Objective:To explore the diagnostic value and correlation of serum tumor markers combined detection of pancreatic cancer. Methods:Selected January 2013 to may 2016 in our hospital in patients with pancreatic cancer in 146 cases,128 cases of non pancreatic cancer with patients and 124 cases of healthy physical examination. Radiation immunity analyzer test groups of serum CA19-9,CA242,CA50,CA125,CEA and TSGF levels and compared between groups. To draw the working characteristic curve(ROC) to analyze the diagnostic value of tumor markers in patients with pancreatic cancer and the correlation of linear correlation analysis of tumor markers. Analysis of independent risk factors for pancreatic cancer using multiple logistic regression models. Results: The pancreatic cancer group of serum CA19-9,CA242,CA50,CA125,CEA and TSGF levels were significantly higher than the control group and non pancreatic cancer group,the differences were statistically significant(P<0. 05 or P<0. 01).Ⅳstage andⅢstage with patients of serum CA19-9,CA242,CA50,CA125 and TSGF levels were significantly higher than Ⅰstage and Ⅱstage with patients(P<0. 01).Ⅳ stage with patients of serum CA19-9, CA242, CA125 and CEA levels were significantly higher than Ⅲ stage with patients ( P<0. 01). The pancreatic cancer group of serum CA19-9,CA242,CA50,CA125,CEA and TSGF of positive rate were significantly higher than that of control group and non pancreatic cancer group(P<0. 01). ROC curves showed that the AUC of serum CA19-9 were higher than other single indexes,the best critical value,sensitivity and specificity were 114. 5 U/ml,81. 2% and 79. 3% respectively. The diagnostic efficacy of the six joint detection were better than the single detection,the sensitivity and specificity were 92. 4% and 76. 5%respectively. Correlation analysis showed that serum CA19-9 were positively correlated with CA242,CA50 and CA125(r=0. 703,P=0. 005;r=0. 572,P=0. 024;r=0. 439,P=0. 036). Multiple logistic regression analysis showed that smoking,incorrect diet,history of diabetes,gallbladder disease history and high levels of CA19-9,CA242,CEA into the regression model,the OR value and 95%CI were 1. 717(0. 736 to 2. 359),2. 865(2. 217 to 3. 685),2. 614(2. 186 to 3. 127),3. 527(2. 842 to 4. 377),4. 214(3. 570 to 4. 962), 2. 315(2. 114 to 2. 539),1. 876(1. 175 to 2. 852). Conclusion: Serum tumor markers combined detection can help to improve the accuracy of early diagnosis of pancreatic cancer and smoking,incorrect diet habits,history of diabetes,biliary disease history and high levels of CA19-9,CA242 and CEA are independent risk factors for pancreatic cancer.

Safety is a critical link restricting the development of TCM injections.Hospital centralized monitoring is of importance in the safety evaluation of TCM injections.However,the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality.Our research team have completed several projects over centralized monitoring in recent years.Based on the previous research experience,this paper mainly discussed the current statuation,the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections,in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.

The launch of the clinical trial registry is a milestone event in the field of clinical research in the 21st century that has played an important role in safeguarding the openness,transparency,ethics,data sharing and process control of clinical research.The current clinical research registry is mainly aimed at clinical trial research with lack of professional registration system for security and other real events of observational study.In order to improve the level of clinical safety research,promote transparency and process quality control,we proactively proposed and established a registration platform for clinical safety research of traditional Chinese medicine.This paper made a brief introduction hereof.

According to the related requirements of safety reevaluation of TCM injections,hospital centralized monitoring of the safety of TCM injection was consecutively pressed ahead.Centralized security monitoring was a large-scale real world research involving numerous data acquisition,transmission,verification and analysis.The quality of data acquisition and data verification directly affected the authenticity and reliability of research data and results.Therefore,data management played a significant role in the safety monitoring of TCM injections.Based on the analysis of previous researches,this paper discussed the implementation content,links and the frequent problems and corresponding solutions of data management during the safety monitoring of TCM injections,combining with the experience in the implementation of projects.

The implementation process management plays a important role for the quality of centralized safety monitoring study of post-marketing Chinese medical injections.One of the critical link is hospital.Currently,there is no principle or specification for hospital choosing,number of monitoring points,data collection responsible part and forms of data collection as well.These issues caused uneven quality,huge differences in results and questioned conclusion.Based on the previous research experience,this paper focused on discussing the link of hospital where research data may be influenced,and proposed some suggestions.

Safety hospital centralized monitoring is one of the important methods for evaluating the medication safety of TCM injections in clinic.It is critical to warrant research quality by reasonable statistical analysis.However,universally accepted standards and guidelines for the statistical analysis of hospital centralized monitoring of TCM injections have not been issued so far,which would probably reduce the research quality of safety hospital centralized monitoring of TCM injections since the unreasonable use of statistical analysis methods.Combined with previous practical experience and understanding,we put forward the problems of statistical analysis of hospital centralized monitoring of TCM injections with the provision of some advice in this paper based on the analysis of the preceding studies,laying a foundation for the same kind of researches.

The safety of TCM injection triggered attentions and hotspots in recent years in China.The centralized monitoring of TCM injection provided important evidence for analyzing the safety risk of TCM injections,recognizing adverse reactions and contraindications and perfecting the instructions.This study aimed at exploring the ethical problems on centralized monitoring.In this paper,we retrieved and screened the ethical issues of TCM injections over hospital centralized monitoring in China National Knowledge Infrastructure (CNKI,1979-Ju1.,2016).Issues over it were put forward and addressed.It is found that the current ethical issues related to hospital centralized monitoring lacks sufficient attentions,corresponding norms and requirements.Based on the ethical issues reflected from the literatures,suggestions should be pressed ahead with the ethical review of centralized surveillance,signing of informed consents,registration of research programs,data statistics and reporting stages,for the better protection of the rights and interests of subjects and improvement of research quality.

At present,the various levels of safety evaluations of traditional Chinese medical (TCM) injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.

Traditional Chinese medicine (TCM) has a long history in treating infectious diseases, and the form of intervention varies with different medical conditions and disease types. "The battle field of Chinese doctor for anti-epidemic" was formed in fighting against severe acute respiratory syndrome (SARS) epidemics in China, and from the battle, valuable experiences of using TCM for prevention and treatment had been obtained. During responding to coronavirus disease 2019 (COVID-19) epidemics, we followed the principle of keeping summary and perfection while treament. And a whole process of TCM pattern or a model was organized, including early prevention in communities, cluster intervention in isolated places, comprehensive intervention in mobile cabin hospitals, centralized treatment in designated hospitals and rehabilitation support in rehabilitation posts. Thus, the innovation of whole process of TCM intervention was involved in the "trench warfare" strategy and platform system for prevention and treatment of new infectious COVID-19 epidemics. At different stages or conditions, different TCMs were used to play advantageous roles to solve various problems and elevate the effects of prevention and treatment of the disease. The construction of TCM mobile cabin hospitals was an innovation of organization form that might offset the constraints in technology and scale of simple community isolation or simple hospital treatment, exploring a new way for TCM to cope with public health emergencies.

AIM: To observe the effect of antibiotic treatment on the inflammatory mediator expression in peritoneum and the peritoneal transport function in rats with acute peritonitis, and explore its mechanisms. METHODS: Eighty-six SD rats were randomly divided into three groups. Control group (n=28) were treated with PBS (ip), peritonitis group (n=28) and treatment group (n=28) were challenged with the E.coli (ip), but at 3 h and 9 h gentamicin was given (ip) in treatment group. Seven rats of every group were randomly sacrificed at 24 h, 48 h, 72 h and 7 d. Peritoneal equilibration test (PET) was did before they were killed. Leukocyte count, pathological changes and the expression of CD45, NF-?B, IL-1?, TNF-? in peritoneum were examined. RESULTS: (1)The blood leukocytes in peritonitis group decreased strikingly, but did not change obviously in other two groups. The peritoneal fluid leukocytes in peritonitis group increased significantly from 24 h to 72 h, while in treatment group, it enhanced more strikingly than peritonitis group at 24 h, and recovered earlier. (2) Both in peritonitis group and treatment group, the expression of activated NF-?B, IL-1?, TNF-? and CD45 increased significantly, but the treatment group was lower than model group at 48 h and 72 h. The mRNA level of IL-1? and TNF-? had the same trend as their protein expression. (3) Compared with the control group, UF and D/D_0 Glu decreased significantly in model group and treatment group, and D/PTP increased dramatically. The D/P TP in treatment group lowered obviously compared with peritonitis group, while the net UF and D/D_0 Glu had not significant difference between treatment group and model group. CONCLUSION: Antibiotic treatment can partly decrease the expression of inflammatory mediators in peritoneum of rats with acute peritonitis and also can improve the protein transport ability to some extent, but can not improve the peritoneal ultrafiltration and the glucose transport function.