1. Identification of a novel coronavirus causing severe pneumonia in human: a descriptive study
Li Li REN ; Ye Ming WANG ; Zhi Qiang WU ; Zi Chun XIANG ; Li GUO ; Teng XU ; Yong Zhong JIANG ; Yan XIONG ; Yong Jun LI ; Hui LI ; Guo Hui FAN ; Xiao Ying GU ; Yan XIAO ; Hong GAO ; Jiu Yang XU ; Fan YANG ; Xin Ming WANG ; Chao WU ; Lan CHEN ; Yi Wei LIU ; Bo LIU ; Jian YANG ; Jie DONG ; Li LI ; Chao Lin HUANG ; Jian Ping ZHAO ; Yi HU ; Zhen Shun CHENG ; Lin Lin LIU ; Zhao Hui QIAN ; Chuan QIN ; Qi JIN ; Bin CAO ; Jian Wei WANG
Chinese Medical Journal 2020;133(0):E001-E001
Background: Human infections with zoonotic coronaviruses (CoVs), including severe acute respiratory syndrome (SARS)-CoV and Middle East respiratory syndrome (MERS)-CoV, have raised great public health concern globally. Here, we report a novel bat-origin CoV causing severe and fatal pneumonia in humans. Methods: We collected clinical data and bronchoalveolar lavage (BAL) specimens from five patients with severe pneumonia from Jin Yin-tan Hospital, Wuhan, Hubei province, China. Nucleic acids of the BAL were extracted and subjected to next-generation sequencing. Virus isolation was carried out, and maximum-likelihood phylogenetic trees were constructed. Results: Five patients hospitalized from December 18 to December 29, 2019 presented with fever, cough, and dyspnea accompanied by complications of acute respiratory distress syndrome. Chest radiography revealed diffuse opacities and consolidation. One of these patients died. Sequence results revealed the presence of a previously unknown β-CoV strain in all five patients, with 99.8–99.9% nucleotide identities among the isolates. These isolates showed 79.0% nucleotide identity with the sequence of SARS-CoV (GenBank NC_004718) and 51.8% identity with the sequence of MERS-CoV (GenBank NC_019843). The virus is phylogenetically closest to a bat SARS-like CoV (SL-ZC45, GenBank MG772933) with 87.6–87.7% nucleotide identity, but is in a separate clade. Moreover, these viruses have a single intact open reading frame gene 8, as a further indicator of bat-origin CoVs. However, the amino acid sequence of the tentative receptor-binding domain resembles that of SARS-CoV, indicating that these viruses might use the same receptor. Conclusion: A novel bat-borne CoV was identified that is associated with severe and fatal respiratory disease in humans.
2.Identification of a novel coronavirus causing severe pneumonia in human: a descriptive study.
Li-Li REN ; Ye-Ming WANG ; Zhi-Qiang WU ; Zi-Chun XIANG ; Li GUO ; Teng XU ; Yong-Zhong JIANG ; Yan XIONG ; Yong-Jun LI ; Xing-Wang LI ; Hui LI ; Guo-Hui FAN ; Xiao-Ying GU ; Yan XIAO ; Hong GAO ; Jiu-Yang XU ; Fan YANG ; Xin-Ming WANG ; Chao WU ; Lan CHEN ; Yi-Wei LIU ; Bo LIU ; Jian YANG ; Xiao-Rui WANG ; Jie DONG ; Li LI ; Chao-Lin HUANG ; Jian-Ping ZHAO ; Yi HU ; Zhen-Shun CHENG ; Lin-Lin LIU ; Zhao-Hui QIAN ; Chuan QIN ; Qi JIN ; Bin CAO ; Jian-Wei WANG
Chinese Medical Journal 2020;133(9):1015-1024
BACKGROUND:
Human infections with zoonotic coronaviruses (CoVs), including severe acute respiratory syndrome (SARS)-CoV and Middle East respiratory syndrome (MERS)-CoV, have raised great public health concern globally. Here, we report a novel bat-origin CoV causing severe and fatal pneumonia in humans.
METHODS:
We collected clinical data and bronchoalveolar lavage (BAL) specimens from five patients with severe pneumonia from Wuhan Jinyintan Hospital, Hubei province, China. Nucleic acids of the BAL were extracted and subjected to next-generation sequencing. Virus isolation was carried out, and maximum-likelihood phylogenetic trees were constructed.
RESULTS:
Five patients hospitalized from December 18 to December 29, 2019 presented with fever, cough, and dyspnea accompanied by complications of acute respiratory distress syndrome. Chest radiography revealed diffuse opacities and consolidation. One of these patients died. Sequence results revealed the presence of a previously unknown β-CoV strain in all five patients, with 99.8% to 99.9% nucleotide identities among the isolates. These isolates showed 79.0% nucleotide identity with the sequence of SARS-CoV (GenBank NC_004718) and 51.8% identity with the sequence of MERS-CoV (GenBank NC_019843). The virus is phylogenetically closest to a bat SARS-like CoV (SL-ZC45, GenBank MG772933) with 87.6% to 87.7% nucleotide identity, but is in a separate clade. Moreover, these viruses have a single intact open reading frame gene 8, as a further indicator of bat-origin CoVs. However, the amino acid sequence of the tentative receptor-binding domain resembles that of SARS-CoV, indicating that these viruses might use the same receptor.
CONCLUSION
A novel bat-borne CoV was identified that is associated with severe and fatal respiratory disease in humans.
Adult
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Aged
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Betacoronavirus
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genetics
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isolation & purification
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Coronavirus Infections
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diagnostic imaging
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therapy
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virology
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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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Pandemics
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Pneumonia, Viral
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diagnostic imaging
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therapy
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virology
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Tomography, X-Ray
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Treatment Outcome
3.The Clinical Analysis of Necrotizing Enterocolitis
Yun-Fen TIAN ; Li LI ; Hong-Ying MI ; Chun-Rong HUANG-FU ; Shan HE ; Xiao-Yan XU ; Yong-Jiu CAO
Journal of Kunming Medical University 2018;39(2):60-64
Objective From May 2010 to May 2013 and from June 2013 to June 2016, we compared the clinical analysis of patients with necrotizing enterocolitis (NEC) in the Department of Pediatrics, studied incidence rate of NEC and the relationship between stages of NEC and prognosis, and compared the prognosis between the two three-year periods to provide the experience of diagnosis and treatment for clinical practice in the future. Methods The clinical data of patients diagnosed with NEC were retrospectively analyzed according to the diagnostic criteria of modified Bell staging classification using SPSS statistical software package. Early diagnosis rate and prognosis were compared between the two three-year periods. P<0.05 showed that statistical significance was found. Results From May 2010 to May 2013, 40 cases of NEC were diagnosed in our hospital, among which 8 was in the first stage (20%),24 in the second stage (60%),and 8 in the third stage (20%) . The number of premature infants was 32, accounting for 80% , among which 25 cases were infants with very low birth weight accounting for 62.5% and 8 cases were full-term infants, accounting for 20% (P<0.05) . In the study, 32 cases (80%) received traditional treatment, which was effective in stage Ⅰ. During the second stage, two abandoned the treatment was confirmed death in the follow-up, two underwent surgery successfully due to the progression of the disease and four (25%) died in the hospital. Statistic significance of treatment of internal medicine was found when comparing stage Ⅰ with stage Ⅱ (P<0.05) . Ten children underwent surgery, among which one gave up treatment after the surgery because of financial problems and was found dead in the follow-up and four (60%) died in the hospital. The comparison of surgical treatment in patients in stage Ⅱ and Ⅲ showed no statistical significance (P>0.05) . Fatality rates were statistically significant (P<0.05) . From June 2013 to June 2016, 41 children were diagnosed with NEC in our hospital, including 24 cases in stage Ⅰ (59%), 14 in stage Ⅱ (34%), and 3 in stage Ⅲ (7%) . The number of premature infants was 33, accounting for 80%, among which 26 cases were infants with very low birth weight accounting for 62.5% and 8 cases were full-term infants, accounting for 20% (P<0.05) . In the study, 35 cases (85.3%) received traditional treatment, which was effective in stage Ⅰ. During the second stage, one underwent surgery successfully due to the progression of the disease. Statistic significance of treatment of internal medicine was found when comparing stage Ⅰ with stage Ⅱ (P<0.05) . Four children underwent surgery, among which one gave up treatment after the surgery because of financial problems and was found dead in the follow-up and the surgery was successful in other three. The comparison of surgical treatment in patients in stage Ⅱ and Ⅲ showed statistical significance (P<0.05) . Fatality rates were statistically significant comparing the two three-year periods (P<0.05) . The comparison of the rates of early diagnosis in the two three-year periods showed statistically significance (P<0.001) . Conclusion Early diagnosis of NEC is the key to reduce mortality. Intestinal fatty acid binding protein (I-FABP) is a serological marker for early diagnosis of NEC. As an important factor, the reduction of the incidence of premature birth will result in the drop in the incidence of NEC.
4.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
5.Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial.
Ying QIAN ; Min CHEN ; Lan SHUAI ; Qing-Jiu CAO ; Li YANG ; Yu-Feng WANG
Chinese Medical Journal 2017;130(13):1513-1520
BACKGROUNDAs medication does not normalize outcomes of children with attention deficit hyperactivity disorder (ADHD), especially in real-life functioning, nonpharmacological methods are important to target this field. This randomized controlled clinical trial was designed to evaluate the effects of a comprehensive executive skill training program for school-aged children with ADHD in a relatively large sample.
METHODSThe children (aged 6-12 years) with ADHD were randomized to the intervention or waitlist groups. A healthy control group was composed of gender- and age-matched healthy children. The intervention group received a 12-session training program for multiple executive skills. Executive function (EF), ADHD symptoms, and social functioning in the intervention and waitlist groups were evaluated at baseline and the end of the final training session. The healthy controls (HCs) were only assessed once at baseline. Repeated measures analyses of variance were used to compare EF, ADHD symptoms, and social function between intervention and waitlist groups.
RESULTSThirty-eight children with ADHD in intervention group, 30 in waitlist group, and 23 healthy children in healthy control group were included in final analysis. At posttreatment, intervention group showed significantly lower Behavior Rating Inventory of Executive Function (BRIEF) total score (135.89 ± 16.80 vs. 146.09 ± 23.92, P= 0.04) and monitoring score (18.05 ± 2.67 vs. 19.77 ± 3.10, P= 0.02), ADHD-IV overall score (41.11 ± 7.48 vs. 47.20 ± 8.47, P< 0.01), hyperactivity-impulsivity (HI) subscale score (18.92 ± 5.09 vs. 21.93 ± 4.93, P= 0.02), and inattentive subscale score (22.18 ± 3.56 vs. 25.27 ± 5.06, P< 0.01), compared with the waitlist group. Repeated measures analyses of variance revealed significant interactions between time and group on the BRIEF inhibition subscale (F = 5.06, P= 0.03), working memory (F = 4.48, P= 0.04), ADHD-IV overall score (F = 21.72, P< 0.01), HI subscale score (F = 19.08, P< 0.01), and inattentive subscale score (F = 12.40, P< 0.01). Multiple-way analysis of variance showed significant differences on all variables of BRIEF, ADHD-rating scale-IV, and WEISS Functional Impairment Scale-Parent form (WFIRS-P) among the intervention and waitlist groups at posttreatment and HCs at baseline.
CONCLUSIONSThis randomized controlled study on executive skill training in a relatively large sample provided some evidences that the training could improve EF deficits, reduce problematic symptoms, and potentially enhance the social functioning in school-aged children with ADHD.
CLINICAL TRIAL REGISTRATIONhttp://www.clinicaltrials.gov; NCT02327585.
6.A Centralized Report on Pediatric Japanese Encephalitis Cases from Beijing Children's Hospital, 2013.
Jiu Wei LI ; Xiao Yan GAO ; Yun WU ; Shi Hong FU ; Xiao Juan TAN ; Yu Xi CAO ; Wei Hua ZHANG ; Zun Dong YIN ; Ying HE ; Yi Xing LI ; Guo Dong LIANG ; Wen Bo XU ; Fang FANG ; Huan Yu WANG ;
Biomedical and Environmental Sciences 2016;29(12):902-908
Fifteen pediatric cases of suspected Japanese encephalitis (JE) were reported in Beijing Children's Hospital during the late summer of 2013. The clinical manifestations in most cases included high fever, seizures, and abnormal magnetic resonance imaging findings. Twelve of 15 cases were laboratory-confirmed as JE cases by pathogen identification. Epidemiological investigations showed that five of the 12 laboratory-confirmed patients had an incomplete JE vaccination history. Follow-up investigations after discharge indicated that seven laboratory-confirmed JE patients without JE vaccinations had relatively poor prognoses, with an average Modified Rankin Scale (MRS) score of 2.6 when compared with the other five laboratory-confirmed, JE-vaccinated patients with an average MRS score of 0.5. The observation of pediatric JE cases among those with a history of JE vaccination warrants further attention.
Beijing
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epidemiology
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Child
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Child, Preschool
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Encephalitis Virus, Japanese
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physiology
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Encephalitis, Japanese
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diagnosis
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epidemiology
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virology
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Female
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Humans
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Japanese Encephalitis Vaccines
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administration & dosage
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Male
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Prognosis
7.Cognitive Function of Children and Adolescents with Attention Deficit Hyperactivity Disorder and Learning Difficulties: A Developmental Perspective.
Fang HUANG ; Li SUN ; Ying QIAN ; Lu LIU ; Quan-Gang MA ; Li YANG ; Jia CHENG ; Qing-Jiu CAO ; Yi SU ; Qian GAO ; Zhao-Min WU ; Hai-Mei LI ; Qiu-Jin QIAN ; Yu-Feng WANG
Chinese Medical Journal 2016;129(16):1922-1928
BACKGROUNDThe cognitive function of children with either attention deficit hyperactivity disorder (ADHD) or learning disabilities (LDs) is known to be impaired. However, little is known about the cognitive function of children with comorbid ADHD and LD. The present study aimed to explore the cognitive function of children and adolescents with ADHD and learning difficulties in comparison with children with ADHD and healthy controls in different age groups in a large Chinese sample.
METHODSTotally, 1043 participants with ADHD and learning difficulties (the ADHD + learning difficulties group), 870 with pure ADHD (the pure ADHD group), and 496 healthy controls were recruited. To investigate the difference in cognitive impairment using a developmental approach, all participants were divided into three age groups (6-8, 9-11, and 12-14 years old). Measurements were the Chinese-Wechsler Intelligence Scale for Children, the Stroop Color-Word Test, the Trail-Making Test, and the Behavior Rating Inventory of Executive Function-Parents (BRIEF). Multivariate analysis of variance was used.
RESULTSThe results showed that after controlling for the effect of ADHD symptoms, the ADHD + learning difficulties group was still significantly worse than the pure ADHD group, which was, in turn, worse than the control group on full intelligence quotient (98.66 ± 13.87 vs. 105.17 ± 14.36 vs. 112.93 ± 13.87, P < 0.001). The same relationship was also evident for shift function (shifting time of the Trail-Making Test, 122.50 [62.00, 194.25] s vs. 122.00 [73.00, 201.50] s vs. 66.00 [45.00, 108.00] s, P< 0.001) and everyday life executive function (BRIEF total score, 145.71 ± 19.35 vs. 138.96 ± 18.00 vs. 122.71 ± 20.45, P < 0.001) after controlling for the effect of the severity of ADHD symptoms, intelligence quotient, age, and gender. As for the age groups, the differences among groups became nonsignificant in the 12-14 years old group for inhibition (meaning interference of the Stroop Color-Word Test, 18.00 [13.00, 25.00] s vs. 17.00 [15.00, 26.00] s vs. 17.00 [10.50, 20.00] s , P = 0.704) and shift function (shifting time of the Trail-Making Test, 62.00 [43.00, 97.00] s vs. 53.00 [38.00, 81.00] s vs. 101.00 [88.00, 114.00] s, P = 0.778).
CONCLUSIONSChildren and adolescents with ADHD and learning difficulties have more severe cognitive impairment than pure ADHD patients even after controlling for the effect of ADHD symptoms. However, the differences in impairment in inhibition and shift function are no longer significant when these individuals were 12-14 years old.
Adolescent ; Attention Deficit Disorder with Hyperactivity ; physiopathology ; Child ; Cognition ; physiology ; Cross-Sectional Studies ; Executive Function ; physiology ; Female ; Humans ; Intelligence Tests ; Learning Disorders ; physiopathology ; Male
8.Value of combined measurement of intestinal fatty acid-binding protein and fecal calprotectin in diagnosis of necrotizing enterocolitis in full-term neonates.
Yun-Fen TIAN ; Li LI ; Hong-Ying MI ; Chun-Rong HUANG-PU ; Shan HE ; Xiao-Yan XU ; Yong-Jiu CAO
Chinese Journal of Contemporary Pediatrics 2016;18(11):1080-1083
OBJECTIVETo study the value of combined measurement of intestinal fatty acid-binding protein (I-FABP) and fecal calprotectin (FC) in the diagnosis of necrotizing enterocolitis (NEC) in full-term neonates.
METHODSA total of 36 full-term neonates with NEC (case group) and 39 neonates without digestive system diseases (control group) were enrolled as study subjects. ELISA was used to measure the serum I-FABP level and fecal FC level, and the clinical value of I-FABP combined with FC in the diagnosis of NEC was evaluated.
RESULTSThe case group had significantly higher I-FABP and FC levels than the control group (P<0.05). In the case group, serum I-FABP level was positively correlated with fecal FC level (r=0.71, P<0.05). In the diagnosis of NEC, I-FABP alone, FC alone, and I-FABP/FC combination had sensitivities of 83.3%, 81.5%, and 79.5%, specificities of 72.5%, 75.8%, and 86.3%, and areas under the ROC curve (AUCs) of 0.82, 0.81, and 0.88. The combined measurement showed significantly higher specificity and AUC than single measurement (P<0.05).
CONCLUSIONSChildren with NEC have significant increases in I-FABP and FC levels, and there is a correlation between them. Combined measurement of I-FABP and FC can increase the specificity of the diagnosis of NEC.
Enterocolitis, Necrotizing ; diagnosis ; Fatty Acid-Binding Proteins ; blood ; Feces ; chemistry ; Female ; Humans ; Infant, Newborn ; Leukocyte L1 Antigen Complex ; analysis ; Male
9.A cohort study on the relationship between cerebrovascular hemodynamic changing and risk of stroke.
Ji-ping GUO ; Jiu-yi HUANG ; Yang-tai GUAN ; Hai-ying CHEN ; Yong-ju YANG ; Yin-ruo TAO ; Yi-feng CAO ; Ying XU ; Xue-hai YU
Chinese Journal of Preventive Medicine 2013;47(4):323-327
OBJECTIVETo study the role of cerebrovascular hemodynamic indexes (CVHI) changing in stroke and to provide reference for stroke prevention and risk factor study.
METHODSFrom 2003 to 2004, participants aged 40 years and above in two communities in Fengxian district were recruited by cluster sampling. Risk factors of stroke and CVHI were investigated and checked during baseline investigation. A total of 10 565 individuals completed the survey and met the inclusion criterion. After baseline investigation, the cohort was followed up for stroke occurrence. Relative risk (RR) of CVHI and common risk factors were estimated by cohort study design.
RESULTSAge of the cohort was (56.2 ± 11.4) years. 4444 (42.1%) were males and 6121 (57.9%) were females. Total follow-up duration was 67 885.7 person-years. A total of 195 stroke cases occurred and incidence density of stroke was 287.2 per 100 000 person-years. Stroke incidence in exposure groups of hypertension, heart disease and alcohol drinking was 3.47% (108/3118), 2.96% (21/710) and 2.50% (47/1882), respectively. The incidence in corresponding non-exposure group was 1.17% (87/7448), 1.77% (174/9855) and 1.70% (148/8683) respectively. There was significant difference between 2 groups (χ(2) value was 62.72, 4.56 and 4.94, respectively, P < 0.05). Stroke incidence in CVHI score < 25, 25 - 49, 50 - 74 and ≥ 75 groups was 9.12% (59/647), 5.68% (44/775), 2.52% (39/1545) and 0.72% (53/7403)(χ(2)trend = 273.57, P < 0.05), respectively. Incidence of stroke in 40 - 49, 50 - 59, 60 - 69, ≥ 70 years age group was 0.22% (8/3565), 1.28% (43/3357), 2.71% (50/1848) and 5.88% (94/1600) (χ(2)trend = 181.48, P < 0.05), respectively. Multiple Cox regression analysis indicated that RR (95%CI) value of hypertension and cigarette smoking was 1.40(1.02 - 1.92) and 1.59(1.19 - 2.12), respectively when comparing with non-exposure group. RR (95%CI) value in CVHI score < 25, 25 - 49 and 50 - 74 points group were 6.15 (4.08 - 9.26), 4.55 (2.98 - 6.96) and 2.68 (1.75 - 4.09), respectively when comparing with the score ≥ 75 points group. RR (95%CI) value in age 50 - 59, 60 - 69 and ≥ 70 years group was 4.61 (2.16 - 9.82), 7.81 (3.67 - 16.60) and 13.49(6.44 - 28.24), respectively when comparing with below 40 years group.
CONCLUSIONCVHI score is the strong independent predictive factor and hypertension, cigarette smoking and age are the independent risk factors of stroke.
Aged ; Brain ; physiopathology ; Cohort Studies ; Female ; Hemodynamics ; Humans ; Male ; Middle Aged ; Risk Factors ; Stroke ; epidemiology ; etiology ; physiopathology
10.Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial.
Jian-Hui ZHOU ; Zhao-Hui NI ; Chang-Lin MEI ; Xue-Qing YU ; Fu-You LIU ; Li-Ning MIAO ; Zhi-Hong LIU ; Wei-Jie YUAN ; Ai-Ping ZHANG ; Hong-Li LIN ; Meng-Hua CHEN ; Jiang-Hua CHEN ; Jin-Yuan ZHANG ; Ya-Ni HE ; Jian CHEN ; Jiu-Yang ZHAO ; Xiao-Qiang DING ; Ying LI ; Rong-Shan LI ; Ru-Juan XIE ; Wen-Hu LIU ; Chang-Ying XING ; Rong WANG ; Yue-Yi DENG ; Xue-Ying CAO ; Guang-Yan CAI ; Shan MOU ; Zhi-Guo MAO ; Xiao YANG ; Hong LIU ; Jing SUN ; Yu-Sheng YU ; Jun LIU ; Shu-Mei SHI ; Long-Kai LI ; Na TIAN ; Xiao-Hui ZHANG ; Wei ZHOU ; Jie YANG ; Yong ZHANG ; Jing-di SUN ; Jun JI ; Tao ZHANG ; Yan YAN ; Xiao-Gang LIU ; Gang WANG ; Li ZHANG ; Hong ZHANG ; Jian-Hua LUO ; Xiang-Mei CHEN
Chinese Medical Journal 2013;126(22):4204-4209
BACKGROUNDA multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions. Some researchers believe that 6 L/d is enough for adequate dialysis, but there is no multi-center prospective study on Chinese population to confirm this. In this study, we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage.
METHODSAdult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages, i.e., 6 L dose with Changfu dialysis solution, 6 L dose with Baxter dialysis solution, 8 L dose with Changfu dialysis solution, and 8 L dose with Baxter dialysis solution. After 48 weeks, the changes of primary and secondary efficacy indices were compared between different types and different dosages. We also analyzed the changes of safety indices.
RESULTSChanges of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr). Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR). Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR. The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group. Change of Ccr was similar. During the 48-week period, the mean Kt/V was above 1.7/w, and mean Ccr was above 50 L×1.73 m(-2)×w(-1). More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization, and the statistical differences disappeared after that.
CONCLUSIONSThe domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution. During 48-week period, a dosage of 6 L/d was enough for these patients to reach adequate PD. Clinical study promotes technological optimization, further helps to improve the safety indices of the medical products.
Adolescent ; Adult ; Aged ; Dialysis Solutions ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Peritoneal Dialysis ; methods ; Young Adult

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