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Edward J. Holland Walter O. Whitley Kenneth Sall Stephen S. Lane Aparna Raychaudhuri Steven Y. Zhang 《Current medical research and opinion》2016,32(10):1759-1765
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. 相似文献
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Sierra Holland 《Sociology of health & illness》2019,41(1):52-66
Medical interactions around reproduction are increasingly extending beyond the physician's office and onto the Internet, where negotiation with medical authority occurs in complex and dynamic ways. Recently, scholars have noted the Internet's potential for creating spaces where women can dialogue with and reconstruct medical authority, yet this growing body of work is overwhelming heteronormative. This paper thus interrogates how lesbian women use the Internet to challenge, deploy, and rework medical authority around reproduction while navigating the transition to parenthood. I draw from 17 online journals authored by lesbian couples during the conception, pregnancy, and birth of their first child, each spanning between 18 months and 2 years, in order to understand how the transition process unfolds over time. I argue that lesbian couples engage with medical authority when seeking affirmation and normalisation yet discard and publicly reject the heteronormative assumptions that accompany reproductive medicine. Further, they chart a new process that I term ‘constructing queer mother‐knowledge’, in which they critique and balance knowledges from institutionalised medicine, their own bodies, and their queer communities. With this new concept, I complicate understandings of lesbian mothers‐to‐be and their interactions with medical authority as they build subversive families. 相似文献
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P E Santos E Piontelli Y R Shea M L Galluzzo S M Holland M E Zelazko S D Rosenzweig 《Medical mycology》2006,44(8):749-753
Infections due to Penicillium species other than P.marneffei are rare. We identified a boy with X-linked chronic granulomatous disease (X-CGD) with a pulmonary nodule and adjacent rib osteomyelitis caused by Penicillium piceum. The only sign of infection was an elevated sedimentation rate. P. piceum was isolated by fine needle aspirate and from excised infected tissues. Surgical removal and one year of voriconazole treatment were very well tolerated and led to complete recovery. Microbiological, microscopic and molecular studies support the fungal diagnosis. P. piceum should be considered as a relevant pathogen in immunocompromised patients. 相似文献
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Stanley J. Bigos John Holland Carole Holland John S. Webster Michele Battie Judith A. Malmgren 《The spine journal》2009,9(2):147-168
Background contextBack problems (BPs), with their cost and disability, are a substantial burden for individuals, employers, and society.PurposeThis systematic review of controlled trials evaluates the effectiveness of interventions to prevent BP episodes in working age adults.Data sourcesWe searched MEDLINE/EMBASE through May 2007, and COCHRANE/Trials Registry through August 22, 2008 using search terms of back pain, back injuries or sciatica, linked to prevention, control, workplace interventions, or ergonomics and searched article bibliographies.Study selectionFor systematic review inclusion, articles had to describe prospective controlled trials of interventions to prevent BPs in working-age adults, with intervention assignment either to individual participants or preexisting groups. Of 185 articles identified as potentially relevant, 20 trials (11%) met inclusion criteria.Data extractionResearchers extracted relevant information from controlled trials and graded methodological quality. Because of heterogeneity of trials, meta-analysis was not performed.ResultsOnly exercise was found effective for preventing self-reported BPs in seven of eight trials (effect size 0.39 to >0.69). Other interventions were not found to reduce either incidence or severity of BP episodes compared with controls. Negative trials included five trials of education, four of lumbar supports, two of shoe inserts, and four of reduced lifting programs.ConclusionsTwenty high-quality controlled trials found strong, consistent evidence to guide prevention of BP episodes in working-age adults. Trials found exercise interventions effective and other interventions not effective, including stress management, shoe inserts, back supports, ergonomic/back education, and reduced lifting programs. The varied successful exercise approaches suggest possible benefits beyond their intended physiologic goals.Level of evidenceSystematic review Level I evidence. 相似文献
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