| PURPOSETo observe the effect of Qi Jiao Sheng Bai Capsule on the prevention and treatm ent of leukocytopenia caused by chemotherapy of breast cancer,and analyze the chang es of TCM syndrome in the prevention and treatment of leukocytopenia caused by ch emotherapy of breast cancer.The effect mechanism is discussed from different perspecti ves of Chinese and Western Medicine,so as to provide reliable clinical application of Qi Jiao Sheng Bai capsule in the treatment of leukocytopenia caused by breast cancer.METHODS?systematic review was used to observe the clinical efficacy of Qi Jiao Sheng B ai capsule in the prevention and treatment of leukocytopenia caused by chemotherapy for breast cancer.?according to the GCP regulations strictly,a randomized double-bli nd,positive drug control trial and a multi center clinical trial were adopted.In strict accordance with the various diagnostic,therapeutic criteria,and related operating specif ications(SOP),the patients who were eligible for the clinical trial were grouped by a central random method,and a 21 day clinical double blind period was performed.The researchers will visit the patients on the day of entry,fifth,tenth,fifteenth,and twen tieth days of chemotherapy,and collect data on the effectiveness and safety assessment and record on the case observation table(CRF).The data collected included the bloo d,urine,routine + occult blood,liver,kidney function and electrocardiogram,and the effectiveness and safety of Qi Jiao Sheng Bai capsule were evaluated through data an alysis.In the experiment,the TCM syndrome was quantified by integral method,and the changes of TCM syndromes before and after treatment were compared to determin e the curative effect of TCM.?Based on the theory of Qi and blood in traditional C hinese medicine,we discuss the theoretical basis of Qi gel Sheng Bai capsule in the prevention and treatment of leucocytopenia caused by chemotherapy for breast cancer.RESULTS1.Main curative effect index:?There was no significant difference in baseline data distribution between the two groups before treatment(P->0.05).? There was no sig nificant difference in white blood cell count and neutrophil count between the two gro ups(P>0.05).? The differences of white blood cell count and neutrophils count in t he two groups before and after treatment(visit one,visit five)and neutrophils count were statistically significant(P<0.05),and there was no statistical significance in the control group(P>0.05).? There was no significant difference in the number of leuk ocytic reduction cases and neutrophils among the two groups(P>0.05).2.Secondary efficacy index changes:? There was no significant difference in TC M syndrome integral distribution between the two groups before treatment(P>0.05).? There was no statistical difference between the two groups of TCM syndrome scor es before and after treatment(P>0.05).The difference in the treatment group was stat istically significant(P<0.05),and there was no statistical significance in the control g roup(P>0.05).?There was no significant difference between the two groups in the efficacy of TCM syndromes(P>0.05).?There was a statistically significant differenc e between the two groups in the single symptom scores before and after treatment(P<0.05).?There was no significant difference between the two groups before and afte r treatment(P>0.05),among which the symptoms of the symptoms of fatigue,shortne ss of breath,dizziness,and self perspiration were improved obviously.?There was no significant difference in the acceptance rate of follow-up chemotherapy in the two gr oups(P>0.05),the acceptance rate of follow-up chemotherapy in the treatment group was 98.6%,and the acceptance rate of follow-up chemotherapy in the control group w as 97.3%.3.The change of safety index:? There was no significant change between the t wo groups of liver and kidney function,red blood cell,hemoglobin and platelet befor e and after treatment(P>0.05),but the treatment group had statistical difference befor e and after AST treatment(P<0.05),but the mean value still remained at the normal level and had no clinical significance.? There was no significant difference in urine routine,routine routine and electrocardiogram between the two groups before and after treatment(P>0.05).CONCLUSIONCombined with the results of systematic and clinical trials,we can conclude that:? Qi Jiao Sheng Bai capsule can effectively improve leukocyte count and neutrophil count in patients with breast cancer chemotherapy induced leukocytopenia.? Qi Jiao Sheng Bai capsule can effectively reduce the symptoms of 6 Qi and blood two defic iency syndrome in the patients with breast cancer chemotherapy related leucocytopenia.? Qi Jiao Sheng Bai capsule does not increase the incidence of adverse drug reacti ons,and has good safety.? Qi Jiao Sheng Bai capsule in treating breast cancer che motherapy induced leukocytopenia is consistent with the theory of Qi and blood in tra ditional Chinese medicine. |
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