1.Thinking on Several Ethical Problems in the Clinical Research
World Science and Technology-Modernization of Traditional Chinese Medicine 2013;(4):721-724
This study was conducted in the First Affiliated Hospital of Zhejiang Chinese Medical University for the project of Establishment and Assessment of Ethics Review Platform for TCM Clinical Research. The Ethics Review Platform for Clinical Research is a complete system, which is a Participant Protection System. It includes four as-pects, which are the medical and health institution, ethics committee, ethics committee office, research departments and researchers. In this system, the establishment of research departments and researchers platform is the most cru-cial part. All treatment, protection, risk control, adverse event supervision, which are closely related to the Partici-pant Protection System are completed by researchers. However, during the assessment process, a series of problems were found, such as the current weak ethical consciousness of researchers, less familiar with ethical review process and do not pay equal attention to the participant protection as clinical research. This kind of problem was also found in other hospital assessments in China, which has become a short board of the Participant Protection System.Therefore, from the aspect of the ethics committee, this article presented several ethics problems which should be paid more attention to by researchers such as participant protection, plan design and conduction during the clinical research and also gave some useful advices to change the situation, according to the Assessment Standard of Ethics Review Platform for TCM Clinical Research. In this way, researchers will develop their ethical consciousness and be more familiar with the ethics review process in order to complete key task of participant protection.
2.Atrial flutter in a neonate.
Ge SUN ; Meng-xia LI ; Yi CHEN
Chinese Journal of Pediatrics 2003;41(12):888-888
3.A single center retrospective study on hospitalization information for 812 cases of very low birth weight and ex-tremely low birth weight infants
Yi ZHANG ; Yang CHEN ; Shiwen XIA
Chinese Journal of Applied Clinical Pediatrics 2016;31(23):1822-1825
Objective To analyze the survival rate and hospitalization information for 81 2 cases of very low birth weight (VLBW)and extremely low birth weight (ELBW)infants.Methods The retrospective study was con-ducted in a single center,Department of Neonatology,Hubei Women and Children Hospital,from January 2009 to De-cember 201 4,where the data of 81 2 infants with birth weight(BW)less than 1 500 g was analyzed in regard to perinatal condition,treatment and complications of these in relation to prognosis.Results (1 )A total of 621 cases(76.5%) had favorable prognosis.(2)There was a significant difference in the favorable prognosis rate between different BW groups (χ2 =28.87,P <0.05)and different gestational age(GA)groups (χ2 =1 4.77,P <0.05).The favorable prog-nosis rate for the male infants(χ2 =4.69,P <0.05),puerpera age between 1 7 -25 and 36 -46 years old (χ2 =1 1 .1 9, P <0.05),usage of prenatal hormones(χ2 =8.02,P <0.05),the infants without intrauterine infection (χ2 =8.61 ,P <0.05),the mother without gestational hypertension (χ2 =7.20,P <0.05)and gestational diabetes mellitus(χ2 =1 9.2, P <0.05)were different compared to the control groups.(3)Infants with peripherally inserted central catheter (PICC) (χ2 =33.31 ,P <0.05)and recovery birth weight within 1 0 days(χ2 =29.65,P <0.05)had higher favorable prognosis rate compared to the control groups,which had significant differences.(4)Infants with intraventricular haemorrhage (IVH)(χ2 =1 3.1 6,P <0.05),respiratory distress syndrome (RDS)(χ2 =7.59,P <0.05),necrotizing enterocolitis (NEC)(χ2 =1 3.02,P <0.05)and serious asphyxia (χ2 =6.05,P <0.05)had lower favorable prognosis rates than those did not,with significant differences.(5)Logistic analysis:the lower BW,smaller GA,earlier birth,unused PICC, serious asphyxia,IVH,RDS were risk factors for poor prognosis(all P <0.05).Conclusions The favorable prognosis rate of VLBW and ELBW infants has improved gradually,and is closely related to GA,BW,maternal age,perinatal care,prevention complication,treatment of disease and social factors etc.
4.A research on clinical literature of cupping therapy
Chunyan LI ; Bo CHEN ; Xia LI ; Zelin CHEN ; Yi GUO
International Journal of Traditional Chinese Medicine 2012;34(6):539-541
This paper evaluates the quality of clinical literature on cupping therapy,analyzes the key factors that influencing the effects of cupping therapy,studies the operation position,tools,accompanied therapy,cupping,cupping frequency,course and other factors in the clinical application of cupping therapy,aiming to provide reference for clinical practice.
5.Effects of astragalus polysaccharides on lipid metabolism and PPAR-α gene expression in myocardium of diabetic hamsters
Wei CHEN ; Wenjie CHEN ; Yanping XIA ; Yi LU ; Maohua YU
Fudan University Journal of Medical Sciences 2010;37(2):194-197,215
Objective This article was designed to observe the effects of astragalus polysaccharides (APS) on glucose and lipid metabolism, and on expressions of proxisome proliferator activated receptors-α (PPAR-α) and its downstream genes in diabetic hamsters cardiomyopathy. Methods Forty-five hamsters were divided into 3 groups randomly: normal control group (15 normal hamsters), diabetic control group [15 streptozotocin (STZ)-induced diabetic hamsters], and astragalus polysaccharides (APS)-therapy group (15 STZ-induced diabetic hamsters administered with APS 2 g/kg per day orally for 10 weeks). The levels of insulin, C-peptide, myocardial enzymes, glycosylated serum protein (GSP) and lipoprotein of all hamsters were measured. The ultrastructure of myocardium was studied, and the gene and protein expressions of PPAR-α, FATP and ACS were also detected by fluorescent quantitative RT-PCR and Western blot. Results It was shown that Compared with DM group, the levels of GSP, myocardial enzymes and lipoprotein of hamsters in APS-therapy group were lower, the myocardial ultrastructure of hamsters in APS-therapy group was well-protected, and the gene and protein expression of PPAR-α, FATP and ACS of hamsters in APS-therapy group were higher. Conclusions APS is partly effective in treating diabetic cardiomyopathy.
6.Applications of global left ventricular myocardial strain in detection of anthracycline-induced cardiotoxicity in breast cancer survivors with postoperative chemotherapy
Yong HAN ; Yun DONG ; Yi LIU ; Lianghua XIA ; Ming CHEN
Chinese Journal of Ultrasonography 2014;23(2):104-108
Objective To assess the clinical significance of three-dimensional speckle tracking imaging (3D-STI) in the evaluation of left ventricular myocardial function in breast cancer survivors with postoperative anthracycline-based chemotherapy.Methods A total of 51 breast cancer survivors with postoperative anthracycline-based chemotherapy were recruited and 31 female healthy volunteers as the controls.Conventional echocardiography and 3D-STI derived parameters [including global longitudinal strain (GLS) and global area strain (GAS)] were measured before and at 3 and 6 anthracycline-based chemotherapeutic cycles.The receiver operating characteristics (ROC) curve was constructed to determine optimal sensitivity and specificity of 3ID-STI derived parameters for the prediction of future cardiotoxicity.Results In comparison with the controls and baseline cases,GLS and GAS deteriorated significantly (P < 0.05 for both).No statistical difference in GCS and conventional parameters showed before and after the initiation of chemotherapy (P <0.05,respectively).The ROC curves showed that GAS as the best 3D-STI predictor of patients who develop cardiotoxicity during the follow-up.The area under ROC(AUC) of GAS was 0.894,and its optimal cut-off value was-28.4%,with a specificity of 88.0% and a sensitivity of 82.9%.AUC of GLS was 0.802,and its optimal cut-off value was-14.3%,with a specificity of 62.0% and a sensitivity of 85.4%.Conclusions Early decreases in GAS and GLS based on 3D-STI may allow the prediction of subsequent cardiotoxic development accurately in breast cancer survivors with postoperative anthracycline-based chemotherapy.
7.Analysis of the newborns who transferred from other hospitals and occurrence of adverse outcomes from 2008 to 2011
Yi ZHANG ; Shiwen XIA ; Yang CHEN ; Pei ZHANG
Chinese Pediatric Emergency Medicine 2014;21(1):6-9
Objective To analyze the characteristics of newborns in occurrence of adverse outcomes that transferred from other hospitals during the past four years,in order to improve the province's perinatal survival quality and reduce mortality.Methods The clinical data of 255 cases in occurrence of adverse outcomes in transit during January 2008 to December 2011 were analyzed retrospectively.According chronologically 255 cases were divided into group A (124 cases,January 2008 to December 2009) and group B (131 cases,January 2010 to December 2011).We analyzed the basic data,perinatal factors and major diseases of the newborns,and compared the changes of related characteristics in different periods.Results Adverse outcomes in male patients were significantly higher than female patients (male:female 3.05:1,192:63) ; there were higher proportion of premature infants (73.3%,187/255) and cesarean section (49%,125/255).The major diseases were respiratory system diseases (71.4%,182/255),followed by circulatory system diseases (40.4%,103/255),and severe congenital abnormalities (26.3 %,67/255).Group B compared with group A:(1) the proportion of hospitalization time < 24 hours increased (73/131 vs 50/124,P < 0.05) ; (2) the proportion of more than two referrals increased (41 / 131 vs 23/124,P < 0.05) ; (3) the proportion of very low birth weight infants (including extremely low birth weight) increased significantly (75/131 vs 43/124,P < 0.05) ; (4) the proportion of respiratory system diseased (131 / 131 vs 124/124),asphyxia (9/131 vs 22/124) and hypoxic ischemic encephalopathy (6/131 vs 16/124) decreased significantly (P < 0.05) ;(5) the proportion of circulation system diseased (60/131 vs 31 / 124) and congenital developmental abnormalities (51/131 vs 23/124) increased significantly (P < 0.05) ;(6) the application of mechanical ventilation (115/131 vs 88/124) and pulmonary surfactant (85/131 vs 52/124) increased significantly (P < 0.05) ;(7) the usage of blood products decreased significantly (39/131 vs 53/124,P < 0.05) ; (8) giving up treatment due to economic reasons reduced significantly (22/131 vs 37/124,P < 0.05).Conclusion For the grassroots medical institutions,the choice of transport time and referral hospital may affect the incidence of adverse outcomes; the high rate of cesarean section may increase the incidence of adverse outcomes; the treatment capacity of extremely low and very low birth weight infants may directly affect the incidence of adverse outcomes ; the respiratory system diseases greatly impact on adverse outcomes,but the accompanied circulatory system diseases impact on adverse outcomes increased in recent years.
8.Expressions of S1P1-3 in the corpus cavernosum of castrated male rats.
Xue-qin CHEN ; Ji-yi XIA ; Bo CHENG ; Rui JIANG
National Journal of Andrology 2016;22(5):393-400
OBJECTIVETo investigate the expressions of sphingosine-1-phosphate receptors 1-3 (S1P1- 3) in the corpus cavernosum of castrated male rats and its relationship with the NOS/NO/cGMP and RhoA/Rho kinase signaling pathways.
METHODSWe equally randomized 18 eight-week-old healthy male SD rats into a sham-operation control, a castration, and a testosterone replacement (TR) group and harvested the bilateral testes and epididymides from the rats in the latter two groups, followed by 4 weeks of subcutaneous injection of testosterone propionate at 3 mg per kilogram of the body weight per day for those in the TR group and that of plant oil for those in the control and castration groups. At the age of 12 weeks, we measured the serum testosterone (T) level and maximum intracavernous pressure/mean arterial pressure (ICPmax/MAP) of the animals and determined the expressions of SlP1-3, eNOS, P-eNOS, ROCK1, and ROCK2 in the corpus cavernosum by Western blot and immunohistochemistry.
RESULTSThe serum T level was significantly decreased in the rats of the castration group as compared with those of the control and TR groups ([0.41 ± 0.04] vs [16.01 ± 1.02] and [15.84 ± 1.32] nmol/L, P < 0.01), with no statistically significant difference between the latter two groups. The ICPmax/MAP at 0 V, 3 V, and 5 V electric stimulation was remarkably lower in the rats of the castration group (0.088 ± 0.014, 0.323 ± 0.014, and 0.432 ± 0.012) than in those of the control group (0.155 ± 0.011, 0.711 ± 0. 010, and 0.819 ± 0.024) and TR group (0.153 ± 0.012, 0.696 ± 0.017, and 0.763 ± 0.027) (P < 0.01), with no significant difference between the latter two groups. With GAPDH as internal control, the animals of the castration group showed markedly reduced expressions of S1P1 ([49.99 ± 3.39]%), eNOS ([46.82 ± 3.81]%) , and P-eNOS ([45.42 ± 4.35]%) in comparison with those in the control group ([72.57 ± 3.06], [89.76 ± 3.98], and [82.53 ± 8.92] and TR group ([71.77 ± 4.43], [87.19 ± 4.23], and [79.82 ± 7.38]%) (P < 0.01) , while the expressions of S1P2, S1P3, ROCK1, and ROCK2 were significantly upregulated in the castration group ([82.35 ± 4.13], [61.03 ± 5.14], [74.50 ± 4.02], and [69.83 ± 5.75]%) as compared with those in the control group ([41.67 ± 1.68], [31.66 ± 2.67], [35.69 ± 5.56], and [39.85 ± 7.17]%) and TR group ([42.80 ± 3.87], [32.25 ± 4.22], 38.06 ± 5.21], and [42.36 ± 4.44]%) (P < 0.01).
CONCLUSIONAndrogen deficiency induces significant reduction of ICPmax/ MAP in male rats, which is possibly associated with the decline of S1P1 in the corpus cavernosum, inhibition of the eNOS/NO/cGMP signaling pathway, increased expressions of S1P2 and S1P3, and activation of the RhoA/Rho kinase signaling pathway.
Animals ; Male ; Nitric Oxide Synthase Type III ; metabolism ; Orchiectomy ; Penis ; metabolism ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Receptors, Lysosphingolipid ; metabolism ; Testosterone ; blood ; pharmacology ; rho-Associated Kinases ; metabolism
9.The hemostatic and protective effect of human fibrin sealant on liver trauma in rats
Shaoqing XIA ; Han CHEN ; Yudong QIU ; Yi XUE
Chinese Journal of Biochemical Pharmaceutics 2001;22(2):76-78
Purpose The aim is to investigate the hemostatic and protective effect of fibrin sealant(FS) on liver trauma in rats.Methods On the surface of cracked wound(type Ⅰ) and resected wound(type Ⅱ),spraying of FS or thrombin or direct suturation, was used receptively. Natural hemostasis was used as control.During postoperation the hemostatic time and the state of wound healing on 1st, 4th, 7th,14th, 50th day were observed.Results Compared with the natural hemostasis,the hemostatical time of the FS group was shorter 86.0%(P<0.01)in liver trauma type Ⅰ and 79.0%(P<0.01)in liver trauma type Ⅱ.Compared with the thrombin group,the hemostatical time of the FS group was shorten 45.0%(P<0.01)in liver trauma type Ⅰ and 84.0%(P<0.05) in liver trauma type Ⅱ.The wound surface of FS group was healed faster than that of other groups.Conclusion FS was an effective hemostatic and healing-promoter on liver trauma of rats.
10.Clinical and prognostic analyses of 77 childhood non-Hodgkin's lymphoma.
Xia GUO ; Yi-Ping ZHU ; Chen-Yan ZHOU
Chinese Journal of Hematology 2012;33(9):778-780
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Infant
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Lymphoma, Non-Hodgkin
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diagnosis
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pathology
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therapy
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Male
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Prognosis
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Retrospective Studies