1.Comparison of the efficacy of unilateral nailing combined with bone cement reinforcement and bilateral nailing in the treatment of osteoporotic thoracolumbar fractures.
Yu-Liang LOU ; Guo-Ying CHEN ; Can-Feng WANG ; Hui FEI ; Guan-Rong SUN ; Ren-Fu QUAN ; Wei LI ; Feng HONG
China Journal of Orthopaedics and Traumatology 2025;38(2):134-149
OBJECTIVE:
To compare the efficacy of percutaneous pedicle screw combined with unilateral nail placement combined with bone cement strengthening and bilateral nail placement in the treatment of osteoporotic thoracic and lumbar fractures.
METHODS:
A retrospective case-control study was used to analyze the clinical data of 78 patients with osteoporotic thoracic and lumbar fractures admitted from October 2017 to May 2019. According to the surgical method, it was divided into percutaneous pedicle screw combined with unilateral nail placement combined with unilateral bone cement strengthening group(bone cement group) and percutaneous pedicle screw combined with bilateral nail placement(screw group). In the bone cement group, 40 patients included 16 males and 24 females, with a mean age of (62.1±8.1) years old. In the screw group, 38 patients included 18 males and 20 females with a mean age of (65.1±9.3) years old. The operation time, intraoperative blood loss, length of hospital stay and postoperative complications were compared between two groups. The kyphosis Cobb angle, anterior edge height ratio, central height ratio and pain visual analogue score(VAS) were compared.
RESULTS:
All patients were followed up for 25 to 36 months. The operation time (70.1±17.3) min of the cement group was shorter than that of the screw group (78.6±18.2) min(P<0.05). There were no significant differences in intraoperative blood loss and length of hospital stay(P>0.05). The VAS in the cement group 1 year 1.5±0.5 and the latest follow-up 0.5±0.3 after operation were lower than 1 year 1.8±0.3 and the latest follow-up 0.8±0.4 in the screw group(P<0.05). The kyphosis Cobb angle, anterior edge height ratio, central height ratio in bone cement group, 1 year (6.2±1.2)°, (86.6±3.5)%, (91.1±2.5)%, the last follow-up (6.4±0.7)°, (85.5±3.3)%, (90.5±6.3)% were better than that of the screw group 1 year (6.8±1.4)°, (83.1±2.4)%, (89.9±3.4)% and the latest follow-up (7.1±1.1)°, (82.6±4.1)%, (87.6±5.9)%(P<0.05). There were 3 cases of bone cement leakage in the cement group, all of which had no clinical symptoms;and 2 cases of pedicle screws were extracted in the screw group, and the screws were removed at the last follow-up.
CONCLUSION
Percutaneous pedicle screw combined with unilateral nail placement combined with bone cement strengthening and bilateral nail placement in the treatment of osteoporotic thoracic and lumbar compression fractures in the elderly can achieve satisfactory efficacy and effectively relieve the pain of patients, but the former internal fixation system is more stable, and the long-term follow-up can effectively maintain the height of the anterior middle column and the correction of kyphosis deformity, and the incidence of chronic low back pain is lower.
Humans
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Male
;
Female
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Aged
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Bone Cements
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Middle Aged
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Thoracic Vertebrae/surgery*
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Lumbar Vertebrae/surgery*
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Retrospective Studies
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Spinal Fractures/surgery*
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Osteoporotic Fractures/surgery*
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Case-Control Studies
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Bone Nails
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Pedicle Screws
2.Novel biallelic MCMDC2 variants were associated with meiotic arrest and nonobstructive azoospermia.
Hao-Wei BAI ; Na LI ; Yu-Xiang ZHANG ; Jia-Qiang LUO ; Ru-Hui TIAN ; Peng LI ; Yu-Hua HUANG ; Fu-Rong BAI ; Cun-Zhong DENG ; Fu-Jun ZHAO ; Ren MO ; Ning CHI ; Yu-Chuan ZHOU ; Zheng LI ; Chen-Cheng YAO ; Er-Lei ZHI
Asian Journal of Andrology 2025;27(2):268-275
Nonobstructive azoospermia (NOA), one of the most severe types of male infertility, etiology often remains unclear in most cases. Therefore, this study aimed to detect four biallelic detrimental variants (0.5%) in the minichromosome maintenance domain containing 2 ( MCMDC2 ) genes in 768 NOA patients by whole-exome sequencing (WES). Hematoxylin and eosin (H&E) demonstrated that MCMDC2 deleterious variants caused meiotic arrest in three patients (c.1360G>T, c.1956G>T, and c.685C>T) and hypospermatogenesis in one patient (c.94G>T), as further confirmed through immunofluorescence (IF) staining. The single-cell RNA sequencing data indicated that MCMDC2 was substantially expressed during spermatogenesis. The variants were confirmed as deleterious and responsible for patient infertility through bioinformatics and in vitro experimental analyses. The results revealed four MCMDC2 variants related to NOA, which contributes to the current perception of the function of MCMDC2 in male fertility and presents new perspectives on the genetic etiology of NOA.
Humans
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Male
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Azoospermia/genetics*
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Meiosis/genetics*
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Spermatogenesis/genetics*
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Adult
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Exome Sequencing
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Microtubule-Associated Proteins/genetics*
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Alleles
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Infertility, Male/genetics*
3.Research of multiparameter flow cytometry in detecting non-neoplastic abnormal cell phenotypes in human bone marrow
Man CHEN ; Rong WANG ; Jing ZHOU ; Minjing FU ; Wei ZHAO ; Gele TONG ; Aixian WANG ; Meiwei GONG ; Hui WANG
Chinese Journal of Laboratory Medicine 2024;47(7):740-746
Objective:To investigate the role of multiparameter flow cytometry (MFC) in detecting non-neoplastic abnormal phenotypes, including monoclonal gammopathy of undetermined significance (MGUS), monoclonal B-cell lymphocytosis (MBL), Fcγ receptor Ⅲb (FcγRⅢB), and CD36 deficiencies.Methods:A retrospective and observational study was conducted on a total of 24 864 patients who underwent one-step screening for leukemia/lymphoma at Hebei Yanda Ludaopei Hospital from January 3, 2020, to March 31, 2024. Clinical data and MFC results of the patients were collected. Patients were grouped by age, group of <45 years (11 495 cases), group of 45-<60 years (5 322 cases), group of ≥60 years (7 081 cases) and disease nature, benign group (8 336 cases), malignant group (15 562), and other diseases group (966 cases). The incidence of non-neoplastic abnormal phenotypes was analyzed across groups.Results:The incidence rates of MGUS, MBL, FcγRⅢB, and CD36 deficiencies were 0.072% (18/24 864), 0.511% (127/24 864), 0.221% (55/24 864), and 0.004% (1/24 864), respectively. MBL incidence was lower in the malignant group than in the benign group ( P<0.001), while MGUS incidence was higher in the malignant group than in the benign group ( P=0.034). The incidence rate of MBL among subtypes within the benign group varied significantly ( P<0.001 ), with the highest incidence in patients with pancytopenia at 2.72% (48/1 765). In the malignant group, the incidence of MBL differed significantly across various disease types ( P<0.001), among which MDS/MPN exhibited the highest incidence at 1.95% (3/154) and 1.30% (2/154). Conclusion:Utility of multiparameter flow cytometry method for one-step screening of leukemia and lymphoma shows variety in detecting non-neoplastic abnormal phenotypes, facilitating the identification of diseases.
4.Metagenomic next-generation sequencing for the diagnosis of Pneumocystis jirovecii pneumonia after allogeneic hematopoietic stem cell transplantation
Rong FU ; Ren LIN ; Zhiping FAN ; Fen HUANG ; Na XU ; Li XUAN ; Yifei HUANG ; Hui LIU ; Ke ZHAO ; Zhixiang WANG ; Ling JIANG ; Min DAI ; Jing SUN ; Qifa LIU
Chinese Journal of Hematology 2024;45(1):62-67
Objectives:To investigate the value of metagenomic next-generation sequencing (mNGS) in the diagnosis of Pneumocystis jirovecii pneumonia (PJP) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) .Methods:The data of 98 patients with suspected pulmonary infection after allo-HSCT who underwent pathogen detection from bronchoalveolar lavage fluid between June 2016 and August 2023 at Nanfang Hospital were analyzed. The diagnostic performance of mNGS, conventional methods, and real-time quantitative polymerase chain reaction (qPCR) for PJP were compared.Results:A total of 12 patients were diagnosed with PJP, including 11 with a proven diagnosis and 1 with a probable diagnosis. Among the patients with a proven diagnosis, 1 was positive by both conventional methods and qPCR, and 10 were positive by qPCR only. Pneumocystis jirovecii was detected by mNGS in all 12 patients. The diagnostic sensitivity of mNGS for PJP was 100%, which was greater than that of conventional methods (8.3%, P=0.001) and similar to that of qPCR (91.6%, P=1.000) . A total of 75% of the patients developed mixed pulmonary infections, and cytomegalovirus and Epstein-Barr virus were the most common pathogens. Mixed infection was detected in eight patients by mNGS and in five patients by qPCR, but not by conventional methods ( P=0.008) . Conclusions:mNGS had good sensitivity for diagnosing PJP after allo-HSCT and was advantageous for detecting mixed infectious pathogens; therefore, mNGS might be an effective supplement to regular detection methods and qPCR.
5.A single-center analysis of pathogenic bacteria distribution and drug resistance in bacterial bloodstream infections among patients with hematological diseases
Mengting CHE ; Chaomeng WANG ; Hui LIU ; Haifang KONG ; Lijuan LI ; Jia SONG ; Huaquan WANG ; Guojin WANG ; Yuhong WU ; Jing GUAN ; Limin XING ; Wen QU ; Hong LIU ; Xiaoming WANG ; Zhidong HU ; Zonghong SHAO ; Rong FU
Chinese Journal of Hematology 2024;45(10):937-943
Objective:To analyze the distribution and drug resistance of pathogens of bacterial bloodstream infection in patients with hematological diseases in the Department of Hematology of Tianjin Medical University General Hospital, and to provide etiological data for clinical empirical anti-infection treatment.Methods:A retrospective analysis was conducted on the general clinical information, pathogenic bacteria and drug susceptibility test results of patients with hematological diseases diagnosed with bacterial bloodstream infection by menstrual blood culture in our center from January 2016 to December 2022.Results:Patients included 498 inpatients, with a total of 639 bacterial strains. Among the patients, 86.9% patients had malignancies, and 76.7% had agranulocytosis. Symptoms of concurrent infections, including those of the respiratory tract, oral mucosa, skin and soft tissues, and abdominal sources were observed in 68.3% patients. Gram-negative bacteria (G -) accounted for 79.0% of the isolated bacteria, and gram-positive bacteria (G +) accounted for 21.0%. The top five isolated pathogens were Klebsiella pneumoniae (22.5%), Escherichia coli (20.8%), Pseudomonas aeruginosa (15.0%), Enterococcus faecium (5.5%), and Stenotrophomonas maltophilum (5.0%). Escherichia coli exhibited a decreasing trend of resistance to quinolones, cephalosporins, and carbapenems. Klebsiella pneumoniae exhibited increasing rates of resistance to quinolones and cephalosporins between 2016 and 2018, but the rated decreased after 2019. The resistance rate to carbapenems exhibited by Pseudomonas aeruginosa was approximately 20%. Carbapenem-resistant strains of Pseudomonas aeruginosa strains were first detected in 2017, with a peak resistance rate of 35.7%, detected in 2019. A 60.0% resistance rate to methicillin was observed in methicillin-resistant coagulase-negative staphylococci (MRCNS), and one case of linezolid-resistant MRCNS was detected. Conclusions:Pathogenic bacteria of bacterial bloodstream infections were widely distributed in our center, and precautions are warranted against carbapenem resistant P. aeruginosa and Klebsiella pneumoniae.
6.Post-operative healthcare-associated infection influencing factors and me-diating effect of diagnosis-intervention packet payment differentials in colorectal cancer patients
Yu RONG ; Qian-Qian HUANG ; Jia-Yi OU ; Shu-Liang YU ; Ye-Ying SONG ; Wei-Qun LU ; Li-Ming REN ; Yao FU ; Jian-Hui LU
Chinese Journal of Infection Control 2024;23(11):1421-1429
Objective To explore the potential influencing factors of post-operative healthcare-associated infection(HAI)in colorectal cancer patients,as well as the mediating effect relationship between the influencing factors and the diagnosis-intervention packet(DIP)payment differentials.Methods Medical data of patients who underwent colorectal cancer surgery in a tertiary first-class cancer hospital in Guangzhou were retrospectively analyzed.According to HAI status,patients were divided into infection group and non-infection group.Baseline demographic information and differences in DIP payment differentials between two groups of patients were compared by rank sum test or chi-square test.The influence of each potential factor on the occurrence of HAI was analyzed by logistic re-gression.Mediating analysis was preformed by bootstrap method,and mediating effect of HAI and total hospitaliza-tion days on DIP payment differentials was evaluated.Results A total of 350 patients were included in analysis,50 were in the infection group and 300 in the non-infection group.The incidence of HAI was 14.29%.Logistic regres-sion analysis result showed that risk of HAI in patients with central venous catheterization ≥10.00 days was 13.558 times higher than that<10.00 days(P<0.001);risk of HAI in patients with urinary catheterization ≥3.00 days was 2.388 times higher than that<3.00 days(P=0.022).There were all statistically significant differences in DIP payment differentials among patients with different ages,prognostic nutritional index(PNI),HAI status,total length of hospitalization stay,duration of surgery,central venous catheterization days,and catheterization days(all P<0.05).The mediating analysis results showed that the occurrence of HAI resulted a change in DIP payment di-fferentials by affecting the total number of hospitalization days.The mediating effect value of total hospitalization days was 0.038,accounting for 35.68%of the total effect.Conclusion Medical institutions should pay attention to HAI resulting from prolonged central venous and urinary catheterization in patients underwent surgery for colorectal cancer,reducing the total length of hospital stay,thus reducing the overruns associated with the increased DIP pay-ment differentials.
7.Carthamus tinctorius L.extract ameliorates alcoholic liver disease by modulating PI3K/Akt/FoxO signaling pathway
Wen-Xuan WANG ; Xiang-Lei FU ; Man QI ; Fu-Rong FAN ; Fu-Rong ZHU ; Yuan-Chuang WANG ; Kai-Yue ZHANG ; Min LIU ; Sheng-Hui CHU
Chinese Pharmacological Bulletin 2024;40(6):1137-1145
Aim To investigate the effects of Cartham-us tinctorius L.extract(CTLE)on oxidative stress,lipid metabolism,and apoptosis levels of mice with al-cohol-induced liver injury and its mechanism of action.Methods The mouse model of alcohol-associated liver disease was established by chronic alcohol feeding and acute alcohol gavage.Mice were randomly divided into four groups.During the modeling period,the state changes of mice were observed every day,and their weight was recorded.At the end of modeling,blood and liver tissues were collected from each group of mice.The blood of mice was analyzed biochemically,and HE staining and Oil Red O staining were used to evaluate further the degree of pathological damage in the liver of mice.Quantitative real-time PCR(qPCR)and Western blot were applied to detect the mRNA and protein expression levels of p-PI3K,PI3K,p-Akt,Akt,p-mTOR,mTOR,p-FoxO1,FoxO1,p-FoxO3a,FoxO3a,p-FoxO4,FoxO4,BCL and BAX factors.Results Compared to the model group,the CTLE administration group showed improved hepatic patho-logical injury and reduced lipid deposition.The bio-chemical indexes in serum and liver,such as ALT,AST,TG,TC,and MDA levels were reduced,while GSH and SOD levels increased.Regulating the PI3K/Akt/FoxO pathway resulted in increased production of SOD,which reduced damage and apoptosis caused by reactive oxygen species(ROS).Conclusions CTLE can exert anti-oxidative stress and anti-apoptotic effects through the PI3K/Akt/FoxO pathway and attenuates alcoholic liver injury in mice,providing new ideas for the treatment of alcoholic liver disease and the develop-ment of related drugs.
8.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
9.Construction and application of a graded exercise rehabilitation program for patients with acute exacerbation of chronic obstructive pulmonary disease
Nana YANG ; Hui ZENG ; Dandan FU ; Yan WANG ; Chuanli CHENG ; Rong LIU ; Luwen LUO
Chinese Journal of Nursing 2024;59(7):773-781
Objective To construct and preliminarily apply a graded exercise rehabilitation program for patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD),and to provide a theoretical basis for the scientific implementation of exercise rehabilitation by medical staff.Methods Based on Triangle model and evidence-based method,the first draft of the graded exercise rehabilitation program was constructed,and the items were revised through 2 rounds of expert consultations from March to October,2023.The graded exercise rehabilitation program was preliminarily applied in 10 patients with AECOPD.Results The effective recovery rates of the 2 rounds of expert consultation questionnaires were 100%;the expert authority coefficients were 0.857 and 0.863;the coefficients of variation were 0-0.285 and 0.052-0.244;the Kendall's harmony coefficients were 0.167 and 0.145,respectively(all P<0.001).The final plan includes 4 first-level indicators,13 second-level indicators,and 25 third-level indicators.The scores of 6 min walking test,mMRC and CAT after exercise were improved compared with those before exercise,and the differences were statistically significant(all P<0.05).Conclusion The graded exercise rehabilitation program for patients with AECOPD constructed in this study has good scientificity and practicability,which can provide references for clinical implementation of exercise rehabilitation.
10.Status of Outcome Index in Randomized Controlled Trials of Traditional Chinese Medicine for Treatment of Tic Disorder in Children
Yujing CHEN ; Hui LIU ; Qianfang FU ; Haihong YAN ; Ping RONG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(20):103-110
This study analyzed the outcome index and related design elements of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in the treatment of children with tic disorder (TD) in the past ten years, so as to provide a basis for the construction of the core index set of TCM in the treatment of children with TD. Eight databases were searched, including four English databases (PubMed, Web of Science, Embase, and Cochrane Library) and four Chinese databases, including China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database, and China Biology Medicine disc (CBMdisc), as well as ClinicalTrials.gov and China Clinical Trial Registry. The search time was limited to from January 1, 2013 to October 29, 2023. RCTs on the TD in children treated with TCM were collected. Two researchers independently conducted literature screening, data extraction, and literature quality evaluation and summarized clinical outcome indexes and related trial design elements through qualitative analysis. A total of 67 RCTs were included, including 63 outcome indexes, with a total frequency of 348 times. The related outcome indexes could be divided into six categories: 12 symptom/sign indexes with a frequency of 134 (38.5%), seven TCM symptom/syndrome indexes with a frequency of 31 (8.9%), 33 physical and chemical examination indexes with a frequency of 97 (27.9%), four safety indexes with a frequency of 67 (19.3%), three long-term prognostic indexes with a frequency of 14 (4.0%), and one kind of quality-of-life evaluation index (0.3%). Currently, the RCTs research design of TCM in the treatment of TD in children has not yet formed a unified standard, and there are many problems in the quality of methodology, which reduces the authenticity and reliability of clinical conclusions. There are problems with clinical outcome indexes, such as significant quantity differences, unclear primary and secondary outcome indexes, unreasonable alternative indexes, non-standard TCM syndrome types and TCM evaluation indexes, lack of economic evaluation indexes, and less attention to long-term prognostic indexes and safety indexes. It is suggested that the researchers should design a more rigorous trial scheme and reasonably design the outcome index which is in line with the clinical trial efficacy evaluation of TCM, so as to construct the core index set with the characteristics of TCM for the treatment TD in children.

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