A randomized,double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design

Objectives: The objective of this paper was to evaluate the efficacy, duration of effect, and tolerability of SHP465 mixed amphetamine salts (MAS) extended-release versus placebo and immediate-release MAS (MAS IR) in adults with attention-deficit/hyperactivity disorder (ADHD).

Methods: Adults with ADHD Rating Scale, Version IV (ADHD-RS-IV) scores ≥24 were randomized to SHP465 MAS (50 or 75 mg), placebo, or 25 mg MAS IR in a double-blind, three-period, crossover study using a simulated adult workplace environment. On the final day of each 7-day treatment period, efficacy was assessed for 16 h postdose. Primary efficacy analyses for Permanent Product Measure of Performance (PERMP) total score averaged across all postdose assessments and each postdose time point were conducted in the intent-to-treat population using a mixed linear model. Secondary end-points included PERMP problems attempted and answered correctly and ADHD-RS-IV scores based on clinician ratings of counselor observations using the Time Segment Rating System and participant self-report. Tolerability assessments included treatment-emergent adverse events (TEAEs) and vital signs.

Results: Least squares mean (95% CI) treatment differences (combined 50/75 mg SHP465 MAS–placebo) significantly favored SHP465 MAS over placebo for PERMP total score averaged across all postdose assessments (18.38 [11.28, 25.47]; P < .0001) and at each postdose assessment (all P < .02). Nominal superiority of MAS IR over placebo for PERMP total score averaged across all postdose assessments was observed (nominal P = .0001); treatment differences between SHP465 MAS and MAS IR were not significant (nominal P = .2443). The two most frequently reported TEAEs associated with SHP465 MAS were insomnia (36.5%) and anorexia (21.2%). Mean increases in pulse and blood pressure with SHP465 MAS exceeded those of placebo.

Conclusions: SHP465 MAS (combined 50/75 mg) significantly improved PERMP total score versus placebo, with superiority observed from 2 to 16 h postdose. The tolerability profile of SHP465 MAS was similar to previous reports of SHP465 MAS in adults with ADHD.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT00928148 identifier is NCT00928148.     

不同容量小水囊用于足月妊娠促宫颈成熟的临床效果分析

目的探讨不同容量小水囊对足月妊娠产妇促宫颈成熟的效果。方法选择2013年1月—2015年1月收治的150例足月妊娠并进行引产产妇,按随机数字表法平均分为3组,每组各50例,30 ml小水囊组(A组)、80ml小水囊组(B组)及150 ml小水囊组(C组)。比较3组产妇引产前后宫颈评分情况、促宫颈成熟效果、产妇分娩结局及新生儿结局。结果 B组产妇促宫颈成熟有效率为96.0%(48/50),C组为98.0%(49/50),均明显高于A组的84.0%(42/50),差异具有统计学意义(χ~2=3.90、4.03,P<0.05);B组及C组产妇的产后Bishop评分明显高于A组,而引产至临产时间及第一产程时间均明显短于A组(P=3.96、3.85、4.05,P<0.05);B组与C组经阴道分娩率分别为90.0%(45/50)及92.0%(46/50),均明显高于A组的54.0%(27/50),比较差异具有统计学意义(χ~2=4.52,P<0.05),而B组与C组比较差异无统计学意义(P>0.05);3组产妇产后出血量、3组新生儿Apgar评分、新生儿体质量比较差异无统计学意义(F=1.24、0.47、0.37,P>0.05),而C组新生儿窒息率、脐带脱垂率明显高于A组及B组,比较差异具有统计学意义(P<0.05)。结论 80 ml小水囊应用于足月妊娠产妇的促宫颈成熟效果好,对产妇及新生儿均不会造成严重不良反应,值得临床推广应用。     

急性基底动脉闭塞早期溶栓的临床预后分析

目的探讨早期静脉溶栓治疗急性基底动脉闭塞(BAO)的疗效及预后。方法回顾性分析2012年1月—2014年2月期间住院部收治的52例行静脉溶栓治疗急性基底动脉闭塞患者的临床资料,分析溶栓效果、临床治疗效果、预后情况,同时探析治疗前神经功能障碍严重程度和溶栓时间窗对预后的影响。结果静脉溶栓治疗后完全再通率为63.46%,溶栓后NIHSS评分(12.55±3.68)分,明显低于治疗前(20.58±2.64)分(t=12.7854,P=0.0000);治愈率为67.31%,6例(11.54%)溶栓后出现脑出血、消化道出血等并发症,无一例死亡;静脉溶栓时间≤180 min者预后良好率82.61%,明显高于静脉溶栓时间>180 min者的预后良好率(44.83%)(χ2=7.7357,P=0.0054);NIHSS评分≤20分者预后良好率为90.91%,明显高于NIHSS评分>20分者预后良好率40.00%(χ2=13.8982,P=0.0002);溶栓后90 d BI指数评分优良率为84.62%。结论静脉溶栓血管再通率较高,能显著改善患者的神经功能,临床治疗效果满意、并发症发生率低,预后良好且显著改善患者的生活质量,可作为临床治疗急性基底动脉闭塞的首选方案。     

Safety,Pharmacokinetics, and Pharmacodynamics of ME-401, an Oral,Potent, and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ, Following Single Ascending Dose Administration to Healthy Volunteers

Purpose

ME-401 is a novel selective inhibitor of phosphatidylinositol 3 kinase p110δ, an enzyme often found overexpressed and overactive in B-cell malignancies. The current study was performed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending oral doses of ME-401 in healthy volunteers.

王会仍教授自拟“王氏止咳方”治疗慢性咳嗽的临床疗效观察

目的:观察"王氏止咳方"治疗慢性咳嗽的临床效果。方法:在呼吸内科门诊选择124例诊断为慢性咳嗽的患者,随机分为对照组和观察组,每组62例。对照组用西药常规治疗,观察组口服"王氏止咳方"加减治疗,观察两组的临床疗效。结果:经治疗后对照组总有效率为70.97%,观察组总有效率为91.94%,观察组总有效率明显优于对照组(P0.05)。结论:"王氏止咳方"加减治疗慢性咳嗽疗效明显,且无不良反应,值得临床推广应用。     

Sensitivity of the SCI-FI/AT in Individuals With Traumatic Spinal Cord Injury

Objective

To examine the ability of the Spinal Cord Injury-Functional Index/Assistive Technology (SCI-FI/AT) measure to detect change in persons with spinal cord injury (SCI).

应用循证护理对缓解期精神分裂症患者负性心理干预疗效观察

目的:应用循证护理对缓解期精神病患者的不良心理干预疗效观察。方法:选择83例住院精神分裂症康复期患者,随机分为观察组和对照组。对照组患者实施常规康复期心理护理,观察组患者在此基础上加用循证护理。两组患者干预前后进行抑郁自评量表(SDS)、焦虑自评量表(SAS)、UCLA孤独量表测定,所有数据用SPSS 10.0统计软件进行处理,用t检验比较两组患者干预前后的疗效。结果:两组患者的SDS、SAS、UCLA孤独量表等各项主要因子有显著差异(P<0.01或P<0.05),而对照组则变化不大(P>0.05),干预组患者的疗效显著。结论:循证护理对缓解期精神病患者的不良心理干预有较好的治疗作用。     

中西医治疗婴幼儿腹泻病47例疗效观察

目的：观察婴幼儿腹泻病中西医结合治疗的临床疗效。方法我院2011年1月—2012年12月收治98例腹泻病患儿,随机分为西医组和中西结合2组,均以液体疗法为基础,西医组配合止泻、抗病毒、助消化药物治疗,中西结合组配以推拿捏脊、艾灸神阙穴、中药穴位外敷治疗,对2组的治疗结果进行对比分析。结果患儿住院3 d~8 d,平均4.5 d,均痊愈出院。2组治疗48 h内的总有效率比较差异有统计学意义（P<0.05）。结论以液体疗法为基础,配以推拿捏脊、艾灸神阙穴、中药穴位外敷治疗婴幼儿腹泻,疗效优于西药治疗。     

股骨近端解剖型锁定接骨板治疗股骨转子间骨折的临床观察

目的：探讨股骨近端解剖型锁定接骨板治疗股骨转子间骨折的临床效果。方法38例转子间骨折患者采用切开复位,应用AO研制的股骨近端解剖型锁定接骨板内固定治疗。从骨折的临床愈合时间,术后髋关节功能恢复程度,术后并发症方面分析临床疗效。结果患者均获得随访,时间6个月~24个月,术后均未出现切口感染,肺栓塞,延迟愈合,骨不连,内置物断裂,股骨头坏死,股骨干及大转子骨折,髋内翻,骨髓炎等并发症,平均骨折愈合时间3.5个月。髋关节功能评分按Harris评分标准,平均（89.0±8.7）分。结论股骨近端解剖型锁定接骨板具有操作步骤简单,固定稳固,手术时间短,并发症少等优点,适用于转子间骨折的治疗。     

New strategies in achieving antiangiogenic effect: Multiplex inhibitors suppressing compensatory activations of RTKs

Pathological angiogenesis plays a crucial role in malignant neoplasia. Vascular normalization has been confirmed as a promising strategy to promote chemotherapy efficacy. However, compensatory activation of alternative angiogenic receptor tyrosine kinases (RTKs) reduces vascular normalization and induces resistance. Moreover, complexity and heterogeneity of angiogenesis make it difficult to treat with single‐target agents. Accordingly, it has been proposed that multiplex inhibition of RTKs could enhance treatment efficacy and overcome resistance on the basis of the vascular normalization concept. Meanwhile, it is feasible to develop multiplex inhibitors against VEGFR‐2/Tie‐2/EphB4 because of their highly conserved ATP‐binding pockets. These inhibitors possess the properties of not only stabilizing the vascular normalization “time window” but also preventing the occurrence of resistance. This novel strategy has yielded promising results in the discovery of antiangiogenic agents. This review highlights the recent progress on the development of such angiogenesis inhibitors.