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.

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.

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.

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.

Objective: To investigate the feasibility and efficacy of percutaneous closure of paravalvuar leak (PVL) in patients after heart valve replacement surgery using Amplatzer vascular plug Ⅲ (AVP Ⅲ). Methods: In this retrospective study, consecutive PVL patients after heart valve replacement surgery receiving percutaneous closure with AVP Ⅲ in Beijing Anzhen hospital between March 2017 and October 2018 (n=21) were enrolled.The preoperative and intraoperative data and short-and mid-term outcome results were analyzed. Results: Theage of patients in this cohort was (54.9±11.7) years, and there were 12 (57.1%) male patients. There were 8 patients (38.1%) post mitral valve replacement, 4 patients (19.0%) post aortic valve replacement and 9 patients (42.9%) post double valves replacements.There were 14 cases (66.7%) of mitral valve PVL,6 cases (28.6%) of aortic valve PVL, and 1 case (4.8%) of double valves PVL.Successful device deployment was accomplished in 18 defects from 17 PVL patients. Technical successful rate of mitral valve PVL closure and aortic valve PVL closure was 12/15 and 6/7,respectively. One patient received surgical repair due to procedure-induced femoral pseudoaneurysm.There were 17 cases of severe PVL and 1 case of moderate PVL before procedure, and there were 2 cases of moderate PVL, 6 cases mild PVL, and PVL disappeared in 10 cases after procedure (P<0.01 vs. pre-procedure). The follow-up time was (8.3±4.7) months. There were 10 cases (58.8%) of New York Heart Association (NYHA) function grade Ⅲ and 7 cases (41.2%) of NYHA function grade Ⅳ before procedure, and there were 12 cases of NYHA function grade Ⅰ(70.6%) and 5 cases (29.4%) of NYHA function grade Ⅱ post procedure (P<0.01). Post procedure, there was no displacement of the occluder and heart valve movement was not affected,and there was no new hemolysis or hemolysis worsening. Conclusion Percutaneous closure of PVL in patients after heart valve replacement surgery with AVP Ⅲ is feasible, and associated with favorable short-and mid-term clinical outcomes.

Objective To investigate the predictive factors for central lymph node metastasis (CLNM) in papillary thyroid microcarcinoma(PTMC).Methods A retrospective study including 2511 cases of PTMC admitted from Jan.2013 to Jan.2016 were enrolled in our study.Chi-square test was used in univariate analysis.Logistic regression analysis was applied for multivariate analysis.The relation between age,sex,tumor size,multifocality,thyroidal extension,nodular goiter and central lymph node metastasis is analyzed.Results Univariate analysis showed that age,sex,tumor size,multifocality,thyroidal extension and nodular goiter had statistical significance.Age less than 45(P＜0.001,x2=17.442);Male gender(P＜0.001,x2=17.029);Tumor size less than 5 mm (P＜0.001,x2=70.164.);Extrathyroid extension factor (P＜0.001,x2=63.197);Nodular hyperplasia factor (P=0.017,x2=5.611).Multivariate analysis showed there was a significant relationship between multifocality and the central lymph node positivity.The odds ratio (OR) was 1.587 in patients with tumor foci ≥2(P＜0.001).While OR increased sharply near to 3 in patients withtumor foci ≥3(OR=2.730).Tumor size(OR=1.926);Extrathyroid extension(OR=1.606).Conclusions Multifocalty,tumor size and thyroidal extension are the main predicative factors for central lymph node metastasis in PTMC.Among them,tumor foci ≥ 3 is an important predictor.Besides the conventional factors such as tumor size,thyroidal extension etc,multifocalty should also be taken into consideration.

Objective: To investigate the feasibility and efficacy of transcatheter closure of anastomotic leakage after aortic surgery using Amplatzer Vascular Plug Ⅲ (AVP Ⅲ). Methods: A retrospective analysis was performed in 5 patients with anastomotic leakage after aortic surgery, who underwent transcatheter closure in our hospital from January to June 2017 using AVP Ⅲ. Surgeries were performed in 3 cases of Standford type A dissection, 1 case of ascending aortic aneurysm and 1 case of persistent truncus.There were 3 males,and age was (43.8±13.1) years old. Anastomotic leakages located at the ascending aorta in 4 patients, and the other one located between the aortic arch and the stent-graft.Three of them had aorta-right atrium fistula and patients suffered from progressive heart failure. False aneurysm between aorta and pulmonary artery was formed in 1 patient, and patent aortic false lumenwas found in the other patient. All the AVP Ⅲ were deployed based on a femoral arteriosus loop. Patients were followed up after transcatheter closure to observe the clinical results. Results: Six AVP Ⅲ were successfully implanted in the 5 patients. Trivial residual shunt was seen in 1 patient after closure. The patients were followed up 6 (1, 6) months. The cardiac function improved from NYHA class Ⅱ-Ⅳ to class Ⅰ-Ⅱ after the procedure in 3 congestive heart failure patients.The right atrium systolic pressure was significantly reduced after the procedure((8.7±1.8) mmHg (1 mmHg=0.133 kPa) vs. (24.3±2.3) mmHg, P=0.03). The diameter of the false aneurysm reduced in 1 patient after the procedure. Complete thrombosis formation of the thoracic false lumen was observed in 1 patient. Conclusion Transcatheter closure of anastomotic leakage after aortic surgery using AVP Ⅲ is feasible and effective according to our primary experience.

Objective: To investigate the effect of emergency thoracic endovascular aortic repair (TEVAR) in patients with acute traumatic thoracic aortic injury. Method: From January 2014 to December 2016, a total of 35 patients with acute traumatic thoracic aortic injuries were treated with emergency TEVAR in our hospital, their clinical data were analyzed retrospectively in this study. Results: The patients were 42 (34, 55) years old,and there were 31 males.All cases were diagnosed by emergency aorta computed tomography angiography (CTA),and 5 cases were diagnosed as aortic transaction, 13 cases were diagnosed as aortic pseudoaneurysm, 7 cases were diagnosed as aortic dissection, and 10 cases were diagnosed as aortic intramural hematoma combined hemothorax.The concomitant injuries included cerebral contusion (3 cases, 8.6%), pulmonary contusion with rib fracture (31 cases, 88.5%), long bone fracture (7 cases, 22.5%), contusion of viscera or internal organs (3 cases, 8.6%).Emergency TEVAR were performed with vascular suture system preset under local anesthesia after diagnosis,and combined injury was treated in related departments.CTA was repeated after 1, 3 and 6 months and yearly thereafter. One patient died before transferring to catheter room,and 34 (97.1%) patients underwent TEVAR procedure successfully.Time from door to operating room was (88.6±26.6) minutes,and the procedure time was (52.0±9.4) minutes. A total of 69 Perclose Proglide vascular suture system were used,and 2 cases underwent surgical suture because of hematoma and pseudoaneurysm formation in femoral arteries.The involved length of thoracic aorta was (44.5±7.4)mm. A total of 46 stent-grafts were implanted, the length of stent-graft was (164.3±15.2)mm,and the proximal oversize rate was (22.3±8.6)%. The follow-up time was 24 (12,24) months, and there were no procedure related complication such as endoleak and paraplegia. Complete aortic remodeling was observed in 14 cases. Fully thrombolization at stent segments were observed in 7 cases. Fully thrombalization of pseudoaneurysms were observed in 13 cases. One patient complained mild left upper limb weakness due to left subclavian artery occlusion. Conclusion Emergency TEVAR is safe and effective procedure for the treatment of patients with acute traumatic thoracic aortic injury.

Objective To evaluate the safety and efficiency of transcatheter anastomotic leakage closure after surgical procedures for non-infected ascending aortic pathology with different occlusion devices. Methods From Dec. 2013 to Sep. 2015, six cases received interventional therapy for anastomotic leakage after surgical procedures for non-infected ascending aortic pathology using occluders. Four cases were with proximal graft-vessel anastomotic leakage, including two pseudoaneurysms at the site of aortic roots and two ascending aorta to right atrium shunts. The other two cases were with artificial grafts to intraoperative stent anastomotic leakage leading to endoleak type Ib. The anastomotic leakage was totally occluded by single ADOⅡrespectively in four cases. Two detachable coils were implanted in one case with artificial graft to intraoperative stent anastomotic leakage, but mild residual shunt to false lumen was detected by DSA and follow-up CTA. The second interventional procedure was carried out one month later, and one ADO Ⅱ was used to close the residual leakage totally. One PDA occluder was implanted along arteriovenous guide-wire track via aortic root to right atrium fistula in one case. Results All the anastomotic leakages of the six cases were totally excluded by different occlude devices percutaneously. The technical success rate was 100%. Follow-up time was from 1 month to 4 years. The patients' clinical condition improved obviously. Follow-up CTA showed no recurrence of anastomotic leakage. Complete thrombosis and marked shrinkage of the pseudoaneurysm were achieved in two cases, and the partial thrombosis and shrinkage of the false lumen were achieved in 2 cases. Conclusion Trans-catheter closure is an alternative treatment for ascending aortic surgical anastomotic leakage, which may achieve satisfactory short-and mid-term results.