1.Association between hearing loss and physical performance in patients on maintenance hemodialysis
Weifeng FAN ; Xiaojing ZHONG ; Qing WU ; Lihong ZHANG ; Zhenhao YANG ; Yong GU ; Qi GUO ; Xiaoyu CHEN ; Chen YU ; Kun ZHANG ; Wei DING ; Hualin QI ; Junli ZHAO ; Liming ZHANG ; Suhua ZHANG ; Jianying NIU
Kidney Research and Clinical Practice 2024;43(3):358-368
The correlation between hearing loss (HL) and physical performance in patients receiving maintenance hemodialysis (MHD) remains poorly investigated. This study explored the association between HL and physical performance in patients on MHD. Methods: This multicenter cross-sectional study was conducted between July 2020 and April 2021 in seven hemodialysis centers in Shanghai and Suzhou, China. The hearing assessment was performed using pure-tone average (PTA). Physical performance was assessed using the Timed Up and Go Test (TUGT), handgrip strength, and gait speed. Results: Finally, 838 adult patients (male, 516 [61.6%]; 61.2 ± 2.6 years) were enrolled. Among them, 423 (50.5%) had mild to profound HL (male, 48.6% and female, 53.4%). Patients with HL had poorer physical performance than patients without HL (p < 0.001). TUGT was positively correlated with PTA (r = 0.265, p < 0.001), while handgrip strength and gait speed were negatively correlated with PTA (r = –0.356, p < 0.001 and r = –0.342, p < 0.001, respectively). Physical performance in patients aged <60 years showed significant dose-response relationships with HL. After adjusting for confounders, the odds ratios (95% confidence intervals) for HL across the TUGT quartiles (lowest to highest) were 1.00 (reference), 1.15 (0.73–1.81), 1.69 (1.07–2.70), and 2.87 (1.69–4.88) (p for trend = 0.005). Conclusion: Lower prevalence of HL was associated with a faster TUGT and a stronger handgrip strength in patients on MHD.
2.Analysis of monitoring results of foodborne pathogens in Baoshan District, Shanghai, 2019‒2021
Na NIU ; Junqing SHEN ; Xu ZHANG ; Jianying MAO ; Ya GAO
Shanghai Journal of Preventive Medicine 2023;35(10):976-981
ObjectiveTo investigate the monitoring status and epidemiological characteristics of foodborne disease pathogens in Baoshan District, Shanghai so as to improve early detection and warning capabilities of foodborne diseases outbreaks, and to provide a scientific basis for the prevention and control of foodborne diseases. MethodsAnal swabs or fecal samples from food-borne diarrhea cases were collected from two sentinel surveillance medical institutions in Baoshan District of Shanghai during 2019 and 2021. Salmonella, diarrheagenic Escherichia coli, Shigella, Vibrio parahaemolyticus, campylobacter and norovirus were tested in anal swabs and fecal samples, and all the testing results were statistically analyzed. ResultsA total of 1 693 cases were reported, among which 1 693 anal swabs and fecal samples were collected, with a male-to-female ratio of 1.04∶1. The largest number of cases was from the age group of 45-64 years (504 cases). The highest number of reported cases was among retirees (762 cases). The high-incidence period of the diseases was in summer and autumn, with the highest number of cases associated with meat and meat products (566 cases). The primary location of exposure was at home (1 260 cases). The detection rate of pathogenic bacteria and virus was 21.32%, among which campylobacter accounted for the largest proportion (10.28%). The peak incidence rate was from May to September. The detection rate of norovirus was 13.29%, with a higher incidence in winter and spring. The predominant serotype of Salmonella was Salmonella enteritidis (41.82%), and the predominant local serotype of diarrheagenic Escherichia coli was EAEC (50.52%). Campylobacter was mainly represented by jejuni (81.61%), and the predominant type of norovirus was GⅡ (60.87%). ConclusionCampylobacter has the highest proportion among foodborne pathogens causing foodborne diseases in Baoshan District, followed by diarrheogenic Escherichia coli. And norovirus GⅡ type is the predominant virus. Appropriate prevention and control measures should be taken based on the characteristics of each pathogen's epidemiology.
3.Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail
Nan CHEN ; Changying XING ; Jianying NIU ; Bicheng LIU ; Junzhou FU ; Jiuyang ZHAO ; Zhaohui NI ; Mei WANG ; Wenhu LIU ; Jinghong ZHAO ; Ling ZHONG ; Xiongfei WU ; Wenge LI ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Aiping YIN ; Ping FU ; Rong WANG ; Gengru JIANG ; Fanfan HOU ; Guohua DING ; Jing CHEN ; Gang XU ; Yuichiro KONDO ; Yuliang SU ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(1):59-70
Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.
4.Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial
Bicheng LIU ; Nan CHEN ; Jinghong ZHAO ; Aiping YIN ; Xiongfei WU ; Changying XING ; Gengru JIANG ; Junzhou FU ; Mei WANG ; Rong WANG ; Jianying NIU ; Ping FU ; Zhaohui NI ; Fanfan HOU ; Jiuyang ZHAO ; Jing CHEN ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Wenge LI ; Gang XU ; Ling ZHONG ; Wenhu LIU ; Guohua DING ; Yuichiro KONDO ; Changhe YUE ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(2):134-144
Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.
5.Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail
Nan CHEN ; Changying XING ; Jianying NIU ; Bicheng LIU ; Junzhou FU ; Jiuyang ZHAO ; Zhaohui NI ; Mei WANG ; Wenhu LIU ; Jinghong ZHAO ; Ling ZHONG ; Xiongfei WU ; Wenge LI ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Aiping YIN ; Ping FU ; Rong WANG ; Gengru JIANG ; Fanfan HOU ; Guohua DING ; Jing CHEN ; Gang XU ; Yuichiro KONDO ; Yuliang SU ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(1):59-70
Background::Erythropoietin is a glycoprotein that mainly regulates erythropoiesis. In patients with chronic renal failure with anemia, darbepoetin alfa can stimulate erythropoiesis, correct anemia, and maintain hemoglobin levels. This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections (Recombinant Human Erythropoietin injection, rHuEPO) when maintaining hemoglobin (Hb) levels within the target range (10.0-12.0 g/dL) for the treatment of renal anemia.Methods::Ninety-five patients were enrolled in this study from April 15, 2013 to April 10, 2014 at 25 sites. In this study, patients ( n = 95) aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group ( n = 56) and a twice or three times per week intravenous epoetin alfa group ( n = 39) for 28 weeks, who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease (CKD) and were undergoing hemodialysis or hemofiltration with ESA-naive (erythropoiesis stimulating agent-naive). The primary efficacy profile was the mean Hb level (the non-inferiority margin was -1.0 g/dL, week 21-28); the secondary efficacy profiles were the Hb increase rate (week 0-4), the target Hb achievement cumulative rate and time, the change trends of the Hb levels, and the target Hb maintenance ratio. Adverse events (AEs) were observed and compared, and the efficacy and safety were analyzed between the two treatment groups. Additionally, the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period. SAS? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group, respectively; the difference of the lower limits of the 95% confidence intervals (CI) between the two groups was 0.1 g/dL (>-1.0 g/dL), and non-inferiority was proven; the Hb levels started to increase in the first four weeks at a similar increase rate; no obvious differences were observed between the groups in the target Hb achievement cumulative rates, and the Hb levels as well as the target Hb level maintenance rate changed over time. The incidence of AEs was 62.5% in the darbepoetin alfa group and 76.9% in the epoetin alfa group. All the adverse events observed in the study were those commonly associated with hemodialysis.Conclusion::Darbepoetin alfa intravenously once per week can effectively increase Hb levels and maintain the target Hb levels well, which makes it not inferior to epoetin alfa intravenously twice or three times per week. Darbepoetin alfa shows an efficacy and safety comparable to epoetin alfa for the treatment of renal anemia.
6.Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients: A randomized, open-label, parallel-group, noninferiority phase III trial
Bicheng LIU ; Nan CHEN ; Jinghong ZHAO ; Aiping YIN ; Xiongfei WU ; Changying XING ; Gengru JIANG ; Junzhou FU ; Mei WANG ; Rong WANG ; Jianying NIU ; Ping FU ; Zhaohui NI ; Fanfan HOU ; Jiuyang ZHAO ; Jing CHEN ; Yuqing CHEN ; Wei SHI ; Jianghua CHEN ; Wenge LI ; Gang XU ; Ling ZHONG ; Wenhu LIU ; Guohua DING ; Yuichiro KONDO ; Changhe YUE ; Changlin MEI
Chronic Diseases and Translational Medicine 2022;08(2):134-144
Background::This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection (recombinant human erythropoietin injection, rHuEPO) for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method::This study was a multicenter, randomized, open-label, intergroup parallel control phase III noninferiority trial from April 19, 2013 to September 9, 2014 at 25 sites. In this study, the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks. The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week. All subjects underwent epoetin alfa administration during the 8-week baseline period. After that, subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group. The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period (noninferiority threshold: -1.0 g/dl) was tested between the two treatments. The time-dependent hemoglobin (Hb) concentration and the maintenance rate of the target Hb concentration (the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl) were also evaluated. Iron metabolism, including changes in the serum iron, total iron-binding capacity, ferritin, transferrin saturation, and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further. Adverse events (AEs) were also observed and compared, and the safety was analyzed between the two treatment groups. The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed. SAS ? software version 9.2 was used to perform all statistical analyses. Descriptive statistics were used for all efficacy, safety, and demographic variable analyses, including for the primary efficacy indicators. Results::Four hundred and sixty-six patients were enrolled in this study, and ultimately 384 cases were analyzed for safety, including 267 cases in the darbepoetin alfa group and 117 cases in the epoetin alfa group. There were 211 cases in the per-protocol set, including 152 cases in the darbepoetin alfa group and 59 cases in the epoetin alfa group. The changes in the average Hb concentrations from the baseline to the end of the evaluation period were -0.07 and -0.15 g/dl in the darbepoetin alfa group and epoetin alfa group respectively. The difference between the two groups was 0.08 g/dl (95% confidence interval [CI]: -0.22 to 0.39), and the lower limit of the 95% CI was -0.22 > -1.0 g/dl. The average Hb concentrations of the two groups were 10.88-11.43 g/dl (darbepoetin alfa) and 10.91-11.38 g/dl (epoetin alfa) during the study period of Weeks 0-28, with the maintenance rates of the target Hb concentration ranging within 71%-87% and 78%-95% in the darbepoetin alfa group and epoetin alfa group respectively. During the period of comparison between the two groups, the incidence of AEs in the darbepoetin alfa group was 61.42%, while in the epoetin alfa group it was 56.41%. All of the adverse events and reactions in the study were those commonly associated with hemodialysis.Conclusion::The overall efficacy and safety of darbepoetin alfa for the treatment of Chinese renal anemia patients undergoing hemodialysis are consistent with those of epoetin alfa.
7.Relationship between acute radiation reactions and doses of total body irradiation before hematopoietic stem cell transplantation
Yanchuan SHI ; Shuzhuang LYU ; Yazhao LIU ; Weitao NIU ; Rongxiao WANG ; Jingya ZHANG ; Yuhui PANG ; Jianying LI ; Gengshen SU
Journal of Leukemia & Lymphoma 2021;30(2):82-86
Objective:To investigate the relationship of the acute radiation reactions of totalbody irradiation before hematopoietic stem cell transplantation with the different total and fractionated doses of irradiation.Methods:The clinical data of 48 patients who underwent 6 MV X-ray total body irradiation pretreatment from May 2015 to December 2019 in Shijiazhuang Ping'an Hospital before undergoing hematopoietic stem cell transplantation were retrospectively analyzed. The patients were divided into 8 Gy group (12 cases), 10 Gy group (31 cases) and 12 Gy group (5 cases) according to the total radiation dose, and divided into 4 Gy/f group (17 cases) and 5 Gy/f group (31 cases) according to the fractionated radiation dose. Acute radiation reactions in the oral mucosa, pharynx, salivary glands, upper gastrointestinal tract, lower gastrointestinal tract and lung of patients in each group after radiotherapy were summarized and compared.Results:Acute pharyngeal reaction in the total radiation dose of 8 Gy group showed that 11 cases (91.7%) were grade 0 and 1 case (8.3%) was grade 1; in the total radiation dose of 10 Gy group, 10 cases (32.3%) were grade 0, 13 cases (41.9%) were grade 1, 4 cases (12.9%) were grade 2, 3 cases (9.7%) were grade 3, and 1 case (3.2%) was grade 4; in the total radiation dose of 12 Gy group, 2 cases (40.0%) were grade 0, 1 case (20.0%) was grade 1, 1 case (20.0%) was grade 2, and 1 case (20.0%) was grade 3. The severity of acute pharyngeal radiation reaction in the total radiation dose of 8 Gy group was better than that in the 10 Gy and 12 Gy groups, and the difference was statistically significant ( χ2 = 11.338, P = 0.003); there was no significant difference in the incidence of acute radiation reactions in other parts (all P > 0.05). Acute pharyngeal radiation reaction in the fractionated radiation dose of 4 Gy/f group showed that 13 cases (76.5%) were grade 0, 2 case (11.8%) was grade 1, 1 case (5.9%) was grade 2, and 1 case (5.9%) was grade 3; in the 5 Gy/f group, 10 cases (32.3%) were grade 0, 13 cases (41.9%) were grade 1, 4 cases (12.9%) were grade 2, 3 cases (9.7%) were grade 3, and 1 case (3.2%) was grade 4. The severity of acute pharyngeal radiation reaction in the fractionated radiation dose 4 Gy/f group was better than that in the 5 Gy/f group, and the difference was statistically significant ( Z = -2.606, P = 0.009); there was no significant difference in the incidence of acute radiation reactions in other parts (all P > 0.05). Conclusion:The total dose of 8 Gy and fractionated dose of 4 Gy/f in the total body irradiation before hematopoietic stem cell transplantation can alleviate the acute pharyngeal radiation reaction.
8.Clinical efficacies of free endoscopic nasobiliary drainage in primary duct closure following laparoscopic common bile duct exploration: a multicenter retrospective study (A report of 312 cases)
Yan YANG ; Jian ZHANG ; Jianying LOU ; Fuyu LI ; Xiaoya NIU ; Zhimin GENG ; Zhiyu CHEN ; Xianhai MAO ; Wei GUO ; Junchuang HE ; Shi CHENG ; Yongyi ZENG ; Jianming WANG
Chinese Journal of Digestive Surgery 2018;17(1):68-75
Objective To investigate the clinical efficacies of free endoscopic nasobiliary drainage (ENBD) in primary duct closure (PDC) following laparoscopic common bile duct exploration (LCBDE) for choledocholithiasis.Methods The retrospective cohort study was conducted.The clinical data of 312 patients with extrahepatic bile duct stones accompanied with or without cholecystolithiasis who were admitted to the 11 medical centers [86 in the Affiliated Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,62 in the Second Affiliated Hospital of Zhejiang University School of Medicine,44 in the West China Hospital of Sichuan University,29 in the First Affiliated Hospital of Xi'an Jiaotong University,27 in the First Hospital Affiliated to Army Medical University (Third Military Medical University),25 in the Hunan Provincial People's Hospital,17 in the Beijing Friendship Hospital of Capital Medical University,10 in the First Affiliated Hospital of Hainan Medical University,5 in the Henan Provincial People's Hospital,4 in the Beijing Tian Tan Hospital of Capital Medical University,3 in the First Affiliated Hospital of Fujian Medical University] from January 2011 to June 2017 were collected.All patients underwent LCBDE+PDC,and 81 and 231 patients with and without ENBD were respectively allocated into the ENBD group and PDC group.Observation indicators:(1) comparisons of operation situations;(2) comparisons of postoperative recovery;(3) comparisons of postoperative complications;(4) follow-up situations.Follow-up using outpatient examination and telephone interview was performed to detect the postoperative complications up to June 2017.Measurement data with normal distribution were represented as x±s.Comparison between groups was analyzed by the t test.Measurement data with skewed distribution were represented M [interquartile range (IQR)],and comparison between groups was analyzed by the nonparametic test.Comparisons of count data were analyzed using the chi-square test and Fisher exact probability.Results (1) Comparisons of operation situations:all the 312 patients underwent successful laparoscopic LCBDE + PDC,without conversion to open surgery,including postoperative death of 1 patient in the PDC group.The common bile duct diameter,cases using interrupted sutures,continuous sutures,absorbable threads and nonabsorbable threads were respectively (1.2±0.4)cm,106,125,195,36 in the PDC group and (1.1±0.5)cm,76,5,79,2 in the ENBD group,with statistically significant differences between groups (t =2.497,x2 =56.706,8.457,P<0.05).The numbers of stones,stone diameter,cases with common bile duct wall (≤ 3 mm and >3 mm),normal and abnormal Oddi sphincter contraction function,volume of intraoperative blood loss and operation time were respectively 2.1±1.7,(1.1-±0.6)cm,148,83,226,5,20 mL (10-45 mL),(116± 49)minutes in the PDC group and 1.9±1.6,(1.0±0.6)cm,49,32,75,6,20 mL (15-30 mL),(113± 23)minutes in the ENBD group,with no statistically significant difference between groups (t =1.021,0.329,x2 =0.329,3.428,Z=1.147,t=0.521,P>0.05).The further analysis:of 312 patients,cases and time using interrupted sutures and continuous sutures were respectively 182,130 and (133±.49) minutes,(103±34) minutes,with a statistically significant difference between groups (t =-6.605,P<0.05).The volume of intraoperative blood loss and cases with postoperative complications using interrupted sutures and continuous sutures were respectively 20 mL (15-31 mL),21 and 20 mL (10-45 mL),18,with no statistically significant difference between groups (Z =-0.285,x2 =0.369,P> 0.05).Of 312 patients,cases,operation time,volume of intraoperative blood loss and postoperative complications using absorbable threads and non-absorbable threads were respectively 274,(116±44)minutes,20 mL (15-40 mL),33 and 38,(115±35) minutes,18 mL (10-26 mL),6,with no statistically significant difference between groups (Z =0.971,t =0.023,x2 =0.154,P> 0.05).(2) Comparisons of postoperative recovery:recovery time of gastrointestinal function,time of abdominal drainage-tube removal,using time of antibiotics and duration of hospital stay were respectively (2.0± 1.5) days,(4.0 ± 2.4) days,(4.0±2.8) days,(5.5±3.0) days in the PDC group and (4.0±1.9) days,(6.9±3.5) days,(10.0± 3.9) days,(11.1±3.7)days in the ENBD group,with statistically significant differences between groups (t =-9.507,-8.258,-15.103,-13.575,P<0.05).The total expenses of hospital stay in the Affiliated Tongji Hospital,Tongji Medical College of Huazhong University of Science and Technology were respectively (5.1 ±0.6)× 104 yuan in the PDC group and (6.5-±0.5)× 104 yuan in the ENBD group,with a statistically significant difference between groups (t =-9.516,P<0.05).(3) Comparisons of postoperative complications:incidence of complications in the PDC group was 14.29% (33/231),including 16 with biliary fistula,11 with biliary tract infection,3 with wound infection,1 with biliary tract bleeding,1 with residual stones of common bile duct and 1 with death;incidence of complications in the ENBD group was 6.17% (5/81),including 2 with biliary fistula,2 with biliary tract infection and 1 with biliary tract bleeding,showing no statistically significant difference between groups (x2 =3.151,P>0.05).(4) Follow-up situations:of 312 patients,252 were followed up for 2-67 month,with a median time of 15 months,including 175 in the PDC group and 77 in the ENBD group.During the follow up,there was no occurrence of jaundice,cholangitis and pancreatitis,and stone recurrence and postoperative cholangiostenosis were not detected by abdominal color Doppler ultrasound or CT or magnetic resonanced cholangio-pancreatography.Conclusion On the basis of grasping operative indication strictly,ENBD in PDC following LCBDE for choledocholithiasis is safe and effective.
9.Irreversible electroporation ablation of tumor: an analysis of perioperative complications
Zilin QIN ; Lizhi NIU ; Bing LIANG ; Liang ZHOU ; Gang FANG ; Wei QIAN ; Weibing ZHU ; Jiongyuan XU ; Yong HU ; Jianying ZENG ; Jibing CHEN ; Kecheng XU
Journal of Interventional Radiology 2018;27(3):223-227
Objective To summarize and analyze the perioperative complications of irreversible electroporation (IRE) ablation in treating tumors at different locations and to discuss their managements. Methods A total of 200 patients with tumors, including pancreatic tumor (n=71), liver tumor (n=64) and other tumors (n =65), were enrolled in this study. All patients received IRE ablation treatment. The perioperative complications were recorded and the data were statistically analyzed. The causes of severe complications and the treatment of complications were discussed. Results None of the patients died during the course of IRE ablation procedure. Severe postoperative complications occurred in the patients with pancreatic tumor or liver tumor, including duodenal artery bleeding in 3 patients with pancreatic tumor, which occurred at 10 days, 11 days and 15 days after IRE ablation respectively, and gastrointestinal bleeding (n =1) and biliary septic shock (n=1) in 2 patients with liver tumor, which occurred at 9 days after IRE ablation, the clinical symptoms were controlled after interventional embolization and/or vascular ligation together with anti-infective therapy. All minor complications were relieved after symptomatic treatment within 14 days. Conclusion IRE ablation has less systemic inflammatory response, and both the intraoperative and postoperative adverse reactions can be easily controlled, besides, IRE ablation has higher clinical safety. Although IRE ablation procedure may damage the internal or peripheral vessels of the pancreatic tumor, this severe complications can be effectively avoided if proper measures are adopted based on the causes of complications. (J Intervent Radiol, 2018, 27: 223-227)
10.Telehealth-based dialysis registration system for the improvement of renal anemia in maintenance hemodialysis:multicenter experiences
Zhaohui NI ; Haijiao JIN ; Gengru JIANG ; Niansong WANG ; Ai PENG ; Zhiyong GUO ; Shoujun BAI ; Rong ZHOU ; Jianrao LU ; Yi WANG ; Ying LI ; Shougang ZHUANG ; Chen YU ; Yueyi DENG ; Huimin JIN ; Xudong XU ; Junli ZHANG ; Junli ZHAO ; Xiuzhi YU ; Xiaoxia WANG ; Liming ZHANG ; Jianying NIU ; Kun LIU ; Xiaorong BAO ; Qin WANG ; Jun MA ; Chun HU ; Xiujuan ZANG ; Qing YU
Chinese Journal of Nephrology 2018;34(11):831-837
Objective To analyze the role of telehealth?based dialysis registration systems in real?time and dynamic reflection of renal anemia in hemodialysis (HD) patients, and discuss the prospect of its application in dialysis registration management. Methods The Red China project was to build up a dialysis registration system based on the WeChat mobile terminal platform. Demographic and baseline laboratory parameters such as age, gender, primary disease, dialysis age, creatinine were recorded in this system. Hemoglobin (Hb) level was monthly recorded. The platform generated Hb statistics report for each HD center monthly, including the detection rate, target rate and the distribution level of Hb, and released it to physicians through the WeChat terminal of mobile phone. After that, physicians could change the treatment of anemia individually on basis of this report. Here the demographic and baseline laboratory parameters, the detection rate, target rate, the average level and the distribution of Hb from June 2015 to October 2017 after the project launched were analyzed. Results From June 2015 to October 2017, 8392 maintenance HD patients from 28 HD centers in Shanghai were enrolled, of whom 5059(60.3%) were male.The average rate age was (60.5 ± 13.7) years old. Baseline average Hb was (108.3±16.0) g/L. Baseline detection rate and target rate were 54.2%and 47.5%, respectively. After 28 months follow?up, the detection rate of Hb increased from 54.2% to 73.6% (P<0.001), the target rate of Hb increased from 47.5% to 56.1% (P<0.001), and the level of average Hb rose from (108.3±16.0) g/L to (110.7±16.0) g/L. The difference between average Hb in two consecutive months was less than 1.3 g/L. Conclusions The telehealth?based dialysis registration system can timely report the anemia situation of HD patients, which may improve the awareness rate of anemia, the degree of attention and the compliance of anemia monitoring, so as to improve the detection rate and target rate of Hb and reduce the fluctuation of Hb, which helps to maintain the HD patients to correct anemia in a timely, stable and long?term way. The telehealth?based dialysis registration system, as an improved mode of dialysis registration is a promising way for long?term management of renal anemia in dialysis patients.

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