BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective To establish the model of rabbit vena arterialization, so as to investigate the difference of mechanical parameters between arteries and veins as well as before and after arterialization. Methods Twenty-four rabbits were randomly divided into experimental group (n=12) and control group (n=12). By establishing the rabbit vena arterialization model for experimental group, the arterial blood could flow into the veins. After model creation, the vein would be removed 4 weeks after surgery. In the meantime, the external jugular veins and cephalic arteries extracted from control group were acquired. Compressive pressurizing and stretching tests on all vessels were conducted at the same time(including arteries, veins and arterialized veins). Observation was supported by HE staining and immune tissue chemical techniques. Results There were no deaths among the 24 rabbits, with unobstructed blood flow in veins. With the increase of intravascular pressure, the outer diameter of veins changed at first and then stabilized at a fixed value. The elasticity of veins was worse than that of arteries. The external diameter of veins increased rapidly with internal pressure of veins increasing and reached its extreme elasticity. Comparatively, the elasticity of arteries increased slowly. HE staining results showed that thickness of the vascular wall was thinner, while it became thicker after vena arterialization. After vena arterialization, proliferating cell nuclear antigen（PCNA） and α-actin showed positive results. It further proved that proliferation existed among smooth muscle cells, and veins showed the tendency of restenosis again. The elasticity of veins after transplantation into the arterial system was improved compared with that before transplantation. Conclusions Accompanied by the increasing pressure, the vein could reach its elasticity extremity faster than the artery. Under such a long-term high pressure, vein intima was vulnerable. After vena arterialization, with the gradual thickening of vein intima, the tendency of vessel restenosis was obvious, and the elasticity of veins has been improved after transplantation.

Objective To explore the feasibility and safety of visualization puncture combined with flexible ureteroscopy in the treatment of lower calyx stones.Method Visualization puncture combined with flexible ureteroscopy to treat the lower calyx stones was done in our center from January to August 2016 in our hospital.32 cases of patients were enrolled to have a retrospective analysis.There were 18 males and 14 females,aged from 25 to 65 years,with an average age of 43 years.The diameter of stone was 1.0-2.0 cm,with an average of (1.4 ± 0.6) cm.We used general anesthesia and then adjusted the surgery bed to operation side lateral elevation was 30 °-35.Flexible ureteroscopy with 200μm holmium laser was used firstly to break calculi as much as possible.Ultrasound-guided F4.8 visualization puncture system was used to establish F4.8 channel.The power option was 2001μm hohnium laser to crush calculus of the renal calculi to treat the calculus of the distal end of soft lens which still can not be touched by ureteroscopy.Routine nephrostomy tube was not placed.The soft ureter sheath F5 double-J tube,and indwelling balloon catheter were routinely placed.We removed the catheter after 1-2 days and the double J tube after 4 to 6 weeks.Results The flexible ureteroscopy lithotripsy operation time was 8-25 mins in all of the 32 patients.Visualization puncture channels were successfully established in 3-7 mins,and the visualized puncture stone search rate of 100％ (32/32).The success rate of first stage lithotripsy was 93.8％ (30/32).Two cases of lower calyx stones diverticulum diverted to PNCL due to poor visibility by bleeding.The operation time was 30-60 mins and the average of 45 mins.KUB review at day one after the surgery showed that there were residual stones in 5 cases.The stone free rate at one month after the surgery is 100.0％.The average postoperative hospital stay was (2.0 ± 1.5) days.There were uo bleeding,ureteral avulsion and perforation,septic shock,pleural effusion and intestinal injury and other serious complications.Conclusions Navigation ultrasound-guided visualization puncture combined with flexible ureteroscopy is safe and effective to treat lower calyx stones.

Objective To observe the clinical effect of modified laparoscopic adrenalectomy for adrenal pheochromocytoma. Methods 23 patients with adrenal pheochromocytoma were treated with modified posterior laparoscopic adrenalectomy. The changes of blood pressure, heart rate, operation time and blood loss during and after operation were observed. Results 23 patients were successfully operated, the operation time was (62.3 ± 11.7) min, the intraoperative blood loss was (34.4 ± 17.7) ml, there has no hemorrhage occurred while 3 cases were transferred to ICU for intraoperative blood pressure and heart rate fluctuation significantly, and back to general ward after 2 days, while there was no significant difference in blood pressure and heart rate preoperatively. Conclusion Modified laparoscopic adrenalectomy is safe and effective for pheochromocytoma and holds the advantages of clear anatomy, short operative time, less bleeding and less change in blood pressure and heart rate.

Objective To observe the clinical effect of oblique supine lithotomy position rigid single-access percutaneous nephrolithotomy combined with FURS in treatment of complex urinary tract stones. Methods From May 2013 to January 2016, 40 cases of multiple kidney stones and staghorn calculi patients underwent oblique supine lithotomy position balloon establish standard single renal access, using percutaneous percutaneous combind with FURS, clinical data of patients, including operative time, blood loss, stone stone clearance rate, hospitalstay, incidence of complications and other indicators. Results The patients were successfully implemented Phase I single-access surgery, the median time 52.5 min, stone stone clearance rate of 100%, before and after surgery no difference in the amount of bleeding, no blood transfusion patients, followed up for 3 months to six months, no significant concurrent operation disease. Conclusion Oblique supine lithotomy bit single-access percutaneous percutaneous combined with FURS treatment of complex renal calculi can improve stone clearance rate, increased patient comfort during surgery to avoid damage to the kidneys multi-channel, shorter operative time, treatment obvious.

Objective To observe ransurethral flexible ureteroscopey for two-step precise method treatment of parapelvic cyst. Methods From May 2014 to November 2015, 23 patients of parapelvic cyst underwent a ransurethral flexible ureteroscopey for two-step precise method treatment, then analyze the clinical data of patients, observe the therapeutic effect. Results All patients underwent primary surgery successfully while 4 cases among them were confirmed as urine level puncture calyceal diverticulum treated with flexible ureteroscopy diverticulum expand drainage, the other 19 cases were confirmed as renal cyst and treated with cyst incision drainage successfully. The hemoglobin before and after surgery showed no changes. With no blood transfusion, the average postoperative hospitalization time was 2 d. 1 day after surgery, KUB was to locate the DJ tube position; 1 month later, ultrasound or CT check show that the cyst volume was significantly reduced, postoperative follow-up range from 6 months to 1 year. All the patients had no long-term complications. Conclusion Ransurethral flexible ureteroscopey for two-step precise method treatment of parapelvic cyst and renal pelvis lamp beside diverticulum provide a clear direction for the next operation. It's simple operation with no significant complications and recovered quickly, which is an ideal method for the treatment of renal pelvic.

Objective To investigate the clinical efficacy and safety of visual standard channel combined with visual ultrafine channel PCNL precision puncture in treatment of complex renal calculi. Methods From June 2015 to October 2016, 48 cases of complicated renal calculi were treated with multi-channel lithotripsy with visual standard channel ultrasonic pneumatic lithotripsy combined with visual superfine channel PCNL precision puncture holmium laser lithotripsy. Including 10 cases of staghorn stone, 38 cases of multiple renal stones. Results 110 channels were established in 48 patients. 4 cases of preoperative renal insufficiency with infection in the puncture found in the pus and stones load larger, intraoperative diarrhea and PCNL simple treatment of obstruction site stones; 44 cases to complete one of the surgery: There were single channel established in every one of 5 cases, and double channels established in every one of 24 cases, three channels in established in every one of 15 cases; There were two cases of surgery in 8 cases and there were 12 new channels established. The average time of unilateral first operation was 75 (35 ~ 125) min. The first clearance rate was 79.2% (38/48), and the total clearance rate of postoperative stone was 87.5% (42/48). 6 cases of residual stone combined with ESWL and drug row of stone, followed up for 3 months, 6 cases of stone row net, the total stone clearance rate of 100.0% (48/48). Two consecutive postoperative no sepsis, bleeding, ureteral injury and other serious complications. Conclusions Visual standard channel combined with visual superfine channel PCNL precise puncture for the treatment of complex renal calculi is safe and effective, with high fruiting rate and low complication, which can be popularized in clinical practice.

Objective To study of primary colorectal adenocarcinoma histone H2B single prime generalization (uH2B) and its relationship with clinicopathological parameters.Methods Colonic canceRtissue samples and para-carcinoma tissue of gastrointestinal surgery resection of 83 cases were selected from January 2013 to January 2016 in ouRhospital,and normal colon tissue of 20 cases was collected,and uH2B protein expression level in tissue samples was observed using immunohistochemical staining,and its relationship with clinical pathological parameters of patients with primary colonic carcinoma was analyzed.Results The positive expression rate of uH2B protein in colon canceRtissues was 46.99%,which was loweRthan 83.13% of adjacent tissues and 90.00% in normal colon mucosa,the differences were statistically significant (P<0.05);But there was no significant difference in the positive expression of uH2B protein in adjacent tissues and normal colonic mucosa (P>0.05);The positive expression rate of tumoRuH2B protein in colon canceRtissues in the TNM stage was correlation with degree of differentiation and lymph node metastasis (P<0.05),and it had no significant relationship with the patient′s age,gender,tumoRinvasion depth,tumoRsize (P>0.05).Conclusion The decreased expression rate of uH2B protein in colon carcinoma tissue is correlated with the TNM stage,differentiation degree and lymph node metastasis of the patients.

Objective To study of primary colorectal adenocarcinoma histone H2B single prime generalization (uH2B) and its relationship with clinicopathological parameters.Methods Colonic canceRtissue samples and para-carcinoma tissue of gastrointestinal surgery resection of 83 cases were selected from January 2013 to January 2016 in ouRhospital,and normal colon tissue of 20 cases was collected,and uH2B protein expression level in tissue samples was observed using immunohistochemical staining,and its relationship with clinical pathological parameters of patients with primary colonic carcinoma was analyzed.Results The positive expression rate of uH2B protein in colon canceRtissues was 46.99%,which was loweRthan 83.13% of adjacent tissues and 90.00% in normal colon mucosa,the differences were statistically significant (P<0.05);But there was no significant difference in the positive expression of uH2B protein in adjacent tissues and normal colonic mucosa (P>0.05);The positive expression rate of tumoRuH2B protein in colon canceRtissues in the TNM stage was correlation with degree of differentiation and lymph node metastasis (P<0.05),and it had no significant relationship with the patient′s age,gender,tumoRinvasion depth,tumoRsize (P>0.05).Conclusion The decreased expression rate of uH2B protein in colon carcinoma tissue is correlated with the TNM stage,differentiation degree and lymph node metastasis of the patients.

Objective To evaluate the efficacy and safety of tubeless of modular flexible ureteroscope combined with ultramini nephrostomy tract for the treatment of upper ureteral calculi in paediatric patients. Methods 20 cases of children with upper ureteral calculi (age≤7 years old), in our hospital underline of modular flexible ureteroscope combined with ultramini nephrostomy tract lithotripsy, the stones located on the left side in 12 cases, 8 cases on the right. The average age of children in the 4 years (2 to 7 years), the average diameter of stones 1.0 cm (0.7 ~1.5 cm), multiple 9 (including 3 cases of multiple bilateral, 6 cases of unilateral multiple) single stones 11 cases. Ultrasound-guided percutaneous nephrolithotomy establish supermicro channel (F11), application modular and flexible uretero﹣scope holmium laser lithotripsy systems. Results Tubeless of modular flexible ureteroscope combined with ultramini nephrostomy tract calculi Clear Phase 91%(21/23), 2 cases of bilateral stones with phased surgical treatment, surgi﹣cal staging stone clearance rate was 100 % (23/23). Postoperative hemoglobin decline was no significant change. Children do not need a blood transfusion, creatinine, blood urea nitrogen and CRP were no significant differences in change, not placed before and after surgery and renal fistula DJ tube (no tube-based). The mean postoperative hospi﹣tal stay was two days, followed up for 6 months to 1 year, all patients had no long-term complications. Conclusion Tubeless of modular flexible ureteroscope combined with ultramini nephrostomy tract for the treatment of Upper ureteral calculi in paediatric patients is an effective and safety method, can shorten hospital stay.