| 1 ObjectiveMalignant tumor is the common disease which seriously does harm to people's physical health,and can usually cause acute,chronic blood loss and malnutritional anemia.Radiotherapy and chemotherapy are commonly means of oncotherapy at the present. Myelosuppression is their frequent harmful side effect,which often aggravates patient's anemia symptom. Accordingly anemia is malignant tumor patients'the common symptom. Not only anemia can significant degrade patients'quality of life,but also seriously impact the effect and prognosis of radiotherapy and chemotherapy, therefore,it becomes a aspect of the therapy of advanced stage tumor clinic.Now blood-transfusion and the application of EPO (recombinant human erythropoietin) are the important method of the treatment of tumor-related anemia, but their cost is high , therapeutic effect is short and side effect is great,which limit their clinic usilization. In the chinese medical science tumor-related anemia belongs to the scale of"xue xu zheng","xue gu","xue lao"and so on. The production of blood has something to do with the entrails of xin,gan,pi and shen,among which pi is playing principal role. We think the key pathogenesis is the weakness of the pi and wei and the deficiency of qi and xue,so we adopt the yizhong shengxue capsule which can Jianpi Yangwei and Yiqi Shengxue to treat tumor-related anemia.By means of the capsule of Yizhong Shengxue we approach the superiority corresponding the treatment of tumor-related anemia in the field of Chinese medicine.2 MethodsOn the basis of clinical research project,qualified cases were on principle of advanced stage tumor testified by clinic,pathology and/or cytology,according to anemia severe degree,the scores of KPS ,and were randomly divided into test group and blank group in two three-grade A grade hospitals in Beijing . When two periods of treatment were over,there were 47 effective cases together.They were randomly divided into two groups including 21 cases in the test group and 26 cases blank group.Blank group:Patients were given necessarily supportive treatment including blood transfusion when their hemoglobin was not so much as 60g/L.The medicine connecting the assessment of therapeutic effect would not be applied(containing Yiqi Yangxue generic Chinese crude drug broth).On the base of the treatment of the blank group,test group were given Yizhong Shengxue capsule three grain one time two times one day by mouth. The medicine would be continuously used four weeks as one course of treatment.We objectively assessed the clinical effect of Yizhong Shengxue capsule suffering from tumor-related anemia by means of prospectively synchronized and randomized control.We observed patients'peripheral blood hemogram,clinical master sign,the score of KPS,harmful side effect and completion rate of radiotherapy and chemotherapy when they were at the first and second course of treatment or at four and eight week.3 ResultsThe results showed:①Chinese medical science symptom:Test group:After treatment 10 cases of them showed significant improvement(47.62%),7 of them had partial amendment(33.33%). The patients'symptom about 80.95% involving Shen pi Fali,Shaoqi Lanyan,Shiyu Buzhen,Xinji,Touyun Muxuan and so on had showed significant improvement. Their quality of life had been improved.Blank group: After treatment 5 cases of them showed significant improvement(19.23%),8 of them had partial amendment(30.77%). The patients'symptom about 50% involving Shen pi Fali,Shaoqi Lanyan,Shiyu Buzhen,Xinji,Touyun Muxuan and so on had showed significant improvement. Their quality of life had been improved. Effective powervival rate of Chinese medical science symptom in test group is higher than Blank group.②Hb: Test group:The level of Hb showed upgrade tendency. The statistical significance (P>0.05) wasn't showed when the level of Hb at four week was compared to treatment before.The statistical significance (P<0.05) was showed when the level of Hb at eight week was compared to treatment before. The level of Hb at eight week was compared to treatment before and showed increased tendency. Blank group: The level of Hb at eight week was compared to treatment before and four week.Their conclusion was both obviously decreased and showed statistical significance(P<0.05).After therapy the distance of level of Hb between two groups was more and more(0.83>-0.74>-2.06).③RDW:Test group: The level of RDW showed upgrade gradually. The statistical significance (P<0.05) was showed when the level of RDW at eight week was compared to treatment before.Blank group: The level of RDW submitted fall-off .The statistical significance (P<0.05) was showed when the the level of RDW at eight week was compared to treatment before.④Peripheral hemogram: The statistical significance (P<0.05) was showed when the level of RBC,Hb and HCT of the test group at four and eight week were compared to the blank group respectively. The statistical significance (P>0.05) wasn't showed when the level of MCH,MCHC ,MCV RDW,WBC,and PLT of the test group at four and eight week were compared to the blank group respectively.⑤The quality of life (QOL) : Test group:The level of QOL showed upgrade gradually. The statistical significance ( P<0.05) was showed when the level of QOL at eight week was compared to 0 week,which approved the QOL of the test group rose up eight weeks later;Blank group: The level of QOL submitted fall-off tendency. The statistical significance (P<0.05) was showed when the level of QOL at eight week was compared to 0 week,which approved the QOL of blank group slowed down eight weeks later.⑥The score of KPS :The variation of the comparison betweeen eight week and pro-treatment in the score of KPS as followed: There were a little increase in the score of KPS between the test group and blank group.There were 0 case for the blank group and 4 cases for the test group,19.05% and 0.00% respectively;Little change had taken place between two groups in the score of KPS. There were 7 cases for the blank group and 11 cases for the test group,26.92% and 52.38% respectively. The unvariation of the score of KPS of the test group was higher than the blank group; There was a decrease in the score of KPS integrated test and blank group,8 cases for the blank group 0 case for the test group ,30.77% and 0.00% respectively. The descender of the score of KPS of the blank group was higher than the test group. By means ofχ2 test, whole curative effect comparison betweeen eight week and pro-treatment in the score of KPS showed statistical significance (P<0.05).After treatment whole score of KPS in the cases of test group was rise up.⑦Toxic and side effects caused by chemotherapy including decrease of white blood cell count,Hb and platelet,nausea,vomit and the functional lesion of liver or kidney showed no statistical significance (P>0.05)between two groups.⑧Factor analysis calculated the grade of QOL of every patient betweeen the test group and blank group in SF-36 tab,when they were at 0,4,8 week respectively. By means of the grade of QOL of every patient ,we could made themselves comparison of the grade of QOL among each group when they were at 0,4,8 week.The QOL of the test group at eight week was obviously elevated,but the blank group was seriously breakdown.⑨Analysed by multiple linear regression , the level of Hb is negative linear correlation with TNM grade and chemotherapy cycles. From standard regression coefficient,we could know TNM grade make more action.4 ConclusionAccording to the results above-mentioned,the conclusion of the study are as the follows:①The key pathogenesis character about tumor-related anemia is Piwei Xuruo,QiXue Liangxu;②Yizhong Shengxue capsule can effectively raise hemoglobin count,alleviate symptoms and improve QOL of patients suffering from tumor-related anemia and has reached the statistical significance.③The tendency on effect for tumor-related anemia appears in the future. |
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