RESUMEN
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.
Asunto(s)
Humanos , Masculino , Antineoplásicos Hormonales/uso terapéutico , Pueblos del Este de Asia , Hormona Liberadora de Gonadotropina/agonistas , Goserelina/uso terapéutico , Antígeno Prostático Específico , Neoplasias de la Próstata/tratamiento farmacológico , TestosteronaRESUMEN
Objective:To explore nursing experimental teaching mode on the basis of simulation technology to improve learning effect.Method:s A total of 374 nursing students of Grade 2012 to 2014 were selected as the experimental group, and 292 nursing students of Grade 2010 to 2011 were selected as the control group. The experimental group adopted the comprehensive experimental teaching based on simulation technology, while the control group used traditional teaching. At the end of the course, the experimental group students were surveyed, and the two groups of students were given a unified examination. Data analyses were performed using SPSS 17.0 and the t-test was adopted to analyze the teaching effect for comparison of the two groups.Result:s The recovery rate of the questionnaires in the experimental group was 100%, and the satisfaction rate was 95%. Behavioral performance self-evaluation showed that students had high self-evaluation in improving their independent learning ability (3.47±0.63), and low self-esteem in caring for the patient's psychological problems (2.62±0.68). The theoretical score of the experimental group was (77.03±2.55), and the theoretical score of the control group was (71.75±3.49). The difference was statistically significant ( P=0.041). Conclusion:The comprehensive nursing experiment project on the basis of simulation technology is conducive to promoting students' autonomous learning and improving their comprehensive quality and professional ability.
RESUMEN
Objective To test the teaching ability, teaching efficacy, teaching quality and its correlated factors of teaching quality in part-time nursing teachers. Methods The questionnaire survey were used in 201 part-time nursing teachers, and the factors influencing teaching quality were tested. Results The total scores in teaching ability were (75.43 ± 11.68) points, (110.45 ± 16.73) points for teaching efficacy, (105.38±12.17) points for teaching quality. There were moderate correlated relationships among these variables. The factors influencing teaching quality included over 5 years in teaching time, teaching training, teaching ability and teaching efficacy by multivariable regression analysis, these variables accounted for 62.0% variance. There were higher coefficients (?=0.61, 0.45) in teaching ability and efficacy. Conclusions The following measures should be performed for part-time nursing teachers, such as teaching training and supervision, in order to improve clinical teaching quality.
RESUMEN
Objective To compare the effect of 89Sr radionuclide therapy and radiotherapy in the treatment of metastatic cancer pain of vertebral column. Methods 80 patients with cancer pain of vertebral metastasis in the second People's hospital of Yibin from April 2015 to April 2017, were randomly divided into the control group treated by radiotherapy treatment (n=40) and the the observation group treated by 89Sr radionuclide therapy(n=40), and the effect of treatment were compared between two groups. Results In the observation group, the total effective rate of pain response in patients with metastatic cancer pain of vertebral column was 85.0%, and the control group was 82.5%. There was no significant difference between two groups. The onset time of treatment in the observation group was (6.5±1.7)d, significantly shorter than that of the control group (12.9±2.6)d, and the difference was statistically significance (P<0.05). Conclusion The application of 89Sr radionuclide therapy in the treatment of vertebral metastatic pain is equivalent to the radiotherapy in improving the pain response, but the efficacy could be achieved in a short period of time, so it is worth popularizing widely in clinical practice.
RESUMEN
Bifidohacterium is an inherent intestinal microflora. It is anaerobic, nonpathogenic and bad-less. Researches have demonstrated that bifidohacterium can inhibit tumor cells growth, induce tumor cells apop-tosis and stimulate the immunocytes secreting cytokines. Because it can selectively localizes and proliferates in solid tumors,it can be used as a delivery system for tumor-targeting enzyme-prodrug in geoe therapy. In vivo studies show that bifidobacterium is an ideal biologic agent which can be used to treat tumor without toxicity.