| Objective:To observe the clinical effect and safety on Bu Xue Pai Du Tang (BXPDT) treating RA (Renal Anemia). To provide scientific basis for BXPDT's application in clinic. Methods:66 case patiences who came from renal clinic or ward in Hu Bei Province TCM (Traditional Chinese Medicine) Hospital were dialogued RA .They were divided into groups randomly:BXPDT combining with rHuEPO (recombinant Human, Erythropoietin ) treatment group(A group) and rHuEPO control group(B group), each of which contained 33 cases. Two group patiences were given rHuEPO 100u per kilogram weight to inject once a week and Ferrous Succinate 0.1 to take three times a day . At the same time , A group was given BXPDT 100ml to take twice a day. All patiences were demanded to examine the Blood Routine , the relicular red cell , kidney function , liver function ,and record the correlated TCM symptoms , the Blood Pressure before they accepted treatment. During the treatment, the Blood Routine, the relicular red cell were examined per two weeks and kidney function was examined once a month. After one day of treatment ,the correlated TCM symptoms , the Blood Pressure and ECG were observed too. If the increasing of Hct no more than 2 percent ,the dose of rHuEPO should be added to 1.5 times of that in former application. If the Hb increased absolutely more than 3g/dl per month or Hb ,Hct surpass the objective mark, the dose of rHuEPO should be decreased 25 percent of that in former dose. Result:1. The rate of distinctive effect of A group was 45.5%, the total effective rate was 87.9%; that of B group was 21.2% ,the total effective rate was 75.8%. There was distinctive difference between groups by statistical analysis(P<0.05).2. The accumulative mark of TCM had distinctly decreased after treatment , comparing with before treatment (P<0.01). There was distinctive difference between groups on the accumulative mark of the correlated TCM after treatment(P<0.05).3. Both drugs can distinctly improve correlated TCM symptoms after treatment (P<0.01 or P<0.05).There were marked difference between two groups on some symptoms of fatigue, poor appetite and pale lips (P<0.05).4. Both of the two group drugs could remedy distinctly the situation of anemia(P<0.05); A group was much faster than B group in remedying the situation of anemia ,and there were remarked difference about Hb,Hct and RBC between two groups in the eighth week and tenth week(P<0.01 or P <0.05 ).5. The dose of rHuEPO began to decrease in A group after eighth week, which had distinctive difference with that of B group (P<0.05). In A group , the dose of rHuEPO was just two thirds of that in B group during the sustain period.6. The kidney function of two group patiences was stable or improved during the treatment period ,which of A group was improved distinctly after treatment. The kidney function of two group patiences had distinctive difference between two group after treatment(P<0.05).7. The systolic pressure of A group was heightened distinctly after treatment (P<0.05) , and the diastolic pressure had no apparent change during the treatment (P>0.05). Before and after treatment ,both systolic pressure and diastolic pressure had no statistical difference between two groups(P>0.05).8. The ECG (electrocardiogram) of two groups patiences was improved distinctly after treatment .(P<0.05)9. The serum ferrin (SF) and transferring (Ts) had not apparent change before and after treatment, they were included in the normal scope .10. Safety inspection : There was not abnormal change by inspecting stool routine and liver function during the treatment period . The ECG and kidney function were stability or improvement after the treatment .The abnormal parameter before treatment had not been aggravated after treatment. All these indicated that BXPDT had not harmful reaction , and it was safety in the course of clinical application . Conclusion:The BXPDT could increase the role of rHuEPO in treatment, and may take the place of part function of rHuEPO in the course of treating Renal Anemia . It could rectify... |
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