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1.

Purpose

A hydrogel rectal spacer (HRS) is a medical device that is approved by the U.S. Food and Drug Administration to increase the separation between the prostate and rectum. We conducted a cost-effectiveness analysis of HRS use for reduction in radiation therapy (RT) toxicities in patients with prostate cancer (PC) undergoing external beam RT (EBRT).

Methods and Materials

A multistate Markov model was constructed from the U.S. payer perspective to examine the cost-effectiveness of HRS in men with localized PC receiving EBRT (EBRT alone vs EBRT + HRS). The subgroups analyzed included site of HRS placement (hospital outpatient, physician office, ambulatory surgery center) and proportion of patients with good baseline erectile function (EF). Data on EF, gastrointestinal and genitourinary toxicities incidence, and potential risks associated with HRS implantation were obtained from a recently published randomized clinical trial. Health utilities and costs were derived from the literature and the 2018 Physician Fee Schedule and were discounted 3% annually. Quality-adjusted life years (QALYs) and costs were modeled for a 5-year period from receipt of RT. Probabilistic sensitivity analysis and value-based threshold analyses were conducted.

Results

The per-patient 5-year incremental cost for spacers administered in a hospital outpatient setting was $3578, and the incremental effectiveness was 0.0371 QALYs. The incremental cost-effectiveness ratio was $96,440/QALY for patients with PC undergoing HRS insertion in a hospital and $39,286/QALY for patients undergoing HRS insertion in an ambulatory facility. For men with good baseline EF, the incremental cost-effectiveness ratio was $35,548/QALY and $9627/QALY in hospital outpatient and ambulatory facility settings, respectively.

Conclusions

Based on the current Medicare Physician Fee Schedule, HRS is cost-effective at a willingness to pay threshold of $100,000. These results contain substantial uncertainty, suggesting more evidence is needed to refine future decision-making.  相似文献   
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We introduce the concept of the metabolic centroid spectrum as the feature space to characterize the distribution of metabolic activity in three-dimensional brains. The method computes the metabolic centroid of a brain subvolume for each increment of metabolic activity occurring in the whole brain. The result is the metabolic spectral signature, a continuous three-dimensional curve whose shape reflects the distribution of metabolic rates in the brain. The method's sensitivity to metabolic distribution asymmetries is greatly increased over that of the metabolic centroid method, while retaining its advantages; it is almost invariant to head size, head positioning, photon scatter, and the positron emission tomography (PET) camera's full width at half-maximum. It does not require magnetic resonance, computed tomography, or x-ray images. To test the method we analyzed the metabolic PET images of 40 normal subjects and 20 schizophrenics. The results show a unification of several metabolic characteristics of schizophrenic brains, such as laterality, hypofrontality, cortical/subcortical abnormalities, and overall brain hypometabolism, which were identified by different laboratories in separate studies using differing methodologies. Here they are presented by a single automatic objective method.  相似文献   
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A prospective blinded study was performed on 191 high-risk patients with pregnancies ranging from 25 to 42 weeks gestation to investigate the value of a single Doppler analysis of the umbilical artery blood flow waveform (systolic-to-diastolic ratio, S/D) for predicting poor perinatal outcome. This was defined as the presence of heavy meconium, delivery of a growth-retarded infant, an umbilical cord arterial pH less than 7.2, or a 5-minute Apgar score less than 7. The interval between Doppler examination and delivery ranged from 12 hours to 15 weeks. No clinical data were available to the examiner performing the Doppler study. Moreover, the Doppler measurements were unknown to the attending physicians. The sensitivity, specificity, and positive and negative predictive values of the Doppler study in predicting outcome were 30.4%, 92.9%, 36.8%, and 92.6%, respectively, with an adverse outcome prevalence of 12%. These results indicate that a single random S/D ratio from the umbilical artery is not an adequate screening test for the risk of perinatal complications.  相似文献   
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The quadriceps tendon and patellar tendon (ligament) were repaired with a Dacron vascular graft used as a tension suture material. In cases of quadriceps tendon ruptures, the Dacron graft is passed transversely through the patellar ligament just below the patella and crossed transversely at the level of the musculotendinous junction with two loops applying tension to the tendon, which brings the tendon ends together by creating a solid structure. In cases of patellar ligament ruptures, the Dacron graft is passed through a hole in the tibia posteriorly to the tibial tuberosity instead of through the patellar ligament below the patella. This technique enables early mobilization on the first day after surgery. The technique was first tested on six dogs with severed quadriceps tendons and patellar ligaments that were repaired with this suture method. All of the animals recovered from surgery and walked and ran normally on the repaired legs within 27 days and with only mild limping after 17 days. The technique was then used on six patients, four with complete quadriceps tendon rupture and two with complete tear (avulsion) of the patellar ligament (tendon). In all of the patients, excellent surgical results were obtained and leg immobilization was virtually eliminated. Physical therapy was prescribed the first day after surgery. The rehabilitation period was significantly reduced.  相似文献   
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The 55-kD bactericidal/permeability-increasing protein (BPI) is a neutrophil-derived polypeptide belonging to a family of lipid and endotoxin binding proteins. BPI is composed of two functionally distinct structural domains: a potently antibacterial and antiendotoxin ∼ 20-kD aminoterminal half, and an opsonic carboxy-terminal portion. In multiple animal models, a recombinant amino-terminal fragment of BPI (rBPI21) is nontoxic and protects against gram-negative bacteria and endotoxin. In humans, rBPI21 is also nontoxic and nonimmunogenic and has undergone phase II/III clinical trials with apparent therapeutic benefit.  相似文献   
8.
BACKGROUND: According to the Center for Disease Control and Prevention (CDC), an estimated 30 million people ride horses each year in the United States. Horseback riding related injuries are common, with an estimated 50,000 emergency room visits annually. The popularity of recreational horseback riding has increased in South Florida and the incidence of associated traumatic injuries is a reflection of this. MATERIAL AND METHODS: Retrospective review of patients admitted to a state designated Level I trauma center that sustained horseback riding associated injuries between January 2000 and December 2003. Information extracted from the Trauma Center's data base included demographics, mechanism of injury and toxicology screening. RESULTS: During the review period, twenty-seven patients were identified. There were 12 men and 15 women. The average age was 36 years. The injuries occurred during pleasure riding in 23 patients and thoroughbred related activities in 4 patients. Multiple severe injuries were common and documented in 24 patients. All patients required hospitalization with an average stay of 5 days. Five patients had a positive toxicology screen on admission. No deaths were documented in this review. CONCLUSION: Horseback riding related injuries tends to be serious. Alcohol and recreational drugs may contribute to exacerbate the extent of these injuries. The use of proper protective equipment, instructions for safe riding, and discouraging drug and alcohol use during riding activities should be emphasized.  相似文献   
9.
Flavocoxid (Limbrel), a proprietary mixture of flavonoid molecules (baicalin and catechin), was tested against a traditional nonsteroidal anti-inflammatory drug, naproxen, for the management of the signs and symptoms of moderate osteoarthritis (OA) in humans. Discomfort and global disease activity were used as the primary end points, and safety assessments were also taken for both treatments as a secondary endpoint. In this double-blind study, 103 subjects were randomly assigned to receive either flavocoxid [500 mg twice daily (BID)] or naproxen (500 mg BID) in a 1-month onset of action trial. Outcome measures included the short Western Ontario and McMaster University Osteoarthritis Index, subject Visual Analogue Scale for discomfort and global response, and investigator Visual Analogue Scale for global response and fecal occult blood. Both flavocoxid and naproxen showed significant reduction in the signs and symptoms of knee OA (P ≤ .001). There were no statistically detectable differences between the flavocoxid and naproxen groups with respect to any of the outcome variables. Similarly, there were no statistically detectable differences between the groups with respect to any adverse event, although there was a trend toward a higher incidence of edema and nonspecific musculoskeletal discomfort in the naproxen group. In this short-term pilot study, flavocoxid was as effective as naproxen in controlling the signs and symptoms of OA of the knee and would present a safe and effective option for those individuals on traditional nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors. A low incidence of adverse events was reported for both groups.  相似文献   
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