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11.

Background

Although it is known that women do not participate in trials as frequently as men, there are limited recent data examining how women recruitment has changed over time.

Methods

We conducted MEDLINE search using a validated strategy for randomized trials published in New England Journal of Medicine, Lancet, and Journal of the American Medical Association between 1986 and 2015, and included trials evaluating pharmacologic or nonpharmacologic therapies. We abstracted data on demographics, intervention type, clinical indication, and trial design characteristics, and examined their relationships with women enrollment.

Results

In total, 598 trials met inclusion criteria. Women enrollment increased significantly over time (21% between 1986 and 1990 to 33% between 2011 and 2015; Pfor trend < 0.001) and did not differ by journal or funding source. Women enrollment varied with clinical indication, comprising 37% for non–coronary artery disease vascular trials, 30% for coronary artery disease trials, 28% for heart failure trials, and 28% for arrhythmia trials (P < 0.001), which were all significantly lower than the expected proportion in disease populations (P < 0.001). Women enrollment varied with trial type (31%, 29%, and 26% for pharmacologic, device, and procedural trials, respectively; P = 0.001). These findings were corroborated using multivariable analysis. We found significant positive correlations between women enrolled, and mean age and total number of participants. Fewer women were enrolled in trials reporting statistically significant results than those who did not (P = 0.001).

Conclusions

Although enrollment of women has increased over time, it remains lower than the relative proportion in the disease population. Future studies should elucidate the reasons for persistent under-representation of women in clinical trials.  相似文献   
12.

Background

Total knee arthroplasty is a treatment option for debilitating arthritis. In the postoperative period, patients experience moderate to severe pain affecting the rehabilitation, hospital stay, and patient satisfaction. This study aims at utilizing current best evidence to determine whether adductor canal block (ACB) or periarticular injection (PAI) is a better modality for managing short-term postoperative pain and opioid consumption.

Methods

Embase, MEDLINE, HealthStar, Emcare, and PubMed were searched for randomized controlled trials from 1946 to August 2018, for literature addressing the comparison of ACB and PAI for pain management in the setting of total knee arthroplasty. A systematic review and meta-analysis were performed.

Results

Six studies were included in our meta-analysis. When examining the combined visual analog scale (VAS) pain values for each group, analysis demonstrated greater reduction in scores for the PAI group, and the difference was statistically significant (P = .001). When comparing the VAS scores of subgroups analyzed at specific periods in time, there was a trend toward lower VAS scores in subgroups analyzed at 24 hours and 48 hours postoperatively (at rest and at movement) in the PAI group. Overall opioid consumption was lower in the PAI group, with demonstrated statistical significance (P = .03). When comparing the postoperative subgroups, there was a trend toward decreased opioid use in the PAI group, with 13.25% less opioid use at 48 hours and 9.5% less opioid use at 24 hours.

Conclusion

PAI could significantly improve postoperative pain and opioid consumption when compared with ACB. Additional, high-quality studies are required to further address this topic.  相似文献   
13.

Objective

Phlebolymphedema (chronic venous insufficiency-related lymphedema) is a common and costly condition. Nevertheless, there is a dearth of evidence comparing phlebolymphedema therapeutic interventions. This study sought to examine the medical resource utilization and phlebolymphedema-related cost associated with Flexitouch (FLX; Tactile Medical, Minneapolis, Minn) advanced pneumatic compression devices (APCDs) relative to conservative therapy (CONS) alone, simple pneumatic compression devices (SPCDs), and other APCDs in a representative U.S. population of phlebolymphedema patients.

Methods

This was a longitudinal matched case-control analysis of deidentified private insurance claims. The study used administrative claims data from Blue Health Intelligence for the complete years 2012 through 2016. Patients were continuously enrolled for at least 18 months, diagnosed with phlebolymphedema, and received at least one claim for CONS either alone or in addition to pneumatic compression (SPCDs or APCDs). The main outcomes included direct phlebolymphedema- and sequelae-related medical resource utilization and costs.

Results

After case matching, the study included 86 patients on CONS (87 on FLX), 34 on SPCDs (23 on FLX), and 69 on other APCDs (67 on FLX). Compared with CONS, FLX was associated with 69% lower per patient per year total phlebolymphedema- and sequelae-related costs net of any pneumatic compression device-related costs ($3839 vs $12,253; P = .001). This was driven by 59% fewer mean annual hospitalizations (0.13 vs 0.32; P < .001) corresponding to 82% lower inpatient costs and 55% lower outpatient hospital costs. FLX was also associated with 52% lower outpatient physical therapy and occupational therapy costs and 56% lower other outpatient-related costs. Compared with SPCDs, FLX was associated with 85% lower total costs ($1153 vs $7449; P = .008) driven by 93% lower inpatient costs ($297 vs $4215; P = .002), 84% lower outpatient hospital costs ($368 vs $2347; P = .020), and 85% lower other outpatient-related costs ($353 vs $2313; P = .023). Compared with APCDs, FLX was associated with 53% lower total costs ($3973 vs $8436; P = .032) because of lower outpatient costs and lower rates of cellulitis (22.4% vs 44.9% of patients; P = .02).

Conclusions

This analysis indicates significant benefits attributable to FLX compared with alternative compression therapies that can help reduce the notable economic burden of phlebolymphedema.  相似文献   
14.

Introduction

Physician communication impacts patient outcomes. However, communication skills, especially around difficult conversations, remain suboptimal, and there is no clear way to determine the validity of entrustment decisions. The aims of this study were to 1) describe the development of a simulation-based mastery learning (SBML) curriculum for breaking bad news (BBN) conversation skills and 2) set a defensible minimum passing standard (MPS) to ensure uniform skill acquisition among learners.

Innovation

An SBML BBN curriculum was developed for fourth-year medical students. An assessment tool was created to evaluate the acquisition of skills involved in a BBN conversation. Pilot testing was completed to confirm improvement in skill acquisition and set the MPS.

Outcomes

A BBN assessment tool containing a 15-item checklist and six scaled items was developed. Students' checklist performance improved significantly at post-test compared to baseline (mean 65.33%, SD = 12.09% vs mean 88.67%, SD = 9.45%, P < 0.001). Students were also significantly more likely to have at least a score of 4 (on a five-point scale) for the six scaled questions at post-test. The MPS was set at 80%, requiring a score of 12 items on the checklist and at least 4 of 5 for each scaled item. Using the MPS, 30% of students would require additional training after post-testing.

Comments

We developed a SBML curriculum with a comprehensive assessment of BBN skills and a defensible competency standard. Future efforts will expand the mastery model to larger cohorts and assess the impact of rigorous education on patient care outcomes.  相似文献   
15.

Background

Atypical hemolytic uremic syndrome (aHUS) is a complement-mediated disease manifesting in thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury. It has a higher incidence of extrarenal manifestations, including central nervous system findings like seizure or stroke, pancreatitis, and cardiac manifestations.

Case Report

We present a case of an unimmunized 14-month-old girl presenting with generalized seizure and ultimately diagnosed with aHUS.

Why Should an Emergency Physician Be Aware of This?

These atypical neurological symptoms can cause the diagnosis to be commonly missed in the emergency department. The etiology of approximately 60% of patients with aHUS can be attributed to genetic mutations in complement regulators including factor H, membrane cofactor protein, factor I, activator factor B, or C3. Although previously treated with plasma transfusion and immunosuppressants, eculizumab is a newer treatment that has been changing prognosis and management of aHUS, but it should be administered within 48 h of symptom onset for best efficacy.  相似文献   
16.
Purpose: Beyond promising experimental results of sensory passive stimulations in spatial cognition disorders, some questions still remain regarding interests of these stimulations during the daily activities in neglect. The aim of this case-study was to evaluate the effects of a protocol combining left neck-muscle vibration with daily simple movements, like arm pointing movements, on perceptivo-locomotor deficits in a left spatial neglect patient.

Materials and methods: Two neuropsychological tests, one subjective straight-ahead pointing (SSA) test and one wheelchair navigation test were carried out before the combination protocol, immediately after, 1?h later, and 24?h later.

Results: The results showed a reduction of neglect spatial bias following the protocol lasted at least 24?h in all the tests (except for the SSA test due to the unavailability of the pointing device).

Conclusions: The range of improvements in the symptoms of spatial neglect suggests that this therapeutic intervention based on the combining neck-muscle vibration to voluntary arm movements could be a useful treatment for this condition. One of future investigation axes should be the development of a vibratory tool in order to facilitate the combining this proprioceptive stimulation to daily activities.

  • Implications for rehabilitation
  • Spatial neglect is a perplexing neuropsychological syndrome, affecting different domains of spatial cognition and impacting also the functional domain.

  • The treatments based on neck-muscle vibration are simple to use, non-invasive and requires none active participation of patient.

  • A therapeutic intervention based on the combining left neck-muscle vibration and voluntary arm movements in a left-spatial-neglect show a lasting reduction of symptoms especially in daily activities.

  • The combination of treatments based on the Bottom–Up approach opens innovative perspectives in rehabilitation.

  相似文献   
17.

Background

While the 11-factor modified frailty index (mFI) has been shown to predict adverse outcomes in patients undergoing total joint arthroplasty, the 5-factor index has not been evaluated in this patient population. The goal of this study was to evaluate the utility of the mFI-5 as a predictor of morbidity and mortality in patients undergoing primary total hip and knee arthroplasty.

Methods

A retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program's database for patients undergoing total hip arthroplasty and total knee arthroplasty between the years 2005 and 2016 was conducted. The 5-factor score, which includes the presence of comorbid diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, and functional status, was calculated for each patient. Multivariate logistic regression models were used to assess the relationship between the mFI-5 and postoperative complications while controlling for demographic variables.

Results

One hundred forty thousand one hundred fifty-eight patients undergoing total hip arthroplasty and 226,398 patients undergoing total knee arthroplasty were identified. After adjusting for demographic variables and comorbid conditions, logistic regression analyses revealed that the mFI-5 was a strong predictor for total complications, Clavien-Dindo grade IV complications (cardiac arrest, myocardial infarction, septic shock, pulmonary embolism, postoperative dialysis, reintubation, and prolonged ventilator requirement), surgical site infections, readmission, and 30-day mortality (P < .001).

Conclusions

The mFI-5 is an independent predictor of postoperative complications including life-threatening medical complications, surgical site infections, hospital readmission, and 30-day mortality after primary hip and knee arthroplasty. This clinical tool can be used to identify high-risk surgical patients and guide preoperative counseling to optimize outcomes.

Level of Evidence

III.  相似文献   
18.

Purpose

The goal of this review was to summarize, analyze, and compare trials studying the efficacy of colchicine in the prevention of atrial fibrillation (AF) post-operatively (POAF) and post–catheter ablation. Ongoing studies and current guidelines are also presented and reviewed.

Methods

Published studies on the field were identified through a literature search of the PubMed and clinicaltrials.gov databases.

Findings

Four original studies regarding POAF, two original studies regarding post–catheter ablation AF, and six meta-analyses were identified. In addition, the 3 most recent guidelines/expert consensus documents were scrutinized.

Implications

AF occurs frequently after cardiac surgery (POAF) and catheter pulmonary vein isolation (postablation AF) and is associated with increased cardiovascular morbidity. A number of trials over the last few years have investigated the role of colchicine in the prevention of POAF and postablation AF targeting the local and systemic inflammatory process that leads to initiation and maintenance of AF. Available data imply that colchicine may have a preventive role in POAF and/or postablation AF. However, certain limitations of these studies underline the need for further investigation.  相似文献   
19.
Optimizing glycemic control remains a shared challenge for clinicians and their patients with diabetes. Flash continuous glucose monitoring (CGM) provides immediate information about an individual’s current and projected glucose level, allowing users to respond promptly to mitigate or prevent pending hypoglycemia or hyperglycemia. Large randomized controlled trials (RCTs) have demonstrated the glycemic benefits of flash CGM use in both type 1 and type 2 diabetes. However, whereas RCTs are mostly focused on the efficacy of this technology in defined circumstances, real-world studies can assess its effectiveness in wider clinical settings. This review assesses the most recent real-world studies demonstrating the effectiveness of flash CGM use to improve clinical outcomes and health care resource utilization in populations with diabetes.

During the past 5 years, increasing numbers of people with type 1 or type 2 diabetes have integrated continuous glucose monitoring (CGM) into their diabetes self-management regimens. Unlike traditional blood glucose meters, CGM systems provide immediate information about the concentration and the direction and rate of change of interstitial glucose. This information enables patients to intervene promptly to prevent or reduce acute hypoglycemia or hyperglycemia.Flash CGM is among the most recent CGM technologies. Currently, the FreeStyle Libre 14-day system (Abbott Diabetes Care) and FreeStyle Libre 2 are the only flash CGM systems available, and these systems are being adopted rapidly. Large randomized controlled trials (RCTs) have confirmed the glycemic benefits of flash CGM use in people with type 1 diabetes (1,2) and those with type 2 diabetes (36). However, because RCTs are mostly focused on measures of efficacy in defined circumstances, real-world studies can usefully assess the effectiveness of flash CGM in wider clinical settings.Although adoption of flash CGM continues to expand within endocrinology and diabetes specialty practices, primary care providers may be less familiar with this technology and how it can benefit patients with diabetes. This review assesses recent real-world studies demonstrating the impact of flash CGM use on clinical outcomes and health care resource utilization in both type 1 and type 2 diabetes populations.  相似文献   
20.
This study aimed to evaluate changes in sleep during the COVID‐19 outbreak, and used data‐driven approaches to identify distinct profiles of changes in sleep‐related behaviours. Demographic, behavioural and psychological factors associated with sleep changes were also investigated. An online population survey assessing sleep and mental health was distributed between 3 April and 24 June 2020. Retrospective questions were used to estimate temporal changes from before to during the outbreak. In 5,525 Canadian respondents (67.1% females, 16–95 years old: Mean ± SD = 55.6 ± 16.3 years), wake‐up times were significantly delayed relative to pre‐outbreak estimates (p < .001,  = 0.04). Occurrences of clinically meaningful sleep difficulties significantly increased from 36.0% before the outbreak to 50.5% during the outbreak (all p < .001, g ≥ 0.27). Three subgroups with distinct profiles of changes in sleep behaviours were identified: “Reduced Time in Bed”, “Delayed Sleep” and “Extended Time in Bed”. The “Reduced Time in Bed” and “Delayed Sleep” subgroups had more adverse sleep outcomes and psychological changes during the outbreak. The emergence of new sleep difficulties was independently associated with female sex, chronic illnesses, being employed, family responsibilities, earlier wake‐up times, higher stress levels, as well as heavier alcohol use and television exposure. The heterogeneity of sleep changes in response to the pandemic highlights the need for tailored interventions to address sleep problems.  相似文献   
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