The Clinical Study Of Qi And Jing Supplement Formula For Children With β-thalassemia Intermedia And "Weakness Of Spleen And Kidney"

ObjectiveThe aim of this paper is to observe the effect of the treatment by the medicine formula of Astragalus membranaceus (Radix Astragali) and Tortoise plastron (Tortoise shell) on the parameters of blood routine test, reticulocyte level, fetal hemoglobin and iron metabolism in pediatric patients with β-thalassemia intermedia with "weakness of spleen and kidney"Methods33 cases of pediatric patients with beta-thalassemia from Guangzhou Hospital of TCM and Nanfang Hospital, Southern Medical University were involved in the research. They were randomly divided into Qi and Jing Supplement formula group (formula medicine group) and placebo control group at the ratio of 1:1.The amount of medicine was dependent on the ages of the pediatric patients: 1 to 3,4 to 6,7 to 11 and 12 to 18 years old. The patients in formula medicine group were treated with oral Astragalus membranaceus and Tortoise plastron granules for 12 weeks. The children in the four age ranges respectively took 10g,15g,20g and 30g of each granule daily. The patients in control group were treated with oral placebo granules (prepared from dextrin, looks similar with the two medicine granules) for 12 weeks. The children in the four age ranges respectively took 20g,30g,40g and 60g of placebo granules daily.Before treatment and at the time of four, eight, twelve weeks after treatment, blood routine were examinated to analyze the Hb, RBC, MCV and MCH of all the patients. Before treatment and twelve weeks after treatment, Ret and HbF proportions were tested. Iron parameters (FER, FE and TIBC), liver function (ALT and AST) and bilirubin parameters (TBIL and IBIL) were also observed.Before treatment and at the time of four, eight, twelve weeks after treatment, blood routine were examinated to analyze the WBC, NEU and PLT. Before treatment and twelve weeks after treatment, liver and kidney parameters (ALT, AST, BUN and Cr) were oberved. The by-effect symptoms were assessed.SPSS 13.0 programme was ultilized for data anylyzation. P<0.05 means significant difference(s).ResultsThe Qi and Jing Supplement formula largely increased the Hb levels of the pediatric patients with β-thalassemia intermedia.The Qi and Jing Supplement formula significantly increased the RBC and MCH values of the pediatric patients with β-thalassemia intermedia. But the MCV and Ret value were almost the same.The Qi and Jing Supplement formula increased the HbF proportion of the pediatric patients with β-thalassemia intermedia greatly.The Qi and Jing Supplement formula reduced the TBIL and IBIL levels of the pediatric patients with β-thalassemia intermedia to a certain extent.For the medicine group and control group, the total efficiencies were 58.8% and 0%, respectively, which shows a significant difference. No placebo effect was observed.The Qi and Jing Supplement formula did not affect the WBC, NEU, PLT, iron parameters and liver and kidney function parameters of the pediatric patients with β-thalassemia intermedia basically.Conelusion(a) This clinical study shows that the Qi and Jing Supplement formula can significantly increase the Hb and HbF levels of the pediatric patients with β-thalassemia intermedia. Furthermore, it can raise the RBC, MCH levels, but lower the TBIL and IBIL.(b) The Qi and Jing Supplement formula basically showed no effect on the WBC, NEU, PLT values, iron parameters together with liver and kidney function parameters of the pediatric patients.(c) This clinical study shows that the total efficiency for the medicine group was much higher than that of the control group. The Qi and Jing Supplement formula showed a certain effect and safety for curing β-thalassemia intermedia. No placebo effect was observed.In summary, the medicine combination of Astragalus membranaceus and Tortoise plastron is an effective and safe therapy method for children with β-thalassemia.