1.Safety and efficacy of the early administration of levosimendan in patients with acute non-ST-segment elevation myocardial infarction and elevated NT-proBNP levels: An Early Management Strategy of Acute Heart Failure (EMS-AHF).
Feng XU ; Yuan BIAN ; Guo Qiang ZHANG ; Lu Yao GAO ; Yu Fa LIU ; Tong Xiang LIU ; Gang LI ; Rui Xue SONG ; Li Jun SU ; Yan Ju ZHOU ; Jia Yu CUI ; Xian Liang YAN ; Fang Ming GUO ; Huan Yi ZHANG ; Qing Hui LI ; Min ZHAO ; Li Kun MA ; Bei An YOU ; Ge WANG ; Li KONG ; Jian Liang MA ; Xin Fu ZHOU ; Ze Long CHANG ; Zhen Yu TANG ; Dan Yu YU ; Kai CHENG ; Li XUE ; Xiao LI ; Jiao Jiao PANG ; Jia Li WANG ; Hai Tao ZHANG ; Xue Zhong YU ; Yu Guo CHEN
Chinese Journal of Internal Medicine 2023;62(4):374-383
Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.
Male
;
Female
;
Humans
;
Aged
;
Natriuretic Peptide, Brain
;
Simendan/therapeutic use*
;
Non-ST Elevated Myocardial Infarction
;
Heart Failure/drug therapy*
;
Peptide Fragments
;
Arrhythmias, Cardiac
;
Biomarkers
;
Prognosis
2. Comparing the process of early control of government between H7N9 avian influenza in Shanghai in 2013 and COVID-19 in Wuhan in 2019
Li LUO ; Ge BAI ; Rui ming DAI ; Qian WANG ; Huan huan ZHU ; Xin LIU ; Ping WU ; Tian Tian ZHANG
Shanghai Journal of Preventive Medicine 2020;32(0):E069-E069
[Objective] To analyze and judge the possibility of early control in Shanghai if COVID-19 begins in Shanghai. [Methods] Compare the process of early control of H7N9 avian influenza in Shanghai in 2013 and Wuhan COVID-19 in 2019. The early incidence data of Korean COVID-19 was simulated and analyzed to predict whether the medical resources needed in Shanghai were available. [Results] (1) It would take 22 days from the first case to the government's emergency response in terms of Shanghai. (2) It is estimated that there would be 602-763 patients with cumulative onset and onset after incubation period. (3) At least 500 beds of infectious diseases can be allocated in Shanghai in case of emergency. Through adding beds and resources reallocation in the whole city, patients can be fully admitted and treated. [Conclusion] If COVID-19 epidemic occurs in Shanghai, early control is possible.
3.CO Laser Moxibustion for Knee Osteoarthritis: Study Protocol for A Multicenter, Double-blind, Randomized Controlled Trial.
Meng-Hu GUO ; Ling ZHAO ; Fan WU ; Jiong DU ; Chen-Huan DING ; Jing-Hua GE ; Ming T TAN ; Li-Xing LAO ; Xue-Yong SHEN ; Ke CHENG
Chinese journal of integrative medicine 2020;26(8):568-576
BACKGROUND:
Knee osteoarthritis (OA) is a major cause of disability among the older adults. Few treatments are safe and effective. Moxibustion is commonly used in treating knee OA in Chinese medicine (CM). CO Laser moxibustion device is a substitute for traditional moxibustion, which mimics the effects of traditional moxibustion. More data are needed to support its application in knee OA.
OBJECTIVE:
ObjectiveThe trial aims to assess the effect and safety of CO laser moxibustion in patients with knee osteoarthritis compared with a sham control.
METHODS:
This is a protocol for a multicenter, randomized, double-blind, placebo-controlled trial. A total of 392 participants were recruited and assigned to the CO laser moxibustion group and sham laser moxibustion group with a 1:1 ratio at 6 outpatient clinics in Shanghai, China. Participants in both groups received treatment at the affected knee(s) at the acupuncture point Dubi (ST 35) and an Ashi point. There were 3 sessions per week for 4 weeks, and an additional 20-week follow-up. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores at week 4. Secondary outcomes were WOMAC function score, stiffness score and overall score, VAS pain, Short-Form heath survey (SF-36), and patients' global assessment. The serum levels of cytokines involved in progress of knee OA were explored. Safety was assessed during the whole trial. Masking effectiveness was assessed by both participants and treatment providers.This is a protocol for a multicenter, randomized, double-blind, placebo-controlled trial. A total of 392 participants were recruited and assigned to the CO laser moxibustion group and sham laser moxibustion group with a 1:1 ratio at 6 outpatient clinics in Shanghai, China. Participants in both groups received treatment at the affected knee(s) at the acupuncture point Dubi (ST 35) and an Ashi point. There were 3 sessions per week for 4 weeks, and an additional 20-week follow-up. Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores at week 4. Secondary outcomes were WOMAC function score, stiffness score and overall score, VAS pain, Short-Form heath survey (SF-36), and patients' global assessment. The serum levels of cytokines involved in progress of knee OA were explored. Safety was assessed during the whole trial. Masking effectiveness was assessed by both participants and treatment providers.
DISCUSSION
CO laser moxibustion device, designed as a substitute for CM moxibustion, is easy to use and control with no choking smoke and smell, and is a plausible method for double-blind research. This study would provide rigorous evidence for the effect and safety of CO laser moxibustion in treating knee OA (Trial registration No.: ISRCTN15030019).
4.Comparison of the early control process of H7N9 avian influenza in Shanghai and COVID-19 in Wuhan
Li LUO ; Ge BAI ; Rui-ming DAI ; Qian WANG ; Huan-huan ZHU ; Xin LIU ; Ping WU ; Ying WANG ; Tian-tian ZHANG
Shanghai Journal of Preventive Medicine 2020;32(6):478-
Objective To analyze and estimate the possibility of early control in Shanghai if COVID-19 had begun in Shanghai. Methods Comparison was made in the processes of early control between H7N9 avian influenza in Shanghai in 2013 and COVID-19 in Wuhan in 2019.The early incidence data of Korean COVID-19 was simulated and analyzed to predict whether the medical resources needed in Shanghai were available. Results If it had occurred in Shanghai, it would have taken 22 days from the first case to the government′s emergency response.It was estimated that there would have been 602-763 patients with cumulative onset and onset after incubation period.At least 500 beds of infectious diseases could have been allocated in Shanghai in case of emergency.Through adding beds and resources reallocation in the whole city, patients could have been fully admitted and treated. Conclusion If COVID-19 epidemic had occurred in Shanghai, it′s early control would have been possible though there might have difficulties.
5.Effects of Vagus Nerve Stimulation on Adenosine Monophosphate Activated Protein Kinase-Silent Mating Type Information Regulation 2 Homolog 1 Pathway in Ischemia-reperfusion Rats
Hai-ping WEI ; Jia GUO ; Huan WANG ; Zhao-ming GE
Chinese Journal of Rehabilitation Theory and Practice 2020;26(7):775-779
Objective:To investigate the effect of vagus nerve stimulation (VNS) on the autophagy in penumbra of rats after middle cerebral artery occlusion (MCAO). Methods:A total of 56 Sprague-Dawley rats were divided into control group (
6.Effects of Niaoduqing Particles () on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study.
Ying ZHENG ; Nian-Song WANG ; Yu-Ning LIU ; Li-Qun HE ; Gui-Hua JIAN ; Xu-Sheng LIU ; Zhao-Hui NI ; Xiao-Hong CHENG ; Hong-Li LIN ; Wen-Hua ZHOU ; Ya-Ping WANG ; Jing-Ai FANG ; Ya-Ni HE ; Hong-Tao YANG ; Li-Juan ZHAO ; Han-Lu DING ; Li-Hua WANG ; Ren-Huan YU ; Wen-Ge LI ; Zhi-Ming YE ; Wang GUO ; Yong-Li ZHAN ; Hui-Juan MAO ; Zhao HU ; Chen YAO ; Guang-Yan CAI ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2019;25(3):168-174
OBJECTIVE:
To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction.
METHODS:
Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period.
RESULTS:
After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (-10.0-41.9) and 17.5 (-6.0-50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were-2.3 (-6.4-1.9) and-3.7 (-7.5-1.1) mL•min•1.73 m, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min•1.73 m per year.
CONCLUSION
Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448).
Adult
;
Disease Progression
;
Double-Blind Method
;
Drugs, Chinese Herbal
;
therapeutic use
;
Female
;
Follow-Up Studies
;
Glomerular Filtration Rate
;
drug effects
;
Humans
;
Kidney Diseases
;
drug therapy
;
physiopathology
;
Male
;
Middle Aged
;
Outcome Assessment (Health Care)
7.Influence of Familiarity on Energy Intake and Plasma Gut Hormone Concentration in Lean and Overweight Young Male Students.
Lei QI ; Yan Bo QI ; Peng ZHAO ; Hong CHAO ; Yu CHENG ; Hai Feng XUE ; Yun Feng HAN ; Bai Ming JIN ; Si Yuan WAN ; Xue Yan QIAN ; Hong Jie LI ; Huan WU ; Gang LI ; Feng Ge LOU
Biomedical and Environmental Sciences 2018;31(10):740-748
OBJECTIVEThis study is to examine the influence of familiarity on energy intake, eating behavior, and concentration of the plasma gut hormones in lean and overweight young male subjects.
METHODSTwenty-eight lean and twenty-eight overweight participants were recruited. Their food consumption was documented and analyzed when they had a test meal while they were paired with friends or strangers at the same weight stature. Their eating behavior was recorded with cameras hidden in the carton, and postprandial plasma gut hormone concentration were measured.
RESULTSCompared with overweight strangers (OS), overweight friends (OF) had increased food consumption, prolonged and decreased number of chews per 10 g food. Compared with OS, postprandial plasma concentration of cholecystokinin-8 was significantly lower in OF group at 30, 60, and 90 min, whereas the concentration of glucagon-like peptide 1 was significantly lower at 60 and 90 min. Plasma ghrelin concentration was significantly higher in the OF group than that in the OS group at 90 and 120 min. No significant differences in gut hormone concentration were observed between lean strangers (LS) and lean friends (LF) groups at all time points.
CONCLUSIONFamiliarity plays an important role in increasing energy intake and in changing of postprandial gut hormone concentration in overweight individuals.
8.Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized,Double-blind, Placebo-controlled, Multicenter Clinical Study
Zheng YING ; Cai GUANG-YAN ; He LI-QUN ; Lin HONG-LI ; Cheng XIAO-HONG ; Wang NIAN-SONG ; Jian GUI-HUA ; Liu XU-SHENG ; Liu YU-NING ; Ni ZHAO-HUI ; Fang JING-AI ; Ding HAN-LU ; Guo WANG ; He YA-NI ; Wang LI-HUA ; Wang YA-PING ; Yang HONG-TAO ; Ye ZHI-MING ; Yu REN-HUAN ; Zhao LI-JUAN ; Zhou WEN-HUA ; Li WEN-GE ; Mao HUI-JUAN ; Zhan YONG-LI ; Hu ZHAO ; Yao CHEN ; Wei RI-BAO ; Chen XIANG-MEI
Chinese Medical Journal 2017;130(20):2402-2409
Background:Chronic kidney disease (CKD) with moderate-to-severe renal dysfunction usually exhibits an irreversible course,and available treatments for delaying the progression to end-stage renal disease are limited.This study aimed to assess the efficacy and safety of the traditional Chinese medicine,Niaoduqing particles,for delaying renal dysfunction in patients with stage 3b-4 CKD.Methods:The present study was a prospective,randomized,double-blind,placebo-controlled,multicenter clinical trial.From May 2013 to December 2013,300 CKD patients with an estimated glomerular filtration rate (eGFR) between 20 and 45 ml,min-1· 1.73 m-2,aged 18-70 years were recruited from 22 hospitals in 11 Chinese provinces.Patients were randomized in a 1∶1 ratio to either a test group,which was administered Niaoduqing particles 5 g thrice daily and 10 g before bedtime for 24 weeks,or a control group,which was administered a placebo using the same methods.The primary endpoints were changes in baseline serum creatinine (Scr) and eGFR after completion of treatment.The primary endpoints were analyzed using Student's t-test or Wilcoxon's rank-sum test.The present study reported results based on an intention-to-treat (ITT) analysis.Results:A total of 292 participants underwent the ITT analysis.At 24 weeks,the median (interquartile range) change in Scr was 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the test and control groups,respectively (Z =2.642,P =0.008),and the median change in eGFR was-0.2 (-4.3-2.7) and-2.2 (-5.7-0.8) ml·min-1.1.73 m-2,respectively (Z =-2.408,P =0.016).There were no significant differences in adverse events between the groups.Conclusions:Niaoduqing particles safely and effectively delayed CKD progression in patients with stage 3b-4 CKD.This traditional Chinese medicine may be a promising alternative medication for patients with moderate-to-severe renal dysfunction.
9.Progress on Post Traumatic Epilepsy and Its Forensic Evaluation.
Yun Ge ZHANG ; Chun Xiao LI ; Guo Fu GUAN ; Ming LÜ ; He Ying CHENG ; Huan CHEN
Journal of Forensic Medicine 2016;32(3):200-203
Post traumatic epilepsy (PTE) refers to the epileptic seizures after traumatic brain injury. Organic damage can be found by imaging examination, and abnormal electroencephalogram can be detected via electroencephalogram examination which has the similar location of the brain injury. PTE has the characteristics of low incidence, absence of case reports, and easy to exaggerate the state of illness, which add difficulties to the forensic identification. This paper reviews the status of epidemiology, pathogenesis, clinical treatment and forensic identification for PTE.
Brain Injuries, Traumatic/physiopathology*
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Electroencephalography
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Epilepsy
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Epilepsy, Post-Traumatic/pathology*
;
Forensic Pathology
;
Humans
;
Incidence
10.Three quantitative methods to continuously monitor Legionella in spring water.
Ge-bin YAN ; Huan-xin WANG ; Tian QIN ; Hai-jian ZHOU ; Ma-chao LI ; Ying XU ; Ming-qiang ZHAO ; Zhu-jun SHAO ; Hong-yu REN
Chinese Journal of Preventive Medicine 2013;47(7):637-640
OBJECTIVETo compare the detection effect of Legionella pollution in spring water by three methods, namely traditional plating method, fluorescent quantitation PCR method and ethidium monoazide (EMA) fluorescent quantitation PCR method.
METHODSEvery month (except May), we collected 11 water samples from the 5 selected hot spring pools in one hot spring resort in Beijing in 2011. A total of 121 water samples were collected, and then were detected by the above three methods qualitatively and quantitatively.
RESULTSIn our study, the Legionella pollution rate was separately 74.4% (90/121), 100.0% (121/121) and 100.0% (121/121) by the above three methods. The quantitative value of Legionella in the 121 water samples detected by the three methods were around 0.10-216.00 colony-forming units (CFU)/ml, 1.47-1557.75 gene units (GU)/ml and 0.20-301.69 GU/ml, respectively. The median (25th and 75th percentiles) was 75.30 (32.51-192.10) GU/ml, 36.46 (16.08-91.21) GU/ml and 5.30 (0.00-33.70) CFU/ml, respectively. The difference in the quantitative value of Legionella detected by the three methods showed statistical significance (χ(2) = 187.900, P < 0.01). The quantitative value of Legionella detected by fluorescent quantitation PCR method was the highest, followed by the value Legionella detected by EMA-fluorescent quantitation PCR method and traditional plating method.
CONCLUSIONThe sensitivity of the PCR methods was higher than traditional plating method, in detecting Legionella pollution in spring water, especially the EMA- fluorescent quantitation PCR method, which was more suitable for detecting Legionella in water.
Environmental Monitoring ; methods ; Hot Springs ; microbiology ; Legionella ; classification ; isolation & purification ; Microbiological Techniques ; Water Microbiology

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