Objective To analyze the central effect of Qi-Yin Deficiency Syndrome (QYDS) scoring in clinical trials of diabetes.Methods Dispensation degree analysis and multiple linear regression analysis were adopted to compare the differences of central effects among the Qi-Yin deficiency syndrome scoring,fasting plasma glucose (FPG) level and 2-hour postprandial blood sugar (2 hPG)level before and after treatment in the suited databases from two phase Ⅲclinical trials of type two diabetes performed in 2004～2005.Results The variation coefficients of QYDS scoring treated with drug A and drug B varied from one tenth to half times of those of FPG and 2 hPG levels before and after treatment.And the influence of centers on QYDS is weaker than those on blood sugar levels (FPG &2 hPG) either referring to the numbers of significant centers or referring to the absolute values of standard regression coefficients in multiple linear regression equation.Conclusion There exists a central effect in QYDS scoring before and after treatment,and the central effect of QYDS scoring is weaker than that of blood sugar levels (FPG &2 hPG) in clinical trials of diabetes.

Objective To epidemiologically analyze the common clinical symptoms of sub-health in Beijing area.Methods By analysis of sub-health,epidemiologlcal data and the method of factors analysis, we studied the features and properties of various symptoms and their relationships that represent various kinds of sub-health.We used the structural equation modeling to validate the relationship between the symptom groups and between the symptom groups and their components.Results The amount of the factors whose weight Values were larger than 1.0 was 13,and the cumulative value of all the factors was 55.67%.With the domain knowledge,however,the total factors were merged into 10.We took fatigue as the main hidden variable to build a structural equation model.The function was x2/df=3.65,and GFI,AGFI,CFI,Tucher Lewis indexes were all above 0.9.The direct effects between the hidden variables showed that fatigue is closely related to fatigue of eyes,sleep,and pain with the weighted coefficient ranging from 0.7 to 1.0. Fatigue is somehow related to the symptoms of stool,pee,fauces,mouth,and sweat with the weighted coefficients about 0.5.The indirect effects between fatigue and hidden vailables showed that fatigue has an effect on moods indirectly with standardized indirect effects and standardized total effects was 0.702 and 0.112.respectively.Conclusions The symptoms of sub-health are complex with a dominating symptom and many other secondary symptoms.The common symptom groups are maladjustment of mood,fatigue, abnormity of sleep,maladjustment of stool and pee,double-minded,fatigue of eyes,and pain.The results of structural equation model shows that the causality between symptoms that are in a symptom group is different,so is the causality between the symptom groups,which shows that the symptoms of the sub-health are of diversity.

Objective To explore the relationship among the disease - syndrome - formula of type 2 diabetes.Methods Based on the clinical data of 2501 cases of type 2 diabetes, to study the relationship among the disease - syndrome - formula of type 2 diabetes by making use of association rules.Results Three formulas, Shengmai Yin (Pulse-activating Fluid), Liuwei Dihuang Decoction (Decoction of Six Herbs Including Rehmannia), and Sijunzi Decoction (Decoction of Four Noble Herbs), were selected from 122 ones to analyze the relationship between the formula and symptoms. The occurrence of fatigue with weakness, dry mouth with thirst, frequent urination with increased volume of urine, numbness of limbs, blurred vision, thirst with preference of drinking water, frequent nocturnal urination, and shortness of breath with inactive talking was in high frequency in those patients who were prescribed Shengmai Yin. The occurrence of fatigue with weakness, thirst with preference of drinking water, blurred vision, frequent nocturnal urination, dry mouth with thirst, numbness of limbs, shortness of breath with inactive talking, and soreness and weakness of lumbus and legs was in high frequency in those patients prescribed Liuwei Dihuang Decoction, and there existed a multi-association among these symptoms. The occurrence of fatigue with weakness, soreness and weakness of lumbus and legs, frequent nocturnal urination, shortness of breath with inactive talking, numbness of limbs, insomnia, and blurred vision was in high frequency in those patients who were prescribed Sijunzi Decoction, and there existed a multi-association among these symptoms.Conclusion The association rule can be adopted to analyze the relationship between formula and syndrome, and to explore the multi-association relationship among the symptoms of type 2 diabetes.

This paper was aimed to understand the clinical features of traditional Chinese medicine (TCM) through the analysis of relevant information among fracture patients treated by the Cervus and Cucumis Polypeptide Injection (CCPI).The study was conducted among fracture patients treated by CCPI in the hospital information systems (HIS) among 26 national triple-A hospitals from 2003 to 2014.The general information,TCM syndrome and solar term of morbidity were analyzed.The results showed that the number of patients from 45-64 years old were the most,accounting for 39.84％.Among them,the number of male patients from 18-44 years old was the most,accounting for 43.38％;the number of female patients from 45-64 year old was the most,accounting for 44.33％.The main TCM syndrome of admission and discharge was qi stagnation and blood stasis,which accounted for 60.53％ and 53.08％,respectively.Beginning of Summer (7th solar term) and Rain Water (2nd solar term) were solar terms with the most patients,which accounted for 5.26％ and 5.24％,respectively.It was concluded that the majority of fractures patients treated with CCPI were the elderly.The syndrome of qi stagnation and blood stasis was the most.The hospital admission of most patients was at the Beginning of Summer and Rain Water.It provided theoretical basis to pay attention on TCM syndrome differentiation in the treatment of clinical fractures.The treatment should be adapted to the characteristics of the disease itself,the change of solar terms,and dialectical medication.

Objective To explore characteristics of the elements of syndrome, the disease position and the relationship between chemical indicators and TCM syndromes of type 2 diabetic encephalopathy. Methods 2 501 cases of type 2 diabetes clinical data were collected from Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing University of Chinese Medicine, Dongzhimen Hospital, Dongfang Hospital, etc. in nearly 3 years, among which, 342 cases were type 2 diabetic encephalopathy. The original clinical data were double entried in epidata by two people, establishment forms in excel, factor analysis and Bayesian networks were used as data mining research methods. Results 20 elements which characteristic root more than 1 were derived by factor analysis, 68.4% were covered. Of all 20 elements, five factors belong to Yin, five factors belong to blood stasis; lassitude, shortness of breath, stool frequency were appeared when fasting glucose abnormalities; lassitude, hemiplegia were appeared when 2-hour postprandial blood glucose abnormalities;lassitude, feverish palms and soles, stool frequency, more nocturnal enuresis when glycated hemoglobin abnormalities by Bayesian networks. Conclusion The Elements of the syndrome of type 2 diabetes encephalopathy were deficiency of Yin and blood stasis; and the main positions for diabetic patients were liver, spleen and kidney. Patients with impaired fasting glucose were Qi deficiency; Patients with impaired 2-hour postprandial glucose were Qi deficiency or pathogenic wind attacking collaterals; Patients with abnormal hemoglobin were Qi deficiency and Yin deficiency.

Objective To explore the influence of MYC expression level on ovarian cancer cells adhesion and invasion ability,and the involvement of the integrinβ1 in the adhesion and invasion control. Methods Comparative study was done to analyze the relationship between the mRNA level of MYC and ITGB1 among sixty cell lines from the NCI-60 cells bank; Western blot was performed to demonstrate the correlation of MYC and ITGB1 protein level in ovarian cancer cell lines;Immunohistochemistry was adopted to compare the expression level of MYC and ITGB1 in paired primary and metastatic ovarian cancer tissue. Furthermore ,we employed in vitro adhesion test to detect the alteration of ovarian cancer cell adhesion ability to ECM molecular like fibronectin ,collagen I and laminin after fluctuation of MYC and ITGB1 expression; Transwell assay was applied to check the invasion ability variation with the disturbance of MYC and ITGB1 level. Results The mRNA levels of MYC and ITGB1 were dramatically inverse-correlated in NCI-60 cells bank(P<0.01);The protein levels of MYC and ITGB1 in ovarian cancer cell lines were also negative correlated; The primary ovarian cancer tissue showed lower expression of ITGB1 and higher expression of MYC,while the matched metastasis displayed the opposite outcome;Ovarian cancer cells reduced adhesive and invasive capacity in case of ITGB1 being down-regulated ,however, the adhesive and metastatic ability improved tremendously with elevation of ITGB1;Promoted adhesion and invasion ability and rise of ITGB1 expression were observed after downregulation of MYC,meanwhile,and inhibition of ITGB1 reversed the increasement of adhesion and invasion ability. Conclusions MYC,inversely-correlated with ITGB1 in ovarian cancer cells,inhibited ovarian cancer cells adhesion and invasion. Inhibition of MYC could lead to enhanced adhesion and invasion ability of ovarian cancer cells.

With the continuous increasement of adverse Chinese drug reaction reporting, especially Chinese traditional medicine injection, it becomes the key part of the post-marketing evaluation. The issue based on this research background becomes the hot research direction. But the truth is that the history of Chinese medicine and western medicine is different and the theory is not a system either, here different means between pharmacovigilance of Chinese medicine and western medicine, there are still many gaps. This becomes a barrier for Chinese medicine entering the international market. This article summarizes try to order the SFDA's adverse reaction reporting database of traditional Chinese medicine, and using three kinds of data mining methods used by WHO, the U. S. Food and Drug Administration, to establish suitable system for Chinese market after the evaluation of pharmacovigilance.
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; Aged ; Child ; Child, Preschool ; Data Mining ; Female ; Humans ; Male ; Medicine, Chinese Traditional ; adverse effects ; Middle Aged ; Pharmacovigilance

With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.
Data Mining ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Pharmacovigilance ; Product Surveillance, Postmarketing

Objective To investigate the safety and efficacy of decitabine combined with CAG regimen in treatment of acute myeloid leukemia (AML) ineligible for conventional chemotherapy. Methods The data of 20 cases with AML ineligible for conventional chemotherapy from January 2013 to May 2015 were retrospectively analyzed. Decitabine combined with CAG regimen was used during induction therapy. The primary induction regimen was used 26 times after remission, the standard 3+7 regimen were used 7 times, and intermediate-dose cytarabine were used 3 times. The total course of treatment included 2-8 cycles. Results All of the 20 patients completed the first cycle of induction therapy, including 11 cases of complete remission (CR), 5 cases of partial remission and no response in 4 cases, and the overall response rate (ORR) was 80 % (16/20). ORR was 69.2 % (9/13) and 100.0 % (7/7) in high-risk group and middle-low risk group respectively. ORR was 60.0%(6/10) in AML evolving from MDS. 8 patients were infected during the induction therapy and the infection rate was 40.0% (8/20). 2 patients were died of pulmonary infection. The median number of suspended red blood cell and platelet infused were (9.1±5.7) U and (57.5±51.9) U respectively. Neutrophil recovery time was (8.7±5.6) days during induction therapy. All patients were followed up for at least 1 year, and 12 cases were dead. Overall survival rate was 85.0%at 3 months, 80.0%at 6 months, and 40.0%at 1 year. While in 12 CR patients relapse-free survival rate was 75.0%at 3 months, 75.0%at 6 months,and 65.6%at 1 year respectively. Conclusion Decitabine combined with CAG regimen with high remission rate and well tolerance, can be used as a first therapy for AML ineligible for conventional chemotherapy.

Objective To explore the semitivity of ovarian cancer cell line SKOV3 to paclitaxel,oroteasome inhibitors,bortezomib,and their combination.Methods The methyl thiazolyl tetrazolitim (MTT)assay was applied to examine the cell viability after treatment.The annexin V-propidium iodide apoptosis detection kit was used to determine the apoptosis rate of different groups.Western blot assay was used to evaluate the expression levels of phosphorylated protein kinase B(AKT)and glycogen synthase kinase-3 beta(GSK-3β).Results In MTT assay,the cell viability ratios of the combination group at serial time points from 12,24,36,48 and 72 hours Were(65.2±5.8)%,(58.3±14.4)%,(35.3±5.0)%,(19.2±1.5)%,and(11.4 ±2.5)%,which were significantly lower than those of the paclitaxel group (P<0.05).After arug treatments,apoptosis rates of paclitaxel group,bortezomib group and the combination group were (14.7±0.5)%,(15.1±0.8)%and(20.5±0.7)%respectively.The rate of the combination group was significantly higher than that of non-treated group and paclitaxel group(P<0.05).Western blot assay showed the changes in expression levels of phosphorylated AKT and GSK-3β,which were decreased significantly after paclitaxd and bortezomib combination treatment [(3.2±0.8)%,(19.3±0.4)%;P<0.05].Conclusions The lethal effect of paclitaxel on tumor cells could be increased significantly by its combination with proteasome inhibitors,bertezomib.The AKT/GSK-3β signaling pathway plays an important role in the molecular mechanism of the combination treatment.