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- Implications for Rehabilitation
The communication highlights a number of issues that have implication for those involved in assistive technology new product development:
?The study defined over 200 well-established research and design methods and design heuristics that are available for use by those who specify and design assistive technology products, which provide a comprehensive reference list for practitioners in the field;
?The review within the study suggests only a limited number of research and design methods are regularly used by industrial design focused assistive technology new product developers; and,
?Debate is required within the practitioners working in this field to reflect on how a wider range of potentially more effective methods and heuristics may be incorporated into daily working practice.
Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent “appointed bodies”) using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs.
Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly.
Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on interpretation of legal text and ECHA helpdesk support are planned to be ready at the end of 2018. 相似文献
Methods: Blood pressure (BP), fasting lipid profiles, and anthropometric parameters were recorded in a cross-sectional study of 11,400 participants (mean age, 54 years; 53% women) from China. Logistic regression models were used to assess associations of CMI, LAP, and BAI with prevalent hypertension.
BAI was evaluated according to hip (cm)/[height (m)1.5]-18; LAP was calculated separately for men [(WC-65) × TG] and women [(WC-58) × TG]; and CMI was defined by TG/HDL-C × waist-to-height ratio.
Results: CMI, LAP, and BAI were independently correlated with higher SBP and DBP, with nonstandardized (B) coefficients ranging from 1.827 to 4.590 mmHg and 1.475 to 2.210 mmHg (all P < 0.001). After adjustment for hypertension risk factors and potential confounders, CMI, LAP, and BAI, modeled as continuous measures, carried hypertension odds (95% CI) of 1.356 (1.259–1.459), 1.631 (1.501–1.771), and 1.555 (1.454–1.662) in women, respectively, per SD increment. In men, each SD increase in CMI, LAP, and BAI experienced a 31%, 65%, and 53% higher hypertension risk, respectively. Moreover, among women, the odds ratio (95% CI) for hypertension were 2.318 (1.956–2.745), 3.548 (2.985–4.217), and 3.004 (2.537–3.557) in the 4th quartile vs the first quartile of CMI, LAP, and BAI, respectively. For men, the corresponding figures were 2.200 (1.838–2.635), 3.892 (3.238–4.677), and 3.288 (2.754–3.927), respectively.
Conclusion: Measurements of CMI, LAP, and BAI provide a more complete understanding of hypertension risk related to variation in body fat distribution and pinpoint hypertensive participants in great risk of cardiovascular disease in the future. 相似文献
Methods: Adults with ADHD Rating Scale, Version IV (ADHD-RS-IV) scores ≥24 were randomized to SHP465 MAS (50 or 75 mg), placebo, or 25 mg MAS IR in a double-blind, three-period, crossover study using a simulated adult workplace environment. On the final day of each 7-day treatment period, efficacy was assessed for 16 h postdose. Primary efficacy analyses for Permanent Product Measure of Performance (PERMP) total score averaged across all postdose assessments and each postdose time point were conducted in the intent-to-treat population using a mixed linear model. Secondary end-points included PERMP problems attempted and answered correctly and ADHD-RS-IV scores based on clinician ratings of counselor observations using the Time Segment Rating System and participant self-report. Tolerability assessments included treatment-emergent adverse events (TEAEs) and vital signs.
Results: Least squares mean (95% CI) treatment differences (combined 50/75 mg SHP465 MAS–placebo) significantly favored SHP465 MAS over placebo for PERMP total score averaged across all postdose assessments (18.38 [11.28, 25.47]; P < .0001) and at each postdose assessment (all P < .02). Nominal superiority of MAS IR over placebo for PERMP total score averaged across all postdose assessments was observed (nominal P = .0001); treatment differences between SHP465 MAS and MAS IR were not significant (nominal P = .2443). The two most frequently reported TEAEs associated with SHP465 MAS were insomnia (36.5%) and anorexia (21.2%). Mean increases in pulse and blood pressure with SHP465 MAS exceeded those of placebo.
Conclusions: SHP465 MAS (combined 50/75 mg) significantly improved PERMP total score versus placebo, with superiority observed from 2 to 16 h postdose. The tolerability profile of SHP465 MAS was similar to previous reports of SHP465 MAS in adults with ADHD.
Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT00928148 identifier is NCT00928148. 相似文献