Objective To investigate the effect of incomplete cryoablation on the biological behavior of prostatic cancer RM-1 cells and its mechanism.Methods RM-1 cells of prostatic cancer were placed in -20℃ icebox to be frozen for 5 min.After the recovery of the cell state,the RM-1 cells were frozen again for 10 min and 15 min successively.After culture for one day,the cellular morphology was microscopically examined.A total of 20 C57/BL mice were used to establish the tumor-bearing models,which were randomly and equally divided into the control group and the incomplete cryoablation group with 10 mice in each group.At scheduled time points the tumor lesion size was measured for all mice.The mice were sacrificed at 14 days,the lung tissues were collected and were stained with lE;the numbers of metastatic lesions in the lung were calculated.Transwell assay was used to test the cell migration and invasion,immuno-blotting method was adopted to determine the epithelial-mesenchymal transition-related (EMT-related) protein expression level,and the enzyme-linked immunosorbent assay (ELISA) was employed to check the secretion volume of transforming growth factor-beta (TGF-β).Results After incomplete cryoablation,RM-1 cells became disorderly arranged,their morphology was changed,and antenna structure might be formed.At 3 and 7 days after cryoablation,the tumor size in the incomplete cryoablation group was slightly smaller than that in the control group,but only the difference at 7 days after cryoablation was statistically significant between the two groups (P=0.019).At 10 and 14 days after cryoablation,the tumor volume of the two groups was almost equal.The pulmonary metastatic lesions in the incomplete cryoablation group were obviously much more than those in the control group (P＜0.001).Transwell assay indicated that the cell migration and invasion ability in the incomplete cryoablation group was stronger than that in the control group (P＜0.05).Immuno-blotting test revealed that,when compared with the control group,in the incomplete cryoablation group the expressions of N-cadherin,MMP-9 and Vimentin were up-regulated,while the expression of E-cadherin was downregulated.ELISA test showed that increased secretion of TGF-β was observed in the incomplete cryoablation group.Conclusion Incomplete cryoablation can enhance the migration and invasion ability of RM-1 cells,increase the number of pulmonary metastatic lesions in tumor-bearing mice,and affect the EMT-related protein expression level.

Objective To discuss the clinical significance of peripheral neutrophil-to-lymphocyte ratio (NLR) changes in patients with castration-resistant prostate cancer (CRPC) after receiving argon-helium cryoablation.Methods A total of 33 CRPC patients,who were treated with argon-helium cryoablation at Tianjin Medical University Cancer Hospital,were included in this study.The clinical and pathological data were collected and analyzed.The following factors that might affect the postoperative overall survival (OS) of patients were analyzed with univariate and multivariate analysis:age,baseline PSA level,hemoglobin,white blood cell count,platelet count,albumin,alkaline phosphatase,NLR,platelet-to-lymphocyte ratio (PLR),hormone sensitive time,chemotherapy,bone metastasis,Gleason score,ECOG score,PSA effective rate.Results A total of 33 patients were enrolled in this study,the average age was 69 years (50-82 years) and the median survival time was 28 months (6-55 months).Univariate analysis showed that the baseline PSA level,alkaline phosphatase,NLR,hormone sensitive time,chemotherapy,bone metastases,Gleason score and PSA effective rate were significantly correlated with OS of CRPC patients after receiving cryoablation (P＜0.05).Multivariate analysis showed that the baseline PSA level (P=0.003),NLR (P=0.009),Gleason score (P＜0.001) were independent predictive factors for OS of CRPC patients after cryoablation therapy.Conclusion NLR can be used as a prognostic predictor for CRPC patients undergoing argon-helium cryoablation,and the increased NLR indicates a poor prognosis.(J Intervent Radiol,2017,26:237-242)

Abstract: Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paper introduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example.

Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial. This study discusses the main difficulties and countermeasures in the case recruitment of large sample, multi-center clinical trials according to the national research project "Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine".

The automation of traditional Chinese medicine(TCM)pharmaceuticals has driven the development of process analysis from offline to online.Most of common online process analytical technologies are based on spectroscopy,making the identification and quantification of specific ingredients still a challenge.Herein,we developed a quality control(QC)system for monitoring TCM pharmaceuticals based on paper spray ionization miniature mass spectrometry(mini-MS).It enabled real-time online qualitative and quantitative detection of target ingredients in herbal extracts using mini-MS without chromatographic separation for the first time.Dynamic changes of alkaloids in Aconiti Lateralis Radix Praeparata(Fuzi)during decoction were used as examples,and the scientific principle of Fuzi compatibility was also investigated.Finally,the system was verified to work stably at the hourly level for pilot-scale extraction.This mini-MS based online analytical system is expected to be further developed for QC applications in a wider range of pharmaceutical processes.

Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.

Objective: To evaluate the effect of Danhong injection on endothelial function after percutaneous coronaryintervention (PCI) in coronary heart disease (CHD) . It provides the basis for further research and design. Methods: Sevendatabases of CNKI, VIP, Wanfang Data, CBM, PubMed, The Cochrane Library, Embase and others were searched bycomputer cents with coronary heart disease treated by Danhong injection combined with conventional drugs. Twoevaluators independently sifted the literature, extracted the data and evaluated the bias risk in the study. The data werestatistically analyzed by RevMan 5.3 software. Results: A total of 12 RCTs, involving 1325 patients were included. Metaanalysis showed that the treatment group (Danhong injection combined with routine therapy) was superior to the controlgroup in improving the endothelium index after operation. The index NO[MD=9.57, 95％CI (8.22, 10.93), P ＜ 0.00001], vWF [MD=-31.60, 95％CI (-41.47, -21.72), P ＜ 0.00001], ET-1 [MD=-2.19, 95％CI (-3.11, -1.27), P ＜ 0.00001], ET[SMD=-0.92, 95％CI (-1.49, -0.35), P ＜ 0.01], FMD[MD = 1.81, 95％CI (1.26, 2.37), P ＜ 0.00001]. There was statisticalsignificance between each index. Conclusion: Danhong injection combined with conventional therapy can improveendothelial function after PCI. However, due to the low quality of included studies and the problem of heterogeneity, these conclusions need to be further verified by high quality multicenter, large sample and double blind randomizedcontrolled trials.

Object: To systematically evaluate the effect of Danhong injection combined with conventional medication on inflammatory factors after percutaneous coronary intervention in coronary heart disease, and providing evidence for further research and design. Methods: PubMed, The Cochrane Library, EMbase, MEDLINE, CBM, VIP, CMCI, CNKI, Wanfang Medical Database and other Chinese and foreign medical databases collected the clinical study of Danhong injection in the treatment of inflammatory factors after coronary intervention, using Revman 5.3 software for analysis.Results: A total of 7 studies were included, including 831 patients. 1) Inflammatory response index: hs-CRP of danhong injection treatment group was significantly different from that of control group [RR=-0.86, 95％CI (-1.03, -0.69), P ＜0.0001]. There were significant differences in IL-6 test values between the danhong injection group and the control group[RR =-1.19, 95％CI (-1.41, -0.96), P ＜ 0.00001]. The MMP-9 test values of danhong injection group were significantly different from those of the control group [RR =-0.39, 95％CI (-0.78, -0.00), P = 0.05]. 2) Myocardial injury index:There were significant differences in the CK MB test values of danhong injection treatment group and control group[RR =-0.89, 95％ CI (-1.12, -0.67, P ＜ 0.00001) ]. The cTnT test values of the danhong injection group were significantly different from those of the control group [RR =-1.25, 95％CI (-1.51, -0.98), P ＜ 0.00001]. Conclusion:Current research indicates that Danhong injection can reduce inflammatory factors hs-CRP, IL-6 and MMP-9 and myocardial injury indicators creatine kinase-MB (CK-MB) and cardiac troponin T (cTnT) after coronary intervention. In other words, Danhong injection can reduce the levels of inflammatory factors such as hs-CRP, IL-6 and MMP-9 and improve the myocardial injury index such as CK-MB and cTnT after coronary intervention, and then have a certain protective effect on the myocardium. However, the above conclusions still need further research and verification.

Objectives: To strengthen the causal link between TCM syndrome differentiation and curative effect of stableangina through standardized evidence-based design, measurement and evaluation methods, so as to improve the clinicalevidence of TCM. Methods: Under the framework of the top-level parental design, this study aims at the research purposeof early intervention of TCM in patients with stable angina, and adopts a multicenter practical randomized controlled trial.This study adopts superior design and refines the design points of clinical trials in terms of subject selection, interventionsetting, index system construction, sample size estimation, safety observation, and quality control. Results: The nationalkey research and development plan project, "Study on Evidence-based Optimization of TCM Syndrome and TreatmentProtocol of Stable Angina Pectoris and Cross-Boundary Syndrome"indicated that the clinical research design ofevidence-based medicine and TCM differentiation and treatment was improved. Conclusions: The practical RCT designcan fully reflect the characteristics of TCM differentiation and treatment. The evidence-based design of TCM can providemethodological support for improving the quality of evidence.

Objective: This paper analyzed the present clinical researches of traditional Chinese medicine (TCM) in the treatment of heart failure caused by coronary heart disease and discusses the ideas and methods of evidence-based optimization. Methods: PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP and CBM were searched to screen the clinical studies of TCM for treating heart failure caused by coronary heart disease. The problems and solutions were discussed by evaluating the risk of bias of the studies and analyzing the outcomes compared with the Cochrane systematic reviews of chronic heart failure. Results: A total of 32 clinical researches were included and the methodological quality of the studies was generally low. In addition, few studies assessed the endpoint events, mortality and readmission, as the primary outcomes in their trials, which is significantly different from the outcomes concerned in the Cochrane systematic reviews. Conclusion: It is really critical to improve the methodological quality of the trials and to choose the endpoint events as the primary outcomes in the evidence-based optimization of the prevention and treatment of TCM for heart failure caused by coronary heart disease Chinese medicine.