1.Treatment of myocardial damage with creatine phosphate following neonatal asphyxia: a meta-analysis.
Po MIAO ; Bing SUN ; Xing FENG
Chinese Journal of Contemporary Pediatrics 2012;14(3):172-176
OBJECTIVETo evaluate the effects of creatine phosphate (CP) in the treatment of myocardial damage following neonatal asphyxia.
METHODSMedical databases were searched for a systematic literature review and meta-analysis of randomized and quasi-randomized trials on the treatment of myocardial damage with CP following neonatal asphyxia. The data was analyzed using Review Manager 5.1.
RESULTSSix trials involving 400 patients (CP treatment/control: 202/198) were included in the survey. The meta-analysis indicated that CP treatment for 7 days decreased serum myocardial enzyme levels (CK, CK-MB, LDH, HBDH and cTnI levels). Both the total effective rate (RR: 1.29; 95% CI: 1.12, 1.48) and the significantly effective rate (RR: 1.78; 95% CI: 1.32, 2.41) in the CP treatment group were significantly higher than in the control group. CP treatment reduced the hospitalization period by 4.07 days compared with the control group (95% CI: -5.25, -2.89).
CONCLUSIONSCP treatment appears to be more effective than routine treatment alone for myocardial damage following neonatal asphyxia. It appears to be safe and it can both decrease serum myocardial enzyme levels and shorten the period of hospitalization. However, as the evidence obtained in this study is not robust due to the poor quality of current studies, further studies of high-quality, large-scale trails are needed.
Asphyxia Neonatorum ; complications ; Cardiomyopathies ; drug therapy ; etiology ; Cardiotonic Agents ; therapeutic use ; Humans ; Infant, Newborn ; Length of Stay ; Myocytes, Cardiac ; pathology ; Phosphocreatine ; therapeutic use ; Randomized Controlled Trials as Topic
2.Correlation between serum vitamin D level and severity of community acquired pneumonia in young children.
Jing REN ; Bin SUN ; Po MIAO ; Xing FENG
Chinese Journal of Contemporary Pediatrics 2013;15(7):519-521
OBJECTIVETo study the correlation between serum vitamin D level and severity of community acquired pneumonia (CAP) in young children, and explore related risk factors for CAP.
METHODSOne hundred and three children with CAP between October 2011 and April 2012 were enrolled in the study, including 15 cases of severe CAP and 88 cases of mild CAP. Ninety healthy children were used as the control group. 25-(OH)D(3) concentrations were measured by enzyme linked immunoassay.
RESULTSThe mean vitamin D concentration in the severe CAP group was significantly lower than in the mild CAP and control groups (P < 0.01), and there was no significant difference between the mild CAP and control groups (P = 0.674). Premature birth and vitamin D < 50 nmol/L were risk factors for severe CAP in the multivariate analysis.
CONCLUSIONSVitamin D deficiency might be associated with the severity of CAP in young children.
Child, Preschool ; Community-Acquired Infections ; blood ; etiology ; Female ; Humans ; Infant ; Logistic Models ; Male ; Pneumonia ; blood ; etiology ; Severity of Illness Index ; Vitamin D ; analogs & derivatives ; blood ; Vitamin D Deficiency ; complications
3.Prevalence and influencing factors for cervical discomfort in medical staff
Qing-Po HU ; Shao-Yan LU ; Jian-Hong GU ; Hong MIAO ; Jing WANG
Journal of Preventive Medicine 2018;30(7):688-692
Objective To understand status and influencing factors for cervical discomfort in medical staff and to provide evidence for cervical spondylosis control. Methods We made a cervical discomfort questionnaire for medical personnel, including information about demography, life style, occupational hazard and symptoms of cervical discomfort. Then we carried out a survey from May to July 2017 in a hospital and used logistic regression model to analyze the influencing factors for cervical discomfort in medical staff. Results There were 965 medical staff participated in the survey, the response rate was 79.88% (965/1 208) . A total of 454 cases reported to have cervical discomfort, the prevalence was 47.05%. The results of multiple logistic regression analysis showed that years of service (OR4-10=2.551, 95% CI: 1.683-3.861; OR >10=1.767, 95% CI:1.325-2.358), air pollution in the workplace (ORgeneral=0.612, 95%CI: 0.418-0.898; ORno=0.684, 95%CI: 0.469-0.997), new business adaptability (OR=1.749, 95%CI: 1.325-2.309) were the influencing factors for cervical discomfort in medical staff. Conclusion The prevalence of cervical discomfort is high in medical staff. Years of service, working environment and new business adaptability are associated with cervical discomfort in medical staff.
4.Risk factors for prognosis of neonatal necrotizing enterocolitis: an analysis of 82 cases.
Lun YU ; Bin SUN ; Po MIAO ; Xing FENG
Chinese Journal of Contemporary Pediatrics 2013;15(12):1082-1085
OBJECTIVETo study the risk factors for prognosis of neonatal necrotizing enterocolitis (NEC).
METHODSA retrospective analysis was performed on the clinical data of 82 neonates with NEC confirmed between January 2008 and October 2012. The possible prognostic factors in NEC were investigated by logistic regression analysis.
RESULTSIn the 82 cases of NEC, the cure rate decreased with the aggravation of condition (P<0.05). The preterm infants had a significantly higher incidence of NEC than the full-term infants at three or more weeks after birth (P=0.004). The univariate analysis showed that the prognosis of NEC was related to the factors such as sepsis, congenital heart disease, scleredema, peritonitis, metabolic acidosis, hyponatremia, leukocyte disorder, thrombocytopenia, elevated C-reactive protein, and severe abdominal X-ray abnormalities (P<0.05), and the further logistic regression analysis revealed that congenital heart disease, scleredema, and metabolic acidosis were main risk factors for the clinical outcome of NEC (P<0.05).
CONCLUSIONSThe onset time of NEC is correlated with gestational age in neonates. There are multiple prognostic factors in NEC; special attention should be paid to the patients with congenital heart disease, scleredema, and metabolic acidosis so that early intervention is performed to reduce mortality.
Enterocolitis, Necrotizing ; mortality ; therapy ; Female ; Humans ; Infant, Newborn ; Logistic Models ; Male ; Prognosis ; Retrospective Studies ; Risk Factors
5.Changes in expression of autophagy-related proteins, Beclin-1 and LC3, and effects of rapamycin on their expression in hypoxic-ischemic hippocampus.
Rong-Hu LI ; Lun YU ; Po MIAO ; Xin DING ; Bin SUN ; Xing FENG
Chinese Journal of Contemporary Pediatrics 2015;17(4):400-404
OBJECTIVETo observe changes in the expression of autophagy-related proteins, Beclin-1 and LC3, in the hippocampal tissue of neonatal rats with hypoxic-ischemic brain damage (HIBD) at different time points, and to investigate the effect of rapamycin (Ra) on the expression of the above two proteins.
METHODSA total of 108 7-day-old Sprague-Dawley rats were randomly divided into sham, HIBD, and Ra groups (n=36 each). The HIBD model was established using the modified Rice method. For sham rats, only the left common carotid artery was separated without ligation or hypoxic treatment. For Ra-treated rats, 0.5 mg/kg Ra was administered by an intraperitoneal injection 1 hour before model establishment. The rats were anesthetized and sacrificed to collect brain tissues at 0, 6, 12, 24, 48, and 72 hours after model establishment. Changes in the expression of Beclin-1 and LC3 proteins in rat hippocampus were examined by Western blot.
RESULTSThe expression level of Beclin-1 in HIBD rats began to increase at 0 hour, peaked at 24 hours, and then declined thereafter, similar as those of Beclin-1 and LC3-II in Ra-treated rats. The expression level of LC3-II in HIBD rats began to increase at 0 hour, peaked at 12 hours, and then declined thereafter. At all time points, both Beclin-1 and LC3-II expression levels were significantly higher in HIBD and Ra-treated rats than in sham rats (P<0.05); except LC3-II at 12 hours, Beclin-1 and LC3-II expression levels were significantly higher in Ra-treated rats than in HIBD rats (P<0.05).
CONCLUSIONSHypoxia-ischemia activates autophagy in rat hippocampal cells, while Ra enhances the expression process of autophagy.
Animals ; Apoptosis Regulatory Proteins ; analysis ; Autophagy ; Beclin-1 ; Female ; Hippocampus ; chemistry ; Hypoxia-Ischemia, Brain ; metabolism ; Male ; Microtubule-Associated Proteins ; analysis ; Rats ; Rats, Sprague-Dawley ; Sirolimus ; pharmacology
6.Clinical study on the changes of plasma melatonin and stress factors in neonatal asphyxia
Ying WANG ; Po MIAO ; Jing REN ; Bin SUN ; Shuai CHENG ; Xin DING ; Xing FENG
Journal of Clinical Pediatrics 2018;36(3):170-174
Objective To explore the changes in plasma melatonin (MT) and glucocorticoid (GC) and the expressions of melatonin receptor 1 (MR1) and glucocorticoid receptor alpha (GR alpha) after neonatal asphyxia. Methods Full-term asphyxia neonates (22 cases of mild asphyxia, 28 cases of severe asphyxia) hospitalized from May 2014 to December 2015 were selected. Another 50 non-asphyxiated full-term newborns hospitalized with single disease such as infection and jaundice at the same time were selected as the control group. Peripheral blood samples were collected within 24 hours after birth and 7 days after birth, and plasma and mononuclear cells were separated. The plasma MT and GC expression levels were detected by ELISA. Real-time PCR was used to detect MR1 and GRα mRNA expression. Results The plasma GC concentrations in mild and severe asphyxia group increased significantly within 24 hours after birth, higher than that in control group. In addition, the plasma GC concentration in severe asphyxia group was significantly higher than that in mild group (P<0.05). The concentration of plasma GC in mild and severe asphyxia group decreased on the 7th day after birth (P<0.05) and was significantly lower than that at 24 hours after birth, but it was still higher in the severe asphyxia group than that in mild group; both the mild and severe asphyxia group had higher GC level than that in control group; the differences are statistically significant (P<0.05). Within 24 hours after birth, the plasma MT concentration in severe asphyxia group was lower than that in mild asphyxia group and control group, and there were significant differences (P<0.05). Compared with 24 hours after birth, the concentrations of plasma MT in severe and mild asphyxia groups increased significantly, higher than that in control group on the 7th day, and there were significant differences (P<0.05). The level of GR alpha mRNA expression decreased within 24 hours after birth in severe asphyxia group, but was increased in the mild asphyxia group, and there were significant differences among the three groups (P<0.05). The expression levels of GRα in both mild and severe asphyxia groups recovered on the 7th days after birth, and there were no significant differences compared with control group (P>0.05). Compared with 24 hours after birth , the expression level of MR1 mRNA in severe asphyxia group increased on the 7th day after birth, higher than that in control group and in mild asphyxia group, and there were significant differences (P<0.05). Conclusions The stress caused by severe asphyxia exceeds the adaptation range in the newborn, and results in the high expressions of MR1 and endogenous MT.
7. General considerations for clinical data management of antineoplastic drugs
Yadong MIAO ; Min ZHOU ; Xi LI ; Yan WANG ; Po GAO ; Hao YU
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(9):1055-1060
With the enormous resources having been invested in oncology drugs development in China in recent years, the Center for Drug Evaluation (CDE) of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials. As data is the cornerstone of clinical trials, data integrity and quality will directly decide the outcome of clinical studies. Given the specific characteristics of oncology therapeutic clinical trials, and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium (CDISC) and the issued industrial guidelines, this article introduces the general considerations of clinical data management for oncology clinical trials, with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study. This article discusses the impact of complex study design on CRF, design CRF according to CDASH, develop DVP scientifically, rolling submissions and data cut-off.