1.Bioequivalence study of olmesartan medoxomil tablet in Chinese healthy subjects
Na SHAN ; Da-Hai JIANG ; Lin-Lin MIAO ; Zhen-Li REN ; Peng-Bo JIN ; Pei-Qi HAO ; Li AN ; Hong ZHU ; Yong XIN ; Guang-De YANG ; Feng LIU
The Chinese Journal of Clinical Pharmacology 2024;40(20):3033-3037
Objective To study the bioequivalence of test and reference olmesartan tablet in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.A total of 48 healthy adult male and female subjects(24 cases of fasting test and 24 cases of fed test)were included in the random crossover administration.Single oral dose 20 mg of test and reference were taken under fasting and postprandial conditions,respectively.Plasma concentration of olmesartan in plasma were determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the fasting group were as follows:Cmax were(653.06±133.53)and(617.37±151.16)ng·mL-1,AUC0-t were(4 201.18±1 035.21)and(4 087.38±889.99)ng·mL-1·h,AUC0-∞ were(4 254.30±1 058.90)and(4 135.69±905.29)ng·mL-1·h.The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the postprandial group were as follows:Cmax were(574.78±177.05)and(579.98±107.74)ng·mL-1,AUC0-t were(3 288.37±866.06)and(3 181.51±801.06)ng·mL-1·h,AUC0-∞ were(3 326.11±874.26)and(3 242.01±823.09)ng·mL-1·h.Under fasting and postprandial conditions,the 90%confidence intervals of the main pharmacokinetic parameters of the test and reference preparations are both 80.00%-125.00%.Conclusion Under fasting and postprandial conditions,a single oral dose of test and reference preparations olmesartan tablets in Chinese healthy adult volunteers showed bioequivalence.
2.Mechanism of Shikonin on spinal cord injury in rats based on TNFR/RIPK1 pathway
Ji-Sheng SHI ; Ji-Ze QINA ; Jin-Guang WANG ; Bin LIN ; Tong-Tao PANG
China Journal of Orthopaedics and Traumatology 2024;37(1):61-68
Objective To explore the effect of shikonin on the recovery of nerve function after acute spinal cord injury(SCI)in rats.Methods 96 male Sprague-Dawley(SD)rats were divided into 4 groups randomly:sham operation group(Group A),sham operation+shikonin group(Group B),SCI+DMSO(Group C),SCI+shikonin group(Group D).The acute SCI model of rats was made by clamp method in groups C and D.After subdural catheterization,no drug was given in group A.rats in groups B and D were injected with 100 mg·kg-1 of shikonin through catheter 30 min after modeling,and rats in group C were given with the same amount of DMSO,once a day until the time point of collection tissue.Basso-Beattie-Bresnahan(BBB)scores were performed on 8 rats in each group at 6,12,and 3 d after moneling,and oblique plate tests were performed on 1,3,7 and 14 d after modeling,and then spinal cord tissues were collected.Eight rats were intraperitoneally injected with propidine iodide(PI)1 h before sacrificed to detection PI positive cells at 24 h in each group.Eight rats were sacrificed in each group at 24 h after modeling,the spinal cord injury was observed by HE staining.The Nissl staining was used to observe survivor number of nerve cells.Western-blot technique was used to detect the expression levels of Bcl-2 protein and apoptosis related protein RIPK1.Results After modeling,BBB scores were normal in group A and B,but in group C and D were significantly higher than those in group A and B.And the scores in group D were higher than those in group C in each time point(P<0.05).At 12 h after modeling,the PI red stained cells in group D were significantly reduced compared with that in group C,and the disintegration of neurons was alleviated(P<0.05).HE and Nissl staining showed nerve cells with normal morphology in group A and B at 24h after operation.The degree of SCI and the number of neuronal survival in group D were better than those in group C,the differ-ence was statistically significant at 24h(P<0.05).The expression of Bcl-2 and RIPK1 proteins was very low in group A and B;The expression of RIPK1 was significantly increased in Group C and decreased in Group D,with a statistically significant dif-ference(P<0.05);The expression of Bcl-2 protein in group D was significantly higher than that in group C(P<0.05).Conclu-sion Shikonin can alleviate the pathological changes after acute SCI in rats,improve the behavioral score,and promote the re-covery of spinal nerve function.The specific mechanism may be related to the inhibition of TNFR/RIPK1 signaling pathway mediated necrotic apoptosis.
3.Clinical safety and validity analysis of retrograde new endo-scopic visual field in miniature pigs
Zhe KUANG ; Peng LI ; Da-Qing JIN ; Yong-Chao ZHANG ; Hui-Li GUO ; Yu-Fei ZHANG ; Guang-Lin HE ; Guo-Feng SUN ; Yuan HE
Chinese Journal of Current Advances in General Surgery 2024;27(1):14-18
Objective:To study the clinical safety and validity of retrograde new endoscopic field of vision in miniature pigs.Methods:6 live miniature pigs were selected as study subjects,En-doscopic Retrograde New View(ERNV)was selected.The performance,image quality and intraoper-ative and postoperative complications were evaluated.To evaluate whether all the experimental ani-mals could complete the relevant endoscopy.Verify ERNV's operating performance,including whether the duodenoscope can enter the biliary tract smoothly,and made sure whether the injection,suction,and instrument channels were unobstructed.Choledochoscope image clarity,color resolu-tion,image deformation and distortion,accurate evaluation of lumen conditions and clear observation of mucosal surface conditions were analyzed.Whether there were operant injuries such as bleeding and perforation,as well as adverse events such as respiratory depression and cardiac arrest.The sur-vival status and adverse reactions of all pigs were observed.Results:The choledochoscope was successfully inserted into the bile duct of 6 miniature pigs.The product had good operation perfor-mance and could enter the bile duct through the duodenoscope smoothly.The injection,suction and instrument channels were relatively smooth.In addition,the endoscopic images are clear,with better color resolution,and without image deformation and distortion,which can realize accurate evaluation of the conditions in the lumen and observe the mucosal surface conditions more clearly.No bile duct stenosis or dilatation occurred in all miniature pigs,and the bile duct mucosa was smooth,without hyperemia and edema,and no abnormal thickening or bending of mucous vessels.During the exami-nation,there were no operational injuries such as bleeding and perforation,and no adverse events such as respiratory depression and cardiac arrest occurred.The vital signs of all miniature pigs tended to be stable after operation,and the survival state was good,and there were no complications such as cholangitis,bleeding and perforation.Conclusion:ERNV has good clinical safety and efficacy,ex-cellent operation performance and excellent image quality,and is worthy of clinical application.
4.Full-field Anterior Chamber Angle Measurement Based on Optical Reflection Tomography
Bi-Wang LIU ; Jun-Ping ZHONG ; Hai-Na LIN ; Ya-Guang ZENG ; You-Ping YU ; Hong-Yi LI ; Ding-An HAN ; Jin-Ying CHEN
Progress in Biochemistry and Biophysics 2024;51(9):2240-2248
ObjectiveAngle-closure glaucoma (ACG) is one of the major eye-blinding diseases. To diagnose ACG, it is crucial to examine the anterior chamber angle. Current diagnostic tools include slit lamp gonioscopy, water gonioscopy, ultrasound biomicroscopy (UBM), and anterior segment optical coherence tomography (AS-OCT). Slit lamp and water gonioscopy allow convenient observation of the anterior chamber angle, but pose risks of invasive operation and eye infections. UBM can accurately measure the structure of the anterior chamber angle. However, it is complex to operate and unsuitable for patients, who have undergone trauma or ocular surgery. Although AS-OCT provides detailed images, it is costly. The aim of this study is to explore a non-invasive, non-destructive optical reflection tomography (ORT) technique. This technique can achieve low-cost three-dimensional imaging and full-field anterior chamber angle measurement of the porcine eye. MethodsThe experiment involved assembling an optical reflection tomography system, which included a complementary metal oxide semiconductor (CMOS) camera, a telecentric system, a stepper motor, and a white light source, achieving a spatial resolution of approximately 8.5 μm. The process required positioning the porcine eye at the center of the field of the imaging system and rotating it around its central axis using a stepper motor. Reflection projection images were captured at each angle with an exposure time of 1.0 ms and an interval of 2°. The collected reflection-projection data were processed using a filtered reflection tomography algorithm, generating a series of two-dimensional slice data. These slices essentially represented cross-sectional views of the three-dimensional structural image, and were reconstructed into a complete three-dimensional structural image. Based on the reconstructed three-dimensional structural image of the porcine eye, the anterior chamber angles at different positions were measured, and a distribution map of these angles was drawn. Simultaneously, the ORT measurements were compared with the standard results obtained from optical coherence tomography (OCT) to assess the accuracy of ORT measurements. ResultsIn this study, we successfully obtained the reflection projection data of a porcine eye using ORT technology, reconstructed its three-dimensional structural image, and measured the anterior chamber angle, generating the corresponding distribution map. To better distinguish the different structural parts of porcine eye, the three-dimensional structural image was marked with blue, green, and yellow dashed lines from the outer to the inner layers. The area between the blue and green dashed lines corresponded to the sclera. The area between the green and yellow dashed lines corresponded to the iris. The area inside the yellow dashed line corresponded to the pupil. The three-dimensional structural image clearly revealed the key anatomical features of the porcine eye. It was able to measure the anterior chamber angle at different positions. Additionally, the anterior chamber angle measurements of the porcine eye using ORT were compared with the measurements obtained using a TEL320C1 type OCT system, showing an average deviation of 0.51° and a mean square error
5.Comparing Outcomes of Banana-Shaped and Straight Cages in Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Diseases: A Systematic Review and Meta-Analysis
Guang-Xun LIN ; Li-Ru HE ; Jin-Niang NAN ; Wen-Bin XU ; Keyi XIAO ; Zhiqiang QUE ; Shang-Wun JHANG ; Chien-Min CHEN ; Ming-Tao ZHU ; Gang RUI
Neurospine 2024;21(1):261-272
Objective:
This meta-analysis aims to refine the understanding of the optimal choice between different cage shapes in transforaminal lumbar interbody fusion (TLIF) by systematically comparing perioperative data, radiological outcomes, clinical results, and complications associated with banana-shaped and straight bullet cages.
Methods:
A meticulous literature search encompassing PubMed, Embase, Scopus, Web of Science, China Knowledge Network, and Wanfang Data was executed up to October 5, 2023. Inclusion criteria focused on studies comparing banana-shaped and straight bullet cages in TLIF. The quality of included studies was assessed using appropriate tools such as the Newcastle-Ottawa Scale (NOS) for nonrandomized studies. Rigorous evaluations were performed for radiographic outcomes, including disc height (DH), segmental lordosis (SL), lumbar lordosis (LL), subsidence, and fusion rates. Clinical outcomes were meticulously evaluated using visual analogue scale (VAS), Oswestry Disability Index (ODI), and complications.
Results:
The analysis incorporated 7 studies, involving 573 patients (297 with banana-shaped cages, 276 with straight cages), all with NOS ratings exceeding 5 stars. No statistically significant differences were observed in operative time, blood loss, or hospitalization between the 2 cage shapes. Banana-shaped cages exhibited greater changes in DH (p = 0.001), SL (p = 0.02), and LL (p = 0.01). Despite statistically higher changes in ODI for straight cages (26.33, p < 0.0001), the actual value remained similar to banana-shaped cages (26.15). Both cage types demonstrated similar efficacy in VAS, complication rates, subsidence, and fusion rates.
Conclusion
Although banana-shaped cages can excel in restoring DH, SL, and LL, straight bullet cages can provide comparable functional improvements, pain relief, and complication rates.
6.Clinical and Radiographic Outcomes of Cervical Disc Replacement Versus Posterior Endoscopic Cervical Decompression: A Matched-Pair Comparison Analysis
Vit KOTHEERANURAK ; Khanathip JITPAKDEE ; Kai-Uwe LEWANDROWSKI ; Guang-Xun LIN ; Weerasak SINGHATANADGIGE ; Worawat LIMTHONGKUL ; Wicharn YINGSAKMONGKOL ; Jin-Sung KIM ; Wongthawat LIAWRUNGRUEANG
Neurospine 2024;21(3):1040-1050
Objective:
To compare clinical and radiographic outcomes between 2 motion preservation surgeries, cervical disc replacement (CDR) and posterior endoscopic cervical decompression (PECD), for unilateral cervical radiculopathy.
Methods:
Between February 2018 and December 2020, 60 patients with unilateral cervical radiculopathy who underwent either CDR or PECD were retrospectively recruited as matched pairs. Clinical outcomes included visual analogue scale (VAS) scores for neck and arm pain, Neck Disability Index (NDI), and satisfaction rates. The radiographic outcome was index level motion. Intraoperative data, complications, and hospital stay were collected. Preoperative and postoperative outcomes were compared.
Results:
Patients undergoing CDR or PECD were included, with 30 cases in each group. Matched pairs were compared in terms of demographic data and preoperative measurements. CDR was associated with shorter operative times, whereas PECD resulted in less intraoperative blood loss. The total complication rate was 5%. NDI and VAS for neck and arm were significantly improved in both groups, with no significant differences between the 2 groups. Satisfaction rates of good and excellent exceeded 87% in both groups. CDR was superior to PECD in the restoration of disc height. Early postoperative follow-up showed no significant difference in terms of index level motion. PECD demonstrated significantly shorter hospital stays and quicker return-to-work times (p<0.05).
Conclusion
PECD achieved equivalent clinical and radiologic outcomes compared with CDR when the certain criteria for surgery were met. Both techniques demonstrated the potential to maintain index level motion. Additionally, PECD resulted in less blood loss, shorter hospital stays, and faster return-to-work times. Conversely, CDR offered shorter operative times and better restoration of disc height.
7.Comparing Outcomes of Banana-Shaped and Straight Cages in Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Diseases: A Systematic Review and Meta-Analysis
Guang-Xun LIN ; Li-Ru HE ; Jin-Niang NAN ; Wen-Bin XU ; Keyi XIAO ; Zhiqiang QUE ; Shang-Wun JHANG ; Chien-Min CHEN ; Ming-Tao ZHU ; Gang RUI
Neurospine 2024;21(1):261-272
Objective:
This meta-analysis aims to refine the understanding of the optimal choice between different cage shapes in transforaminal lumbar interbody fusion (TLIF) by systematically comparing perioperative data, radiological outcomes, clinical results, and complications associated with banana-shaped and straight bullet cages.
Methods:
A meticulous literature search encompassing PubMed, Embase, Scopus, Web of Science, China Knowledge Network, and Wanfang Data was executed up to October 5, 2023. Inclusion criteria focused on studies comparing banana-shaped and straight bullet cages in TLIF. The quality of included studies was assessed using appropriate tools such as the Newcastle-Ottawa Scale (NOS) for nonrandomized studies. Rigorous evaluations were performed for radiographic outcomes, including disc height (DH), segmental lordosis (SL), lumbar lordosis (LL), subsidence, and fusion rates. Clinical outcomes were meticulously evaluated using visual analogue scale (VAS), Oswestry Disability Index (ODI), and complications.
Results:
The analysis incorporated 7 studies, involving 573 patients (297 with banana-shaped cages, 276 with straight cages), all with NOS ratings exceeding 5 stars. No statistically significant differences were observed in operative time, blood loss, or hospitalization between the 2 cage shapes. Banana-shaped cages exhibited greater changes in DH (p = 0.001), SL (p = 0.02), and LL (p = 0.01). Despite statistically higher changes in ODI for straight cages (26.33, p < 0.0001), the actual value remained similar to banana-shaped cages (26.15). Both cage types demonstrated similar efficacy in VAS, complication rates, subsidence, and fusion rates.
Conclusion
Although banana-shaped cages can excel in restoring DH, SL, and LL, straight bullet cages can provide comparable functional improvements, pain relief, and complication rates.
8.Clinical and Radiographic Outcomes of Cervical Disc Replacement Versus Posterior Endoscopic Cervical Decompression: A Matched-Pair Comparison Analysis
Vit KOTHEERANURAK ; Khanathip JITPAKDEE ; Kai-Uwe LEWANDROWSKI ; Guang-Xun LIN ; Weerasak SINGHATANADGIGE ; Worawat LIMTHONGKUL ; Wicharn YINGSAKMONGKOL ; Jin-Sung KIM ; Wongthawat LIAWRUNGRUEANG
Neurospine 2024;21(3):1040-1050
Objective:
To compare clinical and radiographic outcomes between 2 motion preservation surgeries, cervical disc replacement (CDR) and posterior endoscopic cervical decompression (PECD), for unilateral cervical radiculopathy.
Methods:
Between February 2018 and December 2020, 60 patients with unilateral cervical radiculopathy who underwent either CDR or PECD were retrospectively recruited as matched pairs. Clinical outcomes included visual analogue scale (VAS) scores for neck and arm pain, Neck Disability Index (NDI), and satisfaction rates. The radiographic outcome was index level motion. Intraoperative data, complications, and hospital stay were collected. Preoperative and postoperative outcomes were compared.
Results:
Patients undergoing CDR or PECD were included, with 30 cases in each group. Matched pairs were compared in terms of demographic data and preoperative measurements. CDR was associated with shorter operative times, whereas PECD resulted in less intraoperative blood loss. The total complication rate was 5%. NDI and VAS for neck and arm were significantly improved in both groups, with no significant differences between the 2 groups. Satisfaction rates of good and excellent exceeded 87% in both groups. CDR was superior to PECD in the restoration of disc height. Early postoperative follow-up showed no significant difference in terms of index level motion. PECD demonstrated significantly shorter hospital stays and quicker return-to-work times (p<0.05).
Conclusion
PECD achieved equivalent clinical and radiologic outcomes compared with CDR when the certain criteria for surgery were met. Both techniques demonstrated the potential to maintain index level motion. Additionally, PECD resulted in less blood loss, shorter hospital stays, and faster return-to-work times. Conversely, CDR offered shorter operative times and better restoration of disc height.
9.Comparing Outcomes of Banana-Shaped and Straight Cages in Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Diseases: A Systematic Review and Meta-Analysis
Guang-Xun LIN ; Li-Ru HE ; Jin-Niang NAN ; Wen-Bin XU ; Keyi XIAO ; Zhiqiang QUE ; Shang-Wun JHANG ; Chien-Min CHEN ; Ming-Tao ZHU ; Gang RUI
Neurospine 2024;21(1):261-272
Objective:
This meta-analysis aims to refine the understanding of the optimal choice between different cage shapes in transforaminal lumbar interbody fusion (TLIF) by systematically comparing perioperative data, radiological outcomes, clinical results, and complications associated with banana-shaped and straight bullet cages.
Methods:
A meticulous literature search encompassing PubMed, Embase, Scopus, Web of Science, China Knowledge Network, and Wanfang Data was executed up to October 5, 2023. Inclusion criteria focused on studies comparing banana-shaped and straight bullet cages in TLIF. The quality of included studies was assessed using appropriate tools such as the Newcastle-Ottawa Scale (NOS) for nonrandomized studies. Rigorous evaluations were performed for radiographic outcomes, including disc height (DH), segmental lordosis (SL), lumbar lordosis (LL), subsidence, and fusion rates. Clinical outcomes were meticulously evaluated using visual analogue scale (VAS), Oswestry Disability Index (ODI), and complications.
Results:
The analysis incorporated 7 studies, involving 573 patients (297 with banana-shaped cages, 276 with straight cages), all with NOS ratings exceeding 5 stars. No statistically significant differences were observed in operative time, blood loss, or hospitalization between the 2 cage shapes. Banana-shaped cages exhibited greater changes in DH (p = 0.001), SL (p = 0.02), and LL (p = 0.01). Despite statistically higher changes in ODI for straight cages (26.33, p < 0.0001), the actual value remained similar to banana-shaped cages (26.15). Both cage types demonstrated similar efficacy in VAS, complication rates, subsidence, and fusion rates.
Conclusion
Although banana-shaped cages can excel in restoring DH, SL, and LL, straight bullet cages can provide comparable functional improvements, pain relief, and complication rates.
10.Clinical and Radiographic Outcomes of Cervical Disc Replacement Versus Posterior Endoscopic Cervical Decompression: A Matched-Pair Comparison Analysis
Vit KOTHEERANURAK ; Khanathip JITPAKDEE ; Kai-Uwe LEWANDROWSKI ; Guang-Xun LIN ; Weerasak SINGHATANADGIGE ; Worawat LIMTHONGKUL ; Wicharn YINGSAKMONGKOL ; Jin-Sung KIM ; Wongthawat LIAWRUNGRUEANG
Neurospine 2024;21(3):1040-1050
Objective:
To compare clinical and radiographic outcomes between 2 motion preservation surgeries, cervical disc replacement (CDR) and posterior endoscopic cervical decompression (PECD), for unilateral cervical radiculopathy.
Methods:
Between February 2018 and December 2020, 60 patients with unilateral cervical radiculopathy who underwent either CDR or PECD were retrospectively recruited as matched pairs. Clinical outcomes included visual analogue scale (VAS) scores for neck and arm pain, Neck Disability Index (NDI), and satisfaction rates. The radiographic outcome was index level motion. Intraoperative data, complications, and hospital stay were collected. Preoperative and postoperative outcomes were compared.
Results:
Patients undergoing CDR or PECD were included, with 30 cases in each group. Matched pairs were compared in terms of demographic data and preoperative measurements. CDR was associated with shorter operative times, whereas PECD resulted in less intraoperative blood loss. The total complication rate was 5%. NDI and VAS for neck and arm were significantly improved in both groups, with no significant differences between the 2 groups. Satisfaction rates of good and excellent exceeded 87% in both groups. CDR was superior to PECD in the restoration of disc height. Early postoperative follow-up showed no significant difference in terms of index level motion. PECD demonstrated significantly shorter hospital stays and quicker return-to-work times (p<0.05).
Conclusion
PECD achieved equivalent clinical and radiologic outcomes compared with CDR when the certain criteria for surgery were met. Both techniques demonstrated the potential to maintain index level motion. Additionally, PECD resulted in less blood loss, shorter hospital stays, and faster return-to-work times. Conversely, CDR offered shorter operative times and better restoration of disc height.

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