Proxalutamide in metastatic castration-resistant prostate cancer: Primary analysis of a multicenter,randomized, open-label,phase 2 trial

We aim to assess the safety and efficacy of proxalutamide, a novel androgen receptor antagonist, for men with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter, randomized, open-label, phase 2 trial. In our study, the enrolled mCRPC patients were randomized to 100, 200 and 300 mg dose groups at 1:1:1. The primary efficacy endpoint was prostate-specific antigen (PSA) response rate. The secondary endpoints included objective response rate (ORR), disease control rate (DCR) and time to PSA and radiographic progression. Safety and pharmacokinetics were also assessed. Finally, there were 108 patients from 17 centers being enrolled. By week 16, there were 13 (35.1%), 12 (36.4%) and 15 (42.9%) patients with confirmed 50% or greater PSA decline in 100 mg (n = 37), 200 mg (n = 33) and 300 mg (n = 35) groups, respectively. Among the 19 patients with target lesions at study entry, three (15.8%) had a partial response and 12 (63.2%) had stable disease. The ORRs of 20.0%, 22.2%, 0% and DCRs of 80.0%, 88.9%, 60.0% were, respectively, achieved in 100, 200 and 300 mg groups. By the maximum follow-up time of 24 weeks, there were 42.6% and 10.2% of cases experiencing PSA progression and radiographic progression, respectively. Overall, adverse events (AEs) were experienced by 94.4% of patients, most of which were mild or moderate. There were 28 patients experiencing ≥grade 3 AEs. The most common AEs were fatigue (17.6%), anemia (14.8%), elevated AST (14.8%) and ALT (13.0%), decreased appetite (13.0%). These findings preliminarily showed the promising antitumor activity of proxalutamide in patients with mCRPC with a manageable safety profile. The proxalutamide dose of 200 mg daily is recommended for future phase 3 trial (Clinical trial registration no. CTR20170177).     

基于SSR标记与化学成分构建十堰地区天师栗核心种质库＊

目的 利用筛选出十堰的天师栗中高多态性SSR位点评价天师栗种质资源的遗传多样性，结合有效药用成分含量，构建十堰地区天师栗核心种质库。方法 收集十堰地区114份天师栗种质资源，以七叶树基因组为参考，采用荧光毛细管电泳筛选出高多态性SSR位点，对天师栗种质资源进行遗传多样性分析。利用HPLC测定不同种质干燥娑罗子中七叶皂苷的含量。采用最小距离逐步聚类取样策略（LDSS），根据遗传多样性保留程度初步筛选出核心种质，并对该核心种质与原始种质的遗传多样性参数进行T检验，选择与原种质差异不显著的核心种质为最佳核心种质。结果 筛选出13对高多态性SSR分子标记，遗传多样性评价结果表明十堰地区天师栗种质资源遗传多样性较高，遗传分化较小，存在着较大的基因流，114份种质资源未分为不同的亚群，周家坝和辽叶居群间具有较近的遗传亲缘关系，且周家坝居群娑罗子中的七叶皂苷A及七叶皂苷B含量普遍较高。最终筛选出的核心种质共23份，占总种质资源的20.17%，其中周家坝12份样本、辽叶6份样本、普龄5份样本。结论 将SSR分子标记与主要有效药用成分结合，采用LDSS取样策略构建十堰地区天师栗种质资源核心种质库的方法具有可行性，能够有效的保存与管理天师栗种质资源，也为当地天师栗品种改良、新品种选育研究等提供了研究基础。     

临床护理教师胜任力现状及与护生的评价比较

目的 调查临床护理教师胜任力水平及影响因素，为提高临床护理教学质量提供参考。方法 采用临床护理教师胜任力问卷、学习动机量表对重庆市11所三级医院的749名临床护理教师及458名实习护生进行调查。结果 临床护理教师胜任力自评均分为4.38±0.49,护生评价均分为4.12±0.65,护生评价总分及6个维度得分显著低于教师自评(均P<0.01);护龄、职务和学习动机是临床护理教师胜任力的影响因素(均P<0.01)。结论 临床护理教师胜任力处于较好水平，但护生评价低于教师自评；护理管理者可通过激发教师的学习动机进一步培养和提升临床护理教师的胜任力。     

Temporal Trends of Women Enrollment in Major Cardiovascular Randomized Clinical Trials

Background

Although it is known that women do not participate in trials as frequently as men, there are limited recent data examining how women recruitment has changed over time.

加速康复外科在日间病房内镜逆行胰胆管造影治疗胆总管结石中的应用

目的探讨加速康复外科（ERAS）在日间病房内镜逆行胰胆管造影（ERCP）治疗胆总管结石（CBDS）中的安全性、有效性。 方法回顾性分析2015年4月至2018年4月新疆医科大学第一附属医院肝胆包虫科接受ERCP术治疗的CBDS患者211例。其中在2015年4月至2016年3月间接受传统治疗的患者85例，设为传统治疗组；2016年4月至2018年4月间接受ERAS日间治疗的126例，设为ERAS日间组。分析比较两组患者围手术期及随访情况。 结果ERAS日间组患者的首次进食时间、下床活动时间显著早于传统治疗组（P<0.05），平均术后住院时间、医疗费用、口渴/饥饿感、术后恶心呕吐（PONV）发生率、腹胀腹痛发生率及术后3、12 h血清淀粉酶水平明显低于传统治疗组（P<0.05）；ERAS日间组患者满意度评分为（96.66±3.39）分，显著高于传统治疗组的（90.25±4.87）分（t=10.54，P<0.05），术后疼痛评分显著低于传统治疗组（z=-5.12，P<0.05）。两组患者无一例30 d内再入院，术后并发症发生率、白细胞计数比较，差异无统计学意义。 结论在ERAS模式下行日间ERCP治疗CBDS是安全可行的，可加快患者康复，减轻术后疼痛，提高患者满意度。