1.Data mining of current research status of clinical trial drug management in China by bibliometrics
Chang XU ; Xinna ZHOU ; Lu QI ; Yu WANG ; Xinghe WANG
Journal of Pharmaceutical Practice and Service 2025;43(8):404-409
		                        		
		                        			
		                        			Objective To clarify the current development status and research hotspots in the field of experimental drug management in China through data mining by bibliometric. Methods Key words such as “experiment”, “drug”, and “management” were used to search the Chinese literature in China National Knowledge Infrastructure (CNKI). The title, author name, author affiliation, Chinese abstract, Chinese keywords, publication period, journal name, and other content of the literature were extracted from the literature. Cluster analysis was performed by CNKI literature visualization analysis system, CiteSpace and other software, and a network knowledge map was drawn. Results The literature in the field of experimental drug management in China was first published in 1994, and a total of 140 articles were published until 2022. Among them, 20 articles were supported by relevant funds, and the keyword co-occurrence frequency was highest among “subjects”. The most frequently published medium was the Chinese Pharmacological Yearbook. Conclusion At present, the quantity and quality of literature in the field of experimental drug management in China were relatively small, and the cooperation and communication among authors were not close. The funding from various fund projects in this field was also lacking. These factors led to a lower overall development level and slower development speed in this field.
		                        		
		                        		
		                        		
		                        	
2.Effect of parasternal intercostal plane block on postoperative fatigue in elderly patients undergoing off-pump coronary artery bypass grafting
Meiyan ZHOU ; Zhe ZHANG ; Xinghe WANG ; Rongguo WANG ; Jia SUN ; Liwei WANG ; Qian LIU
Chongqing Medicine 2024;53(21):3211-3214,3221
		                        		
		                        			
		                        			Objective To evaluate the effect of parasternal intercostal plane block(PIB)on postopera-tive fatigue in elderly patients undergoing off-pump coronary artery bypass grafting(CABG).Methods A to-tal of 111 elderly patients undergoing elective off-pump CABG in Xuzhou Municipal Central Hospital from May 2021 to January 2023 were selected as the study subjects.The patients were divided into the control group(group C,n=55)and PIB group(group P,n=56)by adopting the random number table method.After induction of anesthesia,the patients in the group P received the ultrasound-guided bilateral PIB,and the group C received the equal volume of normal saline at the same site.The incidence rate of postoperative fatigue syn-drome(POFS)on postoperative 1,3,5,7 d and postoperative 8 weeks,NRS scores immediately after extuba-tion and at postoperative 12,24,48 h,postoperative opioid drugs consumption,ICU stay duration,hospitaliza-tion duration and adverse events occurrence were compared between the two groups.Results Compared with the group C,the incidence rates of POFS on postoperative 1,3,5,7 d and postoperative 8 weeks in the group P were significantly decreased,the NRS scores immediately after extubation and at postoperative 12,24 h in the group P were lower,the postoperative opioid drugs consumption were smaller,the ICU stay duration was shorter,and the differences were statistically significant(P<0.05).The NRS score at postoperative 48 h and hospitalization duration had no statistical differences between the two groups(P>0.05).No nerve block re-lated adverse events in the patients appeared during the study period.Conclusion The ultrasound guided PIB could effectively reduce the incidence rate of POFS in elderly patients undergoing off-pump CABG,promote the patients'prognosis and improve the recovery quality of the patients.
		                        		
		                        		
		                        		
		                        	
3.Bioequivalence of metformin hydrochloride sustained-release tablets under fed condition in healthy subjects
Mingli SUN ; Chen LIU ; Yali WEI ; Qian GAO ; Qianying LIU ; Xinghe WANG
Journal of China Pharmaceutical University 2023;54(1):89-94
		                        		
		                        			
		                        			To evaluate bioequivalence and safety of two kinds of metformin hydrochloride sustained-release tablets (test preparation vs reference preparation) under the condition of fed and single administration.A single center, randomized, open, single-dose, two-period, two-sequence, and double-crossover design was used.32 healthy subjects took 0.5 g of test preparation or reference preparation under fed and single-dose administration.4 mL of venous blood was collected from before administration (0 h) to 1, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12, 15, 24, 36 and 48 h after administration.The concentration of metformin in plasma samples was detected, and then the pharmacokinetic parameters were calculated by WinNonlin 7.0 software.When the 90% confidence intervals of cmax, AUC0-t and AUC0-∞ geometric mean ratio of test preparation and reference preparation were within 80.00%-125.00% equivalent intervals respectively, the bioequivalence of the two preparations was proved.One subject fell off due to adverse events.The main pharmacokinetic parameters of test preparation and reference preparation as follows: cmax were (0.68 ± 0.14) and (0.65 ± 0.11) mg/L, AUC0-t were (7.33 ± 1.65) and (7.00 ± 1.89) h·mg/L, AUC0-∞ were (7.39 ± 1.67) and (7.06 ± 1.91) h·mg/L, respectively.The 90% confidence intervals of the geometric mean ratio of the two main pharmacokinetic parameters were 101.45%-109.14%, 100.08%-112.32% and 100.24%-112.28%, respectively, which fell within the bioequivalence interval of 80.00%-125.00%.There were no serious adverse events and unexpected adverse events during the trial.The results show that test preparation and reference preparation are bioequivalent under fed and single-dose administration, safe and well tolerated in healthy subjects.
		                        		
		                        		
		                        		
		                        	
4.Multi-section ultrasonic diagnosis and classification of congenital clubfoot
Panpan HE ; Chaohua WANG ; Yingmei DONG ; Po YANG ; Hezhou LI ; Bing XIA ; Quanhua LI ; Yanjia WANG ; Xinghe ZHANG ; Chengxu DU
Chinese Journal of Ultrasonography 2023;32(2):156-160
		                        		
		                        			
		                        			Objective:To evaluate and analyze the ultrasonic findings of idiopathic clubfoot and positional clubfoot deformities.Methods:Forty-nine newborn babies with congenital clubfoot were examined in the Department of Ultrasound of the Third Affiliated Hospital of Zhengzhou University from December 2020 to January 2022, Including 21 newborn babies(32 feet) with idiopathic clubfoot, and 28 babies(53 feet) with positional clubfoot. Twenty-two normal infants in the same period and the normal feet of the single clubfoot were selected as control group. The distance between medial malleolus and scaphoids of all feet were measured by ultrasound. The distance from the tangent line of the lateral edge of calcaneus to the midpoint of the lateral edge of the chondroid bone, medial soft tissue thickness and tibial calcaneal angle were measured by ultrasound. The data of idiopathic clubfoot group, positional clubfoot group and control group were statistically analyzed.Results:A total of 71 newborn babies with 142 feet were evaluated.The idiopathic clubfoot group had born and joint changes in the medial, lateral and posterior side, and the differences were statistically significant compared with the control group (all P<0.05). Compared with the control group, there were statistically significant differences in the medial and lateral side of the positional group(all P<0.05). But no significant changes in the posterior side( P>0.05). There were significant differences between medial and posterior side of idiopathic and positional clubfoot group (all P<0.05), but no significant differences in lateral side ( P>0.05). Conclusions:Ultrasonography can clearly display the tarsus bones in clubfoot, and observe the deformity changes of the idiopathic clubfoot and positional clubfoot.
		                        		
		                        		
		                        		
		                        	
5.Feasibility study on deep learning image reconstruction algorithm to improve the quality of low-dose CT images of the brain
Jinjin CUI ; Guanzhong LIU ; Xinghe HU ; Shaojun HAN ; Hong SUN ; Xinjiang WANG ; Hongxiang YAO
Chinese Journal of Radiological Medicine and Protection 2023;43(9):736-740
		                        		
		                        			
		                        			Objective:To explore the effectiveness of deep learning image reconstruction (DLIR) algorithm compared to adaptive statistical iterative reconstruction (ASIR-V) algorithm in improving the quality of low-dose brain CT images.Methods:Retrospective inclusion of patients who underwent brain CT examination in the People's Liberation Army General Hospital from November 2021 to August 2022. Four different algorithms were used to reconstruct low-dose CT scans of all patients to obtain 30% intensity ASIR-V (ASIR-V-30%) images, low intensity DLIR (DLIR-L) images, medium intensity DLIR (DLIR-M) images, and high intensity DLIR (DLIR-H) images. The regions of interest were selected from four sets of images, including superficial white matter, superficial gray matter, deep white matter, and deep gray matter, and their CT values and standard deviations were measured for calculating signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR).Subjective evaluation of image quality was conducted by three neuroimaging physicians based on the Likert 5-component scale. The objective and subjective scores of the 4 groups of images were analyzed using ANOVA or Kruskal Wallis. If there are overall differences, pairwise comparisons were conducted within the group.Results:A total of 109 patients were enrolled, including 104 males and 5 females, aged 65-110 years (89.16 ± 9.53) years. The radiation exposure of brain CT low-dose scanning was (0.93 ± 0.01)mSv, significantly lower than that of conventional scanning (2.92 ± 0.01) mSv ( t = 56.15, P < 0.05). The differences in objective image quality analysis of ASIR-V-30%, DLIR-L, DLIR-M, and DLIR-H images of low-dose CT in SNR deep gray matter, SNR deep white matter, SNR superficial gray matter, SNR superficial white matter, CNR deep gray white matter, and CNR superficial gray white matter were statistically significant( F =98.23, 72.95, 68.43, 58.24, 241.13, 289.91, P < 0.05). Among them, DLIR-H images had the lowest noise in deep gray matter, deep white matter, superficial gray matter, and superficial white matter, and had statistically significant differences compared to other image groups ( t = 167.43, 275.46, 182.32, 361.54, P < 0.05). The subjective score of DLIR-H image quality was superior to ASIR-V-30%, DLIR-L, and DLIR-M, with the statistically significant difference ( t = 7.25, 8.32, 9.63, P < 0.05). Conclusions:Compared with ASIR-V, DLIR algorithm can effectively reduce image noise and artifacts in low-dose brain CT, and improve SNR and CNR. The subjective and objective image quality evaluation of DLIR-H is the best.
		                        		
		                        		
		                        		
		                        	
6.Effects of enhancing the expression of aryl hydrocarbon receptor in post-traumatic mice macrophages on the inflammatory cytokine level and bactericidal ability
Tianyin KUANG ; Shuangqin YIN ; Weihong DAI ; Li LUO ; Tao CHEN ; Xinghe LIANG ; Rixing WANG ; Huaping LIANG ; Junyu ZHU
Chinese Journal of Burns 2023;39(7):633-640
		                        		
		                        			
		                        			Objective:To explore the expression pattern of aryl hydrocarbon receptor (AhR) in mice peritoneal macrophages (PMs) after major trauma and analyze the effects of enhanced AhR expression on the inflammatory cytokine level and bactericidal ability after trauma.Methods:The experimental study method was used. Forty 6-8-week-old male C57BL/6J mice (the same mouse age, sex, and strain below) were divided into control group, post trauma hour (PTH) 2 group, PTH 6 group, and PTH 12 group according to the random number table (the same grouping method below), with 10 mice in each group. Mice in the latter 3 groups were constructed as severe trauma model with fracture+blood loss, while mice in control group were left untreated. The primary PMs (the same cells below) were extracted from the mice in control group, PTH 2 group, PTH 6 group, and PTH 12 group when uninjured or at PTH 2, 6, and 12, respectively. Then the protein and mRNA expressions of AhR were detected by Western blotting and real-time fluorescence quantitative reverse transcription polymerase chain reaction, respectively, and the gene expressions of AhR signaling pathway related molecules were analyzed by transcriptome sequencing. Twenty mice were divided into control group and PTH 6 group, with 10 mice in each group, and the PMs were extracted. The level of ubiquitin of AhR was detected by immunoprecipitation. Twelve mice were divided into dimethyl sulfoxide (DMSO) alone group, PTH 6+DMSO group, MG-132 alone group, and PTH 6+MG-132 group, with 3 mice in each group. After the corresponding treatment, PMs were extracted, and the protein expression of AhR was detected by Western blotting. Twenty mice were constructed as PTH 6 model. Then, the PMs were extracted and divided into empty negative control adenovirus (Ad-NC) group and AhR overexpression adenovirus (Ad-AhR) group. The protein expression of AhR was detected by Western blotting at 36 h after some PMs were transfected with the corresponding adenovirus. The rest cells in Ad-NC group were divided into Ad-NC alone group and Ad-NC+endotoxin/lipopolysaccharide (LPS) group, and the rest cells in Ad-AhR group were divided into Ad-AhR alone group and Ad-AhR+LPS group. The expressions of interleukin-6 (IL-6) and tumor necrosis factor α (TNF-α) in the cell supernatant were detected by enzyme-linked immunosorbent assay at 12 h after the corresponding treatment ( n=6). Twenty mice were obtained to extract PMs. The cells were divided into control+Ad-NC group, PTH 6+Ad-NC group, control+Ad-AhR group, and PTH 6+Ad-AhR group, and the intracellular bacterial load was detected by plate spread method after the corresponding treatment ( n=6). Data were statistically analyzed with one-way analysis of variance, least significant difference test, analysis of variance for factorial design, and independent sample t test. Results:Compared with 1.16±0.28 of control group, the protein expressions of AhR in PMs in PTH 2 group (0.59±0.14), PTH 6 group (0.72±0.16), and PTH 12 group (0.71±0.17) were all significantly decreased ( P<0.05). The overall comparison of the difference of AhR mRNA expression in PMs among control group, PTH 2 group, PTH 6 group, and PTH 12 group showed no statistical significance ( P>0.05). The AhR signaling pathway related molecules included AhR, AhR inhibitor, cytochrome P450 family member 1b1, cytochrome P450 family member 11a1, heat shock protein 90, aryl hydrocarbon receptor-interaction protein, and heat shock protein 70 interaction protein. The heat shock protein 90 expression of PMs in PTH 2 group was higher than that in control group, while the expressions of other molecules did not change significantly after trauma. Compared with that in control group, the level of ubiquitin of AhR in PMs in PTH 6 group was increased. Compared with that in DMSO alone group, the protein expression of AhR in PMs in PTH 6+DMSO group was decreased, while that in PMs in MG-132 alone group had no significant change. Compared with that in PTH 6+DMSO group, the protein expression of AhR in PMs in PTH 6+MG-132 group was up-regulated. At transfection hour 36, compared with that in Ad-NC group, the protein expression of AhR in PMs in Ad-AhR group was increased. At treatment hour 12, compared with those in Ad-NC+LPS group, the expressions of IL-6 and TNF-α in PM supernatant of Ad-AhR+LPS group were significantly decreased (with t values of 4.80 and 3.82, respectively, P<0.05). The number of intracellular bacteria of 1×10 6 PMs in control+Ad-NC group, PTH 6+Ad-NC group, control+Ad-AhR group, and PTH 6+Ad-AhR group was (3.0±1.8), (41.8±10.2), (1.8±1.2), and (24.2±6.3) colony forming unit, respectively. Compared with that in PTH 6+Ad-NC group, the number of intracellular bacteria of PMs in PTH 6+Ad-AhR group was significantly decreased ( t=3.61, P<0.05). Conclusions:Ubiquitin degradation of AhR in PMs of mice after major trauma results in decreased protein expression of AhR. Increasing the expression of AhR in post-traumatic macrophages can reduce the expressions of LPS-induced inflammatory cytokines IL-6 and TNF-α, and improve the bactericidal ability of macrophages after trauma.
		                        		
		                        		
		                        		
		                        	
7.Role of spinal mTOR/S6K1/Gli1 signaling pathway in chronic morphine tolerance in mice
Long WANG ; Lingfei XU ; Xinghe WANG ; Tong LI ; Junli CAO ; Su LIU
Chinese Journal of Anesthesiology 2021;41(2):172-176
		                        		
		                        			
		                        			Objective:To evaluate the role of spinal mammlian target of rapamycin (mTOR)/ribosomal S6 kinase 1 (S6K1)/glioma associated oncogene homolog 1 (Gli1) signaling pathway in chronic morphine tolerance in mice.Methods:Healthy male Kunming mice, aged 8-10 weeks, weighing 23-25 g, were used in the study.The experiment was performed in two parts.Experiment I Fifty mice were randomly assigned into 2 groups: normal saline group (group S, n=10) and morphine group (group M, n=40). In M and S groups, morphine and normal saline 10 mg/kg were injected subcutaneously, respectively, twice a day for 7 consecutive days.The thermal pain threshold (TPT) was measured and the maximum analgesic effect percentage (MPE) was calculated at 1 day before administration and 30 min after the last administration every day.Ten mice in each group were randomly selected and sacrificed after measurement of TPT at 1, 3, 5 and 7 days after administration in group M and after the last measurement of TPT in group S, and the lumbar segment (L 4-6) of the spinal cord was removed.Experiment Ⅱ Forty mice were randomly divided into 4 groups ( n=10 each): KU-0063794+ morphine group (group KU+ M), dimethyl sulfoxide (DMSO)+ morphine group (group DM+ M), morphine+ KU-0063794 group (group M+ KU) and morphine + DMSO group (group M+ DM). Morphine 10 mg/kg was injected subcutaneously twice a day for 7 consecutive days in 4 groups.At 1-3 days of morphine injection, mTOR specific inhibitor KU-0063794 200μl (1 μg/μl) and 10% DMSO 200 μl was injected intraperitoneally in KU+ M group and DM+ M group at 30 min before administration twice a day.At 5-7 days of morphine injection, KU-0063794 200μl (1 μg/μl) or 10% DMSO 200 μl was injected intraperitoneally in group M+ KU or group M+ DM at 30min before administration, respectively, twice a day.TPT was measured and MPE was calculated at 1 day before morphine injection and at 30 min after the last administration every day.The animals were sacrificed after the last measurement of TPT, and the lumbar segment (L 4-6) of the spinal cord was removed for determination of the expression of spinal mTOR, phosphorylated mTOR (p-mTOR), S6K1, phosphorylated S6K1 (p-S6K1) and Gli1 (using Western blot). Results:Experiment Ⅰ Compared with group S, MPE was significantly increased at each time point after administration at 3, 5 and 7 days after administration, expression of spinal p-mTOR, p-S6K1 and Gli1 was significantly down-regulated ( P<0.05), and no significant change was found in mTOR and S6K1 in group M ( P>0.05). Experiment Ⅱ Compared with group DM+ M, MPE was significantly decreased at 3-7 days after morphine injection, expression of p-mTOR, p-S6K1 and Gli1 in spinal cord was down-regulated ( P<0.05), and no significant change was found in expression of mTOR and S6K1 in group KU+ M ( P>0.05). Compared with group M+ DM, MPE was significantly increased at 6-7 days after morphine injection, expression of p-mTOR, p-S6K1 and Gli1 in spinal cord was down-regulated ( P<0.05), and no significant change was found in mTOR and S6K1 in group M+ KU ( P>0.05). Conclution:Spinal mTOR/S6K1/Gli1 signaling pathway is involved in the development and maintenance of chronic morphine tolerance in mice.
		                        		
		                        		
		                        		
		                        	
8. Progress on clinical trials of cancer drugs in China, 2019
Huiyao HUANG ; Dawei WU ; Haixue WANG ; Jun WANG ; Qi FAN ; Shuhang WANG ; Ying BAI ; Yue YU ; Yuan FANG ; Chao SUN ; Hong FANG ; Hua BAI ; Xin WANG ; Zeyuan LIU ; Min JIANG ; Zhe LIU ; Xinghe WANG ; Haiyan LI ; Ning LI ; Cai CAO ; Binghe XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2020;42(2):127-132
		                        		
		                        			 Objective:
		                        			To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019.
		                        		
		                        			Methods:
		                        			The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies, while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug. Characteristics on stage, scope, indication of those trials, classification and mechanism of involved products, as well as listed anticancer drugs were summarized and depicted.
		                        		
		                        			Results:
		                        			There were 474 cancer drug trials registered in China in 2019, accounting for 21.8% of the total, and 397 (83.8%) were initiated by domestic pharmaceutical enterprises. Overall, international multicenter trials accounted for 13.1%, and phase I trials accounted for 47.3%. Compared with global enterprises, the proportion of international multi-center trials initiated by domestic companies is lower (4.8% vs. 55.8%, 
		                        		
		                        	
9.Comparative study on deep venous thrombosis onset in hospitalized patients with different underlying diseases
Mingli SUN ; Xinghe WANG ; Jun HUANG ; Jin WANG ; Yong WANG
Chinese Journal of Internal Medicine 2018;57(6):429-434
		                        		
		                        			
		                        			Objective To improve the understanding of deep venous thrombosis (DVT),the present study was conducted to investigate the difference of DVT onset in hospitalized patients with different underlying diseases.Methods This is a single-center retrospective study from Beijing Shijitan Hospital.Clinical data from hospital onset DVT patients from 2007 to 2016 were collected.DVT was confirmed with compression ultrasonography (CUS),color Doppler flow imaging (CDFI),CT venography (CTV),magnetic resonance venography (MRV),lower extremities radionuclide venography(RDV) or conventional venography (CV).The risk factors of DVT in hospital were analyzed with a Chi-square analysis.Results A total of 5 063 patients (1.65%) with DVT involving 5 024 veins were identified from 305 922 inpatients admitted without DVT during ten years.Among DVT patients,2 752 were males (54.36%) and 2 311 were females (45.64%) with age of (74.1±15.9) years (range from 1 to 103 years).Patients with DVT were elder and longer inhospital than those without DVT (P< 0.001).Patients with respiratory diseases had higher incidence of DVT (6.83%,OR=5.498,95%CI 5.151-5.868) than those with other system diseases,in which patients with respiratory failure had the highest incidence of DVT (9.53%,95%CI 6.912-8.018) among all patients.The risks of having DVT were higher in patients with serious internal medicine diseases than those in patients with trauma,or cataclasis / operations,or invasive manipulations.Among all DVT patients,71.54% of them were with inflammation diseases,55.56% were with hypertension and 54.93% were with structural heart disease.DVT often occurred in inferior extremities (83.78%,4 360/5 063) in patients irrespective of underlying diseases.Conclusions There is an association between underlying diseases of hospitalized patients and the development of DVT.Patients with internal medicine diseases had higher risk to develop DVT than those with trauma or cataclasis / operations or invasive manipulations.To prevent the development of DVT,its screening should be emphasized in patients with serious internal diseases.
		                        		
		                        		
		                        		
		                        	
10.Accuracy of high-resolution magnetic resonance imaging in diagnosis of the lymph node metastases and stage of rectal cancer
Xinghe SONG ; Suxing YANG ; Yi WANG
Chinese Journal of Digestive Surgery 2017;16(8):865-873
		                        		
		                        			
		                        			Objective To investigate the accuracy of high-resolution magnetic resonance imaging (MRI) in diagnosis of the lymph nodes metastases (LNMs) and stage of rectal cancer (RC).Methods The retrospective cross-sectional study was conducted.The clinicopathological data of 65 patients with RC who were admitted to the Peking University People's Hospital between April 2014 and April 2016 were collected.The results of postoperative pathological examination:of 65 patients with RC,24 had positive LNMs and 41 had negative LNMs;N0,N1 and N2 were respectively detected in 41,14 and 10 patients.Imaging data were captured using 3.0-Tesla MRI and body phased-array coil.Diagnostic criteria for LNMs of RC:criterion 1:irregular lymph node boundaries and signal characteristics were not considered;criterion 2:heterogeneous signal of lymph nodes and boundary characteristics were not considered;criterion 3:irregular lymph node boundaries and / or heterogeneous signal of lymph nodes.The American Joint Committee on Cancer (AJCC) cancer staging manual (7th edition) have established the N staging scheme for RC.Lymph nodes distribution according to the rectal lymphatic drainage:D1was located in fascia of the mesorectum;D1a above the level of tumor;D1b at the level of tumor;D1c under the level of tumor;D2 around the superior rectal artery and root of inferior mesenteric artery;D3 on the side of pelvic cavity.Observation indicators:(1) Efficiency and comparison of LNMs of RC diagnosed by high-resolution MRI according to the 3 criteria (postoperative pathological result as a gold standard).(2) Efficiency and comparison of N stage of RC diagnosed by high-resolution MRIaccording to the 3 criteria (postoperative pathological result as a gold standard).(3) Efficiency of LNMs of RC diagnosed by high-resolution MRI according to the maximum short diameter of lymph nodes:① maximum short diameter distribution of positive and negative LNMs of RC;②sensitivity,specificity,accuracy and consistency of LNMs diagnosed using different maximum short diameter of lymph nodes as a threshold (postoperative pathological result as a gold standard);③ comparison of accuracy of LNMs diagnosed using maximum short diameter of lymph nodes with highest diagnostic accuracy as a threshold and using the 3 criteria;④ sensitivity,specificity,accuracy and consistency (postoperative pathological result as a gold standard) of LNMs diagnosed using maximum short diameter of lymph nodes with highest diagnostic accuracy as a threshold combined with the highest efficiency in the (1),and its comparison in accuracy of LNMs with highest diagnostic accuracy as a threshold.(4) Distribution of LNMs of RC diagnosed by high-resolution MRI according to the 3 criteria.(5) Follow-up situations.Follow-up using outpatient examination and telephone interview was performed to detect patients' postoperative survival up to October 2016.The sensitivity,specificity,accuracy and comparison of ratio were respectively done by the chi-square test.Kappa test was used for consistency,tκ ≤ 0.40was used as low consistency,0.40<κ≤0.60 as moderate consistency,0.60<κ≤0.80 as higher consistency,and κ> 0.80 very high consistency.Results (1) Efficiency and comparison of LNMs of RC diagnosed by highresolution MRIaccording to the 3 criteria:accuracies of LNMs of RC diagnosed by high-resolution MRI according to the criterion 1,2 and 3 were respectively 93.8%,87.7% and 90.8%,showing very.high,higher and very high consistencies compared with postoperative pathological results (κ =0.87,0.74,0.81,P<0.05),and with no statistically significant difference in diagnostic accuracy among them (x2=1.495,P>0.05).(2) Efficiency and comparison of N stage of RC diagnosed by high-resolution MRI according to the 3 criteria:accuracies of N stage of RC diagnosed by high-resolution MRI according to the criterion 1,2 and 3 were respectively 87.7%,83.1% and 84.6%,showing the same higher consistencies compared with postoperative pathological result (κ =0.77,0.68,0.72,P<0.05),and with no statistically significant difference in N stage among them (x2=0.567,P>0.05).(3) Efficiency of LNMs of RC diagnosed by high-resolution MRI according to the maximum short diameter of lymph nodes:① maximum short diameter distribution of positive and negative LNMs of RC:maximum short diameter ranges were respectively 3-18 mm in positive LNMs and 1-9 mm in negative LNMs,and maximum short diameter <3 mm and ≥ 10 mm were respectively negative and positive LNMs.② Efficiency of LNMs of RC diagnosed using different maximum short diameter of lymph nodes as a threshold:diagnostic accuracy of 70.8%was the highest when maximum short diameter >7 mm was used as a standard of positive LNMs,showing a low consistency compared with postoperative pathological result (κ =0.29,P<0.05).③ Comparison of accuracy of LNMs diagnosed using maximum short diameter of lymph nodes >7 mm as a threshold and using the 3 criteria:there was a statistically significant difference among them (x2 =15.637,P<0.05);accuracies of LNMs of RC diagnosed by high-resolution MRI according to the criterion 1,2 and 3 were higher than that diagnosed using maximum short diameter of lymph nodes >7 mm as a threshold (x2 =10.354,5.656,6.923,P<0.05).④Comparison of accuracy of LNMs diagnosed using maximum short diameter of lymph nodes >7 mm combined with the criterion 3 as a threshold and using maximum short diameter >7 mm as a threshold:the criterion 3 was used as a threshold because there was no statistically significant difference in diagnostic accuracy among the 3 criteria (P> 0.05).Diagnostic accuracy was 78.5% when maximum short diameter >7 mm combined with the criterion 3 as a threshold,showing a low consistency compared with postoperative pathological result (κ =0.36,P<0.05),with no statistically significant difference in diagnostic accuracy compared with maximum short diameter > 7 mm as a threshold (x2=0.154,P>0.05).(4) Distribution of LNMs of RC diagnosed by high-resolution MRI according to the 3 criteria:positive LNMs of RC diagnosed by high-resolution MRI located mostly in D1 (76.1%-83.1%)and D1b(77.8%-81.4%).(5) Follow-up situations:of 65 patients,54 were followed up for 6-25 months,with a median time of 14 months.During the follow-up,7 patients had distant metastases and 47 had tumor-free survival.Conclusions There are higher accuracies of LNMs and N stage of RC diagnosed using preoperative highresolution MRI.Diagnostic accuracy of LNMs of RC cannot be improved when characteristics of lymph node morphology and size are used as a diagnostic standard.The positive LNMs of RC locate mostly in D1 and Dib.
		                        		
		                        		
		                        		
		                        	
            
Result Analysis
Print
Save
E-mail