The Clinical Application Of Fluorouracil Sustained Release Implant In Modified Radical Mastectomy For Breast Cancer

Objective:Fluorouracil sustained release implant is a solid slow-release local chemotherapy drug.In patients with modified radical mastectomy,due to its sustained release and orientation,the drug concentration of local residual tumor cells can be increased and the effective drug concentration time can be prolonged.And to some extent reduce the toxic side effects of the body.This study was to investigate the clinical efficacy and safety of regional sustained release chemotherapeutic drug fluorouracil implants in modified radical mastectomy for breast cancer.Methods:From September 2016 to March 2017,60 patients admitted to the Department of Glandular Vascular Surgery at Yan’an University Hospital for unilateral breast cancer and modified radical mastectomy were enrolled,and they were numbered by random number card.Divided into the implant group and the control group,in which the implanted group was implanted with sustained-release fluorouracil(n=30)in the operation of the suture,and the control group was directly closed(n=30)after the operation.1.Confirm carcinoembryonic antigen(CEA),carbohydrate antigen 15-3(CA15-3),carbohydrate antigen 125 by consulting relevant literature and combining breast cancer tumor markers commonly used in our department with high specificity and sensitivity.(CA125)As a detection index,the results of the two groups of patients before and after 4 weeks were compared by the combined detection method,and the changes of the concentration values were compared.Then the statistical software was used to count the two groups of patients after surgery for 1 year.And 2 years of local recurrence rate,distant metastasis rate and survival rate were plotted as a function curve to visually observe and evaluate the implantation efficacy of fluorouracil implants;2.WHO anti-tumor drug adverse reactions The indexing standard is a reference,and the oncologist’s physician is consulted to combine the clinically common chemotherapeutic drug adverse reactions,and the damage of bone marrow suppression,liver,kidney and digestive system is determined as an indication for evaluation.In terms of myelosuppression,hemoglobin(HB),white blood cell count(WBC),absolute neutrophil count(ANC),and platelet count(PLT)were selected as the detection indexes,and the blood cells of the two groups were obtained by the hospital blood analyzer.The basal level and the change of 1 week after surgery,and then statistically analyzed the damage of bone marrow hematopoietic cells induced by sustained-release fluorouracil.In the liver and kidney damage,total bilirubin(TBIL),alanine aminotransferase(ALT),aspartate aminotransferase(AST),serum creatinine(CRE),blood urea nitrogen(BUN)were selected for detection.Indicators,the preoperative level of liver zymogram and renal function index of the two groups of patients and the change of 1 week after operation were obtained by the hospital biochemical analyzer,and the degree of damage of hepatocytes and renal tubular cells by fluorouracil implants was statistically estimated.The side effects of the digestive system mainly through clinical observation of the symptoms of postoperative gastrointestinal tract in the two groups of patients,such as nausea and vomiting,diarrhea and other common conditions,compare the occurrence to determine whether the sustained release of fluorouracil after implantation has an effect on the digestive system.3.Clinical observation of common complications and finding data after modified radical mastectomy for breast cancer,literature screening of fluorouracil implant local chemotherapy related complications,determination of implant site pain,induration,ulcer,subcutaneous effusion,skin flap necrosis,Incision infection and edema of the affected limb,the safety of the fluorouracil implant was evaluated by a comprehensive analysis by counting the occurrence of postoperative conditions in the two groups.Statistical Methods:Data analysis was performed using SPSS23.0 statistical software.Measurement data were expressed as mean±standard deviation((3?±SD).Two independent samples were used for t test.Count data were expressed using relative numbers,usingχ~2 test;local recurrence rate,distant metastasis rate and survival rate were used.Kaplan-Meier survival analysis estimated that the log-rank test,according to the test level ofα=0.05,P<0.05 was considered statistically significant.Results:1.During the operation,30 patients in the implant group and 30 patients in the untreated group were compared.The general conditions including age,menopausal status,tumor location,pathological type,clinical stage,and molecular classification of breast cancer were statistically analyzed.No significant difference was found,that is,P>0.05,indicating that the general situation is comparable at the statistical level.In addition,through the collection of various indicators required before surgery,including HB,WBC,ANC,PLT,TBIL,ALT,AST,CRE,BUN,CEA,CA15-3,CA125,strict statistical calculations found that the difference is still not significant,that is,P>0.05,indicating that the basic data of the two groups of patients is relatively balanced.2.Regardless of whether or not the sustained-release fluorouracil was implanted during surgery,the concentrations of CEA,CA15-3,and CA125 in the two groups were significantly lower than those before surgery,that is,P<0.05,indicating that surgery is necessary treatment to reduce tumor burden.However,it must be noted that the effects of surgery must be ruled out when implanted drugs play a role in the treatment process.Therefore,the preoperative and postoperative 4 weeks of breast tumor markers in the two groups were observed and compared.It was found that the marker concentration of the drug-treated group was significantly lower than that of the control group at 4 weeks after surgery,that is,P<0.05.It was further determined that the implanted drug is effective for the patient.In order to verify whether the drug is beneficial to improve the survival rate of patients,it is found that the difference of local recurrence rate,distant metastasis rate and survival rate in the two groups after operation is not significant,that is,P>0.05.However,it is still not clear during this time whether the drug works.Therefore,it was observed that the local recurrence rate and distant metastasis rate of the implanted group were significantly lower than those of the control group at 2 years after operation,that is,P<0.05.On the one hand,it indicated that the drug needs sufficient follow-up time,on the other hand,explain that drugs can improve the prognosis of patients.Although there was no significant difference in the 2-year survival rate of follow-up patients,that is,P>0.05,However,by observing the 2-year survival curve of the two groups,it can be found that the survival rate of the implanted group is higher than that of the control group.3.In order to evaluate the side effects of the drug and ensure the safety of the drug,on the one hand,the concentration changes of HB,WBC,ANC,PLT,ALT,AST,TBIL,CRE and BUN in the two groups after operation were counted,and postoperatively.The incidence of gastrointestinal symptoms was found to be inconspicuous,that is,P>0.05.Therefore,the implantation of chemotherapeutic drugs on the hematopoietic cells,hepatocytes,and renal tubular cells of the body has little or no effect.If there is,on the other hand,continue to count the damage index of the above organs after surgery,and found that there is still no statistical difference,that is,P>0.05,so further confirmed that the side effects of local implants,that is,the adverse reactions are basically not.4.The complications of the study included two aspects of surgery and implanted drugs.Through long-term clinical observation and reading of a large number of time books,combined with the actual situation of patients in hospital departments,the recovery of the two groups of patients was analyzed.There were no significant differences in the incidence of pain,induration,ulcer,subcutaneous fluid,skin flap necrosis,wound infection and edema of the affected limb,that is,P>0.05,which confirmed the safety of locally implanted drugs.Conclusions:1.Surgery is the necessary treatment to reduce the tumor burden.On the basis of eliminating the influence,the follow-up time is 1 year,which is not enough to determine whether the local implanted drug plays a role.The follow-up time is extended to 2 years,which indicates that the drug can improve the prognosis.Although the patient’s survival time was not significantly prolonged,there was a certain increase trend,considering fewer cases and relatively shorter follow-up time.2.Implantation of chemotherapy drugs has little effect on the damage of hematopoietic cells,hepatocytes and renal tubular cells of the body.The side effects of localized liver,kidney function and digestive system,that is,adverse reactions,are basically absent.3.Topical implants are safe at both the surgical and implantable levels.In summary,this study shows that local implantation of sustained-release fluorouracil chemotherapy drugs can improve the prognosis of patients,and has a tendency to improve survival time.It is safe in both surgical and implanted drugs.To further clarify its clinical effects,it is necessary to expand the number of cases and extend the follow-up time.