Objective To evaluate the functional and oncological outcomes of patients with locally advanced prostate cancer (PCa) treated by hormone therapy combined with extra-fascia1 laparoscopic radical prostatectomy (LRP) plus extended lymph node dissection (ePLND).Methods From January 2004 to June 2016,a total of 255 PCa cases (pT3-4NxM0) who received LRP plus ePLND were enrolled into our study.The mean age of the patients was 67 (range 44-88) years,and median PSA level was 21.2 (range 0.6-454.0) ng/ml.The patients were divided into earlier group (from January 2004 to December 2011,160 cases) and later group (from January 2012 to June 2016,95 cases) according to different treatment periods.The baseline demographics between the two groups were similar.All patients routinely received adjuvant hormone therapy (AHT) postoperatively.The patients in the later group underwent collapsin response mediator protein 4 (CRMP4) methylation study on the prostatic biopsy preoperatively.Those with a CRMP4 methylation level ＞ 15％ or rectum/bladder neck invasion,were treated by neoadjuvant hormone therapy (NHT) for 3-6 months.Positive surgical margin (PSM),progression-free survival (PFS),cancer-specific survival (CSS),overall survival (OS) and postoperative continence rates between the two groups were analyzed and compared.Results The mean operative time of the earlier and later group were (239 ±65) min and (203±51) min,mean blood loss were (109-±65) ml and (96-±44) ml,mean dissected nodes were (19 ± 5) and (21 ± 7),respectively (all P ＞ 0.05).The total PSM rate was 19.2％,and PSM rates of the two groups were 23.1％ and 12.6％ (P =0.04).All the 255 cases received AHT and 25 cases in the later group underwent NHT.The median follow-up time was 73 months (range 10-152 months).The total 5-year PFS,CSS and OS rates were 77.7％,94.3％ and 87.1％,respectively,and the rates between groups were 73.8％ vs.86.1％ (P=0.03),93.1％ vs.98.6％ (P=0.07),and 85.0％ vs.92.8％ (P =0.11),respectively.The 1-year postoperative continence rates were 91.9％ vs.97.9％ (P =0.09).Conclusions Hormone therapy combined with LRP plus ePLND represents an oncological and functional effective option in patients with locally advanced PCa,and improved PFS might be acquired by preoperative tumor staging.

Objective To compare the efficacy of extended pelvic lymph node dissection (ePLND)and oncological outcome by fluorescence laparoscopic radical prostatectomy (FLRP) versus high-definition laparoscopic radical prostatectomy (HD-LRP) for men with locally advanced prostate cancer (LAPCa).Methods In a prospective trial,we recruited 51 patients with T3a-bNxM0 prostate cancer from July 2015 to April 2018.Patients were assigned to study group or control group according to random number method,and were underwent either FLRP + ePLND or HD-LRP + ePLND.21 in the study group were injected with 5 mg of indocyanine green (ICG) into the bilateral lobes of the prostate transperineally guiled by transrectal ultrasound 30 min before surgery for lymphography.During the surgical procedure a fluorescence laparoscope,optimized for detection in the near infrared range,was used to visualize the lymph nodes (green fluorescent) in the dissection region in the study group while a common laparoscopy introduced in control one.Lymph nodes were removed in the external iliac vessiles,internal iliac artery,obturator fossa regions,common iliac regions and presacral regions in both groups.Radical prostatectomy was completed in the both groups by similar steps.The operation time,blood loss,number of removed lymph nodes and positive lymph nodes,complication rate,biochemical recurrence (BCR) and metastasis free survival rates in 2 years were recorded and compared in the two groups.Results 51 eligible patients were selected,including 21 in the study group and 30 in the control group.The mean age of biopsy of study group and control one were (66.4 ± 7.7) and (66.8 ± 7.4),the mean age PSA (23.5 ± 16.8) ng/ml and (26.0 ± 20.1) ng/ml,the mean Gleason score of biopsy (8.1 ± 1.0) and (7.9 ± 0.9) respectively,and there was no statistical significant difference between two groups.The mean operation time of study group and control one were (45.9 ± 4.6) min and (56.4 ± 3.2) min,the mean removed lymph nodes were (27.7 ± 5.6) and (22.1 ±5.6) respectively,and there was statistical significant difference between two groups (all P ＜ 0.05).Lymph nodes invasion in pathology were reported in 8 cases(38.1％)in the study groups while 9 (30.0 ％) in the control one;the proportion of positive lymph node (metastasis) were 3.2％ (19/583) and 3.4％ (23/663) in the two groups respectively and no statistically significant difference was noted between the two groups.Lymphorrhagia occurred in 4 cases in the control group,and there was no serious complications in both groups.The median follow-up time was 20 (7-33) month and during this time,BCR observed of 1 (4.7％) in the study group and 8 (26.7％) in the control;meanwhile,the MFSR was recorded of 100.0％ (0)in the study group and 86.7％ (4)in the control one,showing a statistically significant difference between the two groups(P =0.04).Conclusions Comparing with LRP,FLRP achieved better results of LN dissection,which will improve oncological outcomes.

To establish and validate the design space of the Digeda-4 flavored decoction( DGD-4D) extraction process by using the quality by design( Qb D) concept. With DGD-4D decoction pieces as a model drug,with the transfer rate of aesculin,picroside I,picroside Ⅱ,geniposide and the yield of extract as critical quality attributes( CQAs),the single factor experiment design was used to determine the level of each factor; the Plackett-Burman experiment design was used to select the critical process parameters( CPPs);and the Box-Behnken experiment design was used to optimize the extraction process. The design space of the DGD-4D extraction process was established,and finally,four experimental points were selected to verify the established model. The single factor experiment determined the levels of each factor,including soaking time 60 min and 30 min,water adding volume 12 times and 8 times,extraction time 90 min and 30 min,number of extraction times 3 times and 1 time,as well as extraction temperature 100 ℃ and 90 ℃.By Plackett-Burman experimental design,the DGD-4D water addition,extraction time and number of extraction times were determined to be CPPs. The Box-Behnken experimental variance analysis showed that P of the regression model was less than 0. 01 and the misstated value was more than 0. 01,indicating that the model had good predictive ability,and the operation space of CPPs in the DGD-4D extraction process was determined as follows: the amount of water addition was 10-12 times; extraction time 50-80 min; and number of extraction times was 3 times. The design space of DGD-4D extraction process based on the concept of Qb D is conducive to improving the stability of product quality and laying a foundation for the future development of DGD-4D.
Chemistry, Pharmaceutical ; methods ; Drugs, Chinese Herbal ; chemistry ; Research Design