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.

ObjectiveTo investigate application value of parametric image processing in contrastenhanced ultrasound imaging in diagnosis of ovarian masses. MethodsFifty cases with ovarian masses underwent routine ultrasound and contrast-enhanced ultrasound imaging using a new dedicated parametric image processing software SonoLiver to analyze patterns of vascular formation and blood stream perfusion in the ovarian mass tissues on a digital video recorder in real time, compare their morphological characteristics of time-intensity curve (TIC) and dynamic vascular patterns (DVP) curve, and analyze quantitatively all indicators generated by SonoLiver.ResultsIn ultrasound imaging of the 50 cases, there were 24 cases (86％) displaying mainly blue lowly-enhanced imaging in those with benign masses and 15 cases (68％)displaying mainly red highly-enhanced imaging in those with malignant masses, with statistical significance (P ＜0. 01 ). There was significantly different characteristics of TIC and DVP between patients with benign and malignant masses. In 23 cases with benign masses, their DVP were significantly higher above the baseline than in those with malignant ones ( P = 0. 000), and in 15 cases with malignant lesions, their DVP were much shorter below the baseline than in those with benign ones, with statistical significance (P ＜0.05). The intensity of contrast medium, the time to reach its peak intensity and average transit time were all significantly higher in those with malignant masses than in those with benign ones (all P ＜ 0. 05 ). But, no statistical difference in the time of initial increasing between the two groups was found (P ＞ 0. 05). ConclusionsThere is significant difference in TIC and DVP of ultrasound imaging between benign and malignant masses, which if combined with contrast enhanced ultrasound parametric image processing can provide a more visualized quantitative information of benign and malignant ovarian masses with SonoLiver software.

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 evaluate the ability of contrast-enhanced ultrasonography (CEUS)in differentiate reactive lymph node,metastatic lymph node and lymphoma.Methods In a prospective study CEUS was performed in 129 patients with cervical lymph node enlargement.The entire process were recorded and preserved in DICOM format.The results were registered with Sonoliver.The receiver operating characteristic curve (ROC curve)analysis was performed to find the corresponding cutoff values. The selected node was removed surgically and submitted for histology.Results Of all the nodes,26 were reactive nodes,85 were metastases and 1 8 were lymphoma.Enhancement pattern was the most accurate way to characterize lymph nodes.The enhancement pattern of reactive lymph nodes was homogeneous and most of them were enhanced by lymphatic type while the metastatic lymph nodes were inhomogeneously enhanced or weakly enhanced by peripheral type.Lymph node lymphoma usually had no fixed enhancement pattern. Arrive time (AT),rise time (RT),time to peak (TTP),mean transit time (mTT),maximum intensity (IMAX),under the curve (AUC),rising slope(Kup),semi descending slope(Kdown)and perfusion index (PI)were significantly different in the three groups(P <0.05).RT,TTP and mTT of reactive lymph nodes were the shortest,which had significant difference compared with those of metastatic lymph nodes and lymphoma (P < 0.05 ).Kup,Kdown,IMAX%,AUC,PI in the reactive lymph nodes were significantly decreased compared with the metastatic group (P <0.05),but there was no significant difference compared with those in lymphoma (P >0.05 ).When TTP≥ 7.74 s,mTT≥26.54 s,metastatic lymph nodes were considered.When RT≥4.62 s,TTP ≥ 7.74 s,mTT ≥ 28.32 s,reactive lymph nodes were not considered. Conclusions Dynamic contrast-enhanced ultrasound image and enhancement pattern can distinguish neck lymph nodes while the optimal cut-off point time of the time-intensity curve parameters can further contribute to the identification of lymph nodes.

Objective To observe the early effect of organ donation after pancreas-kidney transplantation.Methods Eight cases of diabetic nephropathy received combined pancreas kidney transplantation.There were 8 donors,including 6 males and 2 females,with an average age of (26 10) years old (range from 15 to 42 years).There were 4 cases of donors with China during the transition period of brain heart double death organ donation (C-Ⅲ) standard,3 cases of donors in line with the international standard of brain death organ donation (C-Ⅰ) standard,1 case of international standard of heart death organ donation (C-lⅡ M-Ⅲ) citizen donors.There were 6 men and 2 women for recipients of the same blood type.Results Eight cases were awake 4-6 h postoperation and the ventilator was removed 8-14 h after operation.The rehabilitation therapy began 2 days postoperation from surgery intensive care unit (SICU) to the common wards.Serum C-peptide and insulin levels achieved normal range in 1-2 weeks after transplant.Blood glucose returned to the normal level in 2-3 weeks,and the creatinine level decreased to the normal level in 2 weeks postoperation.Duodenal intramural hematoma occurred in one patient intraoperatively,and the pancreatic graft was removed for safe consideration.Other patients had no serious surgical complications within 2 weeks after transplantation.Conclusion For organ donation after death of pancreas kidney transplantation,early organ function recovered well.Under the strict preoperative evaluation,the young donors can be safely used in combined pancreas and kidney transplantation.

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.