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.     

从新型冠状病毒肺炎的寒疫病机探析清肺排毒汤的组方机制

在《新型冠状病毒肺炎诊疗方案(试行第六版)》中推荐的清肺排毒汤,临床观察疗效显著。笔者拟探讨新型冠状病毒肺炎(COVID-19)的寒疫病机以及清肺排毒汤的方药组成机制,认为该方能疏解表里、通调三焦,具有宣肺行气、透邪解毒、润燥化湿、逐水泻热的功效,切合COVID-19寒、燥、湿的病机特点,且能有效的针对症状进行治疗,应推广全国各地广泛使用以遏制疫情蔓延。     

经方中大黄的配伍在慢性肾脏病治疗中的应用

慢性肾脏病已成为公共健康问题,目前仍缺乏有效药物。经方在慢性肾脏病中被广泛应用,尤其是包含大黄配伍的经方治疗慢性肾脏病疗效显著,对现代医学有重要的指导意义。大黄在经方中运用灵活,配伍精妙,深入分析其理论内涵,对慢性肾脏病的诊断和治疗至关重要。慢性肾脏病的病机复杂,总为本虚标实,标实以瘀血、湿热、浊毒内蕴为主,标实证既是脏腑亏损、功能下降的产物,又阻碍脏腑气化,导致慢性肾脏病缠绵难愈,是慢性肾脏病进展的关键,也是慢性肾脏病治疗的难点。标实不祛则正气难复,脏腑气化难以恢复。大黄味苦性寒,具有逐瘀通经、清热利湿、通腑泄浊的功效,配伍诸药切中慢性肾脏病的病机,既通利二便,给邪以出路,又通利六腑以调整脏腑气化,恢复正常功能。从慢性肾脏病的中医病机入手,分析经方中大黄配伍的理论内涵,以指导大黄配伍在慢性肾脏病临床中的应用。     

银康颗粒剂治疗银屑病252例疗效观察

目的:观察纯中药制剂银康颗粒剂治疗银屑病的,临床疗效及治疗前后患者血粘度的变化。方法:将382例患者随机分为2组,治疗组252例应用银康颗粒剂治疗,对照组130例应用复方青黛胶囊治疗;对治疗组部分病例(212例)治疗前后血粘度指标进行观察。结果:治疗组治愈148例,好转82例,未愈22例,总有效率为91.12％;对照组治愈51例,好转46例,未愈33例,总有效率为74.62％,2组总有效率比较,差异有非常显著性意义(P<0.01)。治疗组患者治疗前后全血粘度差异无显著性意义(P>0.05),血浆粘度差异有显著性意义(P<0.05)。结论:风邪外袭、血虚生风、气滞血瘀是致病的主要原因。治疗应以清热祛风与养血活血并举。     

沙漠燥证初探——沙漠石油工人健康调查和保健研究

调查进入沙漠腹地,在酷热、干燥环境下作业的石油工人所出现的不适症状,提出沙漠燥证的概念。分析其症状发生频率、积分、特殊属性和亲疏关系,引入轻重分证、新宿辨证和特质辨证的方法,分别进行计量辨证。结果显示,沙漠燥证是客观存在的临床证候,沙漠组工人的燥证罹患率、燥证类型构成与非沙漠组有显著差别。从而认为,沙漠燥证具有不同于一般燥证的特异性,它涉及多系统多脏器的生理和病理变化,并与心理、精神障碍有关,应当深入研究,采取积极防治措施。     

西北燥证研究概述

对西北燥证研究通过流行病学调查、临床观察和动物实验而阐明其概念、分布规律、病因病机、证候特点、预后状况，探讨其预防与治疗方法。从异病同治角度探求新疆特高发疾病及亚健康状态的普适性防治策略，为新疆长寿因素研究和中医药民族医药抗衰老研究提供可靠依据和有益借鉴。     

中药治疗原发性胆汁性肝硬化引起的皮肤瘙痒2例

皮肤瘙痒是原发性胆汁性肝硬化临床常见症状之一，通过中医辨证施治，以养血润燥、祛风止痒法，或利湿退黄、祛风止痒法，有一定疗效。并举验案2则佐证。     

从肾论治干燥综合征

总结《黄帝内经》相关理论,认为干燥综合征患者当从肾论治。肾与精血、津液的生成关系密切。干燥综合征的病机有阳虚阳郁,津液不化,官窍失养;或精亏肾燥,故治可辛以润燥;或辛凉解郁;或滋肾填精,养血回津。      

湿热证动物模型造模方法及评价研究＊

湿热证是中医临床常见的一种证候类型，病程缠绵反复，贯穿于众多疾病的发展始终，严重影响人们的生活健康。研究人员通过建立动物模型对疾病展开更深入的探讨，目前湿热证动物模型研究较多，以中医病因病机为原理造模，方法较为成熟，操作性强，重复性好；但存在制备方法单一，制备标准模糊，研究方向和研究领域呈扎堆式发展等不足。本文通过对中国知网（CNKI）、维普（VIP）、万方、PubMed数据库建库以来有关湿热证动物模型的研究文献进行整理和分析，从温病湿热证、脏腑湿热证及病证结合湿热证的角度出发，对湿热证动物模型的制备方法以及现存优缺点进行讨论和分析，以期为湿热证动物模型的优化及临床研究提供新的思路与方法。     

Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator

The objective of the study is to evaluate the acceptability of the intravaginal administration of ovules/suppositories of DHEA (dehydroepiandrosterone, prasterone) for the treatment of vulvovaginal atrophy (VVA) in women with moderate to severe dyspareunia who were administered daily for 12 weeks intravaginal 0.50% (6.5 mg) DHEA or placebo. There were a total of 373 women in the per-protocol population who responded to the questionnaire for both treatment groups. While it was planned that the applicator would be evaluated as suitable if at least 80% of participants have a global score ≤?2 units, 99% and 100% of participants had a score ≤?2 units in the placebo and DHEA groups, respectively, for the global score (mean of 5 questions). When asked about like and dislike the technique of drug administration, 284 comments were positive, while 114 women gave no comment. About 92–94% of women indicated that they were very confident to be able use the applicator successfully in the future. The survey shows a high degree of satisfaction and of confidence to use the applicator successfully in the future.