The national standards for biological products include three types of reference materials,vaccines,biotherapeutics,and diagnostics,among which the national standards for vaccines play a crucial role in the production,issuance,and supervision inspection of vaccines. In recent years,the vaccine industry in China has developed rapidly,and especially,the application of new technology platforms such as mRNA in vaccines has highlighted the urgency of further improving the level of national standards for vaccines in China. Referring to WHO(World Health Organization)development requirements for reference materials of vaccines and taking Chinese national standard for SARS-CoV-2 neutralizing antibody as example,this paper summarized the thinking on national standards for vaccines in China,and presented the priority principles of establishing national standards for vaccines which are not traceable to WHO international standard(IS),in view to provide ideas for the further improvement of development and application of national standards for vaccines in China.

Reference materials for vaccine are the standard rulers for quality control,dose determination and effectiveness evaluation of vaccines. Manufacturer's reference materials are a kind of the working standards that are directly used by vaccine enterprises in the process of production,quality control and evaluation,of which the accuracy and stability play a key role in ensuring the consistency between batches,safety and effectiveness of vaccines. Based on the investigation into the current management situation of manufacturer's reference materials in domestic representative vaccine enterprises,and combined with the relevant guidelines and regulations such as World Health Organization guidelines and Chinese Pharmacopoeia,this paper put forward the key points that should be considered in the establishment and application of manufacturer's reference materials of preventive human vaccines. It is also suggested to formulate the guidelines about manufacturer's reference materials in order to regulate the development and application of working reference materials.

Objective To investigate the influence of atorvastatin combined with trimetazidine therapy on blood rheology and endothelial function in elderly patients with unstable angina pectoris.Methods 94 elderly patients with unstable angina pectoris were randomly divided into two groups.Group 1 was treated with ordinary thera-pies,while group 2 was treated in addition of atorvastatin in combination with trimetazidine.The Patients'clinical effects,blood rheology,endothelial function before and after treatment was compared between the two groups.Results The effective rate of group 1 was 74.5%,which was significantly higher than that of group 2(93.6%,P =0.011). The improvement of abnormal ECG turned to be the same result (80.9%,93.6%,P =0.008).There was no differ-ence between the two groups in all above indices (t =0.289,P =0.774;t =0.218,P =0.828;t =0.382,P =0.703;t =0.616,P =0.540;t =1.096,P =0.276;t =0.221,P =0.825;t =0.406,P =0.685).After treatment,the levels of blood and plasma specific viscosity and endothelin-1 in both groups all decreased (group 1:t =6.180,P <0.01;t =10.002,P <0.01;t =4.532,P <0.01;t =4.303,P <0.01;t =4.239,P <0.01;VS group 2:t =15.108,P <0.01;t =14.798,P <0.01;t =7.653,P <0.01;t =7.981,P <0.01;t =8.461,P <0.01),the levels of nitric oxide and FMD all significantly increased (group 1:t =3.627,P <0.01;t =4.833,P <0.01;VS group 2:t =9.945,P <0.01;t =9.707,P <0.01 ),and there was a significantly difference between 2 groups(t =8.750,P <0.01;t =4.388,P <0.01;t =3.415,P <0.01;t =5.132,P <0.01;t =3.052,P =0.003;t =5.754,P <0.01;t =4.503,P <0.01).Conclusion Atorvastatin combined with trimetazidine has an excellent effect on elderly unstable angina pec-toris,with significantly improving blood rheology and endothelial function.

Targeted agents for small cell lung cancer (SCLC)include inhibitors of angiogenesis,tyro-sine kinase inhibitors and signal transduction pathway inhibitors.Bevacizumab,a class of antiangiogenic agent, tends to have no effects on patients.The tyrosine kinase inhibitor,for example sunitinib,may be used as a monotherapy.Signaling inhibitors including Amuvatinib and LDE225 are undergoing phaseⅠand Ⅱ trials.Pri-mary data show that SCLC is not sensitive to targeted therapy,needing more selection,so further studies are requested.

Objective To compare the overall diagnostic accuracy of MRCP with EUS for the detection of choledocholithiasis and malignant obstruction in patients with suspected biliary obstruction.Methods A fully recursive literature search was conducted in The Cochrane Central Register of Controlled Trials CENTRAL,MEDLINE or PUBME (1980-2012),EMBASE (1980-2012),OVID Database (1980-2012),CBM (1980-2012),VIP database (1989-2012),Chinese journal of full-text database (CNKI) (1980-2012),and WANFANG database(1980-2012).The prospective diagnostic studies which evaluated or compared the diagnostic accuracy of MRCP and EUS were included combined with manual searches.We also searched the references of all included articles of important meetings and journals.QUA-DAS items were used to evaluate the quality of the included studies.SEN,SPE,+ LR,-LR and the areas under SROC were detected,then t-test was used to evaluate whether statistically significant difference existed between EUS and MRCP.Results Thirteen studies including 1200 cases were recruited.The overall pooled sensitivities of MRCP and EUS for the detection of choledocholithiasis were 0.870 (95％ CI:0.826-0.906)and 0.935 (95％ CI:0.90-0.96) respectively,whereas their specificities were 0.952 (95％ CI:0.926-0.971) and 0.947 (95％ CI:0.920-0.967),respectively.The overall pooled positive likelihood ratio for MRCP and EUS were 14.055 (95％ CI:6.259-31.561) and 16.653 (95％ CI:6.896-40.212),respectively,with the corresponding negative likelihood ratio of 0.177 (95％ CI:0.108-0.290) and 0.076 (95％ CI:0.049-0.118),respectively.Areas under the ROC curve were 0.9693 and 0.9771,respectively.There were no statistically significant difference for sensitivity (0.84 ± 0.16 vs 0.93 ± 0.07,P =0.108) and specificity (0.93 ±0.10 vs 0.90 ±0.15,P =0.555) between MRCP and EUS.The overall pooled sensitivities of EUS and MRCP for the detection of malignancy were 0.959 (95％ CI:0.908-0.987),and 0.805 (95％ CI:0.724-0.871),respectively,whereas their specificities were 0.975 (95％ CI:0.954-0.988) and 0.927 (95％ CI:0.897-0.951),respectively.The overall pooled positive likelihood ratio for EUS and MRCP were 23.398 (95％ CI:12.987-42.155) and 13.448 (95％ CI:4.961-36.456),respectively,with the corresponding negative likelihood ratio of 0.059 (95％ CI:0.028-0.122) and 0.134(95％ CI:0.046-0.391),respectively.Areas under the ROC curve were 0.9870 and 0.9686,respectively.There were no statistically significant differences for sensitivity (0.95 ± 0.55 vs 0.88 ± 0.14,P =0.22) and specificity (0.96 ±0.03 vs 0.91 ±0.11,P =0.31) between MRCP and EUS.Conclusion MRCP and EUS are both valuable in differential diagnosis of biliary obstruction caused by choledocholithiasis or malignant lesions.

Objective To investigate the effects of combination of aniso-dosage of Astragalus and Arctium on the glycolipin metabolism and renal lesion in diabetic rats.Method Streptozotocin (STZ)-induced diabetic rats were established as experimental model.The diabetic rats were randomized into model group and mixture-treated group.Astragalus and Arctium were divided into three dosages (low,moderate,high) respectively and combined according to orthogonal experimental design and were administrated to the mixture-treated group.At the 4th and 8th week,parameters of blood,urine and renal tissue were examined.The blood sugar,cholesterol,triglycerol,HbA1c were detected by analysis meter of biochemistry,urine microalbumin by radioimmunoassay (RIA) and 24 h urine protein by colorimetry.The HE and PAS staining were used to observe the change of glomerular ECM.Results At the 4th weekend,the combination of Arctium high-dosage had better effects on decreasing blood sugar and cholesterol.While at the 8th weekend,the effects of mixture were gradually augment with the Astragalus dosage increasing on decreasing triglycerol,24 h urine protein and ECM.Conclusion The compatibility of aniso-dosage of Astragalus and Arctium could rectify the metabolic disturbance of glycometabolism and lipid metabolism,and lessen the renal lesions.The compatibility had different effects on various experiment phases.

Next generation sequencing (NGS) based test provided us an unprecedented power for the molecular diagnosis of rare diseases with genetic etiology, thus enabling the practice of precision medicine.In order to maximize the clinical utilities of NGS-based test, attention should be paid to the improvement of the sequencing technology, data quality and the accuracy of data interpretation, as well as the clinical correlations and pre-and post-test genetic counseling services.In doing so, it is believed practice of NGS-based test can bring expected benefit to many patients and families.

Objective: To analyze the relationship between Stat 3 protein expression and clinical staging, tissue types, P53 protein and PCNA in lung carcinoma, and to investigate the role of Stat 3 protein in the pathogenesis of lung carcinoma. Methods: Using immunohistochemical technique, Stat 3 protein, P53 protein and PCNA were detected in different tissue in 42 patients with lung carcinoma without radiotherapy and chemotherapy. Results: The positive rate of Stat 3 was 81.0% in lung carcinoma. The expression intensity of Stat 3 in lung carcinoma was not associated with T,N and clinical stage , but it was associated with the expression intensity of P53 and PCNA and it was related to tissue types.Stat 3 protein were markedly higher in NSCLC than that in SCLC. Conclusion: The expression of Stat 3 protein is abnormal in lung carcinoma. Stat 3 may involve in regulation of p53 gene in lung carcinoma cell and accelerate proliferation of lung carcinoma cell, it may play an important role in generation of lung carcinoma. Inhibition of Stat 3 pathways may become a new therapy for lung carcinoma.

Objective To enhance clinical gastrointestinal physicians’ understanding of ascites resulting from constrictive pericarditis by analyzing clinical features of. Methods A retrospective analysis was carried out in patients with constrictive pericarditis with the major presentation of ascites in our department of gastroenterology from January 1993 to May 2008. Medical records of these patients were reviewed, including data of demographics, course of desease, clinical presentation, relevant imaging studies and so on. Results There were 8 cases of constrictive pericarditis with the major presentation of ascites in our department of gastro-enterology in 15 years. The jugular varicosity was the most common manifestation in the 8 cases, followed by tabdominal distension and oedema. There were some abnormal changes in the electrocard-iography of the 8 cases. In 4 cases, no diagnosis was reached by the echocardiogram. In 8 cases,the definite diagnosis was reached by CT or MRI. Conclusion Cautions should be demanded for the patients with the major presentation of ascites in the department of gastroenterology owing to the possibility of constrictive pericarditis. In these patients, consummate physical examination is demanded such as the jugular varicosity. And the definite reason must be probed in the patients with the abnormal electrocardiographic changes.

AIM: To investigate the influence of Fructus Arctii and its extracts to the renal pathological changes of diabetic rat and its protective mechansim METHODS: The rat model induced by 55mg/kg STZ once intraperitoneally was adoped as the diabetic nephropathy of early stage, the extract and the powder of Fructus Arctii were given to the diabetic rat for six weeks. We observed the changes of general condition, and examined the expressions of TGF-? 1 (transforming growth factor-? 1) mRNA and MCP-1mRNA (monocyte chemoattractant protein-1) by reverse transcription-polymerase chain reaction (RT-PCR). CONCLUSION: The ethanol extract of Fructus Arctii relieved renal pathological changes of diabetic rat. The mechanism perhaps was related to the reduction in the expression of MCP-1mRNA and TGF-? 1mRNA in kidney; The study proved that the ethanol extract of Fructus Arctii was more effective than its water extract and coarse powder.