The paper summarizes the background, development history and current state of good review prac-tice ( GRP) in the United States of America. On this basis, the paper then focuses on measures for the realization of GRP policy objective and introduces the effects of GRP by using the statistical data of the median time to application approval and approval rates of New drug applications( NDAs) and Biological License Applications( BLAs) on the first cycle. Through research, the paper considers a set of scientific and comprehensive GRP that can effectively guarantee the quality of drug reviews and improve the efficiency of drug reviews. However, China’s GRP is not complete yet. So it also suggests that improving GRP in China further by detailing the timeline of drug review in China, developing workable review templates, emphasizing training and the continuous improvement of GRP.

Objective To investigate the effect of nasal continuous positive airway pressure (NCPAP) on cardiac function in children with pneumonia complicated with heart failure.Methods Twenty-two children with pneumonia complicated with heart failure were selected in emergency room of Beijing Children′s Hospital Affiliated to Capital Medical University from Oct.2008 to Mar.2009,aged 1 month and 15 days to 2 years and 8 months,prospective clinical study.Cardiac function[including cardiac index(CI),heart rate(HR) and stroke volume index(SVI)] before and after NCPAP 0.04-0.05 kPa for 30 minutes were monitored by ultrasonic cardiac output monitoring(USCOM).Results After the application of 0.04-0.05 kPa NCPAP for 30 minutes,the heart rate decreased signi-ficantly [(173?10) beats/min vs (151?13) beats/min P0.05].Conclusions NCPAP might improve cardiac function by increasing stroke volume index and decreasing heart rate and respiratory rate in children with pneumonia complicated with heart failure.

Objective To explore the accuracy of the ultrasonic cardiac output monitor(USCOM) device for estimation of children's cardiac output.Methods We conducted a prospective study in Beijing Children's Hospital.Sixty healthy children were enrolled in this study.We evaluated the accuracy of USCOM monitor device in the measurement of cardiac output by comparing with the measurements obtained by the M-Teichholz formula and the Doppler aortic blood flow method.Results The data from the USCOM monitor device had better consistency with those from the M-Teichholz formula (r=0.88,P<0.05),and there was no significant difference (P>0.05) between the two methods.The similar results were found between the USCOM method and the Doppler aortic blood flow method (r=0.83,P<0.05).Conclusion This study shows that cardiac output monitoring by USCOM is accurate,and USCOM is a promising technique in cardiac output monitoring.

Objective:To study the radiation dose rate around patients underwent renal dynamic imaging of SPECT with 99Tcm-DTPA, so as to provide the basis for ensuring the radiation safety of the surrounding environment and the general public.Methods: 109 patients who underwent renal dynamic imaging were enrolled in this study, and the radiation dose rates of different time and different distance after 99Tcm-DTPA was injected patients were measured. And then, the changes of dose rate following time and distance were analyzed. Results: At the 0.5h, 1h, 2h, 3h, 6h, and 7h after radiopharmaceuticals were injected patients underwent renal dynamic imaging, the radiation dose rates were 0.76-8.86 μSv/h, 0.68-7.27 μSv/h, 0.57-4.52 μSv/h, 0.56-3.90 μSv/h, 0.23-2.07 μSv/h and 0.21-1.05 μSv/h, respectively, between 0.5 m and 4 m away from patients. At 24h after radiopharmaceuticals were injected, all of radiation dose rates at different distances around patients were same with background values.Conclusion: The radiation dose rates around patients underwent renal dynamic imaging will rapidly decrease with the increasing of time and distance. At 24h after radiopharmaceuticals were injected, all of radiation dose rates at different distances away from patients were same with background values.

Objective To know the self-perceived burden (SPB) of young and middle-aged patients with first-attack of ischemic stroke and to analyze the influential factors of SPB as well as its relevance to the quality of life.Methods The patients' general information questionnaire,SPB Self-evaluation Scale,QOL-BREF were adopted to investigate young and middle-aged patients with first-attack of ischemic stroke.Results 100 patients were included,66 were male,34 were female.The Minimum age was 19.4 years old.The maximum age was 59 years old.The mean age was (50.80 ± 7.98) years old.The average SPB score was (24.21 ± 7.39) points,which was in the medium level.31 cases (31％) didn't have obvious SPB; 65 cases (65％) suffered mild-to-moderate SPB; 4 cases (4％) claimed they had severe SPB.There was negative correlation between the SPB and their quality of life.The multi-factor analysis showed that gender,the patients' understanding of disease,and caregivers' health situation were the influential factors of SPB.Conclusions Since self-perceived burden is common in young and middle-aged patients with ischemic stroke,clinical nurses should assess patients' self-perceived burden so as to provide targeted nursing intervention and health education,thereby to ease the burden on patients' self feeling,eventually to improve the level of their mental and physical health.

Objective　To find out the morbidity and main pathogens of ventilator-associated pneumonia(VAP) in PICU.Methods　44 VAP cases were reviewed.Results　44 VAP cases were diagnosed and analyzed from 1998, 2 to 2001,1,the morbidity of VAP was 69.8%.The predominant pathogen was Pseudomonas aeruginosa.Conclusion　It has reference value in consideri ng the possible pathogens of pneumonia.

The progressive injury of retinal ganglion cells ( RGCs) is a common occurrence in several eye diseases, which ultimately may lead to irreversible blindness. Currently, there are still no effective or ideal treatments for it in practice, however some recent studies show that stem cell transplantation may provide a promising new idea for neuroprotection and replacement of retinal ganglion cells. This paper will review the research progress of stem cell transplantation-based treatment.

Objective:To investigate the attitude towards task -shifting of mental health among non -psychiat-ric physicians of general hospitals in Guangzhou and to provide evidence for continuing education model and health policy making .Methods:A cross-sectional study was implemented among 1363 participants of 17 general hospi-tals from December 2012 to April 2013 in Guangzhou.Results:Among 1363 participants, there were 941 (69.6%) approved the concept of mental health task shift .Factors of attitude to the concept of mental health task shift include work 8-10 h/day (β=0.404, P=0.006), practice qualification (β=-1.345, P=0.016), less than 10%physical diseases combined with psychological or mental problems in clinical work (β=-0 .452 , P=0.014), demand of training cost/time(β=-0.596, P =0.021), get ready (β=1.436, P <0.001) and have little preparation (β=0 .694 ,P<0 .001 ) preparation for treating mental disorders at present work ( recognition and treatment).The possibility of participants′attitude toward task -shifting mental health is positive the highest (71.0%), followed by neutral (25.5%) and negative (3.5%).Conclusions:Strengthening non -psychiatric physicians′support for mental health task shift with respect to policy and legal levels in general hospitals , improving their recognition and preparation of mental disorders , as well as developing targeted training and courses are the highest priority .

Objective To analyse the clinical data of 77 patients with unsuspected gallbladder carcinoma,and to determine the impact of TNM stage and the timing of the second operation on postoperative survival.Methods A retrospectively analysis of 77 patients operated between January 2008 and January 2013 in our hospital for unsuspected gallbladder carcinoma was carried out.The case inclusion criteria was in strict accordance with the medical records which described without preoperative diagnosis,or cholecystectomy for benign gallbladder diseases,or intraoperative or postoperative pathological diagnosis of gallbladder cancer.References to previous published medical literature and the intervals from initial cholecystectomy to further treatment were analyzed to see whether the prognosis and survival varied depending on the TNM staging and whether secondary radical surgery was carried out.Results For the 77 patients in this study,they all had high risk factors associated with gallbladder cancer which included:women,aged ＞ 50 and gallbladder stones.The initial surgery included laparoscopic cholecystectomy (n =53),and open cholecystectomy (n =24).In 26 patients,intraoperative frozen section confirmed the diagnosis and they were treated according to the TNM staging (radical operation n =7,palliative surgery n =17).The postoperative 1-,2-,3-year cumulative survival rates were 65％,45％ and 20％,respectively.For the 54 patients who underwent radical or extended radical cholecystectomy within a short interval from the first operation,the 1-,2-,3-year cumulative survival rates were 82.5％,62.5％ and 45.7％,respectively.Conclusions For resectable gallbladder cancer,the prognosis of unsuspected gallbladder carcinoma was related not only to the clinical staging,but also to the timing of the radical operation.The shorter time interval,the longer the survival,and the better the prognosis.There was no significant difference in prognosis for the group of patients with time intervals between the two operations of less than two weeks when compared with the group with immediate radical surgery.For advanced stages of gallbladder cancer,palliative surgery should be given according to the patient's general condition,aiming to improve quality of life.

Objective To investigate therapeutic mechanism of radiation therapy associated with Doeetaxel on human uterine cervi-cal carcinoma. Method Hela cells were incubated with 0. 5 μmol/L, 1.01 μmol/Docetaxel for 24 hours, and were radiated with 0, 2, 4, 6, 8Gy X ray. The proliferation activity was detected with MTT method. Apoptosis was evaluated with TUNEL method. Expression of caspase-3 protein and the degradation fragment was measured with Western blot. Result Inhibitory effect of radiation therapy associated Docetaxel on Hela cells was significantly stronger than that of radiation group. Treated with 2 Gy and 6MV X ray radiation, inhibitory rate of Hela cells increased with the increment of associated Docetaxel doses (P<0.05). Inhibitory rate of Hela cells in radiation associated Docetaxel group was significantly increased compared with radiation group. Apoptosis index in radiation associated Docetaxel group 48 hours after treatment was significantly increased compared with radiation group or Docetaxel group with TUNEL method (P<0.05). Western blot results indies-ted that caspase-3 protein was degraded and small active fragments were produced. Conclusion The reason that Docetaxel enhanced Hela cell radiation sensitivity may probably he correlated to easpase-3 protein activation.