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《Value in health》2022,25(1):59-68
ObjectivesWe investigated how health technology assessment (HTA) organizations around the world have handled drug genericization (an allowance for future generic drug entry and subsequent drug price declines) in their guidelines for cost-effectiveness analyses (CEAs). We also analyzed a large sample of published CEAs to examine prevailing practices in the field.MethodsWe reviewed 43 HTA guidelines to determine whether and how they addressed drug genericization in their CEAs. We also selected a sample of 270 US-based CEAs from the Tufts Medical Center’s CEA Registry, restricting the sample to studies on pharmaceuticals published from 1991 to 2019 and to analyses taking a lifetime time horizon. We determined whether each CEA examined genericization (and if so, whether in base case or sensitivity analyses), and how inclusion of genericization influenced the estimated incremental cost-effectiveness ratios.ResultsFourteen (33%) of the 43 HTA guidelines mention genericization for CEAs and 4 (9%) recommend that base case analyses include assumptions about future drug price changes due to genericization. Most published CEAs (95%) do not include assumptions about future generic prices for intervention drugs. Only 2% include such assumptions about comparator drugs. Most studies (72%) conduct sensitivity analyses on drug prices unrelated to genericization.ConclusionsThe omission of assumptions about genericization means that CEAs may misrepresent the long run opportunity costs for drugs. The field needs clearer guidance for when CEAs should account for genericization, and for the inclusion of other price dynamics that might influence a drug’s cost-effectiveness.  相似文献   
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Objective

This paper constitutes the first attempt to draw lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework.

Study Design

Taking the example of new direct-acting antivirals against hepatitis C virus, the paper asks whether and how the cost-effectiveness (CE) opinions issued by the French National Health Authority improve the information available to support the pricing decisions.

Methods

The analysis compares the assessment of these drugs based on three different sources: CE opinions, clinical opinions, and the published cost-utility analyses (CUA) available in the literature and identified through a systematic review.

Results

The results show that CE opinions bring to the fore three issues prone to impact the incremental cost utility ratio and those were not available to the decision maker through clinical opinions or published CUA: the stage of treatment initiation, the modeling of the disease progression, and the uncertainty around the efficacy rates.

Conclusions

France has introduced the criterion of the cost per QALY gained in the pricing and regulation of innovative pharmaceuticals since 2013. Our analysis shows that the use of CUA does enhance the information available to the decision makers on the value of the treatments.  相似文献   
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Previous research reported associations of excessive daytime sleepiness (EDS) with a low vitamin D level, obesity, and sexual maturity. The aim of this study was to identify the association and rank the importance of these with EDS. This study examined 618 children who were 10–12 year-old. The pediatric daytime sleepiness scale (PDSS) was used to evaluate EDS and sleep patterns. EDS was defined as a total PDSS score above 17. We ranked the importance of the relationship of these factors with EDS using random forest analysis. EDS (n = 111, 18%) was positively associated with more advanced pubertal stage in girls, chronic cough, urticaria, and allergic rhinitis. Multivariable analysis with adjustment for confounding indicated that children with low level of 25-hydroxyvitaminD3 (25(OH)D3 (<20 ng/mL) and high-density lipoprotein-cholesterol (HDL-C) (<40 mg/dL) levels had an increased risk of EDS (25(OH)D3:adjusted odds ratio [aOR] = 1.73; 95% confidence interval [CI]: 1.06 to 2.81; P = 0.028; HDL-C: aOR = 2.84; 95% CI: 1.05 to 7.68; P = 0.039). Random forest analysis indicated that 25(OH)D3 level, exercise, and body mass index (BMI) were over three. This study indicated high levels of 25-(OH)D3 and HDL-C and performing regular exercise decreased the risk of EDS.  相似文献   
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ObjectiveTo examine the association between physical activity, screen time, eating habits and daytime sleepiness among Brazilian adolescents.MethodsAdolescents from three high schools (n = 876, 49.8% female, 16.4 ± 1.2 years) participated in this cross-sectional survey. Variables related to lifestyle behaviors (ie, physical activity, screen time, eating habits, sleep duration) were collected through an online questionnaire. Daytime sleepiness was assessed using the Pediatric Daytime Sleepiness Scale (PDSS). Excessive daytime sleepiness was defined as a PDSS score ≥20.ResultsThe average PDSS score was 18.9 (SD ± 4.8) points and 46.8% of adolescents were classified as having excessive daytime sleepiness. Physical activity was inversely associated with PDSS score (β = −0.29, 95% CI -0.47; −0.11). Consuming processed foods frequently (β = 1.16, 95% CI 0.85; 1.47) and using social media (β = 0.22, 95% CI 0.14; 0.30) were positively associated with PDSS score. Similar findings were observed for the odds of excessive daytime sleepiness. Physical activity was inversely associated (OR = 0.91, 95% CI 0.84; 0.99), while frequent consumption of processed foods (OR = 1.55, 95% CI 1.33; 1.82) and using social media (OR = 1.13, 95% CI 1.02; 1.24) were positively associated with excessive daytime sleepiness.ConclusionsLower physical activity level, a higher consumption processed foods, and higher social media use were associated with daytime sleepiness in this sample of Brazilian adolescents.  相似文献   
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ObjectiveTo determine the sleep architecture and sleep respiratory abnormalities and to correlate with sleep symptoms in patients with Myotonic dystrophy type 1 (DM1).MethodsWe recruited a cohort of genetically confirmed patients with DM1, who attended the Neuromuscular clinic between July 2016 and December 2019. Clinical, sleep and whole night polysomnography data were collected. The analysis of sleep architecture, sleep respiratory parameters and comparison with healthy controls (HC) was performed in our sleep laboratory.ResultsA total of 59 patients with DM1 underwent sleep evaluation. Hypersomnolence in 42 (77.8%), ESS>10 in 23 (39%), and PSQI>5 in 18 (30.5%) were found in patients with DM1. Thirty-one (68.89%) patients with DM1 and 22 (95.65%) HC had more than 4-h of total sleep time (TST). More than 4 h of TST was taken to compare respiratory and sleep architecture parameters. Patients with DM1 had reduced sleep efficiency, reduced N2 sleep, and increase in N1 sleep, wake index, stage shift index, nocturnal sleep-onset REM periods compared to HC. AHI>15 was found in 16 (51.61%) DM1 and in 3 HC (13.64%). AHI had positive correlation with BMI, but not with age, ESS or disease progression (MIRS). All DM1 with AHI>15; 8(80%) and 1(33.33%) in AHI5to15, and AHI<5 groups, respectively had hypersomnolence.ConclusionIn this first study on Indian cohort, daytime hypersomnolence, poor nocturnal sleep quality, sleep architecture irregularities are identified to be common in patients with DM1. These abnormalities may be explained by sleep-related breathing disorders that are highly prevalent in these patients.  相似文献   
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ObjectiveSolriamfetol (formerly JZP-110), a dopamine/norepinephrine reuptake inhibitor, is approved in the US to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy (75–150 mg/d) or obstructive sleep apnea (37.5–150 mg/d). In a randomized, double-blind, placebo-controlled trial in participants with narcolepsy, effects of solriamfetol on functional status, health-related quality of life (HRQoL), and work productivity were evaluated.MethodsParticipants with narcolepsy (N = 239) were randomized to solriamfetol 75, 150, or 300 mg, or placebo for 12 weeks. Outcome measures included the Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), 36-Item Short Form Health Survey version 2 (SF-36v2), and Work Productivity and Activity Impairment questionnaire for Specific Health Problem (WPAI:SHP). A mixed-effects model with repeated measures was used for comparisons vs placebo.ResultsAt week 12, solriamfetol increased FOSQ-10 total score, with greatest mean difference from placebo (95% CI) at 300 mg (1.45 [0.31, 2.59]). On SF-36v2, improvements vs placebo were observed in physical component summary scores (300 mg: 2.22 [0.04, 4.41]) and subscales of role physical, general health, and vitality. On WPAI:SHP, solriamfetol 150 mg reduced overall work impairment vs placebo (−15.5 [−29.52, −1.47]), and 150 and 300 mg reduced activity impairment vs placebo (−10.05 [−19.48, −0.62] and −13.49 [−23.19, −3.78], respectively). Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity. Common TEAEs were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety.ConclusionsSolriamfetol improved measures of functional status, HRQoL, and work productivity, particularly at the 150- and 300-mg doses. Most TEAEs were mild to moderate.Trial registrationClinicalTrials.gov identifier NCT02348593, EudraCT number 2014-005487-15.  相似文献   
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