Multi-layered granules were prepared by a fluidized-bed coater and uniformed granules were obtained with a size range between $950{\sim}1000{\mu}m$ in diameter. The granule system was composed of three layers, i.e. seed layer with sugar sphere bead and a water-swellable polymer, middle layer with a drug, solubilizer and polymer, and the top layer of porous membrane with a polymeric binder. The aim of this work is to find out the dependence of a drug dissolution rate on the amount of a water-soluble binder and a solubilizer in the granule system. The results showed that the higher amount of hydrophilic binder in the porous membrane, gave the bigger pore size and porosity and made faster dissolution rate and also the higher amount of solubilizer in drug layer enhanced the dissolution rate of drug.
Penetration rate of large molecule through skin is very low due to the barrier effect of stratum corneum. Novel microneedle treatment device with roll was designed for transdermal delivery of large molecular drugs such as vaccine and protein drugs. The permeation rates of FITC labelled bovine serum albumin (FITC-BSA) as a model protein were determined using modified Franz diffusion cell and hairless mouse skin which were treated by hydrogel or solution containing FITC-BSA. Fluorescent spectrophotometer was used to analyze the concentration of FITC-BSA. Microscope using fluorescent filter was used to capture the image and location of FITC-BSA in the skin. We confirmed that permeation rate of BSA was increased with the treatment by microneedle and was increased by the increasing frequency of treatment. Furthermore, the permeation rate observed from hydrogel treated skin was significantly higher than that from solution treated skin.
Solid dispersions of poorly water-soluble drug, atorvastatin, were prepared with Eudragit L100 to improve the solubility by spray dryer. To investigate the correlation between physicochemical properties and dissolution rate of solid dispersions, the samples were characterized by scanning electron microscopy (SEM), differential scanning calorimeter (DSC) and fourier transform infrared spectroscopy (FT-IR). SEM and DSC were found that atorvastatin is amorphous in the Eudragit L100 solid dispersion. FT-IR was used to analyze the salt formation by interaction between atorvastatin and Eudragit L100. The dissolution rate of solid dispersed atorvastatin was markedly increased compared to drug powder in stimulated intestinal juice (pH 6.8). Thus, the solid dispersed atorvastatin using the spray drying method with Eudragit L100 may be effective for the bioavailability.
Objective : PCB cervical instrument is a newly introduced fusion device which comprises cervical plate, cage (spacer) and screw system. It is developed to enhance fusion rate and stability, as well as to reduce complications related to hardware failure. We investigated the efficacy of clinical and radiological results of PCB instrument and Lubboc bone. Methods : From August, 1998 to October, 1999, authors performed 54 cases of anterior cervical interbody fusion with PCB instrument and Lubboc bone. Retrospective analysis was undertaken based on clinical and radiological findings. Clinical improvement was evaluated according to Odom's criteria. Cervical plain films and tomography were taken every 2 months to evaluate the degree of interbody fusion and disc height changes. Results : Bone fusion was observed in 36 cases(90%) over 6 months after operation, and during which time there was no significant interval change. There were 3 cases of hardware dislodgement. Disc height was increased significantly and preserved in all cases. Clinical outcome over good degree was seen more than 94% of patients. Conclusion : Longer follow-up period and comparative studies to similar instrument appear to be necessary, but this instrumentation system has shown high fusion rate and fewer adverse effects in our series. We believe this system might be indicated for the treatment of cervical trauma and degenerative disease in selective cases.
Objective : Anterior cervical locking plates are the devices for achieving anterior cervical spinal fusion. This study was conducted to evaluate the locking plate system regarding its long-term advantages and disadvantages in the view of interbody fusion rate, hardware-related failures, vertebral change close to the fusion segment and postoperative complications. Method : Eight-six patients, operated from Jan., 1996 to Jun. 1998, were followed-up for more than two years. All of the cases were fused with iliac bone graft and ORION locking plate(Sofamor Danek USA, Inc., Memphis, TN) fixation. The patients were discharged or transferred to rehabilitation department 2-7 days after operation. A comprehensive evaluation of the interbody fusion state, instrument failure, vertebral change and postoperative complications were made by direct interview and cervical flexion-extension lateral plain films. Results : There were 55 male and 31 female with a mean age of 45 years(18-75 years). The mean follow-up period was 29 months(24-43 months). Various disorders that were operated were 40 cervical discs, 6 cervical stenosis including OPLL, 2 infections, and 38 traumas. Fusion level was single in 59 cases, two levels of each disc space in 15 cases, and two levels after one corpectomy in 12 cases. There was no instrument failure. Pseudoarthrosis was observed in two cases(2%) without radiological instability. The other patients(98%) showed complete cervical fusion with stable instrument. Mild settling of interbody graft with upward migration of screws was found in 12 cases(14%). Anterior bony growth at the upper segment was found in 5 cases(6%). Postoperative foreign body sensation or dysphagia was observed in 12 cases(4%), and disappeared within one month in 7 cases and within six months in 4 cases. One patient complained for more than six months and required reoperation to remove paraesophageal granulation tissue. Conclusion : The results show that Orion cervical locking plate has some disadvantages of upward migration of screws, anterior bony growth at the upper segment, or possibility of esophageal compression even though it has advantages of high interbody fusion rate or low instrument failure. Author believe that anterior cervical locking plate in the future should be thinner, and should have short end from the screw hole, and movable screw with adequate stability.
5-Fluorouracil (5-FU) is an antimetabolic of the pyrimidine derivatives that is used in chemotherapy for the treatment of several types of cancer. 5-FU have poor oral absorption and short biological half-time and strong side effects. Microneedle introduced to find a solution of problems. Microneedle device with roll was manufactured for transdermal delivery of various drugs. 5-FU was mixed in non-ionic surfactant such as tween 20 and tween 80. Camscope was used to analysis the permeation magnitude of treated skin by microneedle and trypan blue staining. The 5-FU solution with surfactant measured by ZETA-potential analysis system for stability of solution. The skin permeation rate of 5-FU determined by HPLC. We confirmed that cross treated skin was dyed more deeply than parallel treated skin through trypan blue staining. The results indicate that skin permeation rate of 5-FU was increased with the treatment types and treatment times.
Objective : Posterior lumbar interbody fusion (PLIF) is considered to have the best theoretical potential in promoting bony fusion of unstable vertebral segments by way of a load sharing effect of the anterior column. This study was undertaken to investigate the efficacy of PLIF with cages in chronic degenerative disc disease with Modic degeneration (changes of vertebral end plate). Methods : A total of 597 patients underwent a PLIF with threaded fusion cages (TFC) from 1993 to 2000. Three-hundred-fifty-one patients, who could be followed for more than 3 years, were enrolled in this study. Patients were grouped into 4 categories according to Modic classification (no degeneration : 259, type 1 : 26, type 2 : 55, type 3 : 11). Clinical and radiographic data were evaluated retrospectively. Results : The clinical success rate according to the Prolo's functional and economic outcome scale was 86% in patients without degeneration and 83% in patients with Modic degeneration. The clinical outcomes in each group were 88% in type 1, 84% in type 2, and 73% in type 3. The bony fusion rate was 97% in patients without degeneration and 83% in patients with Modic degeneration. The bony fusion rate in each group was 81% in type 1, 84% in type 2, and 55% in type 3. The clinical success and fusion rates were significantly lower in patients with type 3 degeneration. Conclusion : The PLIF with TFC has been found to be an effective procedure for lumbar spine fusion. But, the clinical outcome and bony fusion rates were significantly low in the patients with Modic type 3. The authors suggest that PLIF combined with pedicle screw fixation would be the better for them.
Kim, Sam Yeol;Yoon, Seung Hwan;Kim, Dokeun;Oh, Chang Hyun;Oh, Seyang
Journal of Korean Neurosurgical Society
/
제60권6호
/
pp.691-700
/
2017
Objective : The authors prospectively analyzed the effect of one-level or two-level anterior cervical discectomy and fusion (ACDF), comparing stand-alone cages and cage-with-plate fixation constructs with respect to clinical outcomes and radiologic changes. Methods : A total of 84 patients who underwent one-level (n=52) or two-level ACDF (n=32) for cervical disc disease and who completed 2 years of follow-up were included in this study. The patients were divided by cervical level and grouped into ACDF-Cage-only and ACDF-Cage-with-plate groups. The following parameters were assessed using radiographs : subsidence, C2-C7 lordosis angle, fusion segment angle, adjacent disc space narrowing, and fusion status. Clinical outcomes were assessed using the neck disability index (NDI) and visual analog scale scores for arm pain. Results : In the comparison of one-level ACDF-cage-only and ACDF-cage-with-plate groups, the NDI score was better in the cage-only group at the 3-, 12-, and 24-month follow-ups : however, no significant difference in clinical outcomes was observed. In the comparison of two-level ACDF-cage-only and ACDF-cage-with-plate groups, no difference in any clinical outcome was observed between the two groups. At the 24-month follow-up, subsidence was observed in 45.8% of patients in the one-level cage-only group and 32.1% of patients in the one-level cage-with-plate fixation group. There was no statistically significant difference in the incidence rate between the two groups (p=0.312). Subsidence in the two-level cage-only group (66.6%) was significantly more frequent than in the two-level cage-with-plate fixation group (30%; p=0.049). The fusion rate for patients in the one-level cage-only group was not significantly different from that in the one-level cage-with-plate fixation group (cage-only, 87.5%; cage-with-plate fixation, 92.9%; p=0.425) ; fusion rate in the two-level patients were also similar between groups (cage-only, 83.3%; cage-with-plate fixation, 95%; p=0.31). Conclusion : Our clinical results showed that for single-level cases, plate fixation had no additional benefit versus cage-only; for two-level ACDF cases, the fusion rate and clinical outcomes were similar, although the cage-with-plate fixation group had a lower incidence of cage subsidence than did the cage-only group. We conclude that physicians should be aware of this possible disadvantage associated with using cervical plates in one-level ACDF. However, in two-level ACDF, subsidence is more likely to occur without plate fixation, and thus the addition of plate fixation should be considered.
Objective : In an aging society, the number of patients with symptomatic degenerative spondylolisthesis (DS) is increasing and there is an emerging need for fusion surgery. However, few studies have compared transforaminal lumbar interbody fusion (TLIF) and lateral lumbar interbody fusion (LLIF) for the treatment of patients with DS. The purpose of this study was to investigate the clinical and radiological outcomes between TLIF and LLIF in DS. Methods : We enrolled patients with symptomatic DS at L4-5 who underwent TLIF with open pedicle screw fixation (TLIF group, n=41) or minimally invasive LLIF with percutaneous pedicle screw fixation (LLIF group, n=39) and were followed-up for more than one year. Clinical (visual analog scale and Oswestry disability index) and radiological outcomes (spondylolisthesis rate, segmental sagittal angle [SSA], mean disc height [MDH], intervertebral foramen height [FH], cage subsidence, and fusion rate) were assessed. And we assessed the changes in radiological parameters between the postoperative and the last follow-up periods. Results : Preoperative radiological parameters were not significantly different between the two groups. LLIF was significantly superior to TLIF in immediate postoperative radiological results, including reduction of spondylolisthesis rate (3.8% and 7.2%), increase in MDH (13.9 mm and 10.3 mm) and FH (21.9 mm and 19.4 mm), and correction of SSA ($18.9^{\circ}$ and $15.6^{\circ}$) (p<0.01), and the changes were more stable from the postoperative period to the last follow-up (p<0.01). Cage subsidence was observed significantly less in LLIF (n=6) than TLIF (n=21). Fusion rate was not different between the two groups. The clinical outcomes did not differ significantly at any time point between the two groups. Complications were not statistically significant. However, TLIF showed chronic mechanical problems with screw loosening in four patients and LLIF showed temporary symptoms associated with the surgical approach, such as psoas and ileus muscle symptoms in three and two cases, respectively. Conclusion : LLIF was more effective than TLIF for spondylolisthesis reduction, likely due to the higher profile cage and ligamentotactic effect. In addition, LLIF showed mechanical stability of the reduction level by using a cage with a larger footprint. Therefore, LLIF should be considered a surgical option before TLIF for patients with unstable DS.
Identification of fusion gene is of prominent importance in cancer research field because of their potential as carcinogenic drivers. RNA sequencing (RNA-Seq) data have been the most useful source for identification of fusion transcripts. Although a number of algorithms have been developed thus far, most programs produce too many false-positives, thus making experimental confirmation almost impossible. We still lack a reliable program that achieves high precision with reasonable recall rate. Here, we present FusionScan, a highly optimized tool for predicting fusion transcripts from RNA-Seq data. We specifically search for split reads composed of intact exons at the fusion boundaries. Using 269 known fusion cases as the reference, we have implemented various mapping and filtering strategies to remove false-positives without discarding genuine fusions. In the performance test using three cell line datasets with validated fusion cases (NCI-H660, K562, and MCF-7), FusionScan outperformed other existing programs by a considerable margin, achieving the precision and recall rates of 60% and 79%, respectively. Simulation test also demonstrated that FusionScan recovered most of true positives without producing an overwhelming number of false-positives regardless of sequencing depth and read length. The computation time was comparable to other leading tools. We also provide several curative means to help users investigate the details of fusion candidates easily. We believe that FusionScan would be a reliable, efficient and convenient program for detecting fusion transcripts that meet the requirements in the clinical and experimental community. FusionScan is freely available at http://fusionscan.ewha.ac.kr/.
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