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Objective: To establish a UPLC-MS/MS method for the determination of the residual quantity of potential genetoxic impurity 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide (EDC) in ledipasvir.Methods: The chromatographic conditions were as follows: an Agilent ZORBAX SB-C18 (75 mm×4.6 mm, 3.5 μm) column was used with methanol-0.1% formic acid (50∶50) as the mobile phase.The flow rate was 0.3 ml·min-1.The column temperature was 30 ℃ and the injection volume was 5 μl.The mass spectrometry conditions were as follows: electrospray ionization source (ESI), multistage reaction monitoring (MRM), positive ion scanning mode, ion spray voltage of 2 500 V, ion source temperature of 500 ℃, atomization gas of 379.0 kPa, auxiliary gas of 275.6 kPa, curtain gas of 137.8 kPa, collision gas of 41.3 kPa, ion collision energy of 15 V and scan time of 100 ms.The MRM ion pair for quantitative analysis was m/z→156.2/86.1.Results: The linear range of EDC was 0.03-2.25 μg·ml-1 (r=0.999 0).The limit of detection was 0.03 ng and the limit of quantitation was 0.08 ng.The average recovery was 98.3%(RSD=5.7%, n=9).Conclusion: The method is simple, rapid and accurate, and can be used for the quality control of EDC in ledipasvir.
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Objective To explore the clinical results of the arthroscopic acromioplasty in the rotator cuff repair.Methods Sixty-five patients (42 males and 23 females) to receive suture bridge repair under the arthroscopy between May 2012 and May 2014 were selected and randomly divided into an experimental group and a control group.The experimental group was given suture bridge repair with acromioplasty,while the control group underwent the suture bridge repair without acromioplasty.The time of operation was recorded.The range of motion (ROM) of the shoulder,the UCLA shoulder scoring system (ULCA) score,American orthopedic surgeon scoring system (ASES) score,the visual analogue scale (VAS) score and Constant score were observed 3 and 12 months after the operation.Results There were no significant differences in age,sex and the affected side between the two groups.Significant differences were found between the two groups in the duration of the operation (t=-18.5,P＜0.05).There were no significant differences in the ROM and the ULCA,ASES,VAS and constant scores of the shoulder 3 and 12 months after the operation.Conclusion No significant differences were found in the ROM and the shoulder function scoring between giving acromioplasty under the arthroscopy or not.However,the operation time of undergoing acromioplasty under the arthroscopy was longer.
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Objective To compare arthroscopic double-pulley knotless suture bridge with conven tional arthroscopic suture bridge in repair of rotator cuff tear.Methods From May 2013 to May 2015,70patients with rotator cuff tear were repaired at our department.They were 38 males and 32 females,with a mean age of 53.7 years.They were randomized into 2 equal groups to receive repair either using arthroscopic double-pulley knotless suture bridge (the experimental group) or using conventional arthroscopic suture bridge (the control group).The 2 groups were compared postoperatively in terms of VAS (visual analogue scale),Constant,ASES (American Shoulder and Elbow Surgeons) and UCLA (University of California at Los Angeles) scores,shoulder range of motion,and rotator cuff retear.Results The 2 groups were compatible with no significant differences in gender,age,laterality,tear type,or preoperative function or range of motion of the shoulder joint (P ＞ 0.05).At 12 months postoperatively,the VAS,Constant,ASES and UCLA scores and shoulder range of motion in the experimental group were respectively 1.1 ± 1.3,86.0 ±8.9,13.3 ± 0.8,32.0 ± 2.9,156.8° ± 15.0° and 55.9° ± 5.8°,significantly improved than the preoperative values (P ＜0.05).At 12 months postoperatively,the VAS,Constant,ASES and UCLA scores and shoulder range of motion in the control group were respectively 1.3 ± 1.3,86.6 ±4.2,13.1 ± 1.0,31.1 ±2.6,153.3°±10.0° and 55.7° ± 5.1 °,significantly improved than the preoperative values (P ＜ 0.05).At 12 months postoperatively,there were no significant differences between the 2 groups in VAS,Constant,ASES or UCLA scores or shoulder range of motion (P ＞ O.05).No case of rotator cuff retear occurred in the experimental group while 5 cases were observed in the control group,showing a significant difference (0 versus 14.3％) (P ＜ 0.05).Conclusions Compared with conventional arthroscopic suture bridge,arthroscopic double-pulley knotless suture bridge presents no significant differences in range of motion or function of the shoulder joint in repair of rotator cuff tear.However,the latter may lead to a lower incidence of rotator cuff retear and,additionally,is less skillfully demanding.
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Quality assurance system for postgraduate education including the implementation system,monitoring and information gathering and feedback system,resource guarantee system was established according to the characteristics of postgraduate education and combined with theory of total quality management.The implementation scheme for total quality management-oriented postgraduate education was formulated from the aspects of training plan,objective requirements,etc.
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BACKGROUND:Obsolete lateral ankle ligament injury is frequently treated by Chrisman-Snook operation.However,this operation destructs some peroneus brevis tendon,and affects the function of peroneus brevis tendon for foot valgus.OBJECTIVE:Based on previous research,to investigate the effect of allogeneic tendon for reconstruction of ankle lateral ligaments.METHODS:A total of 17 cases of ankle lateral ligament injured were selected,with a course of disease from 3 to 6 months.All lateral ligaments were reconstructed by allogeneic tendon & anchors.During the operation,a drill,4.5 rnm diameter,was used to drill a hole on the lateral ankle;one anchor was drilled into the talus at the end of anterior talofibular ligament,another one was threaded on the calcaneus;the allogeneic tendon was permeated through the hole on the lateral ankle,maintaining ankle neutral and moderate valgus position.The allogeneic tendon was sutured with the thread of the anchors.Following operation,the ankle was fixed in neutral position and slightly valgus position;wound healing,AOFAS score and stress radiograph were observed.RESULTS AND CONCLUSION:All 17 patients showed no rejection,and the wound healing well at the primary stage.At 6,12,24 after operation,all patients were followed-up.According to AOFAS criteria,function of ankle in all patients was significantly improved.No patients complained of instability of the ankle,end stress radiograph confirmed this improvement.Reconstruction of lateral ligaments of the ankle with allogeneic tendon and anchors is a practical treatment,which restores stability and function of ankle without long incision or damaging normal tendons.
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BACKGROUND: Literatures report that double-bundle reconstruction is a better choice for posterior cruciate ligament (PCL),but Tibial-inlay technique exhibits no significant difference.OBJECTIVE: To evaluate the effect of Tibial-inlay technique used in the PCL reconstruction with allograft tendons.METHODS: Thirty-one patients with PCL rupture were verified by arthroscopy in the Department of Orthopaedics, at the Affiliated Hospital of Chengde Medical College between February 2006 and May 2008, including 14 knees caused by traffic accident injury,9 knees by crashing, and 8 knees by athletic injury. All the damaged PCLs were reconstructed with allograft tendons by Tibial-inlay technique under arthroscopy. During surgery, the remnants of the original PCL were retained as much as possible,PCL femoral tunnel was prepared. By using of allogeneic patella tendon with bone block at both ends or achilles tendon allograft with bone block at one side, the lateral bone block was chipped into trapezoidal block at a width of 1.0-1.5 cm and a length of 2 cm, that is, in addition to relying on friction force to fix between bone groove and bone graft, it can also generate compressive stress and increase its stability. The PCL tibial attached point was stripped, the trapezoid bone groove was prepared according to the size of bone block at the insertion site, and allogeneic bone block was embedded into bone groove, then the other end was introduced to femoral tunnel using pulling wire through the joint, after tensed at anterior drawer site, the extrusion screw was twisted forward to fix the tendon or bone. Before operation and during follow-ups, the posterior drawer test knee instability, joint activity, Lysholm knee function scores were recorded.RESULTS AND CONCLUSION: No severe complications, such as vascular nerve injury, rejection or infection, occurred in early stage after operations in 31 patients. All of them were followed up for 12-24 months. Posterior drawer test of all the subjects were above 2+ before operation, of which, 3+ and 4+ were 84%; the posterior drawer test re,suits were as the following after operation:4 cases of 0+ (normal), 17 cases of 1 +, 9 cases of 2+ and 1 case of 3+, which shows the improvement of retroposition (P ＜ 0.05);Lysholm score was remarkably improved at follow-up compared with preoperation (P ＜ 0.05), and there were significant improvements in the joint range of motion (P ＜ 0.05). The reconstruction of PCL by Tibial-inlay technique with allograft tendons has advantages of minimal trauma in surgery, reliable fixation and satisfactory outcome.
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BACKGROUND: Donor complications have been detected following autologous tendon transplantation for posterior cruciate ligament reconstruction. Although artificial tendon development and tissue-engineered tendon have achieved great progresses, there are some issues in clinical application. Since 1980's, allogenic tendon transplantation has aroused increasing attention. OBJECTIVE: To explore the selection of allogenic tendon materials and the effect of their application on reconstructing posterior cruciate ligament. METHODS: A total of 17 patients with posterior cruciate ligament injury of knee joint were treated with cryopreserved allogenic tendon by Tibial-inlay technique. During the operation, two tracts of tendons soaked in gentamicin saline for 15 minutes were conduplicated, and one end of the tendon was cancellous bone screw and fixed to the tibia attachment point of posterior cruciate ligament, and the other end was introduced into the joint through retention suture. The posterior joint capsule was repaired. The patient was placed at supine position, and the knee was flexed for 90°. The other end of the graft was introduced to femoral tunnel, and anterior drawer was tensed, and fixed by screw. RESULTS AND CONCLUSlN: The preoperative posterior drawer test of patients was >2+, including 7 cases of 3+ and 6 of 4+. The postoperative posterior drawer test was 0 in 4 cases, 1+ in 8 cases, 2+ in 4 cases and 3+ in 1 case, suggesting the posterior movement of the knee joint was significantly improved. Lysholm scores of patients were (48.5±4.3) points before operation and (88.3±5.4) points after operation. Results show that cryopreserved allogenic tendon by Tibial-inlay technique could restored function of posterior cruciate ligament with a favorable effect.