1.Expression and role of Tim-3 in the pathogenesis of experimental autoimmune uveitis
Xiongfei WU ; Qiujin ZHANG ; Liu ZHENG ; Binbin YANG ; Jinqing LI ; Zhixiang DING
Recent Advances in Ophthalmology 2025;45(1):10-14
Objective To investigate the expression and role of T cell immunoglobulin and mucin domain-containing protein 3(Tim-3)in the pathogenesis of experimental autoimmune uveitis(EAU).Methods A total of 12 male C57BL/6J mice,aged 4 to 5 weeks,were selected and divided into the control group(n=3)and the experimental group(n=9)using a random number table.The control group(modeling time point:0 days after modeling)received no treatment,while the experimental group was induced to establish an EAU model(divided into three subgroups according to the modeling time points:7 days,14 days,and 21 days after modeling,with 3 mice in each subgroup).Firstly,the interphotoreceptor retinoid-binding protein 651-670 and complete Freund's adjuvant were fully mixed and emulsified.Then,the emulsion was subcutaneously injected into the two thighs,tail base,and neck of mice in the experimental group(each mouse received 200 μL of immune emulsion containing 500 pg of interphotoreceptor retinoid-binding protein 651-670).Subsequently,each mouse in the experimental group was also intraperitoneally injected with 1 μg of pertussis toxin.The anterior segment and fundus of mice in each group were observed and photographed under a slit-lamp microscope.The clinical and histopatho-logical scoring of these mice was conducted according to the Caspi grading scale based on the severity of inflammation.The serum levels of IFN-γ and IL-17 were measured using the enzyme-linked immunosorbent assay(ELISA),while the mRNA expression of Tim-3 in the spleen and ocular tissues was detected using the real-time quantitative polymerase chain reaction(RT-qPCR).Western blot was employed to detect the protein expression of Tim-3,and immunohistochemistry was used to examine the protein expression of Tim-3 in the spleen tissue.Statistical analysis was performed using GraphPad Prism 9.0.Results The clinical scores of the anterior segment,fundus,and histopathology of the mice increased over time after modeling,with statistically significant differences among these groups(P<0.05).The serum levels of IFN-γ and IL-17 in the mice also increased over time after modeling,with statistically significant differences among these groups(P<0.05).The relative mRNA expression of Tim-3 in the spleen and ocular tissues of the mice decreased over time after modeling,with statistically significant differences among these groups(P<0.05).The protein expression of Tim-3 in the ocular and spleen tissues showed the same pattern as its mRNA expression.Conclusion The expression of Tim-3 decreases with the exacerbation of inflammation in the progression of EAU,suggesting that Tim-3 may play a negative immunoregulatory role in the development of uveitis.
2.Analysis of sleep quality and influencing factors in migraine patients with patent foramen ovale
Yijun HU ; Diwen ZHANG ; Libo WANG ; Bo LIU ; Hongmei YE ; Xiongfei ZHAO
Sichuan Mental Health 2025;38(3):241-246
BackgroundMigraine is a common chronic neurological disease, and patent foramen ovale (PFO) has been closely associated with migraine. Current research primarily focuses on the pathological mechanism and the therapeutic effects of interventional closure, with limited attention paid to the impact of PFO on sleep quality in migraine patients. ObjectiveTo compare the difference in sleep quality between PFO-positive and PFO-negative migraine patients, and to analyzes influencing factors of sleep quality in PFO-positive migraine patients, so as to provide references for clinical interventions to improve sleep quality in PFO-positive migraine patients. MethodsA total of 673 migraine patients who met the diagnostic criteria of migraine in the International Classification of Headache Disorders, third edition (ICHD-3), and all patients underwent contrast-enhanced transcranial Doppler (c-TCD) and transthoracic echocardiographic right heart contrast echocardiography (cTTE) in the Third Hospital of Mianyang from January 2020 to October 2024. Basic demographic data were collected using a self-designed questionnaire, headache severity was assessed with the Visual Analogue Scale (VAS), and sleep quality was invaluated using the Pittsburgh Sleep Quality Index (PSQI). PFO patients was diagnosed through c-TCD combined with c-TTE. Binary logistic regression analysis was employed to examine the influencing factors of sleep quality in PFO-positive migraine patients. ResultsA total of 673 (100.00%) migraine patients were enrolled, including 223 PFO-positive cases (33.14%) and 450 PFO-negative cases(66.86%). The PFO-positive group showed significantly more severe headache severity (χ2=15.799, P<0.01) and poorer sleep quality (χ2=14.377, P<0.01) compared with PFO-negative group. PFO-positive patients demonstrated significantly higher barrier factor scores of sleep quality, sleep latency, sleep efficiency, sleep disturbance, hypnotic medication use, and daytime dysfunction compared with PFO-negative counterparts (t=3.634, 3.269, 2.785, 3.428, 2.907, 3.637, Bonferroni adjust P<0.05/7=0.007).By contrast, no significant difference was noted in sleep duration scores between the two groups(t=2.349, Bonferroni adjust P>0.05/7=0.007).The Binary Logistic regression analysis revealed that age (OR=1.021, 95% CI: 1.001~1.041), headache severity (OR=6.030, 95% CI: 4.085~8.901), and PFO grade (OR=1.893,95% CI: 1.288~2.784)were significant influencing factors for sleep quality in migraine patients with PFO. ConclusionMigraine patients with PFO-positive exhibited poorer sleep quality compared wtih PFO-negative patients. Older age, higher headache servity, and more severe PFO grade are identified as risk factors for impaired sleep quality in PFO-positive migraine patients.
3.Expression and role of Tim-3 in the pathogenesis of experimental autoimmune uveitis
Xiongfei WU ; Qiujin ZHANG ; Liu ZHENG ; Binbin YANG ; Jinqing LI ; Zhixiang DING
Recent Advances in Ophthalmology 2025;45(1):10-14
Objective To investigate the expression and role of T cell immunoglobulin and mucin domain-containing protein 3(Tim-3)in the pathogenesis of experimental autoimmune uveitis(EAU).Methods A total of 12 male C57BL/6J mice,aged 4 to 5 weeks,were selected and divided into the control group(n=3)and the experimental group(n=9)using a random number table.The control group(modeling time point:0 days after modeling)received no treatment,while the experimental group was induced to establish an EAU model(divided into three subgroups according to the modeling time points:7 days,14 days,and 21 days after modeling,with 3 mice in each subgroup).Firstly,the interphotoreceptor retinoid-binding protein 651-670 and complete Freund's adjuvant were fully mixed and emulsified.Then,the emulsion was subcutaneously injected into the two thighs,tail base,and neck of mice in the experimental group(each mouse received 200 μL of immune emulsion containing 500 pg of interphotoreceptor retinoid-binding protein 651-670).Subsequently,each mouse in the experimental group was also intraperitoneally injected with 1 μg of pertussis toxin.The anterior segment and fundus of mice in each group were observed and photographed under a slit-lamp microscope.The clinical and histopatho-logical scoring of these mice was conducted according to the Caspi grading scale based on the severity of inflammation.The serum levels of IFN-γ and IL-17 were measured using the enzyme-linked immunosorbent assay(ELISA),while the mRNA expression of Tim-3 in the spleen and ocular tissues was detected using the real-time quantitative polymerase chain reaction(RT-qPCR).Western blot was employed to detect the protein expression of Tim-3,and immunohistochemistry was used to examine the protein expression of Tim-3 in the spleen tissue.Statistical analysis was performed using GraphPad Prism 9.0.Results The clinical scores of the anterior segment,fundus,and histopathology of the mice increased over time after modeling,with statistically significant differences among these groups(P<0.05).The serum levels of IFN-γ and IL-17 in the mice also increased over time after modeling,with statistically significant differences among these groups(P<0.05).The relative mRNA expression of Tim-3 in the spleen and ocular tissues of the mice decreased over time after modeling,with statistically significant differences among these groups(P<0.05).The protein expression of Tim-3 in the ocular and spleen tissues showed the same pattern as its mRNA expression.Conclusion The expression of Tim-3 decreases with the exacerbation of inflammation in the progression of EAU,suggesting that Tim-3 may play a negative immunoregulatory role in the development of uveitis.
4.Adjuvant therapy by hyperbaric oxygen for high-energy lower limb fractures: a randomized controlled trial
Xiongfei WANG ; Yajuan LI ; Wenshuo DONG ; Liang LIU ; Yakui ZHANG ; Anhua LONG
Chinese Journal of Orthopaedic Trauma 2025;27(3):222-227
Objective:To explore the effects of adjuvant therapy by hyperbaric oxygen for high-energy lower limb fractures.Methods:This prospective case-control study enrolled the patients with high-energy lower extremity fracture who had been admitted to Department of Orthopaedics, Beijing Luhe Hospital, Capital Medical University from January 2021 to December 2022. Their fracture types included tibial plateau ones, pilon ones, ankle ones complicated with dislocation, and calcaneal ones. The patients were randomly divided into a control group receiving routine orthopedic treatment and a trial group receiving adjuvant therapy by hyperbaric oxygen in addition to routine orthopedic treatment using a random number table. The first adjuvant therapy by hyperbaric oxygen was conducted in the trial group within 48 h after injury before the timing for surgery was decided according to the soft tissue swelling at the affected limb. Follow-up was conducted until one year after surgery. The early and late wound complications, time from injury to surgery, and hospital stay were compared between the 2 groups.Results:A total of 160 patients with high-energy lower extremity fracture were enrolled in this study. Eventually, 7 patients were excluded, 72 patients [48 males and 24 females, with an age of (46.3±12.5) years] included in the trial group and 81 patients [61 males and 20 females, with an age of (47.8±13.4) years] in the control group. There was no significant difference in the preoperative general data between the 2 groups, indicating comparability ( P>0.05). The incidence of early wound complications in the trial group was 5.6% (4/72), significantly lower than that in the control group [18.5% (15/81)] ( P<0.05). The incidences of late wound complications in the trial and control groups were 12.5% (9/72) and 9.9% (8/81) respectively, showing no statistically significant difference ( P>0.05). The time from admission to surgery was respectively 4 (2, 8) days and 4 (2, 6) days, and the hospital stay respectively 10 (7, 14) days and 9 (6, 12) days for the trial and control groups, showing no statistically significant differences between the 2 groups ( P>0.05). Conclusion:In the treatment of high-energy lower extremity fractures, adjuvant therapy by hyperbaric oxygen can reduce the incidence of early wound complications without increasing the hospital stay, but it does not reduce the incidence of late wound complications or shorten the preoperative waiting time.
5.A case-control study of minimally invasive internal fixation for pelvic fractures assisted by an orthopedic surgical robot
Anhua LONG ; Jiafan ZHANG ; Qi YANG ; Xiongfei WANG ; Yakui ZHANG ; Xuefei WANG ; Liang LIU
Journal of Capital Medical University 2025;46(5):791-798
Objective To explore the technical advantages and applicable scenarios of surgical robot-assisted versus conventional freehand minimally invasive surgery for pelvic fractures by comparing clinical indicators,thereby providing evidence for clinical decision-making.Methods A retrospective case-control study was conducted on 59 patients with pelvic fractures treated with minimally invasive internal fixation between January 2022 and December 2024.Patients were divided into a conventional group(26 cases)and a robot-assisted navigation group(33 cases)based on the surgical technique.Pre-and postoperative pelvic computed tomography(CT)scans were performed,and anteroposterior,outlet,and inlet view radiographs were obtained.The maximum residual displacement after pelvic reduction and screw placement accuracy were measured based on radiographic and CT imaging.Intraoperative fluoroscopy frequency,radiation dose,operative time,blood loss,number of implanted screws,maximum residual displacement after reduction,and screw accuracy were recorded.Results No significant differences were observed between the two groups in age,gender,injury mechanism,or fracture classification,indicating comparability.Blood loss and fracture reduction quality showed no significant differences.The operative time was 52.5(30.8,62.3)min in the conventional group and 60(50,82.5)min in the robot-assisted group.Intraoperative fluoroscopy frequency and radiation dose were(19.1±5.4)times and 33.1(27.5,43.9)mGy in the conventional group,compared to(12.1±4.9)times and 123.1(101.1,131.4)mGy in the robot-assisted group.The robot-assisted group demonstrated superior screw placement accuracy,increased utilization of anterior column screws,and shorter postoperative ambulation time.Conclusion Robot-assisted minimally invasive surgery for pelvic fractures significantly outperforms conventional freehand techniques in improving screw placement accuracy and reducing radiation exposure for surgeons.It represents a preferable option for treating unstable pelvic fractures.
6.A case-control study of minimally invasive internal fixation for pelvic fractures assisted by an orthopedic surgical robot
Anhua LONG ; Jiafan ZHANG ; Qi YANG ; Xiongfei WANG ; Yakui ZHANG ; Xuefei WANG ; Liang LIU
Journal of Capital Medical University 2025;46(5):791-798
Objective To explore the technical advantages and applicable scenarios of surgical robot-assisted versus conventional freehand minimally invasive surgery for pelvic fractures by comparing clinical indicators,thereby providing evidence for clinical decision-making.Methods A retrospective case-control study was conducted on 59 patients with pelvic fractures treated with minimally invasive internal fixation between January 2022 and December 2024.Patients were divided into a conventional group(26 cases)and a robot-assisted navigation group(33 cases)based on the surgical technique.Pre-and postoperative pelvic computed tomography(CT)scans were performed,and anteroposterior,outlet,and inlet view radiographs were obtained.The maximum residual displacement after pelvic reduction and screw placement accuracy were measured based on radiographic and CT imaging.Intraoperative fluoroscopy frequency,radiation dose,operative time,blood loss,number of implanted screws,maximum residual displacement after reduction,and screw accuracy were recorded.Results No significant differences were observed between the two groups in age,gender,injury mechanism,or fracture classification,indicating comparability.Blood loss and fracture reduction quality showed no significant differences.The operative time was 52.5(30.8,62.3)min in the conventional group and 60(50,82.5)min in the robot-assisted group.Intraoperative fluoroscopy frequency and radiation dose were(19.1±5.4)times and 33.1(27.5,43.9)mGy in the conventional group,compared to(12.1±4.9)times and 123.1(101.1,131.4)mGy in the robot-assisted group.The robot-assisted group demonstrated superior screw placement accuracy,increased utilization of anterior column screws,and shorter postoperative ambulation time.Conclusion Robot-assisted minimally invasive surgery for pelvic fractures significantly outperforms conventional freehand techniques in improving screw placement accuracy and reducing radiation exposure for surgeons.It represents a preferable option for treating unstable pelvic fractures.
7.Adjuvant therapy by hyperbaric oxygen for high-energy lower limb fractures: a randomized controlled trial
Xiongfei WANG ; Yajuan LI ; Wenshuo DONG ; Liang LIU ; Yakui ZHANG ; Anhua LONG
Chinese Journal of Orthopaedic Trauma 2025;27(3):222-227
Objective:To explore the effects of adjuvant therapy by hyperbaric oxygen for high-energy lower limb fractures.Methods:This prospective case-control study enrolled the patients with high-energy lower extremity fracture who had been admitted to Department of Orthopaedics, Beijing Luhe Hospital, Capital Medical University from January 2021 to December 2022. Their fracture types included tibial plateau ones, pilon ones, ankle ones complicated with dislocation, and calcaneal ones. The patients were randomly divided into a control group receiving routine orthopedic treatment and a trial group receiving adjuvant therapy by hyperbaric oxygen in addition to routine orthopedic treatment using a random number table. The first adjuvant therapy by hyperbaric oxygen was conducted in the trial group within 48 h after injury before the timing for surgery was decided according to the soft tissue swelling at the affected limb. Follow-up was conducted until one year after surgery. The early and late wound complications, time from injury to surgery, and hospital stay were compared between the 2 groups.Results:A total of 160 patients with high-energy lower extremity fracture were enrolled in this study. Eventually, 7 patients were excluded, 72 patients [48 males and 24 females, with an age of (46.3±12.5) years] included in the trial group and 81 patients [61 males and 20 females, with an age of (47.8±13.4) years] in the control group. There was no significant difference in the preoperative general data between the 2 groups, indicating comparability ( P>0.05). The incidence of early wound complications in the trial group was 5.6% (4/72), significantly lower than that in the control group [18.5% (15/81)] ( P<0.05). The incidences of late wound complications in the trial and control groups were 12.5% (9/72) and 9.9% (8/81) respectively, showing no statistically significant difference ( P>0.05). The time from admission to surgery was respectively 4 (2, 8) days and 4 (2, 6) days, and the hospital stay respectively 10 (7, 14) days and 9 (6, 12) days for the trial and control groups, showing no statistically significant differences between the 2 groups ( P>0.05). Conclusion:In the treatment of high-energy lower extremity fractures, adjuvant therapy by hyperbaric oxygen can reduce the incidence of early wound complications without increasing the hospital stay, but it does not reduce the incidence of late wound complications or shorten the preoperative waiting time.
8.Parallel stenting technique for occlusive disease of the aortoiliac artery:analysis of its medium-to-long-term efficacy
Tongjie XU ; Junlong ZHU ; Hao YU ; Weiming WANG ; Lei ZHANG ; Xiongfei XU ; Yong LIU ; Huqiang HE
Journal of Interventional Radiology 2024;33(12):1339-1344
Objective To evaluate the medium-to-long-term efficacy of parallel stenting technology in treating aortoiliac occlusive disease(AIOD).Methods The clinical data of 18 patients with symptomatic AIOD,who received parallel stenting(using metal bare stent or covered stent)to reconstruct the aortoiliac artery at the Affiliated Hospital of Southwest Medical University of China from March 2017 to May 2019,were retrospectively analyzed.The patients included 14 males and 4 females with a mean age of(64.78±9.04)years.The surgical details,clinical success,complications,and stent patency rate were recorded.Results Both technical success and clinical success were achieved in all patients.A total of 62 stents were implanted,including 52 bare metal stents,9 covered stents and one renal artery balloon dilatation stent.After stent implantation,one patient each developed lacunar cerebral infarction,brachial artery pseudoaneurysm,decreased hemoglobin level,and thrombus migration into the renal artery,and after active management the patients were well discharged.The incidence of complications was 22%(4/18).During the follow-up period,3 patients developed in-stent restenosis,and the vascular lumen returned to patency after a second time of endovascular intervention.The postoperative 12-,18-,24-,30-,and 36-month main patency rates were 100%,95%,90%,85%,and 85%,respectively.Conclusion For the treatment of AIOD,parallel stenting technology has obtained satisfactory 3-year results.For the patients with complicated AIOD,this technique also carries a high technical success rate and an acceptable medium-to-long-term patency rate.
9.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.
10.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.

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