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51.
OBJECTIVE—To evaluate the efficacy, safety, and tolerability of pregabalin across the effective dosing range, to determine differences in the efficacy of three times daily (TID) versus twice daily (BID) dosage schedules, and to use time-to-event analysis to determine the time to onset of a sustained therapeutic effect using data from seven trials of pregabalin in painful diabetic peripheral neuropathy (DPN).RESEARCH DESIGN AND METHODS—Data were pooled across seven double-blind, randomized, placebo-controlled trials using pregabalin to treat painful DPN with dosages of 150, 300, and 600 mg/day administered TID or BID. Only one trial included all three of these dosages, and TID dosing was used in four. All studies shared fundamental selection criteria, and treatment durations ranged from 5 to 13 weeks.RESULTS—Pooled analysis showed that pregabalin significantly reduced pain and pain-related sleep interference associated with DPN (150, 300, and 600 mg/day administered TID vs. placebo, all P ≤ 0.007). Only the 600 mg/day dosage showed efficacy when administered BID (P ≤ 0.001). Pain and sleep interference reductions associated with pregabalin appear to be positively correlated with dosage; the greatest effect was observed in patients treated with 600 mg/day. Kaplan-Meier analysis revealed that the median time to onset of a sustained (≥30% at end point) 1-point improvement was 4 days in patients treated with pregabalin at 600 mg/day, 5 days in patients treated with pregabalin at 300 mg/day, 13 days in patients treated with pregabalin at 150 mg/day, and 60 days in patients receiving placebo. The most common treatment-emergent adverse events were dizziness, somnolence, and peripheral edema.CONCLUSIONS—Treatment with pregabalin across its effective dosing range is associated with significant, dose-related improvement in pain in patients with DPN.The prevalence of diabetic neuropathy is as high as 50% in patients who have had diabetes for 25 years (1), and painful diabetic peripheral neuropathy (DPN) occurs in up to 26% of all people with diabetes (2). Symptoms range from mild dysesthesias to severe unremitting pain that can profoundly impact patients’ lives (3,4).Medications of several different classes are used to treat painful DPN with varying degrees of efficacy, safety, and tolerability. The antiepileptic agents gabapentin and pregabalin have attained widespread use in the treatment of painful DPN. These agents bind to the auxiliary α2-δ subunit of the voltage-sensitive calcium channel, thereby decreasing Ca2+ influx at nerve terminals and modulating neurotransmitter release (5).There are seven double-blind, randomized, placebo-controlled trials in painful DPN with pregabalin (6–12), five of which are published in full (7–11). The effective dosing range for treatment of neuropathic pain syndromes is 150 to 600 mg/day, administered either three times daily (TID) or twice daily (BID). Among the seven trials, dosages of 150, 300, and 600 mg/day were used, but only one trial included all three of these dosages. Thus, individually, the seven trials present an incomplete picture of the effective dosing range. In addition, TID dosing was used in the first four trials, whereas the three most recent trials of pregabalin in painful DPN used BID dosing.The objective of the current report is to use the pooled data from these seven trials to evaluate the efficacy, safety, and tolerability of pregabalin across the effective dosing range. We also use these data to determine differences in the efficacy of TID and BID dosing schedules. Finally, we use a time-to-event analysis of the pooled data to determine the time to onset of a sustained therapeutic effect across the range of doses. 相似文献
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Viegas VN Abreu ME Viezzer C Machado DC Filho MS Silva DN Pagnoncelli RM 《Photomedicine and laser surgery》2007,25(6):467-473
OBJECTIVE: This study evaluated the action of low-level laser therapy (LLLT) on the modulation of inflammatory reactions during wound healing in comparison with meloxicam. BACKGROUND DATA: LLLT has been recommended for the postoperative period because of its ability to speed healing of wounds. However, data in the literature are in disagreement about its anti-inflammatory action. METHODS: Standardized circular wounds were made on the backs of 64 Wistar rats. The animals were divided into four groups according to the selected postoperative therapy: group A-control; group B-administration of meloxicam; and groups C and D-irradiation with red (lambda = 685 nm) and infrared (lambda = 830 nm) laser energy, respectively. The animals were killed at 12, 36, and 72 h and 7 days after the procedure. RESULTS: Microscopic analysis revealed significant vascular activation of irradiated sites in the first 36 h. Only group B showed decreases in the intensity of polymorphonuclear infiltrates and edema. Group D showed a higher degree of organization and maturation of collagen fibers than the other groups at 72 h. The animals in group C showed the best healing pattern at 7 days. The anti-inflammatory action of meloxicam was confirmed by the results obtained in this research. The quantification of interleukin-1beta (IL-1beta) mRNA by real-time polymerase chain reaction (PCR) did not show any reduction in the inflammatory process in the irradiated groups when compared to the other groups. CONCLUSIONS: LLLT improves the quality of histologic repair and is useful during wound healing. However, with the methods used in this study the laser energy did not minimize tissue inflammatory reactions. 相似文献
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Hatice Emir Kursat Ceylan Zeynep Kizilkaya Hakan Gocmen Hakki Uzunkulaoglu Erdal Samim 《European archives of oto-rhino-laryngology》2007,264(6):595-599
Our objective was to identify the factors that could influence the success rate of type 1 tympanoplasty in a tertiary care
centre where both residents and senior surgeons perform this operation. Six hundred and seven patients who had been performed
type 1 tympanoplasty as a primary otologic surgery between January 1997 and December 2004 were retrospectively chart reviewed.
The patients had intact and mobile ossicular chain peroperatively. Patients with any other macroscopic otologic pathology
like cholesteatoma, granulation in the middle ear and osteitis in mastoid cells were excluded from the study. Dry ear, intact
and mobile tympanic membrane, improvement of the hearing by at least 10 dB and air-bone gap less than 25 dB were accepted
as success criteria after 12 months of follow-up period. Chi-square test was used for statistical comparison of the different
influencing factors. The male gender, younger age, smaller-sized perforations and experience of the surgeon were stated as
good prognostic factors due to statistical evaluation. Afterwards the data of the study group was reanalysed in order to decide
the cases for the residents. Finally, it was observed that seniors had better results in cases with perforations greater than
50%, dry ears and patients older than 16 years. In training and research clinics where both residents and senior surgeons
perform type 1 tympanoplasty, the rate of success can be enhanced if patients with perforations greater than 50%, dry ears
and patients older than 16 years are operated by the senior surgeons. The reason for this is that these groups have the overall
worse results and should by argument be done by senior surgeons. 相似文献
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Statement of problem
Studies that evaluated the effect of dental technician disparities on the accuracy of presectioned and postsectioned definitive casts are lacking.Purpose
The purpose of this in vitro study was to evaluate the accuracy of presectioned and postsectioned definitive casts fabricated by different dental technicians by using a 3-dimensional computer-aided measurement method.Material and methods
An arch-shaped metal master model consisting of 5 abutments resembling prepared mandibular incisors, canines, and first molars and with a 6-degree total angle of convergence was designed and fabricated by computer-aided design and computer-aided manufacturing (CAD-CAM) technology. Complete arch impressions were made (N=110) from the master model, using polyvinyl siloxane (PVS) and delivered to 11 dental technicians. Each technician fabricated 10 definitive casts with dental stone, and the obtained casts were numbered. All casts were sectioned, and removable dies were obtained. The master model and the presectioned and postsectioned definitive casts were digitized with an extraoral scanner, and the virtual master model and virtual presectioned and postsectioned definitive casts were obtained. All definitive casts were compared with the master model by using computer-aided measurements, and the 3-dimensional accuracy of the definitive casts was determined with best fit alignment and represented in color-coded maps. Differences were analyzed using univariate analyses of variance, and the Tukey honest significant differences post hoc tests were used for multiple comparisons (α=.05).Results
The accuracy of presectioned and postsectioned definitive casts was significantly affected by dental technician disparities (P<.001). The largest dimensional changes were detected in the anterior abutments of both of the definitive casts. The changes mostly occurred in the mesiodistal dimension (P<.001).Conclusions
Within the limitations of this in vitro study, the accuracy of presectioned and postsectioned definitive casts is susceptible to dental technician differences. 相似文献59.
Familial deletion of the HOXA gene cluster associated with Hand–Foot–Genital syndrome and phenotypic variability 下载免费PDF全文
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