Objective:To investigate the current situation of damage compensation for subjects in drugs clinical trials.Methods: Retrospective analyzes was conducted on 70 drug clinical trail from January 2008 to December 2014 in our hospital , including protocols、informed consent and insurance .Results: It was written in most proto-cols that sponsor undertook damage compensation due to experimental drugs , however , lack of detailed rules .Dam-age compensation for subjects was missed in some informed consents .17 drugs clinical trials provided insurance , the rate of jointing insurance 24 .3%.In international trail , the rate of jointing insurance ( 100%) was higher than that in domestic trail (9.1%).As to domestic trail, the rate of jointing insurance increased gradually .There was no difference between insurance of different periods .In 17 insurance , 13 were clinical trial liability insurance , oth-ers were product and general liability insurance;5 provided insurance instruction , only insurance certificate or poli-cy in others;2 insurance applied foreign language .Conclusion:Through project access system , strengthening the ethical approval , strengthening quality management to prevent the damage occurred , participants damage happened after fully protect the health and rights and interests of the subjects , and actively promote clinical trial insurance to perfect our subjects′damage compensation mechanism , the protection of the rights of the subjects , and reduce the risk of clinical trials .

This project is to study chemical constituents of Rubus biflorus Buch (Chinese name "Fenzhimei"), isolated by silica gel chromatography and structure determined by spectroscopic techniques. Two flavones were isolated from Rubus biflorus Buch and identified as 8-methyl-6-(3"-methylbut-2"-enyl)-5, 7-dihydroxy-5'-methoxy-3', 4'-methylenedioxy flavone (A) and 8-methyl-5-methoxy-6,7-(2", 2"-dimethylpyran)-3', 4'-methylenedioxy-5'-(3'''-methylbut-2'''-enyl) flavone (B), named as fenzhimines A and B, respectively. Compounds A and B are two new flavonoids.
Flavones ; chemistry ; isolation & purification ; Molecular Structure ; Plants, Medicinal ; chemistry ; Rosaceae ; chemistry

Objective To study the onset features and axiom of children disease in Duanguan region.Methods A statistic study was carried on 1 782 cases of children disease which confirmed by pathological examinations.The sex,age and pathology(congenital malformation,inflammatory disease,tumor-like lesions,benign tumors,malignant tumors)were registered.Results The inflammatory disease occupied the first place in incidence rate(44.61%),followed by tumor-like lesions(25.03%),benign tumors(23.34%),congenital malformation(5.22%)and malignant tumors(1.80%).Among inflammatory disease,appendicitis was the most common,the next was chronic tonsillitis and tuberculosis.Among tumor-like lesions,cystic disease was the most common;the next was polyps.Among benign tumors,vasculoma was the most common,the next was pilomatricoma,osteoid and chonodroid tumors.Among congenital malformation,ear fistula was the most common,the next was diverticulosis and intestineal duplicateion.Among the malignant tumors,the sarcoma of soft tissue was the most common,the next was the malignant peripheral nerve tumors and lymphoma.Conclusion Children's disease have its own characteristics which varied in age,sex and pathological types,and differ from those of adults.

OBJECTIVETo systematically assess the effect of early enteral nutrition support after gastrointestinal operation on prognosis.

METHODSThe Cochrane Library, PubMed, CBM, CNKI, Wanfang, and VIP databases were retrieved via computer system for randomized controlled trails(RCTs) with early enteral nutrition support to patients undergoing gastrointestinal operation. Quality of studies was evaluated by the Cochrane Jadad rating scale. Nutrition indexes, bowel function indices, postoperative complications, health-economics indices were collected. Meta-analysis was conducted with RevMan 5.2.

RESULTSEleven relevant RCTs studies with 1087 cases were enrolled, including 541 patients in the study group(early enteral nutrition) and 546 in the control group. Meta-analysis showed that patients in the study group had significantly higher levels of plasma albumin and prealbumin than those in the control group(WMD=2.87, 95%CI:1.03-4.71; WMD=0.04, 95%CI:0.02-0.05). The time of postoperative bowel ventilation in the study group was significantly shorter than that in the control group(WMD=4.10, 95%CI:-5.38--2.82). The postoperative complication rate in the study group was significantly lower as compared to the control group(RR=0.64, 95%CI:0.44-0.93).

CONCLUSIONEarly enteral nutrition support after gastrointestinal operation is safe and effective, which can improve the nutritional status, promote bowel function return, and reduce postoperative complication rate.

Digestive System Surgical Procedures ; Enteral Nutrition ; Gastrointestinal Diseases ; surgery ; Humans ; Postoperative Complications ; Prognosis ; Randomized Controlled Trials as Topic

OBJECTIVETo investigate phenotype, cell differentiation and cytogenetic properties of bone marrow (BM) mesenchymal stem cells (MSC) separated from the myelodysplastic syndrome (MDS) patients. And to analyze cytogenetic aberration of MSC derived from MDS (MDS-MSC) and its mechanism in pathogenesis of MDS.

METHODSAdherent MSC from both myelodysplastic (n = 22) and normal (n = 7) marrow were obtained by a stromal culture procedure. Morphological features were observed by optical microscope. The cell-surface antigens were performed by flow cytometer(FCM). Adipogenic and osteogenic differentiation potential of MSC were identified under specific induction conditions. Standard cytogenetic analysis of both hematopoietic cells and MSC were performed by trypsin-Giemsa (GTG) banding. The karyotype analysis DNA content was determined by FCM to verify the results.

RESULTSThe morphology of MDS-MSC was typical slender spindle-shaped cells, MSC obtained from MDS patients had a MSC immunophenotype, lacked the expression of hematopoietic antigens-CD34, CD45 and expressed MSC markers, such as CD73, CD90, and CD105. MDS-MSC layers showed the capability to differentiate towards adipocytes, chondrocytes and osteoblasts. Cytogenetic aberrations were observed in MSC from 14 (64%) MDS patients, usually involve the loss of chromosomal material (92%), and the clonal loss (7 cases, 50%). Two cases of structural aberrations were also detected. Abnormal karyotypes in MSC were still more frequently identified in abnormal hematopoietic cells group (12 out of 13, 92% vs 3 out of 9, 33%, P < 0.05). There were not exactly the same type of chromosomal aberrations between hematopoietic cells and MSC, but different type of the aberrations in the same chromosome were involved.

CONCLUSIONMDS-MSC retains the phenotyping characteristics and differentiated function of normal MSC, but has different type of chromosomal abnormalities. A high proportion of loss of chromosomal may be a marker of chromosomal instability of MDS-MSC. Detection of abnormalities in MDS-MSC suggests enhanced genetic susceptibility of these cells in MDS. This may indicate potential involvement of MSC in the pathophysiology of MDS.

Adult ; Aged ; Aged, 80 and over ; Bone Marrow Cells ; cytology ; Case-Control Studies ; Female ; Flow Cytometry ; Humans ; Immunophenotyping ; Karyotyping ; Male ; Mesenchymal Stromal Cells ; cytology ; Middle Aged ; Myelodysplastic Syndromes ; genetics ; immunology ; Phenotype ; Young Adult

OBJECTIVETo investigate the mechanism of action of emodin for suppressing acute allograft rejection in a rat model of liver transplantation.

METHODSBrown Norway (BW) recipient rats of orthotopic liver transplantation (OLT) were divided into three groups, Group A receiving isografting (with BW rats as donor), Group B receiving allografting (with Lewis rats as donor), Group C receiving allografting and emodin treatment (50 mg/kg daily). They were sacrificed on day 7 of post-transplantation, and their hepatic histology, plasma cytokine levels, and T-cell subset expression were detected.

RESULTSCompared with those in Group A, rats: in Group B exhibited severe allograft rejection with a rejection activity index (RAI) of 7.67+/-0.98, extensive hepatocellular apoptosis with an apoptosis index (AI) of 35.83+/-2.32, and elevated plasma levels of interleukin-2 (IL-2), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-alpha), CD4(+) and CD4 CD4(+)/CD8(+) ratio. However, recipients in Group C showed a decrease in histological grade of rejection and hepatocellular apoptosis, as well as a decrease in plasma levels of IL-2, TNF-alpha, CD4(+) and CD4(+)/CD8(+) ratio, but elevated levels of IL-10 as compared with the allograft group.

CONCLUSIONPost-OLT acute rejection could be attenuated by emodin, its mechanism of action may be associated with protecting hepatocytes from apoptosis, polarizing the Th 1 paradigm to Th2, and inhibiting the proliferation of CD4(+) T cell in plasma.

Acute Disease ; Animals ; Apoptosis ; drug effects ; Cytokines ; blood ; Drug Evaluation, Preclinical ; Emodin ; pharmacology ; therapeutic use ; Graft Rejection ; prevention & control ; Immunosuppressive Agents ; pharmacology ; therapeutic use ; Liver ; drug effects ; pathology ; ultrastructure ; Liver Transplantation ; immunology ; rehabilitation ; Rats ; Rats, Inbred BN ; Rats, Inbred Lew ; T-Lymphocyte Subsets ; immunology ; pathology ; Transplantation, Homologous

In order to clarify the chemical constituents in Qiliqiangxin capsule, a rapid ultra-performance liquid chromatography/orthogonal acceleration time-of-flight mass spectrometry (UPLC-Q-TOF/MS(E)) method was established. Forty peaks were identified on line using this method. The herbal sources of these peaks were assigned. The results implied that triterpenoid saponins, flavonoid glycosides, C21-steroids and phenolic acids were included in the main components of Qiliqiangxin capsule. The method is simple and rapid for elucidation of the constituents of Qiliqiangxin capsule and the results are useful for the quality control of Qiliqiangxin capsule.
Capsules ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; chemistry ; Flavones ; analysis ; Ginsenosides ; analysis ; Glycosides ; analysis ; Hydroxybenzoates ; analysis ; Plants, Medicinal ; chemistry ; Quality Control ; Saponins ; analysis ; Spectrometry, Mass, Electrospray Ionization ; Steroids ; analysis ; Tandem Mass Spectrometry ; Triterpenes ; analysis

OBJECTIVETo study angiogenesis and regulatory factors in the proliferated prostatic tissues of Sprague Dawley (SD) rats with BPH induced by testosterone.

METHODSSixteen castrated SD rats, aged 8 weeks and weighing 200 approximately 250 g, were equally randomized into a model group and a control group, and the BPH model was established by subcutaneous injection of testosterone. Immunohistochemistry and MIAS (micro-image analysis system) were used to test the manifestations of MVD (microvessel density), VEGF (vascular endothelium growth factor), flk-1, endostatin, MMP-2 (matrix metalloproteinase-2) and TIMP-2 (tissue inhibitor of metalloproteinase-2) in the prostatic tissues of both the model and the control groups. Multiple linear regression with the stepwise method was adopted to analyze the data.

RESULTSThe manifestations of MVD, VEGF, flk-1, MMP-2, MMP-2/TIMP-2 and VEGF/endostatin in the model group were higher, while that of endostatin was lower than in the control group (P < 0.01), and the manifestation of TIMP-2 showed no statistical difference between the two groups. The regression analysis indicated that MVD was positively correlated to VEGF, VEGF/endostatin and MMP-2/TIMP-2 (r = 0.974, 0.986, 0.982, P < 0.05) and negatively correlated to endostatin (r = - 0.975, P < 0.05) .

CONCLUSIONTestosterone could induce BPH in SD rats by increasing MVD and promoting the multiplication of vascular endothelial cells after regradation of basement membrane.

Animals ; Disease Models, Animal ; Endostatins ; biosynthesis ; Male ; Matrix Metalloproteinase 2 ; biosynthesis ; Neovascularization, Pathologic ; chemically induced ; metabolism ; Prostate ; blood supply ; metabolism ; Prostatic Hyperplasia ; chemically induced ; metabolism ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Testosterone ; Tissue Inhibitor of Metalloproteinase-2 ; biosynthesis ; Vascular Endothelial Growth Factor A ; biosynthesis ; Vascular Endothelial Growth Factor Receptor-2 ; biosynthesis

OBJECTIVESTo analyze the reason of revisions no more than 5 years after primary hip replacement, and to discuss the methods how to prevent and manage.

METHODSRetrospectively review 11 cases with revision no more than 5 years after primary total hip replacement from January 2002 to June 2007. The reasons for revision were as follows: 2 cases were recurrent dislocation due to malposition of acetabular prosthesis; 5 cases were loosening of acetabular prosthesis; 1 case was abrasion of the native acetabulum by bipolar femoral head; 2 cases were periprosthetic femoral fractures and 1 case was periprosthetic infection. The average follow-up time was 36 months. Each patient was assessed according to Harris hip score. The revision procedures including liner only, acetabular prosthesis only, or both acetabular prosthesis and femoral prosthesis depending on the reasons for revision, two-stage revision was performed on 1 case with periprosthetic infection.

RESULTSThe average of Harris hip score was increased from 46 (28 to 62) preoperatively to 86 (75 to 96) at follow up. The complication occurred in 2 cases: one was postoperative haematoma formation who was performed further surgery for clearance of haematoma, another was slight instability of the hip joint who was accepted skin traction for 3 weeks.

CONCLUSIONSThe main reason for revision after primary total hip replacement is related to uncorrected insert of acetabular prosthesis. Improving surgical technique of insert of acetabular prosthesis is important in primary total hip replacement.

Aged ; Arthroplasty, Replacement, Hip ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Postoperative Complications ; surgery ; Prosthesis Failure ; Reoperation ; Retrospective Studies ; Treatment Outcome

OBJECTIVETo explore the association of gene polymorphism of organophosphate insecticides (OPs) metabolic enzymes with intermediate myasthenia syndrome (IMS) following acute OPs poisoning.

METHODSThirty six of 147 acute OPs poisoning patients developed IMS one to four days after poisoning. Peripheral blood samples were collected from all the patients and whole blood cholinesterase (ChE) activity was determined by DTNB spectrometry. The genetic polymorphism of CYP2E1 (1091C-->T) and GSTP1 (313A-->G) were analyzed by polymerase chain reaction (PCR)-restrict fragment length polymorphism, CYP1A1 (4889A-->G), GSTM1 and GSTT1 by allele-specific PCR, and PON1 at 55 codon (55L-->M) by PCR-single strand conformation polymorphism.

RESULTSThe whole blood ChE activity in IMS patients was not significantly different from non-IMS patients at admission (38.22 +/- 17.56)% and (42.49 +/- 16.23)%, respectively, P > 0.05, but recovered much slower in IMS patients than that in non-IMS patients. The frequencies of heterozygote and variant homozygote of PON1 at 55 codon, GSTM1 null, and both GSTM1 and GSTT1 null were higher in IMS patients than those in non-IMS patients (P < 0.05), with odds ratios and their 95% confident intervals of 2.48 (1.06 - 5.78), 11.23 (2.95- 42.76), 2.53 (1.14 - 5.61) and 2.68 (1.20 - 5.97), respectively.

CONCLUSIONSPatients of OPs and its mixture poisoning with genotype of variant allele at 55 codon of PON1, GSTM1 null and both GSTM1 and GSTT1 null probably had higher risk for IMS.

Adult ; Cholinesterases ; metabolism ; Cytochrome P-450 CYP2E1 ; genetics ; Female ; Genetic Predisposition to Disease ; Genotype ; Glutathione Transferase ; genetics ; Homozygote ; Humans ; Insecticides ; poisoning ; Male ; Middle Aged ; Myasthenia Gravis ; chemically induced ; genetics ; Organophosphorus Compounds ; Point Mutation ; Polymorphism, Restriction Fragment Length ; Polymorphism, Single Nucleotide ; Syndrome