Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial / 中华医学杂志(英文版)

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.

Nursing care of patients with cardiogenic shock combined with acute respiratory distress syndrome treated by extracorporeal membrane oxygenation and transferred outer-hospital in long distance / 中国实用护理杂志

Objective:To summarize the nursing experience in 2 patients with cardiogenic shock combined with acute respiratory distress syndrome(ARDS) treated by extracorporeal membrane oxygenation (ECMO) and transferred outer-hospital in long distance.Methods:There were many risk factors in this transport: high parameters of ECMO included V-A mode, 100% oxygen, and a flow of oxygen from 6 L/min to 10 L/min. High ventilator parameters included oxygen concentration of 100% and positive end-expiratory pressure of 15-17 cmH 2O(1 cmH 2O=0.098 kPa). Transport distance was up to 196 km. And the transport time was up to 2 h 36 min. In this regard, we carried out adequate preparations before transport and professional cares during transport. The main points were as follows: setted up a professional transport team; prepared adequate power and oxygen supply; reduced the number of interruption of ECMO and ventilator support during transport; provided the reasonable remedial actions when ECMO and ventilator support were interrupted. Results:Two patients arrived at the destination safely.Conclusions:Adequate preparations before transport and professional cares during transport could effectively avoid and respond to the occurrence of adverse events, and it is feasible and safe to patients supported by ECMO for long distance outer-hospital transport.

Effect of occupational exposure on job burnout in nurses / 中华劳动卫生职业病杂志

Objective@#To investigate the effect of occupational exposure on job burnout in nurses, and to analyze the mediating effect of negative emotion between occupational exposure and job burnout and the regulatory effect of supervisor support on occupational exposure and negative emotion.@*Methods@#From September to December, 2015, simple random sampling was used to select 543 nurses from six tertiary hospitals in Zhejiang Province, China. The questionnaires consisted of occupational exposure risk questionnaire, negative emotion questionnaire, supervisor support questionnaire, and job burnout questionnaire.@*Results@#The total score of occupational exposure risk in nurses was 11.43±7.19; the score of emotional exhaustion was 3.19±1.24, the score of low sense of personal accomplishment was 3.02±1.21, and the score of sense of working indifference was 2.24±1.06. There were significant differences in occupational exposure score between nurses with different sexes (t=2.61, P<0.01) and working years (F=4.49, P<0.01) . There were significant differences in the scores of emotional exhaustion and low sense of personal accomplishment in nurses with different sexes (t=5.25, P<0.001) and working years (t=-3.48, P<0.01) . Occupational exposure had positive effects on negative emotion (β=0.41, P<0.05) , emotional exhaustion (β=0.47, P<0.05) , sense of working indifference (β=0.42, P<0.05) , and low sense of personal accomplishment (β=0.17, P<0.05) . Negative emotion had a partial mediating effect between occupational exposure and emotional exhaustion (total effect size 30.5%, P<0.05) and between occupational exposure and sense of working indifference (total effect size 37.1%, P<0.05) . Negative emotion had a complete mediating effect between occupational exposure and low sense of personal accomplishment (β=0.08, P>0.05) . Supervisor support negatively regulate the effects of occupational exposure and negative emotion (F=21.73, P<0.001) .@*Conclusion@#In nurses, occupational exposure has a direct positive effect on job burnout and indirectly influences job burnout via negative emotion. Supervisor support can reduce the negative impact of occupational exposure on negative emotion.

Relationship between benign prostatic hyperplasia and insulin resistance in elderly men of different ages / 中华老年医学杂志

Objective To explore the relationship between insulin resistance (IR) and benign prostatic hyperplasia (BPH) in elderly men of different ages.Methods Totally 100 elderly outpatients with BPH in our hospital from January 2012 to June 2012 were recruited in this study.All patients were divided into 2 groups according to age:60-75 years(n =52) and 76-93 years (n=48).Fasting plasma glucose,fasting insulin (FINS) and prostate specific antigen (PSA) were assayed.Insulin resistance index (IRI) was calculated by using the homeostasis model assessment-insulin resistance (HOMA2-IR) software.The body height,body weight,waist circumference were measured and the body mass index (BMI) was calculated.Prostate volume (PV) was measured by abdominal ultrasound.Clinical data were compared between the two groups.Based on HOMA2-IR,patients were divided into insulin resistant group (IR＞ 1.7) and non insulin resistant group (IR＜ 1.7).Serum PSA,PV and waist circumference were compared between the two groups.Results The waist circumference and PV were significantly larger in insulin resistant group than in non-insulin resistant group [(96.6± 7.2) cm vs.(93.1±8.9) cm,(50.0±9.0) ml vs.(46.1±7.8) ml,respectively,P＜0.01,0.05].However,the PSA level was lower in insulin resistant group than in non-insulin resistant group [(1.44±1.08) μg/L vs.(2.1 ±2.0)μg/L,P＜0.05],and no correlation was found between HOMA-IR and PV.There was no correlation between serum PSA levels and PV in patients aged 76-93 years.In patients aged 60-75 years,PSA level was positively correlated with PV (r =0.52,P＜0.05) and negatively correlated with HOMA-IR (r=0.38,P＜0.05).Conclusions Serum PSA level is positively correlated with PV and negatively correlated with HOMA IR in BPH patients under 75 years old.

Clinical significances of nephron sparing surgery for renal cell carcinoma (report of 17 cases) / 中华泌尿外科杂志

Objective To evaluate the role of nephron sparing surgery in patients with renal cell carcinoma. Methods Retrospectively analyzed a total of 17 patients with renal cell carcinoma treated with nephron sparing surgery between September 1997 and September 2002.Among these patients,2 cases were bilateral asynchronous and multicentric tumor,15 cases were unifocal tumor.2 cases were in imperative indications,6 cases in relative indications,and 9 cases in elective indications.The tumor diameter ranged from 2 cm to 6 cm,all tumor were in T 1 (1997 TNM staging system).15 cases underwent tumor enucleation at 1 cm apart from surgical margin,1 case underwent upper polar nephrectomy,1 case underwent wedged resection.Selected 20 patients matched for age, tumor location and stage who underwent radical nephrectomy at same period for comparison with an average follow-up of 36.4 months. Results The patients were followed up for an average period of 35.2 months (range,3 to 63 months),no surgical complication or local recurrence has been observed,and its long-term cancer-free survival was comparable to that after radical nephrectomy. Conclusions Nephron sparing surgery is safe and effective for the treatment of renal cell carcinoma and indicated for patients with small,localized,often incidental tumors and a normal contra-lateral kidney.