1.Long - term changes of macular retinal thickness after idiopathic macular hole surgery
Yan, YANG ; Ke, ZHENG ; Lie, MA ; Jun, LIANG ; Wei, GU
International Eye Science 2014;(12):2262-2265
AlM:To determine the changes of regional macular retinal thickness ( RT ) with spectral domain optical coherence tomography ( SD-OCT ) after successful pars plana vitrectomy ( PPV ) surgery with inner limiting membrane ( lLM ) peeling in patients with idiopathic macular hole.
METHODS:A non-randomized retrospective case study on 17 patients ( 17 eyes ) who were hospitalized between March 1, 2011 and June 30, 2013. All 17 eyes had been diagnosed with idiopathic macular hole and thereafter underwent 25G-PPV surgeries performed by the same surgeon with lLM peeling and short - term gas tamponade. ln the 6mo-plus follow-up after surgery, these eyes were found to have successful closure in the macular hole. The macular RT of the nine areas in the Early Treatment Diabetic Retinopathy Study was measured by SD-OCT. All patients were applied by SD-OCT with linear scan of the macular. At least four examinations on the operated eye were conducted in contrast to the other normal eye: before the surgery, 3~5wk after the surgery (stage A), 2~3mo after the surgery (stage B), and >6mo after the surgery (stage C).
RESULTS:ln stage A, the macular RT of operated eyes in the areas of C, lS, ll, lN, OS, Ol, ON (263. 00±39. 48, 313. 92±18. 35, 311. 00±18. 02, 335. 67±19. 91, 280. 83±33. 74, 269. 92 ± 23. 32, 307. 00 ± 28. 40 ) were significantly thicker than the corresponding areas of the normal fellow eyes (220. 51 ± 23. 94, 292. 08 ± 21. 93, 282. 50 ± 20. 30, 288. 33 ± 20. 76, 251. 25±17. 60, 247. 75±21. 48, 265. 17±24. 76ü m) (P<0. 01) with the exception of the lT (291. 58±18. 97, 280. 33± 20.82üm) and OT (250.83±21.21, 242.08±24.02üm) (P>0. 01). ln Stage B, the macular RT in the areas of ll, lN, OS (335.67±19.20,319.75±19.20, 273.50±16.89üm) were significantly thicker than the corresponding areas of the normal fellow eyes (286. 33±20. 46, 293. 42±17. 64, 252. 50± 16.32üm) (P<0. 01). However, the macular RT of the operated eyes in the areas of C, lS, lT, Ol and OT had no statistically significant difference compared with the corresponding areas of the normal fellow eyes (P> 0. 01). ln Stage C, the macular RT of operated eyes with the areas of lN (321. 17 ± 19. 71ü m) were significantly thicker than the corresponding areas of the normal fellow eyes (296.25±19.57üm) (P<0.01). Meanwhile the other areas of the operated eyes were not significantly different from the normal fellow eyes (P>0. 01). Moreover, the macular RT of operated eyes in the areas of ON, lT (307. 00±28. 40, 291. 58 ± 18. 97ü m ) in stage A significantly decreased compared to that of the corresponding areas in stage C (276. 08±32. 39, 278. 75±10. 19ü m) (P<0. 01).
CONCLUSlON: SD-OCT is a convenient tool for the observation of macular regional changes after macular hole surgery. Macular RT had persistent changes after vitrectomy on eyes with macular hole by SD-OCT. lLM peeling may have caused microstructural changes in wide areas of the macular region after PPV surgery. More support and evidence were provided to the further study of the long - term observation for the structural and function of macular after macular hole surgery.
2.Infrastructure and contents of clinical data management plan.
Tong SHEN ; Lie-dong XU ; Hai-jun FU ; Yan LIU ; Jia HE ; Ping-yan CHEN ; Yu-fei SONG
Acta Pharmaceutica Sinica 2015;50(11):1388-1392
Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.
Clinical Trials as Topic
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Data Collection
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standards
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Database Management Systems
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standards
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Information Storage and Retrieval
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standards
3.Application of computer aided design/computer aided manufactured techniques in mandible defect reconstruction.
Xin XU ; Fei-yun PING ; Jun CHEN ; Jun-lie YAN ; Feng-guo YAN
Chinese Journal of Stomatology 2007;42(8):492-495
OBJECTIVETo investigate the application of CAD/CAM technique in reconstruction of mandible defect.
METHODSBefore surgery, three-dimensional computed tomography was performed in 23 patients with mandible lesions, then the CT data were transformed into a readable format to produce facsimile models by using rapid prototyping (RP) techniques. When individual mandibular models were produced, evaluation and surgical simulation were performed on the model, which included measuring range of mandible lesions, prefabrication of mandibular reconstructive titanium plates or distractors, ascertaining precise position of transport disk, and shaping the free vascularized fibula, etc. According to the simulation, the mandible reconstruction was accomplished in operation.
RESULTSThe surgical simulation on the model produced by CAD/CAM technique highly resembled the real operation. The measurements of the lesion on the model were completely correspondent with those found in operation, and the prefabricated plates and distractor fitted the contour of the mandible. The operation time shortened and the results were satisfactory. The post-operation X-ray showed that the mandible was symmetrical and the maxillofacial contour maintained.
CONCLUSIONSCAD/CAM technique was very helpful for simulation of anatomically complicated mandible defect. By preoperative simulation of the mandible and lesions, surgeons are able to improve or refine surgical planning so that better results can be assured.
Adolescent ; Adult ; Bone Transplantation ; Child ; Child, Preschool ; Computer-Aided Design ; Female ; Fibula ; transplantation ; Humans ; Image Processing, Computer-Assisted ; Male ; Mandible ; surgery ; Mandibular Neoplasms ; surgery ; Middle Aged ; Osteogenesis, Distraction ; Young Adult
4.Application of computer aided design-computer aided manufacture technique in mandible defect reconstruction with individual titanium prosthesis.
Xin XU ; Jun-lie YAN ; Fei-yun PING ; Jun CHEN ; Feng-guo YAN ; Yi-dan SHAN
Chinese Journal of Stomatology 2011;46(7):422-424
OBJECTIVETo investigate the application of computer aided design-computer aided manufacture (CAD-CAM) technique in the reconstruction of mandible defect with individual titanium prosthesis.
METHODSSix patients with large mandibular ramus and angle tumor were spiral CT scanned preoperatively, and the CAD-CAM was used to design and make individual titanium prosthesis for reconstructing the mandibular defects after resection of the tumor. The prosthesis were assembled during operation. Postoperative follow-up period was 9 - 38 months.
RESULTSThe design and manufacture of titanium prosthesis by use of CAD-CAM technique was convenient and the prosthesis fitted the defects very well. The outline of the face, the occlusion and function were restored. After 9 - 38 months of follow-up, the mandibular symmetry was good.
CONCLUSIONSThe application of CAD-CAM provided accurate simulation and fast manufacturing process for the titanium prosthesis in the repair of mandibular defect.
Adult ; Ameloblastoma ; rehabilitation ; surgery ; Computer Simulation ; Computer-Aided Design ; Female ; Follow-Up Studies ; Humans ; Male ; Mandible ; surgery ; Mandibular Neoplasms ; rehabilitation ; surgery ; Mandibular Prosthesis Implantation ; Mandibular Reconstruction ; Middle Aged ; Prosthesis Design ; Titanium ; Tomography, Spiral Computed ; Young Adult
5.Double-step distraction osteogenesis in the reconstruction of unilateral mandibular segmental defects after tumor resection.
Jun CHEN ; Fei-Yun PING ; Jun-Lie YAN ; Feng-Guo YAN ; Shuang-Xia PAN
Chinese Journal of Plastic Surgery 2008;24(3):175-177
OBJECTIVETo investigate the application of double-step distraction osteogenesis in the reconstruction of mandibular segmental defects after tumor resection.
METHODSFrom January 2002 to December 2006, six cases of post-tumor unilateral mandibular segmental defects were reconstructed using distraction osteogenesis. The mandibular body was lengthened first, following by mandibular ramus distraction.
RESULTSNo infection or other complication was observed. The maximal distraction length reached 55 millimeter in the mandibular body, and 42 millimeter in the mandibular ramus. The average distraction length was 52 millimeter in the mandibular body, and 34 millimeter in the mandibular ramus. Both the aesthetic and functional result was excellent in all cases.
CONCLUSIONSDouble-step distraction osteogenesis is effective and easily performed in the reconstruction of unilateral mandibular segmental defects with less morbidities and complications. There is no need for donor site. However, the treatment period is relatively long with three staged operations.
Adolescent ; Adult ; Female ; Humans ; Male ; Mandibular Neoplasms ; surgery ; Middle Aged ; Osteogenesis, Distraction ; methods ; Reconstructive Surgical Procedures ; methods ; Young Adult
6.Study on color matching of equal volume in dental ceramic prothesis materials.
Bei-yan LOU ; Yan ZHANG ; Yun LUO ; Jun SUN ; Yong-lie CHAO
West China Journal of Stomatology 2007;25(5):474-476
OBJECTIVETo study the color changes on brightness and hue in dental ceramic prothesis materials.
METHODSThe different color mark of VINTAGE series was sintered on 15 pieces Ni-Cr alloy denture materials. The sample group and control group was given the sintering of color blending with equivalent volume. The order of color mark was of A1 and A2, A2 and A3, A3 and A4, B1 and B2, B2 and B3, B3 and B4 in sample group, and A1, A2, A3, A3.5, A4, B1, B2, B3 and B4 orderly in control group. The chromatic analysis on samples of VITA had been taken through applying PR 650 spectrum detector and adopted the statistic software of Photo Research and SPSS 12.0 for analysis.
RESULTSThe statistical difference (P<0.05) of L*a*b* value was found in the different color mark of the same color serials. A non-linearity relation had been found in the chromatic parameters a*b*. It means the change of color was visible.
CONCLUSIONSet A has a bigger grading change of brightness than Set B. The change of red-green is obviously in Set A, as well as yellow-blue in Set B.
Ceramics ; Color ; Dental Materials ; Humans
7.Sexual function and mental state in patients with redundant prepuce or phimosis.
Lu YANG ; Lie-Min RUAN ; Ze-Jun YAN ; Yue CHENG ; Guo-Yao WANG ; Yun-Xin JI
National Journal of Andrology 2010;16(12):1095-1097
OBJECTIVETo investigate the correlation of sexual dysfunction with psychological abnormalities by analyzing the sexual function and mental state of the patients with redundant prepuce or phimosis.
METHODSThis study included 216 randomly selected patients with redundant prepuce or phimosis and 85 normal male controls. We conducted investigations among the subjects using a questionnaire on the general data of the patients, Chinese Index of Sexual Function for Premature Ejaculation (CIPE), International Index of Erectile Function (IIEF), and Symptom Checklist 90 (SCL-90). Then we assessed the status of premature ejaculation (PE) and erectile dysfunction (ED), calculated the incidence of psychological abnormalities, such as depression and anxiety, and analyzed the correlation of PE and ED with the mental state of the patients.
RESULTSThe PE and ED patients scored significantly higher than normal controls on SCL-90, somatization, compulsion, depression, anxiety and other factors (P < 0.05). CIPE scores were correlated with the scores on SCL-90, somatization, compulsion, interpersonal sensitivity, depression, anxiety and other factors, while ED-related scores showed no correlation with the scores on SCL-90 and other factors.
CONCLUSIONPatients with redundant prepuce or phimosis have poor mental health, and there is an interaction between PE and the mental state of the patient.
Adolescent ; Adult ; Case-Control Studies ; Erectile Dysfunction ; etiology ; Humans ; Male ; Middle Aged ; Phimosis ; physiopathology ; psychology ; Sexual Behavior ; Sexual Dysfunction, Physiological ; physiopathology ; psychology
8.Study on different thickness and chromatics of various opaques.
Yun LUO ; Bei-yan LOU ; Jun SUN ; Yong-lie CHAO
West China Journal of Stomatology 2006;24(6):506-508
OBJECTIVETo study the effect existed in the course of adopting different thickness and chromatics of various opaques so that a good methods can be provided for clinical care in prosthodontics.
METHODSA model of using the thin plastic paper to control the ceramic thickness was applied in this test. The data of chromaticity was measured by TC-PIIG auto color difference meter and its results was processed by computer.
RESULTSThe value of brightness had an uptrend increase with augment of opaques thickness. Metal base color was opaqued and the basic hue was set. A lower and unstable value, besides a relative stable Y, was measured with the uncompleted opaquing. A stability of hue had been gradually concentrated within a certain range accompanying with the increase of opaquing ceramic thickness. A concentrated hue in the second thickness was found in CARAT ceramic which had high ability of opaque and had a stable hue of ceramic in comparison with other opaques. Among those changes, CARAT's brightness showed a minimal change; a gradual stability of chromatics was presented and was limited with-in a certain range though the augment of opaques.
CONCLUSIONThe metal color in base could be completely opaqued while opaques thickness reaches a certain range. CARAT is the materials of minimal thickness and has relatively strong capacity for opaques.
Ceramics ; Color ; Dental Alloys ; Dental Porcelain ; Materials Testing ; Metal Ceramic Alloys
9.Application of lateral lag screw with sagittal condylar fracture and management of articular disk.
Xin XU ; Yun-fei PING ; Jun-lie YAN
Journal of Zhejiang University. Medical sciences 2008;37(5):519-523
OBJECTIVETo evaluate the application of lateral lag screw and reduction of articular disk in management of intracapsular sagittle fractures of the condylar process.
METHODSThe study group consisted of 16 cases (19 joints), including 10 males (12 joints) and 6 females (7 joints). Condylar sagittal fracture and displaced articular disk were detected in all patients. The condylar segments were repositioned and fixed by using lateral lag screw and the displaced articular disk were repositioned at the same time. The mean postoperative follow-up was 16 months (range 6-28 months). During the follow up, facial nerve function was monitored and radiologic re-examinations were performed to evaluate reposition of condylar process fractures and articular disk, while the mouth opening and occlusion were registered.
RESULTSThe reduction of the displaced condylar fragments and articular disks in all patients were excellent on 3D CT and MRI. No severe complications were observed (including permanent facial nerve palsies, malocclusion, ankylosis). Three months after surgery, all patients showed their better mobility with condylar and disk, and mouth opening reached 43 mm on maximum, 32 mm on minimum, with a mean of 37 mm.
CONCLUSIONThe results by application of lateral lag screw and reduction of articular disk are helpful in anatomical and functional recovery of temporomandibular joint for patients with displaced sagittal condylar process fractures.
Adolescent ; Adult ; Bone Screws ; Child ; Female ; Follow-Up Studies ; Fracture Fixation, Internal ; instrumentation ; methods ; Humans ; Male ; Mandibular Condyle ; injuries ; Mandibular Fractures ; surgery ; Middle Aged ; Range of Motion, Articular ; physiology ; Temporomandibular Joint Disc ; injuries ; surgery ; Young Adult
10.HER-2 expression in advanced gastric cancer and its correlation with clinical features, outcome and prognosis.
Yan WANG ; Jian-ming XU ; Jian-zhi LIU ; Li LIN ; Fei-jiao GE ; Shan-shan LI ; Lie-jun LIU ; Chuan-hua ZHAO
Chinese Journal of Oncology 2011;33(9):671-675
OBJECTIVETo assess the HER-2 status in Chinese advanced gastric cancer patients and explore its correlation with clinical features, treatment response and prognosis.
METHODSA total of 107 patients with advanced gastric cancer treated in our hospital from December 2005 to November 2008 were included in this retrospective analysis. HER-2 status was determined by immunohistochemisty (IHC) and/or fluorescence in situ hybridization (FISH). The correlations of HER-2 status with tumor location, pathology, treatment response and prognosis were analyzed and the efficacy of different chemottherapy regimens was compared.
RESULTSThe overall positive rate of HER-2 expression was 14.7% (15/102). The HER-2 status was detected by both methods in 102 patients, and the concordance of the two methods was 66.5%. The tumor site distribution was gastroesophageal junction (GEJ) 28.0%, proximal stomach 19.4%, gastric corpus 16.1%, antrum 26.9% and whole stomach 9.7%, respectively. There was no significant difference of HER-2 status among different tumor sites (P = 0.726), and no significant correlation between HER-2 expression and differentiation (P = 0.110). Among the evaluable 51 patients treated by first-line chemotherapy, the total objective effective rate was 23.5%. The median time-to-progression was 7.47 months, and median overall survival time was 11.07 months. The effective rate was 43.8% in patients who received XP regimen chemotherapy (cisplatin + capecitabine), significantly higher than the 14.3% in patients treated with other regimens (P = 0.033). Their overall survival was 14.17 months and 9.53 months, respectively (P = 0.059). The TTP was 6.63 months in HER-2 positive patients and 7.47 months in HER-2 negative patients, with a non-significant difference (P = 0.510). However, there was a improving tendency in the efficacy and OS, showing a effective rate of 45.5% and 17.5% (P = 0.102) and OS of 14.17 months and 10.63 months, respectively (P = 0.205).
CONCLUSIONSHER-2-positivity rate in Chinese patients with advanced gastric cancer is similar to those reported in the literature. Along with the increasing use of targeted therapy and targeted agents, the efficacy and survival of gastric cancer patients is improving. HER-2-positive patients may benefit from it.
Adenocarcinoma ; drug therapy ; metabolism ; pathology ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Capecitabine ; Cisplatin ; administration & dosage ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; Disease Progression ; Esophagogastric Junction ; pathology ; Female ; Fluorouracil ; administration & dosage ; analogs & derivatives ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Receptor, ErbB-2 ; metabolism ; Retrospective Studies ; Stomach ; pathology ; Stomach Neoplasms ; drug therapy ; metabolism ; pathology ; Survival Rate