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101.
Tomotaka Shingaki Kentaro Taki Momoha Koyanagi Soshi Nagaoka Kenichi Yoshizawa Norika Oki 《Current medical research and opinion》2020,36(6):947-958
AbstractObjective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice.Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control.Results: The study enrolled 141 patients with T1DM and 1104 patients with T2DM. Pre-study insulin was used by 94.1% of patients with T1DM and 75.0% with T2DM. 65.4% of patients with T1DM and 64.3% with T2DM switched from the reference product (GLY-switched), while 25.0% with T2DM were insulin-naive. Adverse events were reported by 5.7% and 8.5% in T1DM and T2DM, respectively. Similar incidences were reported in GLY-switched. Adverse events were reported by 10.7% in insulin-naive T2DM. Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was –1.2 (p?=?.066) and 0.0 (p?=?.915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was –0.5% (p?<?.001) and –0.9% (p?<?.001), respectively, and –1.5% (p?<?.001) in insulin-naive T2DM.Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice. 相似文献
102.
Hiroto Horikawa Tomotaka Sato Hiroko Gomi Kazuto Yamazaki Yasuo Ishida Ikki Yuzaki Satoshi Fukuzumi 《Pediatric dermatology》2019,36(3):397-399
Both medallion‐like dermal dendrocyte hamartoma and fibroblastic connective tissue nevus are rare benign dermal lesions composed of CD34‐positive spindle cells. Although regarded as different diseases, it is sometimes difficult to distinguish between them due to their clinical and pathological similarities. We present a case of medallion‐like dermal dendrocyte hamartoma that could also be diagnosed as fibroblastic connective tissue nevus and propose the possibility of overlap in these diseases. 相似文献
103.
Kumiko Kito Junko Ishihara Ayaka Kotemori Ling Zha Rong Liu Norie Sawada Motoki Iwasaki Tomotaka Sobue Shoichiro Tsugane 《Nutrients》2020,12(11)
Acrylamide is a probable carcinogen in humans. Few studies have assessed dietary acrylamide intake and the risk of pancreatic cancer; however, these studies are based on Western populations. Our purpose was to investigate the association of dietary acrylamide intake with the risk of pancreatic cancer utilizing data from the Japan Public Health Center-based Prospective Study. We evaluated the data of 89,729 participants aged 45–74 years, who replied to a questionnaire on past medical history and lifestyle habits from 1995–1998. Dietary acrylamide intake was estimated utilizing a validated food frequency questionnaire. We calculated the hazard ratios and 95% confidence intervals by using Cox proportional-hazards regression models. The average follow-up was 15.2 years, and 576 cases of pancreatic cancer were diagnosed. In the multivariate-adjusted model, an association between dietary acrylamide intake and pancreatic cancer risk was not demonstrated (hazard ratio for the highest vs. lowest quartile = 0.83, 95% confidence interval: 0.65–1.05, p for trend = 0.07). Furthermore, in the analyses stratified by sex, smoking status, coffee consumption, green tea consumption, alcohol consumption, and body mass index, no significant association was detected. Dietary acrylamide intake was not associated with the pancreatic cancer risk in Japanese individuals. 相似文献
104.
Reliability of low platelet counts--comparison of microscopic counts with automated hematology analyzer XE-2100 总被引:1,自引:0,他引:1
Orito M Shibayama M Yoshida T Takami A Asakura H Fujita S Nakao S 《Rinsho byori. The Japanese journal of clinical pathology》2005,53(9):793-801
Sysmex XE-2100 is an automated hematological analyzer with excellent features that can count platelets by both impedance and optical fluorescent method. Particularly, it is notable that platelet counts by optical fluorescent method (PLT-O) are automatically adopted when platelet counts by impedance method (PLT-I) are less than 50 x 10(3)/microl or platelets have abnormal distribution. We compared PLT-I with PLT-O, and also with microscopic counts, using the samples with thrombocytopenia. Regarding reproducibility, mean coefficient of variation values were 5.3% in both PLT-I and PLT-O, when no flags of "PLT Abn Distribution" appeared in the samples with thrombocytopenia. Coefficient of variation values was 10.4% in PLT-I and 5.9% in PLT-O, when flags of "PLT Abn Distribution" appeared in the sample with thrombocytopenia. Correlation among the data obtained by PLT-I, PLT-O and microscopic counts were excellent. When a large difference was observed between PLT-I and PLT-O, PLT-O was more closely consistent with microscopic counts. PLT-O was useful compared with PLT-I, and this system was considered to measure platelet counts more correctly in the samples with thrombocytopenia. Thus, it was suggested that reliable platelet counts could be reported even in the samples with thrombocytopenia by switching system in XE-2100. 相似文献
105.
Optical Dynamic Analysis of Thrombus Inside a Centrifugal Blood Pump During Extracorporeal Mechanical Circulatory Support in a Porcine Model 下载免费PDF全文
Tatsuki Fujiwara Daisuke Sakota Katsuhiro Ohuchi Shu Endo Tomoki Tahara Tomotaka Murashige Ryo Kosaka Keiji Oi Tomohiro Mizuno Osamu Maruyama Hirokuni Arai 《Artificial organs》2017,41(10):893-903
Complications due to pump thrombus remain the weak point of mechanical circulatory support (MCS), such as the use of a left ventricular assist device (LVAD) or extracorporeal membrane oxygenation, leading to poor outcomes. Hyperspectral imaging (HSI) is an effective imaging method using a hyperspectral (HS) camera, which comprises a spectrophotometer and a charge‐coupled device camera to discriminate thrombus from whole blood. Animal experiments were conducted to analyze dynamic imaging of thrombus inside a prototype of a hydrodynamically levitated centrifugal blood pump using an HSI system. Six pigs were divided into a venous circulation group (n = 3) and an arterial circulation group (n = 3). Inflow and outflow cannulae were inserted into the jugular veins in the venous circulation group. The latter simulated an LVAD application. To create thrombogenic conditions, pump flow was maintained at 1 L/min without anticoagulation. An image of the bottom surface of the pump was captured by the HS camera every 4 nm over the wavelength range of 608–752 nm. Real‐time dynamic images of the inside of the pump were displayed on the monitor. Appearance of an area displaying thrombus was detected within 24 h after the start of the circulation in every experiment. This imaging system also succeeded in determining the origins of pump thrombus: from inside the pump in two cases, and from outside in four cases. Two main possible sources of pump thrombus originating outside the pump were identified on autopsy: wedge thrombus around the inflow cannula; and string‐like thrombus at the junction between the pump inlet and circuit tube. The results of this study from close observation of the changing appearance of pump thrombus may contribute to improvements in the safety of extracorporeal MCS. 相似文献
106.
Tomotaka?ShingakiEmail authorView authors OrcID profile Yumiko?Katayama Takayoshi?Nakaoka Tadayuki?Takashima Kayo?Onoe Takashi?Okauchi Emi?Hayashinaka Yasuhiro?Wada Yilong?Cui Yasuyoshi?Watanabe 《Pharmaceutical research》2016,33(5):1235-1248
Purpose
To select appropriate antiemetics relieving teriparatide-induced nausea and vomiting during osteoporosis treatment using PET molecular imaging and pharmacokinetic analysis.Methods
Rats were pretreated with subcutaneous teriparatide, followed by oral administration of antiemetics with different pharmacological effects. The pharmacokinetics of antiemetics were assessed by oral administration of 2-deoxy-2-[18F]fluoro-d-glucose ([18F]FDG) under free moving conditions in vivo. The effect of teriparatide on the permeability of Caco-2 cell membranes to [18F]FDG was assessed in vitro. The effects of antiemetics on teriparatide-induced suppression of gastrointestinal motility in vivo was assayed by positron emission tomography (PET) using orally administered [18F]FDG.Results
Teriparatide delayed the time-radioactivity profile of [18F]FDG in blood and significantly reduced its absorption rate constant (k a ), determined from non-compartmental analysis, to 60% of control. In contrast, co-administration of granisetron or mosapride restored the time-radioactivity profile and k a of [18F]FDG to control levels. Teriparatide had no effect on Caco-2 membrane permeability to [18F]FDG. Pharmacokinetic PET imaging data analysis quantitatively showed the pharmacological effects of teriparatide-induced suppression of upper gastrointestinal motility and its restoration by granisetron and mosapride.Conclusions
Teriparatide-induced abdominal discomfort might be attributed to GI motility, and PET imaging analysis is a useful tool to for the selection of appropriate antiemetics.107.
108.
109.
Mechanical circulatory support devices have been used clinically for patients with heart failure for over 10 years. However, thrombus formation inside blood pumps remains a risk to patient life, causing pump failure and contributing to neurological damage through embolization. In this article, we propose a method for preventing thrombus formation by applying vibrational excitation to the impeller. We evaluate the ability of this method to enhance the antithrombogenic properties of a magnetically levitated centrifugal blood pump and ensure that the impeller vibration does not cause undue hemolysis. First, 3 vibrational conditions were compared using an isolated pump without a mock circulation loop; the vibrational excitation frequencies and amplitudes for the impeller were set to (a) 0 Hz‐0 μm, (b) 70 Hz‐10 μm, and (c) 300 Hz‐2.5 μm. The motor torque was measured to detect thrombus formation and obtain blood coagulation time by calculating the derivative of the torque. Upon thrombus detection, the pump was stopped and thrombi size were evaluated. The results showed an increase in the blood coagulation time and a decrease in the rate of thrombus formation in pumps with the impeller vibration. Second, an in vitro hemolysis test was performed for each vibrational condition to determine the effect of impeller vibration on hemolysis. The results revealed that there was no significant difference in hemolysis levels between each condition. Finally, the selected vibration based on the above test results and the non‐vibration as control were compared to investigate antithrombogenic properties under the continuous flow condition. The blood coagulation time and thrombi size were investigated. As a result, vibrational excitation of the impeller at a frequency of 300 Hz and amplitude of 2.5 μm was found to significantly lengthen clotting time, decreasing the rate of pump thrombus compared to the non‐vibration condition. We indicate the potential of impeller vibration as a novel mechanical antithrombogenic mechanism for rotary blood pumps. 相似文献
110.