The risk and benefit assessment is an important part of ethical review in clinical trials, of which the significance is to minimize the risk and maximize the benefit, thus to protect the rights of the subject. Begin with introducing the nature of the risk and benefit of clinical trial, this paper analyzed the way of ethical review based on risk consideration and discussed some key points of risk and benefit assessment including the minimum risk, the risk and benefit of vulnerable groups, risk informing, benefit of clinical trials, the fairness of recruitment and the importance of strengthening follow-up review. Ethical review should play a role as the balance, which neither-hinder the development of clinical trial to protect the rights of the subjects nor damage the rights and interests of subject to develop clinical trials.

Objective To analyze cellular immunological function of cancer patients in order to provide an evidence for immunological treatment to malignant tumors.Methods T lymphocyte subgroups(total T lymphocytes,Th,Ts,Th/Ts and NK)were determined by flow cytometry in 54 patients with lung cancer,42 with gynecologic cancer,44 with gastrointestinal cancer and 30 healthy individuals.Statistical data were analyzed by SPSS.Results T helper lymphocytes covered(29.41?9.24)%,(34.62?10.27)%,and(32.48?11.64)% respectively in lung,gynecologic and gastrointestinal cancer,significantly lower than that of health people(P

Objective To explore the clinical value of renal biopsy in the diagnosis of atypical lupus nephri-tis(LN). Methods The clinical and renal pathological data of 28 cases with atypical LN were analyzed retrospective-ly. Results All 28 patients could not fulfill the ACR diagnostic criterion,misdiagnosed as primary nephritic syndrome 21 eases,chronic glomerulone-phritis syndrome 4 cases ,asymptomatic hematuria 2 cases and asymptomatic proteinuria 2 cases,all renal biopsy showed changes consistent to lupus nephritis,pathological types:3 cases were class Ⅱ,4 cases were class Ⅲ,21 cases were class Ⅳ ,7 cases were class Ⅴ,2 cases was class Ⅳ+ Ⅴlupus nephritis,the clinical manifestations of nephritic syndrome were mostly pathological type Ⅳ and Ⅴ, the chronic glomerulonephritis syndrome showed diversification of pathological type, asymptomatic hematuria and/or proteinuria were mostly pathological type Ⅱ and Ⅲ. Conclusion clinical manifestations of atypical LN is no specific and easy to be misdiagnosed. Renal bi-opsy has great value in the diagnosis of atypical LN.

Objective To analyze labor duration in nulliparous women and discuss the change about curve of labor duration. Methods Two thousand, one hundred and forty nulliparous, full-term pregnant, singleton, cephalic presentation and vaginal delivery women who delivered at Peking University First Hospital were included. There were 1 300 cases between January 1, and December 31, 2009, while 840 cases between January 1, and May 31, 2013. A retrospective study was conducted. Data on maternal age, gestational age at delivery, body mass index at delivery, newborn weight, time of labor initiation, cervical dilatation and the amount of bleeding within the first 24 h after delivery were recorded. Data were compared by t test and χ2 test. The median time span corresponding to one-centimeter-increase in cervical dilatation was calculated. Results (1)Compared with data from 2009, the maternal age [(29.0±3.0) vs (29.6±2.8) years, t=4.77], incidence of postpartum hemorrhage [1.8%(24/1 300) vs 4.3%(36/840),χ2=11.17], proportion of induced labor [37.3%(485/1 300) vs 64.0%(538/840),χ2=146.23] and proportion of analgesia during labor [54.2%(705/1 300) vs 61.5% (517/840), χ2=11.15] were all higher in 2013 (all P<0.01). (2)The median (minimum–maximum) time span corresponding to a one-centimeter-increase in cervical dilatation was 3-4 cm which corresponded to 2.2 h(0.8-4.3 h), 4-5 cm which corresponded to 1.9 h(0.6-4.0 h), 5-6 cm which corresponded to 1.8 h(0.5-4.0 h), 6-7 cm which corresponded to 1.6 h(0.5-2.0 h), 7-8 cm which corresponded to 1.8 h(0.8-2.0 h), 8-9 cm which corresponded to 1.3 h(0.2-2.5 h), and 9-10 cm which corresponded to 0.6 h(0.1-2.5 h). The curve of labor duration showed a slow uptrend with time on the horizontal axis and cervical dilatation on the vertical axis. Conclusions The curve of labor duration exhibits a slow uptrend with neither an acceleration phase nor a deceleration phase. It is important to redefine the time span of labor duration in China for appropriate clinical treatment.

OBJECTIVE To learn the molecular epidemiologic character of 21 genotypes of human papillomavirus(HPV).METHODS Totally 500 samples from women genital tract secretion were monitored by flow-through hybridization and gene chip,then studying the molecular epidemiologic character of HPV included HPV6,11,16,18,31,33,35,39,42,43,44,45,51,52,53,56,58,59,66,68,and CP8304.RESULTS The total positive rate of 21 genotypes of HPV was 53% in women cervicitis patients,high-risk HPV genotypes were 60% in all positive samples.Among 21 genotypes of HPV,the positive rate of HPV11 was the first(12.4%),but HPV16 positive rate was the first among high-risk genotypes(11.2%).Among the positive rates in different stage of years,the 21-30 years old group was the highest,the 31-40 years old group was the second,total of two groups was 76.6%.CONCLUSIONS The molecular epidemiologic results can be used in development of HPV vaccine,and in prevention and cure of HPV infection.

OBJECTIVE:To establish a method for the simultaneous determination of paracetamol,amantadine hydrochloride, caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablet. METHODS:GC was performed on the column of HP-5 sillica capillary,temperature programmed,detector was FID detector,with the temperature of 300 ℃,car-rier gas was nitrogen gas,the flow rate is 1.5 mL/min,the split ratio was 20:1 and injection volume was 1μL. RESULTS:The lin-ear range was 156.0-4990.4 μg/mL for paracetamol,125.7-4023.2 μg/mL for amantadine hydrochloride,19.14-612.4 μg/mL for caffeine and 2.515-80.48 μg/mL for chlorphenamine maleate(all r=0.9999);the limits of quantification were 1.4,0.5,1.1,0.9 ng,limits of detection were 0.4,0.2,0.3,0.3 ng;RSDs of precision,stability and reproducibility tests were lower than 2.0%;re-coveries were 99.59%-101.77%(RSD=0.8%,n=9),99.56%-101.80%(RSD=0.7%,n=9),98.44%-100.83%(RSD=0.7%,n=9) and 100.05%-101.91%(RSD=0.6%,n=9),respectively. CONCLUSIONS:This method is simple,rapid,accurate and reli-able,and suitable for the simultaneous determination of paracetamol,amantadine hydrochloride,caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablet.

ObjectiveTo observe the imitation of menopause and the change of spatial cognition in mice administrated with D-galactose and to evaluate the molecular mechanism of estrogen to protect the function of hippocampal neurons.MethodsAdult female C57BL/6 mice were bilateral ovariectomy (OVX) and subcutaneously treated with D-galactose (100 mg/kg). In estrogen replacement therapy(ERT) mice were i.p. administrated with E2 (50 μg/kg). It took 8 weeks to induce the model and treat with ERT. Morris water maze was used test the function of spatial learning and memory. Estrogen and oxidative stress enzymes were detected by kit. 8-oxo-dG was immunohistochemical stained, and the expression of MTH1 in brain hippocampus was detected by Western blotting.ResultsThe level of E2 in blood in model group was one fifth of that in Sham group(P<0-01), and E2 level obviously increased in ERT group; the escape latency significantly prolonged in model group(P<0-01), and obviously shortened in ERT group(P<0-05). SOD and GSH-Px significantly reduced and MDA obviously increased in model group(P<0-05); and approached normal in ERT group. 8-oxo-dG as a DNA oxidative damage marker was obviously increased in the hippocampus of model group. However, the expression of DNA repair protein MTH1 significantly reduced(P<0-05), and both of them returned to normal in ERT group(P<0-05).ConclusionEstrogen can improve the function of spatial cognition in aging mice model by repairing the DNA damage of hippocampal neurons.

OBJECTIVE:To establish an HPLC method for the detection of Prednisone acetate, Hydrocortisone, Dexamethasone acetate, Piroxicam, Diclofenac sodium, Indometacin and Ibuprofen, the 7 chemical constituents in antirheumatic traditional Chinese medicine. METHODS: The chromatographic separation was performed on a Hypersil BDS C18 column (200 mm?4.6 mm,5 ?m) using methanol-1 g?L-1KH2PO4(58∶42) (adjusted to pH 4.0?0.05 with H3PO4) as the mobile phase at a flow rate of 1.0 mL?min-1. The detective wavelength was set at 220 nm. RESULTS: Seven chemical constituents were all well-separated with good linearity within respective range of sample size. CONCLUSION: The method is rapid and convenient, and can be used for the quantitative and qualitative analyses of 7 chemical constituents in antirheumatic traditional Chinese medicine and to detect whether there is addition of chemical constituents in antirheumatic traditional Chinese medicines.

ObjectiveTo investigate the efficiency of autologous transplantation of peripheral blood stem cells for treatment of patients with diabetic lower limb ischemia.MethodsEighteen patients of type 2 diabetes with diabetic lower limb ischemia (30 legs) were treated by autologous transplantation of peripheral blood stem cells.ResultsThe limb pain, cool feeling and numbness feeling improved significantly after PBSC transplantation,the improvement rate were 96.7％, 100.0％ and 95.8％ respectively.Intermittent claudication was also relieved significantly, total remission rate was 76.9％.The ABI and TcPO2 of patients increased significantly at 3 months after transplantation.After the transplantation ABI raised from 0.60 ± 0.11 to 0.71 ±0.12(t =-6.882, P ＜ 0.01) .93.3％ of patients' TcPO2 raised in different degrees.The foot infections were well controlled.Ulcer or toes gangrene got better or healed.No obvious complications or adverse reaction were observed after the transplantation.ConclusionAutologous transplantation of peripheral blood stem cells shows to be a simple, safe and effective method in treating patients with diabetic lower limb ischemia.

Objective To investigate the effect and its mechanism of diazoxide on the blood-brain barrier (BBB) of rats after cerebral ischemia/reperfusion (I/R) injury.Methods Sixty Wistar rats were randomly divided into sham operation group,I/R group,and diazoxide pretreatment groups of low,middle,large dose (5,10,20 mg/kg).The I/R models of rats were performed to undergo middle cerebral artery embolism by thread.BBB permeability was estimated by Evans blue (EB) dyeing,transmission electron microscope (TEM) was used to observe the modification of interendothelial tight junction (TJ) of capillaries.The expression of aquaporin-4 (AQP4) in every rat brain tissues was detected by immunity histochemistry technique.Results (1) Compared to sham operation group,the permeability extent of EB were significantly increased by I/R,which was distinctly attenuated in middle and large dose of diazoxide pretreatment rats,while no obvious changes were found between I/R and low dose groups.(2) TEM showed that TJ of the brain tissue opened after I/R injury and no significant opening of TJ was observed in middle and large dose of diazoxide preconditioning groups.(3) Compared to sham operation group,the expression of AQP4 in the brain tissue of the I/R group was apparently increased (P ＜0.01).Compared to I/R group,the expression of AQP4 was apparently increased in middle and large dose pretreatment groups (P ＜ 0.01),and there were no obvious difference between low dose group and the I/R group.Conclusions Preconditioning of ischemia/reperfusion injury with diazoxide protects the blood-brain barrier,which may due to keep the TJ closed and decrease expression of AQP4 protein.