1.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.
2.Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine (version 2024)
Xiao CHEN ; Hao ZHANG ; Man WANG ; Guangchao WANG ; Jin CUI ; Wencai ZHANG ; Fengjin ZHOU ; Qiang YANG ; Guohui LIU ; Zhongmin SHI ; Lili YANG ; Zhiwei WANG ; Guixin SUN ; Biao CHENG ; Ming CAI ; Haodong LIN ; Hongxing SHEN ; Hao SHEN ; Yunfei ZHANG ; Fuxin WEI ; Feng NIU ; Chao FANG ; Huiwen CHEN ; Shaojun SONG ; Yong WANG ; Jun LIN ; Yuhai MA ; Wei CHEN ; Nan CHEN ; Zhiyong HOU ; Xin WANG ; Aiyuan WANG ; Zhen GENG ; Kainan LI ; Dongliang WANG ; Fanfu FANG ; Jiacan SU
Chinese Journal of Trauma 2024;40(3):193-205
Osteoporotic proximal humeral fracture (OPHF) is one of the common osteoporotic fractures in the aged, with an incidence only lower than vertebral compression fracture, hip fracture, and distal radius fracture. OPHF, secondary to osteoporosis and characterized by poor bone quality, comminuted fracture pattern, slow healing, and severely impaired shoulder joint function, poses a big challenge to the current clinical diagnosis and treatment. In the field of diagnosis, treatment, and rehabilitation of OPHF, traditional Chinese and Western medicine have accumulated rich experience and evidence from evidence-based medicine and achieved favorable outcomes. However, there is still a lack of guidance from a relevant consensus as to how to integrate the advantages of the two medical systems and achieve the integrated diagnosis and treatment. To promote the diagnosis and treatment of OPHF with integrated traditional Chinese and Western medicine, relevant experts from Orthopedic Expert Committee of Geriatric Branch of Chinese Association of Gerontology and Geriatrics, Youth Osteoporosis Group of Orthopedic Branch of Chinese Medical Association, Osteoporosis Group of Orthopedic Surgeon Branch of Chinese Medical Doctor Association, and Osteoporosis Committee of Shanghai Association of Integrated Traditional Chinese and Western Medicine have been organized to formulate Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine ( version 2024) by searching related literatures and based on the evidences from evidence-based medicine. This consensus consists of 13 recommendations about the diagnosis, treatment and rehabilitation of OPHF with integrated traditional Chinese medicine and Western medicine, aimed at standardizing, systematizing, and personalizing the diagnosis and treatment of OPHF with integrated traditional Chinse and Western medicine to improve the patients ′ function.
3.Exploration and Practice of the "One Combination, Two Highlights, Three Combinations, Four in One" Innovative Talents Training Mode in Forensic Medicine.
Jiang-Wei YAN ; Jun-Hong SUN ; Hong-Xing WANG ; Zhi-Wen WEI ; Xiang-Jie GUO ; Ji LI ; Cai-Rong GAO ; Geng-Qian ZHANG ; Xin-Hua LIANG ; Qiang-Qiang ZHANG ; Hong-Wei WANG ; Si-Jin LI ; Ying-Yuan WANG ; Ke-Ming YUN
Journal of Forensic Medicine 2023;39(2):193-199
Talent is one of the basic and strategic supports for building a modern socialist country in all aspects. Since the 1980s, the establishment of forensic medicine major and the cultivation of innovative talents in forensic medicine have become hot topics in higher education in forensic medicine. Over the past 43 years, the forensic medicine team of Shanxi Medical University has adhered to the joint education of public security and colleges, and made collaborative innovation, forming a training mode of "One Combination, Two Highlights, Three Combinations, Four in One" for innovative talents in forensic medicine. It has carried out "5+3/X" integrated reform, and formed a relatively complete talent training innovation mode and management system in teaching, scientific research, identification, major, discipline, team, platform and cultural construction. It has made a historic contribution to China's higher forensic education, accumulated valuable experience for the construction of first-class major and first-class discipline of forensic medicine, and provided strong support for the construction of the national new forensic talent training system. The popularization of this training mode is conducive to the rapid and sustainable development of forensic science, and provides more excellent forensic talents for national building, regional social development and the discipline construction of forensic science.
Humans
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Forensic Medicine/education*
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Aptitude
4.Revealing characteristics and rules of acupoint sensitization phenomena: based on knee osteoarthritis.
Gui-Xing XU ; Yu-Mei ZHOU ; Ning SUN ; Jin CUI ; Xiao-Rong CHANG ; Lai-Xi JI ; Si-Yu LIU ; Liao-Jun LUO ; Xiao-Jia LIU ; Dan WANG ; Ling ZHAO ; Ding-Jun CAI ; Hui ZHENG ; Ming-Sheng SUN ; Guo-Yan GENG ; Jian CHENG ; Fan-Rong LIANG
Chinese Acupuncture & Moxibustion 2022;42(1):51-57
OBJECTIVE:
To explore the characteristics and rules of acupoint sensitization phenomena based on knee osteoarthritis (KOA), one of the clinical dominant diseases of acupuncture-moxibustion.
METHODS:
In combination with literature and expert experiences, the acupoints with the highest use frequency in treatment of KOA were screened, e.g. Heding (EX-LE 2), Liangqiu (ST 34), Mingmen (GV 4), Neixiyan (EX-LE 4), Ququan (LR 8) and Dubi (ST 35). In 814 patients with KOA and 217 healthy subjects, the acupoint temperature, mechanic pain threshold and pressure pain threshold were detected separately. Using machine learning method, the sensitization was judged at each acupoint.
RESULTS:
Compared with healthy subjects, the acupoint temperature was increased and the mechanic pain threshold and pressure pain threshold were reduced in KOA patients (P<0.05). Besides, the cut-off value was presented to distinguish whether the acupoint was sensitized or not. The results of machine learning showed that the highest prediction accuracy of acupoint sensitization was 86.7% (Shenshu [BL 23]) and the lowest one was 73.9% (Heding [EX LE 2]). The prediction accuracy at the third clinical stage trial was higher, the highest was 93.3% (Ququan [LR 8]) in KOA patients.
CONCLUSION
It is confirmed that the acupoint sensitization reflects the characteristics of disease and is correlative with the conditions of illness, which may provide the reference for the auxiliary diagnosis and condition assessment of KOA.
Acupuncture Points
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Acupuncture Therapy
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Humans
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Moxibustion
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Osteoarthritis, Knee/therapy*
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Treatment Outcome
5.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
BACKGROUND:
Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE:
This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
MAIN OUTCOME MEASURES:
The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS:
A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION:
SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER
NCT02063100 on ClinicalTrials.gov.
6.Advances in molecular pathogenesis and treatment of intrahepatic cholangiocarcinoma
Tian PU ; Qiang FANG ; Zixiang CHEN ; Ming CAI ; Dong JIANG ; Xiaoping GENG ; Fubao LIU
Chinese Journal of Digestive Surgery 2020;19(6):697-702
Intrahepatic cholangiocarcinoma (ICC) is a group of adenocarcinoma that derives from epithelium of the subbranches of intrahepatic bile ducts, which is characterized by difficulty in early diagnosis, high malignancy and poor prognosis. ICC is relatively rare, but it is the second most common in primary liver cancer, and its incidence has gradually increased worldwide. Radical resection is recognized as the only treatment that can bring better long-term survival currently. However, many surgery-related problems, such as lymph node dissection and major vascular resection and reconstruction, are still controversial. Adjuvant therapy, including chemotherapy, regional therapy, targeted therapy and immunotherapy, has received increasing attention in recent years. Although there is no uniform standard, a large number of related studies have supported its efficacy. In this article, the authors have reviewed the molecular pathogenesis of ICC and advances in treatment.
7.Primary hepatic adenosquamous carcinoma: report of 5 cases
Zixiang CHEN ; Jiangming CHEN ; Qi GUO ; Qingsong XIE ; Qiang FANG ; Tian PU ; Ming CAI ; Kun XIE ; Yijun ZHAO ; Xiaoping GENG ; Fubao LIU
Chinese Journal of General Surgery 2020;35(11):874-878
Objective:To explore the clinicopathological characteristics of the primary hepatic adenosquamous carcinoma(ASC).Methods:A retrospective analysis was performed on the clinical data of 5 ASC patients admitted to the First Affiliated Hospital of Anhui Medical University from 2006 to 2019 who underwent surgical resection and were pathologically confirmed.Results:Among the 5 ASC cases, there were 4 males and 1 female. The age ranged from 48 to 73 years. As for the initial symptoms, there were 5 cases complaining upper abdominal pain, 2 cases presenting fever, 1 case presenting weight loss and 1 case presenting jaundice. CA19-9 was significantly higher than normal in 4 cases, while AFP was normal in all. None had definite preoperative diagnosis.All the 5 patients underwent surgical resection with pathology proved primary hepatic ASC. Lymph node metastasis was found in 4 cases and nerve invasion in 2 cases. There were 4 cases at TNM stage ⅣA, one at stage ⅠB. The median disease-free survival (DFS) was 5 months and the overall survival (OS) was 9 months.Conclusions:Primary hepatic adenosquamous carcinoma is a rare type of liver malignant tumor with an extremely poor prognosis. Surgical resection helps little in improving the prognosis.
8.Urodynamic analysis of extraperitoneal Studer orthotropic ileal neobladder following radical cystectomy
Keke CAI ; Yang YAN ; Jiang GENG ; Jianhua HUANG ; Ming LUO ; Junfeng ZHANG ; Shiyu MAO ; Mengnan LIU ; Xudong YAO
Chinese Journal of Urology 2019;40(3):183-187
Objective To evaluate changes of the urodynamics of extraperitoneal Studer orthotropic ileal neobladder after radical cystectomy.Methods Between July 2013 and October 2017,Retrospective analysis was performed on 58 bladder cancer patients.58 patients who underwent retrograde extraperitoneal approach of radical cystectomy and Studer orthotopic ileal neobladder.The patients were comprised of 56 male and 2 female patients with average age of 62 years.There were 9 cases of T1,26 cases of T2,20 cases of T3,and 3 cases of T4.All operations were completed by open suprapubic extraperitoneal approach,then entered the abdominal cavity.An ileal segment 50-55 cm long was isolated which was 25 cm proximal to the ileocecum.The 35-40 cm ileal segment was detubularized along its antimesenteric border.The anterior wall was folded forward with U-shaped and the edges were sutured to formed a neobladder.The proximal 15cm was reserved for the double isoperistaltic afferent limb.The lowest part of the neobladder was anastomosed with urethral stump,the peritoneum was closed at the mesentery,and the neobladder was completely placed extraperitoneal.Upper urinary tract function was examined by renal function test,enhanced CT,IVU or cystography.Uroflowmetry,urodynamic evaluation,diurnal and nocturnal continence were performed at 3,6,12,24 months following the surgery.Results After removed of the catheter,all patients were able to urinate through the urethra.The 3,6,12,24 month follow-up data of urodynamic were compared.The maximum neobladder capacity was[(378 ±66) vs.(381 ± 102)vs.(438 ± 75)vs.(472 ±96)] ml,the maximum flow rate [(10.2 ± 2.8) vs.(14.9 ± 4.3) vs.(16.4 ± 3.6) vs.(17.6 ± 2.1)] ml/s,maximum bladder pressure during filling was [(23.0 ± 4.6) vs.(21.7 ± 7.1) vs.(20.6 ± 6.4) vs.(18.8 ±6.3)] cmH2 O,the PVR was[(68.0 ± 33.2) vs.(36.2 ± 10.1) vs.(30.6 ± 11.9) vs.(14.0 t 9.6)] ml.There were significant differences between the 6-month and 12-month.There were no significant differences in the maximum bladder pressure during flowing [(38.6 ± 7.4) vs.(49.2 ± 6.8) vs.(58.4 ± 10.5) vs.(56.8 ± 7.4)] cmH2O.53 cases were followed up 12 months after surgery.Excellent daytime and nighttime continence was 98% (52/53)and 83 % (44/53)in the first year.Mild unilateral hydronephrosis occurred in 2 cases 1 month after surgery.Blood electrolytes and renal function were within the normal range.1 case presented bilateral mild hydronephrosis 12 months after surgery,without bladder and ureter regurgitation.The blood electrolyte and renal function of the other patients were in normal range with no signs of ureteral stricture and upper urinary tract hydronephrosis.Conclusions Extraperitoneal Studer orthotopic ileal neobladder reduced the interference of postoperative intraperitoneal intestinal tract on neobladder function.Postoperative patients have a smooth urination,a safe pressure during the storage period.The urination period,and the function of day and night urinary control is close to normal physiological characteristics.
9.Interferon-Gamma Release Assay is Not Appropriate for the Diagnosis of Active Tuberculosis in High-Burden Tuberculosis Settings: A Retrospective Multicenter Investigation.
Wan-Li KANG ; Gui-Rong WANG ; Mei-Ying WU ; Kun-Yun YANG ; A ER-TAI ; Shu-Cai WU ; Shu-Jun GENG ; Zhi-Hui LI ; Ming-Wu LI ; Liang LI ; Shen-Jie TANG
Chinese Medical Journal 2018;131(3):268-275
BACKGROUNDInterferon-gamma release assay (IGRA) has been used in latent tuberculosis (TB) infection and TB diagnosis, but the results from different high TB-endemic countries are different. The aim of this study was to investigate the value of IGRA in the diagnosis of active pulmonary TB (PTB) in China.
METHODSWe conducted a large-scale retrospective multicenter investigation to further evaluate the role of IGRA in the diagnosis of active PTB in high TB-epidemic populations and the factors affecting the performance of the assay. All patients who underwent valid T-SPOT.TB assays from December 2012 to November 2015 in six large-scale specialized TB hospitals in China and met the study criteria were retrospectively evaluated. Patients were divided into three groups: Group 1, sputum culture-positive PTB patients, confirmed by positive Mycobacterium tuberculosis sputum culture; Group 2, sputum culture-negative PTB patients; and Group 3, non-TB respiratory diseases. The medical records of all patients were collected. Chi-square tests and Fisher's exact test were used to compare categorical data. Multivariable logistic analyses were performed to evaluate the relationship between the results of T-SPOT in TB patients and other factors.
RESULTSA total of 3082 patients for whom complete information was available were included in the investigation, including 905 sputum culture-positive PTB cases, 914 sputum culture-negative PTB cases, and 1263 non-TB respiratory disease cases. The positive rate of T-SPOT.TB was 93.3% in the culture-positive PTB group and 86.1% in the culture-negative PTB group. In the non-PTB group, the positive rate of T-SPOT.TB was 43.6%. The positive rate of T-SPOT.TB in the culture-positive PTB group was significantly higher than that in the culture-negative PTB group (χ2 = 25.118, P < 0.01), which in turn was significantly higher than that in the non-TB group (χ2 = 566.116, P < 0.01). The overall results were as follows: sensitivity, 89.7%; specificity, 56.37%; positive predictive value, 74.75%; negative predictive value, 79.11%; and accuracy, 76.02%.
CONCLUSIONSHigh false-positive rates of T-SPOT.TB assays in the non-TB group limit the usefulness as a single test to diagnose active TB in China. We highly recommend that IGRAs not be used for the diagnosis of active TB in high-burden TB settings.
10.Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study.
Xue-Ying CAO ; Ya-Ni HE ; Jian-Hui ZHOU ; Shi-Ren SUN ; Li-Ning MIAO ; Wen CHEN ; Jing-Ai FANG ; Ming WANG ; Nian-Song WANG ; Hong-Li LIN ; Jian LIU ; Zhao-Hui NI ; Wen-Hu LIU ; Yu NA ; Jiu-Yang ZHAO ; Zhi-Yong GUO ; Hong-Guang ZHENG ; Wei SHI ; Geng-Ru JIANG ; Guang-Yan CAI ; Xiang-Mei CHEN
Chinese Medical Journal 2018;131(23):2785-2791
Background:
Automated peritoneal dialysis (APD) can cater to individual needs, provide treatment while asleep, take into account the adequacy of dialysis, and improve the quality of life. Currently, independent research and development of APD machines made in China are more conducive to patients. A randomized, multicenter, crossover study was conducted by comparing an APD machine made in China with an imported machine. The safety, effectiveness, and manipulability of the two machines were compared.
Methods:
Two hundred and sixty patients who underwent peritoneal dialysis (PD) on a regular basis in 18 centers between August 2015 and February 2016 were included. The inclusion criteria include age ≥18 years and PD ≥30 days. The exclusion criteria were as follows: hemodialysis; exit site or tunnel infection; and peritonitis ≤30 days. The patients were randomly divided into Group A, who were first treated with a FM machine made in China, then changed to an imported machine; and Group B, who were treated using the reverse sequence. APD treatment was performed with 10 L/10 h and 5 cycles of exchange. After 72 h, the daily peritoneal Kt/V, the accuracy of the injection rate, accuracy of the injection temperature, safety, and manipulability of the machine were assessed. Noninferiority test was conducted between the two groups.
Results:
The daily peritoneal Kt/V in the APD machine made in China and the imported APD machine were 0.17 (0.14, 0.25) and 0.16 (0.13, 0.23), respectively. There was no significant difference between the groups (Z = 0.15, P = 0.703). The lower limit of the daily Kt/V difference between the two groups was 0.0069, which was greater than the noninferiority value of -0.07 in this study. The accuracy of the injection rate and injection temperature was 89.7% and 91.5%, respectively, in the domestic APD machine, which were both slightly better than the accuracy rates of 84.0% and 86.8% in the imported APD machine (89.7% vs. 84.0%, P = 0.2466; 91.5% vs. 86.8%, P = 0.0954). Therefore, the APD machine made in China was not inferior to the imported APD machine. The fuselage of the imported APD machine was space-saving, while the APD machine made in China was superior with respect to body mobility, man-machine dialog operation, alarm control, and patient information recognition.
Conclusions:
The FM machine made in China was not inferior to the imported APD machine. In addition, the FM machine made in China had better operability.
Trial Registration
Clinicaltrials.gov, NCT02525497; https://clinicaltrials.gov/ct2/results?cond=&term=NCT02525497&cntry=& state=&city=&dist=.
Adult
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China
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Cross-Over Studies
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Female
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Humans
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Male
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Middle Aged
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Multicenter Studies as Topic
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Peritoneal Dialysis
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adverse effects
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instrumentation
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methods
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Quality of Life
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Temperature

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