Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials

Objective: Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED).

Research design and methods: Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed.

Main outcome measures: Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0–4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0–4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0–100).

Results: Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05–0.65; p?=?0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10–0.38; p?=?0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35–24.33; nominal p?=?0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51–16.70; p?<?0.0001).

Limitations: Trials were conducted over 12 weeks; efficacy beyond this period was not assessed.

Conclusions: Across three trials, lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.     

Improved Diagnostic Sensitivity of Bowel Disease of Prematurity on Contrast-Enhanced Ultrasound

Bowel diseases of prematurity, including necrotizing enterocolitis, are dreaded ailments of neonates. Early diagnosis is difficult, with clinical and radiographic findings often inconclusive. We present a novel use of contrast-enhanced ultrasound in detection of pediatric bowel disease. Early identification of compromised blood flow or an at-risk bowel can be quantitatively detected and monitored. This ability has implications for guidance of emerging therapies, allowing targeting of inflammation. These findings represent an advancement in detection of bowel disease in neonates.     

甲磺酸伊马替尼联合VDLD化疗方案治疗急性淋巴细胞白血病患儿的长期随访研究

目的探究甲磺酸伊马替尼联合VDLD化疗方案治疗急性淋巴细胞白血病(ALL)患儿的应用价值。方法选取2015年5月~2018年6月收治的74例ALL患儿,按照治疗方案不同分组。对照组(37例)实施VDLD方案治疗,联合组(37例)实施甲磺酸伊马替尼+VDLD化疗方案治疗。对比两组疗效、不良反应发生率、随访1年无复发生存率(RFS)及治疗前、治疗2个疗程后血清B淋巴细胞刺激因子(BAFF)、增殖诱导配体(APRIL)水平。结果联合组总有效率(91.89%)高于对照组(72.97%)(P<0.05);联合组治疗2个疗程后血清BAFF、APRIL水平低于对照组(P<0.05);两组不良反应发生率、随访1年RFS对比无显著差异(P>0.05)。结论甲磺酸伊马替尼联合VDLD化疗方案治疗ALL,疗效确切,能显著降低血清BAFF、APRIL水平,且安全性高。     

支气管哮喘急性发作期气道炎症表型与中医辨证分型的关系

支气管哮喘是由多种细胞和细胞组分参与的气道慢性炎症性疾病,其气道炎症反应的复杂性,给临床诊断和治疗带来了困难[1]。2009年全球哮喘防治倡议(GINA)第一次提出“表型”这一概念,并提出基于表型分类有助于哮喘治疗及判断预后[2]。中医药治疗哮喘有其独特优势,但辨证分型缺乏明确统一的客观化、量化指标。     

护士分层级管理对急性肝炎患者护理满意度的影响

目的分析护士分层级管理的实施对急性肝炎患者护理满意度的影响。方法该院自2018年3月起实施护士分层级管理,以该院10名肝病科护理人员为研究对象,其中2017年3月—2018年2月实施前(对照组)及2018年3月—2019年2月实施后(研究组)的管理效果。结果与对照组比较,研究组患者的病房管理、患者护理、文书书写、基础护理、入院宣教方面的护理质量评分均明显升高(P<0.05);与对照组82.29%的护理总满意率比较,研究组护理总满意率显著升高,达到了97.92%(P<0.05);与对照组工作自我满意度比较,研究组患者的自我价值体现等方面的工作自我满意度评分均明显升高(P<0.05)。结论护士分层级管理策略的实施,有效提高了急性肝炎患者护理满意度,提升了科室护理质量。     

心达康滴丸联合地尔硫卓治疗冠心病心绞痛的临床研究

目的探讨心达康滴丸联合盐酸地尔硫卓片治疗冠心病心绞痛的临床疗效。方法选择2018年7月—2019年7月在武汉市江夏区中医医院治疗的冠心病心绞痛患者94例,根据用药的差别分成对照组(47例)和治疗组(47例)。对照组口服盐酸地尔硫卓片,30mg/次,3次/d;治疗组在对照组基础上口服心达康滴丸,18粒/次,3次/d。两组患者均经4周治疗。观察两组患者临床疗效,同时比较治疗前后两组患者心绞痛发作次数和持续时间,临床症状积分、SAQ和GQOLI-74评分,血清C反应蛋白(CRP)、S100钙结合蛋白A12(S100A12)、白细胞介素-18(IL-18)、妊娠相关血清蛋白A(PAPP-A)、内皮素-1(ET-1)和肌钙蛋白I(CTnI)水平及心功能。结果治疗后,对照组和治疗组临床有效率分别为80.85%和97.87%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者心绞痛发作次数及持续时间都显著改善降低(P0.05),且治疗组比对照组改善更显著(P0.05)。治疗后,两组患者SAQ积分和GQOLI-74评分均明显升高,而临床症状积分明显降低(P0.05),且治疗组这些评分明显好于对照组(P0.05)。治疗后,两组患者血清CRP、S100A12、IL-18、PAPP-A、ET-1、CTnI水平均明显降低(P0.05),且治疗组明显低于对照组(P0.05)。治疗后,两组患者左心室射血分数(LVEF)和心排血量(CO)均升高,而左室收缩末期内径(LVESD)明显降低(P0.05),且治疗组LVEF、CO和LVESD比对照组改善更明显(P0.05)。结论心达康滴丸联合盐酸地尔硫卓片治疗冠心病心绞痛可明显改善患者临床症状,改善生活质量,具有一定的临床推广应用价值。     

甲状腺手术患者围术期优质护理干预效果探讨

目的观察分析在甲状腺手术患者护理中予以围术期优质护理干预的应用价值。方法此研究从本院甲状腺手术患者中选取样本,总例数为80例,研究时间始于2017年4月,止于2019年4月,依据护理方案的异同对患者进行分组,试验组予以围术期优质护理干预,对照组予以常规性护理干预,对比两组护理结果。结果研究可得,试验组护理满意率相对较高,组间数据对比得知与对照组相比统计值合理(P<0.05)。研究可得,试验组并发症发生率相对较低,组建数据对比得知与对照组相比统计值合理(P<0.05);研究可得,试验组预后生活质量相对较高,组建数据对比得知与对照组相比统计值合理(P<0.05)。结论此研究得知,在甲状腺手术患者护理中予以围术期优质护理干预,能提高患者护理效果,降低其并发症发生情况,并进一步改善患者预后效果。     

Pharmacotherapeutic strategies for critical asthma syndrome: a look at the state of the art

ABSTRACT

Introduction

‘Critical Asthma Syndrome’ (CAS) is an umbrella term proposed to include several forms of asthma, responsible for acute and life-threatening exacerbations. CAS requires urgent and adequate supportive and pharmacological treatments to prevent serious outcomes.     

Metastatic disease of the breast and local recurrence

Multimodality primary therapies for breast cancer combined with earlier detection have led to a sharp decline in the death rate from breast cancer in the UK over the last 40 years in the face of a rising incidence. The latest UK statistics from Cancer Research UK report 55,122 new cases of breast cancer in 2015 with 11,563 deaths from breast cancer recorded in 2016. Crudely, this equates to a cure rate of around 80% for all comers and demonstrates a clear improvement in outcome with 50,285 new cases in 2011 and 11,716 deaths in 2012. Despite this good news, there are still significant numbers of women (and men) who suffer from either a local recurrence or metastatic disease following apparently successful treatment for early breast cancer (Stage I to III). Only a minority of individuals, 6.6% with the stage recorded at diagnosis, present with stage IV disease. This review considers the treatment options available to individuals with locally recurrent and advanced breast cancer (ABC).