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Inna Y. Gong Nigel S. Tan Sammy H. Ali Gerald Lebovic Muhammad Mamdani Shaun G. Goodman Dennis T. Ko Andreas Laupacis Andrew T. Yan 《The Canadian journal of cardiology》2019,35(5):653-660
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3.
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miR-30c has been acknowledged as a tumor suppressor in various human cancers, such as ovarian cancer, gastric cancer, and prostate cancer. However, the role of miR-30c in glioblastoma (GBM) needs to be investigated.
In our study, we found that the expression of miR-30c was significantly downregulated in GBM tissues and
cell lines. We found that overexpression of miR-30c inhibited cellular proliferation of GBM cells in vitro and
in vivo. More GBM cells were arrested in the G0 phase after miR-30c overexpression. Moreover, we showed
that miR-30c overexpression suppressed the migration and invasion of GBM cells. Mechanistically, we found
that SOX9 was a direct target of miR-30c in GBM cells. Overexpression of miR-30c inhibited the mRNA
and protein levels of SOX9 in GBM cells. Moreover, there was a negative correlation between the expression
of miR-30c and SOX9 in GBM tissues. Finally, we showed that restoration of SOX9 in GBM cells reversed
the proliferation, migration, and invasion of GBM cells transfected with miR-30c mimic. Collectively, our
results demonstrated that miR-30c suppressed the proliferation, migration, and invasion of GBM cells via
targeting SOX9. 相似文献
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Fabrice Barlesi Edward B. Garon Dong-Wan Kim Enriqueta Felip Ji-Youn Han Joo-Hang Kim Myung-Ju Ahn Mary Jo Fidler Matthew A. Gubens Gilberto de Castro Veerle Surmont Qiao Li Anne C. Deitz Gregory M. Lubiniecki Roy S. Herbst 《Journal of thoracic oncology》2019,14(5):793-801
Introduction
In the phase II/III KEYNOTE-010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1–expressing (tumor proportion score ≥ 1%), advanced NSCLC. Health-related quality of life (HRQoL) results are reported here.Methods
Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel 75 mg/m2 every 3 weeks. HRQoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30 (C30), EORTC QLQ–Lung Cancer 13 (LC13), and EuroQoL-5D. Key analyses included mean baseline-to-week-12 change in global health status (GHS)/quality of life (QoL) score, functioning and symptom domains, and time to deterioration in a QLQ-LC13 composite endpoint of cough, dyspnea, and chest pain.Results
Patient reported outcomes compliance was high across all three instruments. Pembrolizumab was associated with better QLQ-C30 GHS/QoL scores from baseline to 12 weeks than docetaxel, regardless of pembrolizumab dose or tumor proportion score status (not significant). Compared with docetaxel, fewer pembrolizumab-treated patients had “deteriorated” status and more had “improved” status in GHS/QoL. Nominally significant improvement was reported in many EORTC symptom domains with pembrolizumab, and nominally significant worsening was reported with docetaxel. Significant prolongation in true time to deterioration for the QLQ-LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two-sided p = 0.03), but not for the 2-mg/kg dose.Conclusions
These findings suggest that HRQoL and symptoms are maintained or improved to a greater degree with pembrolizumab than with docetaxel in this NSCLC patient population. 相似文献7.
《Journal of Clinical Orthopaedics and Trauma》2019,10(5):890-895
IntroductionPelvic/acetabular fractures are associated with significant morbidity, mortality and cost to the society. We sought to utilize a national surgical database to assess the incidence and factors associated with prolonged length of stay (LOS), non-home discharge destination, 30-day adverse events and readmissions following surgical fixation of pelvic/acetabular fractures.Materials & methodsThe 2011–2016 ACS-NSQIP database files were queried using CPT codes (27215, 27217, 27218, 27226, 27227, 27228) for patients undergoing open reduction/internal fixation (ORIF) for pelvic/acetabular fractures. Patients undergoing additional procedures for associated fractures (vertebral fractures, distal radius/ulna fractures or femoral neck/hip fractures) were excluded from the analysis to ensure that a relevant population of patients with isolated pelvic/acetabular injuries were included in the analysis. A total of 572 patients were included in the final cohort. Severe adverse events (SAE) were defined as: death, ventilator use >48 h, unplanned intubation, stroke, deep venous thrombosis, pulmonary embolism, cardiac arrest, myocardial infarction, acute renal failure, sepsis, septic shock, re-operation, deep SSI and organ/space SSI. Minor adverse events (MAE) included – wound dehiscence, superficial SSI, urinary tract infection (UTI) and progressive renal insufficiency. An extended LOS was defined as >75th centile (>9days).ResultsFactors associated with AAE were partially dependent functional health status pre-operatively (p = 0.020), transfusion ≥1 unit of packed RBCs (p = 0.001), and ASA > II (p < 0.001). Experiencing a SAE was associated with congestive heart failure (CHF) pre-operatively [p = 0.005), total operative time >140 min (p = 0.034) and Hct <36 pre-operatively (p = 0.003). MAE was associated with transfusion≥1 unit of packed RBCs (p = 0.022) and ASA > II (p = 0.007). Patients with an ASA > II (p = 0.001), total operative time>140 min (p < 0.001) and Hct <36 (p = 0.006) were more likely to have a LOS >9 days. Male gender (p = 0.026), prior history of CHF (p = 0.024), LOS >9 days (p = 0.030) and >10% bodyweight loss in last 6 months before the procedure (p = 0.002) were predictors of 30-day mortality.ConclusionPatients with ASA grade > II, greater co-morbidity burden and prolonged operative times were likely to experience adverse events and have a longer length of stay. Surgeons can utilize this data to risk stratify patients so that appropriate pre-operative and post-operative medical optimization can take place. 相似文献
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《Transfusion and apheresis science》2020,59(6):102908
IntroductionTemperature and time conditions during storage and distribution of blood components (BC) and their permissible deviations are strictly regulated. The degree of compliance with these requirements in daily practice of transfusion services (TS) is not well known.Materials and methodsWe conducted a survey among Spanish hospital TS covering different aspects of BC management in their daily activity.ResultsEighty-three TS managing 56 % of total transfusions answered the survey. Monitoring of red blood concentrates (RBC) temperature during in-hospital distribution was routinely performed by only 12 % of the TS. The main criterion for BC re-entry into the stock was the total time spent outside controlled temperature. Up to 41 % of the TS apply the “30-minute rule” to distributed RBC, while most services use a 60-minute rule for PC. No adverse events were detected when RBC that had remained longer than 30 or 60 min outside the TS were transfused. Fresh frozen plasma is usually thawed 2 h preissue and stored at 4 °C up to 24 h.Discussion and conclusionsIn the Spanish context, the 30- and 60-minute rules for re-entry of RBC and PC into the TS stock are loosely followed. Feedback for a large number of TS suggests that the extension of the 30-minute RBC rule to at least 60 min is feasible, if other safety requirements are met. Flexibility with some requirements could help reduce product loss without deleterious effect on BC safety. 相似文献