1.Current situation of and countermeasures for achievement transformation and management in tertiary medical hospitals in Shanghai
Yunwei ZHANG ; Changying WANG ; Na LI ; Yuhong NIU
Modern Hospital 2024;24(2):300-303
Objective To investigate the current situation of achievement transformation in tertiary medical hospitals in Shanghai and propose countermeasures for the existing problems to enhance the effectiveness of achievement transformation.Methods A questionnaire survey was done on the transformation and management of scientific research achievements in 47 terti-ary hospitals in Shanghai.Meanwhile,interviews were carried out among the managers and researchers from these hospitals.Re-sults In the past three years,the rate of transformation achievements in the hospitals was only 2.8%.In the achievement trans-formation existed such problems as weak awareness of scientific researchers,low patent quality,lack of full-time managers,and inflexible management mode.It was also believed that there is a need to improve main responsibilities,achievement management,system establishment,personnel training,resource sharing,department coordination and other related aspects.Conclusion The rate of achievement transformation in tertiary medical institutions in Shanghai is at a lower level.There are numerous problems and difficulties in the transformation.Therefore,urgent efficient countermeasures are needed to promote the transformation of a-chievement.
2.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.
3.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.
4.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.
5.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.
6.Clinical application of lateral musculocutaneous perforator flap of crus for repairing soft tissue defect of foot and ankle
Shenxing TAN ; Xiaosheng LU ; Zhe CAO ; Yongqiang GUO ; Xiaoqin LIANG ; Yuanyuan LIU ; Changying NIU
Chinese Journal of Medical Aesthetics and Cosmetology 2020;26(4):335-337
Objective:To explore the clinical application of peroneal artery pedicled with lateral calf muscle wear skin flap in repair of foot and ankle soft tissue defect.Methods:From February 2017 to May 2019, the peroneal artery pedicled with lateral calf muscle wear foot and ankle soft tissue defect was used with skin flap in 20 cases, which included car accident injuries in 11 cases, 3 cases of heavy injuries, skin ulcer in 4 cases, and 2 cases of bone scars. All of the affected limb wounds presented with the exposure of deep tissue such as bone or tendons. The flap cut ranged from 5.0 cm×4.0 cm~7.0 cm×5.0 cm. The donor area was closely sutured in 5 cases, and inguinal full thickness skin pack was used with skin grafting in 15 cases.Results:20 cases of postoperative skin flap survived of all, healing of wounds and cuts for phase I. After follow-up of 5~18 months, the flap had good shape and wear-resistant quality, without feeling bloated. The two points of flap were different within 3~5 mm; the functional activity of the ankle joint was good in the affected limb, with satisfactory results.Conclusions:It is a convenient and reliable procedure, with smaller surgical trauma, which is an ideal skin flap for repair of soft tissue defect in foot and ankle.
7.Role of intracellular Ca2+ in regulating NHE3 expression in Caco-2 cells during rotavirus infection
Peng WANG ; Meilan NIU ; Changying CHEN ; Ling LI ; Yuanyuan FAN ; Shiguang WANG ; Yiwen SUN
Chinese Journal of Microbiology and Immunology 2019;39(2):94-99
Objective To investigate the effects of rotavirus ( RV) on the expression and bioactiv-ity of Na+-H+ exchanger 3 ( NHE3 ) in Caco-2 cells and the possible regulatory mechanism. Methods Caco-2 cells expressing NHE3 were constructed and divided into four groups as follows: control ( CTL ) group, RV group, BAPTA-AM ( a Ca2+ chelator) group and BAPTA-AM+RV group. Na+-H+ exchanger ac-tivity and NHE3 expression on cell surface were determined using BCECF-AM and biotinylation assay, re-spectively. Expression of Cdc42 at protein level was measured by Western blot. Results Compared with the control group, RV infection significantly decreased the activity of NHE3 and its expression on cell surface. BATPA-AM antagonized the inhibitory effects on NHE3. Moreover, the expression of Cdc42 at protein level was increased following RV infection, which was also antagonized by BATPA-AM. Conclusions Intracellu-lar Ca2+-mediated Cdc42-dependent endocytosis pathway might be involved in regulating the expression and bioactivity of NHE3 during RV infection.
8.Cdc42-dependent endocytosis pathway in the regulation of Na+/H+exchanger 3 (NHE3) expression on rotavirus-infected Caco-2 cells
Mei-Lan NIU ; Peng WANG ; Changying CHEN ; Rongfang FENG ; Zixiao CHEN ; Jiawei JIAO ; Yuanyuan LI ; Haoyu XU ; Ling LI
Chinese Journal of Microbiology and Immunology 2018;38(3):181-186
Objective To observe the effects and regulatory mechanism of rotavirus infection on the expression and bioactivity of Na+/H+exchanger 3 (NHE3) on Caco-2 cells. Methods A cell model of Caco-2 cells expressing NHE3 was constructed. Four groups were set up,which were control(CTL) group, rotavirus(RV) infection group, Cdc42 inhibitor (Pirl-1) group and Pirl-1+RV group. Bioactivity and ex-pression of NHE3 on the surface of Caco-2 cells were determined by BCECF-AM and biotinylation method, respectively. Expression of Cdc42 protein was measured by Western blot. Co-immunoprecipitation was per-formed to detect the interaction between NHE3 and Cdc42. Results Compared with the CTL group,RV in-fection significantly inhibited the bioactivity and expression of NHE3 on Caco-2 cells. These inhibitory effects were antagonized by Pirl-1. Moreover,RV infection enhanced the expression of Cdc42 protein and promoted the interaction between NHE3 and Cdc42, which were also antagonized by Pirl-1. Conclusion RV infec-tion might regulate the expression and bioactivity of NHE3 through Cdc42-dependent endocytosis pathway.
9.Effect of rotavirus infection on regulating the expression of Na+-H+ exchanger 3 in Caco-2 cells via clathrin dependent endocytosis pathway
Meilan NIU ; Yanyan PEI ; Peng WANG ; Yuanyuan FAN ; Changying CHEN ; Shiguang WANG ; Wu YUAN
Chinese Journal of Infection and Chemotherapy 2018;18(6):599-603
Objective To observe the effect of rotavirus (RV) infection on expression level and bioactivity of Na+-H+ exchanger 3 (NHE3) in Caco-2 cells. Methods Model of NHE3-expressing Caco-2 cells was constructed and studied in terms of intervention: control, RV, clathrin antagonist chlorpromazine (CPZ), and CPZ + RV. NHE3 activity and NHE3 protein amount on cell surface were determined by BCECF-AM and biotinylation, respectively. Expression level of clathrin was assayed by Western blot. Results Compared with control group, NHE3 activity and NHE3 surface protein level significantly decreased when the cells were treated with RV. These effects could not be completely cancelled by clathrin antagonist CPZ. Moreover, RV treatment could increase cellular protein level of clathrin, which was cancelled by CPZ. Conclusions The effect of RV infection on NHE3 expression level and biological activity may be related to clathrin-dependent endocytosis pathway, and may be also affected by other endocytosis pathways.
10. Research and development of primary bilateral lipedema
Zhe CAO ; Zhaohui ZHAI ; Shenxing TAN ; Changying NIU ; Jinghan WANG ; Biaobing YANG ; Yangyang HAN ; Shengjian TANG ; Xiaoqin LIANG
Chinese Journal of Plastic Surgery 2018;34(4):315-318
Lipedema is secondary to local fat deposition, a disease characterized by the symmetric thickening of lower limbs, mostly occurs in women, especially in adolescence and pregnancy. In its early stage, it could be easily confused with lymphedema. Extensive literature review on primary fat edema in recent years, as well as a summary of the clinical symptoms and signs and diagnosis and treatment of lipedema were conducted, so as to provide a useful reference for clinicians.

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