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 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 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 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 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.

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 observe the clinical effect of Shengxueling Granule (SXLG) in treating idiopathic thrombocytopenic purpura (ITP), and to study its possible mechanism. METHODS: Eighty-six cases of ITP were divided into two groups randomly. Fifty-six cases in the treatment group were treated with SXLG, a traditional Chinese medicine, and 30 cases administered with Western medicine (prednisone) were taken as control. Patients in each group took drugs for three months and were under follow-up observation. RESULTS: In SXLG-treated group, the total effective rate in 3 months was 85.71%, similar to 83.33% in prednisone-treated group (P>0.05), while the total effective rate in 6 months in the SXLG-treated group was 91.07%, higher than 53.33% of the prednisone-treated group (P<0.01), and no obvious side-effects were observed. The patients' bleeding was alleviated or stopped, and their general condition was improved. And the blood platelet count (BPC) was increased, the platelet associated immunoglobulin (PAIg) and interleukin-4 (IL-4) were markedly dropped, the level of natural killer cells activity (NKCA) increased, and the rate of T lymphocyte subsets gradually returned to normal level. Megakaryocytes tended toward maturation on bone marrow smear after SXLG treatment. All differences above were statistically significant. CONCLUSION: SXLG is an effective and safe medicine for ITP. It can regulate the cellular immunity, inhibit the platelet antibody to reduce the destruction of the platelet and to increase the number of platelet, promote the differentiation and maturation of megakaryocyte, facilitate the production and release of platelet, lower the fragility of capillary, and prevent the hemorrhagic tendency.

Objective To explore the clinical characteristics of treatment?resistant depression ( TRD) and of its relevance with thyroid hormones. Methods 43 patients with TRD and 48 patients with non?TRD were as?sessed with 17?item Hamilton depression scale ( HAMD?17) and Hamilton anxiety scale ( HAMA) . The serum lev?el of thyroid?stimulating hormone ( TSH) ,total triodothgronine ( TT3) ,total thyroxine ( TT4) ,free triodothgronine ( FT3) and free thyroxine ( FT4) were determined by radioimmunoassay. χ2 test and t test were used for statistic a?nalysis. The quantitative relation of FT3 level with TRD was analyzed and the value of FT3 level in TRD diagnosis was evaluated by ROC curve.Results Compared with non?TRD patients,the TRD patients showed a younger dis?ease onset age ((16.98±2.25)years vs (23.50±3.38)years) and a longer disease course ((10.14±6.47)years vs (5.48±4.15)years) for total disease course;(60.35±23.64)months vs (5.00±3.40)months for current disease course),and had shorter education years ((8.53±1.72)years vs (11.04±2.07)years) and higher HAMD total scores (19.09±1.59 vs 15.69±2.38) and behavior retarding factor scores (8.72±0.98 vs 4.98±1.63). In addition, the FT3 level of TRD patients was lower than that of non?TRD patients ((3.92±0.15)pmol/L vs (4.16±0.20) pmol/L).All the above differences between two groups were statistically significant (P<0.05). The logistic regres?sion analysis showed that the risk of suffering TRD increased by 1. 006?fold when FT3 level reduced 0. 1 pmol/L (OR=2.006,95%CI=(1.501,2.681). The area under ROC curve was 0.821 (P<0.001) with its 95% confidence interval of (0.734,0.907). Conclusion Compared with non?TRD patients,TRD patients have a longer disease course,a younger disease onset age, a lower education level, higher HAMD total scores, more severe retardation symptoms,and a lower FT3 level. The serum FT3 level has a high reference value in diagnosis of TRD.