This article elaborated on the importance of collecting archives of drug clinical trails. Taking the drug clinical trial archives into account, the first value is the effort of clinical researchers. Sec-ond, the archives of drug clinical trials are the requirement to obtaining the evaluation before the new drug projects are approved. Third, the archives are the important evidence as getting professional certification from relevant drug research organizations and governmental officials. Making good drug clinical archive man-agement depends on the system and relevant regulations. A system should clarify the responsibilities of the collectors and managers for the archival materials. It also should make clear what are needs for collection, the rule of project numbering, and the rule of transferring. A good system also establishes the functionalities of monitoring and controlling. Last, the article pointed out the usual problem appeared in archive manage-ment of drug clinical trials.

This paper discussed the deviation of the intellectual property strategy applied in hospitals. The deviation, which is reflected on excessive enthusiasm and over-evaluation on research publication on the one hand, and negligence and insufficiency in the protection of whereas relevant patents and technique (commercial) secrets on the other hand. This deviation in the management can impede the hospital development in the long run. Measures should be taken to tackle this problem, which includesis, increasing the awareness, building up stimulation system, improving hospital cultural atmosphere, and training specialized administrators.

Objective To verify the performance of three kinds of ischemia‐modified albumin(IMA) reagents .Methods The performance of three IMA reagents(labeled as reagent A ,B ,C) using colorimetric method from Shanghai Aikang Biotechnology Co .,Ltd .,Zhejiang Kuake Bioscience Technology Co .ltd .and Beijing Jiuqiang Biotechnology Co .,Ltd .were assessed by using O‐lympus AU5800 automatic biochemistry analyzer .According to the National Committee for Clinical Laboratory(NCCLS) EP6‐A , EP15‐A and EP7‐A documents and WS/T 420‐2013 verificationof analytical performance of quantitative kits by clinical labo‐ratory ,the precision ,linearity range ,accuracy and anti‐interference capability were assessed .Results The within‐run coefficient of variations(CVs) of reagent A ,B and C were 0 .59% -0 .82% ,0 .27% -0 .54% and 0 .62% -0 .69% respectively .The between‐run CVs of reagent A ,B and C were 0 .98% -1 .74% ,0 .99% -1 .01% and 0 .71% -0 .78% ,respectively ,which were lower than decla‐rations of these reagent kits .The linearity range of reagent A ,B and C were 11 -142 U/mL(r2 = 0 .993) ,10 -120 U/mL(r2 =0 .996) ,14-123 U/mL(r2 =0 .992) respectively ,which showed good linearities .About interference tests ,no remarkable interfer‐ences(all Bias were less than ± 10% ) of reagent A ,B and C were detected when Vitamin C≤10 mg/dL ,hemoglobin≤200 mg/dL , bilirubin≤40 mg/dL and triglyceride≤500 mg/dL .Conclusion The three IMA reagents show high precision ,which could meet clinical requirements ,nevertheless ,differences of anti‐interference capabilities are observed in these three reagents .

Objective To validate the analytical performance of four LP(a)reagents with Immunoturbidimetry method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of four LP(a)reagents (labeled as A,B,C,D)with method from RANDOX,Zhejiang Kuake Co.,Beijing Leadman Co.and Beijing Jiuqiang Co.on Olympus AU5800 automatic biochemistry analyzer were assessed.The precision,linearity range,accuracy,disturbance (vita-min C,bilirubin,hemoglobin,TG)were assessed.Results The within-run CVs of the four reagents (A,B,C and D)were 0.64%~1.18%,3.59%~4.75%,1.33%~3.05% and 1.43%~2.01% respectively.The between-run CVs in A,B,C and D were 1.04%~1.7%,3.81%~4.93%,2.16%~4.76% and 2.33%~3.21% respectively,lower than the stated.The lin-earity range was 82~923 mg/L (r2 =0.997),130~935 mg/L (r 2 =0.996 4),120~1025 mg/L (r 2 =0.992 1)and 117~943 mg/L (r2 =0.999 5)in the four reagents,which demonstrated a sound linear correlation.For interference tests,no re-markable interferences (<±10%)of reagent A and reagent D were detected when Vitamin C≤10 mg/dl,hemoglobin≤200 mg/dl,bilirubin≤40 mg/dl and TG≤500 mg/dl.Interference of reagent B was found when VC≥5 mg/dl,TG≥250 mg/dl and when TG≥250 mg/dl reagent C was interfered significantly.The four LP(a)reagents were used to detect the lipid con-trol,and the deviations of the target value were - 8.07%,1.34%,- 8.05% and 7.38% respectively.Conclusion When used in automatic biochemical analyzer,the four LP(a)reagents showed high precision.The four reagents are all able to meet clinical test requirements,nevertheless,anti-interference capability were different.

Objective To observe the effect of constraint-induced movement therapy combined with motor imagery on unilateral spatial neglect (USN) in stroke patients. Methods Fifty stroke patients with USN were randomly divided into a treatment group ( n = 27 ) and a control group ( n = 23 ). Both groups received routine physical therapy training, including with the Bobath technique and low frequency electrotherapy, while the treatment group received constraint-induced movement therapy and motor imagery in addition. All the patients were assessed with 4 scales of the regular USN assessment ( cancellation tests, line bisection tests, clock drawing tests,copying drawing tests) and with the Barthel index (BI) before and after 8 weeks of treatment. Results After 8 weeks of treatment, both groups' average USN assessments and Barthel indices improved significantly. Furthermore, both the USN results and the Barthel index scores in the treatment group were, on average, significantly better than those in the control group. Conclusion For USN stroke patients, constraint-induced movement therapy combined with motor imagery improves the symptoms of USN and ADL ability significantly better than routine physical therapy treatment alone.

Objective To investigate the relationship between Helicobacter pylori (H. pylori) infection and concentration of reactive oxygen species (ROS) in AGS cells. Methods AGS cells were cultured with either Hp11638 (CagA~+ , VacA~+ ) extract or Hp11638 mutant (CagA~+ , VacA~-) extract for 48 hours, then the cells and supernatants were collected. The concentration of ROS in AGS cells was measured by flow cytometry. The eytochrome C reduction was detected by spectrophotometer at 550 nm. Results The ROS levels in the AGS cells were correlated with two H. pylori strains in a concentration- and time-dependent manner. The ROS levels in AGS cells treated with Hp11638 extract in different concentrations or times were correspondingly higher than those treated with Hp11638 mutant extract. Similar results were found in examination of cytochrome C reduction. Conclusion The elevation of ROS in AGS cells is related to effects of H. pylori proteins, and the VaeA protein involves in the process.

Objective To evaluate the clinical applications and surgical methods of combined laparoscopic common bile duct (CBD) exploration with choledochoscopy. Methods From 2006 to 2009,clinical data of 42 patients with choledocholithiasis undergoing laparoscopic common bile duct exploration were retrospectively analyzed. We applied a step-by-step electric coagulating incision technique on the CBD,the step-by-step suturing technique, and the step-by-step clamping technique with alligator forceps, and soft tube irrigating technique with suctioning by selecting the proper exploration route, improving the common bile duct incision technique and calculus removing techniques. Results Procedures were successful in all the cases. There was no conversions to open surgery, no postoperative bleeding and no operative mortality. The mean operating time was 120 minutes (ranging, 90 to 150 minutes) with minimal intraoperative blood loss ( ranging, 20 to 40 ml). Ductal stone clearance was successful in 41 out of 42 patients ( 93% ). The largest number of the common bile duct stones was 16. With the diameter of stones larger than 15 mm in 18 cases in which the biggest was 30 mm. Bile leak developed in 1 patient, retained stones found in 3 patients,including intrahepatic cholelithiasis in one case. As a result, 38 out of 42 patients underwent common bile duct exploration. 35 patients were placed on T-tubes. Four patients underwent cystic duct exploration in which 3 had primary suture of the cystic duct and 1 had drainage. There was no infection and stenosis of biliary tract in the 42 followed-up cases. Conclusions Laparoscopic common bile duct exploration with stone extraction can be performed with high efficiency, minimal morbidity and without mortality. Improving the way of operation and selecting suitable exploration can result in better clinical outcomes.

Objective:To evaluate the application efficacy of enhanced recovery after surgery(ERAS)in laparoscopic colorectal cancer surgery in primary hospitals.Methods:A total of 116 patients who underwent laparoscopic colorectal cancer surgery from January 2017 to December 2018 at our hospital were enrolled in this study.According to the perioperative rehabilitation program, 116 patients were divided into the group A(n=67, receiving enhanced recovery after surgery)and the group B(n=49, receiving traditional recovery after surgery).Results:The incidences of preoperative thirst and hunger were lower in the group A than in the group B(11.9% vs.53.1%, 16.4% vs.51.0%, χ2=23.10 and 15.83, respectively, P<0.001). The levels of CRP and blood glucose in the two groups were significantly higher after operation than before operation, and reached the peak values on the 3rd day after the operation.At different time points after operation, CRP levels and blood glucose levels were higher in the group B than in the group A(all P<0.05). On the 7th day after operation, blood glucose level was recovered to the preoperative level in the group A, while it was not so in the group B. The incidence of complication in the group A was similar to the group B(7.46% vs.12.2%, χ2=0.75, P>0.05). The hospitalization period was shorter and the hospitalization cost was less in the group A than in the group B(8.16±1.33)d vs.(15.39±2.81)d, (46100±1800)yuan vs.(56900±5600)yuan, t=10.98 and 9.96, P=0.000). Conclusions:The application of enhanced recovery after surgery is beneficial for perioperative safety, can reduce surgical stress response, promote postoperative recovery, shorten hospitalization time after surgery and reduce hospitalization costs in laparoscopic colorectal cancer surgery.

Continuous renal replacement therapy (CRRT) will eliminate antibiotics while eliminating water and solutes from the body,so adjusting antibiotics dose timely is important for patients undergoing CRRT.Pharmacological characteristics of antimicrobials,pathological and physiological statues of the patients,effects of CRRT on antibiotics clearance and other factors would affect the pharmacokinetics of antibiotics.In order to achieve the desired therapeutic effect,the monitoring of drug concentration and individualizing the dosage of antibiotics are cecessary.

Objective To investigate the efficacy and safety of gastric peroral endoscopic myotomy ( G-POEM) for postsurgical gastroparesis. Methods A retrospective analysis was performed on data of 47 patients with gastroparesis after subtotal gastrectomy, who underwent G-POEM at Zhongda Hospital Southeast University form August 2016 to June 2018. G-POEM procedure, complications related to G-POEM, and improvement of symptoms and gastric emptying function were observed. Results All patients underwent G-POEM successfully. No serious G-POEM-related complications were observed. During a follow-up period of 9. 8±5. 8 months (range 3-18 months), the scores of gastroparesis cardinal symptoms index (GCSI) were 1. 6±0. 5, 1. 2±0. 4, 1. 1±0. 6, 1. 4±0. 3 and 1. 7±0. 3 respectively at the 1st, 3rd, 6th, 12th, and 18th months after G-POEM, and all scores were lower than that before G-POEM (3. 8±1. 1, all P<0. 01). The results showed the symptoms of gastroparesis were improved significantly. Gastric emptying imaging showed the hemi-emptying time was 23. 8±8. 8 min, 21. 2±9. 5 min, 20. 9±8. 3 min and 26. 4±7. 8 min at the 1st, 6th, 12th and 18th months after G-POEM, respectively, significantly shorter than that before G-POEM (67. 8±12. 5 min, all P<0. 01). Three-dimensional ultrasonography results of gastric antrum volume showed that the hemi-emptying time was 26. 4 (21. 8, 40. 3) min, 22. 6 (13. 9, 32. 7) min, 24. 3 (18. 2, 36. 5) min and 26. 8 (16. 4, 38. 5) min at the 1st, 6th, 12th and 18th months after G-POEM, respectively, which were all significantly shorter than that before G-POEM [ 72. 5 ( 48. 3, 108. 6 ) min, all P<0. 01 ] . Conclusion G-POEM has a satisfactory long-term efficacy on the treatment of gastroparesis after subtotal gastrectomy with good safety.