Objective To develop and verify a reporter gene assay for the determination of antibody dependent cellular phagocytosis(ADCP)potency of Ig G2 monoclonal antibody(m Ab)against epidermal growth factor receptor(EGFR)by combining Design of Experiment(DOE)and one factor at a time(OFAT).Methods The Jurkat/NFAT-Re/FcγRⅡa stably transformed cell line was used as effector cells,while the A431 cell line as the target cells.The JMP software was used to optimize the seven key factors in the experiment by combining DOE and OFAT analysis,while the ratio of upper and lower asymptotes(D/A)was used as the statistic,and the reporter gene method was developed to evaluate the ADCP potency of Ig G2 anti-EGFR m Ab.The method was verified according to the general chapter<9401>of Chinese Pharmaco-poeia（Ⅲ/Ⅳvolume,2020 edition)and used to determine the biological potency of Ig G2 anti-EGFR m Ab injection.Results After three rounds of experiments,the reporter gene method to evaluate the ADCP potency of Ig G2 anti-EGFR m Ab was developed.The method showed a dose-response relationship and was consistent with the four-parameter regression equa-tion y=(A-D）/[1+(x/C)~B]+D.The range of seven key conditions was determined:the density of effector cells was(1.25-3.75）×10~4 cells/well,the density ratio of effector cells to target cells was 1.0-2.0,the incubation time of target cells was 20-40 min,the incubation time of administration was 15-30 min,the total time was 5.5-6.5 h,and the color time was 5-30 min with luciferase detection system(Bright-Glo)as the color agent.The method had good specificity.Six independent tests were run for the five potency levels,with the correlation coefficient r of 0.994 5 and the linear regression equation slope of 1.02.The relative potency of five potency levels respectively was(62.15±1.38)%,(78.53±2.82)%,(99.12±3.95)%,(123.27±4.59)%and(155.22±7.04)%,the range of relative biases was-2.9%-0.2%,and the range of generalized cross-validation(GCV)was 2.2%-4.6%.The method had good linearity,relative accuracy and precision in the range of 64%-156%.The mean value of the potency of IgG2 anti-EGFR m Ab in three tests was(101.5±2.8)%.Conclusion The reporter gene assay developed in this study can be used to evaluate the ADCP potency of IgG2 anti-EGFR mAb

Objective To investigate the clinical characteristics and feasibility of laparoscopic repair of giant hiatal hernia. Methods From January 2008 to August 2010, 25 consecutive patients with giant hiatal hernia underwent laparoscopic repair. Crural closure was performed by means of two or three interrupted nonabsorbable sutures plus a tailored PTFE/ePTFE composite mesh. It was patched across the defect and secured to each crura with staples. Laparoscopic fundoplication was performed concomitantly in 16 cases according to the specific conditions of patients. Para-operative clinical parameters were recorded. All patients were routinely followed up. Clinical outcomes were collected and analyzed. Results All laparoscopic surgeries were accomplished successfully. The operating time was 85 -210 minutes (mean, 106 minutes) ,the operative blood loss was 55 - 150 ml( mean, 94 ml) ,the postoperative hospital stay was 4 -21 days( mean, 6.8 days). The symptoms in most cases were adequately relieved after operation. There was no severe postoperative morbidity. After the follow-up period of 3 - 35months ( mean, 13.6 months), the satisfaction rate of surgery was 88%. 4 cases had mild symptom recurrence of acid reflux.Hiatal hernia recurrence occurred in 1 case. Conclusions Laparoscopic repair of giant hiatal hernia is a safe and effective minimally invasive procedure, with the advantages of minimized trauma, quick recovery and reliable effect. The use of a tailored PTFE/ePTFE composite mesh ( Bard CruraSoft Mesh)for giant hiatal hernia proved to be effective in reducing the operation time and technique demands, and the rate of postoperative hernia recurrence, with a very low incidence of mesh-related complications.

Objective To investigate the feasibility and clinical value of laparoscopic surgery in treating patients with gastroesophageal reflux disease. Methods From September 2001 to August 2009, 372 patients with gastroesophageal reflux disease undertwent laparoscopic fundoplication, including 146 cases of Nissen fundoplication, 79 Toupet fundoplication, and 147 anterior 180 degrees partial fundoplication. Para-operative clinical parameters were recorded. All patients were routinely followed up. Clinical outcomes were collected and analyzed. Results Laparoscopic surgery was successfully performed in all patients, and no conversions were required. The operating time was 50 -210 minutes (mean, 85 minutes), the operative blood loss was 40 - 150 ml( mean, 86 ml) ,the postoperative hospital stay was 3 - 21 days( mean, 4.3 days ). The symptoms in most cases were adequately relieved after operation. There were no severe postoperative morbidity and mortality. Endoscopy, radiology, esophageal manometry and 24-hour pH monitoring were repeated 3 months after surgery. After the follow-up period of 3 -63 months ( mean, 27.3 months), the satisfaction rate of operation was 92.57%. 19 cases had mild dysphagia when eating solid food. Symptoms recurrence of acid reflux occurred in 6 cases, which were controlled by antacid medications. Hiatal hernia recurrence occurred in 1 case. Conclusions Laparoscopic operation should be the method of choice to treat the moderate to severe gastroesophageal reflux disease, with the advantages of minimized trauma,quick recovery, safety,feasibility and reliable effect. According to individual condition of patients, appropriate fundoplication procedure should be employed carefully to ensure results of operations, reduce operating difficulties and the rate of postoperative complications.

Benign diseases of gastroesophageal junction include gastroesophageal reflux disease,hiatal hernia and achalasia of the cardia.Surgical intervention is superior in the treatment of moderate to severe cases.With the rapid development of laparoseopic technology,minimally invasive surgical procedures,such as laparoscopic fundoplication,laparoscopic rear of hiatal hernia and laparoscopic cardiamyotomy are widely applied with excellent efficacy.According to our experience and clinical study,laparoscopic surgery,with advantages of minimal trauma,rapid recovery,safety and reliable efficacy,could be the first-line treatment for benign diseases of gastroesophageal junction.

Objective To study the approach of the combination of endoscopy and laparoscopic hepatectomy in the treatment of intra-and extrahepatic bile duct stones.Methods Eighty-one patients with intra-and extrahepatic bile duct stones who had been admitted to Nankai Hospital from July 2004 to March 2008 were divided by random number table into 2 groups.Twenty patients in group A underwent open hepatectomy+biliary exploration.Sixty-one patients in group B received duodenoscopy first,and patients with successful clearance of stones in the extrahepatic bile duct underwent total laparoscopic hepatectomy or hand-assisted laparoscopic hepateetomy according to the location of the stones in the liver;patients with residual stones in the extrahepatic bile duct underwent hand-assisted laparoscopie hepateetomy+biliary exploration.The changes of the indexes during perioperative period of the 2 groups were analyzed by t test.Results Minimally invasive surgeries were successfully carried out in group B.Satisfactory outcomes were obtained,and no severe complication was observed.The gastrointestinal function recovery time of patients who underwent hand-assisted laparoscopic hepatectomy+biliary exploration in group B was significantly shorter than in group A(t:3.062,P＜0.05),but there was no significant difference in operation time and perioperative blood loss between the 2 groups(t=0.953,0.911,P＞0.05).Compared with patients who underwent hand-assisted laparoscopic hepateetomy,the operation time was significantly longer,hut the gastrointestinal function recovery time was significantly shorter in patients who underwent total laparoscopic hepatectomy(t:2.046,2.316,P＜0.05),there was no significant difference in operation time between the 2 groups(t=0.874,P＞0.05).Conclusion Endoscopy+laparoscopic hepatectomy is safe and effective,and can decrease the trauma to the minimum for patients with intra-and extrahepatic bile duct stones.

This paper makes persuasive demonstrations on some problems about the human ear sound transmission principle in existing physiological textbooks and reference books, and puts forward the authors' view to make up for its literature. Exerting the knowledge of lever in physics and the acoustics theory, we come up with an equivalent simplified model of manubrium mallei which is to meet the requirements as the long arm of the lever. We also set up an equivalent simplified model of ossicular chain--a combination of levers of ossicular chain. We disassemble the model into two simple levers, and make full analysis and demonstration on them. Through the calculation and comparison of displacement amplitudes in both external auditory canal air and internal ear lymph, we may draw a conclusion that the key reason, which the sound displacement amplitude is to be decreased to adapt to the endurance limit of the basement membrane, is that the density and sound speed in lymph is much higher than those in the air.
Acoustics ; Ear Canal ; Ear Ossicles ; physiology ; Ear, Inner ; physiology ; Humans ; Lymph ; Models, Anatomic ; Sound

Objective To investigate the management of complications after laparoscopic adjustable gastric banding (LAGB).Methods The clinical data of 83 obese patients who were treated by LAGB at the Nankai Hospital from September 2005 to June 2011 were retrospectively analyzed.The complications after LAGB were analyzed.The adjustable gastric band was installed under laparoscope so as to form a small gastric pouch with a volume ranged between 20-30 ml.The water pump was fixed in the rectus abdominis anterior sheath under the appendix ensiformis.The gastric band was adjusted according to the changes of the body weight,symptoms after diet and results of imaging examination of upper gastrointestinal tract.Patients were followed up via out-patient examination and phone call till July 2013.Results The incidence of complications of the 83 patients was 44.6％ (37/83).Six patients had short-term complications and 31 patients had long-term complications.The short-term complication mainly presented as post-prandial vomiting.The symptoms of 5 patients were relieved by changing of eating habit.The condition of 1 patient was severe,and the symptom was relieved 5 days later after fasting and nutritional support.For the 31 patients with long-term complications,25 were complicated with band erosion into gastric lumen via gastric wall (6 patients were complicated with infection of the water pump site),and they were cured by removal of band laparoscopicly.Ten patients were complicated with water pump-related complications,including 6 with infection of the water pump site and 4 with pump migration.The water pumps of the 4 patients with pump migration were surgically removed.Two patients had band slipping to the stomach.The band was restored to the original place after removing the liquid from the band and reducing the food intake,and then the position of the band in 1 patient was restored to normal,and no change was observed in another patient,and the band was removed laparoscopicly.Conclusions The incidence of complications after LAGB is high,and it increases as the time passes by.Most of the long-term complications after LAGB need to be treated by reoperation.

To discuss background of Medicare hospital payment system reform in the U.S., its legislative and administrative system and the key issues incurred during the design and implementation process, then summarized the experiences and lessons and suggestions were proposed for current provider payment reforms in China.

Objective To explore the effect of information system management mode intervention on quality of life in systemic lupus erythematosus (SLE) patients.Methods There were 40 SLE patients after hospitalization and the patients condition were under control.But they still needed outpatient treatment.In our study,when they joined the investigation group,the medical outcomes study 36-item short-form health survey (MOS SF-36) scale was used for measuring the quality of life.All patients would receive a baseline questionnaire evaluation before observation and endpoint evaluation after one year.The SF-36scores of all the patients were investigated and analyzed.Results One year later,the SF-36 scores of the patients indicated that the scores of patients' physiological role functioning,general health,social role functioning,emotional role functioning,mental health improved with statistical significance.The scores of patients' physical functioning,physical pain,and vitality had no statistical significance compared with those one year before.Conclusions Information system management mode can provide long-term,systematic and effective management for the SLE patients.It can improve the level of mental health and quality of life for SLE patients.

Objective To evaluate the efficacy and safety of double-frequency laser lithotripsy under endoscope in the treatment of refractory biliary stones. Methods A total of 23 patients with refractory biliary stones underwent double-frequency Nd:YAG laser lithotripsy from January 2002 to June 2004. The authors performed the laser lithotripsy during laparoscopic common bile duct exploration in 14 patients and during postoperative choledochoscopy in 9 patients. Results Biliary stones were completely removed in 19 patients, the stone free rate for refractory biliary stones being 82.6% (19/23). No bile duct or T-tube tract injuries occurred. Conclusions Double-frequency laser lithotripsy has the advantages of mini invasion, high efficiency, and low postoperative complication rate. It is an effective alternative for patients with refractory biliary stones during endocopic surgery.