| ObjectiveIn order to making the supplementing qi and nourishing yin to treat the fever after chemotherapy of leukemia clinical research on a more rigorous scientific basis, the main topic of clinical epidemiology,clinical research methodology and statistics analysis were randomized controlled clinical study of the supplementing qi and nourishing yin to treat the fever after chemotherapy of leukemia clinical to make an objective of efficacy and safety, in order to further standardize the clinical efficacy, access to better social benefits.MethodsSelect from March 2008 to December 2009 during Chen Yu of any out-patient treatment,70 cases of leukemia patients that meet the screening criteria. Randomized 1:1 divided into the test group (conventional chemotherapy+ antibiotics Shengbai medicine+ supplementing qi and nourishing yin medicine) and the control group (conventional chemotherapy+ antibiotics Shengbai medicine) group,35 cases of each group. Chinese drug should be decocted in water for oral dose, one dose daily, for 4 weeks,4 weeks for a course of treatment, observation of a course of treatment. Before and after treatment recorded white blood cell count (WBC),hemoglobin (Hb),platelet values (PLT) and the rate of side effects such as infection,fever,nausea and bleeding incidence. All patients in two groups were tested the axillary temperature for 10min after treatment 0.5h,1. Oh,2.0 h,24h and were observed the clinical symptom.Database was set up with the software of Epi Data3. 1.The statistical analysis was used with the software of SPSS15.0. Measurement data was represented by mean±standard deviation (x±s), numeration data was represented by constituent ratio (%).The classification data was observed usingχ2 Test and the ranked data by Wilcoxon rank-sum Test. Independent T-test or Wilcoxon rank-sum Test was applied for group comparison. Matched t-test or Wilcoxon matched-rank-sum test was applied for self-AP:PA comparison. The software of Graph Pad Prism 4.03 was used for statistical figure.ResultsIn this study,70 cases patients collected all were outpatients, aged 12 to 55 years old,55 cases were acute lymphoblastic leukemia with type of pathological,7 cases were acute myeloid leukemia,3 cases were acute leukemia of heterozygosity,5 cases were Granulocytic leukemia,2 cases were chronic lymphocytic leukemia. Both test group and control group was 35 cases, the experimental group were 20 males and 15 females, the average age was 25.83±5.85 years, with conventional chemotherapy drugs and antibiotics Shengbai and supplementing qi and nourishing yin Chinese medicine; the control group had 22 men and 13 females patients, the average age was 27.27±4.97 years, with the conventional chemotherapy drugs and antibiotics Shengbai medication.Comparability of baseline characteristics of patients in the two groups of gender, age, pathological type, treatment of blood WBC, HB, PLT count and adverse conditions, there was no statistical significance analysis which showed that the baseline data between the two groups were comparable.Blood test:After one course of treatment, the two treatment methods can improve leukemia WBC, HB, PLT, within each group before and after treatment, there was significant differences between two groups (P<0.01). There was significant difference between before and after treatment (P<0.05). It was showed that the effective of the test group was better than that the control group for increasing WBC, HB, PLT.Temperature aspect:There was not significant difference between two groups in the extent of pyretolysis after treatment,0.5h, 1.0h (P> 0.05). But there was significant difference between two groups after treatment 2. Oh, 24. Oh(P<0.05). Known by the statistical value of two treatment methods can reduce the body temperature. The experimental group markedly reduced the body temperature after 0.5h, and returned to normal after lh-2h. Table2.7 showed that the temperature was reduced slowly in the control group and returned to normal after 1~2h.The situation of the main clinical symptoms and signs disappeared and adverse reactions:The disappearance rates of two groups were statistically significant in reducing main clinical symptoms and signs (headache, weakness, exhaustion). The disappearance rate of headache, fatigue, exhaustion in test group was 84.4% and 85.7%,97.1% which higher than the control group. After treatment, the test group had two cases of gastrointestinal reaction, accounting for only 5.7%. The control group had 13 cases subcutaneous bleeding, 29 cases occurred in patients with gastrointestinal reactions, accounting for 37.1%,82.8%. Comparison of adverse reactions rate of the two groups, there had statistically significant (P<0.01). This study showed that the experimental group could better improve the clinical signs and symptoms, reduce the patient's adverse reaction incidence. The combined Yiqiyangyin medicine treatment of leukemia could improve the clinical efficacy and the quality of life of patients.Clinical curative effect:The experimental group had 35 cases,16 cases were clinically cured, accounting for 45.7percent; 5 cases had markedly effective, accounting for 14.3percent; 11 cases had effective curative effect, accounting for 31.4 percent; 3 cases had no effective, accounting for 8.6 percent, the total effective rate is 91.4 percent. The control group had 35 cases,12 cases were clinically cured, accounting for 34.3percent; 3 cases had excellence curative effect, accounting for 8.6 percent; 9 cases had effective curative effect, accounting for 25.7percent, ineffective 11 cases, accounting for 31.4percent, the total effective rate is 68.6percent. The difference was not statistically significant between two groups, However, there was significant difference in the total effective rate (P<0.05). It showed that combined supplementing qi and nourishing yin medicine could increase the clinical efficacy for patients with leukemia.ConclusionConcluded the above findings, using supplementing qi and nourishing yin medicine as adjuvant therapy for treated leukemia, on the one hand it could clear the blood "cult poison", on the other hand determination of treatment based in pathogenesis obtained through differentiation of symptoms and signs, regulated of yin and yang, enhance immune function, made "evil to being safe". it not only could prevent the chemotherapy side effects, but also enhance the effect of chemotherapy and improve clinical efficacy. It was worth for the further development. |
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