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 detect the levels of tumor necrosis factor-α (TNF-α) and interleukin 10 (IL-10) in the plasma of patients with ulcerative colitis (UC); To investigate the clinical efficacy ofBaitouweng Decoction for UC and its influence on intestinal mucosal healing and partial mechanism.Methods Totally 66 patients with UC were randomly assigned to the treatment group and the control group. Patients in the treatment group were treated with Baitouweng Decoction (oral and enema treatment) and those in the control group took Mesalazine for 4 weeks. Before and after treatment, the therapeutic effects were assessed by Mayo scoring system and the grading of activities was evaluated by Baron Endoscope. Serum levels of TNF-α and IL-10 were detected by ELISA. Besides, another 20 healthy volunteers were recruited as the healthy control group for comparison.Results The endoscopic remission rate was 51.4% (19/35) in treatment group, higher than that of the control group (25.8%, 8/31,P0.05). Serum levels of TNF-α were obviously positive correlated with Mayo score, Baron score and histology score (r=0.836, 0.735, 0.527,P<0.01). Serum levels of IL-10 were obviously negative correlated with Mayo score, Baron score and histology score (r=-0.704, -0.695, -0.509,P<0.01). Compared with pre-treatment, the serum levels of TNF-α significantly decreased (P<0.01), while the serum levels of IL-10 significantly increased (P<0.01) after treatment withBaitouweng Decoction.ConclusionBaitouweng Decoction (oral and enema treatment) is effective and safe in patients with UC. Its effects might be involved in regulating the imbalance of pro-inflammatory factors and anti-inflammatory factors, and promoting mucosal healing.
ABSTRACT
Objective To evaluate the clinical effect and safety of transurethral enucleation of prostate with the bipolar plasma kinetic technique(PKEP)in the treatment of benign prostate hyperplasia (BPH)more than 80 mL.Methods The data from the 116 patients who underwent the PKEP were analyzed retrospectively.The clinical parameters include operation time,blood loss, postoperative catheter retention time,postoperative complication rates,the differences of the clinical parameters pre-and postopera-tively were compared,include maximum urine flow rate(Qmax),residual urine(RU),international prostate symptoms score(IPSS), and quality of life(QOL).Results Mean operation time was (87.46±25.01)min,Mean blood loss was (129.15±44.35)mL.Mean resected tissue weight was (77.67±19.56)g.No patient had the transurethral resection syndrome(TURS),All cases were followed up for 3 to 6 months,the clinical parameters pre-and postoperatively was respectively:Qmax(6.04±2.37)mL/s vs.(17.85±2.55) mL/s;RU(116.25±53.18)mL vs.(8.85±7.66)mL;IPSS(25.06±4.23)vs.(5.90± 1.91);QOL(4.85 ±0.65)vs.(1.71± 0.54).Conclusion The transurethral enucleation of prostate with the bipolar PKEP resects the proliferated prostate cleanly,had lesser bleeding and complication rates,had advantages of high safety,and satisfactory efficacy for the treatment of BPH more than 80 mL.
ABSTRACT
Objective To observe the effectiveness and mechanism of Xiaoyao San (Xiaoyao Powder for Soothing Liver and Relieving Depression) in improving depression-like behavior of rats. Methods Male Wistar rats were randomized into normal group, model group, Xiaoyao San (1.9 g·kg-1·d-1) group, and fluoxetine (2 mg·kg-1·d-1) group. The rats were exposed to chronic unpredictable mild stress ( CUMS) to induce rat depression-like behavior. Field test was performed for the observation of effect of Xiaoyao San on rat depression-like behavior, Luminex liquid chip system was applied to detect the serum cytokines, and the amount and size of rat hepatic sinusoidal endothelial window were examined under electron microscope, and hepatic indoleamine 2, 3-dioxygenase ( IDO) and tryptophan 2, 3 -dioxygenaes ( TDO) expression levels were detected by immunohistochemical and Western blot methods. Results Xiaoyao San showed obvious effect on increasing sugar water consumption, the number of crossing the blocks and erection frequency in rats, decreasing serum levels of tumor necrosis factor alpha ( TNF-α) and interleukin 6 ( IL-6) , increasing the amount of hepatic sinusoidal endothelial window, promoting hepatic sinusoidal endothelial vascularization, and reducing TDO and IDO expression ( P<0.05 or P<0.01). Conclusion Xiaoyao San exerts obvious effect on improving rat depression-like behaviors, and the mechanism is probably related with the decrease of inflammatory factors, inhibition of IDO pathway, and improvement of hepatic sinusoidal endothelial function.
ABSTRACT
Objective To identify the role of survivin gene in colorectal carcinogenesis.Methods Using immunohistochemical method,expression of survivin gene were detected in colorectal mucosal tissues.Results Expression rates of survivin in four tissues were 62.5%,17.2%,0 and 0.there were significant differences between them(P0.05).Conclusion Survivin may play an important role in onset and progression of colorectal cancer.
ABSTRACT
To observe the therapeutic effect of Naohuandan Capsule (mainly composed of Radix Ginseng, Radix Rehmanniae Preparata,etc.) in treating mild and moderate cases of vascular dementia (VD).Forty five cases of VD, which are subjected to the diagnostic standard of American Association of Psychiatry (DSM Ⅳ), were randomly allocated to two groups for a 3-month treatment course. Group A (n=22) was treated with Naohuandan Capsule and Group B (n=23) with Naofukang Tablet. Therapeutic effect was evaluated by scoring of mini-mental state examination (MMSE) and activity of daily living (ADL) and serum levels of estradiol (E 2) and testosterone (T) were also observed.Scores of MMSE and ADL were increased, E 2 and T levels were elevated and the ratio of E 2/T was decreased in Group A(P0 05). [Conclusion]Naohuandan Capsule has a definite effect in preventing and treating VD and its mechanism may be related to the increase of E 2 and T levels, decrease of E 2/T ratio and the regulation of neuroendocrine function.