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Irina V. Poddubnaya Sergey M. Alekseev Kamil D. Kaplanov Les M. Lukavetskyy Grigoriy B. Rekhtman Tuphan K. Dolai V. Satya Suresh Attili Carlos D. Bermúdez Aleksandr A. Isaev Ekaterina V. Chernyaeva Roman A. Ivanov 《Hematological oncology》2020,38(1):67-73
BCD-020 is a proposed rituximab biosimilar, which has shown high similarity to rituximab in quality and nonclinical studies in vitro and in vivo. International multicenter clinical trial was conducted to compare efficacy and safety of BCD-020 and reference rituximab in adult (older than 18 years) patients with indolent lymphomas (follicular lymphoma grade 1-2, splenic marginal zone lymphoma, and nodal marginal zone lymphoma). Pharmacokinetics, pharmacodynamics, and immunogenicity were also studied. Patients with no previous biologic treatment for lymphoma were randomly assigned 1:1 to receive BCD-020 or comparator 375 mg/m2 for 4 weeks. Primary study outcome was day 50 overall response rate defined as complete or partial remission. Equivalence range was −20% to 20% for 95% CI for overall response rates difference. Secondary outcomes included adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity. One hundred seventy-four patients were enrolled, 89 in BCD-020 arm and 85 in comparator arm. The overall response rate was 44.71% in BCD-020 arm and 41.89% in comparator arm. Limits of 95% confidence interval (CI) for difference of overall response rates between arms were (−12.62%-18.24%) showing equivalent efficacy. Sixty-one (68.54%) and 59 (69.41%) patients had at least one adverse event in BCD-020 arm or comparator arm, respectively. No unexpected adverse reactions were reported. Antidrug antibodies with no neutralizing activity were detected in two patients in comparator arm on day 14 further declining below detection threshold. Rituximab concentrations had equivalent pattern after intravenous administration of both drugs. Both drugs caused depletion of B-cells without significant influence on other blood cell lineages. In this study, we showed equivalent efficacy of BCD-020 and reference rituximab when used in patients with CD20-positive indolent lymphomas. We also confirmed pharmacokinetic equivalence of BCD-020 and reference rituximab. Safety profile, pharmacodynamics, and immunogenicity of BCD-020 were also comparable with those of reference rituximab. 相似文献
3.
Jadwiga Najib Ekaterina Didenko Daria Meleshkina Kamila Yusupov Kateryna Maw Justin Ramnarain 《Current medical research and opinion》2020,36(10):1717-1735
Abstract
Objective
Lisdexamfetamine dimesylate is a stimulant prodrug with low abuse and diversion potential that is used in treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. This current literature review article aims to examine safety and efficacy of LDX in children and adolescents for the treatment of ADHD based on currently available data. 相似文献4.
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Denis A. Mogilenko Oleg Shpynov Prabhakar Sairam Andhey Laura Arthur Amanda Swain Ekaterina Esaulova Simone Brioschi Irina Shchukina Martina Kerndl Monika Bambouskova Zhangting Yao Anwesha Laha Konstantin Zaitsev Samantha Burdess Susan Gillfilan Sheila A. Stewart Marco Colonna Maxim N. Artyomov 《Immunity》2021,54(1):99-115.e12
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Dmitrii I. Shiriaev Alina A. Sofronova Ekaterina A. Berdnikovich Dmitrii A. Lukianov Ekaterina S. Komarova Valeriya I. Marina Yuliya V. Zakalyukina Mikhail V. Biryukov Tinashe P. Maviza Yan A. Ivanenkov Petr V. Sergiev Ilya A. Osterman Olga A. Dontsova 《Antimicrobial agents and chemotherapy》2021,65(5)
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Gregory Lazarian Shanye Yin Elisa ten Hacken Tomasz Sewastianik Mohamed Uduman Alba Font-Tello Satyen H. Gohil Shuqiang Li Ekaterina Kim Heather Joyal Leah Billington Elizabeth Witten Mei Zheng Teddy Huang Mariano Severgnini Valerie Lefebvre Laura Z. Rassenti Catherine Gutierrez Catherine J. Wu 《Cancer cell》2021,39(3):380-393.e8
9.
Briana Nixon Thomas Jandl Ryan S. Teller Ekaterina Taneva Yanhua Wang Umadevi Nagaraja Patrick F. Kiser Betsy C. Herold 《Antimicrobial agents and chemotherapy》2014,58(2):1153-1160
Increased susceptibility to genital herpes in medroxyprogesterone-treated mice may provide a surrogate of increased HIV risk and a preclinical biomarker of topical preexposure prophylaxis safety. We evaluated tenofovir disoproxil fumarate (TDF) in this murine model because an intravaginal ring eluting this drug is being advanced into clinical trials. To avoid the complications of surgically inserting a ring, hydroxyethylcellulose (HEC)-stable formulations of TDF were prepared. One week of twice-daily 0.3% TDF gel was well tolerated and did not result in any increase in HSV-2 susceptibility but protected mice from herpes simplex virus 2 (HSV-2) disease compared to mice treated with the HEC placebo gel. No significant increase in inflammatory cytokines or chemokines in vaginal washes or change in cytokine, chemokine, or mitochondrial gene expression in RNA extracted from genital tract tissue was detected. To further evaluate efficacy, mice were treated with gel once daily beginning 12 h prior to high-dose HSV-2 challenge or 2 h before and after viral challenge (BAT24 dosing). The 0.3% TDF gel provided significant protection compared to the HEC gel following either daily (in 9/10 versus 1/10 mice, P < 0.01) or BAT24 (in 14/20 versus 4/20 mice, P < 0.01) dosing. In contrast, 1% tenofovir (TFV) gel protected only 4/10 mice treated with either regimen. Significant protection was also observed with daily 0.03% TDF compared to HEC. Protection was associated with greater murine cellular permeability of radiolabeled TDF than of TFV. Together, these findings suggest that TDF is safe, may provide substantially greater protection against HSV than TFV, and support the further clinical development of a TDF ring. 相似文献
10.
Rapid detection and destruction of squamous cell carcinoma of the head and neck by nano‐quadrapeutics 下载免费PDF全文
Survival and quality of life remain poor for patients with head and neck squamous cell carcinoma (HNSCC) that cannot be fully resected safely, and form therapy‐resistant residual and recurrent tumors. We report novel cell‐level technology, quadrapeutics. Quadrapeutics converts surgery, drug, and radiation therapies into on‐demand microtreatment that unites the diagnosis and treatment in 1 rapid procedure by using 4 standard components: (1) targeted gold colloids; (2) liposomal drugs; (3) a laser pulse; and (4) radiation, all at safe doses. The therapeutic strength of quadrapeutics increases with cancer aggressiveness. In animal models of a primary and microscopic residual HNSCC, quadrapeutics increased the efficacy of standard chemoradiation therapy by more than 17‐fold by using only 3% to 6% of clinical doses of drug and radiation, did not cause side effects, and detected residual microtumors in vivo intraoperatively. Quadrapeutics can be applied to detect and eradicate HNSCC and similar microtumors in a safe and rapid theranostic procedure. © 2015 Wiley Periodicals, Inc. Head Neck 37: 1547–1555, 2015 相似文献