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31.

Background

Robotic-assisted laparoscopic radical prostatectomy (RALP) has been rapidly adopted despite a daunting learning curve with bladder neck dissection as a challenging step for newcomers.

Objective

To describe an anatomic, reproducible technique of bladder neck preservation (BNP) and associated perioperative and long-term outcomes.

Design, settings, and participants

From September 2005 to May 2009, data from 619 consecutive RALP were prospectively collected and compared on the basis of bladder neck dissection technique with 348 BNP and 271 standard technique (ST).

Surgical procedure

RALP with BNP.

Measurements

Tumor characteristics, perioperative complications, and post-operative urinary control were evaluated at 4, 12 and 24 months using (1) the Expanded Prostate Cancer Index (EPIC) urinary function scale scored from 0–100; and (2) continence defined as zero pads per day.

Results and limitations

Mean age for BNP versus ST was 57.1 ± 6.6 yr versus 58.9 ± 6.7 yr (p = 0.033), while complication rates did not vary significantly by technique. Estimated blood loss was 183.7 ± 95.8 ml versus 224.6 ± 108 ml (p = 0.938) in men who underwent BNP versus ST. The overall positive margin rate was 12.8%, which did not differ at the prostate base for BNP versus ST (1.4% vs. 2.2%, p = 0.547). Mean urinary function scores for BNP versus ST at 4, 12, and 24 mo were 64.6 versus 57.2 (p = 0.037), 80.6 versus 79.0 (p = 0.495), and 94.1 versus 86.8 (p < 0.001). Similarly, BNP versus ST continence rates at 4, 12, and 24 mo were 65.6% versus 26.5% (p < 0.001), 86.4% versus 81.4% (p = 0.303), and 100% versus 96.1% (p = 0.308).

Conclusions

BNP versus ST is associated with quicker recovery of urinary function and similar cancer control.  相似文献   
32.
Background  Completion axillary lymph node dissection (CALND) is routinely performed in breast cancer patients with positive sentinel lymph nodes (SLN). We sought to determine the sociodemographic, pathologic, and therapeutic variables that were associated with CALND. Methods  From 7/1997 to 7/2003, 1,470 patients with invasive breast cancer were SLN positive by intraoperative frozen section or final pathologic exam by hematoxylin–eosin and/or immunohistochemistry (IHC). A comorbidity score was assigned using Adult Comorbidity Evaluation-27 system. Fisher’s exact, Wilcoxon tests, and multivariate logistic regression analysis were used. Results  CALND was performed less often in patients with age ≥ 70 years compared with age < 70 years, moderate or severe comorbidities compared with no or mild, IHC-only positive SLN and breast conservation therapy (BCT compared with mastectomy. Patients who did not undergo CALND were less likely than CALND patients to have grade III disease, lymphovascular invasion multifocal disease, tumor size > 2 cm or to receive adjuvant chemotherapy. However, they were more likely to undergo axillary radiotherapy (RT). On multivariate analysis, age ≥ 70 years [odds ratio (OR) 0.4, 95% confidence interval (CI) 0.26–0.63], IHC-only positive SLN (OR 0.13, 95%CI 0.09–0.19), presence of moderate to severe comorbidities (OR 0.64, 95%CI 0.41–0.99), tumor size ≤ 2 cm (OR 0.44, 95%CI 0.29–0.66), axillary RT (OR 0.39, 95%CI 0.20–0.78), and BCT (OR 0.54, 95%CI 0.37–0.79) were all independently associated with lower odds of CALND. Conclusions  The decision to perform CALND following positive SLN biopsy was multifactorial. Patient factors were a primary determinant for the use of CALND in our study. The decreased use of CALND in the BCT patients probably reflects reliance on the radiotherapy tangents to maintain local control in the axilla.  相似文献   
33.

Background/Purpose

Fetal tracheal occlusion (TO) was developed in an attempt to enhance prenatal lung growth and improve survival in fetuses with severe congenital diaphragmatic hernia (CDH). We conducted a randomized, controlled clinical trial in 24 fetuses with severe left CDH (liver herniated into the thorax and low lung-to-head ratio) to compare survival after endoscopic fetal TO vs standard perinatal care (control) and prospectively followed up the 16 survivors (9 control, 7 TO) to compare neurodevelopmental, respiratory, surgical, growth, and nutritional outcomes.

Methods

At 1 and 2 years old, subjects underwent evaluation consisting of medical and neurological history and physical, developmental testing, nutritional assessment, oxygen saturation and pulmonary function testing, chest radiograph, and echocardiogram. Growth and developmental measures were corrected for prematurity. Data were analyzed by Mann-Whitney rank sum test, Fisher's Exact test, and logistic and linear regression.

Results

Infants with TO were significantly more premature at birth (control vs TO, 37.4 ± 1.0 vs 31.1 ± 1.7 weeks; P < .01). Growth failure (z score for weight <2 SDs below mean) was severe in both groups at 1 year of age (control vs TO, 56% vs 86%; P = .31). There was considerable catch-up growth by age 2 years (growth failure: control vs TO, 22% vs 33%; P = .19). There were no differences in other growth parameters. There were also no differences in neurodevelopmental outcome at 1 and 2 years. Supplemental oxygen at hospital discharge was a significant predictor of worse neurodevelopmental outcome at 1 and 2 years old (P = .05 and P = .02, respectively). Hearing loss requiring amplification has been diagnosed in 44% of the group (control vs TO, 44% vs 43%; P = 1.0).

Conclusions

In this group of infants with severe CDH, there were no differences in outcome at 2 years old despite significant prematurity in the TO group. Oxygen supplementation at hospital discharge identified the most vulnerable group with respect to neurodevelopmental outcome, but all infants had significant growth failure, and hearing impairment is a substantial problem in this population. Severe CDH carries significant risk of chronic morbidity.  相似文献   
34.
Our purposes were to determine the incidence of BK viruria, viremia or nephropathy with tacrolimus (FK506) versus cyclosporine (CyA) and whether intensive monitoring and discontinuation of mycophenolate (MMF) or azathioprine (AZA), upon detection of BK viremia, could prevent BK nephropathy. We randomized 200 adult renal transplant recipients to FK506 (n = 134) or CyA (n = 66). Urine and blood were collected weekly for 16 weeks and at months 5, 6, 9 and 12 and analyzed for BK by polymerase chain reaction (PCR). By 1 year, 70 patients (35%) developed viruria and 23 (11.5%) viremia; neither were affected independently by FK506, CyA, MMF or AZA. Viruria was highest with FK506-MMF (46%) and lowest with CyA-MMF (13%), p = 0.005. Viruria >/= 9.5 log(10) copies/mL was associated with a 3-fold increased risk of viremia and a 13-fold increased risk of sustained viremia. After reduction of immunosuppression, viremia resolved in 95%, without increased acute rejection, allograft dysfunction or graft loss. No BK nephropathy was observed. Choice of calcineurin inhibitor or adjuvant immunosuppression, independently, did not affect BK viruria or viremia. Viruria was highest with FK506-MMF and lowest with CyA-MMF. Monitoring and preemptive withdrawal of immunosuppression were associated with resolution of viremia and absence of BK nephropathy without acute rejection or graft loss.  相似文献   
35.
ObjectiveThe Recruitment Innovation Center (RIC), partnering with the Trial Innovation Network and institutions in the National Institutes of Health-sponsored Clinical and Translational Science Awards (CTSA) Program, aimed to develop a service line to retrieve study population estimates from electronic health record (EHR) systems for use in selecting enrollment sites for multicenter clinical trials. Our goal was to create and field-test a low burden, low tech, and high-yield method.Materials and MethodsIn building this service line, the RIC strove to complement, rather than replace, CTSA hubs’ existing cohort assessment tools. For each new EHR cohort request, we work with the investigator to develop a computable phenotype algorithm that targets the desired population. CTSA hubs run the phenotype query and return results using a standardized survey. We provide a comprehensive report to the investigator to assist in study site selection.ResultsFrom 2017 to 2020, the RIC developed and socialized 36 phenotype-dependent cohort requests on behalf of investigators. The average response rate to these requests was 73%.DiscussionAchieving enrollment goals in a multicenter clinical trial requires that researchers identify study sites that will provide sufficient enrollment. The fast and flexible method the RIC has developed, with CTSA feedback, allows hubs to query their EHR using a generalizable, vetted phenotype algorithm to produce reliable counts of potentially eligible study participants.ConclusionThe RIC’s EHR cohort assessment process for evaluating sites for multicenter trials has been shown to be efficient and helpful. The model may be replicated for use by other programs.  相似文献   
36.

Introduction

First-line targeted therapies have been developed for advanced non–small-cell lung cancer (NSCLC). However, small biopsy samples pose a challenge to testing all relevant biomarkers. The present study characterized clinician-ordered single-gene lung cancer testing and evaluated tissue stewardship and the ability to successfully determine mutation status with single-gene testing or investigational use of the Oncomine Dx Target Test.

Materials and Methods

Clinician-submitted orders for 3659 single-gene tests (EGFR, ALK, ROS1, BRAF, KRAS, ERBB2, MET, RET, FGFR1) across 1402 samples at a large US-based commercial reference laboratory and 169 investigational Oncomine Dx Target Tests were retrospectively evaluated. The testing success rates and tissue consumption were evaluated by sample type, test type, and number of single-gene tests per sample.

Results

The large majority of lung tissue samples submitted for clinical testing were small (70.5% core needle biopsies; 10.0% fine needle aspirations). With single-gene testing, mutation status was successfully reported for ≥ 1 biomarker for 88.4% of the clinical samples. The success rates decreased and tissue consumption increased with testing of additional biomarkers. Investigational Oncomine Dx Target Tests were permitted 1 tissue slide each and demonstrated success rates similar to single-gene testing for ≥ 5 biomarkers on core needle biopsies, ≥ 4 biomarkers on fine needle aspirations, and ≥ 2 biomarkers on surgical resection specimens.

Conclusion

Tissue stewardship is important to enable successful completion of genetic testing and informed NSCLC treatment decisions. Preliminary assessment of the investigational Oncomine Dx Target Test suggests it could facilitate access to multiple biomarker testing using small tissue samples to support therapy decisions for patients with advanced NSCLC.  相似文献   
37.
‘Revenge porn’ or ‘cyber rape’ occurs when intimate images that were previously sent with permission are leaked to a wider audience without consent. This research investigated the perceptions that individuals form about ‘revenge porn’ victims, aiming to gain more understanding from a victimisation perspective as a first step towards improving victim outcomes. One hundred and twenty-two individuals were presented with a scenario depicting a leaked intimate image with a female victim. Two distinct nudity levels: low (lingerie) and high (bare-chest, breasts exposed) were included, and participants’ responses to the Sexual Double Standards Scale were analysed to determine whether acceptance of the traditional sexual double standard was correlated with victim perception. Results indicated that victims were perceived as more promiscuous and more blameworthy when they were more naked, and by participants with more traditional gender roles. There is a need for policy to address potential stigma directed at ‘revenge porn’ victims.  相似文献   
38.
39.

Objective

To evaluate the impact of opioid controlled substance agreements (CSAs) enrollment on health care utilization.

Patients and Methods

We retrospectively evaluated health care utilization changes among 772 patients receiving long-term opioid therapy for chronic noncancer pain enrolled in a CSA between July 1, 2015, and December 31, 2015. We ascertained patient characteristics and utilization 12 months before and after CSA enrollment. Decreased utilization was defined as a decrease of 1 or more hospitalizations or emergency department visits and 3 or more outpatient primary and specialty care visits. Multivariate modeling assessed demographic characteristics associated with utilization changes.

Results

The 772 patients enrolled in an opioid CSA during the study period had a mean ± SD age of 63.5±14.9 years and were predominantly female, white, and married. The CSA enrollment was associated with decreased outpatient primary care visits (odds ratio [OR], 0.16; 95% CI, 0.14-0.19) and increased diagnostic radiology services (OR, 1.22; 95% CI, 1.02-1.47). After CSA enrollment, patients with greater comorbidity (Charlson Comorbidity Index score >3) were more likely to have reduced hospitalizations (adjusted OR, 2.8; 95% CI, 1.3-6.0; P=.008), reduced outpatient primary care visits (adjusted OR, 2.0; 95% CI, 1.2-3.2; P=.005), and reduced specialty care visits (adjusted OR, 2.0; 95% CI, 1.2-3.3; P=.006).

Conclusion

For patients receiving long-term opioid therapy for chronic noncancer pain, CSA enrollment is associated with reductions in primary care visits and increased radiologic service utilization. Patients with greater comorbidity were more likely to have reductions in hospitalizations, outpatient primary care visits, and outpatient specialty clinic visits after CSA enrollment. The observational nature of the study does not allow the conclusion that CSA implementation is the primary reason for these observed changes.  相似文献   
40.

Background and aims

Children with first complex febrile seizure (CFS) are often admitted for observation. The goals of this study were 1) to assess the risk of seizure recurrence during admission, 2) to determine whether early EEG affects acute management.

Design/methods

We retrospectively reviewed a cohort of children 6–60 months of age admitted from a Pediatric Emergency Department for first CFS over a 15 year period. We excluded children admitted for supportive care of their febrile illness. Data extraction included age, gender, seizure features, laboratory and imaging studies, EEG, further seizures during admission, and antiepileptic drugs (AEDs) given.

Results

One hundred eighty three children met inclusion criteria. Seven patients had seizures during the admission (7/183 or 3.8%) Since 38 children were loaded with anti-epileptic medication during their visit, the adjusted rate is 7/145 or 4.8.Increased risk of seizure recurrence during admission was observed in children presenting with multiple seizures (P = 0.005).EEG was performed in 104/183 children (57%) and led to change in management in one patient (1%, 95% C.I. 0.05–6%). Six of the 7 children with seizure had an EEG. The study was normal in 3 and findings in the other 2 did not suggest/predict further seizures during the admission.

Conclusions

Children with first CFSs are at low risk for seizure recurrence during admission. Multiple seizures at presentation are associated with risk of early recurrence and may warrant an admission. EEG had limited effect on acute management and should not be an indication for admission.  相似文献   
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