Is It Necessary To Give Prostate Biopsy For Patients With TPSA In The Scope Of 4?10ng/ml

Part 1 To investigate the positive rate of prostate biopsy in patients with t-PSA in the scope of 4?10ng/ml.Background Prostate cancer is one of the highest incidences of cancers in the genitourinary system,its global incidence being in fifth place,ranking second in the male cancer incidences,and the incidence is increasing year by year.In America,prostate cancer is the highest incidence tumor in males,the ratio being about 28%.Compared with America,the incidence of prostate cancer in China is low,being 1/78 of America.But the incidence of prostate cancer in China increases very fast.Diagnosis of prostate cancer in China mainly occurs in older men,in 75?79 years old.A lower incidence of prostate cancer happens in men aged less than 60 years old,while a significant increase of incidence in prostate cancer happens in men over the age of 60.Prostate-specific antigen,PSA,is a kind of serine proteases,produced by epithelial cells of prostate,having a high specificity and sensitivity of prostate tissue.As a general rule,the parclose made by the endothelial cells in the prostate,basal cells and basilar membrane can prevent most PSA from entering into blood.Only a small part of PSA enters into the blood stream by diffusion,so the level of PSA is very low in normal men.But when the parclose is broken,PSA can enter into blood,leading PSA to a high level.The common reasons are invade diseases and mechanical injury.The high level of PSA caused by invade diseases rarely decreases,such as prostate cancer.The most common method of early screening and diagnosis of prostate cancer is digital examination of rectum allied with PSA detection.The judgement of abnormal results of PSA,is the same at home and abroad,namely PSA>4ng/ml,while whether taking prostate biopsy or not is controversial when t-PS A is in the scope of 4?10ng/ml,namely gray area in PSA.Objective It is advised to take prostate biopsy when PSA is over 10ng/ml,which is a common view.It is a gold standard to diagnose prostate cancer by prostate biopsy.While whether taking prostate biopsy or not is controversial in China when t-PSA is in the scope of 4?10ng/ml.Some scholars think it is vital to strictly control the indications of prostate biopsy,because of the low incidence of prostate cancer,favourable prognosis of prostate cancer,complications such as infection,pain and hematuria of prostate biopsy.Some scholars think we should wide indications of prostate biopsy,because of quick growth of prostate cancer,being a high incidence tumor and prostate biopsy becoming mature.Chinese urology guideline of 2014 says that prostate biopsy positive rate is 15.9%when t-PSA is in the scope of 4?10ng/ml.In this situation,prostate biopsy positive rate is 11.6%,when f/t PSA>0.16;prostate biopsy positive rate is 17.4%,when f/t PSA<0.16.The guideline get the data from a survey of 344 patients in Cancer hospital of Peking University.The data is single central and a small sample,its level of evidence of evidence-based medicine is degree III,so its compelling needs to be further validation.For this purpose,this study collected the domestic related literature,to discuss the diagnostic efficiency of prostate biopsy when t-PSA is in the scope of 4?10ng/ml.Methods Relevant studies of prostate biopsy with t-PSA level at t-PSA 4?10ng/ml inn PubMed,MEDLINE,EMBASE,Cochrane,Chinese Knowledge Network and Wanfang database(January 1990 to September 2016)were retrieved.The retrieval process was conducted manually according to the reference catalogue of aforementioned study and literature,which included original studies,reviews,guidelines,and papers returned when searching following keywords PSA,prostate biopsy,prostate puncture,prostate specific antigen(in Chinese),prostate biopsy(in Chinese),4,10.The selection process,that is the inclusion and exclusion process,is based on the topic first,followed by summary and full text,while excluding case reports and research progress.A total of 20 articles were included in this study.After data were extracted,meta-analyses were conducted using R software in which random effects model or fixed effect model were used to calculate the rate value,I2 test analyses were used to evaluate its heterogeneity,and funnel maps were used to assess the bias.Results After the database retrieval process was completed and repeated search results were excluded,a total of 826 literature remained,which reduced to 52 when irrelevant papers were excluded from the literature.Another 32 papers were excluded after the inclusion criteria and exclusion criteria were applied,for they are not about single variable data.Thus,20 papers were included in this Meta analysis,which were all published in China between 20017 and 2015.The medical cases included in these 20 papers vary from 63 to 1226 with patients age range from 32 to 88 years.In this study,the Meta analysis results show that in the fixed effect model the positive rate was 0.21 with 95%CI = 0.20?0.22,whereas in the random effect model,the positive rate was 0.21 with 0.19 to 0.23 while 12 = 66.3%in both models.Since in studies about single variable Meta analysis,single group of variables were used in original literature whose stabilities were different from control studies with two groups of variables,so the statistical heterogeneity at the time of the merger is generally relatively large,which can be affirmed in the various articles on Meta-analysis of individual rate published at home and abroad.The analysis also shows that I2 is greater than 50%,less than 75%,thus as a single variable meta-analysis,its heterogeneity can be accepted,and because of the use the random effect model for analysis,the results are true.?~2 analysis was carried out on the two data of which the positive rate of prostate biopsy was 15.9%(344)and the positive rate of prostate biopsy in this meta-analysis was 20.6%(5481).With P<0.05 statistically significant,the results showed that when the value of?~2 was 4.186 and P<0.05,it has statistically significance.According to the instruction of evidence-based medicine,the level of evidence-based evidence of medical guide data is grade ?.while the evidence-based medical evidence level of this meta study is grade I a.Conclusion Prostate puncture is the most reliable test for diagnosing prostate cancer.When the patient tPSA is between 4?10ng/ml,the guide gives a puncture positive rate of 15.9%,while our meta-analysis gives a rate of 20.6%.This rate difference is of statistically significant.The guideline states that when the f/tPSA is greater than 0.16,the positive rate of puncture is 11.6%and when the f/tPSA is lesser than 0.16,the positive rate of puncture is 17.4%;therefore,the guidelines indicate that prostate biopsy should be performed when PSA is between 4 and 10 ng/ml and f/tPSA<0.16.The guideline is based on the condition of 344 prostate biopsy patients with 4?10 ng/ml tPSA at Peking University Tumor Hospital.However,this is a small sample based on a single hospital,its data evidence level based on evidence-based medicine is grade ?.The data collected by this Meta-analysis are multi-center,large-scale,whose evidence level based on evidence-based medical reaches grade I a.Thus,this meta-analysis is more convincing than the data for the guide.Therefore,when t-PSA is at 4?10ng/ml,regardless of f/tPSA ratio,patients should conduct prostate biopsy surgeries to improve the detection rates of prostate cancer.Part 2 The comparison between data from Meta analysis and data from guideline.Objective We get the data of positive rate of prostate biopsy in patients with t-PSA in the scope of 4?10ng/ml.In this part,it is necessary to evaluate the grade level of evidence-based medicine between data from Meta analysis and data from guideline,in order to appraise the diagnostic capacity of prostate biopsy in patients with t-PSA in the scope of 4?10/ml,which will contribute to clinical practice.Methods Having data analysis by using SPSS 13.0,choose ?~2 test to compare two enumeration data,according to statistical analysis rules.The difference is statistically significant when P<0.05.Contents Data from guideline:the positive rate of prostate biopsy in patients with t-PSA is in the scope of 4?10/ml,according to the situation of 344 patients of Cancer hospital of Peking University.Data from Meta analysis:there are 20 case studies in the Meta analysis,with a total of 5481 patients.It is concluded that the positive rate of prostate biopsy is 0.21,95%CI= 0.20?0.22,in fixed effects model,while the positive rate of prostate biopsy is 0.21,95%CI= 0.19?0.23,I2=66.3%,in random effects model.As the Meta analysis is a single variable analysis,the heterogeneity is acceptable,and choose the random effects model.The positive rate of prostate biopsy in patients with t-PSA in the scope of 4?10ng/ml is 20.6%(5481).Results T(?~2)is 4.186,after calculation by ?~2 test,according to the positive rate of 15.9%(344)and 20.6%(5481).The degree of freedom of this x2 test being 1,after looking up to Chi-square critical value table,the outcome is P<0.05.Namely there is statistically significant between the two data.Conclusions It is necessary to give patients prostate biopsy,with tPSA between 4.0 and 10 ng ml-1,regardless of the rate of f/tPSA.