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91.
Najib NM Idkaidek N Adel A Admour I Astigarraga RE Nucci GD Alam SM Dham R Qumaruzaman 《Biopharmaceutics & drug disposition》2003,24(5):183-189
The pharmacokinetics of two brands of simvastatin 40 mg tablets were compared in 24 healthy human volunteers after a single oral dose in a randomized cross-over study, conducted at IPRC, Amman, Jordan. Reference (Zocor, MSD, Netherlands) and test (Simvast, Julphar, UAE) products were administered to fasted volunteers; blood samples were collected at specified time intervals, plasma separated and analyzed for simvastatin and its active metabolite (beta-hydoxy acid) using a validated LC-MS/MS method at Cartesius Analytical Unit, Institute of Biomedical Sciences - USP, Sao Paulo, Brazil. The pharmacokinetic parameters AUC(0-t), AUC(0-variant), C(MAX), T(MAX), T(1/2) and elimination rate constant were determined from plasma concentration-time profile for both formulations and were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Julphar's Simvast is bioequivalent to Zocor of MSD, Netherlands. 相似文献
92.
目的:探讨辛伐他汀对老年高脂血症伴骨量减少病人骨代谢的影响。方法:收集86例确诊为高脂血症的病人,随机分为试验组(49例)和对照组(ST例)。两组病人均给予相似饮食以及等剂量阿法骨化醇和复方氨基酸螯合钙,试验组在此基础上加用辛伐他汀40mg/d,疗程3个月。于用药前、用药后3个月分别采集静脉血测定骨代谢指标及检查骨密度。结果:试验组和对照组病人用药后总碱性磷酸酶(TAP)及骨源性碱性磷酸酶(BAP)均有明显升高(P〈0.01或P〈0.05),试验组TAP及BAP比对照组用药后升高更显著(P〈0.05)。试验组和对照组用药后尿脱氧吡啶啉与肌酐的比值、骨宽频超声衰减值差异均无统计学意义。结论:辛伐他汀短期内对骨形成的生化指标有促进作用,因时间较短,对骨吸收的生化指标和骨密度的影响尚无统计学意义,有待进一步研究。 相似文献
93.
目的探讨辛伐他汀对大鼠心肌梗死后心室重塑的影响及其与磷酸化细胞外信号调节激酶1/2(p-ERK1/2)的关系。方法结扎Wistar大鼠冠状动脉左前降支建立心肌梗死模型,大鼠随机分为4组(n=8~10):心肌梗死对照组、辛伐他汀20、40mg处理组和假手术组。4wk后心脏超声检测各组心脏形态和功能,免疫组化法和Western blot检测p-ERK1/2表达。结果与假手术组相比,心肌梗死对照组及辛伐他汀处理组左室舒张末期内径(LVEDd)、左室后壁厚度(LVPWd)明显增加(P<0.01),左室射血分数(LVEF)、短轴缩短率(FS)、每博输出量(SV)和心输出量(CO)明显降低(P<0.01),心肌p-ERK1/2表达明显升高(P<0.01)。与心肌梗死对照组相比,辛伐他汀处理组LVEDd、LVPWd明显减少(P<0.01),LVEF、FS、SV和CO明显升高(P<0.01),心肌p-ERK1/2表达明显下降(P<0.01);其中辛伐他汀40mg组比20mg组心肌p-ERK1/2表达下降更明显(P<0.05)。结论辛伐他汀改善心肌梗死后心室重塑和心功能,其机制可能与下调心肌p-ERK1/2表达有关。 相似文献
94.
目的:比较国产辛伐他汀与进口辛伐他汀治疗原发性高胆固醇血症的疗效及安全性。方法:采用开放区组随机对照、多中心的临床设计。150例高胆 固醇血症病人分为验证组(50例)、对照组(48例)和开放组(52例),剂量均为每晚顿服10mg,服药8周。结果:验证组与对照组服药前后比较,血清总胆 固醇(TC)分别降低26.36%和28.3%,低密度脂蛋白胆固醇(LDL-C)分别降低33.17%和35.51%;验 相似文献
95.
目的:比较辛伐他汀标准和强化治疗对新诊断糖耐量减低(IGT)病人血脂谱、胰岛素抵抗(IR)及血清炎症因子的影响。方法:106例伴有不同程度血脂异常的新诊断IGT病人随机分为2组:常规组54例,男性26例,女性28例,年龄(54±s6)a;强化组52例,男性27例,女性25例,年龄(52±6)a。在给予生活方式干预的同时常规组予辛伐他汀20mg·d~(-1),强化组予辛伐他汀40mg·d~(-1),均睡前服药,疗程为12 wk。比较治疗前后血脂、胰岛素抵抗指数(IRI)、及血清高敏C反应蛋白(HS—CRP)、纤维蛋白原(FIB)的变化。结果:2组治疗后三酰甘油(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、HS-CRP均明显降低(P<0.01),强化组的下降幅度大于常规组,差异非常显著(P<0.01)。强化组IRI和空腹胰岛素(FINS)治疗后亦降低(P<0.01),而常规组无显著变化(P>0.05),2组间有非常显著差异(P<0.01)。强化组不良反应发生率8%,常规组6%(P>0.05)。结论:对IGT合并血脂异常病人予他汀类药物治疗能有效改善血脂谱、减轻IR和炎症状态,并有良好的安全性。 相似文献
96.
Joseph Pagkalos Jae Min Cha Yunyi Kang Manolis Heliotis Eleftherios Tsiridis Athanasios Mantalaris 《Journal of bone and mineral research》2010,25(11):2470-2478
Statins are potent inhibitors of cholesterol synthesis. Several statins are available with different molecular and pharmacokinetic properties. Simvastatin is more lipophilic than pravastatin and has a higher affinity to phospholipid membranes than atorvastatin, allowing its passive diffusion through the cell membrane. In vitro studies on bone marrow stromal cells, osteoblast‐like cells, and embryonic stem cells have shown statins to have cholesterol‐independent anabolic effects on bone metabolism; alas, statins were supplemented in osteogenic medium, which does not facilitate elucidation of their potential osteoinductive properties. Embryonic stem cells (ESCs), derived from the inner cell mass of the blastocyst, are unique in that they enjoy perpetual self‐proliferation, are pluripotent, and are able to differentiate toward all the cellular lineages composing the body, including the osteogenic lineage. Consequently, ESCs represent a potentially potent cell source for future clinical cellular therapies of various bone diseases, even though there are several hurdles that still need to be overcome. Herein we demonstrate, for the first time to our knowledge, that simvastatin induces murine ESC (mESC) differentiation toward the osteogenic lineage in the absence of osteoinductive supplements. Specifically, we found that a simvastatin concentration in the micromolar range and higher was toxic to the cells and that an effective concentration for osteoinduction is 0.1 nM, as shown by increased alizarin red staining as well as increased osteocalcin and osetrix gene expression. These results suggest that in the future, lipophilic simvastatin may provide a novel pharmacologic agent for bone tissue engineering applications. © 2010 American Society for Bone and Mineral Research. 相似文献
97.
J Emmerich I Aubert B Bauduceau C Dachet B Chanu D Erlich D Gautier B Jacotot J Rouffy 《European heart journal》1990,11(2):149-155
The effects and safety of simvastatin, an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase, were investigated alone or in association with cholestyramine in 66 patients with hypercholesterolaemia, in a 1-year study. In type IIa hypercholesterolaemia (41 patients), the association was more effective than simvastatin used alone in lowering total cholesterol (37% vs 29%) and LDL-cholesterol (45% vs 37%). In type IIb hypercholesterolaemia (23 patients), the association simvastatin-cholestyramine did not appear more effective than simvastatin used alone. The decrease of apoprotein B was parallel to the LDL-cholesterol decrease. Apoprotein A1 did not change significantly. The long-term safety of simvastatin was good. No lens opacity was noted. The most serious side-effect in our study was myolysis which occurred in two patients with a marked increase in creatine phosphokinase. 相似文献
98.
Effects of simvastatin on blood lipids, vitamin E, coenzyme Q10 levels and left ventricular function in humans 总被引:1,自引:0,他引:1
Colquhoun DM Jackson R Walters M Hicks BJ Goldsmith J Young P Strakosch C Kostner KM 《European journal of clinical investigation》2005,35(4):251-258
BACKGROUND: As statin therapy has been reported to reduce antioxidants such as vitamin E and coenzyme Q10 and there are indications that this reduction may cause impairment of left ventricular function (LVF), we studied the influence of simvastatin on LVF and serum vitamin E and coenzyme Q10 levels in humans. MATERIAL AND METHODS: We assessed the effect of simvastatin on left ventricular function and coenzyme Q10 levels in 21 (11 male, 10 female) hypercholesterolaemic subjects (mean age = 56 years) with normal LVF, over a period of 6 months. Subjects were re-tested after a 1-month wash-out period (7 months). Echocardiography was performed on all subjects before commencement of simvastatin (20 mg day(-1)), and at 1, 3, 6 and 7 months after initiation of treatment. Fasting blood samples were also collected at these intervals to assess lipids, apoproteins, vitamin E and coenzyme Q10. RESULTS: Serum lipids showed the expected reductions. Plasma vitamin E and coenzyme Q10 levels were reduced by 17 +/- 4% (P < 0.01) and 12 +/- 4% (P < 0.03) at 6 months. However, the coenzyme Q10/LDL-cholesterol ratio and vitamin E/LDL-cholesterol ratio increased significantly. Left ventricular ejection fraction (EF) decreased transiently after 1 month, while no significant change was observed at 3 and 6 months. Other markers of left ventricular function did not change significantly at any time point. CONCLUSION: Despite reduced plasma vitamin E and coenzyme Q10, 20 mg of simvastatin therapy is associated with a significantly increased coenzyme Q10/LDL-cholesterol ratio and vitamin E/LDL-cholesterol ratio. Simvastatin treatment is not associated with impairment in left ventricular systolic or diastolic function in hypercholesterolaemic subjects after 6 months of treatment. 相似文献
99.
100.
MD Kirandeep Kaur MD Jaswant Rai DA MD Geeta Sharma MD FCCP FICA FIACM Baljinder Singh Bal 《Current therapeutic research》2004,65(6):455-469
Abstract