Combined with work experience, this paper described the project process of clinical research pro-jects and ethical review points, and pointed out that clinical research projects should be submitted to peer reviewers prior to ethical review. The ethics committee would review the projects in accordance with legality, scientificity, feasibility, ethics, and other points in detail. Accurately grasp of the balance between innovations and ethics ensure the standardized development of clinical research.

OBJECTIVE:To provide reference for performing quality control and protecting the subjects’rights and interests. METHODS:233 severe adverse events (SAE) cases reported by our hospital during Jan. 2012-Jun. 2015 were collected and ana-lyzed statistically in respects of subjects’gender and age,department,drug/equipment types,SAE types,relationship of SAE with drug/equipment,comorbidities,etc. RESULTS:The incidence of SAE in male was higher than female(71.2% vs. 28.8%);SAE mainly occurred in people over the age of 50(189 cases,81.1%);the incidence of SAE in cardiology department was the highest (137 cases,58.8%);main SAE type was hospitalization(183 cases,78.5%);most of SAE had nothing to do with studied drugs (164 cases,70.4%);more than half of the subjects suffered from other comorbidities(128 cases,54.9%). CONCLUSIONS:In order to ensure the quality of drug clinical trial data and safety of subjects,the investigator should strengthen the management of the elderly subjects and those suffering from comorbidities,to ensure that each SAE case is timely processed and accurately record-ed and reported.

Objective: To investigate the expression of midkine (MK) gene in childhood acute lymphoblastic leukemia (ALL) and the clinical significance of MK thereof. Methods: The real-time PCR was used to assay MK gene expression in bone marrow of 15 normal children and 124 childhood ALL patients, including 73 patients in progression and 51 patients in complete remission. Three stratifications of progressing patients were established by prognostic factors such as white blood cell count, age, immunopherotype and response to the 7-day prednisolone prephase. Results: The significant statistic difference in MK gene expression was found between the progression group, the complete remission group and the normal group (P< 0.01). The MK gene expression was over-expressed in B-ALL than that in normal group. Furthermore, there was statistic difference between B-ALL and T-ALL (P< 0.01). But there was no difference in MK mRNA expression between the normal control and T-ALL. The assay in risk stratifications showed that the levels of MK gene were higher in standard risk group and mid-risk group than that in high risk group (P< 0.01 and P< 0.05, respectively). There was no significant difference between standard risk group and mid -risk group (P = 0.32). No correlations were found between MK level and age, gender or lactate dehydrogenase level in serum. The expression of MK was significantly lower in the group with higher white blood cells(WBC≥ 25×10~9/L) than that with lower WBC (WBC<25×l0~9/L) in peripheral blood (P< 0.05). Conclusion: The high level of MK was a favorable prognostic factor in childhood acute lymphoblastic leukemia patients.

Objective: To observe the perioperative changes of serum thrombomodulin in patients with and without cardiogenic shock undergoing off-pump coronary artery bypass grafting surgery. Methods: A total of 66 patients with coronary artery disease who underwent off-pump coronary artery bypass grafting surgery between June and December 2015 in our hospital were included in this study.The patients were divided into non-cardiogenic shock group (n=51) and shock group (n=15) according to the absence or presence of cardiogenic shock.The clinical data of the two groups were analyzed.Arterial blood samples were collected immediately after anesthesia, and at 4, 8, 16, 24, 48 and 72 hours after surgery.The levels of serum thrombomodulin were tested with enzyme-linked immunosorbent assay. Results: (1)The prevalence of diabetes was significantly higher (64.7%(33/51) vs. 20.0%(3/15), P<0.01), while prevalence of myocardial infarction was significantly lower (41.2%(21/51)vs. 100%(15/15), P<0.01) in non-cardiogenic shock group than in cardiogenic shock group.(2)The peak plasma creatinine level, troponin I level and creatine kinase MB level were significantly lower in the non-cardiogenic shock group than in the cardiogenic shock group ((88.5±36.7) μmol/L vs. (122.6±71.1) μmol/L, 1.3(0.2, 2.7) μg/L vs. 16.4(5.8, 23.4) μg/L and (18.8±4.7) μg/L vs.(49.3±15.9) μg/L, respectively, all P<0.05). (3)Mechanical ventilation time was significantly longer (11.5 (9.0, 18.0) hours vs. 20.0 (8.5, 82.5) hours, P=0.02), and frequency of intra-aortic balloon pump use (0 vs. 100%, P<0.01) was significantly higher in the cardiogenic shock group than in the non-cardiogenic shock group.(4) Prevalence of atrial fibrillation (5.9%(3/51) vs. 80.0%(12/15)) and myocardial infarction (19.6%(10/51)vs. 93.3%(14/15)) that occurred during and after surgery was significantly lower in the non-cardiogenic shock group than in the shock group(all P<0.01). (5)The serum thrombomodulin concentration was similar among various time point in the non-cardiogenic shock group: 3.30(2.68, 7.44), 4.09(2.95, 7.18), 4.35(2.68, 8.22), 3.50(2.95, 8.00), 3.41(2.60, 5.97), 3.30(2.65, 5.42)and 3.94(2.82, 5.60) μg/L, taken immediately after anesthesia, and at 4, 8, 16, 24, 48 and 72 hours after surgery respectively, and was 2.44(1.97, 2.67), 2.21(1.93, 2.83), 2.64(2.29, 2.67), 2.84(2.26, 2.94), 3.35(2.43, 4.05), 2.76(2.73, 2.97) and 3.81(2.96, 5.96)μg/L respectively, in the cardiac shock group (all P>0.05). The serum thrombomodulin levels at 4 and 8 hours after surgery were higher in the non-cardiogenic shock group than cardiogenic shock group(all P<0.05). Conclusion Compared with the non-cardiogenic shock group, the peak serum thrombomodulin level appears later and recovers slower in cardiogenic shock patients who underwent off-pump coronary artery bypass grafting surgery.

Objective: To prove the validity and accuracy of the digitizer instead of the conventional electronics plug-in for radionuclide measurement. Methods:  Based on a large-area flow-gas multi-wire proportional counter for 2πα and 2πβ surface particle emission rate measurement, the DT5730 digital waveform sampler developed by CAEN was used for waveform signal acquisition, amplitude analysis, and data processing of the α-plane source 241Am and the β-plane source nuclides 14C, 36Cl, and 90Sr-90Y of different energies. Results: The deviations between the α and β surface particle emission rate results obtained after dead time and background corrections and the measurements obtained based on the plug-in calibrator were all within 0.6%, within the uncertainty range, under consistent experimental conditions such as electronics threshold and high pressure. Conclusion The digitizer is an effective alternative to conventional electronics plug-ins for α and β signal acquisition and processing and the accurate measurement of α and β emission rates.

Objective To correct the counting loss of ³⁷Ar below the activity threshold during the measurement of the absolute activity of the inert radioactive gas ³⁷Ar using the proportional counter filled with gas. Methods Monte Carlo simulation with Geant4 was performed to establish a proportional counter model and output the energy deposition spectrum of ³⁷Ar, which were used to simulate and analyze the causes and correction of counting loss. Results The photon detection efficiency was only 38.7% at 60 kPa. The counting loss was mainly caused by the wall effect produced by the photons, which could be reduced by increasing the gas pressure and corrected by extrapolation. The influence of wall effect at 100 kPa was 4.4%, and the deviation between simulation and experiment was < 0.6%. Conclusion A factor could be calculated by Geant4 simulation for the correction of counting loss, thus achieving the accurate measurement of ³⁷Ar activity by proportional counter.

Based on the current situation and task of fighting COVID-19, and combined with emergency management mode of public health emergencies and participation of multi-times emergency rescue practices along with the case analysis and literature review and brain-storming, we constructed a basic framework of the emergency command system of public health emergencies in COVID-19 epidemic prevention and control background. The framework contained four modules: the response mechanism, the organizational structure, the emergency capacity, and the supervisory mechanism and the advantages and key points in implementing this emergency command system was discussed.

Objective    To summarize the perioperative outcome of patients undergoing robot-assisted thoracic surgery (RATS) or four-port single-direction video-assisted thoracic surgery (VATS) right upper lobectomy (RUL), and to discuss the safety and the essentials of the surgery. Methods    The clinical data of 579 patients with non-small cell lung cancer (NSCLC) undergoing minimally invasive RUL in Dr. Luo Qingquan’s team of our center from 2015 to 2018 were retrospectively analyzed. There were 246 males and 333 females aged 33-78 years. The 579 patients were divided into a RATS group (n=283) and a VATS group (n=296) according to surgical methods. Baseline characteristics and perioperative outcomes including dissected lymph nodes, postoperative duration of drainage, postoperative hospital stay, postoperative complications and surgery cost were compared between the two groups. Results    There was no significant difference in baseline data between the two groups (P>0.05), and no postoperative 30 d mortality or intraoperative blood transfusion was observed. Compared with VATS, RATS had shorter operation time (90.22±12.16 min vs. 92.68±12.26 min, P=0.016), postoperative hospital stay (4.67±1.43 d vs. 5.31±1.59 d, P<0.001) and time of drainage (3.55±1.38 d vs. 4.16±1.58 d, P<0.001). No significant difference was observed between the two groups in the lymph nodes dissection, blood loss volume, conversion rate or complications. The cost of RATS was much higher than that of VATS (93 275.46±13 276.69 yuan vs. 67 082.58±12 978.17 yuan, P<0.001). Conclusion    The safety and effectiveness of robot-assisted and video-assisted RUL are satisfactory, and they have similar perioperative outcomes. However, RATS costs relatively shorter operation time and postoperative hospital stay.