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151.
K Nakagawa T Tamura S Negoro S Kudoh N Yamamoto N Yamamoto K Takeda H Swaisland I Nakatani M Hirose R-P Dong M Fukuoka 《Annals of oncology》2003,14(6):922-930
BACKGROUND: This phase I dose-escalating study investigated the tolerability and toxicity of the selective epidermal growth factor receptor tyrosine kinase inhibitor gefitinib ('Iressa', ZD1839) in Japanese patients with solid tumors. Thirty-one patients were included. PATIENTS AND METHODS: Patients initially received a single oral dose of gefitinib followed by 10-14 days of observation. Oral gefitinib was subsequently administered on 14 consecutive days, every 28 days. Dose escalation was from 50 mg/day to a maximum of 925 mg/day or dose-limiting toxicity (DLT). RESULTS: Most adverse events were mild (grade 1/2); the most frequent were an acne-like rash and gastrointestinal effects. Two of six patients at 700 mg/day had DLT; no further dose escalation occurred. C(max) was reached within 3-7 h and exposure to gefitinib increased with dose. Mean terminal half-life following multiple dosing was 50.1 h (range 27.8-79.7 h). A partial response (duration 35-361 days) was observed in five of the 23 patients with non-small-cell lung cancer over a range of doses (225-700 mg/day), and seven patients with a range of tumors had disease stabilization (duration 40-127 days). CONCLUSIONS: In conclusion, gefitinib showed a favorable tolerability profile in Japanese patients. The safety profile, pharmacokinetic parameters and antitumor activity observed in our study are comparable to those observed in patients from the USA and Europe. 相似文献
152.
153.
A. Tamura K. Agematsu R. Urasawa K. Naganuma A. Komiyama 《European journal of pediatrics》1998,157(6):475-478
Systemic lupus erythematosus (SLE) was observed in a 7-year-old boy with IgG2 and IgG4 subclass deficiencies who had been treated with immunoglobulin (100–200 mg/kg/4 weeks) since 2 years of age. The mother and
the half-brother displayed the same deficiency. Serum IgG mainly consisted of IgG1 (98.9%) during the acute phase of SLE due to transient IgG3 deficiency. While he had no common manifestations of SLE such as arthritis or nephropathy, he developed cardiac tamponade
due to massive pericardial effusion.
Conclusion The clinical features of SLE in the present case such as the development of cardiac tamponade and the absence of renal involvement
may result from the markedly imbalanced IgG subclass distribution among auto-antibodies.
Received: 20 May 1997 and in revised form: 7 October 1997 / Accepted: 21 October 1997 相似文献
154.
Kasai T; Ohe Y; Nishio K; Kunitoh H; Tamura T; Sekine I; Kubota K; Yamamoto N; Nakamura Y; Shinkai T; Kodama T; Saijo N 《Japanese journal of clinical oncology》1998,28(3):214-221
BACKGROUND: It is important to minimize the incidence of ineligible cases
to improve the quality of clinical trials. To determine factors which may
influence the incidence of ineligible cases, the incidence of and reasons
for ineligibility in clinical trials were retrospectively analyzed.
METHODS: We retrospectively examined the incidence of and reasons for
ineligibility for inclusion in eight clinical trials conducted by the Lung
Cancer Chemotherapy Study Group of the Japan Clinical Oncology Group and
four trials financed by trust funds from a pharmaceutical company. RESULTS:
In these 12 clinical studies, the incidence of ineligibility was 4.2%
(32/762) (range 0-10.6%). Specific factors that might influence the
incidence of ineligible cases were then analyzed. There was a significant
difference in the incidence of ineligibility between the methods of
registration (P < 0.05). The incidences using a central registration and
without using a central registration system were 2.8% (9/322) and 5.2%
(23/440) respectively. We also analyzed ineligible cases in clinical
studies published in the Journal of Clinical Oncology. In clinical studies
published in the Journal of Clinical Oncology recently and 10 years ago,
the incidences of ineligible cases were 5.0% (942/18 878) and 4.1%
(206/4995) respectively. In clinical studies on lung cancer published in
the Journal of Clinical Oncology from 1984 to 1995, the incidence of
ineligible cases was 4.7% (900/19,116). There was no significant difference
in the incidence of ineligible cases between our 12 studies and the Journal
of Clinical Oncology clinical studies by the chi 2 test (P > 0.05).
CONCLUSIONS: We conclude that the incidence of ineligible cases in our
studies is similar to that in clinical trials published in the Journal of
Clinical Oncology. Central registration systems are useful for checking for
ineligibility, and to increase the quality of clinical trials.
相似文献
155.
Emergency and elective embolotherapy of various systemic arteries in 64 patients was carried out at a tertiary centre of Armed Forces. Specific indications were haemoptysis (n=43), preoperative (n=18), haematuria (n=1), epistaxis (n=1) and chemoembolization (n=1). The procedures were performed with gelfoam pellets (n=46), gelfoam pellets and absolute alcohol (n=1), polyvinyl alcohol particles (PVA) (n=14), steel coils (n=2) and Adriamycin-in-oil emulsion (n=1). Embolotherapy resulted in complete haemostasis in 37 (82.2%) out of 45 cases of haemorrhage. In eight cases (17.8%), it resulted in significant improvement. Complete haemostasis was achieved in both cases of haematuria and epistaxis. Pre-operative embolotherapy resulted in considerable reduction of peroperative blood loss in all the cases. Chemoembolization of Hepatocellular carcinoma resulted in partial regression of the tumour. The purpose of this study was to assess the efficacy, safety and reliability of vascular embolotherapy for control of life threatening haemorrhage and preoperative reduction of lesions.KEY WORDS: Embolization, Embolotherapy, Haemorrhage 相似文献
156.
157.
M Hasumura K Yasuhara T Tamura T Imai K Mitsumori M Hirose 《Food and chemical toxicology》2004,42(3):439-444
The subchronic toxicity of enzymatically decomposed rutin, which consists mainly of isoquercitrin, was investigated in male and female Wistar rats with dietary administration at concentrations of 0, 0.2, 1 and 5% for 13 weeks. No mortality or abnormal clinical signs were observed throughout the experimental period in any groups. Body weight gain was reduced from week 10 to the end of the experiment in the 5% dosed males as compared to the 0% controls. Decreased erythrocytic parameters, i.e. red blood cell count, hemoglobin concentration and hematocrit, and significantly lowered serum triglyceride levels were also detected in the 5% males. Organ weight measurement, macro and microscopic observation revealed no test substance-related toxicological changes. Based on the above findings, no-observed-adverse-effect levels (NOAELs) for male and female rats were estimated to be 1 and 5%, respectively, translating into 539 and 3227 mg/kg b.w./day. 相似文献
158.
159.
Saori Matsuo Miwa Takahashi Kaoru Inoue Kei Tamura Kaoru Irie Yukio Kodama Akiyoshi Nishikawa Midori Yoshida 《Experimental and toxicologic pathology》2013,65(6):863-873
Patched1 (Ptch1) encodes a receptor for Sonic hedgehog (Shh) and is major gene related to human medulloblastoma (MB) in the Shh subgroup. MB is thought to arise from residual granule cell precursors (GCPs) located in the external granular layer (EGL) of the developing cerebellum. As the detailed preneoplastic changes of MB remain obscure, we immunohistochemically clarified the derived cell, early events of MBs, and the cerebellar developmental processes of Ptch1+/? (Ptch1) mice, an animal model of human MB of the Shh subgroup. In Ptch1 mice, the earliest proliferative lesions were detected at PND10 as focal thickened areas of outer layer of the EGL. This area was composed of GCP-like cells with atypia and nuclei disarrangement. In the latter cerebellar developmental period, GCP-like cell foci were detected at high incidence in the outermost area of the cerebellum. Their localization and morphological similarities indicated that the foci were derived from GCPs in the EGL. There were two types of the foci. A Ki-67-positive focus was found in Ptch1 mice only. This type resembled the GCPs in the outer layer of EGL characterized by having proliferating activity and a lack of neuronal differentiation. Another type of focus, Ki-67-negative, was observed in both genotypes and exhibited many of the same features of mature internal granule cells, suggesting that the focus had no preneoplastic potential. Due to morphological, immunohistochemical characteristics, our results indicate that the focal thickened area of EGL and Ki-67-positive foci are preneoplastic lesions of MB. 相似文献
160.