1.Considerations on Unlicensed and Off-Label Drug Uses
Liping LIU ; Yuling CHEN ; Jin XIE ; Yiwen WANG ; Jin HAN
China Pharmacy 2007;0(25):-
OBJECTIVE: To provide reference for dealing with the problems arose from unlicensed and off-label drug uses.METHODS: The rationality of unlicensed and off-label drug uses and the possible problems induced by which were analyzed.RESULTS: The existence of unlicensed and off-label drug used has its rationality,and it also in line with the international practices,but it may cause some problems related to policy,laws and regulations and medication safety etc.CONCLUSION: The concerned department and trade association should attach great importance to unlicensed and off-label drug uses and establish a generally accepted principle and strategies to tackle the problems.
2.The overcrowding of osteal posterior cranial fossa in adults: multi-slice CT measurements and clinical significance
Zhongfu XIE ; Chao TIAN ; Song JIN ; Tong HAN ; Shimin CUI
Chinese Journal of Radiology 2010;44(3):260-264
Objective To assess the clinical value of MSCT in diagnosing the overcrowding of osteal posterior cranial fossa (PCF) in adults.Methods MSCT images of a cohort of 52 adult patients with foramen magnum osteal malformation confirmed by surgery (diseased group), and 100 healthy adults (control group) were retrospectively reviewed.Images post-processing techniques included multi-planer reformation (MPR) and volume rendering (VR).The posterior cranial fossa volume (PCFV), posterior cranial fossa height (PCFH), clivus length (CL), clivus gradient (CG), supraocciput length (SL), and anteroposterior diameter of the foramen magnum (FMD) were measured on sagittal images in 52 patients and 100 normal adults.Independent-sample student's t test was used to compare the differences between patients and normal adults.Results The results of PCFV, PCFH, CL, SL,FMD and CG, male of control group were (168.2 ±12.3) cm~3, (38.2 ±1.2), (47.1 ±2.8), (41.1 ±1.8), (36.6 ±4.9) mm, (51.5±3.6)°, female of control group were (157.5 ±10.2) cm~3, (36.5 ±1.4), (46.2 ±2.2), (39.7 ±1.3), (35.2 ±3.8), (49.6±3.1)° ;diseased group were (128.7 ±11.7) cm~3, (30.6 ±1.9), (36.2 ±1.4), (37.3 ±0.9), (33.9 ±3.5)mm, (44.5 ±2.8)° .There was significant sex difference in PCFV, PCFH, CL, SL and CG in control group (t =4.70, 6.44, 4.84, 4.43 and 2.81 respectively, P<0.01), but FMD was not significant(t=1.97,P>0.05); the results of PCFV, PCFH, CL, CG and SL were significant different between diseased group and male of control group (t=16.62, 24.04, 25.01, 14.17 and 10.99 respectively,P<0.01) ; the results of PCFV, PCFH, CL, CG and SL were significant different between diseased group and female of control group (t=13.23, 17.80, 27.50, 11.67 and 8.73 respectively,P<0.01) ;but there were no significant differences of FMD between diseased group and control group, both male and female (t=2.96,2.07, P> 0.05).Conclusions The overcrowding of PCF can be accurately measured by MCST.As a routine preoperative examination, MSCT is helpful in the therapeutic selection and the anatomic and pathologic study of PCF.
3.Evaluation of osteal posterior cranial fossa in adults by multi-slice CT measurements before and after operation in basilar invagination patients
Zhongfu XIE ; Chao TIAN ; Song JIN ; Yi WANG ; Tong HAN ; Shimin CUI
Chinese Journal of Radiology 2011;45(12):1151-1154
ObjectiveTo evaluate the clinical effect of MSCT measurements in the pre- and postoperational osteal posterior cranial fossa for the adult patients of basilar invagination.Methods We reviewed the images of a cohort of 31 adult patients with basilar invagination,which were treated by surgical operation.According to the presence of atlantoaxial dislocation,the patients were divided into groups A and B.The basion-dens interval (BDI),atlanto-dental interval (ADI),space available of the spinal cord ( SAC),clivus-canal angle( CCA),Highly index( HI),and Chamberlian line(CBL) of the posterior cranial fossa were obtained in all the patients.Independent-sample Student's t test was used to compare the differences between groups A and groups B.Spearman correlations were analyzed between CT measurement data and effects of operations.ResultsIn Group A,the BDI,ADI,SAC,CCA,HI,CBL before and after surgery were 12.6 mm,8.3 mm,4.5 mm,3.3 mm;18.2 mm,20.8 mm,138.3°,150.4°,28.7 mm,43.4 mm,6.3 mm,3.3 mm respectively.There were significant differences ( t = 5.603,2.323,3.124,5.531,4.278 and 2.375,respectively,P <0.05 ).Preoperative JOA score in groups A was 10 points,and was 14 points after surgery.There was significant difference between the JOA scores before and after surgery ( t = 3.526,P < 0.05 ).There were 7 effective cases and 4 stable cases after surgery in group A.Before and after surgery,JOA score and BDI,ADI,SAC,CCA,HI,CBL were significantly correlated( r = -0.667,- 0.673 ; - 0.571,- 0.619 ; 0.642,0.513 ; 0.525,0.558 ; 0.587,0.511 ; - 0.532,- 0.596,respectively,P<0.05).The SAC,CCA,and CBL before and after surgery in group B were 18.3 mm,19.6 mm,146.8°,150.2°,2.7 mm,1.8 mm.The difference was statistically significant after operation ( t = 5.359,4.126,0.769,P <0.05).The BDI,ADI,and HI before and after surgery in group B were 7.2 mm,6.6 mm,2.4 mm,2.1 mm,39.3 mm,41.5 mm.And there were no significant differences (t = 1.482,2.374,0.153,P>0.05).The preoperative JOA score in groups B was 11 points,and the postoperative score was 16 points.JOA scores before and after surgery were significantly different (t =2.874,P <0.05).There were 14 effective cases and 6 stable cases after operation in group B.The JOA score before and after surgery and BDI,ADI,and HI had no correlation (r =0.341,0.387;0.154,0.182; 0.192,0.167,P >0.05),and CBL,SAC and CCA were correlated (r = -0.756,-0.728;0.651,0.672; 0.726,0.695,P <0.05).ConclusionMSCT measurements for basilar invagination before and after surgery are helpful for understanding changes of osteal posterior fossa anatomy and comprehensive evaluation of surgical treatment.
5.Effect of preoperative thyroid dysfunction on the 30-day postoperative mortality and complications in elderly patients with hip fracture
Anhua LONG ; Zongyan XIE ; Dacheng HAN ; Jialong WANG ; Feifei ZHAO ; Lu JIN ; Xuefei WANG ; Yakui ZHANG
Chinese Journal of Orthopaedic Trauma 2021;23(3):216-220
Objective:To investigate the influence of preoperative thyroid dysfunction on the 30-day postoperative mortality and complications in elderly patients with hip fracture.Methods:A retrospective analysis was conducted of the 349 elderly patients with hip fracture who had been admitted to Department of Orthopedic Trauma, Beijing Luhe Hospital Affiliated to Capital Medical University from January 2018 to December 2019. They were 108 males and 241 females, with an average age of 76.3 years (from 60 to 104 years). There were 190 femoral intertrochanteric fractures and 159 femoral neck fractures. By the preoperative level of thyroid function, the patients were divided into a normal function group of 290 cases and a dysfunction group of 59 cases. The 2 groups were compared in terms of hospital stay, mortality and incidence of complications within 30 days postoperation.Results:In this cohort, the rate of 30-day postoperative mortality was 3.4%(12/349) and the incidence of 30-day postoperative complications 14.6%(51/349). The 2 groups were comparable because there was no significant difference between them in the preoperative general data except for the preoperative comorbidity of coronary heart disease ( P>0.05). In the dysfunction group, the hospital stay averaged (10.2±6.9) d, the rate of 30-d postoperative mortality 1.7%(1/59) and the incidence of 30-day postoperative complications 16.9%(10/59), which were insignificantly different from those in the normal function group [(10.7±7.5) d, 3.8%(11/290) and 14.1%(41/290), respectively] ( P> 0.05). Conclusion:Since preoperative thyroid dysfunction does not affect the 30-day postoperative mortality and postoperative complications in the elderly patients with hip fracture but no definite thyroid disease, routine thyroid function screening is not recommended for them.
6.Three-dimensional visualization of simulated surgery for distal femoral fractures based on unigraphics NX and mimics
Dan WANG ; Xiaorui JIANG ; Le XIE ; Lujun HAN ; Dan JIN ; Zhiqiu ZHAO ; Guoxian PEI
Chinese Journal of Orthopaedic Trauma 2010;12(1):53-56
Objective To report computer-aided three-dimensional visualization of simulated surgery for distal femoral fractures using software Unigraphics NX and Mimics. Methods The preoperative CT scans of 6 patients with distal femoral fractures were used for three-dimensional reconstruction of distal femoral fractures using software Mimics. Three-dimensional reconstruction of the surgical instruments using the modeling function of software Unigraphics NX. The assembly function of software Unigraphics NX was used to vi-sualize the simulated internal fixations of distal femoral fractures with both Less Invasive Stable System plates and the retrograde nails. The operative procedures simulated by the software Unigraphics NX were analyzed preoperatively. Results The simulated operative procedures were clearly and vividly visualized in three-dimensions, The fracture reduction and operative effects could be predicted. Conclusion This system of three-dimensional visualization of simulated surgery for distal femoral fractures using software Unigraphics NX and Mimics can help surgeons make preoperative predictions and select reliable methods to improve the reliability and effectiveness of the orthopaedic surgery.
7.Study on the distinction of glycemic variability among different glucose regulation populations by phase space reconstruction of time series
Yun XIE ; Baoyi LI ; Xiaojun LUAN ; Jian ZHOU ; Liping HAN ; Jin LI ; Lele LIU ; Weiping JIA
Chinese Journal of Endocrinology and Metabolism 2012;28(9):722-725
Sixty-six volunteers,including 24 subjects with normal glucose tolerance(NGT),18 patients with impaired glucose regulation (IGR),and 24 patients with type 2 diabetes mellitus ( T2DM ),underwent a test of continuous glucose monitoring.The data of continuous glucose monitoring were embedded into two-dimension Euclid space by Takens' embedding theory.Glycemic phase diagram was drawn by MATLAB.The area and center distance of glycemic phase diagram were calculated by computer.The distinction of glycemic variability and average glycemic level among different glucose regulation populations were analyzed.The results showed that there existed significant differences in body mass index,systolic blood pressure,diastolic blood pressure,low density lipoprotein-cholesterol,high density lipoprotein-cholesterol,triglyceride,total cholesterol,creatinine,and alanine aminotransferase among three groups( all P<0.05 ).The levels of HbAIC,fasting plasma glucose( FPG ),postprandial 2 h plasma glucse (2hPG),area and center distance of glycemic phase diagram in T2DM group were higher than those in NGT and IGR groups( P<0.01 ),and the levels of FPG,2hPG,area and center distance of glycemic phase diagram in IGR group were higher than those in NGT group( P<0.01 ).The levels of FPG and 2hPG were correlated with area and center distance of glycemic phase diagram ( all P<0.01 ).These results suggest that measuring the area and center distance of glycemic phase diagram is a good method to assess glycemic variability and average glycemic level during continuous glucose monitoring.
8.Quantitative study of the spatial angles among cardiac chambers and great vessels in the normal fetuses by spatiotemporal image correlation
Hua YUAN ; Zuoping XIE ; Bowen ZHAO ; Qiqi HUA ; Shehong JIN ; Xiaoyan SHEN ; Xinhong HAN ; Jiamei ZHOU ; Min FANG ; Jinhong CHEN
Chinese Journal of Ultrasonography 2011;20(3):237-241
Objective To establish the reference ranges of the spatial angles among cardiac chambers and great vessels in second and third trimester fetuses measured by spatiotemporal image correlation (STIC).Methods Volume images of 352 normal fetuses from 20 to 38 weeks of gestation were recruited in the study.An off-line analysis of acquired volume datasets was carried out with multiplanar mode.Parameters measured included angles between:(1) the 4-chamber view and the left ventricular long axis view; (2) the left ventricular long axis view and main pulmonary artery; and (3) the ductal arch and aortic arch.The relationships between above-mentioned angles and gestational age were assessed by correlation and regression analysis.Results The angle between the 4-chamber view and the left ventricular long axis view (range:55.7° - 35.7°,mean:45.7° ± 5.12°) was uncorrelated with gestational age (r = 0.03,P = 0.51).In contrast,the angle between the left ventricular long axis view and main pulmonary artery,and the angle between the ductal arch and aortic arch were correlated with gestational age (P < 0.001),and the correlation coefficient was - 0.53 and 0.57 respectively.The best-fit exponential curve regression equations of the angle between the left ventricular long axis view and main pulmonary artery was:Y = 154- 4.24X +0.05X2 ,and the angle between the ductal arch and aortic arch was:Y = - 20.8 + 2.65X - 0.37X2.Conclusions The angles among cardiac chambers and great arteries of fetuses from 20 to 38 weeks of gestation can be quantitatively measured by STIC.The reference ranges provide a reliable quantitative standard to estimate the spatial relationships of the cardiac large arteries of fetuses,which may be clinically useful in prenatal screening congenital heart disease.
9.Uptake volume index of 18F-FDG PET/CT for the prediction of prognosis in nasopharyngeal carcinoma
Peng, XIE ; Han-xi, ZHAO ; Xue-fen, TAN ; Xin-dong, SUN ; Li, KONG ; Zheng, FU ; Jin-ming, YU
Chinese Journal of Nuclear Medicine 2010;30(3):151-154
Objective To evaluate the prognostic value of serial 18F-fluorodeexyglucose (FDG) PET/CT in patients with nasopharyngeal carcinoma (NPC).Methods Thirty-seven NPC patients who had 18F-FDG PET/CT scan before and after external beam intensity-modulated radiotherapy, were studied retrospectively.All patients were followed for five years.Correlation analysis between metabolic tumor volume (MTV)/uptake volume index (UVI) and survival was performed by Kaplan-Meier analysis, Log-rank test and multivariate Cox model.Results The 5-year overall survival (OS) and disease-free survival (DFS) rates were 70.3% (26/37) and 62.2% ( 23/37 ), respectively.Patients with a lower MTV (MTV<30 cm3) had significantly higher 5-year OS ( 82.6% ( 19/23 ) ) and DFS (73.9% ( 17/23 )) rates than those with a higher MTV (OS:50.0% (7/14),x2 =5.28, P<0.05; DFS:42.9% (6/14),x2 =4.84, P<0.05).Patients with a lower UV1 (UVI<150) had significantly higher 5-year OS( 87.5%( 21/24 )) and DFS (79.2% (19/24)) rates than those with a higher UVI (OS:38.5% (5/13),x2 =10.72, P<0.01;DFS:30.8% (4/13), x2 =11.04, P<0.01).Multivariate analysis showed that UVI and metabolic response (MR) were independent predictors of DFS.Conclusions Tumor volume parameters, UVI and MR, are independent prognostic factors for patients with NPC.Patients with a high UVI may benefit from more aggressive treatment.
10.Changes of nerve conduction velocity in 60Co-irradiated rabbit sciatic nerve autograft after orthotopic replantation
Xin-Yuan WANG ; De-Hai CHANG ; Xu-Jun WEI ; Shi-Hua XIE ; Chun-Ming HAN ; Jin-Sheng SHENG
Chinese Journal of Neuromedicine 2009;8(6):567-568
Objective To evaluate the changes of nerve conduction velocity in degenerative rabbit sciatic nerve authograft induced by 60Co irradiation after orthotopic replantation. Methods A 30-mm-long segment was severed from normal adult rabbit sciatic nerve and exposed to 60Co irradiation at the dose of 350 Cry to induce neural degeneration. The nerve segment was then replanted orthotopicaily, and the nerve conduction velocity was determined using electrophysiological test at 4, 6 and 8 months after the replantation. Results At 6, 8 months after the replantation, the nerve conduction velocity in the degenerative nerve autograft showed no significant difference from that in normal sciatic nerve (P>0.05). But at 4 months after the replantation, the nerve conduction velocity in the autograft was significantly lower than the normal velocity (P<0.05). Conclusion The nerve conduction velocity can be obtained by replantation of a long (3 mm) degenerative nerve segment due to 60Co irradiation.