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81.
FDA’S Perspectives on Cardiovascular Devices 总被引:1,自引:0,他引:1
Eric A. Chen Sonna M. Patel-Raman Kathryn O’Callaghan Matthew G. Hillebrenner 《Journal of cardiovascular translational research》2009,2(2):143-146
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a
review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices
and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the
health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug
& Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization
therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical
bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer
to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device
performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different
marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular
device in a U.S. clinical trial. 相似文献
82.
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84.
Introduction
Although ependymoma is the third most common pediatric brain tumor, we know little about the genetic/epigenetic basis of its initiation, maintenance, or progression. This is due in part to the heterogeneity of the disease, as well as the small sample size of the cohorts analyzed in most studies. 相似文献85.
Eric Y. T. Chan Daniel K. Ng Chung-hong Chan Ka-li Kwok Pok-yu Chow Josephine M. Cheung Suk-yu Leung 《Sleep & breathing》2009,13(1):59-63
Background and objective The purpose of this study is to assess whether Chinese children with high apnea–hypopnea index (AHI) are sleepier by a modified Epworth Sleepiness Scale (ESS).
Materials and methods Records were retrospectively reviewed. We included children who were between 3 and 12 years old, admitted for overnight polysomnogram
because of suspected obstructive sleep apnea syndrome (OSAS). A modified ESS was used to assess excessive daytime sleepiness
(EDS) of the children.
Results One hundred ninety-two Chinese children were included. Children with high AHI, defined as AHI > 5.0, were sleepier than children with AHI less than or equal
to 5. After adjustment by age, gender, and obesity, children with high AHI remained significantly sleepier. Modified ESS was
significantly correlated with AHI (rho = 0.124, 95% CI = 0.004–0.281). Modified ESS score of >8 was the best cutoff point
with the sensitivity and specificity of 0.29 and 0.91, respectively. The odds ratio of children with modified ESS > 10 having
high AHI was 4.231 (95%CI = 1.248 to 14.338) and children with modified ESS > 8 had the highest odds ratio, 4.295(95%CI = 1.66
to 11.1), of having high AHI.
Conclusion
Chinese children with high AHI appear to be sleepier than children with low AHI. Children with suspected OSAS and high modified ESS,
i.e., ESS > 8, had significantly higher odds ratio of having high AHI. Increased sleepiness is a specific but not a sensitive
symptom in snoring children with high AHI. Screening for EDS in snoring children may help us identify those with high AHI
and prioritize the management of those children.
All authors worked and the study was carried out in Kwong Wah Hospital in Hong Kong. There was no conflict of interest and
no specific source of funding for the study. 相似文献
86.
Peter Angelos 《World journal of surgery》2009,33(4):609-611
87.
Kentaroh Miyoshi Minoru Naito Tsuyoshi Ueno Shinji Hato Hideo Ino 《General thoracic and cardiovascular surgery》2009,57(11):629-632
A benign esophageal leiomyoma with abnormally increased fluorine-18-fluorodeoxyglucose uptake on positron emission tomography
(PET) was resected thoracoscopically. The tumor, of which the maximum standardized uptake value of the lesion was 4.7, was
well defined and 38 mm in diameter. Neither mitotic activity nor degeneration was found histologically; and immunoreactivity
for CD34, CD117, MIB-1, and glucose transporter-1 was negative immunohistochemically. A diagnosis of gastrointestinal stromal
tumor was ruled out by an oncogenic kinase gene mutation study. This case cautions against PET-dependent evaluation for malignant
potential of esophageal submucosal tumors. 相似文献
88.
89.
Jing‐Ping Zhang Limin Zheng Jiang‐Hai Wang Karl‐Eric Magnusson Xin Liu 《Phytotherapy research : PTR》2009,23(6):844-850
Ganoderma sinensis has been used widely in Oriental countries for the prevention and treatment of various diseases including cancer. Previous studies have shown that the lipid extract from Ganoderma exhibits direct cytotoxicity against tumor cells. Here, it is reported that the lipid extract from germinating G. sinensis spores, at lower concentrations that have no direct tumoricidal activity, induce potent antitumor immune responses in human monocytes/macrophages. Upon stimulation with the lipid extract, monocytes/macrophages exhibited markedly increased production of proinflammatory cytokines and surface expression of costimulatory molecules. Conditioned medium from stimulated cells effectively suppressed the growth of tumor cells. Apparently, the lipid extract triggered macrophage activation via a mechanism different from that associated with LPS. Moreover, it was observed that the lipid extract could partially re‐establish the antitumor activity of the immunosuppressive tumor‐associated macrophages. These results indicated that in addition to its direct tumoricidal activity, the lipid extract from G. sinensis spores could exert antitumor activity by stimulating the activation of human monocytes/macrophages. Copyright © 2008 John Wiley & Sons, Ltd. 相似文献
90.
Timothy M. Pawlik Kelly Olino Ana Luiza Gleisner Michael Torbenson Richard Schulick Michael A. Choti 《Journal of gastrointestinal surgery》2007,11(7):860-868
Some investigators have suggested that preoperative chemotherapy for hepatic colorectal metastases may cause hepatic injury
and increase perioperative morbidity and mortality. The objective of the current study was to examine whether treatment with
preoperative chemotherapy was associated with hepatic injury of the nontumorous liver and whether such injury, if present,
was associated with increased morbidity or mortality after hepatic resection. Two-hundred and twelve eligible patients who
underwent hepatic resection for colorectal liver metastases between January 1999 and December 2005 were identified. Data on
demographics, clinicopathologic characteristics, and preoperative chemotherapy details were collected and analyzed. The majority
of patients received preoperative chemotherapy (n = 153; 72.2%). Chemotherapy consisted of fluoropyrimidine-based regimens: 5-FU monotherapy, 31.6%; irinotecan, 25.9%; and
oxaliplatin, 14.6%. Among those patients who received chemotherapy, the type of chemotherapy regimen predicted distinct patterns
of liver injury. Oxaliplatin was associated with increased likelihood of grade 3 sinusoidal dilatation (p = 0.017). Steatosis >30% was associated with irinotecan (27.3%) compared with no chemotherapy, 5-FU monotherapy, and oxaliplatin
(all p < 0.05). Irinotecan also was associated with steatohepatitis, as two of the three patients with steatohepatitis had received
irinotecan preoperatively. Overall, the perioperative complication rate was similar between the no-chemotherapy group (30.5%)
and the chemotherapy group (35.3%) (p = 0.79). Preoperative chemotherapy was also not associated with 60-day mortality. In patients with hepatic colorectal metastases,
preoperative chemotherapy is associated with hepatic injury in about 20 to 30% of patients. Furthermore, the type of hepatic
injury after preoperative chemotherapy was regimen-specific.
Presented at the American Hepato-Pancreato-Biliary Association 2006 Annual Meeting, March 11, Miami, Florida. 相似文献