OBJECTIVE: To establish a clinically applicable model of rapid identification of adverse drug reaction program (RiADP) for risk management and decision-making of clinical drug use. METHODS: Based on the theory of disproportion analysis, frequency method and Bayes method, a clinically applicable RiADP model in R language background was established, and the parameters of the model were interpreted by MedDRA coding. Based on the actual monitoring data of FDA, the model was validated by the assessing hepatotoxicity of lopinavir/ritonavir (LPV/r). RESULTS: The established RiADP model included four parameters: standard value of adverse drug reaction signal information, empirical Bayesian geometric mean value, ratio of reporting ratio and number of adverse drug reaction cases. Through the application of R language parameter package "phViD", the model parameters could be output quickly. After being encoded by MedDRA, it was converted into clinical terms to form a clinical interpretation report of adverse drug reactions. In addition, the evaluation results of LPV/r hepatotoxicity by the model were matched with the results reported in latest literature, which also proved the reliability of the model results. CONCLUSIONS In this study, a rapid identification method of adverse reactions based on post marketing drug monitoring data was established in R language environment, which is capable of sending rapid warning of adverse reactions of target drugs in public health emergencies, and providing intuitive evidence for risk management and decision-making of clinical drugs.
Databases, Pharmaceutical ; Decision Making, Computer-Assisted ; Drug Monitoring ; Drug-Related Side Effects and Adverse Reactions ; HIV Protease Inhibitors ; adverse effects ; pharmacology ; Humans ; Liver ; drug effects ; Lopinavir ; adverse effects ; toxicity ; Models, Statistical ; Reproducibility of Results ; Software ; standards

Curcumae Longae Rhizoma,Curcumae Radix and Curcumae Rhizoma are different medicinal parts of the same plant.Nevertheless,they are different in medicinal effects due to the different Chinese herbal nature. In this study,traditional Chinese medicines database( TCMD2009),traditional Chinese medicine system( TCMSP),and Ch EMBL database were retrieved to screen the active components and targets,and construct the target PPI network. By a graph theoretic clustering algorithm identifying protein complex algorithm( IPCA),the protein modules were identified and analyzed by gene ontology( GO) enrichment. A comparative study of Curcumae Longae Rhizoma and Curcumae Radix illustrate that Curcumae Longae Rhizoma regulates blood coagulation through P2 RY12,GNG2 and other genes to exert the analgesic effect. Curcumae Radix regulates lipid metabolism,plasma lipoprotein particle levels,platelet activation,response to oxidative stress,apoptotic process through LDLR,APOB,PRKCA,SOD1,TP53 and other genes to perform a function in clearing the heart and cooling the blood. A comparative study of Curcumae Radix and Curcumae Rhizoma demonstrate that Curcumae Rhizoma on regulates the nervous system by GRIA2,GRIA4 and other genes to exert blood-breaking effect; Curcumae Radix regulates lipid metabolism,plasma lipoprotein particle levels,platelet activation,response to oxidative stress,apoptotic process by genes such as CALM1,LPL,APOB,SOD1 and TP53 to play the role of clearing heart and cooling blood. Cluster analysis of the protein interaction network of the nature combination is helpful to explain the intrinsic link between the nature combination and efficacy.
Apoptosis ; Curcuma ; chemistry ; Databases, Pharmaceutical ; Drugs, Chinese Herbal ; pharmacology ; Humans ; Lipid Metabolism ; Medicine, Chinese Traditional ; Oxidative Stress ; Plant Roots ; chemistry ; Research ; Rhizome ; chemistry

Salviae Miltiorrhizae Radix et Rhizoma and Carthami Flos are commonly traditional Chinese medicines with invigorating blood circulation and eliminating blood stasis,but they are different in effects due to differences in five tastes and four properties. In this study,Salviae Miltiorrhizae Radix et Rhizoma and Carthami Flos are selected as research vectors to obtain the active ingredients and targets through TCMD,TCMSP database and Ch EMBL database. The protein interaction information of the target is used to obtain from STRING online database,then imported into Cytoscape software to plot the protein interaction network and perform GO enrichment analysis.The results show that the heart-liver protein interaction network,involving blood circulation and hepatic lipid metabolism,thereby exerting the effect of activating blood circulation. The cold-bitter protein interaction network involves the biological process of vasoconstriction,thereby exerting cooling blood and the efficacy of eliminating phlegm. The warm-pungent protein interaction network involves blood coagulation,lipid metabolism and other biological processes to play the role of phlegm pain. Through analysis,it is found that the relationship between pharmacological efficacy and medicinal properties has a certain degree of specificity,which facilitates the subsequent scientific and systematic study of medicinal properties on the basis of this study.
Blood Coagulation ; Carthamus ; chemistry ; Databases, Pharmaceutical ; Drugs, Chinese Herbal ; pharmacology ; Flowers ; chemistry ; Humans ; Lipid Metabolism ; Medicine, Chinese Traditional ; Plant Roots ; chemistry ; Rhizome ; chemistry ; Salvia miltiorrhiza ; chemistry

The thrombus is a deposit that is formed on the surface of the endovascular or at the site of repair,and known as the main complication of cardiovascular disease and the cause of death. At the same time,thrombus is mainly treated by the following three ways: anticoagulation,anti-platelet aggregation and thrombolysis. In this study,the chemical constituents of seven traditional Chinese medicines in the Xixian Tongshuan Preparation were collected to construct a component database. Subsequently,the pharmacophore were used to screen out the component database,and molecular docking was used to screen out the results of pharmacophore for explaining the material basis and mechanism that Xixian Tongshuan Preparation exerts anti-thrombotic activity by inhibiting platelet aggregation. First of all,P2 Y12,GPⅡb/Ⅲa and PAR1 were selected as study vectors,the optimal models of inhibitors were obtained respectively through verification and evaluation of the pharmacophore models. Afterwards,the component database was screened out by the optimal pharmacophore models of PAR1,P2 Y12 and GP Ⅱ b/Ⅲ a,and the molecular docking method was used to further refine the screening results. The screening results indicated that the anti-platelet aggregation effect of Xixian Tongshuan Preparation was correlated with the inhibition of P2 Y12,PAR1 and GPⅡb/Ⅲa expressions with saffower yellower,hirudin and candidin and notoginseng triterpenes,folinic acid,respectively. The material basis and mechanism of anti-platelet aggregation of Xixian Tongshuan Preparation provided a theoretical basis for the clinical use of the preparation and the lead compounds for the development of anti-platelet aggregation drugs.
Databases, Pharmaceutical ; Drugs, Chinese Herbal ; pharmacology ; Humans ; Molecular Docking Simulation ; Platelet Aggregation ; Platelet Aggregation Inhibitors ; pharmacology ; Thrombosis

To investigate the herbal prescription rules of Professor Jiang Liangduo in the treatment of abdominal mass based on the traditional Chinese medicine inheritance support system software (TCMISS) of version 2.5, find out new herbal formulas for the treatment of abdominal mass, and then provide new reference to its traditional Chinese medicine therapy. By the method of retrospective study, one hundred and thirty-two outpatient prescriptions of Professor Jiang for the treatment of abdominal mass were collected to establish a typical database with TCMISS. Four properties, five tastes, channel tropism, frequency count, Chinese herbal prescriptions rules and the new prescriptions were analyzed so as to dig out the prescription rules. There were 57 herbs with a frequency>=15, and then 91 core combinations of 2-5 herbs were evolved and 9 new prescriptions were created. It was found out that these drugs mainly had the effects of liver nourishing and soothing, soft-moist and dredging-tonifying, supporting right and dispeling evil, cooperating with the method of calming the liver and resolving hard lump according to the actual situation. It reflected the thought of treatment based on syndrome differentiation in TCM, and provided a new reference for its clinical treatment and research.
Abdomen ; Databases, Pharmaceutical ; Drug Prescriptions ; standards ; Drugs, Chinese Herbal ; standards ; Humans ; Liver ; drug effects ; Medicine, Chinese Traditional ; standards ; Retrospective Studies

Over the past decade, there has been a substantial increase in the number of men who are treated with testosterone. Despite this increase in the use of testosterone, the risks of adverse cardiovascular events are unclear as meta-analyses have reported conflicting findings and no clinical studies have been large enough or long enough to adequately assess for cardiovascular risks. The goal of this paper is to review large prescription database studies of testosterone treatment and adverse cardiovascular events and mortality with the aim of providing some guidance for clinicians and researchers in this controversial area.
Androgens/therapeutic use* ; Cardiovascular Diseases/epidemiology* ; Databases, Pharmaceutical ; Hormone Replacement Therapy ; Humans ; Male ; Mortality ; Myocardial Infarction/epidemiology* ; Testosterone/therapeutic use* ; Thrombosis/epidemiology*

Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans

In order to clarify the chemical constituents of Si-Wu Decoction rapidly and holistically, we analyzed the ethanol extract of Si-Wu Decoction by UPLC/Q-TOF-MSE and UNIFI which based on traditional Chinese medicine database, the probable structures of 113 compounds were identified. The results show that this method can rapidly and effectively characterize the chemical compounds of Si-Wu Decoction and provide a new solution for identification of components from complex TCM extract.
Chromatography, High Pressure Liquid ; Databases, Pharmaceutical ; Drugs, Chinese Herbal ; chemistry ; Medicine, Chinese Traditional

BACKGROUNDChanging health care providers frequently breaks the continuity of care, which is associated with many health care problems. The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C, D and X drugs.

METHODSA 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 were chosen for this study. The association between the number of changes in health care providers and with pregnancy exposure to category C, D, and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures.

RESULTSA total of 18 568 women were included in this study. Rates of FDA C, D, and X drug uses were 14.35%, 17.07%, 21.72%, and 31.14%, in women with no change of provider, 1-2 changes, 3-5 changes, and more than 5 changes of health care providers. An association between the number of changes of health care providers and pregnancy exposure to FDA C, D, and X drugs existed in women without chronic diseases but not in women with chronic disease.

CONCLUSIONChange of health care providers is associated with pregnancy exposure to FDA category C, D and X drugs in women without chronic diseases.

Adult ; Continuity of Patient Care ; Databases, Factual ; Drug Prescriptions ; statistics & numerical data ; Drug Utilization ; statistics & numerical data ; Female ; Health Personnel ; Humans ; Logistic Models ; Pharmaceutical Preparations ; Pregnancy ; drug effects ; Saskatchewan ; United States ; United States Food and Drug Administration

In this study, prescriptions were collected to establish a database based on the traditional Chinese medicine inheritance support system (TCMISS). Such data-mining methods as software's statistical statement module, data analysis module and apriori algorithm were used to analyze the frequency of single drug, the frequency of drug combination, the association rules and the core drug combinations of ostreae concha-containing prescriptions. The results showed that Ostreae Concha-containing prescriptions were frequently used to treat insomnia, vertigo, stomach-ache and other syndromes. The frequently used drugs included Ossis Mastodi Fossilia, Parched Ziziphi Spinosae Semen, Polygoni Multiflori Caulis, Salviae Miltiorrhizae Radix and Paeoniae Rubra Radix. The frequently used drug combinations included "Ostreae Concha and Ossis Mastodi Fossilia", "Ostreae Concha and Parched Ziziphi Spinosae Semen", and "Ostreae Concha and Polygoni Multiflori Caulis". The drug association rules with the confidence coefficient of more than 0. 95 included "Ossis Mastodi Fossilia-->Ostreae Concha", "Cocos Poria-Ossis Mastodi Fossilia-Ostreae Concha", "Ossis Mastodi Fossilia-Parched Ziziphi Spinosae Semen-->Ostreae Concha", and "Salviae Miltiorrhizae Radix-Ossis Mastodi Fossilia--Ostreae Concha".
Animals ; Chemistry, Pharmaceutical ; Data Mining ; Databases, Pharmaceutical ; Drug Prescriptions ; Humans ; Medicine, Chinese Traditional ; methods ; Ostrea ; chemistry ; Physicians ; Software