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Bioavailability and biological efficacy of a new oral formulation of salmon calcitonin in healthy volunteers. 总被引:6,自引:0,他引:6
Thierry Buclin Monica Cosma Rochat Peter Burckhardt Mo?se Azria Martine Attinger 《Journal of bone and mineral research》2002,17(8):1478-1485
Salmon calcitonin (SCT) is a well-tolerated peptide drug with a wide therapeutic margin and is administered parenterally for long-term treatments of bone diseases. Its clinical usefulness would be enhanced by the development of an orally active formulation. In this randomized crossover double-blinded phase I trial, controlled by both a placebo and a parenteral verum, we have tested a new oral formulation of SCT associated with a caprylic acid derivative as carrier. Eight healthy volunteers received single doses of 400, 800, and 1200 microg of SCT orally, a placebo, and a 10-microg (50 IU) SCT intravenous infusion. SCT was reliably absorbed from the oral formulation, with an absolute bioavailability of 0.5-1.4%, depending on the dose. It induced a marked, dose-dependent drop in blood and urine C-terminal telopeptide of type I collagen (CTX), a sensitive and specific bone resorption marker, with the effects of 1200 microg exceeding those of 10 microg intravenously. It also decreased blood calcium and phosphate, and increased the circulating levels of parathyroid hormone (PTH) and, transiently, the urinary excretion of calcium. It was well-tolerated, with some subjects presenting mild and transient nausea, abdominal cramps, diarrheic stools, and headaches. This study shows that oral delivery of SCT is feasible with reproducible absorption and systemic biological efficacy. Such an oral formulation could facilitate the use of SCT in the treatment of osteoporosis and other bone diseases. 相似文献
6.
He Li Lawrence M Schopfer Florian Nachon Marie-Thérèse Froment Patrick Masson Oksana Lockridge 《Toxicological sciences》2007,100(1):136-145
Some organophosphorus compounds are toxic because they inhibit acetylcholinesterase (AChE) by phosphylation of the active site serine, forming a stable conjugate: Ser-O-P(O)-(Y)-(XR) (where X can be O, N, or S and Y can be methyl, OR, or SR). The inhibited enzyme can undergo an aging process, during which the X-R moiety is dealkylated by breaking either the P-X or the X-R bond depending on the specific compound, leading to a nonreactivatable enzyme. Aging mechanisms have been studied primarily using AChE. However, some recent studies have indicated that organophosphate-inhibited butyrylcholinesterase (BChE) may age through an alternative pathway. Our work utilized matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry to study the aging mechanism of human BChE inhibited by dichlorvos, echothiophate, diisopropylfluorophosphate (DFP), isomalathion, soman, sarin, cyclohexyl sarin, VX, and VR. Inhibited BChE was aged in the presence of H2O18 to allow incorporation of (18)O, if cleavage was at the P-X bond. Tryptic-peptide organophosphate conjugates were identified through peptide mass mapping. Our results showed no aging of VX- and VR-treated BChE at 25 degrees C, pH 7.0. However, BChE inhibited by dichlorvos, echothiophate, DFP, soman, sarin, and cyclohexyl sarin aged exclusively through O-C bond cleavage, i.e., the classical X-R scission pathway. In contrast, isomalathion aged through both X-R and P-X pathways; the main aged product resulted from P-S bond cleavage and a minor product resulted from O-C and/or S-C bond cleavage. 相似文献
7.
Anne?Helene?Garde ?se?Marie?Hansen Johnni?Hansen 《International archives of occupational and environmental health》2009,82(10):1219-1228
Background
Sleep problems are common effects of shift work. The aim of the present study was to evaluate how different types of shift affect sleep and sleepiness, and to relate sleepiness to urinary 6-sulfatoxymelatonin. 相似文献8.
J. Åberg B. Abrahamsson M. Grind G. Nyberg B. Olofsson 《European journal of clinical pharmacology》1997,52(6):471-477
Objective: The primary aim of this study was to investigate whether bioequivalence is achieved for a new fixed combination of extended-release
(ER) felodipine and controlled-release (CR/ZOK) metoprolol␣compared with the free combination of felodipine ER metoprolol
CR/ZOK. The second aim was to study whether there was an interaction in pharmacokinetics and pharmacodynamics between felodipine
and metoprolol when administered as ER formulation.
Methods: Two four-way cross-over studies were performed in 36 young subjects and 24 elderly subjects with frequent measurement of
drug plasma concentrations, blood pressures and heart rate. The pharmacokinetic analysis included enantioselective analysis
in six subjects.
Results: Bioequivalence between the fixed combination and the free combination was observed for the two drugs (mean difference 27%)
except for a minor deviation regarding Cmax of metoprolol in the elderly. No significant interaction was shown except for a small increase (6%) of metoprolol AUC in
the younger subjects. Mean plasma S-/R-enantiomer ratios were almost identical for the different treatments. Blood pressure and heart rate was significantly reduced
for the fixed combination compared with felodipine ER in the younger and the elderly subjects. No significant difference regarding
pharmacodynamics was detected between the fixed combination and the corresponding free combination.
Conclusion: The fixed combination consistently provides fairly constant and effective felodipine and metoprolol concentrations after
once-daily administration of one tablet. It is clinically interchangeable with the free combination of metoprolol CR/ZOK tablets
and felodipine ER tablets. Finally, felodipine and metoprolol do not interact on a pharmacokinetic level when administered
as the fixed combination.
Received: 29 October 1996 / Accepted in revised form: 21 March 1997 相似文献
9.
To determine the influence of the duration of postoperative lumbar immobilization with the aid of a rigid lumbar orthosis on the consolidation of posterolateral lumbosacral fusions, 22 patients with no previous osseous spinal surgery and with fusion without osteosynthesis due to spondylolysis-olisthesis Grade 1 to 2 or intervertebral disc or facet joint disorder were examined by roentgen stereophotogrammetric analysis in supine and erect positions and by conventional radiography for 1 year after surgery. In Series 1, patients (n = 11) were instructed to keep the trunk straight with the aid of a molded, rigid lumbar orthosis for 5 months after surgery; and in Series 2 (n = 11), the same instructions were given, but for 3 months. In Series 1, osseous fusion was seen on radiographs in eight patients. In these patients, the intervertebral translations between the fused vertebrae began to decrease 3-6 months after surgery, and within 1 year, the fusions became rigid, as defined by roentgen stereophotogrammetric analysis, or intervertebral translations of mostly less than 1 mm persisted. In three patients with poor fusion still seen on radiographs 1 year after surgery, no rigid fusion was obtained and intervertebral translations of up to 10 mm persisted. In Series 2, a similar roentgen stereophotogrammetric analysis pattern was noted in two patients with osseous fusion and in seven with poor fusion seen on radiographs. The fusion was radiographically doubtful in two patients. In these patients, the intervertebral translations decreased, but translations of 1.5 mm persisted 1 year after surgery.(ABSTRACT TRUNCATED AT 250 WORDS) 相似文献