Objective To identify major factors which affect the completion quality of projects and build predictive models,and to propose strategies and suggestions for total process quality management of clinical research projects of the hospital.Methods Collect relevant literatures from home and abroad;consult completion reports of various research projects completed from 2003 to 2010 and sum up problems found in such projects.Carry out in-depth interviews with principal investigators,supervisors of scientific research of the hospital as well as administrators of sponsor institutions.A questionnaire survey was made on completed clinical research projects undertaken from 2003 to 2010.Results Six key factors affecting implementation of such projects were derived from factor analysis,which are research technology and external environment,project teamwork,research subject availability,project organization,manpower input,and research design.A multiple logistic regression analysis found project internal management and manpower input as two leading predictive factors for project completion outcomes,while the former has a greater impact than the latter.Conclusion Project management should focus on the 6 key factors affecting project quality.The two main predictive factors should attract greater attention and resources in both supervision and management.

ObjectiveTo investigate the effect of soluble β-amyloid protein (Aβ) oligomers on the expression levels of insulin signaling transduction cascades-associated proteins including insulin receptor ( InsR),insulin receptor substrate-Ⅰ( IRS-Ⅰ) and protein kinase B (PKB) of rat hippocampal neurons,and the pathogenesis of Alzheimer's disease (AD) in depth.MethodsSoluble Aβ oligomers (5 μl) were injected into the lateral ventriculus of the AD group by a microinjector under the stereotaxic apparatus.Normal saline solution ( NS,5 μl) was injected into the NS group in the same way,and the control group received the puncture without injection. It was repeated after 1 week and the behavior of all rats was evaluatedbyY-mazetestafter2weeks.Thenhippocampuswasremovedandunderwent immunohistochemical staining to detect the expression of proteins associated.ResultsCompared with the other groups,learning and memory ability of the Aβ-treated rats were impaired.To be specific,the times of learning were increased and the times of memory were decreased. However,there was no significant difference between the NS group and the control group.Besides,the expression levels of InsR,IRS-Ⅰ,and PKB were decreased in AD group showing that a mean optical density of staining on these proteins ( InsR:0.12 ± 0.0l ; IRS-Ⅰ:0.14 ± 0.02; PKB:0.12 ± 0.03 ) was reduced in contrast with that in the NS group and the control group.Whereas there was no significant difference between the NS group (0.40 ± 0.02,0.39 ± 0.06,0.38 ± 0.03,mean difference:- 0.13,- 0.13,- 0.17,all P ＜ 0.05 ) and the control group (0.38 ± 0.07,0.35 ± 0.03,0.35 ± 0.06,mean difference:- 0.15,- 0.07,- 0.73,all P ＜ 0.05 ).ConclusionsSoluble Aβ1-42 induced learning and memory disability of the rats.The mechanism might be that Aβ can lead to disorders of the insulin signaling transduction pathway of hippocampal neurons and decrease the expression levels of the proteins in the pathway.

BACKGROUND: Hanshibi granule indicates rheumatism due to blockage of cold and damp.OBJECTIVE: To observe the effects and safety of intervention of hanshibi granule on rheumatism due to blockage of cold and damp and the comparative observation was carried on by taking zhengqingfengtongning as the control drug.DESIGN: Case randomized-controlled observation was designed.SETTING: Luoyang Bone-setting Hospital of Henan Province.PARTICIPANTS: Totally 400 cases of rheumatism due to blockage of cold and damp visited in Luoyang Orthopedic Hospital of Henan Province were volunteered in the observation from May 2000 to February 2002.Hanshibi granule was composed of fuzhi (Radix Aconiti Praeparata),huangqi (Radix Astragali), weilingxian (Radix Clematidis), more than 10 herbs, 10 g each bag. Zhengqing fengtongning tablet is 20 mg each tablet.METHODS: Based on the randomization and sequence of visiting, the cases were divided into observing group and the control at the ratio of 3:1.In the observing group, hanshibi granule was administrated, 1 bag/time,3 times/day, infused with water. In the control, zhengqing fengtongning tablet was administered orally, 2 tablets/time, 3 times/day; 1 week later,if there was no harmful reaction, it was administered 3 tablets/time,3 times/day. For rheumatic arthritis (RA) and ankylosing spondylitis (AS),the drugs were taken for 2 months as 1 course, and for knee osteoarthritis,the drugs were taken for 1 month as 1 course. The changes of ESR, C-reactive protein (CRP) and rheumatic factor (RF) and uric acid (UA) were determined and recorded. Criteria on evaluation: ① Evaluation on therapeutic effects on syndromes: Remarkable effect: the symptoms were improved remarkably after treatment and symptom integral was 0-1 score or decreased by ≥ 2/3. Effect: the symptoms were improved after treatment and the symptom integral was decreased by≥1/3.② Evaluation on therapeutic effects on symptoms: Remarkable effect: The symptom integral was reduced to 0 score or reduced by 2 scores after treatment, such as joint pain, swelling, tender pain, morning stiffness and functional impairment. Effect: the integral was reduced by 1 score after treatment. ③ Evaluation on total therapeutic effects on diseases: Remarkable effect: the symptoms and physical signs disappeared basically, the main laboratory indexes were improved remarkably and reduced by ≥ 50%. Effect: The symptoms and physical signs were alleviated and the main laboratory indexes were improved.MAIN OUTCOME MEASURES:① Total clinical therapeutic effect,therapeutic effect on different symptoms and diseases between two groups.②Safety of hanshibi granule.RESULTS: Totally 400 cases were employed, of which, 300 cases were in observing group and 100 cases in the control. In observing group, 19 cases were dropped out and 281 cases were in the statistics. In the control,6 cases were dropped out and 94 cases were in the statistics.①Comparison of total clinical therapeutic effects between two groups: The total effective rate in the observing group was higher significantly than that in the control (94.31％, 84.04％, P ＜ 0.01). ② Comparison of therapeutic effects on different symptoms between two groups: There was no significant difference in the therapeutic effects on joint pain, swelling,tender pain, functional disturbance and morning stiffness between two groups (P ＞ 0.05). ③ Comparison of therapeutic effects on different diseases between two groups: There was no significant difference in the therapeutic effects on RA, AS and knee osteoarthritis (P ＞ 0.05). ④ Safetyof hanshibi granule: abnormal urine routine for a part of cases before treatment was improved after treatment. ST-T wave alternation in ECG for a part of cases before treatment was not aggravated obviously after medication.CONCLUSION: Both hanshibi granule and zhengqingfengtong tablet, the control drug improves significantly joint pain, swelling, tender pain, functional impairment and morning stiffness in rheumatism due to blockage of cold and damp, in which, the effect of intervention of hanshibi granule is superior to that of the control drug, without obvious harmful reactions;therefore, such drug can be taken as a safe and effective one for rheumatism due to blockage of cold and damp.

Objective To explore the effect of peritoneal dialysis to treat renal failure in children.Methods There were 11 admitted patients of renal failure in our department from July 2003 to April 2008.Their clinical data and follow-up results were analyzed.Results No patient was dead during treatment.The average time of peritoneal dialysis treatment in the children with acute renal failure was 15.5 days in hospital,which was 22.8 days in the chronic patients.After treatment the levels of serum nitrogen and creatine were decreased significantly from (34.03±8.44)mmol/L and (710.09±167.54)μmol/L to (15.94±4.93)mmol/L and (233.87±92.71)μmol/L (P＜0.01).The serum sodium and bicarbonate ion were increased from (130.91±9.15)mmol/L and (14.56±2.07)mmol/L to (139.46±3.98)mmol/L and (22.47±3.29)mmol/L (P＜0.05,P＜0.01).The duration of follow-up were from one month to 5 years.The level of serum nitrogen and creatine in 5 patients of acute renal failure were normal and the analysis of urine was also normal during follow-up.One patient had renal transplantation after peritoneal dialysis.Three patients still regularly underwent peritoneal dialysis.Conclusion The peritoneal dialysis combining with multi-modality treatment was the better style of renal replacement therapy in renal failure patients.

Objective To investigate the effect of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) combined with recombinant bovine basic fibroblast growth factor (rb-bFGF) in the treatment of oral ulcer caused by chemotherapy.Methods 108 patients of oral ulcer caused by chemotherapy were randomly divided into two groups.54 cases in the control group were treated with cydiodine buccal tablets at first,then received the aerosol treatment which was prepared by mixing gentamicin,dexamethasone,2 ％ lidocaine and physiologic saline,three times per day.54 cases in the treatment group firstly received the gargle which was prepared by mixing rhGM-CSF,dexamethasone and physiologic saline,then were treated with rb-bFGF by spraying on the oral ulcer surface,three times per day.Results The effective rate of the treatment group was 96.30 ％ (52/54),which was significantly higher than that of the control group [64.81％ (35/54)],there was a significant difference between the two groups (x2 =17.08,P ＜ 0.05).Conclusion The effect of rhGM-CSF combined with rb-bFGF in the treatment of oral ulcer caused by chemotherapy is very significant.

Objective To investigate the effect of montelukast sodium chewable tablets on pulmonary function in children with allergic asthma . Methods 86 cases of children with allergic asthma were randomLy divided into 2 groups, 43 cases in the control group were treated with routine clinical treatment, 43 cases in the experiment group received more with montelukast sodium chewable tablets.Serum T lymphocyte subsets, IL-6, TNF-α, IL-4 concentration levels, as well as FVC, FEV1, PEF levels and clinical efficacy were compared of two groups pre-and post-treatment.Results Compared with pre-treatment, Serum CD4 +, CD4 +/CD8 +, FVC, FEV1 and PEF levels in 2 groups increased, serum CD8 +, IL-4, IL-6, TNF-a levels decreased, compared with the control group, serum CD4 +, CD4 +/CD8 +, FVC, FEV1, PEF level and the effective rate in the experiment group post-treatment were higher, serum CD8 +, IL-4, IL-6, TNF-αlevels and the ineffective rate were lower, the differences were statistically significant (P<0.05).Conclusion Montelukast sodium chewable tablets can effectively improve the imbalance of immune function in children with allergic asthma , improve lung function, and has good clinical efficacy.

Paroxysmal nocturnal haemoglobinuria ( PNH) is a clonal hematopoietic stem cell disease characterized by intravascular hemolytic anemia , pancytopenia and thrombosis .Although PNH is an non-malignant disease , its complications have very negative impacts on patient's quality of life .The most common serious complication is thrombosis formation .

Objective To explore the effect of residual UDG on all dU-DNA PCR products. Methods The hybridization percentage of dU-DNA PCR products, which were stored at 37℃ for 20 hours as well as at -20℃,4℃,room temperature and 37℃,respectively, were detected by employing microplate hybridization technique. The effect of inactivating the products at 94 ℃ for 10 minutes on the activity of Taq polymerase was also analysed. Results Compared with the control, A value decreased by 13.281% and 20.557%, respectively after adding 0.2u and 10u UDG (P

Objective To explore the role of metabotropic glutamate receptors (mGluRs)group Ⅲ and its subtypes mGluR7 and mGluR8 in nucleus tractus solitarius(NTS)in cardiac-somatic motor reflex (CMR),and to clarify the modulation role of mGluR Ⅲ and its subtypes in NTS in cardiac nociceptoion.Methods 40 SD rats were randomly divided into L-AP4 group,microinjection of mGluRs Ⅲ agonist L-AP4 0.1,1.0,10.0 or 20.0 nmol in NTS;AMN082 group,microinjection of mGluR7 agonist AMN082 1,2 or 4 nmol;DCPG group,microinjection of mGluR8 agonist DCPG 4, 6 or 8 nmol;MSOP group, microinjection of mGluR Ⅲ antagonist MSOP 20 or 100 nmol,20 nmol MSOP+410 nmol L-AP,20 nmol MSOP+2 nmol AMN082,20 nmol MSOP+6 nmol DCPG. The changes of CMR of the rats in various groups were observed.Results Compared with control,the CMR in L-AP4 and AMN082 groups was decreased (P<0.05);the CMR in DCPG group was increased (P<0.05);the CMR in MSOP group after injection of 20 nmol MSOP had no change (P>0.05);the CMR in MSOP group after injection of 100 nmol MSOP was increased (P<0.05);the CMR in MSOP group after injection of 20 nmol MSOP followed L-AP4 or AMNO82 had no change (P>0.05).Conclusion The group Ⅲ mGluRs in the NTS play an inhibitory role in cardiac nociception, and mGluR7 has anti-nociceptive effects while mGluR8 has pro-nociceptive effects.

Objective To study the role of glutamate receptor subtypes in nucleus tractus solitarius(NTS)in cardiac-somatic motor reflex (CMR)induced by intrapericardial administration of capsaicin,and to clarify the modulation mechanism of NTS to cardiac nociceptoion.Methods 60 SD rats were randomly divided into ibotenic (IBO)group, glutamate group, MK-801 group, MCGP group, MK-801 + MCPG group and DNQX group. The NTS microinjected with 130 mmol·L-1 IBO 100 nL,100,200,500 mmol·L-1 L-glutamate 100 nL,NMDA receptor antagonist 40 and 60 mmol · L-1 MK-801 100 nL, metabotropic glutamate receptors antagonist 25 and 50 mmol·L-1 MCPG 100 nL,25 mmol· L-1 MCPG 50 nL plus 40 mmol· L-1 MK-801 50 nL,non-NMDA receptor antagonist 20 and 50 mmol·L-1 DNQX 100 nL,respectively.The changes of CMR of the rats in various groups were observed.Results Compared with control group,the CMR of the rats in IBO group was decreased (P<0.05);the CMR was increased as the concentration increased in glutamate group(P<0.05);the CMR in MK-801 and MCPG groups were decreased (P<0.05);the CMR in MK-801+MCPG group was decreased (P<0.05);the CMR in DXQX group had no changes (P>0.05).Conclusion NTS play an facilictory role in cardiac nociception,and the NMDA receptors and mGluRs receptors mediate this facilitory modulation.