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1.
Ralf Wagner Juliane Meißner Elena Grabski Yuansheng Sun Stefan Vieths Eberhard Hildt 《Allergy》2022,77(1):72-82
The ongoing COVID-19 pandemic caused by the SARS-CoV-2 coronavirus has affected the health of tens of millions of people worldwide. In particular, in elderly and frail individuals the infection can lead to severe disease and even fatal outcomes. Although the pandemic is primarily a human health crisis its consequences are much broader with a tremendous impact on global economics and social systems. Vaccines are considered the most powerful measure to fight the pandemic and protect people from COVID-19. Based on the concerted activities of scientists, manufacturers and regulators, the urgent need for effective countermeasures has provoked the development and licensure of novel COVID-19 vaccines in an unprecedentedly fast and flexible manner within <1 year. To ensure the safety and efficacy of these novel vaccines during the clinical development and the routine use in post-licensure vaccination campaigns existing regulatory requirements and procedures had to be wisely and carefully adapted to allow for an expedited evaluation without compromising the thoroughness of the regulatory and scientific assessment. In this review, we describe the regulatory procedures, concepts and requirements applied to guide and promote the highly accelerated development and licensure of safe and efficacious COVID-19 vaccines in Europe. 相似文献
2.
Sommer Falk Untch Elisa Spoerl Eberhard Herber Robert Pillunat Lutz E. Terai Naim 《International ophthalmology》2022,42(1):113-121
International Ophthalmology - To investigate the effect of “skin-only” upper eyelid blepharoplasty on corneal biomechanics and central as well as peripheral topographic/tomographic... 相似文献
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Decanter Gauthier Stoeckle Eberhard Honore Charles Meeus Pierre Mattei Jean Camille Dubray-Longeras Pascale Ferron Gwenael Carrere Sébastien Causeret Sylvain Guilloit Jean-Marc Fau Magali Rosset Philippe Machiavello Jean-Christophe Delhorme Jean Baptiste Regenet Nicolas Gouin François Blay Jean-Yves Coindre Jean-Michel Penel Nicolas Bonvalot Sylvie 《Annals of surgical oncology》2019,26(11):3526-3534
Annals of Surgical Oncology - The benefits of systematic re-excision (RE) after initial unplanned excision (UE) of soft tissue sarcoma (STS) are unknown. The aim of this study was to evaluate the... 相似文献
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6.
Sara S. McMillan Michelle King Mary P. Tully 《International journal of clinical pharmacy》2016,38(3):655-662
Introduction The Nominal Group Technique (NGT) and Delphi Technique are consensus methods used in research that is directed at problem-solving, idea-generation, or determining priorities. While consensus methods are commonly used in health services literature, few studies in pharmacy practice use these methods. This paper provides an overview of the NGT and Delphi technique, including the steps involved and the types of research questions best suited to each method, with examples from the pharmacy literature. Methodology The NGT entails face-to-face discussion in small groups, and provides a prompt result for researchers. The classic NGT involves four key stages: silent generation, round robin, clarification and voting (ranking). Variations have occurred in relation to generating ideas, and how ‘consensus’ is obtained from participants. The Delphi technique uses a multistage self-completed questionnaire with individual feedback, to determine consensus from a larger group of ‘experts.’ Questionnaires have been mailed, or more recently, e-mailed to participants. When to use The NGT has been used to explore consumer and stakeholder views, while the Delphi technique is commonly used to develop guidelines with health professionals. Method choice is influenced by various factors, including the research question, the perception of consensus required, and associated practicalities such as time and geography. Limitations The NGT requires participants to personally attend a meeting. This may prove difficult to organise and geography may limit attendance. The Delphi technique can take weeks or months to conclude, especially if multiple rounds are required, and may be complex for lay people to complete. 相似文献
7.
Thomas Backhaus 《The AAPS journal》2016,18(4):804-813
The ecotoxicological risk of pharmaceutical mixtures typically exceeds the risk of each individual compound, which calls specific attention to the fact that monitoring surveys routinely find complex pharmaceutical mixtures in various environmental compartments. However, although the body of evidence on the ecotoxicology of pharmaceutical mixtures is quite consistent, the current guidelines for the environmental risk assessment of pharmaceuticals often do not explicitly address mixture effects. Data availability and acceptable methods often limit such assessments. A tiered approach that begins with summing up individual risk quotients, i.e., the ratio between the predicted or measured environmental concentration and the predicted no effect concentration (PNEC) is therefore suggested in this paper, in order to improve the realism of the environmental risk assessment of pharmaceuticals. Additionally, the use of a mixture-specific assessment factor, as well as the classical mixture toxicity concepts of concentration addition and independent action is explored. Finally, specific attention is given to the exposure-based waiving of environmental risk assessments, as currently implemented in screening or pre-screening phases (tier 0 in Europe, categorical exclusion in the USA), since even low, individually non-toxic concentrations might combine to produce substantial mixture effects. 相似文献
8.
Francesco Benedetti Sara Poletti Thomas A. Hoogenboezem Clara Locatelli Oliver Ambrée Harm de Wit Annemarie J. M. Wijkhuijs Elena Mazza Chiara Bulgarelli Benedetta Vai Cristina Colombo Enrico Smeraldi Volker Arolt Hemmo A. Drexhage 《Journal of neuroimmune pharmacology》2016,11(2):248-258
Growth factors involved in neurogenesis and neuroplasticity could play a role in biological processes that drive depression recovery. Combined total sleep deprivation and morning light therapy (TSD + LT) can acutely reverse depressive symptoms, thus allowing to investigate the neurobiological correlates of antidepressant response. We tested if changes on plasma levels of Brain Derived Neurotrophic Factor (BDNF), S100 calcium binding protein B (S100-B), Stem Cell Factor (SCF), Insulin-like Growth Factor-Binding Protein 2 (IGFBP-2), Epidermal Growth Factor (EGF), Platelet-Derived Growth Factor-BB (PDGF-BB), and Vascular Endothelial Growth Factor (VEGF) are associated with response to TSD + LT in 26 inpatients affected by a major depressive episode in the course of bipolar disorder. Regional grey matter (GM) volumes were assessed at baseline, and BOLD fMRI neural responses to a moral valence decision task were recorded before and after treatment. 61.5 % of patients responded to treatment. SCF plasma levels increased significantly more in responders, and correlated with GM volumes in frontal and parietal cortical areas. The pattern of change of SCF also associated with both GM volumes and changes of BOLD fMRI neural responses in the anterior cingulate and medial prefrontal cortex. SCF is both a hematopoietic growth factor and a neurotrophic factor, involved in neuron-neuron and neuron-(micro) glia interactions, fostering neuronal growth and an anti-inflammatory milieu. We correlated SCF levels with antidepressant response and with functional and structural MRI measures in cortical areas that are involved in the cognitive generation and control of affect. SCF may be a candidate growth factor that contributes to neurotrophic and immune effects that are involved in the process of remission/recovery from depression. 相似文献
9.
Muhammad Jawad Ahmad Syed Fahad Hassan Riffat Un Nisa Khurshid Ayub Muhammad Shahid Nadeem Samina Nazir Farzana Latif Ansari Naveeda Akhtar Qureshi Umer Rashid 《Medicinal chemistry research》2016,25(9):1877-1894
In this study, we have investigated small multitargeted molecules containing 2-aminopyrimidine scaffold that may further act as precursor for developing more potent antibacterials. An efficient route to 2-amino-1,4-dihydropyrimidines by using ultrasound irradiation as the energy source was developed. In silico density functional theory calculations illustrated that tin chloride-mediated Biginelli reaction to produce 2-amino-1,4-dihydropyrimidines has energetics quite accessible under the reaction conditions. Calculated minimum inhibitory concentrations against the various bacterial strains showed that compounds 3 and 11 displayed comparable in vitro activity to ciprofloxacin in Staphylococcus aureus strains and reduced potency in Escherichia coli strains. Further, we investigated in silico ADMET profiling of synthesized compounds in order to understand the mechanism of action that help in explaining in vitro results. Lead compounds 3, 6, and 11 are predicted to have acceptable pharmacokinetic/drug-like properties. Data mining and computational analysis were employed to derive compound promiscuity phenomenon. All the compounds were found nonsubstrate towards various aminergic G-protein coupled receptors, ion-channels, kinase inhibitor, nuclear receptor ligand, protease inhibitor, and enzyme inhibitor. Compound 3 was further investigated by in silico binding to different antibacterial targets. Binding energy data revealed that that these compounds have the ability to bind with other bacterial targets. Hence, combined in silico and in vitro studies shed insights into the mechanism of synthesis and antibacterial activity of 2-amino-1,4-dihydropyrimidines. Results of this study are promising and can be used for further investigation by medicinal chemists to explore their chemical functionalization and in vivo studies. 相似文献
10.
Yahiya Y. Syed 《Am J Cardiovasc Drugs》2016,16(4):297-304
Idarucizumab (Praxbind®), a humanized monoclonal antibody, is a specific reversal agent for the direct oral thrombin inhibitor dabigatran, available as its prodrug dabigatran etexilate (Pradaxa®). Idarucizumab is approved in several countries (including the USA, the EU, Canada and Australia) for use in adult patients on dabigatran when the reversal of its anticoagulant effects is required for emergency surgery/procedures or in the event of life-threatening or uncontrolled bleeding. In the ongoing pivotal RE-VERSE AD trial in these populations (n = 90), intravenous idarucizumab 5 g reversed dabigatran-induced prolongation of dilute thrombin time (dTT) and ecarin clotting time (ECT) within minutes. The median maximum percentage reversal was 100 % for both assays (primary endpoint). Idarucizumab normalized dTT and ECT in 88?98 % of patients who had elevated levels at baseline. After idarucizumab administration, bleeding stopped in 97 % of evaluable patients in the bleeding cohort within 24 h (median time to cessation of bleeding was 11.4 h), and the rate of normal intraoperative haemostasis was 92 % in the surgical cohort. Idarucizumab was generally well tolerated. In conclusion, idarucizumab is a unique and specific treatment option for the reversal of the anticoagulant effects of dabigatran in adult patients requiring emergency procedures or in the event of life-threatening or uncontrolled bleeding. 相似文献