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OBJECTIVE： To establish a method for the determination of related substances in rifabutin crude drug and capsules by HPLC. METHODS： HPLC method was adopted. The determination was performed on Agilent XDB-C8 column with mobile phase consisted of acetonitrile-0.1 mol/L potassium dihydrogen phosphate solution （pH 6.5±0.1） （50 ∶ 50， V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 254 nm， the column temperature was 30 ℃， and sample size was 20 μL. The mobile phase was used as solvent to prepare the sample solution with a mass concentration of 1.0 mg/mL. The system suitability test was performed by using newly established method and current method （mass concentration of sample solution 0.5 mg/mL， C18 column） stated in quality standard of rifabutin crude drug and capsules. Related substance test was conducted for 6 batches of rifabutin crude drug and capsule （peak area normalization method）. RESULTS： The linear range of rifabutin was 0.8-16 μg/mL（r＝1.000 0）， RSDs of precision， reproducibility and stability tests （12 h） were all lower than 2.0％ （n＝6）； the limits of detection and quantification were 0.025 4， 0.085 2 μg/mL. In system suitability test， by using new method and current method， separation degree of rifabutin peak and pre-degradation product peak were 7.50 and 3.47. When 6 batches of samples were determined， the number of impurities detected by this method was 1-5 more than that by the current method， and the total amount of impurities was 0.19％-0.55％ higher. CONCLUSIONS： Established new method is well-separated and sensitive， and can be used for the determination of related substance in rifabutin crude drug and capsules， which helps the quality control of drugs.
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BACKGROUND:It is notable to treat cervical spondylosis using the anterior cervical discectomy and fusion, but there are such complications as cervical instability and low fusion rate. Titanium plate with cage can solve those defects, while anterior unfamiliar matter and dysphagia appear. A new anterior cervical interbody fusionZero-Pwith support and fixation function has been widely used in clinic. OBJECTIVE:To analyze early stability in repairing cervical spondylosis using a newZero-Pinterbody fixation and fusion system, and compare with a titanium plate with cage interbody fixation andfusion system. METHODS:We retrospectively analyzed the clinical date of 31 patients with cervical spondylosis who underwent the anterior cervical discectomy and fusion in the Department of Orthopedics, Affiliated Hospital of Jiangsu University between August 2010 and August 2014. Fifteen patients were treated with aZero-P implant (Zero-Pgroup) and sixteen patients with a titanium plate with cage (cage group). We recorded operation time, intraoperative blood loss, preoperative and postoperative Visual Analogue Scale scores and Japanese Orthopedic Association scores, postoperative incidence of dysphagia and degeneration rate of adjacent joint. RESULTS AND CONCLUSION:(1) Postoperative symptoms were apparently improved, without severe complications in both groups. (2) Operation time and intraoperative blood loss were better in theZero-P group than in the cage group (P 0.05). (4) Mild dysphagia was experienced by one case (7%) in theZero-Pgroup, but nine cases (44%) in the cage group. Significant difference in the incidence of dysphagia was detected between the two groups after treatment (P=0.037). However, no significant difference in degeneration rate was detectable between the two groups (P=0.48). (5) These findings verify that in the anteriorcervical discectomy and fusion, the new Zero-Pand titanium plate with cage interbody fixation and fusion system are effective choices for cervical spondylosis. However, theZero-Pinterbody fixation and fusion system showed a low incidence of postoperative dysphagia and better stability.
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BACKGROUND:Once lumbar degenerative diseases merge with lumbar spinal stenosis, lumbar instability and degenerative scoliosis, surgical therapy is required for corresponding clinical symptoms, and the usage of internal fixators cannot be inevitable. Osteoporosis is rather common in the elderly. Therefore, how to implant stable pedicle screw fixation system in serious osteoporosis patients wil be a big difficulty. In recent years, some studies have proven the biomechanical stability of polymethylmethacrylate augmentation of a cannulated and fenestrated pedicle screw in the vertebral body, so it becomes very hot in the spine surgery. OBJECTIVE: To explore the clinical efficacy of the use of polymethylmethacrylate augmentation of a cannulated and fenestrated pedicle screw fixation for the treatment of lumbar degenerative disease accompanied with osteoporosis. METHODS:Thirty-one patients with lumbar degenerative disease accompanied with osteoporosis from Jun 2008 to Jan 2013 were selected, including 11 males and 20 females with an average age of 73.5 years (range, 65-86 years). There were 14 cases of lumbar degenerative stenosis, 9 of lumbar intervertebral disc herniation combined with segmental instability, 6 of lumbar degenerative spondylolisthesis, and 2 of lumbar degenerative scoliosis. The patients were treated with lumbar canal decompression, fusion and polymethylmethacrylate augmentation of a cannulated and fenestrated pedicle screw fixation according to their clinical features and imaging data. Visual analog scale for pain evaluation was used before and after fixation, the Japanese Orthopaedic Association (JOA) scale was used for assessment of neurological function and life skils before internal fixation and during folow-up. RESULTS AND CONCLUSION:Al cases were folowed up for 40 months (range, 36-48months). No screw breakage, rod breakage, screw extraction, loosening, pseudoarticulation formation, or incision infection was found. The postoperative visual analog scale score and the JOA score was remarkably improved (P < 0.05). For patients suffering from lumbar degenerative disease accompanied with osteoporosis, polymethylmethacrylate augmentation of a cannulated and fenestrated pedicle screw fixation is helpful for increasing the stabilization of screw and preventing from loosening and dislocation of the screws, and thereby beneficial for improvement and maintenance of clinical efficacy.
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BACKGROUND: The most commonly used rod-screw posterior spinal fixation system has some biomechanical drawbacks. The screw-plate system is more preferred for patients.OBJECTIVE: To prepare a new posterior spinal fixation system based on imaging results of distance between two pedicles,radian of spine flexion, extension and the height of intervertebral space of Chinese population.METHODS: The thoracolumbar data of 129 normal people were measured. According to the imaging measurements and relative documents, a device of gear-distraction plate (GDP) for spine reduction and fixation was designed. Eighteen fresh calf lumbar specimens were randomly divided into 3 groups, the test group was fixed by GDP and the other groups were fixed by CD and Steffee plate, respectively. The results of the displacement, strain, strength, stiffness and ultimate strength were measured under the states of vertical compression, flexion, extension and lateral bending respectively, and the results were statistically analyzed.RESULTS AND CONCLUSION: GDP could meet the need of strength and stiffness of human bodies. It showed superior to the CD and Steffee plate groups in strength and stiffness (P ＜ 0.05), with 13% or 14% torsion intensity greater than that of the CD or Steffee plate groups. The ultimate mechanical performance test showed that, the load bearing of the GDP group was greater than that of the CD and Steffee plate groups (P ＜ 0.05). The findings demonstrated that GDP for Chinese human presented with good biomechanical stability, which can promote vertebrae fracture union and prevent kyphosis relapses or vertebral height loses.
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OBJECTIVE: To explore the clinical effects of using custom-made tumor prosthesis replacement to treat malignant tumor located in the distal femur or proximal tibia. METHODS: A retrospective study of 29 cases malignant tumors around knee treated surgically from June 2001 to October 2008. In the study there were 19 males and 10 females, aging from 17 to 65 years, with an average of 38.5 years. The location of tumors was at distal femur in 22 cases and 7 cases at proximal tibia. After the tumor was extensively resected or radically resected, custom-made tumor prosthesis replacement was performed for reconstruction, simultaneously, neoadjuvant chemotherapy and radioactive-therapy were used in treating the tumor according the pathology. RESULTS: All patients were followed-up for 18-84 months, with average follow-up period of 54.2 months. The 3 year survival rate was 79.8%, and the 5 year survival rate was 63%. As for the complications, prosthesis breakage occurred in 2 patients, aseptic loosening in 1 patients, 2 had a recurrence of the soft tissue tumor for which the diseased limb amputation was performed. The mean MSTS score showed excellent limb function in 15 patients, good in 8 patients, fair in 5 patients and poor in 1 patient. The overall excellent and good function was obtained in 79% of the patients. No superficial or deep infection occurred. Two patients suffered common peroneal nerve injury, but were cured by symptomatic treatments. CONCLUSION: Application of tumor prosthesis can give a satisfactory functional outcome, which is an effect method in limb salvage treatment of malignant tumor around the knee.
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[Objective]A new device of gear-distraction plate (GDP) for spine reduction and fixation was designed and its biomechanical characteristics was evaluated.[Method]The GDP implants were made of titanium alloy (TC4,Ti6AL4V) and the instruments were made of stainless steel after design.Eighteen fresh calf lumbar specimens were randomly divided into three groups, the GDP group had a biomechanical test contrast to control group(CD, Steffee) in load-responsive change, load-displacement, strength, stiffness, torsion intensity and ultimate strength.[Result]Results It is better than control group in load-responsive change, load-displacement, strength, stiffness, torsion intensity and ultimate strength, there was a significant difference between them (P
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[Objective]To investigate results of surgical treatment of intradural tumors of the cervical spinal cord.[Method]Twenty-one cases with cervical intradural tumor were treated surgically under posterior approach from 1999 to 2005,all patients were performed cervical laminae resection before tumor resection,and some received internal fixation.All patients were followed up for 8 months to 38 months respectively.All the clinical materials were analyzed retrospectively.[Result]All patients survived the operation,symptoms disappeared 13,relieved 7 and deteriorated 1.Total resection in 15 cases,subtotal 4 cases and partial 2 cases.[Conclusion]To succeed the operation,it is very important to make clear the location and size of the tumor and the relationship between the tumor and spinal cord;in order to gain total resection of tumor,both careful protection of spinal cord and vertebral artery and intraspinal cannal veins are essence.
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Objective: We examined the cause、level of pathology、onset of symptoms、time taken to treatment and outcome of 14 patients with cauda equina syndrome(CES) to determine how these factors influenced the eventual outcome.Methods:14 patients with CES treated at our hospital between 1991 and 1997 underwent laminectomy followed by bilateral decompression.The mean time of followup was 35 months(range 22～48months).Logistical regression analysis was used to manage the data.Results:Out of 14 patients,11 had satisfactory recovery at 2 years postdecompression;3 patients were left with some residual dysfunction.Conclusion:There was a clear correlation between delayed decompression and the poor overall outcome,as well as the presence of perineal anaesthesia and significant sphicter dysfuncation.