1.Effects of community building environment and sports with fitness APP usage on physical exercise habits in teachers in the Yangtze River Delta Region
WU Jin, LUO Yan, ZHANG Jiuyang, LIU Kuo, YANG Yuhang, LI Liqiang, LI Weimin
Chinese Journal of School Health 2024;45(3):341-345
Objective:
To explore the effects of community building environment and sports with fitness APP usage and their interactions on teachers exercise habits in the Yangtze River Delta Region, so as to provide a scientific basis for the development of a sports and health promotion intervention program for teachers.
Methods:
A total of 2 530 in service teachers from four provinces and cities in the Yangtze River Delta region, namely, Shanghai, Zhejiang, Jiangsu and Anhui Province, were sampled in May-June 2023 by using convenient cluster random sampling method. Self designed questionnaire was used to collect the basic information of the surveyed teachers, Physical Activity Building Environment Evaluation Questionnaire and the Sports with Fitness APP Usage Questionnaire were used to measure the teachers subjective perception of the community building environment and the usage of sports with fitness APP, respectively. Physical Exercise Habituation Scale was used to assess the level of exercise habits. Logistic regression models were applied to analyze the effects of community building environment and sports with fitness APP usage on physical exercise, and the interaction effects were analyzed by using additive and multiplicative models.
Results:
Among all the teachers surveyed, 658 of them reported good physical exercise habits (26.0%), and differences in the rate of physical activity habit formation by gender, age, years of teaching, as well as subject of teaching were statistically significant ( χ 2=42.94, 39.73, 35.47, 218.23 , P <0.05). Teachers with physical exercise habits had significantly higher community building environment scores and sports and fitness APP use than teachers without exercise habits ( t =12.17,16.54, P <0.05). Adjusting for the confounders of age, gender, years of teaching experience, and subjects taught, multifactorial unconditional Logistic regression analysis showed that the probability of teachers having good physical exercise habits increased by 22% for every 1-point increase in the community building environment score on average ( OR =1.22, 95% CI =1.11-1.40), and the probability of teachers having good physical exercise habits increased by 16% for every 1-point increase in the sports with fitness APP score on average ( OR = 1.16 , 95% CI =1.03-1.31) ( P <0.05). Interaction analyses showed that there was an additive interaction between the effects of community building environment and sports and fitness APP use on teachers physical exercise habits after adjustment, and the 95% CI for RERI , API and SI were 1.17 -1.65, 0.12-0.46 and 1.78-3.33 ( P <0.05), respectively, and there was no multiplicative interaction ( P >0.05).
Conclusions
The community building environment and the usage of sports & fitness APP show impacts in the formation of teachers physical exercise habits in the Yangtze River Delta region, and there is an interaction effect. Enhancing the construction of smart sports centers around the community can provide a high quality external environment for the physical exercise habits formation.
2.Application of ME-FICE combined with small ultrasound probe in the diagnosis of early gastric cancer and precancerous lesions
Wei HU ; Jiuyang LIU ; Xi CHEN ; Qin DENG ; Guozhen LI
China Medical Equipment 2024;21(8):65-69
Objective:To explore the application value of magnifying endoscope and flexible spectral imaging colour enhancement(ME-FICE)combined with small ultrasound probe in the diagnosis of early gastric cancer and precancerous lesions.Methods:A total of 80 patients with suspected gastric cancer who admitted to Wuhan Red Cross Hospital from April 2021 to April 2022 were selected,and the ME-FICE was used to distinguish positive and/or negative lesions,and then,small ultrasound probe with high-frequency were used to explore the depth of the infiltration of the lesions.After the examination,biopsy should be performed on the obvious position of lesion under FICE mode.The endoscopic mucosal resection(EMR),endoscopic submucosal dissection(ESD)or surgical resection were performed on the lesions according to the different intentions of the positive patients.The result of postoperatively pathological examination was the"gold standard"for diagnosis.Kappa consistency test was used to evaluate the consistency of benign and malignant diagnosis,the assessment of infiltration depth under endoscope and the assessment of infiltration depth after surgery between ME-FICE combined with small ultrasound probe and pathological examination.Results:The sensitivity,specificity and accuracy of ME-FICE combined with small ultrasound probe were respectively 90.63%,79.17%and 83.75%for benign and malignant diagnosis,which were at higher levels.The Kappa value of that was 0.887,which had favorable consistency with the result of biopsy for cases.The sensitivity,specificity and accuracy of ME-FICE combined with small ultrasound probe were respectively 66.67%,90.00%and 81.25%for the assessment of infiltration degree,indicating poor sensitivity and higher level of other indicators,with a Kappa value of 0.803,which had favorable consistency with postoperatively pathological results.Conclusion:ME-FICE combined with small ultrasound probe is suitable for the diagnosis of early gastric cancer and precancerous lesions,which can improve the sensitivity and accuracy of disease diagnosis,and more accurately assess the degree of infiltration before surgery,and provide guidance for subsequently surgical selection and treatment.
3.Age-Related Changes of Biomechanical Properties for Limb Bones in Male Rats
Lin YANG ; Man LI ; Jiang HUANG ; Jie WANG ; Bing XIA ; Jiuyang DING ; Cuiyun LE ; Mingjie LI ; Zhengdong LI ; Jiawen WANG
Journal of Medical Biomechanics 2023;38(1):E170-E175
Objective To investigate the age-related changes of biomechanical properties for humerus, femur and tibia in male rats and their application values in age estimation. Methods According to different weeks of age, 90 healthy male SD rats were divided into 2, 4, 6, 8, 17, 26, 52, 78 and 104-week groups with 10 rats in eachgroup. After the rats were executed by excessive anesthesia, humerus, femur, and tibia were separated and the attached soft tissues were removed. The length of the above-mentioned bones and the diameter of the middle section (compression site) were measured with vernier caliper, and the three-point bending test was conducted with electronic universal material testing machine to detect the ultimate load and displacement under ultimate load. Results There were significant differences in the ultimate load of humerus, femur and tibia among male rats in different age groups (P<0. 05). With the increase of week age, the ultimate loads of the humerus, femur and tibia increased first and then decreased, and reached the peak value in 52-week age group, showing a strong positive correlation with week age before 52 weeks ( r = 0. 884,0. 933,0. 929, P<0. 05). There was no significant difference in humerus and tibia. The displacement of femur under ultimate load was weakly positively correlated with week age (R= 0. 406,P<0. 05). The age prediction accuracy for automatic linear modeling of ultimate load for humerus, femur, tibia and three above-mentioned bones in rats before 52-week age was 78. 2% , 86. 8% , 84. 1% and 88. 3% , respectively. There was a strong positive correlation between the length of humerus, femur and tibia and the ultimate load (R= 0. 904, 0. 897, 0. 814, P<0. 05). The diameters of humerus, femur and tibia were strongly positively correlated with the ultimate load (R = 0. 759, 0. 814 and 0. 745, P<0. 05). Conclusions The ultimate loads of humerus, femur and tibia in male rats increased first and then decreased with age, and were positively correlated with age before 52 weeks, which could be used for age inference. The highest accuracy of age estimation was ultimate loads of three bones, followed by femur. The length/ middle diameter of humerus, femur and tibia were strongly positively correlated with the ultimate load.
4.Clinical and imaging features of the SMARCB1-de?cient sinonasal carcinoma
Zhongyu YAN ; Zongrui ZHANG ; Zheng LI ; Jian GUO ; Jiuyang WANG ; Junfang XIAN
Chinese Journal of Radiology 2023;57(5):498-503
Objective:To assess the clinical and imaging features of SMARCB1-deficient sinonasal carcinoma.Methods:Form January 2016 to November 2021, the clinical data and pretreatment imaging findings of 16 cases with pathologically proven SMARCB1-de?cient sinonasal carcinomas were analyzed retrospectively in Beijing Tongren Hospital, Capital Medical University. Immunohistochemistry for SMARCB1 showed loss of the protein in the tumor nuclie. Clinical and imaging features, including tumor location, TNM stage, size, density of CT, bone change, MRI signal intensity, enhancement pattern, type of time-intensity curve (TIC) of dynamic contrast enhanced MRI (DCE-MRI), apparent diffusion coefficient (ADC) value and diffusion weighted imaging (DWI) were evaluated. For 14 cases, correlation of the ADC value and Ki-67 index was subsequently evaluated with Pearson correlation analysis.Results:For the 16 cases SMARCB1-deficient sinonasal carcinomas, clinical stage of T4 was 12 cases and T3 was 4 cases. The location included ethmoid sinus ( n=4), nasal cavity only ( n=1), both nasal cavity and ethmoid ( n=8), ethmoid and maxillary sinus ( n=1), ethmoid and frontal sinus ( n=1), ethmoid and sphenoid sinus ( n=1). The tumor size was (4.5±1.2) cm. Iso-attenuated of CT images was showed in 13 cases and heterogeneous with necrosis was showed in 3 cases. Focal bone erosion was found in 13 cases and extensive bone destruction was found in 3 cases. Compared with adjacent muscles, T 1WI of all 16 cases showed isointense, with focal hypointense in 3 cases. On T 2WI, the tumor was graded as isointense in 9 cases, hyperintense in 7 cases, with lower inner septal in 6 cases. Enhancement was graded as mild in 11 cases, moderate in 5 cases.MRI Enhancement images showed mild enhancement in 11 cases, moderate enhancement in 5 cases, heterogeneous enhancement in 6 cases, and homogeneous enhancement in 10 cases. For DCE-MRI of 14 cases, there were 10 cases of Ⅲ type and 4 cases of Ⅱ type of the TIC. The ADC value of 14 cases was (1.02±0.27)×10 -3 mm 2/s. The Ki-67 index was 48%±21%. No correlation was observed between Ki-67 index and ADC value ( r=-0.38, P=0.183). Conclusions:SMARCB1-deficient carcinomas are mostly centered in the nasal and ethmoid region of anatomic distribution. Tendency to be infiltrative the adjacent bone structure with invasive bone reaction, mild to moderate heterogeneous enhancement, T 2WI with lower inner septal, and Ⅲ types of TIC are certain suggestive imaging features of the entity.
5.Genome-wide identification and effect of MdPEPC family genes during axillary bud outgrowth in apple (Malus domestica Borkh.).
Jiuyang LI ; Congjian SHI ; Yashuo SUN ; Caizhen GAO ; Yaohui ZHANG ; Ming TAN ; Bowen LIANG
Chinese Journal of Biotechnology 2022;38(10):3728-3739
The PEPC family proteins are ubiquitous in various plants and play an important role in the process of photosynthetic carbon assimilation and have many non-photosynthetic biological functions. However, PEPC genes have not been reported in apple. In this study, the members of apple MdPEPC family were identified based on the new apple genome data by bioinformatics analysis, and their expression patterns in different tissues and the apple axillary bud transcriptome treated by decapitation and TDZ (cytokinin) were analyzed in order to explore the role of MdPEPC genes in apple axillary bud outgrowth. The results showed that 6 MdPEPC family members were identified in apple, which distributed on 6 different chromosomes, and had similar physicochemical characteristics. Phylogenetic tree and sequence alignment analysis showed that the MdPEPC could be divided into two subgroups (Group Ⅰ and Group Ⅱ), in which four members in MdPEPC family were clustered into Group Ⅰ, belonging to plant-type PEPCs. However, MdPEPC4 and MdPEPC5 were clustered into Group Ⅱ with AtPPC4, belonging to bacterial-type PEPCs. There were 7 pairs of fragments repeats among MdPEPC members, but no tandem repeats existed. The promoter cis-acting element analysis showed that MdPEPC genes were not only affected by light and stress, but also regulated by multiple hormones. The expression profiles showed that all MdPEPCs except MdPEPC4 and MdPEPC5 were expressed in different apple tissues. Transcriptome data analysis showed that the expression levels of MdPEPC1 and MdPEPC3 were up-regulated after decapitation and TDZ treatment, whereas MdPEPC2 was significantly down-regulated at 48 h after treatments. In conclusion, MdPEPC1, MdPEPC2 and MdPEPC3 were selected as the candidate genes involved in axillary bud outgrowth regulation for further study.
Malus/metabolism*
;
Gene Expression Regulation, Plant
;
Phylogeny
;
Decapitation
;
Family
;
Plant Proteins/metabolism*
6.Imaging and clinical features of NUT gene-related carcinoma in the nasal cavity and sinus
Zhongyu YAN ; Zongrui ZHANG ; Zheng LI ; Jian GUO ; Xiao WANG ; Shijun WANG ; Jiuyang WANG ; Junfang XIAN
Chinese Journal of Radiology 2022;56(8):849-854
Objective:To assess the clinical and imaging features of NUT gene-related sinonasal carcinomas (NUT midline carcinome).Methods:The clinical data and pretreatment imaging findings of 5 cases with pathologically proven NUT sinonasal carcinomas were analyzed retrospectively in Beijing Tongren Hospital, Capital Medical University from January 2016 to December 2020. Of 5 cases, the tumors affected 4 females and 1 male with an age range of 15 to 48 years (median 19 years). Clinical data of all cases were available before surgery with both CT and MR examination. Tumor location, CT density, boney change, calcification, tumor size, T 1WI, T 2WI and diffusion weighted imaging (DWI) signal intensity, appearance diffusion coefficient (ADC), type of time intensity curve (TIC) of dynamic contrast-enhanced (DCE)-MRI were evaluated. Results:All five cases belonged to T4 stage of the clinic TNM system. The locations were nasal cavity ethmoid, sphenoid and maxillary sinus ( n=1), nasal and maxillary sinus ( n=1), nasal cavity and ethmoid sinus ( n=3). Iso-attenuated in 3 cases, heterogeneous with local necrosis in 2 cases, and heterogeneous with calcification in 3 cases on CT imaging. Bone erosion was found in 4 cases, and bone erosion with destruction in 1 case. The tumor sizes ranged from 4.2 to 4.9 cm (median 4.5 cm) on MR axial imaging. On T 1WI, 5 cases showed isointense compared with adjacent temporal muscles, with focal hypointense in 2 cases. On T 2WI, the tumor was graded as isointense in 3 cases, and hyperintense in 2 cases. Heterogeneous enhancement in all cases with mild in 3 cases, and moderate in 2 cases on postcontrast MR imaging. On DCE-MRI of 5 cases, there were 3 cases of type Ⅲ (washout-shaped curves), and 2 cases of type Ⅱ of the TIC (plateau-shaped curves). The range of ADC values was from 0.63×10 -3 to 1.17×10 -3 mm 2/s, and median ADC value was 0.84×10 -3 mm 2/s, of 5 cases with varying degrees of high signal on DWI. The Ki-67 index ranged from 30% to 80% of the tumor. An immunohistochemical study showed that the tumor cells of 5 cases were all positive for both NUT and INI-1 genes. One case was performed with biopsy and followed by chemotherapy, four cases were performed with surgery, combined with the following chemotherapy, and one also was implemented with radiation therapy. The follow-up time was 7-16 months. Five cases were all alive during the follow-up. Conclusions:The NUT midline sinonasal tract carcinoma is a rare, gene-related solid malignant tumor. The tumor is more commonly seen in young patients, mostly centered in the nasal and ethmoid region with invasive growth, more calcification on CT, and heterogeneous enhancement on MRI. These findings are some characteristics of the tumor.
7.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.
8.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.
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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