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991.
Clinical input of anti‐D quantitation by continuous‐flow analysis on autoanalyzer in the management of high‐titer anti‐D maternal alloimmunization 下载免费PDF全文
992.
Anne F. Kristensen Søren R. Kristensen Ursula Falkmer Anna-Marie B. Münster Shona Pedersen 《Scandinavian journal of clinical and laboratory investigation》2018,78(3):175-179
Background: The Calibrated Automated Thrombography (CAT) is an in vitro thrombin generation (TG) assay that holds promise as a valuable tool within clinical diagnostics. However, the technique has a considerable analytical variation, and we therefore, investigated the analytical and between-subject variation of CAT systematically. Moreover, we assess the application of an internal standard for normalization to diminish variation.Methods: 20 healthy volunteers donated one blood sample which was subsequently centrifuged, aliquoted and stored at ?80?°C prior to analysis. The analytical variation was determined on eight runs, where plasma from the same seven volunteers was processed in triplicates, and for the between-subject variation, TG analysis was performed on plasma from all 20 volunteers. The trigger reagents used for the TG assays included both PPP reagent containing 5?pM tissue factor (TF) and PPPlow with 1?pM TF. Plasma, drawn from a single donor, was applied to all plates as an internal standard for each TG analysis, which subsequently was used for normalization.Results: The total analytical variation for TG analysis performed with PPPlow reagent is 3–14% and 9–13% for PPP reagent. This variation can be minimally reduced by using an internal standard but mainly for ETP (endogenous thrombin potential). The between-subject variation is higher when using PPPlow than PPP and this variation is considerable higher than the analytical variation.Conclusion: TG has a rather high inherent analytical variation but considerable lower than the between-subject variation when using PPPlow as reagent. 相似文献
993.
Red blood cells treated with the amustaline (S‐303) pathogen reduction system: a transfusion study in cardiac surgery 下载免费PDF全文
Veronika Brixner Arndt‐Holger Kiessling Katharina Madlener Markus M. Müller Johannes Leibacher Sarah Dombos Iuliia Weber Hans‐Ulrich Pfeiffer Christof Geisen Michael Schmidt Reinhard Henschler Anne North Norman Huang Nina Mufti Anna Erickson Christine Ernst Salvador Rico Richard J. Benjamin Laurence M. Corash Erhard Seifried 《Transfusion》2018,58(4):905-916
994.
Marcas M. Bamman Gary R. Cutter David M. Brienza John Chae Daniel M. Corcos Stephanie DeLuca Edelle Field-Fote Mona N. Fouad Catherine E. Lang Anne Lindblad Robert W. Motl Carla G. Perna Darcy Reisman Kenneth M. Saag Sean I. Savitz Kathryn H Schmitz Jennifer Stevens-Lapsley John Whyte Mary E. Michel 《Archives of physical medicine and rehabilitation》2018,99(12):2637-2648
The purpose of this Special Communication is to summarize guidelines and recommendations stemming from an expert panel convened by the National Institutes of Health, National Center for Medical Rehabilitation Research (NCMRR) for a workshop entitled The Future of Medical Rehabilitation Clinical Trials, held September 29-30, 2016, at the NCMRR offices in Bethesda, Maryland. The ultimate goal of both the workshop and this summary is to offer guidance on clinical trials design and operations to the medical rehabilitation research community, with the intent of maximizing the effect of future trials. 相似文献
995.
Cognitive‐Behavioral Therapy for Insomnia to Reduce Chronic Migraine: A Sequential Bayesian Analysis 下载免费PDF全文
996.
997.
Guido van Amerongen Kawita Kanhai Anne Catrien Baakman Jules Heuberger Erica Klaassen Tim L. Beumer Rob L.M. Strijers Joep Killestein Joop van Gerven Adam Cohen Geert Jan Groeneveld 《Clinical therapeutics》2018,40(9):1467-1482
Purpose
The aim of the present study was to evaluate the efficacy of an oral formulation of Δ9-tetrahydrocannabinol (ECP002A) in patients with progressive multiple sclerosis (MS).Methods
This accelerated proof-of-concept study consisted of 2 phases: a crossover challenge (dose-finding) phase and a 4-week, parallel, randomized, placebo-controlled treatment phase. Twenty-four patients with progressive MS and moderate spasticity were enrolled. During the treatment phase, biomarkers for efficacy and secondary pharmacodynamic effects were measured at baseline and after 2 and 4 weeks of treatment. Serum samples were collected to determine pharmacokinetic properties and perform population modeling. Safety and tolerability profiles were assessed based on adverse events and safety measurements.Findings
Pain was significantly reduced when measured directly after administration of ECP002A in the clinic but not when measured in a daily diary. A similar pattern was observed in subjective muscle spasticity. Other clinical outcomes were not significantly different between active treatment and placebo. Cognitive testing indicated that there was no decline in cognition after 2 or 4 weeks of treatment attributable to ECP002A compared with placebo.ImplicationsThis study specifically underlines the added value of thorough investigation of pharmacokinetic and pharmacodynamic associations in the target population. Despite the complex interplay of psychoactive effects and analgesia, the current oral formulation of Δ9-tetrahydrocannabinol may play a role in the treatment of spasticity and pain associated with MS because it was well tolerated and had a stable pharmacokinetic profile. 相似文献998.
999.
Ippei Ikushima Lene Jensen Anne Flint Tomoyuki Nishida Jeppe Zacho Shin Irie 《Advances in therapy》2018,35(4):531-544
Introduction
Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.Methods
In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC0–168h)].Results
Steady-state exposure of semaglutide was similar for both populations: AUC0–168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (Cmax) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02. Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC0–168h ERR 1.11; Cmax ERR 1.14). Dose-dependent increases in AUC0–168h and Cmax occurred in both populations. Accumulation was as expected, based on the half-life (t1/2, ~ 1 week) and dosing interval of semaglutide. Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo. No new safety issues were identified.Conclusions
The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects.Funding
Novo Nordisk A/S, Denmark.Trial registration
ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.1000.
Kara E. Bischoff David L. ORiordan Kristyn Fazzalaro Anne Kinderman Steven Z. Pantilat 《Journal of pain and symptom management》2018,55(3):881-889