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

Micronutrients (MNs), including vitamins and trace elements, play an indispensable role in human metabolism, immune function and other aspects. Due to the chronic microinflammation and long-term chemoradiotherapy, patients with malignant tumors often suffer from malnutrition, resulting in different degrees of MNs deficiency. In severe cases, MNs deficiency is closely related to the adverse clinical outcomes. Therefore, reasonable MNs supplementation is of great significance in improving the prognosis and quality of life of patients with tumors. Recently, multiple guidelines have made recommendations on the application of MN supplementation in various clinical settings, providing evidence for the standardized MN supplementation in patients with malignant tumors.

Objective To explore the availability and safety of ileal ureter replacement combined with ileal augmentation cystoplasty in treating ureteral stenosis with contracted bladder.Methods From August 2015 to November 2018,three patients who underwent ileal ureter replacement combined with augmentation cystoplasty were treated with ileal ureter replacement combined with augmentation cystoplasty.There were 1 male and 2 females with the age ranging from 34 to 55 years (mean 39 years).Two patients suffered from left ureter stenosis,and one patient had stenosis on the both sides.The length of the ureter stenosis ranged from 6 to 18 cm (mean 9.8 cm).The preoperative bladder capacity ranged from 60 to 150 ml (mean 103.3 ml).In the surgery,part of ileum was used to replace the ureter,and the distal intestine was made into U-shape to enlarge the bladder.Results All operation were completed successfully.The operation time ranged from 220 to 400 min (mean 303.0 min),and the blood loss ranged from 150 to 500 ml (mean 283.3 ml).Laparoscopic surgery was performed in 1 case and open surgery in 2 cases.Three weeks after the surgery,the bladder volume underwent cystography ranged from 300 to 400 ml (mean 360.0 ml).Three months after the surgery,the postvoid residual urine volume ranged from 20 to 50 ml (mean 33.3 ml).Postoperative frequency and urgency of urine were completely relieved in 1 case,alleviated in 2 cases.Flank pain was completely relieved in 1 case,and alleviated in 2 cases postoperatively.The serum creatinine of 2 patients mildly increased after the surgery,while 1 patient remained stable.For complications,1 patient had urinary infection,and 1 patient suffered from metabolic acidosis.Conclusions Ileal ureteral replacement combined with augmentation cystoplasty can be the choice of treatment for long segment ureteral stenosis and enlarge the bladder simultaneously.The postoperative complications and the kidney functions should be regularly followed up.

Objective To explore the feasibility of extracorporeal membrane oxygenation (ECMO) in protecting the donor liver in donation after citizen's death. Methods Clinical data of 16 donors and recipients undergoing liver transplantation using ECMO to protect the donor liver were retrospectively analyzed. The effect of ECMO on different indicators of the donors was evaluated. The liver function and clinical prognosis of the recipients after liver transplantation were observed. Results Compared with the time before ECMO, the heart rate, total bilirubin (TB), alanine transaminase (ALT) and aspartate transaminase (AST) of the donors after ECMO were significantly reduced, whereas the systolic blood pressure, diastolic blood pressure and partial pressure of arterial oxygen (PaO₂) were remarkably increased (all P < 0.05). The liver function of the recipients was properly recovered after liver transplantation, and gradually restored normal at postoperative 7 to 28 d. Postoperative complications occurred in 3 recipients, including delayed liver function recovery in 1 case, biliary tract stenosis in 1 case and portal vein thrombosis in 1 case. Among them, the patient with portal vein thrombosis died after secondary operation, and the other 2 patients were recovered and discharged after symptomatic treatment. Conclusions The hemodynamics, liver function and other indicators of donors from donation after citizen's death are significantly improved after ECMO, and the liver function of the recipients also recover well.

Objective To explore the clinical application of renal replacement therapy in renal transplan-tation from donation after citizen's death(DCD).Methods A total of 41 cases of the patients with renal replace-ment therapy after renal transplantation from DCD from January 2013 to December 2016 were involved,of which 14 cases received peritoneal dialysis,21 intermittent hemodialysis(IHD)and 6 continuous renal replacement ther-apy(CRRT).The therapeutic effect and complications of three renal replacement therapies were retrospectively ana-lyzed. Results After dialysis treatment,the concentration of blood BUN,Crea,and potassium was significantly lower than that before the treatment(P<0.05);the difference of Crea and BUN before and after the treatment in IHD and CRRT group was higher than that in peritoneal dialysis group(P<0.05)but there was no statistically sig-nificant difference between IHD and CRRT group(P > 0. 05). Conclusion The renal replacement after kidney transplantation from DCD should be based on the patient's condition,which is the key to protect their kidneys even to save patients'lives.

Objective: To assess the feasibility of HEAD-US scale in the clinical application of hemophilic arthropathy (HA) and propose an optimized ultrasound scoring system. Methods: From July 2015 to August 2017, 1 035 joints ultrasonographic examinations were performed in 91 patients. Melchiorre, HEAD-US (Hemophilic Early Arthropathy Detection with UltraSound) and HEAD-US-C (HEAD-US in China) scale scores were used respectively to analyze the results. The correlations between three ultrasound scales and Hemophilia Joint Health Scores (HJHS) were evaluated. The sensitivity differences of the above Ultrasonic scoring systems in evaluation of HA were compared. Results: All the 91 patients were male, with median age of 16 (4-55) years old, including 86 cases of hemophilia A and 5 cases hemophilia B. The median (P₂₅, P₇₅) of Melchiorre, HEAD-US and HEAD-US-C scores of 1 035 joints were 2(0,6), 1(0,5) and 2(0,6), respectively, and the correlation coefficients compared with HJHS was 0.747, 0.762 and 0.765 respectively, with statistical significance (P<0.001). The positive rates of Melchiorre, HEAD-US-C and HEAD-US scale score were 63.0% (95%CI 59.7%-65.9%), 59.5% (95%CI 56.5%-62.4%) and 56.6% (95%CI 53.6%-59.6%) respectively, and the difference was statistically significant (P<0.001). Even for 336 cases of asymptomatic joints, the positive rates of Melchiorre, HEAD-US-C and HEAD-US scale score were 25.0% (95%CI 20.6%-29.6%), 17.0% (95%CI 12.6%-21.1%) and 11.9% (95%CI 8.4%-15.7%) respectively, and the difference was statistically significant (P<0.001). There were significant changes (P<0.05) in the ultrasonographic score of HA before and after onset of hemorrhage in 107 joints of 40 patients. The difference in variation amplitude of HEAD-US-C scores and HEAD-US scores before and after joint bleeding was statistically significant (P<0.001). Conclusion Compared with Melchiorre, there were similar good correlations between HEAD-US, HEAD-US-C and HJHS. HEAD-US ultrasound scoring system is quick, convenient and simple to use. The optimized HEAD-US-C scale score is more sensitive than HEAD-US, especially for patients with HA who have subclinical state, which make up for insufficiency of sensitivity in HEAD-US scoring system

Objective: To explore the evaluation of joint injury by HEAD-US-C (Hemophilic Early Arthropathy Detection with UltraSound in China, HEAD-US-C) in patients with moderate or severe hemophilia A treated with prophylaxis vs on-demand. Methods: The patients from June 2015 to July 2017 with moderate or severe hemophilia A were examined by ultrasound imaging of the elbows, knees and ankles; Meanwhile the HEAD-US-C ultrasound assessment scale and hemophilia joint health score scale 2.1 (HJHS2.1) were used to score the joint status. The correlation between the HEAD-US-C and HJHS score was performed in prophylaxis group and on-demand group patients, respectively. Results: A total of 925 cases of joint ultrasonography were conducted in 70 patients with moderate or severe hemophilia A. Among patients with moderate hemophilia, the median (IQR) of HEAD-US-C score and HJHS score in on-demand group were significantly higher than those in the prophylaxis group[1 (0, 6) vs 0.5 (0, 3) , z=0.177, P=0.046],[2 (0, 4) vs 2 (0, 3) z=0.375, P=0.007], even though there was no significant difference of the median (IQR) number of annualized target joints bleeding episodes between on-demand and prophylaxis groups[1 (0, 7) vs 1 (0, 5) , z=1.271, P=0.137]. Unlike in moderate cases, on-demand treatment group had more annualized target joints bleeding episodes than prophylaxis group among patients with severe hemophilia[3 (0, 8) vs 2 (0, 8) , z=0.780 P=0.037]. The prophylaxis group compared favorably with on-demand therapy group in terms of HEAD-US-C score[1 (0, 6) vs 4 (0, 7) , z=2.189, P=0.008], and HJHS score[2 (0, 5) , 4 (1, 6) , z=3646, P<0.001]for the severe hemophilia patients. The positive correlation between HEAD-US-C score and HJHS score was identified (P<0.05) , whether on-demand treatment or prophylaxis groups. The correlation coefficient between HEAD-US-C score and HJHS score in on-demand treatment and prophylaxis groups were 0.739 (95% CI 0.708-0.708) , 0.865 (95% CI 0.848-0.848) respectively, and 95% CI didn’t overlap (P<0.05) , indicating that the correlation coefficient in prophylaxis group had stronger correlation than that in on-demand group. Conclusions Clinical effects of prophylaxis were significantly better than those of on-demand treatment in patients with moderate or se-vere haemophilia A. HEAD-US-C scoring system could effectively evaluate joints damage in hemophilia A patients treated with on-demand or prophylaxis, companied by significantly positive correlation with HJHS clinical evaluation system, and provided objective index for clinical effect assessment.

Objective To evaluate the effect of self-management program in patients with rheumatoid arthritis(RA).Methods Self-management of RA patients was performed using a chronic disease self-management program (CDSMP).The health status,overall function,disease activity index,joint swelling and tenderness,joint pain score were analyzed at 12 and 24 weeks.Results At 12 and 24 weeks,health status,overall function,disease activity index,joint swelling and tenderness,joint pain score showed significant differences in two groups.Conclusion Self-management program may reduce complications,restore joint functions and improve social interactions,and improve quality of life.

Objective To evaluate the effect of self-management program in patients with rheumatoid arthritis(RA).Methods Self-management of RA patients was performed using a chronic disease self-management program (CDSMP).The health status,overall function,disease activity index,joint swelling and tenderness,joint pain score were analyzed at 12 and 24 weeks.Results At 12 and 24 weeks,health status,overall function,disease activity index,joint swelling and tenderness,joint pain score showed significant differences in two groups.Conclusion Self-management program may reduce complications,restore joint functions and improve social interactions,and improve quality of life.

Objective To develop a new botox-like polypeptide with anti-wrinkle and anti-aging functions, which will be used in the field of cosmetics and dermatology. Methods A series of new peptide compounds were synthesized via modifying the structure of SYN-AKE by peptide synthesis technology. Simulating muscle contraction by using co-culture model of human muscle cells and mouse embryonic spinal cord neurons to test the effects. Results Six new synthetic peptides were selected. The results showed that the muscle contraction frequency was lowered by adding C19 H30 N5 O4 compound than adding SYN-AKE in 1 min(P<0.05). Conclusion C19H30N5O4 is expected to become a new cosmetic peptide raw material and dermatology drug in the field of anti-wrinkle and anti-aging.