| Objective: To observe and evaluate the efficacy and safety of Pomegranate Buxue Syrup in treating iron deficiency anemia(deficiency of both Qi and blood),so as to provide new ideas and opportunities for further exploring the treatment and application of traditional Chinese medicine in iron deficiency anemia.Methods:This study was a randomized,open,positive drug parallel control,multi-center clinical study.Sixty IDA patients in our center were randomly divided into experimental group and control group,with 30 patients in each group.The control group was given Shengxuebao mixture orally,while the experimental group was given Pomegranate Buxue Syrup orally.After 8 weeks of continuous application,a series of functional indexes such as hemoglobin level,red blood cell related parameters,iron metabolism index and TCM syndrome score before and after treatment were statistically analyzed,and the safety of related drugs was evaluated.SPSS24.0 was adopted for data processing and statistical analysis.Results:1.The curative effect of TCM: Compared with before treatment,the scores of TCM syndromes in the two groups showed a decreasing trend in different degrees(P<0.05),the effective rates of the two groups were 86.67%and 76.67% respectively,with significant difference(P<0.05).2.Laboratory indicators: Hb levels of patients in both groups increased in different degrees compared with those before treatment(P<0.05),and the experimental group was better than the control group(P<0.05).Hb increased after stratified treatment,patients in the experimental group were mainly distributed in the range of 10~15g/L,while those in the control group were mainly distributed in the range of 5~10g/L,but neither of the two groups reached the clinically effective standard of 15g/L.The levels of RBC,MCV,MCH and MCHC in both groups were significantly higher than those before treatment(P<0.05),and the experimental group was better than the control group(P<0.05).SI,SF,TS of both groups showed an upward trend(P<0.05),while TIBC showed a downward trend(P<0.05),and the improvement degree of the experimental group was better than that of the control group(P<0.05).3.During the whole trial,there were no adverse events in both groups;No abnormality is found in the safety index test results.Conclusion:1.The Pomegranate Buxue Syrup has a certain clinical effect in treating iron deficiency anemia(deficiency of both Qi and blood),and at the same time,it can improve the TCM syndromes,hemogram and iron metabolism indexes of patients,and it is superior to Shengxuebao mixture orally;2.Pomegranate Buxue Syrup has no clinical adverse reactions and is safe in practical clinical application. |