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61.
An evaluation of the cardiovascular safety profile of duloxetine: findings from 42 placebo-controlled studies. 总被引:3,自引:0,他引:3
Joachim Wernicke Alberto Lledó Joel Raskin Daniel K Kajdasz Fujun Wang 《Drug safety》2007,30(5):437-455
BACKGROUND AND OBJECTIVE: In recent years, new classes of medication, such as the serotonin-noradrenaline reuptake inhibitors (SNRIs), have been developed for use in the treatment of major depressive disorder (MDD). For many years, treatment options were largely limited to the use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). However, there have been published reports of orthostatic hypotension, arrhythmias and corrected QT (QTc) interval changes in patients treated with TCAs. As new medications become available, it is important to understand how their cardiovascular safety profile compares with that of more established agents to aid clinicians and patients in choosing the best treatment options. This study was designed to evaluate the cardiovascular safety profile of the SNRI duloxetine through evaluation of cardiovascular-related parameters and adverse events (AEs). METHODS: The cardiovascular safety of duloxetine was assessed using all placebo-controlled duloxetine clinical trial data as of December 2005. This consisted of data from 42 placebo-controlled clinical trials of 8504 patients who were treated with duloxetine. Additional information from a high-dose clinical pharmacology study and postmarketing safety surveillance are also presented. Of the placebo-controlled trials included in this analysis, clinical indications under investigation included MDD (15 studies), diabetic peripheral neuropathic pain (3 studies), fibromyalgia (2 studies), generalised anxiety disorder (3 studies) and lower urinary tract disorders (19 studies, all related to incontinence). Cardiovascular safety was evaluated based on vital signs, ECGs and the incidence of treatment-emergent AEs potentially related to cardiovascular safety. These safety parameters were analysed across all indications. To identify both serious and non-serious cardiovascular-related AEs, as well as AEs reported as the reason for discontinuation, a comprehensive list of terms derived from the Medical Dictionary for Regulatory Activities (version 8.0) was generated and used to search the duloxetine databases for cardiovascular-related events. RESULTS: Calculation of change from baseline to maximum in ECG parameters showed significant differences between treatment groups for all parameters, with decreases from baseline in RR, QRS and QT intervals for patients receiving duloxetine and increases from baseline for patients treated with placebo. These shifts were related to small heart rate changes, but the mean differences were not considered clinically relevant. Categorical analyses of shifts from normal to abnormal (or abnormal to normal) for heart rate and QT corrected for heart rate using Fridericia's formula (QTcF) values showed that most patients did not shift from their baseline category. Patients with MDD who were treated for up to 1 year with duloxetine had blood pressure changes early in treatment that then stabilised. Even in patients with elevated blood pressure at baseline in these clinical trials, no increased risk of sustained blood pressure elevation with duloxetine treatment was found. CONCLUSION: Overall, the findings presented here support our conclusions that use of duloxetine does not appear to be associated with significant cardiovascular risks in patients with conditions for which the drug has been approved or studied. 相似文献
62.
63.
Imad Sheiban M. D. Dino Casarotto Giampaolo Trevi Paolo Benussi Alberto Marini Roberto Accardi Antonio Motta Massimo Brunelli Claudio Muneretto Alessandro Tenuti Ludovico Antonio Scuro 《Cardiovascular and interventional radiology》1987,10(3):157-161
The accuracy of two-dimensional echocardiography in the detection of intracardiac masses was verified in 334 patients who
underwent cardiac catheterization in our laboratory over 21 consecutive months. A complete two-dimensional echocardiographic
(2DE) examination was performed a day before catheterization. The presence or absence of a mass was verified at surgery in
77 patients who successively underwent mitral or aortic valve replacement (51), left ventricular aneurysmectomy with or without
myocardial revascularization (25), and resection of atrial myxoma (2). In 32 patients 2DE revealed the presence of a mass-left
or right atrial thrombi in 12, left atrial myxoma in 2, left ventricular thrombi in 16, and endocardial vegetations in 2.
The other 45 patients were free of intracardiac masses on 2DE. Anatomic verification at surgery revealed the presence of an
intracardiac mass in 34 patients. In 30 (true positives) of these, 2DE revealed the mass as well, and in 4 (false negatives)
the presence of a mass had not been identified by 2DE. In 2 patients (false positives) the predicted mass was not found at
surgery. Absence of a mass was correctly predicted by 2DE in 41 patients (true negatives). Thus 2DE detected intracardiac
masses with sensitivity of 88.2% and a specificity of 95.3%. We recommend that 2DE be performed in all patients prior to hemodynamic
study and/or cardiac surgery to enable safer management of patients with intracardiac masses during cardiac catheterization
and/or cardiac surgery. 相似文献
64.
Gianmauro Sacchetti Eugenio Inglese Angelo S Bongo Franco Aina Marco Brambilla Alberto Baroli Carmelo Cernigliaro Pierfranco Dellavesa Edgardo Pittaluga Marco Rudoni 《European journal of nuclear medicine and molecular imaging》1997,24(10):1230-1236
The aim of this study was to determine the diagnostic accuracy of technetium-99m tetrofosmin myocardial imaging for the localization
of coronary artery stenoses of different degrees of severity. Stress-rest single-photon emission tomography (SPET) was performed
on separate days in 80 patients (64 males, 16 females; mean age 61 years; 43 patients with previous myocardial infarction;
18 patients with pharmacological stress), within 6 months of coronary angiography. Scintigraphic images were blindly and independently
evaluated by three observers. Coronary stenosis was defined as a >50% narrowing in luminal diameter; severe stenosis was defined
as a proximal stenosis of >75% or a peripheral stenosis of >90%. Coronary angiography revealed normal coronary arteries or
insignificant coronary stenosis in 13 patients and significant coronary stenoses in 67 patients. The sensitivity and specificity
of 99mTc-tetrofosmin SPET in respect of severely stenosed vessels were, respectively, 80% and 65% for the left anterior descending
artery (LAD), 100% and 46% for the right coronary artery (RCA) and 58 and 78% for the left circumflex artery (LCx) territories.
Considering all the significantly stenosed vessels, a significant decrease in sensitivity was observed for LAD territories
(to 59%, P=0.05), and a nonsignificant decrease for RCA (88%) and LCx (47%) territories while specificity values remained essentially
unchanged. No significant changes in sensitivity or specificity were observed when regions with previous myocardial infarction
were excluded. In conclusion, the sensitivity of 99mTc-tetrofosmin SPET for the localization of individual stenosed vessels is only moderate when all significant stenoses are
considered, but the ability of this technique to predict the location of severe coronary artery stenoses seems satisfactory,
with the exception of the low specificity in respect of RCA territories.
Received 26 April and in revised form 7 June 1997 相似文献
65.
Coppo R; Cirina P; Amore A; Sinico R; Radice A; Rollino C; the Italian Group of Renal Immunopathology Collaborative Study on Henoch-Schonlein purpura in adults f; children i 《Nephrology, dialysis, transplantation》1997,12(11):2269-2276
Background: The presence and the pathogenetic role of
circulating IgA reacting with neutrophil cytoplasmic antigens (IgA-ANCA) in
patients with Henoch-Schonlein purpura (HSP) is still debated. This study
was aimed to investigate some characteristics of serum IgA and
macromolecular IgA in HSP patients, focusing on IgA-ANCA.
Methods: Eighty-seven HSP patients with biopsy proved
renal involvement (51 adults and 36 children) enrolled in a multicentre
study of the Italian Group of Immunopathology were investigated.
Results: Significantly high levels of IgA immune
complexes were found in both adults (P <0.05) and children (P
<0.01), while the binding of IgA to jacalin, was significantly low
in children with HSP (P <0.01) only. Two series of ELISA were done
for IgA-ANCA, in two different laboratories. Increased binding to PMN crude
extracts (P <0.01) without any modification in IgA binding to
proteinase 3 was found by either specific ELISA. Conversely, the binding of
IgA to myeloperoxidase (MPO) was found to be significantly (P <0.05)
increased with positive values in 25% of patients by one assay only. Three
of four sera with positive IgA-MPO ANCA exhibited binding in Western-blot
studies with the MPO preparation used in ELISA to a 28-kDa species.
D-galactose and N-acetyl-glucosamine decreased the binding of serum IgA to
MPO more in HSP than in controls (P <0.05).
Conclusions: The conflicting reports on IgA-ANCA may
reflect some atypical characteristics of the reaction which can be detected
only by some ELISAs. We suggest that not an antigen-antibody reaction but a
lectinic interaction due to abnormal composition of IgA carbohydrate side
chains may account for the IgA-ANCA reaction in patients with HSP
nephritis. 相似文献
66.
Marc G Weisskopf Honglei Chen Michael A Schwarzschild Ichiro Kawachi Alberto Ascherio 《Movement disorders》2003,18(6):646-651
Anxiety disorders are common in Parkinson's disease (PD). However, the risk of PD among people with anxiety has not been examined in a prospective cohort study. We examined this relation prospectively within the Health Professionals Follow-Up Study, a cohort of US male health professionals. In 1988, anxiety was assessed using the Crown-Crisp phobic anxiety index in 35,815 men without PD, stroke, or cancer at baseline. There were 189 incident cases of PD during 12 years of follow-up. After adjusting for age, smoking, and caffeine intake, the relative risk of PD among men with the highest level of anxiety (Crown-Crisp index scores of 4 and above) was 1.5 (95% CI = 1.0-2.1; P-trend = 0.01) compared to men with the lowest level of anxiety. This positive association persisted after excluding cases of PD with onset in the first 2 years of follow-up. Use of anxiolytic medication was also associated with an elevated risk of PD (RR= 1.6; 95% CI = 0.9-3.1), but adjusting for this potential confounder did not materially affect the association between anxiety and risk of PD. Our results suggest that anxiety is a risk factor for PD. Whether this association is causal or the result of shared underlying biology remains a question. 相似文献
67.
Renato S. Gomez L. O. F. Andrade J. R. Rezende Costa 《Journal canadien d'anesthésie》1997,44(7):732-734
Purpose To present a case of brainstem anaesthesia as a complication of peribulbar anaesthesia.
Clinical features A 75-yr-old woman received peribulbar anaesthesia for cataract surgery. A few seconds after the block was performed, she had
a respiratory arrest, became unconscious, and developed hypertension and tachycardia followed by hypotension and bradycardia.
Ventilatory and haemodynamic support were performed before the patient regained adequate spontaneous breathing and normal
heart rate and blood pressure.
Conclusion Peribulbar anaesthesia generally cames a low risk of serious complications. However, respiratory arrest and brainstem anaesthesia
may occur as complications of peribulbar blocks.
Résumé Objectif Présenter un cas d’anesthésie du tronc cérébral compliquant une anesthésie péribulbaire. éléments cliniques Un bloc péribulbaire était réalisé chez une femine de 75 ans pour l’extraction d’une cataracte. Quelques secondes après l’injection, la patiente cessait de respirer et perdait conscience. Elle devenait hypertendue et tachycarde puts hypotendue et bradycarde. La ventilation et la circulation devaient être supportées jusqu’au retour spontané à la normale. Conclusion En général, l’anesthésie péribulbare comporte un faible risque de complications sérieuses. Un arrêt respiratoire par anesthésie du tronc cérébral est toujours possible.相似文献
68.
Andrea Gallamini Alberto Biggi Adriana Fruttero Francesco Pugno Giobatta Cavallero Patrizia Pregno Mariella Grasso Chiara Farinelli Alessandro Leone Eugenio Gallo 《European journal of nuclear medicine and molecular imaging》1997,24(12):1499-1506
The purpose of this study was threefold: to evaluate the role of gallium-67 scintigraphy in the staging of low-grade non-Hodgkin’s
lymphomas (LGNHL), to assess the relationship between the expression of CD71 on the surface of the neoplastic cells and the
67Ga uptake by the tumour, and to establish the contribution of 67Ga scan in defining the prognosis of LGNHL. Forty-eight patients with untreated LGNHL diagnosed in a single institution over
a decade were reviewed. The end point of the study was survival of the patients according to the scintigraphic 67Ga score at diagnosis. In addition to 67Ga scan, other prognostic variables were studied, relating to the neoplastic burden, the biology of the tumour and the host.
Univariate and multivariate analyses were used. 67Ga scan identified only 116/286 (41%) nodes involved by lymphoma that were detected by clinical examination or computed tomography
scan. A scintigraphic scoring system with an arbitrary cut-off value of 3 (high scan score) was able to predict patients with
a dismal prognosis: with a mean follow-up of 47 months (range: 1–146 months) the median survival time was 28 months in patients
with a high scan score and 74 months in patients with a low scan score (P=0.002). CD71 values were 27.4%±14.9% (mean ±SD) in the former and 8.9%±7.2% in the latter (P=0.0001). Only performance status and extranodal sites were significant variables for prognosis in multivariate analysis.
It is concluded that 67Ga scan is inaccurate in staging but might be very important in defining the prognosis in LGNHL, in association with other
prognostic variables.
Received 1 May and in revised form 6 August 1997 相似文献
69.
70.
Alberto Falchetti Marco Di Stefano Francesca Marini Francesca Del Monte Carmelo Mavilia Debora Strigoli Maria L De Feo Giovan Isaia Laura Masi Antonietta Amedei Federica Cioppi Valentina Ghinoi Susanna Maddali Bongi Giuseppina Di Fede Carmela Sferrazza Giovan B Rini Daniela Melchiorre Marco Matucci-Cerinic Maria L Brandi 《Journal of bone and mineral research》2004,19(6):1013-1017
PDB is genetically heterogeneous. Mutations of the sequestosome1 gene have been reported in sporadic and familial forms of Paget's in patients of French Canadian and British descent. Mutational analyses in different ethnic groups are needed to accurately investigate hereditary diseases. We describe two novel mutations of sequestosome1 in 62 Italian sporadic patients, confirming the role of the encoded protein in this disorder. INTRODUCTION: Paget's disease of bone (PDB) is a relatively common disease of bone metabolism reported to affect up to 3% of whites over 55 years of age. The disorder is genetically heterogeneous, and at present, there is scientific evidence that at least eight different human chromosomal loci are correlated with its pathogenesis. Mutations of the sequestosome1 (SQSTM1) gene were identified as responsible for most of the sporadic and familial forms of Paget in patients of French Canadian and British descent. Such mutations were located at exon 7 and 8 levels, encoding for the ubiquitin protein-binding domain (UBA) and representing a mutational hot spot area. MATERIALS AND METHODS: To verify the involvement of this gene in Italian subjects affected by PDB, we performed mutational analysis in 62 sporadic PDB cases. RESULTS: We described three different mutations at exon 8 level: P392L, already described in the French Canadian population and families predominantly of British descendent, and two novel mutations consisting of the amino acid substitutions M404V and G425R. No significant differences in the clinical history of PDB have been observed in patients with SQSTM1 mutations in respect to those without. CONCLUSIONS: Even though our findings suggest a minor involvement of the SQSTM1 gene in the pathogenesis of sporadic Italian Paget's cases, the identification of different significant mutations within the SQSTM1 gene in unrelated, but clinically similar individuals, offers extremely convincing evidence for a causal relationship between this gene and PDB. Longitudinal studies are needed to assess the penetrance of genotype/phenotype correlations. Our findings confirm the evidence of a clustered mutation area at this level in this disorder. 相似文献