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41.
Background:The effects of long-distance walking on the cardiovascular system have been little studied.Objectives:The general objective of this study was to verify these effects on the behavior of diastolic function and the cardiac biomarkers CK-MB (mass), troponin T, and NT-proBNP, in amateur athletes.Method:This longitudinal study, conducted in 2015, evaluated participants during the following 5 stages: E0 (baseline) before starting the trajectory and the others, E1, E2, E3, and E4, at the end of each day, totaling 244.7 km. At all stages, the biomarkers NT-proBNP, CK-MB (mass), and troponin T were measured. Echocardiogram was performed to analyze the E, A and E'' waves. P < 0.05 was adopted as significant.Results:The study evaluated 25 participants, with an average age of 46 ± 10.5 years and body mass index of 20.2 ± 2.3 kg/m2. Increased values were found for NT-proBNP from E0 to E1, E2, E3, and E4 (p < 0.001), CK-MB (mass) from E0 to E2 (p < 0.001), and E'' wave from E0 to E1, E2, E3, and E4 (p < 0.001). Positive correlations were identified between the following: CK-MB (mass) and troponin T (E1: r = 0.524, p = 0.010; E4: r = 0.413, p = 0.044); CK-MB (mass) and NT-proBNP (E4: r = 0.539, p = 0.006); and E/A and E'' (E0: r = 0.603, p < 0.001; E1: r = 0.639, p < 0.001; E4: r = 0.593, p = 0.002). A negative correlation was found between CK-MB (mass) and E/A (E1: r = −0.428, p = 0.041).Conclusion:The effects of intense, prolonged, and interspersed physical activity were verified based on significant variations in the behavior of CK-MB (mass), NT-proBNP, and the E'' wave. Notwithstanding the alterations found, there were no criteria suggestive of myocardial damagePalavras-chave: Walking, Biomarkers, Biological, Blood Pressure, Troponin-T, Natriuretic Peptide Brain, Athletes, Echocardiography, Doppler/methods  相似文献   
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Seamless phase II/III clinical trials in which an experimental treatment is selected at an interim analysis have been the focus of much recent research interest. Many of the methods proposed are based on the group sequential approach. This paper considers designs of this type in which the treatment selection can be based on short‐term endpoint information for more patients than have primary endpoint data available. We show that in such a case, the familywise type I error rate may be inflated if previously proposed group sequential methods are used and the treatment selection rule is not specified in advance. A method is proposed to avoid this inflation by considering the treatment selection that maximises the conditional error given the data available at the interim analysis. A simulation study is reported that illustrates the type I error rate inflation and compares the power of the new approach with two other methods: a combination testing approach and a group sequential method that does not use the short‐term endpoint data, both of which also strongly control the type I error rate. The new method is also illustrated through application to a study in Alzheimer's disease. © 2015 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.  相似文献   
44.

Purpose

In the placebo-controlled Phase III TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) trial, the oral tryptophan hydroxylase inhibitor telotristat ethyl significantly reduced bowel movement (BM) frequency during a 12-week, double-blind treatment period in 135 patients with metastatic neuroendocrine tumors with carcinoid syndrome and ≥4 BMs per day. Patients (mean [SD] age, 63.5 [8.9] years; mean [SD] body mass index, 24.9 [4.9] kg/m2) received placebo, telotristat ethyl 250 mg, or telotristat ethyl 500 mg 3 times per day (TID) in addition to somatostatin analogue therapy. Weight loss is associated with uncontrolled carcinoid syndrome and may be associated with reduced survival.

Methods

Assessment of the occurrence of weight change ≥3% at week 12 was prespecified in the statistical analysis plan.

Findings

In 120 patients with weight data available, weight gain ≥3% was observed in 2 of 39 patients (5.1%) taking placebo TID, 7 of 41 (17.1%) taking telotristat ethyl 250 mg TID, and 13 of 40 (32.5%) taking telotristat ethyl 500 mg TID (P = 0.0017) at week 12. Weight loss ≥3% was observed in 5 of 39 patients (12.8%) taking placebo TID, 4 of 41 (9.8%) taking telotristat ethyl 250 mg TID, and 6 of 40 (15.0%) taking telotristat ethyl 500 mg TID (P = 0.77). Biochemical and metabolic parameters of serum albumin and cholesterol significantly increased (P = 0.02 and P = 0.001, respectively) in patients gaining weight and decreased in patients who lost weight, suggesting an improvement in overall nutritional status.

Implications

Up to 32.5% of patients treated with telotristat ethyl experienced significant, dose-dependent weight gain, associated with reduced diarrhea severity and improved biochemical and metabolic parameters. Improved nutritional status could be an additional aspect of telotristat ethyl efficacy among patients with functioning metastatic neuroendocrine tumors. ClinicalTrials.gov identifier: NCT01677910.  相似文献   
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On the basis of examinations of altogether 197 patients the results of the changes of GOT and GPT were compared with the old and new colour tests of the AWD Dresden in normal histology, virus hepatitis, fatty liver, liver cirrhosis and posthepatic occlusion. Though the new colour test reveals a higher sensitivity, the differential diagnosis between selected liver diseases, especially virus hepatitis and posthepatic occlusion syndrome have become more difficult. The cause for this is the less significant separability between the individual regions of reference.  相似文献   
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ObjectiveThis retrospective study evaluates the occurrence and frequency of different fracture patterns in a series of computed tomography (CT) scans in terms of the AOCMF Trauma Classification (TC) orbit module and correlates the assigned defects with measurements of the fracture area in order to get an approximate guideline for fracture size predictions on the basis of the classification.Material and methodsCT scans of patients with orbital floor fractures were evaluated using the AOCMFTC to determine the topographical subregions. The coding consisted of: W = orbital wall, 1 = anterior orbit, 2 = midorbit, i = inferior, m = medial. The 3-dimensional surface area size of the fractures was quantified by the “defect body” method (Brainlab, Munich, Germany). The fracture area size and its confidence and prediction interval within each topographical subregion was estimated by regression analysis.ResultsA total of 137 CT scans exhibited 145 orbital floor fractures, which were combined with 34 medial orbital wall fractures in 31 patients. The floor fractures – W1(i)2(i) (n = 86) and W1(i) (n = 19) were the most frequent patterns. Combined floor and medial wall fractures most frequently corresponded to the pattern W1 (im)2 (im) (n = 15) ahead of W1 (im) 2(i) (n = 10). The surface area size ranged from 0.11 cm2 to 6.09 cm2 for orbital floor and from 0.29 cm2 to 5.43 cm2 for medial wall fractures.The prediction values of the mean fracture area size within the subregions were computed as follows: W1(i) = 2.25 cm2, W2(i) = 1.64 cm2, W1(i)2(i) = 3.10 cm2, W1(m) = 1.36 cm2, W2(m) = 1.65 cm2, W1(m)2(m) = 2.98 cm2, W1 (im) = 3.35 cm2, W1 (im) 2(i) = 4.63 cm2, W1 (im)2(m) = 4.06 cm2 and W1 (im)2 (im) = 7.16 cm2.ConclusionThe AOCMFTC orbital module offers a suitable framework for topographical allocation of fracture patterns inside the infero-medial orbital cavity. The involvement of the subregions is of predictive value providing estimations of the mean 3-D fracture area size.  相似文献   
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Seventy-eight patients with genitourinary tuberculosis were evaluated during a 12 year period. Active tuberculosis was confined to the genitourinary tract in all but 10 patients. Aside from five cases of miliary tuberculosis, most genitourinary infections developed from the breakdown of granulomes acquired earlier during transient dissemination from a primary pulmonary infection. Patients with genitourinary tuberculosis exhibited features of local organ dysfunction rather than systemic symptoms of infection; fever, weight loss and anorexia were uncommon. Seventy-one per cent of the patients with active tuberculosis of kidneys, ureters and bladder presented because of urinary tract symptoms. Twenty per cent were asymptomatic and were detected because of abnormal urinary sediments. The diagnosis of genitourinary tuberculosis should be suspected on the basis of an abnormal urinalysis (hematuria and/or pyuria) with negative routine cultures, and a positive tuberculin skin test. Intravenous pyelograms disclosed abnormalities in most patients but were rarely diagnostic. Serial intravenous pyelograms disclosed increasing ureteral obstruction during chemotherapy in three patients. Multiple drug chemotherapy is the mainstay of treatment, but reconstructive surgery remains important.  相似文献   
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