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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

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Chronic Diseases and Translational Medicine 2022年第1期8卷 59-70页

作者： 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 Department of Nephrology Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai 200025China Department of Nephrology Jiangsu Provincial HospitalNanjingJiangsu 210036China Department of Nephrology Shanghai Fifth People's HospitalFudan UniversityShanghai 200240China Department of Nephrology Zhongda Hospital Southeast UniversityNanjingJiangsu 210009China Department of Nephrology Guangzhou First People's HospitalGuangzhouGuangdong 510180China Department of Nephrology The Second Hospital of Dalian Medical UniversityDalianLiaoning 116027China Department of Nephrology Renji Hospital Shanghai Jiaotong University School of MedicineShanghai 200001China Department of Nephrology Peking University People's HospitalBeijing 100044China Department of Nephrology Beijing Friendship HospitalCapital Medical UniversityBeijing 100050China Department of Nephrology Xinqiao Hospital of Army Medical UniversityChongqing 400037China Department of Nephrology The Second Affiliated Hospital of Chongqing Medical UniversityChongqing 400010China Department of Nephrology Southwest Hospital of Army Medical UniversityChongqing 400039China Department of Nephrology China-Japan Friendship HospitalBeijing 100029China Department of Nephrology Peking University First HospitalBeijing 100034China Department of Nephrology Guangdong Provincial People's HospitalGuangzhouGuangdong 510080China Department of Nephrology The First Affiliated HospitalZhejiang University School of MedicineHangzhouZhejiang 310003China Department of Nephrology First Affiliated Hospital of Xi'an Jiaotong UniversityXi'anShaanxi 710061China Department of Nephrology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Nephrology Shandong Provincial HospitalJinanShandong 250021China Department of Nephrology Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200092China Department of Nephrology Nanfang Hospital Southern Medical UniversityGuangzhouGuangdong 5105

Background:Erythropoietin is a glycoprotein that mainly regulates *** patients with chronic renal failure with anemia,darbepoetin alfa can stimulate erythropoiesis,correct anemia,and maintain hemoglobin *** 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 ***:Ninety-five patients were enrolled in this study from April 15,2013 to April 10,2014 at 25 *** 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 *** events(AEs)were observed and compared,and the efficacy and safety were analyzed between the two treatment ***,the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment ***?software version 9.2 was used to perform all statistical *** statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy ***: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(C

关键词： anemia chronic renal failure darbepoetin alfa hemodialysis recombinant human erythropoietin

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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

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Chronic Diseases and Translational Medicine 2022年第2期8卷 134-144页

作者： 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 Department of Nephrology Zhongda Hospital Southeast UniversityNanjingJiangsu 210009China Department of Nephrology Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai 200025China Department of Nephrology Xinqiao Hospital of Army Medical UniversityChongqing 400037China Department of Nephrology First Affiliated Hospital of Xi'an liaotong UniversityXi'anShaanxi 710061China Department of Nephrology Southwest Hospital of Army Medical UniversityChongqing 400039China Department of Nephrology Jiangsu Provincial HospitalNanjingJiangsu 210036China Department of Nephrology Xinhua Hospital Affiliated to Shanghai丨iao Tong University School of MedicineShanghai 200092China Department of Nephrology Guangzhou First People's HospitalCiuaiigzhouGuangdong 510180China Department of Nephrology Peking University People's HospitalBeijing 100044China Department of Nephrology Shandong Provincial HospitallinanShandong 250021China Department of Nephrology Shanghai Fifth People's HospitalFudan UniversityShanghai 200240China Department of Nephrology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Nephrology Henji Hospital Shanghai Jiaotong University School of MedicineShanghai 200001China Department of Nephrology Nanfang Hospital Southern Medical UniversityGuangzhouGuangdong 510510China Department of Nephrology The Second Hospital of Dalian Medical UniversityDalianLiaoning 116023China Department of Nephrology Huashan HospitalFudan UniversityShanghai 200040China Department of Nephrology Peking University First HospitalBeijing 100034China Department of Nephrology Guangdong Provincial People's HospitalGuangzhouGuangdong 510080China Department of Nephrology The First Affiliated HospitalZhejiang University School of MedicineHangzhouZhejiang 310003China Department of Nephrology China-Japan Friendship HospitalBeijing 100029China Department of Nephrology Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhanHubei

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 ***: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 *** this study,the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two *** members of the control drug epoetin alfa group underwent intravenous administration two or three times per *** subjects underwent epoetin alfa administration during the 8-week baseline *** that,subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa *** 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 *** 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 *** 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 *** events(AEs)were also observed and compared,and the safety was analyzed between the two treatment *** conversion rate switching from epoetin alfa to darbepoetin alfa was also ***?software version 9.2 was used to perform all statistical *** statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy ***:Four hundred and sixty-six patients were enrolled in this study,and ultimately

关键词： anemia conversion ratio darbepoetin alfa epoetin alfa hemodialysis

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Long-term dexamethasone treatment diminishes store-operated Ca^(2+) entry in salivary acinar cells

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International Journal of Oral Science 2019年第1期11卷 25-32页

作者： yuichiro Kusuda Yusuke kondo Yuta Miyagi Takashi Munemasa Yusuke Hori Fumiko Aonuma Shintaro Tsuka Taro Mukaibo Chihiro Masaki Ryuji Hosokawa Division of Oral Reconstruction and Rehabilitation Kyushu Dental University

Corticosteroids are used in the treatment of many diseases; however, they also induce various side effects. Dexamethasone is one of the most potent corticosteroids, and it has been reported to induce the side effect of impaired salivary gland function. This study aimed to evaluate the effects of dexamethasone on mouse submandibular gland function to gain insight into the mechanism of dexamethasone-induced salivary hypofunction. The muscarinic agonist carbachol(CCh) induced salivary secretion and was not affected by short-term dexamethasone treatment but was decreased following long-term dexamethasone administration. The expression levels of the membrane proteins Na^+-K^+-2 Cl-cotransporter, transmembrane member 16 A, and aquaporin 5 were comparable between the control and long-term dexamethasone treatment groups. The CCh-induced increase in calcium concentration was significantly lower in the presence of extracellular Ca^(2+) in the long-term dexamethasone treatment group compared to that in the control group. Furthermore, CCh-induced salivation in the absence of extracellular Ca^(2+) and Ca^(2+) ionophore A23187-induced salivation was comparable between the control and long-term dexamethasone treatment ***, salivation induced by the Ca^(2+) -ATPase inhibitor thapsigargin was diminished in the long-term dexamethasone treatment group. In summary, these results demonstrate that short-term dexamethasone treatment did not impair salivary gland function, whereas long-term dexamethasone treatment diminished store-operated Ca^(2+) entry, resulting in hyposalivation in mouse submandibular glands.

关键词： Corticosteroids carbachol(CCh)induced

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Use of transabdominal (external) ultrasound during balloon dilatation to diagnose tracheobronchial remnant in congenital esophageal stenosis

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World Journal of Pediatric Surgery 2018年第1期1卷 9-11页

作者： Kengo Hattori Shigeru Takamizawa yuichiro Miyake Tomoko Hatata Katsumi Yoshizawa Tomoko Furukawa Yoshiaki kondo Department of Surgery Nagano Children's HospitalNaganoJapan Department of Radiology Nagano Children's HospitalNaganoJapan

Preoperativedifferential diagnosis between tracheobronchial remnant(TBR)and other typesof congenital esophageal stenosis(CES)is challenging,even when usingendoscopic ultrasonography(EUS).This report is the first to demonstrate theuse of transabdominal(external)ultrasound during balloon dilatation todiagnose TBR in *** simple technique is a promising diagnostic tool forTBR as an alternative to EUS.

关键词： balloon esophageal congenital

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Electrical Stimulation in Addition to Passive Exercise Has a Small Effect on Spasticity and Range of Motion in Bedridden Elderly Patients: A Pilot Randomized Crossover Study

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Health 2019年第8期11卷 1072-1086页

作者： Hideki Kataoka Shunpei Nakashima Hideki Aoki Kyo Goto Junichiro Yamashita yuichiro Honda Yasutaka kondo Tatsuya Hirase Junya Sakamoto Minoru Okita Department of Rehabilitation Nagasaki Memorial Hospital Nagasaki Japan Department of Physical Therapy Science Nagasaki University Graduate School of Biomedical Sciences Nagasaki Japan Department of Rehabilitation Nagasaki University Hospital Nagasaki Japan Department of Rehabilitation Nagasaki Genbaku Hospital Nagasaki Japan Institute of Biomedical Sciences Nagasaki University Nagasaki Japan

Purpose: Belt electrode skeletal muscle electrical stimulation (B-SES) can stimulate large portions of muscles including deep sites without localisation of the stimulation area. The purpose of this study is to investigate both immediate treatment effects of B-SES and long-term treatment effects of B-SES with passive exercise on range of motion (ROM) and muscle tone of lower extremities in bedridden elderly patients. Methods: Outcome measures before and after B-SES treatment alone (4 Hz, 20 min, both lower extremities) were examined for the immediate effect. Outcome measures were: ROM and Modified Ashworth scale (MAS) of hip flexion and adduction;knee flexion and extension;and knee joint distance at position of flexion abduction in hip (distance of knee). A randomized crossover trial was conducted to examine the long-term effect of adding B-SES to passive exercise on ROM and MAS. Results and Discussion: The immediate effect study had 18 patients. ROM and MAS of 4 joint angles in 2 joints and distance of knee significantly improved after B-SES treatment. The long-term effect study had 11 patients. Friedman test revealed ROM and MAS of 4 joint angles in 2 joints and distance of knee significantly improved during B-SES intervention but not control intervention. B-SES in addition to passive stretch has a more statistically significant effect on contracture and spasticity in large portions of the lower extremities of bedridden elderly patients than passive stretching alone. Conclusions: We consider B-SES a useful tool to improve the ROM in lower extremities of bedridden patients.

关键词： Bedridden Patients Belt Electrode Skeletal Muscle Electrical Stimulation Lower Extremity Muscle Tone Restriction of Range of Joint Motion

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