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。     

2型糖尿病患者基础胰岛素剂量自我调整方案的随访管理

目的评价2型糖尿病患者基础胰岛素剂量自我调整方案的随访管理效果。方法将849例2型糖尿病患者按住院时间分为对照组(423例)和观察组(426例)。对照组采用由医生门诊调整胰岛素剂量的常规方案,观察组由糖尿病专科护士依据医生制定的血糖调整方案卡对患者自我调整胰岛素剂量进行全程随访管理。干预12周后比较两组血糖指标、糖尿病知识水平、授权能力、自我管理能力。结果观察组血糖控制水平显著优于对照组(P0.05),两组低血糖发生率差异无统计学意义(P0.05);观察组糖尿病知识水平、授权能力、自我管理能力显著优于对照组(P0.05,P0.01)。结论糖尿病专科护士对患者自我调整基础胰岛素剂量进行全程随访管理在血糖控制方面安全有效,且能提高患者自我管理能力和授权能力。     

肝脏CT动态增强扫描非刚性对位减影技术的质量评价

目的利用血管减影前后的吻合程度，探讨非刚性对位减影技术在肝脏CT动态增强检查中的质量评价。 方法收集2018年12月至2019年2月于中山大学附属第一医院行肝脏CT动态增强检查的50例患者资料，使用非刚性对位减影技术获得减影图像，对减影前后的图像质量进行评价，定性评价包括图像伪影情况及解剖错配程度，定量评价测量各血管（腹主动脉、肝右动脉、肝左动脉、门静脉主干、门静脉右支、门静脉左支）减影前后在动脉晚期、门静脉晚期的CT值。采用混合线性效应模型及拟合方程评估减影前后各血管的CT值曲线拟合程度。 结果减影后图像均无明显解剖结构错配导致的伪影，3名测量者一致性较高（ICC=0.844，P<0.001）。减影技术一定程度上会降低各血管的CT值，与强化分期不存在交互作用。无论是在动脉晚期还是门静脉晚期，减影前后各血管CT值走势一致，CT值变化曲线吻合。 结论非刚性对位减影技术可轻松实现肝脏CT动态增强检查的图像减影，并获得良好的图像质量。     

机器人辅助ALPPS手术治疗右肝巨块型肝癌

正【内容简介】ALPPS全称为联合肝脏离断和门静脉结扎的二步肝切除术,一期手术离断或分割肝实质,结扎门静脉分支;二期手术彻底离断病肝并取出。此术式主要针对因肝脏肿瘤占位过大、常规切除会导致剩余肝脏体积(FLR)不够且需要行扩大肝切除术的肝脏恶性肿瘤而采用的手术方法。其目的为通过一期手术促进健侧肝脏增生,从而为二期手术施行根治性切除创造有利条件。该视频病例采用机器人辅助进行一期手术,开腹     

高危原发前列腺胃肠道外间质瘤诊疗体会及文献复习

目的探讨前列腺原发胃肠道外间质瘤诊治要点。 方法回顾性分析我院2017年9月诊治的1例高危原发性前列腺胃肠道外间质瘤临床病理特征资料、随访情况，总结现有文献讨论总结本病诊治心得。 结果65岁男性，因"前列腺电切术后2年，反复血尿3个月余"入院。术前MRI考虑为来源不清的盆腔巨大实性占位（115 mm×105 mm×85 mm），经直肠穿刺诊断为梭形细胞来源的肿瘤。行盆腔肿瘤切除+膀胱前列腺腺切除+盆腔淋巴结清扫术+Bricker术。术后病理提示为前列腺原发胃肠道外间质瘤[CD117（+）；Dog1（+）；CD34（+）；PSA（+）；AR（+）；P504s（+）；Ki-67（2%）]。术后肿瘤组织全外显子测序提示为C-Kit基因（Exon 11 p.Q556-V560del）存在明显临床意义突变，筛选靶向药物甲磺酸伊马替尼+比卡鲁胺（PSA平稳后停用）口服，术后随访18个月无肿瘤复发及不良并发症。 结论前列腺原发胃肠道外间质瘤罕见，需与前列腺其他良恶性肿瘤相鉴别诊断。全外显子测序了解其发病高危基因，同时筛选药物辅助治疗可使患者生存获益。     

两种保留自主神经D3根治术治疗中低位直肠癌的安全性及生存质量比较

目的比较腹腔镜保留自主神经D3根治术与开腹术治疗中低位直肠癌的安全性及生存质量差异。 方法回顾性分析2015年6月至2017年8月间84例低位直肠癌患者资料，根据手术方式不同分为腹腔镜组(n＝46)和开腹组(n＝38)，应用SPSS21.0软件完成数据分析。手术相关指标采用( ±s)表示，独立样本t检验；并发症发生率、复发率及生存率等指标采用χ²检验；P<0.05为差异有统计学意义。 结果腹腔镜组患者的手术时间长于开腹组(P<0.05)，而术中出血量、住院时间、尿管保留时间、肛门排气时间均短于开腹组(均P<0.05)。腹腔镜组术后并发症总发生率为6.5%低于开腹组的26.3%(χ²＝4.6517，P<0.05)。两组患者1年局部复发率及生存率差异均无统计学意义(均P>0.05)。腹腔镜组患者术后10 d排尿功能、术后2个月勃起功能、术后2个月射精功能均优于开腹组(均P<0.05)。 结论腹腔镜保留自主神经D3根治术治疗中低位直肠癌安全性较高，复发率及生存率与开腹术相当，并能显著提高患者的生存质量，值得推广应用。     

Derivation and Validation of a Model to Predict 30-Day Readmission in Surgical Patients Discharged to Skilled Nursing Facility

ObjectivesTo identify factors associated with 30-day all-cause readmission rates in surgical patients discharged to skilled nursing facilities (SNFs), and derive and validate a risk score.DesignRetrospective cohort.Setting and participantsPatients admitted to 1 tertiary hospital's surgical services between January 1, 2011, and December 31, 2014 and subsequently discharged to 110 SNFs within a 25-mile radius of the hospital. The first 2 years were used for the derivation set and the last 2 for validation.MethodsData were collected on 30-day all cause readmissions, patient demographics, procedure and surgical service, comorbidities, laboratory tests, and prior health care utilization. Multivariate regression was used to identify risk factors for readmission.ResultsDuring the study period, 2405 surgical patients were discharged to 110 SNFs, and 519 (21.6%) of these patients experienced readmission within 30 days. In a multivariable regression model, hospital length of stay [odds ratio (OR) per day: 1.03, 95% confidence interval (CI) 1.02-1.04], number of hospitalizations in past year (OR 1.24 per hospitalization, 95% CI 1.18-1.31), nonelective surgery (OR 1.33, 95% CI 1.18-1.65), low-risk service (orthopedic/spine service) (OR 0.32, 95% CI 0.25-0.42), and intermediate-risk service (cardiothoracic surgery/urology/gynecology/ear, nose, throat) (OR 0.69, 95% CI 0.53-0.88) were associated with all-cause readmissions. The model had a C index of 0.71 in the validation set. Using the following risk score [0.8 × (hospital length of stay) + 7 × (number of hospitalizations in past year) +10 for nonelective surgery, +36 for high-risk surgery, and +20 for intermediate-risk surgery], a score of >40 identified patients at high risk of 30-day readmission (35.8% vs 12.6%, P < .001).Conclusions/ImplicationsAmong surgical patients discharged to an SNF, a simple risk score with 4 parameters can accurately predict the risk of 30-day readmission.