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排序方式: 共有3399条查询结果,搜索用时 15 毫秒
1.
Marta López-Fauqued Laura Campora Frédérique Delannois Mohamed El Idrissi Lidia Oostvogels Ferdinandus J. De Looze Javier Diez-Domingo Thomas C. Heineman Himal Lal Janet E. McElhaney Shelly A. McNeil Wilfred Yeo Fernanda Tavares-Da-Silva 《Vaccine》2019,37(18):2482-2493
Background
The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.Methods
Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30?days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12?months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.Results
Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.Conclusions
No safety concerns arose, supporting the favorable benefit-risk profile of RZV. 相似文献2.
3.
Alberto Rivero Luis Crovetto Lidia Lopez Ricardo Maselli Martín Nogus 《Muscle & nerve》1995,18(9):943-947
We performed single fiber electromyography (SFEMG) in the superior rectus and levator palpebralis (SR-LP) muscles of 17 patients with pure ocular myasthenia gravis (MG) and 9 controls. Thirteen patients were also assessed with SFEMG in the orbicularis oculi (OO) muscle. All the MG patients but none of the control subjects showed abnormal SFEMG jitter in the SR-LP muscles. On the other hand, only 62% of the MG patients had abnormal SFEMG jitter in the OO muscle. The procedure was well tolerated by the patients, and complications were minor. We conclude that SFEMG of the SR–LP muscles is a safe and highly sensitive technique for the diagnosis of ocular MG. © 1995 John Wiley & Sons, Inc. 相似文献
4.
5.
Individualized anticoagulation with dermatan sulphate for haemodialysis in chronic renal failure 总被引:1,自引:0,他引:1
Boccardo P; Melacini D; Rota S; Mecca G; Boletta A; Casiraghi F; Gianese F 《Nephrology, dialysis, transplantation》1997,12(11):2349-2354
Background: Dermatan sulphate (DS) is a selective
thrombin inhibitor with antithrombotic properties and low bleeding
potential. In preliminary studies it was reported to be effective for
preventing clot formation in the haemodialysis circuit.
Methods: Ten patients on maintenance haemodialysis for
chronic renal failure underwent three consecutive investigation phases. In
phase 1 (individual dose titration), repeated dialyses were preformed with
increasing doses of DS until successful dialysis was obtained in two
sessions at the same dose. In phase 2, individualized DS doses were
validated by a randomized crossover comparison with the individual heparin
dose of each patient. In phase 3, each patient underwent 24 consecutive
dialyses with DS over 8 weeks. Successful dialysis was defined as
completion of the procedure without visible clot formation in the bubble
traps and lines or a greater than 20% decrease in dialyser capacity.
Dialysis efficiency (decrease in serum urea and creatinine, Kt/V), APTT
prolongation, bleeding time, and DS plasma concentrations were also
assessed. Results: Phase 1: successful dialysis was
achieved in nine patients with 4 mg/kg DS as a predialysis intravenous
bolus followed by continuous infusion of 0.65 mg/kg/h. One patient required
5 mg/kg plus 1.3 mg/kg/h. Phase 2: no statistically significant differences
were found between DS and heparin in any of the investigated variables.
Residual dialyser capacity and dialysis efficiency indexes indicated
equivalent efficacy. Phase 3: residual dialyser capacity and dialysis
efficiency did not change with time. There was no accumulation of DS in
plasma. No bleeding or thrombocytopenia were observed.
Conclusions: The dose of DS can be individually
titrated to suppress clot formation during haemodialysis as efficiently as
with individualized heparin. Such an individualized DS regimen maintains
its anticoagulant efficacy and is safe in prolonged use. Key
words: anticoagulation; clinical trial; dermatan sulphate;
haemodialysis; heparin
相似文献
6.
7.
Lidia I. Malinova Georgy V. Simonenko Tatyana P. Denisova Valery V. Tuchin 《Medical Laser Application》2007,22(3):173-184
The blood flow pattern investigations are of great importance in coronary blood flow destabilization pathogenesis understanding, and consequently in acute coronary event (ACE) risk stratification in patients with coronary heart disease. The aim of the study was to research the principal hormonal and metabolic blood flow regulative aspects and its structure in patients with ischemic heart disease and the contribution to cumulative ACE risk.A total of 182 patients with stable angina pectoris were included in the prospective study (2000–2006). Complex clinical examination, biochemical tests and blood tests were performed. Whole-blood (WB) viscosity, erythrocyte aggregation and deformation ability, WB suspension stability, and initial erythrocytes disaggregation parameter were studied. Dynamic characteristics of blood flow were obtained in the experiment.Received results allow marking the principle components of blood flow pattern with proven high prognostic value of ACE in patients with ischemic heart disease. ACE risk stratification program was developed. 相似文献
8.
Mazur G Bogunia-Kubik K Wróbel T Karabon L Polak M Kuliczkowski K Lange A 《Immunology letters》2005,96(2):241-246
Multiple myeloma (MM) is a plasma cell malignancy characterised by bone marrow infiltration and the presence of a monoclonal protein in serum and/or urine. Interleukin-6 (IL-6) has been identified as one of the most important cytokines that contributes to myeloma cell survival and proliferation. Recent investigations suggest involvement of another cytokine, IL-10, in the activation of MM cells. The present study aimed to determine whether there is an association between the polymorphic features located within the promoter regions of IL-6 and IL-10 genes and progression the disease. IL-6 (-174 G/C) and IL-10 (-1082 A/G, -819 C/T, -592 A/C) promoter single nucleotide polymorphisms (SNPs) were determined by PCR-SSP technique using commercial primers. Our single centre results were compared with the data from literature and combined in cumulative analysis employing the Mantel-Haenszel method. In univariate analysis, only IL-10 ACC genotype tended to prevail in our (Polish) group of patients. None of IL-6 genotypes or IL-10 (-1082) alleles was found to associate with MM disease either in our single centre or in cumulative study. Among patients who died within 36 months of diagnosis, a significant prevalence (P < 0.05) of IL-6 heterozygous cases as opposed to IL-6 homozygotes was observed. IL-6 and IL-10 promoter gene polymorphisms were not found to associate with the susceptibility to the development of MM. However, the IL-6 polymorphic features appeared as factors that might affect the survival of MM patients. The latter observation warrants further study. 相似文献
9.
Daniela Concolino Simona Sestito Francesca Falvo Giusy Romano Miriam Ceravolo Elisa Anastasio Licia Pensabene Elisa A. Colombo Lidia Larizza 《European journal of medical genetics》2019,62(1):73-76
Clericuzio-type poikiloderma with neutropenia is a well-defined nosological entity, but despite a remarkable number of clinical reports, no long term follow-up data has been presented to date regarding patients with this rare condition.Here we describe the results of clinical follow-up of three siblings, one male (Patient 1) and two females (Patients 2 and 3), subsequent to their first clinical and then molecular diagnosis of Clericuzio-type poikiloderma with neutropenia syndrome due to mutation of USB1gene. Patient 1 always expressed the most severe phenotype, while patients 2 and 3 showed an intermediate and mild phenotype, respectively, as observed since their first clinical evaluation. None of the patients developed skin cancer and/or myelodysplastic disorders considering the peripheral haematological findings. Lens opacity, never reported before, was found in two of the three patients.The long term follow-up observations confirm the stability over time of the pronounced intra-familial heterogeneity of clinical manifestations observed prior to and upon molecular diagnosis. We conclude that prolonged follow-up is an adjunct tool to monitor intra-familial variability of PN clinical spectrum which may favour surveillance of more serious complications of the disease among siblings, when a patient-specific clinical expressivity is present. 相似文献
10.
Phylogenetic and mathematical analyses for investigating putative mother-to-infant transmission chains when only GB virus C (hepatitis G virus) 5' noncoding region sequences are available 下载免费PDF全文