ABSTRACT
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.
Subject(s)
Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , TestosteroneABSTRACT
Objective:To isolate and identify the phenotype and biological characteristics of human placental microvascular endothelial cells(HPMEC).Methods:The HPMEC were isolated from term placenta and cultured in ECM medium. The morphology of the cells was observed under microscope. The functions of HPMEC were detected by uptake of Dil-Ac-LDL, tube formation and cell proliferation. Western Blot was used to detect the expression of endothelial nitric oxide synthase (eNOS), PROKR1 and PROKR2.Results:The HPMEC isolated from the placenta could expressed eNOS, PROKR1 and PROKR2, and were capable of the functions of Dil-Ac-LDL uptaking, tube formation, cell proliferation.Conclusions:HPMEC can be isolated from the placenta, proliferate effectively in vitro and maintain the characteristics of endothelial cells.
ABSTRACT
Objective To study the clinical value of tamsulosin in prevention of urinary retention after radical hysterectomy.Methods Sixty-six patients after radical hysterectomy were enrolled in this study, and divided into two groups in random.Thirty-three cases in the treatment group were treated with tamsulosin 0.2 mg once every night,3 days before the catheter was drawn.While 33 cases in the control group only with placebo.Catheter keeping days, residual urine volume at first extraction,the rate of urinary retention and urinary tract infection,hospitalization time and drug adverse reaction were compared in two groups.Results Catheter keeping days and hospitalization time were shorter in the treatment group than those in the control group(P< 0.05).The residual urine volume at first extraction was(38.2 ± 5.6) ml in the treatment group and (168.5 ± 11.8) ml in the control group,there was significant difference between two groups (P< 0.05).The rate of urinary retention was 18.2%(6/33) in the treatment group and 36.4%(12/33) in the control group,there was significant difference between two groups (P <0.05).There was no adverse reaction resulted from tamsulosin in the treatment group.Conclusion Tamsulosin is an effective drug which could prevent and treat the urinary retention after radical hysterectomy.