Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

Risk Management Analysis of Medical Device Registration Self-inspection / 中国医疗器械杂志

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.

Clinical application of nutritional risk scale in pediatric cancer patients:a review / 中国实用护理杂志

The basic information and clinical application of nutritional risk scales for children with cancer were reviewed, and the strengths and weaknesses of each scale were analyzed. After systematic search and reading, the scales with more clinical applications included universal scales: Pediatric Malnutrition Assessment Screening Tool (STAMP), Nutritional Risk and Stunting Malnutrition Screening Tool (STRONG kids), Pediatric Yorkhill Malnutrition Score (PYMS), Pediatric Subjective Global Nutritional Risk Assessment (SGNA); specific scales: Nutritional Screening Tool for Childhood Cancer (SCAN), Nutritional Risk Screening for Childhood Cancer (NRS-PC). In order to effectively manage the nutritional risk of pediatric cancer patients, we should selectively use and further actively Chinese or develop specific nutritional risk measurement tools adapted to our national conditions.

Incidence and factors associated with hepatitis B surface antigen seroclearance in patients co-infected with HBV/HIV during antiretroviral therapy in Guangdong, China / 中华医学杂志(英文版)

BACKGROUND@#Hepatitis B surface antigen (HBsAg) clearance is vital for a functional cure of hepatitis B virus (HBV) infection. However, the incidence and predictors of HBsAg seroclearance in patients co-infected with HBV and human immunodeficiency virus (HIV) remain largely unknown in Guangdong, China.@*METHODS@#Between 2009 and 2019, patients co-infected with HBV/HIV undergoing antiretroviral therapy (ART) in Guangzhou Eighth People's Hospital affiliated to Guangzhou Medical University were retrospectively reviewed with the endpoint on December 31, 2020. The incidence and risk factors for HBsAg seroclearance were evaluated using Kaplan-Meier and multivariate Cox regression analyses.@*RESULTS@#A total of 1550 HBV/HIV co-infected patients were included in the study, with the median age of 42 years and 86.0% (1333/1550) males. Further, 98.3% (1524/1550) received ART containing tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC). HBV DNA was examined in 1283 cases at the last follow-up. Over the median 4.7 years of follow-up, 8.1% (126/1550) patients achieved HBsAg seroclearance, among whom 50.8% (64/126) obtained hepatitis B surface antibody, 28.1% (137/488) acquired hepatitis B e antigen seroconversion, and 95.9% (1231/1283) undetectable HBV DNA. Compared with patients who maintained HBsAg positive, cases achieving HBsAg seroclearance showed no differences in age, gender, CD4 + T cell count, alanine aminotransferase (ALT) level, or fibrosis status; however, they presented lower HBV DNA levels, lower HBsAg levels, and higher rates of HBV genotype B at the baseline. Multivariate analysis showed that baseline HBsAg <1500 cutoff index (COI) (adjusted hazard ratio [aHR], 2.74, 95% confidence interval [95% CI]: 1.48-5.09), ALT elevation >2 × upper limit of normal during the first six months after receiving ART (aHR, 2.96, 95% CI: 1.53-5.77), and HBV genotype B (aHR, 3.73, 95% CI: 1.46-9.59) were independent predictors for HBsAg seroclearance (all P <0.01).@*CONCLUSIONS@#Long-term TDF-containing ART has high anti-HBV efficacy including relatively high overall HBsAg seroclearance in HBV/HIV co-infected patients. Lower baseline HBsAg levels, HBV genotype B, and elevated ALT levels during the first six months of ART are potential predictors of HBsAg seroclearance.

Mechanism and intervention strategies of alexithymia / 四川精神卫生

The purpose of this article is to review the mechanism and intervention strategies of alexithymia， in order to provide a new direction for clinical treatment and research of alexithymia. Alexithymia is not only related to a variety of psychosomatic diseases， but also exists in mental diseases such as depression， anxiety and eating disorders， which seriously affects the quality of life of patients. This article reviews alexithymia and its mechanism in different diseases from cognition， neurological and social-psychological factors， and summarizes the intervention strategies， aiming to provide references for the clinical treatment of alexithymia.

Modification effects of temperature on outpatient visits caused by ozone in Linzhi / 公共卫生与预防医学

Objective To investigate the modification effect of atmospheric temperature on outpatient visits caused by O3 in Linzhi City. Methods The daily outpatient data, the daily O3 concentration and daily meteorological data (including daily average temperature, average relative humidity, etc.) in Linzhi City from 2018 to 2019 were collected. The distributed lag non-liner-model (DLNM) was used to quantitatively evaluate the impact of O3 in different temperature layers on the risk of outpatient visits. Results At low temperature layers, the cumulative relative risk (CRR) of total outpatient visits and non-injury outpatient visits increased by 53.8%（4.2% -126.9%) and 59.1%（5.8% -139.2%）for every 10 μg/m3 increase of O3 concentration, respectively. The subgroup analysis showed that for every 10 μg/m3 increase of O3 concentration at low temperature, the CRR of patients with circulatory diseases, men, women, and people being 3 in Linzhi City. In general, the cumulative risk increases as the temperature decreases.

Adjuvant or salvage radiotherapy in patients with adverse pathological features after radical prostatectomy / 中华泌尿外科杂志

Radical prostatectomy(RP)was commonly used in localized prostate cancer. For patients with adverse pathological features (APF) after RP, it was controversial about choosing adjuvant radiotherapy or salvage radiotherapy (SRT). Recent studies have found that early salvage radiotherapy(ESRT) had both the same cancer control and reduced overtreatment compared to adjuvant radiotherapy. Nomogram and Gene Classifier(GC) could predict the risk of recurrence after RP and contribute to choose adjuvant radiotherapy or ESRT. PSMA PET/CT was more sensitive to detect distant metastasis after biochemical recurrence, which was helpful to decide whether to implement SRT.

Analysis and interpretation of genetic testing results from 249 Chinese high to very-high risk non-metastatic prostate cancer patients / 中华泌尿外科杂志

Objective:To analyze germline genetic testing in Chinese high-to very-high-risk non-metastatic prostate cancer patients.Methods:This study included 249 Chinese patients with high- to very-high-risk non-metastatic prostate cancer for germline genetic testing, in Fudan University Shanghai Cancer Center, West China Hospital and Cancer Center of Sun Yat-sen University, from January 2018 to December 2022. High risk and very-high risk are termed according to National Comprehensive Cancer Network (NCCN) Prostate Cancer Guideline (2022 V1). The mean age of the patients was (66.7±9.2) years old and median PSA level was 28.50 (ranging 2.43 - 1481.11) ng/ml. Within these 249 patients, 84 (33.7%) were T 1-2, 98 (39.3%) were T 3-4, while 67 (26.9%) were unclear in T stage. Additionally, 51 patients (20.5%) were classified into International Society of Urological Pathology(ISUP) grade group 1-3 group and 198 patients (79.5%) were in ISUP 4-5 group. Focusing on 16 genetic susceptibility genes for prostate cancer, we interpret the germline genetic testing data in accordance with the American College of Medical Genetics and Genomics and the Association for Molecular Pathology (ACMG/AMP) guideline, clarify the germline pathogenic mutation rate and elucidate the clinicopathological characteristics of germline pathogenic mutation carriers. Results:Among Chinese high-to very-high-risk non-metastatic prostate cancer patients, 7.2% (18/249) had germline pathogenic mutations. Patients with mutations had a significantly higher proportion of first-degree relatives with a history of malignancy than those without mutations (50% vs. 13%, P<0.001), but there was no difference in age of onset [(68.2±9.3)years vs. (66.6±9.2) years], PSA level (median: 40.68 ng/ml vs. 28.00 ng/ml), T stage [T 3-4: 38.9%(7/18)vs. 39.4%(91/231)] and ISUP grade [group 4-5: 88.9%(16/18) vs. 78.8%(182/231)]. Germline pathogenic mutations were observed in BRCA2 (7 patients, 38.9%), MSH2 (3 patients, 16.7%), PALB2 (2 patients, 11.1%), ATM (2 patients, 11.1%), RAD51C (1 patient, 5.6%), PMS2 (1 patient, 5.6%), MSH6 (1 patient, 5.6%) and HOXB13 (1 patient, 5.6%). By comparing with normal controls of East-Asian population, germline pathogenic mutations in BRCA2 ( OR=11.1, 95% CI 4.8-25.6, P<0.001) and MSH2 ( OR= 43.5, 95% CI 8.5-200.0, P<0.001) can significantly increase the risk of developing high- to very-high-risk prostate cancer in Chinese males. Conclusions:This study identified a germline pathogenic mutation rate of 7.2% in 249 Chinese patients with high- or very-high-risk non-metastatic prostate cancer. Carrying germline BRCA2 or MSH2 pathogenic mutations can significantly increase the risk of high- or very-high-risk prostate cancer in Chinese men.

Caution in cytoreductive radical prostatectomy for metastatic prostate cancer / 中华泌尿外科杂志

A number of retrospective studies suggested that patients with metastatic prostate cancer can benefit from cytoreductive radical prostatectomy. However, high-level evidence is still lack, and the efficacy and patients' characteristics who will benefit from the treatment are not clear. It should be carried out with caution in clinical practice.

The progress of novel androgen receptor inhibitors for non-metastatic castration-resistant prostate cancer / 中华泌尿外科杂志

Prostate cancer is one of the most common cancers threatening the health of males. The incidence of prostate cancer in China is on the rise. Non-metastatic castration-resistant stage is a special disease stage during the progression of prostate cancer, early identification of nmCRPC and prompt intervention can help delay disease progression and prolong patient survival. In recent years, many studies demonstrated the efficacy of novel androgen receptor inhibitors such as apalutamide, in prolonging metastasis-free survival and time to symptomatic progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). This article reviews the recent progress of novel androgen receptor inhibitors for nmCRPC.

A multicenter comparative study of limited and extended pelvic lymph node dissection for high-risk prostate cancer patients / 中华泌尿外科杂志

Objective:To compare the pathological results and complications of limited and extended pelvic lymph node dissection among high-risk prostate cancer patients, and to explore the risk factors that affect the rate of lymph node metastasis in high-risk prostate cancer patients.Methods:The data of 800 high-risk prostate cancer patients who underwent radical prostatectomy and pelvic lymph node dissection from January 2016 to December 2020 in three affiliated hospital of Sun Yat-sen University were analyzed retrospectively. According to the scope of pelvic lymph node dissection, they were divided into limited pelvic lymph node dissection (LPLND) group and extended pelvic lymph node dissection (EPLND) group. There were 172 patients underwent LPLND, and 628 patients underwent EPLND.The age of the patients in the LPLND group was 67 (62, 72) years old, diagnosed PSA 20.7 (10.9, 54.8) ng/ml. The biopsy Gleason score 6 in 22 cases, 7 in 59 cases, 8 in 56 cases and 9-10 in 35 cases.The clinical T stage: T 1 in 29 cases, T 2 in 102 cases, T 3 in 37 cases, T 4 in 4 cases; N 0 in 160 cases and N 1 in 12 cases. 50 patients received neoadjuvant hormonal therapy. The age of patients in the EPLND group was 67 (63, 72) years old, diagnosed PSA was 23.9 (14.0, 46.8) ng/ml. Biopsy Gleason Score 6 in 51 cases, 7 in 194 cases, 8 in 218 cases and 9-10 in 165 cases. Clinical T stage: T 1 in 114 cases, T 2 in 341 cases, T 3 in 144 cases, T 4 in 29 cases; N 0 in 526 cases and N 1 in 102 cases.158 patients received neoadjuvant hormonal therapy. There were no significant differences in the age, PSA, puncture Gleason score, clinical T stage, and whether or not to receive neoadjuvant hormonal therapy between the two groups of patients ( P>0.05). The difference in clinical N staging was statistically significant ( P=0.002). The number of postoperative lymph nodes, positive pelvic lymph nodes and postoperative complications and other related clinical and pathological data of the two groups were analyzed. Multivariate logistic regression was used to analyze the risk factors of patients with positive lymph nodes. Results:The median number of lymph nodes harvested [13(8, 19)vs. 6(4, 13), P<0.001] and the rate of positive lymph node cases[31.2%(196/628) vs. 10.5%(18/172), P<0.001] in the EPLND group was significantly higher than those in the LPLND group. Preoperative PSA, clinical N staging, Gleason score, and way of lymph node dissection were independent risk factors for postoperative positive pelvic lymph node in high-risk prostate cancer patients. Compared with the LPLND group, the ELPND group had a higher postoperative complication rate [19.9%(125/628) vs. 11.0%(11/172), P=0.007]. Conclusions:Compared with the LPLND, EPLND in high-risk prostate cancer patients can harvest more lymph nodes and increase the detection rate of positive lymph nodes. The complications of EPLND were higher than those of LPLND. Preoperative PSA, clinical N stage, Gleason score, and the way of lymph node dissection are independent risk factors for positive pelvic lymph node dissection.

Prognostic factors of salvage radiotherapy after radical prostatectomy / 中华泌尿外科杂志

Objective:To investigate the prognosis after salvage radiotherapy with or without hormone therapy for prostate cancer.Methods:From May 2014 to December 2020, 248 patients undergoing salvage radiotherapy due to prostate-specific antigen (PSA)persistence or biochemical progression after radical prostatectomy at Sun Yat-sen University Cancer Center (n=157) and West China Hospital, Sichuan University (n=91) were analyzed. Median age was 66 (45-78) years old. Median PSA was 23.50 (0.18-845.00) ng/ml. The number of PSA persistence and biochemical progression were 143 (59%) and 105 (42%). The number of pT 2, pT 3a, pT 3b, pT 4, and unknown T stage was 99, 49, 78, 15 and 7 cases.The number of N 0, N 1 and unknown N stage was 153, 44 and 51 cases. 165 cases had positive surgical margin. Gleason score of 6, 7, 8, >8 score and unknown was in 12, 104, 34, 90 and 8 patients. Early and late salvage radiotherapy was performed in 117 and 131 patients, and 70 patients (28%) were CRPC. Hormone therapy was used combined with radiotherapy in 182 patients (73%). PSA decline after radiotherapy was compared with Chi-squre test. Kaplan-Meier method and log-rank test were used to compare progression free-survival (PFS)after radiotherapy. Univariate and multivariate analyses of PFS were performed using Cox proportional hazards model. Early salvage radiotherapy was defined as PSA≤0.5 ng/ml before radiotherapy, and late salvage radiotherapy was defined as PSA>0.5ng/ml. Results:PSA response (PSA decline ≥50%) rate was 94% (233/248), and 82% (203/248) patients had PSA decline ≥ 90%. Twelve (5%) patients had rising PSA after completing radiotherapy, but only 4 (2%) had real progression. The median PFS was 69 months (95% CI 68-70), and 3-year and 5-year PFS rate were 80% and 67%. PFS of PSA persistence and biochemical progression were similar ( HR =0.71, 95% CI 0.37-1.37, P=0.311). Compared with late salvage radiotherapy, early salvage radiotherapy had better PFS [69 (95% CI 68-70) vs. 59 (95% CI 44-74) months, P<0.001]. Compared with hormone sensitive, castration-resistant was associated with worse PFS (5-year PFS rate 74% vs. 51%, P<0.001). In multivariate analysis, Gleason score>8, castration-resistant and late salvage radiotherapy were unfavorable prognostic factors. Conclusions:In patients receiving salvage radiotherapy with or without hormone therapy for PSA persistence and biochemical progression after radical prostatectomy, high PSA level before radiotherapy and castration resistant is associated with poor prognosis.

Impact of low level viremia on the antiviral effect of human immunodeficiency virus/acquired immunodeficiency syndrome patients received anti-retroviral therapy / 中华传染病杂志

Objective:To investigate the impact of low level viremia (LLV) on the prognosis of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients received anti-retroviral therapy (ART).Methods:From January to December 2015, the HIV/AIDS patients with LLV received ART over one year were recruited in Guangzhou Eighth People′s Hospital, Guangzhou Medical University (LLV group). Patients with viral load (VL) less than 50 copies/mL were matched at ratio of 1∶1 according to gender, age and the transmission route were included in the control group (suppression group). The LLV group was divided into three subgroups according to VL (LLV-1 subgroup was 50-200 copies/mL, LLV-2 subgroup was 201-400 copies/mL, and LLV-3 subgroup was 401-1 000 copies/mL). The influence of LLV on the antiviral response during the following three years was investigated.The Wilcoxon signed rank test, Kruskal-Wallis test and chi-square test were used for statistical analysis.Results:One hundred and thirty-seven patients were enrolled in the LLV group, of whom 111 were males and 26 were females, with age of (39.5±13.5) years old. At the same time, 137 patients were included in the suppression group. There were 93 cases in LLV-1 subgroup, 25 cases in LLV-2 subgroup and 19 cases in LLV-3 subgroup. There were no significant differences in the CD4 + T lymphocyte counts and CD4 + /CD8 + T lymphocyte counts ratios between LLV group and suppression group before ART (both P>0.05). During the three-year follow-up, the cumulative number of viral failures in LLV group (7.3%(10/137)) was significantly higher than that in the suppression group (1.5%(2/137)) ( χ2=5.578, P=0.018). Virological failure occurred in eight patients (8.6%) in the LLV-1 subgroup, two patients (8.0%) in the LLV-2 subgroup, and no patients in the LLV-3 subgroup. There was no statistical significance in the incidence of virological failure among all the subgroups ( P>0.05). At one, two, three years follow-up, the CD4 + T lymphocyte counts increased in both LLV group and suppression group without statistical differences (all P>0.05), and the CD4 + /CD8 + T lymphocyte counts ratios in each LLV group were lower than that in the suppression group ( Z=-3.183, -2.094 and -2.312, respectively, all P<0.05). At one, two, three years follow-up, There were no significant differences in CD4 + /CD8 + T lymphocyte counts ratios among the LLV-1, LLV-2 and LLV-3 subgroups (all P>0.05). Conclusion:HIV/AIDS patients with LLV having received ART over one year are more likely to develop virological failure and delay the recovery of immune function, which requires early relevant interventions.

Comparison of ARIMAX and multivariate LSTM model in predicting daily death toll in Yancheng City / 公共卫生与预防医学

Objective To compare the effects of Autoregressive Integrated Moving Average model-X (ARIMAX) and multivariate Long Short Term Memory Network (multivariate LSTM) in the prediction of daily total death toll in Yancheng City. Methods Based on total death toll data, meteorological data and air quality data from January 1st, 2014 to June 30th,2017 in Yancheng City, Jiangsu province, ARIMAX model and multivariate LSTM model were established to predict the daily total death toll from July 1st,2017 to July 14th,2017. RMSE, MAE and MAPE were used as evaluation indexes to compare the prediction effects of these two models. Results RMSE, MAE and MAPE of ARIMAX model and multivariate LSTM model were 20.742、15.094、9.921 and 47.182、35.863、19.633, respectively. Conclusion ARIMAX model is better than multivariate LSTM model to predict the daily death toll in Yancheng city.

Suggestion of novel hormone therapy for metastatic prostate cancer / 中华泌尿外科杂志

Several phase Ⅲ clinical trials have confirmed that androgen deprivation therapy combined with novel hormone therapy can prolong the survival of patients with metastatic prostate cancer. It has become a commonly used scheme in clinical practice. The physical condition, concomitant diseases and economic status of patients, side effects, accessibility, costs and approved indications of drugs should also be considered when selecting the novel hormone therapy drugs for these patients. The sequential use of novel hormone therapy drugs and the conversion of corticosteroids benefit some patients, which can be selected carefully.

A time-series study on the impact of air pollution on the death of permanent residents in Yancheng City / 公共卫生与预防医学

Objective To investigate the effects of air pollution on non-accidental death of residents in Yancheng City. Methods Data of daily air pollutions (PM2.5, PM10, NO2, SO2 and O3), average temperature, average relative humidity, and daily death information during 2014-2019 were collected. The time series semi parametric generalized additive model was used to analyze the impact of short-term exposure of air pollutants on non-accidental death in Yancheng City. Results The average daily non-accidental deaths of the entire population, respiratory system, and circulatory system were 154, 25, and 51, respectively. With the increase of 10 µg/m3 SO2, the risk of the estimated non-accidental death and respiratory death was increased by 1.19% (95%CI: 0.26%-2.12%) and 2.37% (95%CI: 0.65%-4.12 %), respectively. With the increase of 10 µ g/m3 NO2, the risk of the estimated non-accidental death, circulatory system death and respiratory death was increased by 1.50%（95%CI:0.94%-2.05%）, 1.11%（95%CI:0.08%-2.16%）, and 1.53%（95%CI:0.71%-2.36%）, respectively. With the increase of 10 µg/m3 O3, the risk of the estimated non-accidental death, circulatory system death and respiratory death was increased by 0.64%（95%CI: 0.25%-1.04%）, 0.81%（95%CI: 0.04%-1.58%）, and 0.78%（95%CI: 0.18%-1.37%）, respectively. Conclusion The short-term exposure of air pollutants affects the non-accidental death of the residents in Yancheng, and there are lag effects, of which NO2, SO2 and O3 have a greater impact.

Switch from prednisone to dexamethasone in metastatic castration-resistant prostate cancer patients progressing on abiraterone plus prednisone / 中华泌尿外科杂志

Objective:To evaluate the efficacy and safety of switch from prednisone (AA+ P) to dexamethasone (AA+ D) in metastatic castration-resistant prostate cancer patients (mCRPC) progressing on abiraterone plus prednisone.Methods:Between November 2016 and December 2019, 46 mCRPC patients were switched to AA+ D after progression on AA+ P at Sun Yet-sen University Cancer center. Median age was 72 years(50 to 89 years), with median androgen deprivation therapy (ADT) duration 14.6 months(2.1 to 168.5 months). PSA level at the time of diagnosis, the initiation of AA+ P treatment, the time of switch were 258.9 ng/ml, 56.6 ng/ml, 25.1 ng/ml, respectively. 42 (91.3%), 12(26.1%), 7(15.2%) patients had bone metastasis, lymph node metastasis, visceral metastasis, respectively. 28 patients had Gleason score ≥8, and 11 patients had Gleason score<8. The primary endpoint was progression free-survival (PFS). Secondary endpoints included PSA response rate of PSA decline ≥50% and ≥30% and safety. Patients were divided into different risk level groups according to PSA level at the time of switch and PFS on AA+ P.Results:The median follow-up of 46 patients was 4.9 months, 40 patients progressed at the last follow-up, the treatment was terminated in 1 patient because of cerebral infarction, 5 patients were still on the treatment of AA+ D. Median PFS on AA+ D of 46 patients was 3.7 (1.6-24.1) months. A total of 12 (26.1%) patients showed a PSA decline≥50% after treatment with AA+ D, and 21 (45.7%) patients showed a PSA decline ≥30%. The median PFS was 8.5 (2.7-24.1) and 3.0 (1.6-17.8) months for patients with PSA decline≥50% and PSA didn’t decline ≥50%, respectively. Four factors below were significantly associated with a longer PFS on AA+ D after steroid switch in univariate analysis: lower PSA level at the time of switch (<30 ng/ml, HR=0.30, 95% CI 0.14-0.64, P=0.002), longer ADT sensitivity duration (≥18 months, HR=0.55, 95% CI 0.28-1.06, P=0.045), longer AA+ P treatment PFS (≥8 months, HR=0.36, 95% CI 0.18-0.72, P=0.004), and greater PSA decline on AA+ D (≥50%, HR=0.30, 95% CI 0.17-0.75, P=0.007). The above mentioned factors were also independent prognostic factors associated with better PFS on AA+ D after steroid switch in multivariate analysis. Treatment with AA+ D was well tolerated in all patients, with no grade 3/4 toxicity reported. Conclusions:Switching from prednisone to dexamethasone is effective and safe in mCRPC patients progressing on abiraterone plus prednisone. Patients with lower PSA level at the time of switch, longer ADT sensitivity duration, longer AA+ P treatment PFS and greater PSA decline on AA+ D might gain better efficacy.

The update interpretation of 2020 EAU prostate cancer guideline(Part Ⅳ) / 中华泌尿外科杂志

Adjuvant therapy is the supplemental treatment to radical prostatectomy (RP) aiming to decrease the risk of relapse, including adjuvant androgen deprivation therapy, adjuvant radiation therapy (ART) and adjuvant chemotherapy. The 2020 version of the EAU guideline updated with a new RCT of ART to emphasize the importance of ART in high-risk patients, and to recommend that RT should be given to the pelvic lymphatics and the prostatic fossa for the pN 1 patients.

Construction of primary prostate cancer cell bank using conditional reprogramming cell technology / 中华泌尿外科杂志

Objective:To cultivate human-derived prostate cancer (PCa) cells via conditional reprogramming cell (CRC) technology, and establish individualized cell bank for PCa research in vitro.Methods:We obtained three fresh PCa tissue samples from different patients between January 2019 and April 2019. Then each sample was divided into two parts. One was used for cancer nature confirmation by intraoperative biopsy. Another part was sent to the laboratory and digested into single primary cancer cells with 0.25% EDTA enzyme for CRC technology. The details were described as followed: 1. The primary PCa cells were co-cultured with 3T3-J2 cells irradiated by 30 Gy (feeder cells) in conditioned medium, and observed for the growth of cell clones, 2. The feeder cells were removed by 0.25% EDTA trypsin for 1 minute before primary PCa cells digested for passage. All primary PCa cells were validated by multiple experiments such as immunofluorescence, immunohistochemistry, immunoblotting and fluorescence in situ hybridization (FISH).Results:Total three cases of human-derived PCa cell lines were successfully established during 15days through CRC technology. All those primary PCa cells could be steadily and continuously passaged, which also expressed AR, CK5, CK18, P504s and PSA. FISH demonstrated that each cell line harbored≥1.6% TMPRSS2/ERG fusion and conformed to the features of PCa.Conclusion:CRC technology can be used for stable and continuous PCa cell culture in vitro.

Factors predicting 2014 ISUP pathology grade upgrading from prostate biopsy to radical prostatectomy pathology / 中华泌尿外科杂志

Objective To investigate the risk factors predicting pathology grade upgrading after radical prostatectomy using the 2014 International Society of Urologic Pathology (ISUP) grading system.Methods A total of 205 patients who underwent biopsy and radical prostatectomy from January 2017 to December 2018 were reviewed retrospectively.The median and range of the patients' age,PSA level,prostate volume,number of biopsy core examined,Gleason score and ISUP grade were 66 (45-81) years old,17.16(0.89-1254.00)ng/ml,36.4(4.1-152.1) rnl,10(1-15),7(6-10),and 3(1-5) respectively.The patients were divided into group of upgrading ISUP grade and group without upgrading ISUP grade.Multivariate Logistic regression analysis and receiving operating characteristic curve analysis were performed to identify predictors of ISUP upgrading and determine the optimal cut off value respectively.Result The median and range of Gleason score and ISUP grade after radical prostatectomy were 7 (6-10),and 3 (1-5) respectively.The radical prostatectomy ISUP grade upgraded in 73 (35.6％) out of 205 cases when compared with biopsy ISUP grade.Radical prostatectomy ISUP grades were concordant in 91 cases (44.4％) and downgraded in 41 cases(20.0％).Of 101 with biopsy ISUP grades less than or equal to 2,the ISUP grade of radical prostatectomy upgraded in 58 cases (57.4％),while radical prostatectomy ISUP grade upgraded in only 18 (26.9％) of 67 patients with biopsy ISUP grades of 3 or 4.Biopsy ISUP grades represent an independent predictor for ISUP grade upgrading after radical prostatectomy (OR =0.496,P ＜ 0.001).Conclusion Patients with biopsy ISUP grades less than or equal to 2 are at great risk of ISUP grade upgrading after radical prostatectomy.