The expanded clinical trial system is designed to provide clinical trial drugs for patients suffering from serious or life-threatening diseases for which there is no effective treatment， essentially seeking a balance between the accessibility of drugs to patients and the soundness of the development of the pharmaceutical industry， as well as between the risk of expanding the use of clinical trial drugs and the need to safeguard the rights and interests of patients’ lives and health. Article 23 of China's Drug Administration Law provides only a principled description of the applicable standards and operating procedures for this system， with no implementing regulations， making it difficult for the system to function effectively in practice. The United States， Japan， and Canada have made detailed provisions on the conditions of application， applicants， review subjects and contents， and safeguards of the system through laws， regulations， and guidelines. Based on China's legislative environment and regulatory reality， and considering that the system is still in the initial stage in China， it is recommended that appropriate reference be made to the beneficial experience of foreign countries and that regulations and normative documents be promulgated as soon as possible to clarify the types of expanded clinical trials， applicants， review subjects etc.， and to determine the responsibilities of all the parties involved， to promote the standardization of China’s expanded clinical trial system， to promote the availability of medicines to patients， and to effectively safeguard the rights and interests of patients’ lives and health， and the soundness and safety of the development of the pharmaceutical industry.

Lymphoma is a malignant tumor of the lymphatic system, including Hodgkin's lymphoma and non-Hodgkin's lymphoma. Lymphoma is the fourth most common primary malignant tumor during pregnancy and one of the major malignant diseases affecting maternal and infant outcomes. This review summarizes the clinical features, diagnosis, maternal and fetal outcomes, and clinical lymphoma treatment during pregnancy. It is suggested that clinicians should pay attention to the symptoms, including unexplained lymphadenectasis, systemic symptoms, extranodal lesions, and the　symptoms of pressure exerted on the involved local organs, especially those in the breast and reproductive system, and make a timely diagnosis in line with the biopsy or puncture results. Management should be based on the classification, stage, and clinical manifestations of lymphoma. Besides, the gestational age at diagnosis, maternal and child conditions, and the willingness to continue the pregnancy should also be considered. Most mothers and their children can have good outcomes after individualized treatment through multidisciplinary cooperation and close perinatal management.

Objective:To explore the effect of visual mind mapping based on Mini-CEX evaluation combined with case-based learning (CBL) on improving the learning ability and teaching satisfaction of nursing students in department of general surgery.Methods:A total of 120 nurses rotating in the Department of General Surgery, Panzhihua Central Hospital (Clinical Medical College of Panzhihua University) from September 2019 to July 2020 were selected as research objects, and randomly divided into a control group and a study group, with 60 nurses in each group. The control group used traditional teaching, and the study group used visual mind mapping based on Mini-CEX evaluation combined with CBL. After the training, the clinical comprehensive ability of the nurses was evaluated by theoretical and practical assessment, and the self-learning ability and teaching satisfaction of the nurses were analyzed through self-made questionnaire survey. SPSS 22.0 was used for t test and chi-square test. Results:The theoretical and practical assessment scores of nursing students in the study group were significantly higher than those in the control group[(95.01±3.52) vs. (83.26±4.05); (96.14±3.22) vs. (81.17±4.30)] ( P=0.001). Before the rotation training, there was no statistical difference between the study group and the control group in the scores of self-motivation beliefs, task analysis, self-monitoring and adjustment, and self-evaluation ( P>0.05). After the rotation training, the scores of above 4 aspects were significantly higher in study group than the control group ( P<0.05). The nurse trainees in the study group were significantly superior to those in control group in the following 7 aspects: reasonable arrangement of the teaching plan, novelty of the teaching mode, improvement of clinical nursing skills, improvement of the nurse-patient communication ability, improvement of the emergency response ability, and overall teaching satisfaction ( P=0.001). Conclusion:Visual mind mapping based on Mini-CEX evaluation combined with CBL applied to clinical teaching training of nursing students in the department of general surgery can effectively improve the effectiveness of nursing teaching and teaching satisfaction, improve the learning ability of nurses, and improve the nursing level of nursing students in the department of general surgery.

BACKGROUND: Autophagy plays a crucial role in chemotherapy resistance of triple-negative breast cancer (TNBC). Hence, autophagy-related gene 5 (ATG5), an essential molecule involved in autophagy regulation, is presumably associated with recurrence of TNBC. This study was aimed to investigate the potential influence of single-nucleotide polymorphisms in ATG5 on the disease-free survival (DFS) of early-stage TNBC patients treated with anthracycline- and/or taxane-based chemotherapy. METHODS: We genotyped ATG5 SNP rs473543 in a cohort of 316 TNBC patients treated with anthracycline- and/or taxane-based chemotherapy using the sequenom's MassARRAY system. Kaplan-Meier survival analysis and Cox proportional hazard regression analysis were used to analyze the association between ATG5 rs473543 genotypes and the clinical outcome of TNBC patients. RESULTS: Three genotypes, AA, GA, and GG, were detected in the rs473543 of ATG5 gene. The distribution of ATG5 rs473543 genotypes was significantly different between patients with and without recurrence (P = 0.024). Kaplan-Meier survival analysis showed that patients carrying A allele of ATG5 rs473543 had an increased risk of recurrence and shorter DFS compared with those carrying the variant genotype GG in rs473543 (P = 0.034). In addition, after adjusting for clinical factors, multivariate Cox regression analyses revealed that the AA/GA genotype of rs473543 was an independent predictor for DFS (hazard risk [HR], 1.73; 95% confidence interval [CI], 1.04-2.87; P = 0.034). In addition, DFS was shorter in node-negative patients with the presence of A allele (AA/GA) than in those with the absence of A allele (P = 0.027). CONCLUSION ATG5 rs473543 genotypes may serve as a potential marker for predicting recurrence of early-stage TNBC patients who received anthracycline-and/or taxane-based regimens as adjuvant chemotherapy.
Adult ; Aged ; Anthracyclines ; administration & dosage ; adverse effects ; Autophagy-Related Protein 5 ; genetics ; Bridged-Ring Compounds ; administration & dosage ; adverse effects ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Genetic Association Studies ; Genetic Predisposition to Disease ; Humans ; Kaplan-Meier Estimate ; Middle Aged ; Neoplasm Recurrence, Local ; drug therapy ; genetics ; pathology ; Polymorphism, Single Nucleotide ; genetics ; Taxoids ; administration & dosage ; adverse effects ; Triple Negative Breast Neoplasms ; drug therapy ; genetics ; pathology

OBJECTIVE: To explore the feasibility of using network system to carry out desktop health emergency response exercise for sudden poisoning incidents,and to understand the emergency response capability on sudden poisoning incident in Guangdong Province. METHODS: A chemical poisoning incident caused by drinking polluted water was simulated. Eight questions were designed in 4 sections including the emergency report,response,disposal and strain capacity to the emergency. A total of 10 teams from prefecture-level city in Guangdong Province answered through the desktop network exercise system designed by National Institute of Occupational Health and Poison Control. Meanwhile,the experts judged score using this system. RESULTS: Ten teams were familiar and adapted to the network system in a relatively short period of time. The scores of emergency report,response,disposal and strain capacity on emergency were(14. 9 ± 2. 3),(6. 0 ±2. 2),(20. 7 ± 4. 1) and(13. 2 ± 3. 5),respectively. The score rates of above 4 sections were(74. 5 ± 11. 5) %,(50. 4 ±18. 7) %,(43. 5 ± 8. 5) % and(66. 2 ± 17. 5) %,respectively. The score rate of emergency report was higher than that of response and disposal( P < 0. 05). The score rate of strain was higher than that of disposal( P < 0. 05). The total score of desktop exercises of the 10 teams was(55. 0 ± 8. 0),which was low on the whole. CONCLUSION: The network system can be used for desktop exercise for sudden poisoning incidents. There is a weak link in the health emergency response capacity of sudden poisoning incidents in Guangdong Province and the capability of emergency response and disposal should be strengthened.

Objective To compare the development of intraoperative atrial fibrillation in elderly patients undergoing thoracic surgery using different anesthetic methods in a large sample clinical trial.Methods A total of 1 380 patients of both sexes,aged 60-80 yr,with body mass index of 16-33 kg/m2,of American Society of Anesthesiologists physical status Ⅰ or Ⅱ,scheduled for elective radical operations for lung or esophageal cancer,were divided into 3 groups (n =460 each) using a random number table:general anesthesia group (group G),general anesthesia combined with paravertebral block group (group GP),and general anesthesia combined with epidural block group (group GE).After induction of anesthesia,an epidural catheter was placed at T4-7 interspace on the operated side,and 0.375％ ropivacaine 8 ml was administrated via the catheter in group GP.After induction of anesthesia,the patients were tracheally intubated and mechanically ventilated,and the end-tidal pressure of carbon dioxide was maintained at 35-45 mmHg in the 3 groups.Maintenance of anesthesia was as follows:propofol was given by target-controlled infusion with the target plasma concentration of 2.5-4.0 μg/ml in the 3 groups;intermittent iv boluses of sufentanil 10 μg were given,and the total dosage was not expected to exceed 1.0 μg/kg in group G;sufentanil 10 μg was injected intravenously when necessary in group GP;0.25％ ropivacaine 5 ml was injected epidurally every 1.5 h in group GE;bispectral index value was maintained at 40-60;rocuronium was injected intravenously according to the condition in the 3 groups.The development of intraoperative atrial fibrillation was recorded.Results The incidence of intraoperative atrial fibrillation was 6.1％,3.7％ and 2.2％ in G,GP and GE groups,respectively.Compared with group G,the incidence of intraoperative atrial fibrillation was significantly decreased in group GE (P＜0.05),and no significant change was found in the incidence of intraoperative atrial fibrillation in group GP (P＞0.05).Conclusion Compared with general anesthesia,general anesthesia combined with epidural block can decrease the development of intraoperative atrial fibrillation,it is more suitable for this type of patients,however,general anesthesia combined with paravertebral block produces no improvement in the development of intraoperative atrial fibrillation in elderly patients undergoing thoracic surgery.

Objective To analyze the spatial and temporal clustering characteristics of typhoid and paratyphoid fever and its change pattern in Yunnan, Guizhou and Guangxi provinces in southwestern China in recent years. Methods The incidence data of typhoid and paratyphoid fever cases at county level in 3 provinces during 2001-2012 were collected from China Information System for Diseases Control and Prevention and analyzed by the methods of descriptive epidemiology and geographic informatics. And the map showing the spatial and temporal clustering characters of typhoid and paratyphoid fever cases in three provinces was drawn. SaTScan statistics was used to identify the typhoid and paratyphoid fever clustering areas of three provinces in each year from 2001 to 2012. Results During the study period, the reported cases of typhoid and paratyphoid fever declined with year. The reported incidence decreased from 30.15 per 100000 in 2001 to 10.83 per 100000 in 2006 (annual incidence 21.12 per 100000);while during 2007-2012, the incidence became stable, ranging from 4.75 per 100000 to 6.83 per 100000 (annual incidence 5.73 per 100000). The seasonal variation of the incidence was consistent in three provinces, with majority of cases occurred in summer and autumn. The spatial and temporal clustering of typhoid and paratyphoid fever was demonstrated by the incidence map. Most high-incidence counties were located in a zonal area extending from Yuxi ofYunnan to Guiyang of Guizhou, but were concentrated in Guilin in Guangxi. Temporal and spatial scan statistics identified the positional shifting of class Ⅰ clustering area from Guizhou to Yunnan. Class Ⅰ clustering area was located around the central and western areas (Zunyi and Anshun) of Guizhou during 2001-2003, and moved to the central area of Yunnan during 2004-2012. Conclusion Spatial and temporal clustering of typhoid and paratyphoid fever existed in the endemic areas of southwestern China, and the clustering area covered a zone connecting the central areas of Guizhou and Yunnan. From 2004 to 2012, the most important clustering area shifted from Guizhou to Yunnan. Findings from this study provided evidence for the identifying key areas for typhoid and paratyphoid fever control and prevention and allocate health resources.

Objective To evaluate the immunopotentiating effect of cyclic guanosine monophos-phate-adenosine monophosphate (cGAMP) as an adjuvant on norovirus (GⅡ. 4) virus like particles (VLPs) in the development of norovirus vaccine. Methods BALB/c mice were intramuscularly immunized with norovirus (GⅡ.4) VLPs composed of capsid protein VP1 in combination with cGAMP or Al(OH)3. Norovirus VLPs-specific antibodies in serum were detected by ELISA. A synthetic histo-blood group antigen (HBGA)-VLPs blocking assay was used to analyze neutralizing antibodies against norovirus VLPs in serum samples. Results Immunization with norovirus VLPs in the presence of cGAMP induced a strong humoral immune response in BALB/c mice. Levels of specific IgG antibodies in serum induced by using cGAMP as the adjuvant were significantly higher than those induced by using Al(OH)3adjuvant when immunization of BALB/c mice with the same dosage of VLPs. The antibody level induced by 1 μg of VLPs in combination with cGAMP was equivalent to that elicited by 10 μg of VLPs combined with Al(OH)3adjuvant. Results of the synthetic HBGA-VLPs blocking assay showed that the blocking rate in cGAMP+VLPs immunization group were significantly higher than that in Al(OH)3+VLPs immunization group when using the same dosage of VLPs. No significant difference in blocking rate was observed between cGAMP+VLPs(1 μg) and Al(OH)3+VLPs (10 μg) immunization groups. Conclusion cGAMP significantly enhanced the specific humoral immune response induced by norovirus (GⅡ.4) VLPs in mice as compared with Al(OH)3adjuvant. It might be used as a novel adjuvant to replace the traditional aluminum adjuvant in the development of norovir-us vaccine.

The strategy of optimizing anesthetic management was carried out in all the patients un?dergoing thoracic surgery in our hospital from January 1, 2012: the patients were monitored using routine electrocardiogram combined with invasive arterial blood pressure monitoring, double?lumen central venous catheter pathway was established, and when severe bradycardia ( heart rate<40 beats∕min) occurred, inter?vention was carried out immediately, and chest compression was performed timely. Medical records of 15 212 patients from July 1, 2006 to December 31, 2011 ( before optimizing anesthetic management) as well as medical records of 17 078 patients from January 1, 2012 to January 15, 2015 ( after optimizing an?esthetic management) were reviewed. The data including baseline patient characteristics as well as the time period and causes of cardiac arrest, rescue time, rescue measures, successful resuscitation and prognosis in the patients developing intraoperative cardiac arrest were collected. Before optimizing anesthetic manage?ment, 28 patients developed cardiac arrest, the incidence was 0?184%, successful resuscitation was found in 25 cases, the success rate of resuscitation was 89%, and there were 3 cases in whom resuscitation failed due to massive hemorrhage?induced cardiac arrest. After optimizing anesthetic management, 17 patients de?veloped cardiac arrest, the incidence was 0?109%, massive hemorrhage?induced cardiac arrest was not found in patients, and the success rate of resuscitation was 100%. Prognosis was good after surgery in suc?cessfully resuscitated patients. Compared with the values before optimizing anesthetic management, the in?cidence of cardiac arrest was significantly decreased (P=0?05), and no significant change was found in the other parameters after optimizing anesthetic management ( P>0?05) , and the incidence of cardiac arrest was decreased by 45% after optimizing anesthetic management. In conclusion, the strategy of optimizing anesthetic management is helpful in decreasing the occurrence of cardiac arrest during thoracic surgery.

OBJECTIVE:To study the correlation between antibacterials amount and drug resistance of Echerichia coli,and to provide reference for clinical use of antibacterials. METHODS:Retrospective review was used to calculate DDDs of antibacterials and resistance rate of Escherichia coli to 11 kinds of antibacterials each quarter. The correlation analysis was carried out using the SPSS 13.0 statistical software. RESULTS:The resistance rates of E. coli to piperacillin/tazobactam,cefoperazone/sulbactam and le-vofloxacin were with upward trends,and the others showed downward trends. The resistance rates of E. coli to meropenem and imi-penem/cilastatin appeared in 2014,increasing from 0 to 8.8% and 9.4%,respectively. DDDs of them were significantly correlated to drug resistance of E. coli,showing positive correlation(r=0.915,0.793,P<0.01). DDDs of piperacillin/tazobactam was signif-icantly correlated to resistance rate of E. coli(r=0.807,P<0.01),while that of ceftazidime was negatively correlated to resistance rate of E. coli(r=-0.672,P<0.05). There was no statistical significance in resistance rate of E. coli to other 7 kinds of antibacte-rials. CONCLUSIONS:There are some correlations between the DDDs and resistance rates. We should strengthen the monitoring of bacterial resistance and the management of rational application of antibacterials.