| OBJECTIVE:To study the clinical efficacy of Qiyu Liujun Decoction in preventing and treating bone marrow suppression after chemotherapy with TC regimen in patients with ovarian epithelial cancer,and to evaluate its efficacy and safety in prevention and treatment of bone marrow suppression after chemotherapy.To Provide theoretical reference and clinical basis for Chinese medicine treatment of bone marrow suppression after chemotherapy.METHODS:Sixty-four patients with ovarian epithelial cancer who received first chemotherapy were randomly divided into chemotherapy group and Chinese medicine group.Both groups were treated with TC regimen(paclitaxel 135mg/m~2 ivgtt d1,carboplatin AUC=5 ivgtt d1),and chemotherapy group was used alone,Chinese medicine group combined with Qiliujun decoction on the basis of chemotherapy group(taken 1 day before the first chemotherapy,21 days for a course of treatment),21 days as a cycle,a total of 1 cycle was observed.The blood counts of white blood cells(WBC),neutrophils(NEU),hemoglobin(HGB),and platelets(PLT)were compared between 1day before chemotherapy and 5 days,10 days,15 days,and 20 days after chemotherapy.The number of cases of myelosuppression after chemotherapy was observed.The degree of myelosuppression was recorded.The TCM syndrome grade,KPS score and subsequent chemotherapy acceptance rate of the two groups were compared.The above data were analyzed by SPSS 24.0 statistical software,and the P value was set to<0.05to be statistically significant.RESULTS:There were no differences in age,white blood cell count,neutrophil count,hemoglobin,platelet count,surgery,clinical stage,pathological type,TCM syndrome level,and KPS score between the two groups(P>0.05).1.Main efficacy indicators:The main efficacy indicators include white blood cell count,neutrophil count,hemoglobin,and platelet count before and after chemotherapy.(1)Comparison of white blood cell counts before and after chemotherapy:(1)Comparison within the group:The white blood cell count on the 20th day after chemotherapy in the Chinese medicine group was similar to that before the chemotherapy,and the difference was not significant(P>0.05).The white blood cell count on the 20th day after chemotherapy in the chemotherapy group was significantly lower than that before chemotherapy,and the difference was extremely significant(P<0.01).(2)Comparison between groups:The average white blood cell count measured by the Chinese medicine group during the four follow-up visits was significantly higher than that of the chemotherapy group,and the difference was significant(P<0.05).(3)The number of cases of white blood cell count reduction between groups:comparison of white blood cell counts during four follow-up visits after chemotherapy.There was no significant difference in the number of cases with grade I-IV leukopenia decline between the two groups(P>0.05).(2)Comparison of neutrophil counts before and after chemotherapy:(1)Comparison within the group:The neutrophil level in the Chinese medicine group and the chemotherapy group on the 20th day after chemotherapy decreased significantly compared with the day before chemotherapy,and the difference was extremely significant(P<0.01).(2)Comparison between groups:After 5 days,10 days,15 days,20days of follow-up after chemotherapy,the neutrophil count in the Chinese medicine group and the chemotherapy group decreased significantly,but the degree of decline in the Chinese medicine group was less than that in the chemotherapy group.There was significant difference between the two groups on the 5th and 15th days(P<0.05).There was no significant difference between the two groups on the 10th and 20th days after chemotherapy(P>0.05).(3)Comparison of the number of neutrophil counts between groups:On the 10th day after chemotherapy,the number of cases with decreased I-IV neutrophil count in the Chinese medicine group was lower than that in the chemotherapy group,and the difference between the two groups was significant(P<0.05).There was no significant difference between the two groups on the 5th,15th and 20th day after chemotherapy(P>0.05).(3)Comparison of hemoglobin levels before and after chemotherapy:(1)Comparison within the group:The amount of hemoglobin on the 20th day after chemotherapy in the Chinese medicine group was not significantly different from that before chemotherapy(P>0.05),the hemoglobin level in the chemotherapy group on the 20th day after chemotherapy was significantly different from that on the 1st day before chemotherapy(P<0.01).(2)Comparison between groups:The amount of hemoglobin in the two groups was not significantly different during the four follow-up periods after chemotherapy,and the difference was not significant(P>0.05).(3)The number of cases of hemoglobin decreased between groups:the number of cases with decreased I-IV hemoglobin between the two groups after chemotherapy was not significantly different during the four follow-up periods(P>0.05).(4)Comparison of platelet counts before and after chemotherapy:(1)Comparison within the group:There was no significant difference in platelet count between 20 days after chemotherapy and 1 day before chemotherapy(P>0.05).The platelet count of the chemotherapy group was significantly different from that of the one day before chemotherapy on the 20th day after chemotherapy(P<0.05).(2)Comparison between groups:The platelet count between the two groups was not significantly different during the four follow-up periods after chemotherapy(P>0.05).(3)Number of intergroup thrombocytopenia cases:Among the four follow-up visits after chemotherapy,there was no significant difference in the number of patients with thrombocytopenia of degree I to IV between the two groups(P>0.05).2.Secondary efficacy indicators:secondary efficacy indicators include changes in TCM syndrome levels before and after chemotherapy,changes in KPS scores,and subsequent chemotherapy acceptance rates.(1)The changes of TCM Syndrome Grade:(1)The changes of TCM syndromes grade before and after chemotherapy in the two groups were obvious.The number of cases with TCM syndromes grade increased significantly compared with before chemotherapy,and the level of TCM syndromes grade increased significantly.There was significant difference between before and after chemotherapy in the TCM group(P<0.05),and there was significant difference between before and after chemotherapy in the chemotherapy group(P<0.01).(2)Comparison between groups:On the 20th day after chemotherapy,the number of TCM syndromes in the chemotherapy group was significantly higher than that in the traditional Chinese medicine group.Compared with the chemotherapy group,the Chinese medicine group can significantly reduce the shortness of breath caused by qi and blood deficiency,burnout,spontaneous sweating,pale complexion,There was a significant difference in the occurrence of symptoms such as palpitations and insomnia(P<0.05).(2)The changes of KPS score:(1)Comparison within the group:Compared with the first day before chemotherapy,the KPS scores of the two groups were decreased on the 20th day after chemotherapy,but the difference was not significant in the Chinese medicine group(P>0.05).The chemotherapy group showed a significant decrease,and the difference was significant(P<0.05).(2)Comparison between groups:There was no significant difference between the two groups before the first day of chemotherapy and the 20th day after chemotherapy(P>0.05).(3)Reception rate of follow-up chemotherapy:The acceptance rate of follow-up chemotherapy in the Chinese medicine group was 96.9%,and the acceptance rate of chemotherapy in the chemotherapy group was 93.8%.There was no significant difference between the two groups(P>0.05).3.Changes of safety indicators:There were no significant differences in ALT,AST,AST/ALT,Cr,BUN,urine,stool routine+Occult blood,ECG results between the two groups before and after chemotherapy(P>0.05).There were no significant differences in ALT,AST,AST/ALT,Cr,BUN,urinary routine,stool routine+occult blood,ECG results between the two groups before and after chemotherapy(P>0.05).Suggesting that Qiliujun Decoction will not increase adverse reactions.Conclusion:Qiyu Liujun Decoction can reduce the decrease of leukocyte count,neutrophil count,hemoglobin count and platelet count after chemotherapy,reduce the number of cases of bone marrow depression after chemotherapy,prevent and treat bone marrow depression after chemotherapy,the treatment of leukocyte and neutrophils is the most significant.Qiyu Liujun Decoction also reduce the occurrence of TCM syndromes such as deficiency of Qi and blood,and improve the quality of life of patients.The safety evaluation of Qiyu Liujun Decoction is good.It will not increase the incidence of adverse drug reactions. |
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