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《Vaccine》2022,40(27):3721-3726
We initiated a randomized, placebo-controlled, phase 1/2 trial to evaluate the safety and immunogenicity of the S-268019-b recombinant protein vaccine, scheduled as 2 intramuscular injections given 21 days apart, in 60 randomized healthy Japanese adults. We evaluated 2 regimens of the S-910823 antigen (5 μg [n = 24] and 10 μg [n = 24]) with an oil-in-water emulsion formulation and compared against placebo (n = 12). Reactogenicity was mild in most participants. No serious adverse events were noted. For both regimens, vaccination resulted in robust IgG and neutralizing antibody production at days 36 and 50 and predominant T-helper 1-mediated immune reaction, as evident through antigen-specific polyfunctional CD4+ T-cell responses with IFN-γ, IL-2, and IL-4 production on spike protein peptides stimulation. Based on the interim analysis, the S-268019-b vaccine is safe, produces neutralizing antibodies titer comparable with that in convalescent serum from COVID-19-recovered patients. However, further evaluation of the vaccine in a large clinical trial is warranted. 相似文献
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目的探究门冬胰岛素联合吡格列酮二甲双胍治疗糖尿病患者的临床效果及安全性。方法 90例糖尿病患者,采取随机数字表法分为观察组与对照组,各45例。对照组给予门冬胰岛素30治疗,观察组在对照组基础上加用吡格列酮二甲双胍治疗。对比两组治疗前后的血糖相关指标、胰岛素用量、不良反应发生率。结果治疗后,观察组空腹血糖(5.66±1.09)mmol/L、餐后2 h血糖(9.80±1.97)mmol/L、糖化血红蛋白(6.40±1.15)%均低于对照组的(8.57±1.25)mmol/L、(15.43±3.09)mmol/L、(7.85±1.27)%,差异有统计学意义(P<0.05)。观察组治疗期间胰岛素用量(32.78±5.50)U少于对照组的(41.08±6.33)U,差异有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论门冬胰岛素联合吡格列酮二甲双胍治疗糖尿病患者可取得较好的降低血糖水平的目的,安全性高。 相似文献
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周杨 《中国现代药物应用》2022,(2)
目的探讨小儿肠胃康颗粒联合酪酸梭菌活菌散治疗小儿消化不良性腹泻的临床疗效及安全性。方法104例小儿消化不良性腹泻患儿,依据随机抽签法分为对照组与观察组,各52例。对照组采用小儿肠胃康颗粒治疗,观察组采用小儿肠胃康颗粒联合酪酸梭菌活菌散治疗。对比两组症状改善时间、治疗效果及不良反应发生情况。结果观察组腹泻、腹部疼痛及食欲下降改善时间分别为(1.93±1.05)、(2.05±1.06)、(2.47±1.04)d,均短于对照组的(4.88±1.49)、(3.62±1.55)、(3.63±1.15)d,差异有统计学意义(P<0.05)。观察组治疗总有效率为94.23%,高于对照组的76.92%,差异有统计学意义(P<0.05)。观察组不良反应发生率为1.92%,低于对照组的13.46%,差异有统计学意义(P<0.05)。结论小儿肠胃康颗粒联合酪酸梭菌活菌散治疗小儿消化不良性腹泻疗效显著,且安全性较高,值得临床合理推行实践。 相似文献
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BackgroundMost patients who have an ankle replacement in the United Kingdom stay in hospital for 2–4 days. This study looked at the safety & cost-effectiveness of a day case ankle replacement pathway.MethodsThis was a retrospective case-control study looking at day case pathway for ankle replacements set up in collaboration with anaesthetists, nurses and physiotherapists. Patients practiced mobilization with crutches before surgery. Patients were discharged home with enough analgesia, and reviewed within 2–5 days of discharge.ResultsTwenty ankle replacements done between November 2017 and November 2019 were reviewed with a mean follow up of 38.4 months. None of these patients required to be readmitted within the first 28 days. No complications were related to the surgery being done as day case. Except one, all patients described the experience as excellent or good.ConclusionPer case the cost savings are estimated to be £880 in comparison to 20 matched inpatient ankle replacements. We conclude that ankle replacements can be safely carried out as day case with appropriate patient selection, pre-operative education and a multi-disciplinary approach. 相似文献
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目的探讨主动脉瓣重度狭窄患者接受经导管主动脉瓣置换术(TAVR)治疗的有效性和安全性。方法回顾性选取2017年9月至2019年12月接受TAVR的主动脉瓣重度狭窄患者36例。收集患者的人口学、实验室检查、影像辅助检查等全部临床资料,对手术过程、成功率、并发症以及手术前后超声心动图结果等进行分析。结果患者平均年龄(72.42±6.14)岁,瓣膜置入成功率100%。与术前相比,术后第1天的脑钠肽、主动脉瓣最大跨瓣压差、主动脉瓣跨瓣流速差异均有统计学意义(均P<0.01),术后6个月随访左心室射血分数、左心室舒张末期内径及左心室收缩末期内径都有显著改善(均P<0.01)。并发症方面,住院期间1例(2.8%)患者因三度房室传导阻滞行永久性起搏器植入;术后1周有2例(5.6%)患者存在轻度瓣周漏(<2 mm),术后6个月随访时只有1例(2.8%)患者存在轻度瓣周漏;术后6个月随访时1例(2.8%)患者缺血性卒中。结论主动脉瓣重度狭窄患者行TAVR治疗有较好的安全性和有效性,可有效改善左心室重塑。 相似文献
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《Radiography》2022,28(2):454-459
IntroductionMR facilities must implement and maintain adequate screening and safety procedures to ensure safety during MR examinations. The aim of this study was to evaluate a multi-step MR safety screening process used at a 7T facility regarding incidence of different types of safety risks detected during the safety procedure.MethodsSubjects scheduled for an MR examination and having entered the 7T facility during 2016–2019 underwent a pre-defined multi-step MR safety screening process. Screening documentation of 1819 included subjects was reviewed, and risks identified during the different screening steps were compiled. These data were also related to documented decisions made by a 7T MR safety committee and reported MR safety incidents.ResultsPassive or active implants (n = 315) were identified in a screening form and/or an additional documented interview in 305 subjects. Additional information not previously self-reported by the subject, regarding implants necessitating safety decisions performed by the staff was revealed in the documented interview in 102 subjects (106 items). In total, the 7T MR safety committee documented a decision in 36 (2%) of the included subjects. All of these subjects were finally cleared for scanning.ConclusionA multi-step screening process allows a thorough MR screening of subjects, avoiding safety incidents. Different steps in the process allow awareness to rise and items to be detected that were missed in earlier steps.Implications for practiceSafety questions posed at a single timepoint during an MR screening process might not reveal all safety risks. Repetition and rephrasing of screening questions leads to increased detection of safety risks. This could be effectively mitigated by a multi-step screening process. A multi-disciplinary safety committee is efficient at short notice responding to unexpected safety issues. 相似文献