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

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*

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

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

Aromatic traditional Chinese medicines have a long history in China, with wide varieties. Volatile oils are active ingredients extracted from aromatic herbal medicines, which usually contain tens or hundreds of ingredients, with many biological activities. Therefore, volatile oils are often used in combined prescriptions and made into various efficient preparations for oral administration or external use. Based on the sources from the database of Newly Edited National Chinese Traditional Patent Medicines (the second edition), the author selected 266 Chinese patent medicines containing volatile oils in this paper, and then established an information sheet covering such items as name, dosage, dosage form, specification and usage, and main functions. Subsequently, on the basis of the multidisciplinary knowledge of pharmaceutics, traditional Chinese pharmacology and basic theory of traditional Chinese medicine, efforts were also made in the statistics of the dosage form and usage, variety of volatile oils and main functions, as well as the status analysis on volatile oils in terms of the dosage form development, prescription development, drug instruction and quality control, in order to lay a foundation for the further exploration of the market development situations of volatile oils and the future development orientation.
Databases, Pharmaceutical ; statistics & numerical data ; Drug Therapy ; statistics & numerical data ; Humans ; Medicine, Chinese Traditional ; Nonprescription Drugs ; Oils, Volatile ; classification ; therapeutic use ; Outcome Assessment (Health Care) ; statistics & numerical data ; Phytotherapy ; statistics & numerical data ; Plant Oils ; classification ; therapeutic use

The survey of traditional knowledge related to Chinese materia medica resources is the important component and one of the innovative aspects of the fourth national survey of the Chinese materia medica resources. China has rich traditional knowledge of traditional Chinese medicine (TCM) and the comprehensive investigation of TCM traditional knowledge aims to promote conservation and sustainable use of Chinese materia medica resources. Building upon the field work of pilot investigations, this paper introduces the essential procedures and key methods for conducting the survey of traditional knowledge related to Chinese materia medica resources. The essential procedures are as follows. First is the preparation phrase. It is important to review all relevant literature and provide training to the survey teams so that they have clear understanding of the concept of traditional knowledge and master key survey methods. Second is the field investigation phrase. When conducting field investigations, survey teams should identify the traditional knowledge holders by using the 'snowball method', record the traditional knowledge after obtaining prior informed concerned from the traditional knowledge holders. Researchers should fill out the survey forms provided by the Technical Specification of the Fourth National Survey of Chinese Materia Medica Resources. Researchers should pay particular attention to the scope of traditional knowledge and the method of inheriting the knowledge, which are the key information for traditional knowledge holders and potential users to reach mutual agreed terms to achieve benefit sharing. Third is the data compilation and analysis phrase. Researchers should try to compile and edit the TCM traditional knowledge in accordance with intellectual property rights requirements so that the information collected through the national survey can serve as the basic data for the TCM traditional knowledge database. The key methods of the survey include regional division of Chinese materia medica resources, interview of key information holders and standardization of information.' In particular, using "snowball method" can effectively identify traditional knowledge holder in the targeted regions and ensuring traditional knowledge holders receiving prior informed concerned before sharing the information with researcher to make sure the rights of traditional knowledge holders are protected. Employing right survey methods is not only the key to obtain traditional knowledge related to Chinese materia medica resources, but also the pathway to fulfill the objectives of access and benefit sharing stipulated in Convention on Biological Resources. It will promote the legal protection of TCM traditional knowledge and conservation of TCM intangible, cultural heritage.
China ; Data Collection ; Databases, Pharmaceutical ; Drugs, Chinese Herbal ; Materia Medica ; Medicine, Chinese Traditional