OBJECTIVETo systematically evaluate the effectiveness of integrative medicine (IM) for preventing postoperative recurrence of primary hepatic carcinomas (PHC).

METHODSSuch databases as The Cochrane Library, PubMed, EMbase, China National Knowledge Infrastructure (CNKI), VIP Database, Wan-fang Database were retrieved to collect randomized controlled trials (RCTs) on preventing postoperative recurrence of PHC by IM. The retrieval period started from database establishment to June 2013. Literature screening, data extraction, and quality evaluation were performed by two reviewers strictly according to inclusion criteria. Meta-analysis was conducted using RevMan 5.2 Software.

RESULTSA total of 5 RCTs involving 367 patient cases were included. Results of Meta-analysis showed that the IM group was superior to the Western medicine (WM) group in the 1-, 2-, and 3-year recurrence rates (P < 0.05).

CONCLUSIONIn the prevention of postoperative recurrence of PHC, the effectiveness of IM was more significant, when compared with treatment of Western medicine.

Drugs, Chinese Herbal ; therapeutic use ; Humans ; Integrative Medicine ; Liver Neoplasms ; prevention & control ; Neoplasm Recurrence, Local ; prevention & control ; Postoperative Period ; Randomized Controlled Trials as Topic ; Treatment Outcome

Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.
China ; Data Collection ; standards ; Documentation ; standards ; Information Storage and Retrieval ; methods ; standards

Objective To investigate the clinical efficacy of intraoperative methylprednisolone used in combination with perioperative enteral nutrition support in improving liver synthetic function after hepatectomy and postoperative recovery.Methods In this prospective controlled trial,79 patients treated with hepatectomy at Departement of Hepatobiliary Pancreatic Surgery in Drum Tower Hospital between June 2013 and May 2014 were included and divided into control group (n =39) and steroid group (n =40) according to the order of surgery.The control group underwent hepatectomy only,while the steroid group received intraoperative methylprednisolone (500 mg) at the start of liver excision.Both of the two groups were given the same perioperative enteral nutrition support.Liver function,prealbumin (PA),and C-reactive protein (CRP) levels were measured before and on days 1,3,and 5 after the operation.Human blood albumin infusion volume,postoperative gas passing,postoperative hospital stay,and incidence of complications were recorded.Results The serum level of PA on day 3 after hepatectomy was significantly higher in the steroid group than in the control group [(101.26 ±61.17) mg/L vs.(81.84 ±43.58) mg/L,t =-1.607,P =0.049].The serum level of cholinesterase on day 1 after hepatectomy was significantly higher in the steroid group than in the control group [(5.60±1.54) kU/Lvs.(4.68±1.01) kU/L,t=-3.136,P=0.004].On day1 and day 3 after hepatectomy,the serum levels of CRP were significantly lower in the steroid group than in the control group [(41.79 ±20.86) mg/L vs.(62.08 ±38.33) mg/L,t =2.933,P=0.027;(64.14 ±32.38) mg/L vs.(102.64 ± 49.05) mg/L,t =4.127,P =0.006].The postoperative hospital stay was significantly shorter in the steroid group than in the control group [(12.62 ±5.74) d vs.(15.41 ± 10.00)d,t =1.514,P =0.002].Conclusion Intraoperative use of methylprednisolone combined with perioperative enteral nutrition support may inhibit postoperative inflammatory response,promote early recovery of liver synthetic function,and help to promote rehabilitation after hepatectomy.

Objective To observe the Th17, IL-17 and Tr cells equilibrium state as well as their changes of HIV infected or AIDS suffered patients in one-year HAART treatment. Methods Select 33 HIV/AIDS patients received HAART treatment while 33 healthy volunteers as controls. Flow cytometry was used to analyze Th17 and Tr cells in venous blood at the time of pre-therapy, 6th, 12th month when IL-17 levels in serum are tested by ELISA. Results The ratio of Th17 cells in CD4 cells in HIV/AIDS patients and volunteers were (1.20±0.37)%, (2.50±1.03)%, (3.70±1.56)%, (4.70±1.43)%, respectively; The ratio of Tr cells were (9.16±3.33)%, (7.19±2.91)%, (5.53±1.88)%, (4.43±0.97)%, respectively; The levels of IL-17 in serum were (5.3±2.5) pg/ml, (7.7±2.4) pg/ml, (10.4±3.1) pg/ml, (17.7±6.6) pg/ml respectively. The Th17 cells' level was positively correlative with the amount of CD4 cells, negatively correlate with the count of viral load. However, the Tr cells level is positively correlative with the count of viral load, negatively relate to the quantity of CD4 cells. Conclusion HIV could make IL-17, Th17 cells and Tr cells lost their balance, but the immune equilibrium state may gradually recover after HAART treatment. Which indicates the IL-17, Th17 cells and Treg cells may play an important role in the pathogenesis of AIDS, and they are likely to be the effective indexes to observe the progress of AIDS and the treatment effect of highly active antiretroviral therapy(HAART).

Objective　To investigate the expression of glial fibrillary acidic protein (GFAP) gene and its significance in the process of glioma cell differentiation induced by nordihydroguaiaretic acid (NDGA). Methods　Immunohistochemistry (IHC) and in situ hybridization were used to detect the expression changes of GFAP protein and GFAP mRNA qualitatively and quantitatively. Results　The expression levels of GFAP protein and GFAP mRNA in NDGA treatment group were significantly increased compared with the control group (P<0.01). Conclusion　NDGA could induce GFAP gene in malignant glioma cells and the up-regulation of this gene expression might be one of the mechanisms by which NDGA induces glioma differentiation.

OBJECTIVEThis study aimed to explore the scene-trait coping style of military rescuers in Wenchuan earthquake in an effort to provide scientific evidences for mental intervention program for Chinese military personnel.

METHODSBy cluster sampling, a total of 151 military rescuers and 331 control servicemen were administered the military personnel scene-trait coping style scale (MPSTCSS).

RESULTSAll active coping factor scores, and passive coping factor scores of affection, health and economy in the rescuer group were significantly higher than those in control group (P < 0.05). The 21-above age subgroup, the 3-year plus service subgroup, and the officer subgroup had significantly higher active coping factor scores on military tasks, military experience and personal development than those of the 21-below age subgroup, 3-year minus service subgroup and the soldier subgroup, respectively (P < 0.05 or P < 0.01).

CONCLUSIONThe earthquake relief servicemen can cope with stressful situations better than control group by taking active coping style. The officers, servicemen older than 21 years, and servicemen with more service duration than 3 years could usually take active coping style.

Adaptation, Psychological ; Disasters ; Earthquakes ; Humans ; Military Personnel ; psychology ; Stress, Psychological

OBJECTIVETo identify the distribution and differentiation of ABL kinase domain mutation in the Chinese Han nationality imatinib resistant chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+)ALL).

METHODSBone marrow or peripheral blood samples of 112 imatinib resistant CML patients and 21 Ph(+)ALL patients were obtained from the first affiliated hospital of Soochow university according to local law. Total RNA was extracted from the mononuclear cells using a TRIzol reagent. ABL kinase domain (KD) mutation was detected by direct sequencing.

RESULTSOf the 112 imatinib resistant CML patients, 54.46%(61 cases) had ABL KD mutation. Twenty-three mutants were identified in 20 amino acid sites and 23.21% (26 cases) ABL KD mutations were in P-loop region. ABL KD mutations were also detected in 71.43% (15 cases) imatinib resistant Ph(+)ALL patients, with 10 mutations in 8 amino acid sites. The most frequent mutation was T315I (28.57%), followed by E255K/V (19.05%) and Y253F/H (14.29%). The frequency of T315I was much higher in imatinib resistant Ph(+) ALL than that in imatinib resistant CML (P = 0.001). Ph(+)ALL with additional chromosomal aberrations also had a higher rate of ABL KD mutation than that of CML (P = 0.010). Ph(+)ALL gained ABL KD mutation faster than CML (P < 0.010).

CONCLUSIONChinese imatinib resistant CML and Ph(+)ALL patients had different characteristics in ABL KD mutation. The rate of ABL KD mutation in Ph(+)ALL with additional chromosomal aberrations was much higher than that of CML with additional chromosomal aberrations.

Adolescent ; Adult ; Aged ; Asian Continental Ancestry Group ; genetics ; Benzamides ; pharmacology ; Chromosome Aberrations ; Drug Resistance, Neoplasm ; genetics ; Female ; Humans ; Imatinib Mesylate ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive ; genetics ; Middle Aged ; Mutation ; Philadelphia Chromosome ; Piperazines ; pharmacology ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; genetics ; Protein-Tyrosine Kinases ; genetics ; Proto-Oncogene Proteins c-abl ; genetics ; Pyrimidines ; pharmacology ; Young Adult

OBJECTIVETo study the efficacy of bedside treatment by laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU).

METHODSThe clinical data of 30 cases of ROP who underwent peripheral laser ablation on bedside in the NICU from March to August 2009 were studied retrospectively.

RESULTSA total of 59 eyes from 30 patients received the laser therapy, with a total cure rate of 95%. According to the International Classification of ROP, 26 eyes of 13 infants had zone 1 disease, and 33 eyes of 17 infants had zone 2 disease. The birth gestational age and birth weight as well as corrected gestational age and corrected weight at operation in the zone 1 disease group were significantly lower than those in the zone 2 disease group. The number of laser spots in the zone 1 disease group was significantly higher than that in the zone 2 disease group. The cure rate in the zone 2 disease group (100%) was significantly higher than that in the zone 1 disease group (88%).

CONCLUSIONSLaser retinal photocoagulation on bedside in the NICU is effective for both zone 1 and zone 2 ROP. As compared with the infants with zone 2 disease, the infants with zone 1 disease may have a poor outcome.

Birth Weight ; Female ; Gestational Age ; Humans ; Infant, Newborn ; Laser Coagulation ; Male ; Retinopathy of Prematurity ; surgery

Objective To investigate the immunological pathogenesis of immune reconstitution inflammatory syndrome (IRIS) during highly active antiretroviral therapy( HAART), in this prospective cohort study we analyzed the lymphocyte subsets, lymphocyte activation, changes in regulatory T cells, and levels of Th1 and Th2 cytokines in both IRIS and non-IRIS groups. Methods Two hundred and thirty-eight AIDS patients received HAART and participated prospective research cohort for 24 weeks follow-up. Forty-seven IRIS cases and 191 non-IRIS cases were enrolled in the IRIS group or non-IRIS group respectively. Blood samples were collected in both groups at pre- and post-HAART 12 weeks, 24 weeks. Using flow cytometer to detect the immunophenotypes of lymphocyte subsets (CD4 + CD45RA+ CD62L+, CD8+ CD45RA+ CD62L+naive T cells; CD4+ CD45RO+, CD8+ CD45RO+ memory T cells), activated T lymphocytes (CD4+CD38 +, CD8 + CD38 + cells), and regulatory T cell ( CD4 + CD25 + Foxp3 + ). Blood samples collected at pre-and post-HAART4 weeks, 12 weeks, 24 weeks and used ELISA to detect IL-2, IFN-γ, IL-4, IL-10and IL-7 cytokine serum levels. Results The percentages of CD4 + and CD8 + naive T cells and mlemory T cells exhibited no significant differences at the baseline, 12 weeks, 24 weeks of HAART initiation between both groups, but CD4 + and CD8 + memory T cells were demonstrated a trend towards to increase while compared to baseline during HAART. The percentages of CD4 + and CD8 + activated T cells are significantly higher at the baseline while compared to normal control and demonstrated a downward trend, but between both groups showed no significant difference. The percentages of CD4 + regulatory T cell was lower in IRIS group than non-IRIS group at the baseline, 12 weeks, 24 weeks and the onset of IRIS. Th1 cytokines, IL-2 and IFN-γshowed an upward trend during HAART at the levels of IRIS group had significantly increased at 4 weeks and the onset of IRIS. Th2 cytokines, IL-4 and IL-10 showed a downward trend during HAART,and the levels of IL-10 in IRIS group had significantly decreased at 4 weeks and the onset of IRIS. IL-7 was higher than normal control at the baseline in two groups and showed a downward trend during HAART. The level of IL-7 was higher than non-IRIS group at all follow-up points. Conclusion Memory T cells appear rapid increase in the early stage of HAART and may play a significant role in the inflammatory response of IRIS. CD4 + and CD8 + naive T cells, memory T cells and activated T cells showed no significant difference between IRIS and non-IRIS group within 24 weeks after HAART started. There was a significant reduction in the frequency of regulatory T cells in IRIS group without obvious upward trend during HAART, suggesting that the immune suppression function of regulatory T cells in IRIS was impaired. IL-2 and IFN-γ significantly increased while IL-10 significantly decreased at 4 weeks post-HAART initiation and onset of IRIS in IRISgroup than non-IRIS group, suggested that IRIS was related to cytokines environment disorder. That is, a significant increase in inflammatory cytokines, while the relative lack of non-inflammatory cytokines. The level of IL-7 decreased gradually after HAART started, and it was higher in IRIS group when compared to non-IRIS group in the first 24 weeks after HAART started. Also IL-7 may play a role in the pathogenesis of IRIS.

OBJECTIVETo study the expression of CXCR4 in acute leukemic cells and its clinical significance.

METHODBone marrow samples from 73 acute leukemia patients and leukemic cell lines were investigated by flow cytometry (FCM), the expression of SDF-1 in human marrow stromal cells and meninges were studied by using reverse transcription polymerase chain reaction (RT-PCR). Adhesion, migration and invasion of U937, NB4 and K562 cells were studied in vitro.

RESULTSThe expression rates of CXCR4 in ALL and AML patients was 65.6% and 17.1%, respectively. And it was 0.2%, 41.0% and 52.0% in K562, U937 and NB4 cells, respectively. The extramedullary infiltration rates were 61.9% and 18.2% for CXCR4 positive and negative groups of ALL, respectively (P < 0.05); while in AML, the number of peripheral white blood cells in CXCR4 positive group was lower than that in CXCR4 negative group (P < 0.05). SDF-1alpha could enhance the adhesion, migration and invasion capacity of leukemic cells in vitro.

CONCLUSIONOverexpression of CXCR4 in AL cells might be the molecular mechanism of extramedullary infiltration in leukemia.

Acute Disease ; Adolescent ; Adult ; Aged ; Bone Marrow Cells ; metabolism ; pathology ; Cell Adhesion ; Cell Line, Tumor ; Cell Movement ; Chemokine CXCL12 ; genetics ; Female ; Fibroblasts ; metabolism ; pathology ; Flow Cytometry ; Gene Expression Regulation, Neoplastic ; Humans ; K562 Cells ; Leukemia ; genetics ; metabolism ; pathology ; Leukemic Infiltration ; metabolism ; pathology ; Male ; Meninges ; metabolism ; pathology ; Middle Aged ; Receptors, CXCR4 ; biosynthesis ; Reverse Transcriptase Polymerase Chain Reaction ; U937 Cells