Informed consent is the important thesis in life ethics and life law,which gives the patients and experimenters the right of self-decision making on medical procedures and experiments.As the development of public health and public health ethics,informed consent has been paid more attention,especially on informed consent problems in epidemiology and public health practice.The requirement of informed consent varies in different research fields.According to different practice purposes,the researchers choose relevant applicable methods.

Objective:To establish a liquid chromatography-mass spectrometry(LC-MS) method for determining the concentration of amlodipine besylate in human plasma and to evaluate the bioequivalence of 2 kinds of amlodipine besylate tablets.Methods: Twenty healthy male volunteers were enrolled into a single crossover study.A single dose of the suspension equivalent to 10 mg amlodipine besylate or a reference preparation was given in a crossover way.The plasma concentrations of amlodipine besylate were determined by LC-MS method in the volunteers at different time points;the pharmacokinetic parameters and relative bioavailability were calculated and the bioequivalence of the 2 preparations were evaluated.Results: The pharmacokinetic parameters for experimental and the reference preparations were: C_max(6.21?1.88) vs(6.03?1.08) ng/ml;AUC_0-120(250.68?52.61) vs(246.14?52.11) ng h/ml;T_max(6.0?2.3) vs(6.1? 2.5) h;t_1/2(40.45?6.68) vs(43.74?9.05) h,respectively.The linear range of the present method was 0.1-20.0 ng/ml;the lowest detectable concentration of amlodipine besylate was 0.1 ng/ml.There was no significant difference in pharmacokinetic parameters between the 2 tablets.Conclusion: The present method is simple to use,fast,and accurate.The 2 preparations of amlodipine besylate are bioequivalent.

Objective To compare the long-term results of hypospadias surgery and analyze the influencing factors. Methods Sixty-four hypospadiac patients were followed up, cosmetic and sexual functional results were assessed by hypospadiac patients and surgeon using a designed questionnaire and 5-item version of the international index of erectile function (IIEF-5). Selected 35 adult as normal controls. Maximum flow rate and average flow rate Were used to assess evaluation of voiding function. Results All cases were followed up for 3-11 (7.5 ± 2.3) years. The satisfaction with the long-term results of penile appearance had significant differences between hypospadiac patients and surgeon,hypospadiac patients were less satisfied than surgeon (P< 0.05 or < 0.01). No significant differences were noted between hypospadiac patients and normal controls regarding the maximum flow rate [(23.37 ±2.92), (24.41 ±2.94) ml/s], average flow rate [(16.84± 1.75), (17.34 ±2.14) ml/s] and erectile function [(22.31 ± 1.94), (22.80 ± 1.73) pointe](P> 0.05). The average penile lengths[(5.93 ± 1.06) cm] and circumferences[(6.17 ±0.83) cm] of hypospadiac patients under flaccid conditions after operation were significantly shorter than those of normal controls [ (7.38 ± 0.79 ), ( 7.53 ± 0.75 ) cm ] ( P < 0.01). The important factors to influence the results including the age at which surgery was completed, hypospadiac severity, the number of operation and complication. ConclusionsIt is useful to improve the long-term efficacy by minimizing the number of operation and complication, and treating hypospadiac patients earlier. Surgeon should pay more attention to the long-term cosmetic results of hypospadias surgery.

OBJECTIVE: To investigate the potential protective role of Cistanche extracts on 1-methyl-4-phenylpyridinium ion (MPP(+))-induced Parkinson's disease (PD) cellular model, and to find out whether this effect is achieved through the regulation of growth arrest- and DNA damage-induced gene 153 (GADD153). METHODS: MPP(+))-induced cellular injury and the protective effect of Cistanche extracts on the SH-SY5Y cell line viability treated by MPP(+)) were investigated by using methyl thiazolyl tetrazolium (MTT) assay. The mRNA of GADD153 in SH-SY5Y cell line treated by MPP(+)) and Cistanche extracts were evaluated by reverse transcriptase-polymerase chain reaction (RT-PCR). The protein level of GADD153 in SH-SY5Y was assessed by Western blotting. RESULTS: Cistanche extracts (100 mug/ml) increased the cell viability (P<0.01). And the mRNA of GADD153 in the Cistanche extracts pretreatment group was much less than that in the MPP(+)) group (P<0.01). The result of Western blotting showed that GADD153 had a lower level in the Cistanche extracts pretreatment group, compared with MPP(+)) group, especially in the 100 microg/ml group (P<0.01). CONCLUSION: Cistanche extracts pretreatment has a protective effect on the MPP(+))-treated SH-SY5Y cell line, and its down-regulation of GADD153 may contribute to the effect.

OBJECTIVE: Adopting methods of cell culture to explore the effects and mechanisms of Jianpi Bushen Huoxue Prescription (JPBSHXP), a traditional Chinese compound herbal medicine for strengthening spleen, reinforcing kidney and activating blood circulation, in inhibiting hematopoietic cells apoptosis in a mouse model of aplastic anemia (AA). METHODS: Blood serum of AA mice was made from an AA mouse model. Blood serums containing different traditional Chinese compound herbal medicine were made from rats after intragastric administration of JPBSHXP and its related decoctions, respectively. Bone marrow cells of normal mice were incubated by these blood serums for 24 hours, respectively. The apoptosis of the bone marrow cells were assayed by flow cytometry and transmission electron microscopy (TEM). RESULTS: It was indicated that the bone marrow cells of normal mice incubated with blood serum of AA mice displayed typical apoptosis. The apoptosis rates of bone marrow cells of the AA mice incubated by blood serum containing different traditional Chinese herbal medicine were decreased. The effect of Bushen (reinforcing kidey) Recipe was better than Jianpi (strengthening spleen) Recipe and Huoxue (activating blood circulation) Recipe, while the effect of JPBSHXP was the best. TEM results showed that the effect of Bushen Recipe was better than that of the Jianpi Recipe and the Huoxue Recipe, while the effect of JPBSHXP was the best. CONCLUSION: JPBSHXP and its related decoctions can significantly decrease the apoptosis rate of bone marrow mononuclear cells of the AA mice. It is inferred that JPBSHXP can promote bone marrow hematogenesis.

Objective To evaluate the therapeutic methods for stones in congenital anomalous kidneys. Methods The clinical outcomes of 126 patients(75 males and 51 females: mean age 39 years, range 12-66 years)who underwent extracorporeal shock wave lithotripsy (ESWL, n= 37), minimally invasive percutaneous nephrolithotomy (MPCNL, n = 41) or open surgery (n = 48) were retrospectively reviewed. There were 40 horseshoe kidneys(31.8%), 51 duplex kidneys(40.5%), 35 malrotated kidneys(27.8%). Seventyl calculi were located in left kidneys(55.6%)and 56 in right kid-neys(44.4%). There were 96 single stones(76.2%)and 30 complex stones(23.8%). The greatest di-ameter of stone ranged from0.8 cm to 2.2 cm(mean 1.5 cm) in ESWL group, 1.0 cm to 4.0 cm (mean 2.5 cm) in MPCNL group and 1.5 cm to 3.8 cm(mean 2.7 cm) in open surgery group. The therapeutic effects of 3 methods were compared. Results The stone-free rate at 1 session was 78.4%(29/31) in ESWL group, 85.4%(35/41) in MPCNL group and 87.5%(42/48) in open sur-gery group. No significant difference was found among the 3 groups(x2 = 1.39,P=0.50). The inci-dence of complications was 13.5% in ESWL group, 9.7% in MPCNL group and 6.3% in open sur-gery group(x2=1.28, P=0.53). Only 1 case of malrotated kidney suffered massive hemorrhage and was cured by selective embolism of renal artery. No major complications occurred in the other pa-tients. Conclusions With rigorous indication, ESWL or MPCNL is as safe and effective as open sur-gery in the management of stones in congenital anomalous kidneys. It should be considered as the pri-mary therapy. But the treatment must be individualized in terms of the type anomalous kidney, stone characteristics and obstruction.

Objective To investigate the diagnostic value of parametric imaging of contrast-enhanced ultrasound (CEUS) in retroperitoneal tumors using SonoLiver software. Methods Sixty cases of retroperitoneal tumors were analyzed by CEUS with SonoLiver software. The color-mapped images of timedependent indexes, such as rise time(RT), time to peak(TTP), mean transit time(mTT), were abserved in the regions of interests(ROIS). The degree of the coincidence between pathologic diagnosis and parametric imaging diagnosis was carefully study by comparing parametric images with histopathological findings.Results 1 ) There was statistical significance of RT, TTP and mTT between the benign and malignant retroperitoneal tumors. 2) The time-dependent parametric images were obvious different between benign lesions and malignant lesions. The malignant lesions enjoyed a confused boundary and distribute disorderly,while the benign tumors had a clear distribution. There was a good coincidence degree between pathologic diagnosis and parametric imaging diagnosis(κ =0. 625, P =0. 000). Sensibility, specificity, the rate of misdiagnosis and missed diagnosis, the degree of accuracy respectively was 85.3 ％, 76.9 ％, 23.1 ％, 14.7 ％,81.7％ by the new diagnosis method. Conclusions Parametric imaging is a very useful way of evaluating the level of blood flow with the tumors and provides a new vision in the diagnosis of retroperitoneal tumors. It demonstrates retroperitoneal tumors clearly and objectively.

Objective To assess the safety and effectiveness of minimally invasive percutaneous nephrolithotomy(MPCNL) in treating renal stones in patients with congenital anomalous kidneys.MethodsFrom January 2000 to November 2007 a total of 41 patients with renal stones complicated with congenital anomalous kidneys,including 12 cases of horseshoe kidneys,19 cases of duplex kidneys,and 10 cases of malrotated kidneys were treated by MPCNL in our hospital.Of the 41 patients,4 had upper calyx calculi,6 had middle calyx calculi,7 had lower calyx calculi,3 had pelvic calculi,4 had the upper segment calculi in duplex kidney,12 had multiple calculi,and 5 had staghorn calculi.The largest diameter of the stones ranged from 1.0 to 4.0 cm(mean 2.5 cm).Ureteral calculi that were found in 13 of the patients were treated at one time.ResultsThe procedure were completed in all of the cases with the operation time ranged from 45 to 210 minutes(mean 95 minutes),and blood loss ranged from 30 to 150 ml(mean 80 ml).The overall stone-free rate at one session was 85.4%(35/41).One of the duplex kidney cases and two of the horseshoe kidney cases were cured by a second operation.And two of the duplex kidney cases and one of the malrotated kidney cases were treated by ESWL after the MPCNL.One patient,who had malrotated kidney,suffered massive hemorrhage(800 ml) during the MPCNL,and was cured by selective embolization of the renal artery.No severe complications occurred in the other patients.The cases were followed up for 5-12 months,during the Period no patient had recurrence.ConclusionsMPCNL is safe and reliable for the treatment of stones in patients with congenital anomalous kidneys.The treatment must be individualized in terms of the type of the renal abnormalities,and the size and location of the stones.

Objective To study the effects of soybean isoflavone(SI) on lipid peroxidation and liver ultrastructure in ovariectomized rats. Methods Seventy female Sprague-Dawley(SD) rats were randomly divided into 7 groups according to the levels of total cholesterol(TC) in serum: hyper-lipoid group,estrogen group,low-dose SI group,middle-dose SI group,high-dose SI group,sham group and normal control group.After bilateral ovaries were extirpated except sham and normal control groups for a week,the estrogen,different doses of SI or deionized water were fed with intragastric administration for 12 weeks.The rat body weight was weighted once per week and blood samples were collected at the time of ovariectomization,the 4th and 8th weeks after administeration at the time of being killed.The serum TC,triglyceride(TG),high or low density lipoprotein-cholesterol(HDL-C,LDL-C),lipoprotein(a) and antioxygen enzyme were assayed. Results LDL-C levels in SI intervention groups were significantly lower than that in hyper-lipoid groups but higher than that in normal control group;the levels of lipoprotein(a) were changed;there was almost no effect on HDL-C in serum.SI could retain integrity and ultrastructure of hepatocyte;there was similar structure in high dose SI group and normal control group.An obvious damage was detected in hyper-lipoid group.Conclusion SI can improve lipoprotein(a) and lipid peroxidation in ovariectomized rats.A continuous intervention with high-SI can reduce LDL-C to normal lever and retain integrity and ultrastructure of hepatocyte.

Objective To explore the features of sustained attention in the patients with social anxiety disorder and their first degree relatives.Methods 60 cases of normal controls,58 cases of patients with social anxiety disorder and 68 cases of their first degree relatives were performed with continuous performance test.Results In reaction time task(a simple performance),all of CPT parameters in patient group (number of cancel (5.2±6.9),number of omission(6.7± 13.6),reaction time(421.0± 112.0) ms,variance coefficient(47.3±38.1) ％)were higher than those in the first degree relatives group(number of cancel (2.9± 3.3),number of omission (1.5±2.1),reaction time (342.0±47.0) ms,variance coefficient(28.9± 10.1) ％) and controlled group (number of cancel (2.8 ± 2.9),number of omission (1.3 ± 0.7),reaction time (329.0 ± 53.0) ms,variance coefficient (27.8± 9.7) ％),the differences were significant(P＜0.01),while all of CPT parameters in the first degree relatives were similar to those in controlled group(P＞0.05).In X task (a complex performance),the results of CPT in the first degree relatives were between the patients and the normal controls,and the differences were statistically significant(P＜0.05).Conclusion The anxiety disorder patients showed no sustained attention impairment in simple performance while in a complex performance there were some defects of sustained attention functions in the patients with social anxiety disorder and their first degree relatives.