| Objective:The objective of this study was to evaluate the clinical efficacy and safety of Busui Prescription combined with Western medicine in the treatment of elderly patients with Low-or-Int-Risk myelody-splastic syndrome, in order to find safe and effective treatment methods for the patients.Method:All the 46 elderly patients wiht Low-or-Int-1-Risk myelody-splastic syndrome were selected from the inpatient and out-patient units of the Hematology Division of Hubei Provincial Hospital between October 2012 and December 2014. Eventually 22 patients in the treatment group and 21 patients in the control group underwent the efficacy observation and safety evaluation The control group was treated with Western medicine and the treat-ment group was given Busui Prescription additionally. Clinical observation lasted for 3 months. Eventually, we observed and recorded the clinical symptoms, peripheral hemogram. myelogram, blood transfusion and safety from the before and after treatment in both groups. Statistical analysis was performed using SPSS17.0 software. The statistical results were statistically significant when P< 0.05.Results:1. After 3 months of treatment, there was 1 with basic relief, 5 with partial relief,6 with improvement and 9 without response in the control group. The overall effective rate was 57.1%. Relatively, there was 5 with basic relief,8 with partial relief, 6 with improvement and 3 without response in the treatment group. Therefore the overall effective rate was 86.4%, which was significantly different from that of the control group (P< 0.05).2. After 3 months of treatment, the patient’s white cell count, hemoglobin count in the treatment group had an obvious improvement, compared with those in pre-treatment as well as the control group (P<0.05)3. After treatment, the bone marrow proliferation demonstrated no improvement(P>0.05). The patients of treament group had a more obvious improvement in bone marrow erythroid hematopoiesis (P< 0.05). The reduction of BM blasts have no obvious difference compared with pre-treatment and the control group’s (P<0.05).4. In reducing the amount of RBC transfusion, there was an obvious improvement in the treatment group compared with the control group (P< 0.05).5. After treatment, the clinical symptoms scores of the both groups were significantly different compared with pre-treatment. And there was an obvious difference between the two groups as well. Analysis of efficacy of TCM svmptoms as follow: in the control group,4 cases were marked excellent,7 cases were effective,10 patients were invalid. The general effective rate in the control group was 52.4%. in the treatment group,1 cases were clinical cured, 8 marked as excellent cases,10 were effective cases, and 3 cases were invalid, the general effective rate in the treatment group was 86.4%. The differences of total effective rate between the two groups was statistically significant (P<0.05).6. Regarding the security aspects, both groups had one patient that suffered from slight liver dysfunction, which may be caused by the side effect of Andriol during the process of treatment.But they were relieved after corrective treatment and it was unnecesary to withdraw from the drug use.And there was no significant difference between the tow groups in urine routine, stool routine,renal function and ECG.Conclusion:It proved that the combination of Busui Prescription and Western medicine in the treatment of elderly patients with IPSS Low-or Int-1-Risk MDS has definite clinical therapeutic effect of improving clinical symptoms of the patients as well as perpheral hemogram, myelogram,blood transfusion, in order to improve the patients’ quality of life. Therefore, it’s worth our further study. |
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