Objective:To explore the effect and application of interventional measures with concept of risk management in adverse events of medical devices,and assess their effectiveness in reducing the incidence of adverse events and in enhancing patients'safety.Methods:The intervention measures with concept of risk management was adopted to carry out risk assessment and hierarchical management for medical devices,and the operating status of medical devices was monitored in real time,and the standard operating procedures of using medical device were formulated for conducting risk management for medical devices.A total of 2,222 conventional medical devices in clinical use at Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University from January 2022 to March 2024 were selected.Among them,1,064 devices(with random values≤0.48)were managed using conventional methods by stratified random sampling without proportional allocation.Another 1,158 devices(random value>0.48)applied the risk intervention management method.A comparative analysis was conducted on the incidence of adverse events of medical devices,the qualified rate of medical device cleaning and the wet package rate of the two management methods,as well as the score of medical device knowledge level of nursing staff.Results:Among the 1,158 medical devices that adopted the risk intervention management method,the incidences of adverse events in non-surgical departments,surgical departments and diagnosis-related departments were 0.69%(8/1,158),1.90%(22/1,158)and 3.11%(36/1,158),respectively.All were lower than 3.85%(41/1,064),4.98%(53/1,064),and 8.93%(95/1,064)of 1,064 medical devices under the conventional management method,respectively.The differences were statistically significant(x2=25.716,16.143,33.852,P<0.05).The incidence of adverse events at different risk levels of medical devices was lower than that of conventional management method,and the difference was statistically significant(x2=7.625,P<0.05).The qualified rate of cleaning medical device was higher than that of the conventional management method,while the rate of wetting package was lower than that of the conventional management method,and the differences were statistically significant(x2=9.091,17.540,P<0.05).The knowledge levels and total scores of nursing staffs for the composition of medical devices,usage norms,cleaning and sterilization,defect examination,maintenance and precautions of management method with risk intervention were all higher than those of conventional management method,and the differences were statistically significant(t=2.158,2.422,2.544,2.391,2.152,4.528,P<0.05).Conclusion:The intervention measure with the concept of risk management can significantly reduce the incidence of adverse events of medical device,and improve the qualified rate of cleaning medical device,and improve the knowledge level of nursing staffs for medical device.

Objective:To explore the effect and application of interventional measures with concept of risk management in adverse events of medical devices,and assess their effectiveness in reducing the incidence of adverse events and in enhancing patients'safety.Methods:The intervention measures with concept of risk management was adopted to carry out risk assessment and hierarchical management for medical devices,and the operating status of medical devices was monitored in real time,and the standard operating procedures of using medical device were formulated for conducting risk management for medical devices.A total of 2,222 conventional medical devices in clinical use at Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University from January 2022 to March 2024 were selected.Among them,1,064 devices(with random values≤0.48)were managed using conventional methods by stratified random sampling without proportional allocation.Another 1,158 devices(random value>0.48)applied the risk intervention management method.A comparative analysis was conducted on the incidence of adverse events of medical devices,the qualified rate of medical device cleaning and the wet package rate of the two management methods,as well as the score of medical device knowledge level of nursing staff.Results:Among the 1,158 medical devices that adopted the risk intervention management method,the incidences of adverse events in non-surgical departments,surgical departments and diagnosis-related departments were 0.69%(8/1,158),1.90%(22/1,158)and 3.11%(36/1,158),respectively.All were lower than 3.85%(41/1,064),4.98%(53/1,064),and 8.93%(95/1,064)of 1,064 medical devices under the conventional management method,respectively.The differences were statistically significant(x2=25.716,16.143,33.852,P<0.05).The incidence of adverse events at different risk levels of medical devices was lower than that of conventional management method,and the difference was statistically significant(x2=7.625,P<0.05).The qualified rate of cleaning medical device was higher than that of the conventional management method,while the rate of wetting package was lower than that of the conventional management method,and the differences were statistically significant(x2=9.091,17.540,P<0.05).The knowledge levels and total scores of nursing staffs for the composition of medical devices,usage norms,cleaning and sterilization,defect examination,maintenance and precautions of management method with risk intervention were all higher than those of conventional management method,and the differences were statistically significant(t=2.158,2.422,2.544,2.391,2.152,4.528,P<0.05).Conclusion:The intervention measure with the concept of risk management can significantly reduce the incidence of adverse events of medical device,and improve the qualified rate of cleaning medical device,and improve the knowledge level of nursing staffs for medical device.

Objective:To investigate the clinical efficacy of Later-cut overlap anastomosis versus Roux-en-Y anastomosis in laparoscopic total gastrectomy.Methods:The propensity score matching and retrospective cohort study was conducted. The clinicopathological data of 1 804 patients with gastric cancer who underwent laparoscopic total gastrectomy in Fujian Medical University Union Hospital from January 2014 to March 2019 were collected. There were 1 346 males and 458 females, aged from 18 to 91 years, with a median age of 63 years. Of 1 804 patients, 100 undergoing Later-cut overlap anastomosis for digestive tract reconstruction in totally laparoscopic total gastrectomy and 1 704 undergoing Roux-en-Y anastomosis in laparoscopic-assisted total gastrectomy were allocated into modified group and traditional group, respectively. Observation indicators: (1) the propensity score matching conditions and comparison of general data between the two groups after propensity score matching; (2) intraoperative and postoperative situations; (3) complications; (4) follow-up, including ① functional scales of European Organization for Research and Treatment of Cancer quality of life questionnaire-core 30 (EORTC-QLQ-C30) for two groups after propensity score matching, ② symptom scales of EORTC-QLQ-C30 for two groups after propensity score matching, ③ symptom scales of European Organization for Research and Treatment of Cancer quality of life questionnaire of stomach 22 (EORTC-QLQ-STO22) for two groups after propensity score matching, ④ subgroup analysis; (5) learning curve of Later-cut overlap anastomosis. Patients were followed up by outpatient examination, paying a visit, Email and telephone interview once every 3 months within postoperative 2 years and once every 6 months within postoperative 3-5 years to detect postoperative life quality up to December 2019. The propensity score matching was conducted by 1∶1 matching using the nearest neighbor method. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was done using the t test. Count data were represented as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test. Comparison of ordinal data between groups was analyzed using the nonparametric rank sum test. Measurement data with skewed distribution were represented as M ( P25, P75) or M (range), and comparison between groups was done using the U test. The cumulative sum curve was used to analysis minor changes between individual and overall data, with the equation of CUSUM=∑ n,i=1 ( x i- μ), x i as esophagojejunostomy time of individuals, μ as the average time of esophagojejunostomy, n as serial number of patients. Results:(1) The propensity score matching conditions and comparison of general data between the two groups after propensity score matching: 200 of 1 804 patients had successful matching, including 100 in the modified group and 100 in the traditional group respectively. Before propensity score matching, the gender (males or females), age, tumor diameter, cases with tumor located at upper, middle or total stomach (tumor location), cases with differentiated or undifferentiated tumor (tumor differentiation degree), level of preoperative Alb, cases in stage T1, T2, T3, T4a (T staging), cases in stage N0, N1, N2, N3 (N staging), cases in stage Ⅰ, Ⅱ, Ⅲ (Union International Control Cancer staging) were 62, 38, (55±13)years, 4.5 cm(1.5 cm, 7.5 cm), 22, 67, 11, 72, 28, (42±4)g/L, 36, 11, 39, 14, 58, 16, 8, 18, 44, 29, 27 of the modified group, versus 1 284, 420, (62±11)years, 6.5 cm(2.5 cm, 8.0 cm), 891, 675, 138, 1 392, 312, (39±7)g/L, 148, 200, 393, 963, 498, 517, 257, 432, 322, 604, 778 of the traditional group, showing significant differences in the above indicators between the two groups ( χ2=8.89, t=5.69, Z=2.75, χ2=35.31, 5.80, t=3.91, Z=-9.97, -5.44, -5.41, P<0.05). After propensity score matching, the above indicators were 62, 38, (55±13)years, 4.0 cm(1.5 cm, 7.5 cm), 22, 67, 11, 82, 18, (42±4)g/L, 36, 11, 39, 14, 58, 16, 8, 18, 44, 29, 27 of the modified group, versus 68, 32, (56±11)years, 4.0 cm(1.5 cm, 7.4 cm), 12, 74, 14, 87, 13, (41±5)g/L, 23, 18, 45, 14, 54, 18, 10, 18, 42, 40, 18 of the traditional group, showing no significant difference in the above indicators between the two groups ( χ2=0.79, t=0.30, Z=0.87, χ2=3.65, 0.95, t=1.49, Z=-0.94, 1.43, -0.50, P>0.05). (2) Intraoperative and postoperative situations: after propensity score matching, the operation time, volume of intraoperative blood loss, the number of lymph node dissected, time to the first flatus, time to fluid diet intake, duration of postoperative hospital stay, treatment expenses were (195±41)minutes, 72 mL(range, 5-125 mL), 44±15, (3.4±1.1)days, (4.1±1.3)days, (10.7±4.3)days, (74 299±20 102)yuan of the modified group, versus (192±78)minutes, 67 mL(range, 10-195 mL), 40±18, (3.7±1.2)days, (4.5±1.9)days, (14.0±9.2)days, (71 029±12 231)yuan of the the traditional group, respectively. There was no significant difference in the operation time, the number of lymph node dissected, time to the first flatus, time to fluid diet intake, or treatment expenses between the two groups ( t=0.35, 1.73, 1.84, 1.74, 1.38, P>0.05). There were significant differences in the volume of intraoperative blood loss and duration of postoperative hospital stay between the two groups ( Z=0.62, t=3.25, P<0.05). (3) Complications: three patients in the modified group had complications, including 2 cases of anastomotic leakage and 1 case of abdominal infection. Four patients in the traditional group had complications, including 2 cases of anastomotic leakage, 1 case of anastomotic hemorrhage, 1 case of abdominal infection. There was no significant difference in the complications between the two groups ( χ2=0.00, P>0.05). Patients with anastomotic leakage and abdominal infection were cured after conservative treatments including adequate drainage, nutritional support, anti-inflammation. Patients with anastomotic hemorrhage were cured after blood transfusion and hemostatic therapy. There was no perioperative death in either group. (4) Follow-up: 146 patients received life quality evaluation at postoperative 6 months, including 78 in the modified group and 68 in the traditional group. ① Functional scales of EORTC-QLQ-C30 for two groups after propensity score matching: the scores of overall health functioning, physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning were 31(22, 48), 75±27, 77±21, 79±15, 80±21, 76±29 for the modified group, respectively, versus 38(22, 57), 77±30, 79±27, 82±30, 82±31, 78±30 for the traditional group, showing no significant difference between the two groups ( Z=0.46, t=0.39, 0.40, 0.66, 0.49, P>0.05). ② Symptom scales of EORTC-QLQ-C30 for two groups after propensity score matching: the scores of fatigue, nausea and vomiting, pain, dyspnea, hyposomnia, anorexia, constipation, diarrhea, financial difficulty were 75±22, 89±19, 82±19, 77±19, 90±23, 74±14, 67±27, 74±28, 61±29 for the modified group, respectively, versus 72±28, 88±23, 91±23, 72±19, 88±19, 79±29, 68±28, 72±23, 61±24 for the traditional group; there was no significant difference in the scores of fatigue, nausea and vomiting, dyspnea, hyposomnia, anorexia, constipation, diarrhea or financial difficulty between the two groups ( t=0.70, 0.26, 1.56, 0.49, 0.43, 0.20, 0.43, 0.09, P>0.05), while there was a significant difference in the score of pain ( t=2.48, P<0.05). ③ Symptom scales of EORTC-QLQ-STO22 for two groups after propensity score matching: the scores of dysphagia, chest pain or abdominal pain, gastroesophageal reflux, eating disorder, anxiety, dryness of mouth, taste disorder, appearance disturbance, hair loss were 11(6, 20), 13(4, 22), 9(4, 21), 11(7, 20), 23(11, 34), 24(10, 31), 11(5, 21), 19(11, 35), 11(6, 25) for the modified group, respectively, versus 16 (7, 31), 14 (6, 22), 7(5, 16), 11(6, 20), 22 (13, 29), 28 (12, 33), 9 (5, 17), 20 (10, 25), 13 (5, 23) for the traditional group; there was no significant difference in the scores of chest pain or abdominal pain, gastroesophageal reflux, eating disorder, anxiety, dryness of mouth, taste disorder, appearance disturbance, hair loss between the two groups ( Z=0.41, -0.01, 0.99, -0.03, 0.52, 0.46, -0.20, 0.44, P>0.05), while there was a significant difference in the score of dysphagia ( Z=-2.07, P<0.05). ④ Subgroup analysis: after propensity score matching, cases with no, mild, moderate, severe pain (degree of pain perception) for pain-related items in EORTC-QLQ-C30 were 49, 24, 4, 1 of the modified group, versus 43, 9, 14, 2 of the traditional group, showing a significant difference between the two groups ( Z=-2.519, P<0.05). (5)Learning curve of Later-cut overlap anastomosis. The cumulative sum curve for esophagojejunostomy time of the 100 patients in the modified group showed a inflection point at the 33th patient, so the 1st-33th patients were allocated into learning phase and the 34th-100th patients were allocated into stable phase. The operation time, anastomosis time, volume of intraoperative blood loss, the number of lymph node dissected, time to first flatus, time to postoperative liquid diet intake, duration of hospital stay, treatment expenses for patients in the learning phase were (216±60)minutes, (28±10)minutes, 70 mL(range, 10-204 mL), 41±17, (4.5±0.9)days, (5.0±0.8)days, (11.1±4.3)days, 68 722 yuan(range, 52 312-94 943 yuan), respectively, versus (189±51)minutes, (23±8)minutes, 65 mL(range, 5-200 mL), 43±16, (4.4±1.0)days, (5.3±1.1)days, (10.6±6.8)days, 67 380 yuan(range, 49 289-92 732 yuan) for patients in the stable phase. There were significant differences in the operation time and anastomosis time between the two groups ( t=2.27, 2.87, P<0.05). There was no significant difference in the volume of intraoperative blood loss, the number of lymph node dissected, time to first flatus, time to postoperative liquid diet intake, duration of hospital stay or treatment expenses between the two groups ( Z=0.57, t=0.69, 0.49, 1.39, 0.39, Z=0.69, P>0.05). Conclusion:Later-cut overlap anastomosis is a digestive tract reconstruction method after totally laparoscopic total gastrectomy, which can reduce the volume of intraoperative blood loss, relieve postoperative eating obstruction and pain and improve postoperative life quality of patients.

The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9, 3.7, 2.5 mg/(kg.d), and the second stage doses of 1.2, 0.25 mg/(kg.d) by the intravenous route. The results showed that the NOAEL of nickel ion is 0.25 mg/(kg.d) for SD rats, and the result was verified by subchronic systemic toxicity test of nickel alloy. The threshold of toxicological concern (TTC) of nickel is 150 μg/d (based on application of 100-fold uncertainty factor and a body weight of 60 kg)deduced by these data.
Animals ; Equipment and Supplies/adverse effects* ; Nickel/toxicity* ; No-Observed-Adverse-Effect Level ; Rats ; Rats, Sprague-Dawley ; Risk Assessment

Objective To investigate the application value of indocyanine green (ICG) fluorescence imaging in lymphadenectomy of laparoscopic radical gastrectomy for gastric cancer.Methods The retrospective cohort study was conducted.The clinicopathological data of 702 patients with primary gastric cancer who underwent laparoscopic radical gastrectomy and D2 lymphadenectomy in the Fujian Medical University Uuion Hospital between April and December 2017 were collected.There were 517 males and 185 females,aged from 22 to 91 years,with an average age of 61 years.Of the 702 patients,39 using ICG fluorescence imaging in the surgery and 663 not using ICG fluorescence imaging were allocated into ICG group and non-ICG group,respectively.Observation indicators:(1) surgical situations and postoperative recovery;(2) postoperative complications;(3) average number of lymph node dissected and positive lymph nodes;(4) follow-up situations.The number of lymph node dissected in the first station (No.1-7 group) and second station (No.8-12 group) were analyzed respectively.Follow-up using outpatient examination and telephone interview was performed to detect complications of patients up to June 2018.Measurement data with normal distribution were represented as Mean±SD,comparison between groups was analyzed using the t test.Measurement data with skewed distribution were described as M (range),comparison between groups was analyzed using the Mann-Whitney U test.Count data were represented as absolute number or percentage,comparison between groups was analyzed using the chi-square test.Comparisons of ordinal data were analyzed by the Mann-Whitney U test.Results (1) Surgical situations and postoperative recovery:702 patients underwent successfully laparoscopic radical gastrectomy and D2 lymphadenectomy,without injuries of important vessels and adjacent organs,without combined multiple organs resection or conversion to open surgery.Of 39 patients in the ICG group,cases undergoing total radical gastrectomy,distal subtotal gastrectomy and proximal subtotal gastrectomy,cases with Roux-en-Y esophagojejunostomy,Billroth Ⅰ anastomosis,Billroth Ⅱ anastomosis,Roux-en-Y gastrojejunostomy and esophagogastric anastomosis,operation time,volume of intraoperative blood loss,time for out-of-bed activities,time to initial anal exsufflation,time to first fluid diet intake and duration of postoperative hospital stay were 21,16,2,21,3,13,2,0,(173±28) minutes,40 mL (range,5-200 mL),(2.1±0.6)days,(3.5±1.4)days,(4.8± 1.3)days,(8.6±3.6) days.The above indexes were 363,299,1,363,27,267,1,5,(174±41)minutes,50 mL(range,0-1 750 mL),(2.2±0.8)days,(3.4± 1.1) days,(4.6± 1.5) days,(9.4± 5.0) days in the non-ICG group.There were statistically significant differences in the surgical type and digestive reconstruction method (x2 =9.550,11.388,P＜ 0.05) and no statistically significant difference in the operation time,volume of intraoperative blood loss,time for out-of-bed activities,time to initial anal exsufflation,time to first fluid diet intake and duration of postoperative hospital stay (t =0.221,Z =-0.651,t =0.492,-0.826,-0.842,0.995,P＞0.05).(2) Postoperative complications:92 out of the 702 patients had postoperative complications,without death of complications.The incidence of complication was 15.38％(6/39) and 12.97％(86/663) in the ICG group and non-ICG group,with no statistically significant difference between the two groups (x2=0.188,P＞0.05).Six patients with complications (1 of Clavien-Dindo Ⅳ,2 of Clavien-Dindo Ⅲa,3 of Clavien-Dindo Ⅰ) in the ICG group and 86 (6 of Clavien-Dindo Ⅳ,16 of Clavien-Dindo Ⅲ,61 of Clavien-Dindo Ⅱ,3 of Clavien-Dindo Ⅰ) in the non-ICG group were cured after symptomatic treatment.(3) Average number of lymph node dissected and positive lymph nodes:the average number of lymph node dissected and positive lymph nodes was 37 (range,3-112) and 1 (range,0-68) of 702 patients,38 (range,24-70) and 2 (range,0-42) in the ICG group,37 (range,3-112) and 1 (range,0-68) in the non-ICG group,with no statistically significant difference between the two groups (Z=-1.454,-0.514,P＞0.05).Stratified analysis:the average number of No.1-7 group lymph nodes dissected and positive lymph nodes was 34 (range,16-67) and 2 (0-38) in the ICG group,33 (range,3-91) and 1 (range,0-56) in the non-ICG group.The average number of No.8-12 group lymph nodes dissected and positive lymph nodes was 11 (range,4-22) and 0 (range,0-13) in the ICG group,9 (range,0-31) and 0 (range,0-25) in the non-ICG group.There was a statistically significant difference in the average number of No.8-12 group lymph nodes dissected between the two groups (Z=-1.984,P＜0.05).There was no statistically significant difference in the average number of No.1-7 group lymph nodes dissected,positive No.1-7 group lymph nodes and the average number of positive No.8-12 group lymph nodes between the two groups (Z =-1.302,-0.463,-0.758,P＞0.05).(4) Follow-up situations:702 patients were followed up for 6-14 months,with a median time of 10 months.There was no readmission caused by postoperative complications in the two groups.Conclusion ICG fluorescence imaging in lymphadenectomy of laparoscopic radical gastrectomy for gastric cancer is beneficial to dissection of perigastric lymph nodes and increase number of lymph nodes dissected,but cannot increase operation time and incidence of postoperative complications.

Objective To investigate the development trend,safety and clinical effects of laparoscopic radical gastrectomy (LRG) for gastric cancer.Methods The retrospective and descriptive study was conducted.The clinicopathological data of 4 435 patients with gastric cancer who underwent LRG in the Fujian Medical University Union Hospital between January 2008 and December 2017 were collected.There were 3 263 males and 1 172 females,aged (61±11)years,with a range of 12-93 years.According to the operation time,4 435 patients were divided into two periods,including 1 588 patients of the early period (2008-2012) and 2 847 patients of the later period (2013-2017).Observation indicators:(1) the clinicopathological data of patients;(2) intraoperative and postoperative situations;(3) postoperative complications;(4) follow-up and survival situations.Follow-up using outpatient examination,visit to home,mail and telephone interview was performed to detect survival of patients once every 3 months within 2 years postoperatively and once every 6 months after 2 years postoperatively up to June 2018.Survival time was from operation time to the last follow-up,death or deadline of follow-up database such as loss to follow-up or death of other diseases.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was analyzed by the t test.Measurement data with skewed distribution were represented as M (range).Count data were described as frequency or percentage,comparison between groups was analyzed using the chi-square test.Linear analysis was done using the unitary linear regression.The survival rate and survival curve were respectively calculated and drawn by the Kaplan-Meier method,and Log-rank test was used for survival analysis.Results (1) The clinicopathological data of patients:there were 3 263 males and 1 172 females of the 4 435 patients,accounting for 73.574％(3 263/4 435) and 26.426％ (1 172/4 435),respectively.TNM staging of the 4 435 patients:1 133 cases were detected early gastric cancer (T1 stage) and 3 302 cases were detected advanced gastric cancer including 518,1 431,1 353 in T2,T3 and T4a stages respectively.Linear regression analysis showed a linear correlation between the cases of LRG and operation year (R2 =0.911,P＜0.05) and a gradually increasing in cases of LRG.The sex (male),cases with tumor at upper stomach,middle stomach,lower stomach,＞ 2 regions (tumor location),tumor diameter,cases with undifferentiated and differentiated tumor (pathological types),cases in pT1,pT2,pT3,pT4a stages (pT staging),in pN0,pN1,pN2,pN3a,pN3b stages (pN staging),in Ⅰ A,Ⅰ B,Ⅱ A,Ⅱ B,ⅢA,ⅢB,ⅢC stages (pTNM staging) were 1 204,383,302,714,189,(4.8±2.7)cm,361,1 227,382,193,418,595,588,212,255,318,215,325,137,150,172,253,267,284 in patients of the early period,and 2 059,807,530,1 128,382,(4.3±2.6) cm,976,1 871,751,325,1 013,758,1 138,444,505,486,274,616,258,378,322,528,443,302 in patients of the later period,with statistically significant differences between patients of the two periods (x2 =6.411,15.699,t =10.946,x2 =57.801,90.437,26.502,98.773,P＜0.05).(2) Intraoperative and postoperative situations:the volume of intraoperative blood loss,cases with intraoperative blood transfusion,cases with Billroth Ⅰ,Billroth Ⅱ,residual stomach Roux-en-Y anastomosis,esophagogastric anastomosis,esophageal Roux-en-Y anastomosis of digestive tract reconstruction,number of lymph nodes dissected,time for initial fluid diet intake,time for initial semi-fluid diet intake,duration of postoperative hospital stay were (120±75)mL,38,599,122,0,32,835,32±13,(4.5±l.7)days,(8.6±2.5)days,(13.0± 7.3) days in patients of the early period,(104±68)mL,17,441,673,21,18,1 694,37±15,(4.1± 1.5)days,(7.9±2.8) days,(12.3±7.6) days in patients of the later period,showing statistically significant differences between patients of the two periods (t=2.169,x2 =26.843,397.185,t=-10.764,2.125,3.347,2.779,P＜0.05).Further linear regression analysis showed a linear correlation between the average number of lymph nodes dissected and operation year (R2=0.826,P＜0.05) and a gradually increasing in average number of lymph nodes dissected.(3) Postoperative complications:690 of 4 435 patients had postoperative complications,with an incidence rate of 15.558％ (690/4 435),including 242 patients of the early period and 448 of the later period,showing no statistically significant difference (x2 =0.191,P ＞ 0.05).Eight patients died of severe postoperative complications,with a death rate of 0.180％ (8/4 435),including 5 of the early period and 3 of the later period,showing no statistically significant difference (x2 =2.485,P＞0.05).Of 4 435 patients,561 had stage Ⅰ-Ⅱ complications,with an incidence rate of 12.649％ (561/4 435),129 had stage Ⅲ-Ⅳ complications,with an incidence rate of 2.909％(129/4 435).There were 196 and 46 patients of the early period with stage Ⅰ-Ⅱ complications and stage Ⅲ-Ⅳ complications,365 and 83 of the later period with stage Ⅰ-Ⅱ complications and stage Ⅲ-Ⅳ complications,showing no statistically significant difference between patients of the two periods (x2 =0.211,0.001,P＞0.05).(4) Follow-up and survival situations:4 250 of 4 435 patients including 1 465 of the early period and 2 785 of the later period were followed up for 1-123 months,with a median time of 37 months.The 5-year cumulative survival rate was 63.9％.The 5-year cumulative survival rate was 91.8％,80.2％ and 39.5％ in the stage Ⅰ,Ⅱ,Ⅲ patients,respectively,showing a statistically significant difference (x2 =810.146,P＜0.05).The 5-year cumulative survival rate was 60.8％ and 66.7％ in patients of the early and later period,respectively with a statistically significant difference (x2 =17.887,P＜0.05).Stratified analysis of TNM staging:the 5-year cumulative survival rates of stage Ⅰ A,Ⅰ B,Ⅱ A,Ⅱ B,Ⅲ A,Ⅲ B,Ⅲ C patients in the early period were 92.7％,85.6％,79.4％,74.5％,58.1％,37.6％,18.9％ and 95.6％,90.4％,87.6％,79.5％,52.7％,41.2％,19.5％ in patients of the later period,with no statistically significant difference (x2 =0.414,2.575,2.872,2.119,0.632,0.972,2.212,P＞0.05).Conclusions Surgical volume of the LRG has shown an increasing trend year by year,and the number of lymph nodes dissected and postoperative recovery of patients are improving.LRG is a safe procedure with acceptable clinical efficacy for gastric cancer.

Objective: To investigate the clinical efficacy of Da Vinci robotic total gastrectomy combined with spleen-preserving splenic hilar lymphadenectomy for gastric cancer. Methods: The retrospective cross-sectional study was conducted. The clinicopathological data of 47 patients with gastric cancer who were admitted to Fujian Medical University Union Hospital from September 2016 to June 2018 were collected. There were 37 males and 10 females, aged from 23 to 75 years, with an average age of 60 years. Patients underwent Da Vinci robotic total gastrectomy combined with spleen-preserving splenic hilar lymphadenectomy. Observation indicators: (1) intraoperative situations; (2) postoperative situations; (3) postoperative pathological examination; (4) follow-up. Follow-up was conducted by outpatient examination and telephone interview to detect postoperative survival of patients up to September 2018. Measurement data with normal distribution were represented as Mean±SD, and measurement data with skewed distribution were expressed by M (range). Count data were represented as absolute numbers. Results: (1) Intraoperative situations: 47 patients underwent Da Vinci robotic total gastrectomy combined with spleen-preserving splenic hilar lymphadenectomy for gastric cancer, without conversion to open surgery. The operation time, hilar lymph node dissection time, volume of intraoperative blood loss, number of lymph node dissected, number of splenic hilar lymph node dissected, number of metastatic lymph nodes, number of metastatic splenic hilar lymph node were (225±36) minutes, (20±6) minutes, (40±27) mL, 40 (range, 17-112), 2 (range, 0-10), 2 (range, 0-29), 0 (range, 0-3). (2) Postoperative situations: time to first out-of-bed activities, time to first anal flatus, time to gastric tube removal, time to initial liquid diet intake, time to initial semi-liquid diet intake, time to drainage tube removal, and duration of postoperative hospital stay were (2.0±0.3)days, (3.4±0.9)days, (3.4±1.1)days, (4.8±1.0)days, (6.7±1.5)days, (8.5±2.5)days, and (12.0±8.3)days, respectively. Of 47 patients, 3, 2, 1, 1, and 1 were detected pulmonary infection, abdominal bleeding, anastomotic fistula, postoperative intestinal obstruction, and abdominal infection. There were 1, 5, and 2 patients with complications in grade Ⅰ, Ⅱ, and Ⅲ of Clavien-Dindo classification. There was no death in the postoperative 30 days. Two patients with abdominal bleeding were cured by intervene therapy, and patients with other complications were cured by conservative treatment. (3) Postoperative pathological examination: tumor diameter, cases with nodal or vascular or neural invasion, cases with differentiated and undifferentiated tumor (histological differentiation), cases in T1, T2, T3, T4 stages (T staging), cases in N0, N1, N2, N3 stages (N staging), cases in Ⅰ, Ⅱ, Ⅲ stages (TNM staging) were (4.2±1.6)cm, 26, 31, 16, 5, 22, 17, 3, 18, 9, 8, 12, 13, 20, 14, respectively. (4) Follow-up: 47 patients were followed up for 3-25 months, with a median time of 9 months. During the follow-up, 3 of 47 patients died of tumor recurrence, 1 had tumor-bearing survival, and 43 had tumor-free survival. Conclusion Da Vinci robotic total gastrectomy combined with spleen-preserving splenic hilar lymphadenectomy for gastric cancer is safe and feasible.

The purpose of this study was to investigate the cytotoxicity of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Seven cell lines were chosen. They were L929, h9c2(2-1), 293[HEK-293], hFOB1.19, THLE-3, H9 and IM-9 respectively. According to the principle of biological evaluation of medical devices, MTT method was chosen to test the cytotoxicity in different concentrations of nickel ion. For each cell line, the relative growth rate (RGR) was obtained and the cytotoxic grade was classified. Besides, IC50 values were calculated. As a result, it was found that the sensitivity was different among all cell lines. H9 was the most sensitive one, while the L929 was the most tolerant one. The concentration which is not above 1.25 mg/L was safe for all seven cell lines, because the cytotoxicity for all cells exposed in this concentration were not higher than grade 1. According to the criteria for medical devices, the concentrations not above 5 mg/L were safe for L929 cells. This result helps us to roughly assess the cytotoxicity and systematic toxicity caused by nickel contained in medical devices.
Cell Line ; Equipment and Supplies ; HEK293 Cells ; Humans ; Ions ; toxicity ; Nickel ; toxicity

Objective To explore the role of caspase-3 activation and DNA fragmentation in later period of neonatal rat hypoxic-ischemic brain damage(HIBD). Methods DNA fragmentation,caspase-3 mRNA and caspase-3 protein were measured in 2 wks、3 wks and 4wks after setting HIBD animal model in newborn wistar rats by FCM, RT-PCR and Immunohistochemistry. Results (1) Apoptosis lasted 4ks after HIBD. This suggested a long lasting role of apoptosis in neonatal HIBD by TNNEL and EM.(2)Caspase-3 mRNA expression was estimated by semi-quantitative RT-PCR. It was higher in HIBD group(0.771?0.074) than in control group(0.620?0.038, P0.05. Average Avalue of Caspase-3 protein in HIBD group(0.374 ?0.038) at 3 wks was significantly higher than that in control group(0.356?0.020,P

Epilepsy is a kind of brain dysfunction syndrome caused by so many reasons instead of a certain disease. Abnormal neuron discharge can cause epilepsy. Idiopathic epilepsy refers to epilepsy or epilepsy syndrome without any latent reasons but inherited trait. Idiopathic epilepsy is confirmed as an ion channelopathy at present. The first genemutation was found in idiopathic epilepsy in 1995, and a lot of genes coding either voltage-gated or ligand-gated ion channels have been found since then. In the present review, some new advances in research on ion channels dysfunction in idiopathic epilepsy are summarized.