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Background:
Among different categories of sedative agents, benzodiazepines have been prescribed for more than three decades to patients of all ages. The effective and predictable sedative and amnestic effects of benzodiazepines support their use in pediatric patients. Midazolam is one of the most extensively used benzodiazepines in this age group. Oral form of drug is the best accepted route of administration in children.Objectives:
The purpose of this study was to compare the efficacy and safety of a commercially midazolam syrup versus orally administered IV midazolam in uncooperative dental patients. Second objective was to determine whether differences concerning sedation success can be explained by child‘s behavioral problems and dental fear.Patients and Methods:
Eighty eight uncooperative dental patients (Frankl Scales 1,2) aged 3 to 6 years, and ASA I participated in this double blind, parallel randomized, controlled clinical trial. Midazolam was administered in a dose of 0.5 mg/kg for children under the age 5 and 0.2 mg/kg in patients over 5 years of age. Physiologic parameters including heart rate, respiratory rate, oxygen saturation and blood pressure were recorded. Behavior assessment was conducted throughout the course of treatment using Houpt Sedation Rating Scale and at critical moments of treatment (injection and cavity preparation) by North Carolina Scale. Dental fear and behavioral problems were evaluated using Child Fear Schedule Survey-Dental Subscale (CFSS-DS), and Strength and Difficulties Questionnaire (SDQ). Independent t-test, Chi-Square, and Pearson correlation were used for statistical analysis.Results:
Acceptable overall sedation ratings were observed in 90% and 86% of syrup and IV/Oral group respectively; Chi-Square P = 0.5. Other domains of Houpt Scale including: sleep, crying and movement were also not significantly different between groups. Physiological parameters remained in normal limits during study without significant difference between groups.Conclusions:
“Orally administered IV midazolam” preparation can be used as an alternative for commercially midazolam syrup. 相似文献Objective
The objective of this study was to assess changes in upper trapezius myoelectric activity and pain in patients with nonspecific neck pain after a single session of acupuncture (ACP).Methods
A blinded randomized clinical trial was conducted. Fifteen patients with nonspecific neck pain and 15 healthy participants were enrolled in a randomized, single-blinded, crossover study. Each participant was subjected to a single session of ACP and sham acupuncture (SACP). The electromyography (EMG) signal of the upper trapezius muscle was recorded during different step contractions of shoulder elevation force (15%-30% maximal voluntary contraction) before and after ACP treatment.Results
Significant effects were confirmed after the treatment (ACP and SACP) for Numeric Rating Scale scores (F1,28 = 51.61; P < .0001) and pain area (F1,2 = 32.03; P < .0001). Significant decreases in the EMG amplitude were identified for the nonspecific neck pain group (NPG) (F1,112 = 26.82; P < .0001) and the healthy participant group (HPG) (F1,112 = 21.69; P < .0001) after ACP treatment. No differences were identified between the ACP and SACP treatment protocols for Numeric Rating Scale score (NPG: F1,28 = 0.95; P = .33), pain area (NPG: F1,28 = 1.97; P = .17), or EMG amplitude (NPG: F1,112 = 0.47; P = .49; HPG: F1,112 = 0.75; P = .38).Conclusion
The effect of ACP at acupoints triple energizer 5 and large intestine 11 triple energizer 5, or in close proximity, contributes to pain relief among patients with nonspecific neck pain. The electromyographic analysis indicated a greater resistance to muscle fatigue and decrease of activity of the upper trapezius muscle among healthy participants and patients with nonspecific neck pain. 相似文献The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2012. This is an extension of the previously reported study of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, which found that over three-quarters of all these trials were disclosed within 12 months and almost 90% were disclosed by the end of the study.
Methods:
The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2012, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2014.
Outcome measures and results:
The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2014 (end of survey). Of the completed trials associated with 23 new medicines licensed to 17 different companies in 2012, results of 90% (307/340) had been disclosed within 12 months, and results of 92% (312/340) had been disclosed by 31 July 2014.
Conclusions:
The disclosure rate within 12 months of 90% suggests the industry is now achieving disclosure in a timely manner more consistently than before. The overall disclosure rate at study end of 92% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2012. 相似文献