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31.
Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer. 总被引:1,自引:0,他引:1
Ramzi Dagher Ning Li Sophia Abraham Atiqur Rahman Raji Sridhara Richard Pazdur 《Clinical cancer research》2004,10(24):8147-8151
PURPOSE: Docetaxel, a taxane previously approved for the treatment of breast cancer and non-small cell lung cancer, was approved by the United States Food and Drug Administration on May 19, 2004 for use in combination with prednisone for the treatment of metastatic androgen-independent (hormone-refractory) prostate cancer. The purpose of this summary is to review the database supporting this approval. EXPERIMENTAL DESIGN: In a randomized, global study enrolling 1,006 patients, two schedules of docetaxel were compared with mitoxantrone + prednisone as follows: MTZ q 3w, mitoxantrone 12 mg/m2 every 21 days + prednisone 5 mg twice a day for a total of 10 cycles; TXT q 3w, docetaxel 75 mg/m2 every 21 days + prednisone 5 mg twice a day for a total of 10 cycles; and TXT qw, docetaxel 30 mg/m2 days 1, 8, 15, 22, and 29 every 6 weeks + prednisone 5 mg twice a day for a total of 5 cycles. RESULTS: There was a statistically significant overall survival advantage shown for the TXT q 3w arm over MTZ q 3w (median survival 18.9 months versus 16.5 months, P = 0.0094). No overall survival advantage was shown for TXT qw compared with MTZ q 3w. The most commonly occurring adverse events included anemia, neutropenia, infection, nausea, sensory neuropathy, fluid retention, alopecia, nail changes, diarrhea, and fatigue. CONCLUSIONS: This report describes the Food and Drug Administration review supporting this first approval of a combination therapy for hormone-refractory prostate cancer based on demonstration of a survival benefit. 相似文献
32.
Antitumor effects of a monoclonal antibody that binds anionic phospholipids on the surface of tumor blood vessels in mice. 总被引:2,自引:0,他引:2
Sophia Ran Jin He Xianming Huang Melina Soares Douglas Scothorn Philip E Thorpe 《Clinical cancer research》2005,11(4):1551-1562
PURPOSE: We recently reported that anionic phospholipids, principally phosphatidylserine, become exposed on the external surface of viable vascular endothelial cells in tumors, possibly in response to oxidative stresses present in the tumor microenvironment. In the present study, we tested the hypothesis that a monoclonal antibody directed against anionic phospholipids might exert antitumor effects by causing vascular damage in tumors. EXPERIMENTAL DESIGN: A new mouse immunoglobulin G3 monoclonal antibody, 3G4, was raised that binds anionic phospholipids in the presence of serum or beta2-glycoprotein I. The antibody was tested for its ability to localize to tumor vessels and exert antitumor effects in mice. RESULTS: 3G4 recognized anionic phospholipids on the external membrane of H(2)O(2)-treated endothelial cells and in vitro. It localized specifically to tumor vascular endothelium and to necrotic tumor cells after injection into severe combined immunodeficient mice bearing orthotopic MDA-MB-435 tumors. Treatment with 3G4 retarded the growth of four different tumors in mice. It reduced the growth of established orthotopic MDA-MB-231 and MDA-MB-435 human breast tumors in mice by 75% and 65% respectively, large L540 human Hodgkin's tumors by 50%, and small syngeneic Meth A fibrosarcomas by 90%. Histologic examination revealed vascular damage, a reduction in vascular density, and a reduction in tumor plasma volume. Treatment with 3G4 induced the binding of monocytes to tumor endothelium and infiltration of macrophages into MDA-MB-435 and MDA-MB-231 tumors. No toxicity to the mice was observed. CONCLUSIONS: 3G4 localizes specifically to complexes of anionic phospholipids and serum proteins on the surface of vascular endothelial cells in tumors in mice. This results in damage to tumor vasculature and suppression of tumor growth. 相似文献
33.
Edvardas Kaminskas Ann Farrell Sophia Abraham Amy Baird Li-Shan Hsieh Shwu-Luan Lee John K Leighton Hasmukh Patel Atiqur Rahman Rajeshwara Sridhara Yong-Cheng Wang Richard Pazdur 《Clinical cancer research》2005,11(10):3604-3608
PURPOSE: This article summarizes data submitted to the U.S. Food and Drug Administration for marketing approval of azacitidine as injectable suspension (Vidaza, Pharmion Corporation, Boulder, CO) for treatment of patients with myelodysplastic syndrome. EXPERIMENTAL DESIGN: In one phase 3 controlled trial, 191 study subjects were randomized to treatment with azacitidine or to observation; an additional 120 patients were treated with azacitidine in two phase 2 single arm studies. The primary efficacy end point was the overall response rate, defined as complete or partial normalization of peripheral blood counts and bone marrow blast percentages for at least 4 weeks. RESULTS: In the controlled trial, the overall response rate was 15.7% in the azacitidine treatment group; there were no responders in the observation group (P < 0.0001). Response rates were similar in the two single arm studies. During response patients stopped being red cell or platelet transfusion dependent. Median duration of responses was at least 9 months. An additional 19% of azacitidine-treated patients had less than partial responses, most becoming transfusion independent. The most common adverse events attributed to azacitidine were gastrointestinal, hematologic, local (injection site), and constitutional. There were no azacitidine-related deaths. CONCLUSIONS: On May 19, 2004 the U.S. Food and Drug Administration approved azacitidine as injectable suspension for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. Full prescribing information is available at http://www.fda.gov/cder/foi/label/2004/050794lbl.pdf. Azacitidine is the first agent approved for treatment of myelodysplastic syndrome. 相似文献
34.
Severus E Seemuller F Berger M Dittmann S Obermeier M Pfennig A Riedel M Frangou S Moller HJ Bauer M 《BMC medicine》2012,10(1):67
ABSTRACT: BACKGROUND: Randomized, double-blind, placebo-controlled trials constitute the gold standard in clinical research when testing the efficacy of new psychopharmacological interventions in the treatment of major depression. However, the blinded use of placebo has been found to influence clinical trial outcome and may bias patient selection. DISCUSSION: To improve clinical trial design in major depression so as to reflect clinical practice more closely we propose to present patients with a balanced view of the benefits of study participation irrespective of the assignment to placebo or active treatment. In addition every participant should be given the option to finally receive the active medication. A research agenda is outlined to evaluate the impact of the proposed changes on the efficacy of the drug to be evaluated and on the demographic and clinical characteristics of the enrolment fraction with regard to its representativeness of the eligible population. SUMMARY: We propose a list of measures to be taken to improve the external validity of double-blind, placebo-controlled trials in major depression. The recommended changes to clinical trial design may also be relevant for other psychiatric as well as medical disorders in which expectations regarding treatment outcome may affect the outcome itself. 相似文献
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36.
Sophia A. Traven Russell A. Reeves Molly G. Sekar Harris S. Slone Zeke J. Walton 《The Journal of arthroplasty》2019,34(1):140-144
Background
While the 11-factor modified frailty index (mFI) has been shown to predict adverse outcomes in patients undergoing total joint arthroplasty, the 5-factor index has not been evaluated in this patient population. The goal of this study was to evaluate the utility of the mFI-5 as a predictor of morbidity and mortality in patients undergoing primary total hip and knee arthroplasty.Methods
A retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program's database for patients undergoing total hip arthroplasty and total knee arthroplasty between the years 2005 and 2016 was conducted. The 5-factor score, which includes the presence of comorbid diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, and functional status, was calculated for each patient. Multivariate logistic regression models were used to assess the relationship between the mFI-5 and postoperative complications while controlling for demographic variables.Results
One hundred forty thousand one hundred fifty-eight patients undergoing total hip arthroplasty and 226,398 patients undergoing total knee arthroplasty were identified. After adjusting for demographic variables and comorbid conditions, logistic regression analyses revealed that the mFI-5 was a strong predictor for total complications, Clavien-Dindo grade IV complications (cardiac arrest, myocardial infarction, septic shock, pulmonary embolism, postoperative dialysis, reintubation, and prolonged ventilator requirement), surgical site infections, readmission, and 30-day mortality (P < .001).Conclusions
The mFI-5 is an independent predictor of postoperative complications including life-threatening medical complications, surgical site infections, hospital readmission, and 30-day mortality after primary hip and knee arthroplasty. This clinical tool can be used to identify high-risk surgical patients and guide preoperative counseling to optimize outcomes.Level of Evidence
III. 相似文献37.
Sophia Rangwala A.B. Ashley Wysong M.D. M.S. Megha M. Tollefson M.D. Phuong Khuu M.D. Latanya T. Benjamin M.D. Anna L. Bruckner M.D. 《Pediatric dermatology》2014,31(3):402-404
Abstract: Rapidly involuting congenital hemangioma (RICH) is an uncommon, often high‐flow vascular tumor that presents at birth and involutes within the first year of life. It is clinically and histologically distinct from infantile hemangioma, kaposiform hemangioendothelioma, and tufted angioma, the latter two being associated with Kasabach–Merritt phenomenon. We present a female infant with RICH and profound, transient thrombocytopenia and review the extent and clinical course of thrombocytopenia in the context of congenital vascular tumors. 相似文献
38.
Jessica C Levenson Brian C Thoma Jessica L Hamilton Sophia Choukas-Bradley Rachel H Salk 《Sleep》2021,44(3)
Study ObjectivesStigmatized youth experience poorer sleep than those who have not experienced stigma. However, no studies have examined the sleep of gender minority adolescents (GMAs). Examining sleep disparities between GMAs and non-GMAs is critical because poor sleep is associated with mental health outcomes experienced disproportionately by GMAs. We examined sleep duration, sleep problems, and sleep quality among our sample and compared these parameters between GMAs and non-GMAs.MethodsAdolescents aged 14–18 years (n = 1,027 GMA, n = 329 heterosexual non-GMA, n = 415 sexual minority non-GMA; mean age = 16 years; 83% female sex at birth) completed a cross-sectional online survey, reporting sex assigned at birth and current gender identity, sleep duration, sleep problems (too much/too little sleep and inadequate sleep), sleep quality, and depressive symptoms.ResultsAccounting for demographic covariates, GMAs were more likely to report inadequate sleep and shorter sleep duration and had higher odds of reporting poor sleep quality and getting too little/too much sleep than heterosexual non-GMAs. After also adjusting for depressive symptoms, the finding that GMAs more often reported poor sleep quality remained significant.ConclusionsThis first large, nationwide survey of sleep among GMAs suggests that GMAs may be more likely to have poor sleep than non-GMAs. The significance of our results was reduced when adjusting for depressive symptoms, suggesting that poorer sleep may occur in the context of depression for GMAs. Future work should include objective measures of sleep, examine the emergence of sleep disparities among GMAs and non-GMAs, and explore pathways that increase risk for poor sleep among GMAs. 相似文献
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