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.

ObjectiveTo evaluate prognosis and its clinical factors in patients with primary pontine hemorrhage. Methods Patients with primary pontine hemorrhage who were hospitalized in the First Affiliated Hospital of Wenzhou Medical College within 24 hours after stroke onset between April 2007 and April 2009 were registered conscutively. The patients were followed up for one year. Kaplan-Meier methods were used to analyze survival rate. Cox proportional hazards model was used to study risk factors for 1-year mortality. ResultsA total of 41 patients with primary pontine hemorrhage were studied. Their mean age was (63.5 ± 10. 1 ) years.The overall 1-year mortality rate was 61.0％, the median survival time was (80. 0 ±54.4) days (95％ CI 0-186. 64). After one-year follow-up, the mortality rate in patients with primary dorsal pontine hemorrhage( 18.2％ ) was significantly lower than that in patients with primary ventral pontine hemorrhage(72. 7％ ; x2 = 8. 800, P = 0. 003 ). Patients with massive primary pontine hemorrhage had significantly higher mortality rate than patients with dorsal primary pontine hemorrhage( x2 = 8. 927, P =0. 003). The average hematoma volume of the survivor group and mortality group was (3. 043 ± 1. 718) ml and (5. 984 ± 2. 707) ml, respectively, showing statistical significance (t = 3. 661, P = 0. 001 ). Analysis with Cox proportional hazards model showed that the risk factors associated with mortality were hematoma location ( RR = 2. 428, 95 ％ CI 1. 055-5. 587 ), hematoma volume ( RR = 1. 283, 95 ％ CI 1. 044-1. 577 ),GCS score on admission(RR =3. 389, 95％ CI 1. 177-9. 756). Patients with pontine hematomas in dorsal had a significantly better outcome than in other locations.Conclusions The survival and prognosis in primary dorsal pontine hemorrhage are better than with hemorrhaging in other parts of pontine. A significant correlation was observed between poor prognosis and hematoma volume, hematoma location and GCS score on admission.

Objective To investigate the clinical efficacies of free endoscopic nasobiliary drainage (ENBD) in primary duct closure (PDC) following laparoscopic common bile duct exploration (LCBDE) for choledocholithiasis.Methods The retrospective cohort study was conducted.The clinical data of 312 patients with extrahepatic bile duct stones accompanied with or without cholecystolithiasis who were admitted to the 11 medical centers [86 in the Affiliated Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,62 in the Second Affiliated Hospital of Zhejiang University School of Medicine,44 in the West China Hospital of Sichuan University,29 in the First Affiliated Hospital of Xi'an Jiaotong University,27 in the First Hospital Affiliated to Army Medical University (Third Military Medical University),25 in the Hunan Provincial People's Hospital,17 in the Beijing Friendship Hospital of Capital Medical University,10 in the First Affiliated Hospital of Hainan Medical University,5 in the Henan Provincial People's Hospital,4 in the Beijing Tian Tan Hospital of Capital Medical University,3 in the First Affiliated Hospital of Fujian Medical University] from January 2011 to June 2017 were collected.All patients underwent LCBDE+PDC,and 81 and 231 patients with and without ENBD were respectively allocated into the ENBD group and PDC group.Observation indicators:(1) comparisons of operation situations;(2) comparisons of postoperative recovery;(3) comparisons of postoperative complications;(4) follow-up situations.Follow-up using outpatient examination and telephone interview was performed to detect the postoperative complications up to June 2017.Measurement data with normal distribution were represented as x±s.Comparison between groups was analyzed by the t test.Measurement data with skewed distribution were represented M [interquartile range (IQR)],and comparison between groups was analyzed by the nonparametic test.Comparisons of count data were analyzed using the chi-square test and Fisher exact probability.Results (1) Comparisons of operation situations:all the 312 patients underwent successful laparoscopic LCBDE + PDC,without conversion to open surgery,including postoperative death of 1 patient in the PDC group.The common bile duct diameter,cases using interrupted sutures,continuous sutures,absorbable threads and nonabsorbable threads were respectively (1.2±0.4)cm,106,125,195,36 in the PDC group and (1.1±0.5)cm,76,5,79,2 in the ENBD group,with statistically significant differences between groups (t =2.497,x2 =56.706,8.457,P＜0.05).The numbers of stones,stone diameter,cases with common bile duct wall (≤ 3 mm and ＞3 mm),normal and abnormal Oddi sphincter contraction function,volume of intraoperative blood loss and operation time were respectively 2.1±1.7,(1.1-±0.6)cm,148,83,226,5,20 mL (10-45 mL),(116± 49)minutes in the PDC group and 1.9±1.6,(1.0±0.6)cm,49,32,75,6,20 mL (15-30 mL),(113± 23)minutes in the ENBD group,with no statistically significant difference between groups (t =1.021,0.329,x2 =0.329,3.428,Z=1.147,t=0.521,P＞0.05).The further analysis:of 312 patients,cases and time using interrupted sutures and continuous sutures were respectively 182,130 and (133±.49) minutes,(103±34) minutes,with a statistically significant difference between groups (t =-6.605,P＜0.05).The volume of intraoperative blood loss and cases with postoperative complications using interrupted sutures and continuous sutures were respectively 20 mL (15-31 mL),21 and 20 mL (10-45 mL),18,with no statistically significant difference between groups (Z =-0.285,x2 =0.369,P＞ 0.05).Of 312 patients,cases,operation time,volume of intraoperative blood loss and postoperative complications using absorbable threads and non-absorbable threads were respectively 274,(116±44)minutes,20 mL (15-40 mL),33 and 38,(115±35) minutes,18 mL (10-26 mL),6,with no statistically significant difference between groups (Z =0.971,t =0.023,x2 =0.154,P＞ 0.05).(2) Comparisons of postoperative recovery:recovery time of gastrointestinal function,time of abdominal drainage-tube removal,using time of antibiotics and duration of hospital stay were respectively (2.0± 1.5) days,(4.0 ± 2.4) days,(4.0±2.8) days,(5.5±3.0) days in the PDC group and (4.0±1.9) days,(6.9±3.5) days,(10.0± 3.9) days,(11.1±3.7)days in the ENBD group,with statistically significant differences between groups (t =-9.507,-8.258,-15.103,-13.575,P＜0.05).The total expenses of hospital stay in the Affiliated Tongji Hospital,Tongji Medical College of Huazhong University of Science and Technology were respectively (5.1 ±0.6)× 104 yuan in the PDC group and (6.5-±0.5)× 104 yuan in the ENBD group,with a statistically significant difference between groups (t =-9.516,P＜0.05).(3) Comparisons of postoperative complications:incidence of complications in the PDC group was 14.29％ (33/231),including 16 with biliary fistula,11 with biliary tract infection,3 with wound infection,1 with biliary tract bleeding,1 with residual stones of common bile duct and 1 with death;incidence of complications in the ENBD group was 6.17％ (5/81),including 2 with biliary fistula,2 with biliary tract infection and 1 with biliary tract bleeding,showing no statistically significant difference between groups (x2 =3.151,P＞0.05).(4) Follow-up situations:of 312 patients,252 were followed up for 2-67 month,with a median time of 15 months,including 175 in the PDC group and 77 in the ENBD group.During the follow up,there was no occurrence of jaundice,cholangitis and pancreatitis,and stone recurrence and postoperative cholangiostenosis were not detected by abdominal color Doppler ultrasound or CT or magnetic resonanced cholangio-pancreatography.Conclusion On the basis of grasping operative indication strictly,ENBD in PDC following LCBDE for choledocholithiasis is safe and effective.