Objective To investigate the effect of minitype titanium plate fixation through transoral approach in the treatment of unstable atlas fractures.Methods A retrospective case series study was made on 21 patients with unstable atlas fractures treated by minitype titanium plate fixation through transoral approach from June 2008 to June 2014.There were 15 males and 6 females,at age of (40.9 ± 10.6)years (range,21 to 57 years).Anterior 1/2 Jefferson fractures were seen in 12 patients and 1/2 ring Jefferson fractures in 9 patients.Preoperative visual analogue score (VAS) was 4-9 points [(7.6 ± 1.3) points].Before operation,degree of mobility of the cervical vertebra was (15.4 ± 3.9) °in bending,(10.8 ± 2.5) °in extending,(18.3 ± 3.1) ° in left-bending,(18.9 ± 2.7) ° in right-bending,(21.8 ± 5.8) °in left-rotation and (22.4 ± 4.6) ° in right-rotation.Operation time,intraoperative blood loss,VAS,cervical mobility and bone healing were detected after operation.Results Operation time was (86.3 ±25.3)m in,and intraoperative blood loss was (120.5 ± 33.3)ml.VAS was improved to 0-2 points [(1.6 ± 0.4) points] at postoperative 3 days (P ＜ 0.05).All patients were followed up for 12 to 48 months[(23.7 ±5.9) months].VAS was improved to 0-2 points[(0.6 ± 0.1) points] at postoperative 3 months (P ＜ 0.05).Degree of mobility of the cervical vertebra was improved significantly at postoperative 3 months,with the bending of(38.6 ± 4.5) °,extending of (39.3 ± 4.0) °,left-bending of (39.2 ± 4.0) °,right-bending of (39.2 ± 2.9) °,left-rotation of (66.8 ± 8.8) ° and right-rotation of (66.3 ± 9.2) ° (P ＜ 0.05).Postoperatively,there were no surgical wound incision infections and vertebral artery or spinal injuries,Bone union was found in all patients,without the occurrence of implant loosening or breakage and the dysfunction of the cervical vertebra.Conclusion Minitype titanium plate fixation through transoral approach is associated with less trauma,high healing rate and preservation of the activity of cervical vertebra in the treatment of unstable atlas fractures.

Objective To compare the outcomes of percutaneous pedicle instrumentation combined with vertebral augmentation or vertebra pedicle instrumentation for treatment of osteoporotic thoracolumbar fractures (OVCF) in elderly patients.Methods A retrospective case cohort study was conducted on 62 patients with OVCF manifesting non-neurological symptoms treated from January 2009 to January 2012.There were 22 males and 30 females,with a mean age of 61.3 years (range,55 to 70 years).Fracture level was T11 in 8 patients,T12in 20,L1 in 22 and L2 in 12.Treatments included percutaneous pedicle instrumentation combined with vertebral fracture fixation in 36 patients (Group A) and percutaneous pedicle instrumentation combined with vertebral augmentation in 26 patients (Group B).Operation time,intraoperative blood loss,anterior vertebral body height,sagittal Cobb angle and visual analogue score (VAS) were compared between the two groups.Results All patients were followed up for average 46.5 months (range,36 to 58 months).Operation time in Group A [(82.6 ±16.2) min] was shorter than that in Group B [(96.8 ± 20.6) min] (P ＜ 0.05).Blood loss in Group B [(40.5 ± 10.2) ml] was less than that in Group A [(52.2 ± 15.5) ml] (P ＜ 0.05).Before operation and 3 days and 1 year after operation,the anterior vertebral body height and sagittal Cobb angle in Group A showed no significant differences compared to Group B (all P ＞ 0.05).At the final follow-up,the ratio of anterior vertebral height and Cobb angle in Group B [(87.8 ± 2.5) ％,(7.8 ± 3.5) °] were better than these in Group A [(82.6 ±3.2)％,(9.1 ± 1.8)°] (P＜0.05).VAS showed no statistical significance between the two groups before and after operation (P ＞ 0.05).Bone cement leakage was seen in four patients in Group B.During the perioperative period,there were 3 patients with lung infection in Group A and 1 patient with lower limb deep vein thrombosis in Group B.No implant failure occurred in both groups.Conclusion Both procedures are effective in treating elderly patients with OVCF,but percutaneous pedicle instrumentation combined with vertebral augmentation is associated with better results in maintaining vertebral height and preventing kyphosis.

Objective To investigate the clinical efficacy of percutaneous posterior short-segment pedicle screw fixation combined with vertebroplasty for stage Ⅲ Kümmell's disease without neurological deficit.Methods A retrospective case series study was conducted to analyze the clinical data of 36 patients with stage Ⅲ Kümmell's disease without nerve injury admitted to Xiaoshan Hospital of Traditional Chinese Medicine from January 2012 to January 2017.There were 10 males and 26 females,aged 55-75 years,with an average of 67.5 years.The injuried vertebrae were located at T11 in 9 patients,at T12 in 12,at L1 in 10 and at L2 in 5.The course of disease ranged from 6 to 48 months,with an average of 28.5 months.X-ray,CT and MRI were performed before operation.All patients underwent percutaneous posterior short-segment pedicle screw fixation combined with vertebroplasty.The operation time,intraoperative bleeding volume,complications,visual analogue scale (VAS),Oswestry dysfunction index (ODI) and sagittal Cobb angle of the injured vertebrae were recorded before operation,1 week after operation and at the last follow-up.Results All patients were followed up for an average of 32.5 months (range,12-48 months).Operation time ranged from 0.6 to 1.5 hours [(1.1 ± 0.4) hours].The intraoperative blood loss was 50-90 ml [(62.5 ± 17.5)ml].There was no internal fixation failure or fracture of adjacent vertebra.The VAS was improved from preoperative (8.6-± 0.4) points to (2.5 ±0.7) points one week after operation and (2.9 ± 0.7) points at the last follow-up (P ＜ 0.05).The ODI was improved from preoperative 68.2 ± 3.9 to 22.7 ± 4.3 one week after operation and 25.3 ± 4.8 at the last follow-up (P ＜ 0.05).The Cobb angle was improved from preoperative (24.3 ± 9.3) ° to (8.6 ±3.2)° 1 week after operation and (10.5 ±4.1)° at the last follow-up (P＜0.05).Conclusion For stage Ⅲ Kümmell's disease without neurological deficit,percutaneous posterior short-segment pedicle screw fixation combined with vertebroplasty can significantly relieve pain,improve spinal function and maintain spinal stability.

OBJECTIVE：To provide reference for constructing and improving the pharmacovigilance signal management sys - tem in China by comparing signal management system among the European Union （EU），the United States （U. S. ）and Japan. METHODS：Literature analysis method was used to systematically compare the similarities and differences on definitions ，sources， detection methods and management process of pharmacovigilance signals among EU ，U. S. and Japan. Some suggestions were put forward for pharmacovigilance management in China. RESULTS & CONCLUSIONS ：Regulatory authorities of the EU ，U. S. and Japan did not have a uniform definition on signals ；EU drug administration adopted the definition of the eighth working group of Council for International Organizations of Medical Sciences ，FDA adopted its own definition ，while the Japanese regulatory agency had no clear definition. Currently ，post-marketing surveillance still relied mainly on spontaneous reporting systems ；EU，U. S. and Japan had carried out the signal detection based on the spontaneous reporting system ；EU mainly adopted the proportional reporting ratio method ，U. S. mainly adopts the multiple gamma Poisson Shrinker ，and Japan mainly adopted the reporting ratio method. EU had special guidelines for signal management process ，while the U. S. and Japan did not. It is recommended to accelerate the deve- lopment of the legal and regulatory framework on pharmacovigilance in China ，draw up guidelines on pharmacovigilance practices ， strengthen the active ADR surveillance and promote the application of data mining techniques in signal detection field ，for accelerat - ing the standardization and internationalization of China ’s pharmacovigilance work.

OBJECTIVESTo compare the prognostic value of three lymph node(N) staging systems, including the number of metastatic lymph nodes(pN), the metastatic lymph node ratio (Nr) and the log odds of positive lymph nodes (LODDS), in gastric cancer patients after radical resection.

METHODSClinical and pathological data of 1 796 patients who underwent gastric cancer radical resection with complete follow-up information from January 2000 to December 2010 at Sun Yat-sen University Cancer Center were retrospectively analyzed. For each patient, N stages were classified according to three lymph node staging systems (pN, Nr, and LODDS). The relationship between each N staging was examined. Survival was analyzed using the Cox's proportional hazard model, and discrimination of staging system was determined using the change value of Chi squared statistic (▹χ) from the log-likelihood test. A larger ▹χvalue indicates a better discriminatory ability. The homogeneity of 5-year overall survival across each pN stage within each Nr and LODDS stage was compared by using the log-rank test. The subgroup analysis was performed to evaluate whether each of the competing system was affected by the number of lymph nodes retrieved.

RESULTSThe mean number of lymph node examined and positive nodes in the entire cohort was 21.1±12.1 and 7.9±8.2,respectively. The median overall survival of all the patients was 45 months (95% CI: 42.6 to 47.4 months), and the 5-year survival rate was 55.0%(95% CI: 52.6% to 57.4%). The ▹χof Nr system was 198.546, which was higher than that of pN(191.255) and LODDS(196.557) system. Except for the pN3b stage, significant heterogeneity was found among patients of different Nr subcategories in 5-year overall survival rate (all P<0.05) within each pN stage. While there was no significant difference in overall survival when any of the Nr stages was stratified by pN stages(all P>0.05). Significant difference in survival among patients of different LODDS subcategories was also seen within each pN stage. But for the LODDS system, the survival rate was similar among patients of different pN subcategories (all P>0.05) apart from the LODDS3 stage. The hazard ratios of patients with insufficient lymph nodes examined (≤15) were higher than those with sufficient nodes examined (>15) when the pN classification was used (all P<0.05), whereas similar results were not found if the Nr or LODDS classification was applied.

CONCLUSIONCompared with the pN staging system, both the Nr and LODDS staging system, especially the former, have a higher degree of discrimination ability and robustness to predict the prognosis in patients with gastric cancer after radical resection.

Aged ; Female ; Gastrectomy ; Humans ; Lymph Nodes ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Prognosis ; Proportional Hazards Models ; Retrospective Studies ; Stomach Neoplasms ; pathology ; surgery ; Survival Rate