4th week after treatment,which was near normality;(126.0±9.49)g/L(n=30)at the 6th week with complete normality and(130.7±7.95)g/L(n=23)at the 8th week.MCV,MCH and MCHC increased gradually after treatment.Serum total iron biding capacity decreased,while serum iron and ferritin increased gradually,and the three indexes were significantly different at the 4th week after treatment as compared with those before treatment(P﹤0.01).Subjective symptoms were improved in the 1st week from starting treatment among all the cases.The adverse events were mainly gastrointestinal irritation,occurring in 7/200 cases(3.5%).[Conclusions]Jianpi Shengxue Tablet is quite effective and safe in the treatment of iron deficiency anemia,with rapid comprehensive improvement of anemia-related symptoms and increase of hemoglobin and red blood cell parameters.

Comparative efficacy and safety of Chinese patent medicines of iron deficiency anemia during pregnancy:A network meta-analysis

BACKGROUND Iron deficiency anemia(IDA)is a prevalent nutritional disorder during pregnancy.Clinical studies indicate that incorporating Chinese patent medicines(CPMs)with oral iron(OI)in treating IDA in pregnancy can reduce adverse effects and improve clinical outcomes.Nonetheless,the comparative efficacy of different CPMs remains unclear.AIM To assess the safety and effectiveness of different CPMs for treating IDA during pregnancy using network meta-analysis.METHODS We conducted a search for randomized controlled trials(RCTs)that combined CPM and OI for IDA treatment in pregnancy,spanning from 2013 to the present.Data analysis was performed using Rev Man 5.3 and Stata 14.0 on literature that satisfied the quality criteria.RESULTS The analysis included 45 RCTs,encompassing 4422 pregnant patients with IDA.Six CPMs were examined,including Shengxuebao Mixture,Shengxuening Tablets(SXN),Yiqi Weixue CPMs(YQWX),Jianpi Shengxue CPMs(JPSX),Yiqi Buxue Tablets,and Compound Hongyi Buxue Oral Liquid(FFHY).Findings indicated that FFHY+OI significantly improved the clinical effective rate.SXN+OI was most effective in boosting red blood cells counts and hemoglobin levels.YQWX+OI showed superior results in improving serum ferritin,and SXN+OI was most effective in increasing serum iron levels.JPSX+OI was optimal in reducing adverse pregnancy outcomes,while YQBX+OI effectively minimized adverse events.A cluster analysis suggested that SXN+OI could be the potentially optimal therapeutic regimen for IDA in pregnancy.CONCLUSION This study demonstrates that the combination of OI with CPMs offers better outcomes than OI alone.Based on clinical efficacy and other measured outcomes,SXN+OI emerges as the most effective treatment modality for improving the health of pregnant patients with IDA.

Effect of Yisui Shengxue Granule (益髓生血颗粒) on the Oxidative Damage of Erythrocytes from Patients with Hemoglobin H Disease

Objective： To investigate the effect of Yisui Shengxue Granule （益髓生血颗粒, YSSXG）, a complex Chinese medicine, on the oxidative damage of erythrocytes from patients with hemoglobin H （HbH） disease. Methods： Twenty-two patients with HbH disease and 22 healthy volunteers were observed. YSSXG was given to patients with HbH disease for 3 months. Before and after the 3-month treatment, blood parameters [hemoglobin （Hb）, red blood cells （RBCs）, and reticulocyte percent （Ret）] were examined; inclusion bodies in erythrocytes were observed by transmission electron microscopy （TEM）; activities of antioxidant defense enzymes [superoxide dismutase （SOD）, glutathione peroxidase （GSH-Px）, and catalase （Cat）] and erythrocyte membrane malondialdehyde （MDA） concentrations were determined. Results： In patients with HbH disease, measured values of RBC and Hb obtained from the first to the third months after treatment with YSSXG were significantly higher than before treatment （P〈0.01）. Measured values of Ret from the second to the third months aftertreatment were significantly lower than before treatment （P〈0.05 and P〈0.01, respectively）. Prior to treatment with YSSXG, TEM images of RBCs showed the presence of numerous inclusion bodies. After treatment with YSSXG, the amount and volume of inclusion bodies decreased. Treatment with YSSXG also led to a significant increase in SOD activity （P〈0.01）, a decrease in Cat activity （P〈0.01）, and no significant differences in GSH-Px activity （P〉0.05） or MDA concentration （P〉0.05）. However, compared with the healthy counterparts, SOD, GSH-Px, and Cat activities presented at high levels （P〈0.01） both before and after treatment. Conclusions： YSSXG could improve the degree of hemolysis and anemia in patients with HbH disease. The mechanism may be related to its antioxidative effects, which could elevate the activity of total SOD in erythrocytes and efficiently inhibit the oxidative precipitation of β-globin chains.

Genomewide DNA Methylation Responses in Patients with β-Thalassemia Treated with Yisui Shengxue Granules (益髓生血颗粒)

Objective: To examine the clinical effects of Yisui Shengxue Granules(益髓生血颗粒) in the treatment of β-thalassemia and explore its mechanism on DNA methylation levels. Methods: A randomized placebo-controlled double-blinded trial was conducted. Forty patients with β-thalassemia were recruited and distributed randomly by envelope method into an experimental group and a control group, 20 patients in each group. The patients were given Yisui Shengxue Granules in the experimental group and placebo in the control group(12 g/bag, 3 times a day) during a 3-month intervention. Before and after 1, 2, and 3 months of treatment, peripheral intravenous blood was sampled, and blood parameters such as hemoglobin(Hb), red blood cells(RBCs), reticulocytes(Ret), and fetal hemoglobin(HbF) were analyzed. Mononuclear cells from 5 patients, who showed an obvious treatment effect, were isolated by density gradient centrifugation. DNA methylation was analyzed using an Affymetrix USA GeneChip Human Promoter 1.0 Array and Input-promoter 1.0. Results: Compared with pre-treatment, there was an obvious increase in Hb and RBCs counts after 1, 2, and 3 months in the experiment group(P<0.01 or P<0.05). Meanwhile, HbF increased from the 2 nd to the 3 rd month(P<0.05). In the control group, Hb and RBCs showed no obvioas change. After 3-month treatment, DNA methylation results from 5 patients revealed that there were 24 hypomethylated genes and 3,685 hypermethylated genes compared with pre-treatment. Genes of insulin-like growth factor 1 receptor(IGF1 R) and Janus kinase 3(JAK3) revealed the most relations with other genes(degree: 21) and genes of 1-phosphatidylinositol-4, 5-bisphosphate phosphodiesterase gamma 2(PLCG2) and mitogen-activated protein kinase 10(MAPK10) showed a stronger intermediary role(betweenness centrality=0.04). Conclusions: JAK3 and MAPK10 are two key genes in bone marrow and the lymphatic system, and JAK3 is likely to be related to hematopoietic cytokines in the process of early hematopoiesis.(Registration No. NCT01549080).

Clinical Study of Shengxue Mixture (生血合剂) in Treating Aplastic Anemia

Objecive: To observe the clinical effect of Shengxue Mixture (SXM) in treating aplastic anemia and study the possible mechanism.Methods: Eighty-four patients in the treated group with Spleen-Kidney Yang deficiency syndrome and Spleen-Kidney Yin deficiency syndrome were treated with SXM-I and SXM-II respectively, and 30 patients in the control group were treated with Stanozolol. The clinical effect and several experimental parameters were also observed.Results: The basic cure was gained in 18 cases, remission in 23, markedly improved in 32, ineffective 11, total effective rate and cure remission rate of the treated group were 86.90% and 48.81% respectively, which were obviously better than those of the control group (P < 0.05) with no obvious side-effect. While the patient’s symptoms were alleviated, the peripheral blood cells increased, the ratio of T lymphocyte subsets tended to balance, the level of natural killer cell activity increased, interleukin-2 reduced, and reproduction of the bone marrow were markedly improved in most of the patients treated by SXM.Conclusions: SXM is an effective and safe drug for aplastic anemia. Its mechanism might be likely due to its regulating the immune function, which facilitates the recovery of the bone marrow hematopoiesis function.