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Kayla Ann Andrews Joel S. Owen James McCarthy David Wesche Nathalie Gobeau Thaddeus H. Grasela Jrg J. Mhrle 《CTS Clinical and Translational Science》2021,14(2):712
Volunteer infection studies using the induced blood stage malaria (IBSM) model have been shown to facilitate antimalarial drug development. Such studies have traditionally been undertaken in single‐dose cohorts, as many as necessary to obtain the dose‐response relationship. To enhance ethical and logistic aspects of such studies, and to reduce the number of cohorts needed to establish the dose‐response relationship, we undertook a retrospective in silico analysis of previously accrued data to improve study design. A pharmacokinetic (PK)/pharmacodynamic (PD) model was developed from initial fictive‐cohort data for OZ439 (mixing the data of the three single‐dose cohorts as: n = 2 on 100 mg, 2 on 200 mg, and 4 on 500 mg). A three‐compartment model described OZ439 PKs. Net growth of parasites was modeled using a Gompertz function and drug‐induced parasite death using a Hill function. Parameter estimates for the PK and PD models were comparable for the multidose single‐cohort vs. the pooled analysis of all cohorts. Simulations based on the multidose single‐cohort design described the complete data from the original IBSM study. The novel design allows for the ascertainment of the PK/PD relationship early in the study, providing a basis for rational dose selection for subsequent cohorts and studies. Study Highlights
- WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?
- WHAT QUESTION DID THIS STUDY ADDRESS?
- WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?
- HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?
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Maria Fedchenko Zacharias Mandalenakis Helena Dellborg Grel Hultsberg‐Olsson Anna Bjrk Peter Eriksson Mikael Dellborg 《Congenital heart disease》2019,14(4):549-558
Background: The aging patient with adult congenital heart disease (ACHD) faces
the risk of developing atherosclerotic disease. Patients with coarctation of the aorta
(CoA) are especially vulnerable because of an inherent high risk of developing hy‐
pertension. However, data on the prevalence of other cardiovascular risk factors are
scarce. Therefore, this study aimed to describe the prevalence of traditional cardio‐
vascular risk factors (diabetes, hypertension, hyperlipidemia, smoking, obesity, and
sedentary lifestyle) in adult patients with CoA.
Methods: Patients with CoA who were registered at the ACHD clinic in Gothenburg were asked to participate in a comprehensive cardiovascular risk assessment. This assessment included a glucose tolerance test, cholesterol profile, ambulatory blood pressure measurements, and a lifestyle questionnaire.
Results: A total of 72 patients participated. The median age was 43.5 years and 58.3% were men. Sixty‐six (91.7%) patients had ≥one cardiovascular risk factor and 40.3% had ≥three risk factors. Three (4.2%) patients were newly diagnosed with diabetes or impaired glucose tolerance. More than half of the patients had hyperlipidemia (n = 42, 58.3%) and 35 patients (48.6%) were overweight or obese. Only three (4.2%) patients smoked regularly. Of the 60 patients who underwent 24‐hour ambulatory blood pressure measurement, 33 (55.0%) were hypertensive. Of the 30 patients with known hypertension only 9 (30.0%) had well‐controlled blood pressure on ambula‐ tory blood pressure measurement.
Conclusions: Cardiovascular risk factors among patients with CoA are prevalent. This may indicate a need for more aggressive screening strategies of traditional risk fac‐ tors to minimize the risk of these patients also developing atherosclerotic disease. 相似文献
Methods: Patients with CoA who were registered at the ACHD clinic in Gothenburg were asked to participate in a comprehensive cardiovascular risk assessment. This assessment included a glucose tolerance test, cholesterol profile, ambulatory blood pressure measurements, and a lifestyle questionnaire.
Results: A total of 72 patients participated. The median age was 43.5 years and 58.3% were men. Sixty‐six (91.7%) patients had ≥one cardiovascular risk factor and 40.3% had ≥three risk factors. Three (4.2%) patients were newly diagnosed with diabetes or impaired glucose tolerance. More than half of the patients had hyperlipidemia (n = 42, 58.3%) and 35 patients (48.6%) were overweight or obese. Only three (4.2%) patients smoked regularly. Of the 60 patients who underwent 24‐hour ambulatory blood pressure measurement, 33 (55.0%) were hypertensive. Of the 30 patients with known hypertension only 9 (30.0%) had well‐controlled blood pressure on ambula‐ tory blood pressure measurement.
Conclusions: Cardiovascular risk factors among patients with CoA are prevalent. This may indicate a need for more aggressive screening strategies of traditional risk fac‐ tors to minimize the risk of these patients also developing atherosclerotic disease. 相似文献
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Torture victims often show symptoms of dental anxiety when receiving dental care, but little systematic research is available. The purpose of this study was to explore torture experiences, symptoms of post‐traumatic stress disorder (PTSD), and dental anxiety in refugees in Norway and to test the hypothesis that refugees with torture experiences are more prone to dental anxiety than refugees with no such experiences. A total of 173 refugees were interviewed shortly after an oral examination. The Modified Dental Anxiety Scale (MDAS) and the Harvard Trauma Questionnaire‐PTSS16 were administered verbally through attending interpreters. Among torture victims (47%, n = 81), the prevalence of torture experiences involving mouth or teeth was 35% and 23%, respectively. Harvard Trauma Questionnaire mean sum scores were statistically significantly higher in torture victims (34.3 vs. 24.8). Torture survivors report a larger number of symptoms of PTSD, and dental anxiety shows a higher prevalence in refugees reporting PTSD symptoms than in refugees who do not report such symptoms. When analysed using logistic regression models, the data showed the odds of high levels of dental anxiety being 6.1 times higher in refugees with torture experiences compared with other refugees and 9.3 times higher in torture victims with PTSD symptoms. Oral health professionals should be aware of these associations when providing dental care to refugees. The hypothesis that tortured refugees are more prone to dental anxiety is supported. 相似文献
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