| Part one:Retrospective clinical study of Shengxuening tablet in the treatment of renal anemia.Objective:Renal anemia is one of the most common complications in patients with CKD,which is common in patients with end-stage renal disease.Renal anemia not only accelerates the progression of CKD and increases the risk of death,but also significantly affects the quality of life of patients with CKD.ESA combined with iron is the main treatment at present,but there are many problems in clinical application.As an auxiliary means to treat renal anemia,traditional Chinese medicine has been paid more and more attention.In this part,a retrospective cohort study was conducted to observe the clinical efficacy and safety of Shengxuening tablet in the treatment of renal anemia.Methods:A retrospective cohort study was conducted on patients with renal anemia who were treated in the Xiyuan Hospital from January 2014 to December 2019.They were divided into treatment group and control group according to exposure factors.The treatment group was treated with Shengxuening tablet alone or Shengxuening tablet combined with ESA.The control group was treated with ferrous succinate tablets alone or ferrous succinate tablets combined with ESA.The patients were divided into two groups according to whether they had combined ESA or not The blood routine,liver function,renal function,blood lipids,electrolytes and iron metabolism were observed before treatment and 3 months,6 months,9 months and 12 months after treatment,and the efficacy and safety were analyzed.Results:(1)A total of 285 patients were included,including 146patients in the treatment group and 139patients in the control group.There was no significant difference in baseline data before treatment between the two groups,including age,sex,diagnosis of primary disease,CKD stage,degree of anemia,albumin level and so on.(2)curative effect:when treated alone,the hemoglobin and hematocrit of the treatment group and the control group showed an upward trend,and the curative effect was the same at 3,6,9 and 12 months of treatment(P>0.05).The hemoglobin and hematocrit of the treatment group and the control group showed an upward trend,and the curative effect was the same at 3,6,9 and 12 months of treatment(P>0.05).There was no significant difference in the rate of reaching the standard of hemoglobin between the treatment group and the control group,but the weekly dose of ESA in the treatment group was significantly lower than that in the control group(P<0.05).(3)Safety:when treated alone,there was no significant change in liver function,blood lipid and electrolyte levels between the treatment group and the control group before and after treatment(P>0.05).After 6 months of treatment,the level of total protein in the treatment group was higher than that in the control group(P<0.05),and the level of triglyceride in the treatment group was lower than that in the control group 9 months after treatment(P<0.05).(4)Iron metabolism:according to the level of serum ferritin,the patients were divided into two groups:ferritin substandard group and ferritin standard group.When the ferritin did not reach the standard,the ferritin in the treatment group and the control group increased after treatment(P<0.05),and the treatment group was superior to the control group(P<0.05).The saturation of transferrin in the treatment group increased significantly(P<0.05),but there was no significant change in the control group.the treatment group was better than the control group(P<0.05).When ferritin reached the standard,the saturation of transferrin increased significantly in the treatment group(P<0.05),but there was no significant change in the control group,and the treatment group was superior to the control group(P<0.05).(5)adverse reactions:In this study,patients who were treated for 3-6 months were followed up by telephone to count the occurrence of adverse reactions.Among them,there were 6 patients in the treatment group,with an incidence of 7%,and 14 in the control group,with an incidence of 16.7%.There were adverse reactions related to the research drugs,such as epigastric discomfort,nausea,vomiting and so on.Conclusion:1.The effect of Shengxuening tablet in the treatment of renal anemia is similar to that of ferrous succinate tablet,and its safety is higher.2.When combined with ESA,Shengxuening tablet can reduce the dosage of ESA.3.In the case of long-term treatment,Shengxuening tablets have more advantages than ferrous succinate tablets.4.The effect of Shengxuening tablet on improving iron metabolism is better than that of ferrous succinate.Part two:Effect of Shengxuening tablet on ferritin and microinflammation.Objective:Based on the prospective observation of the state of microinflammation and the level of ferritin,to explore the mechanism of Shengxuening tablet in the treatment of renal anemia.Methods:CKD3-5 patients with renal anemia treated with Shengxuening tablet in the Xiyuan Hospital from January 2020 to January 2021 were selected for prospective observation.The patients in stage CKD1-2 were matched in the same period.The observation time node was before treatment and 2 months after treatment.The main observation indexes were interleukin-6,hypersensitive C-reactive protein and serum ferritin.To explore the mechanism of Shengxuening tablet in the treatment of renal anemia.Results:(1)A total of 30 patients with CKD3-5 renal anemia were included in this study,of which 16 cases were actually included because of the epidemic situation,4 cases fell off after the baseline index was collected,12 cases were actually completed,and 13 CKD1-2 patients were collected as the control group.(2)the levels of interleukin-6,hypersensitive C-reactive protein and serum ferritin in patients with stage CKD1-5 were significantly higher than those in stage CKD3-2(P<0.05).After treatment,the levels of interleukin-6,hypersensitive C-reactive protein and serum ferritin in patients with CKD3-5 renal anemia were lower than those before treatment,but there was no significant difference(P>0.05),which may be related to the small amount of samples included in this study and the short course of treatment.(3)adverse reactions and events:there were no adverse reactions and events in the course of treatment.Conclusion:1.The levels of ferritin and microinflammatory factors were increased in patients with CKD3-5 renal anemia.2.Shengxuening tablet can reduce the level of serum ferritin and inflammation index in patients with CKD3-5 renal anemia.The mechanism of Shengxuening tablet in the treatment of renal anemia may be related to the improvement of micro-inflammatory state and the level of ferritin in the body. |
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