1.Biomechanics of lumbar cortical bone trajectory screw fixation
Yu YAO ; Huawei XUE ; Jian ZHAO ; Feng ZHANG ; Yong CAO ; Xiangdong CHEN ; Jinlong ZHAO ; Xingjie JIANG
Chinese Journal of Tissue Engineering Research 2017;21(3):362-366
BACKGROUND:Santoni put forward the cortical bone trajectory technology by changing the traditional pedicle screw placement for lumbar internal fixation in order to obtain better control of the screw and bone in 2009. OBJECTIVE:To analyze biomechanical stability of cortical bone trajectory system in the lumbar fusion. METHODS:Twenty fresh newborn calf L3/4, L5/6 motion segment specimens were obtained, and their ranges of motion were detected under different states, as normal controls. Subsequently, twenty samples were divided into cortical bone trajectory screw group and traditional pedicle screw group, which underwent cortical bone trajectory screw fixation combined with posterior lumbar fusion and traditional pedicle screw fixation combined with posterior lumbar fusion, respectively. Without destruction, ranges of motion were detected under different states in both groups. In the revision group, after the test in the traditional pedicle screw group, screw was withdrawn, and cortical bone trajectory screw was used to detect its range of motion under different states. RESULTS AND CONCLUSION:Ranges of motion at bending to the left and right, anteflexion, posterior extension and axial rotation were significantly lower in the cortical bone trajectory screw group and traditional pedicle screw group than in the normal control group (P<0.05). No significant difference in bending to the left and right, anteflexion, posterior extension and axial rotation was detected between the cortical bone trajectory screw and revision groups and traditional pedicle screw group (P>0.05). These results confirmed that cortical bone trajectory technology combined with posterior lumbar fusion can obtain identical stability as the traditional pedicle screw fixation combined with posterior lumbar fusion. Simultaneously, it is a new choice for revision after traditional pedicle screw fixation.
2. Bioequivalence of rosuvastatin calcium tablets in Chinese healthy subjects
Ying CAO ; Wenping WANG ; Xiaobin LI ; Huawei WANG ; Xin SUI ; Ming YU ; Lu CHEN ; Xiaoyan DOU ; Xiujun WU ; Ran MA ; Meiye LI ; Xue GAO
Chinese Journal of Clinical Pharmacology and Therapeutics 2020;25(12):1369-1375
AIM: To study the bioequivalence of rosuvastatin calcium tablets produced by two different manufacturers on a fasting and postprandial basis in Chinese healthy subjects. METHODS: A single-center, randomized, balanced, open, two-sequence, two-cycle, double-crossover, and single-dose trial design was used in this study. Each of the fasting group and the postprandial group was enrolled in 52 healthy subjects. Fasting/postprandial oral rosuvastatin calcium tablets 10 mg test preparation or reference preparation, the validated LC-MS/MS method was used to determine the concentration of rosuvastatin calcium tablets in plasma, and the pharmacokinetic parameters were calculated. Human bioequivalence and safety evaluation of two rosuvastatin calcium tablets were evaluated. RESULTS: The t