Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
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Zhongguo Zhong Yao Za Zhi · Sep 2013
[Explore dengzhan xixin injection effecting on outcome of coronary heart disease based on propensity score].
Records of 2 325 patients with CHD were extracted from 20 hostpial information systems, who were divided into two groups, one group has 768 patients using Dengzhan Xixin, the other group has 1 557 patients without using Dengzhan Xixin. Using generalized boosted models (GBM) with propensity scores to balance confounding factors and using three Logistic regressions to analysis the cure rates of coronary heart disease. ⋯ Propensity score could be a good method to balance confounding factors in a retrospective data analysis. However it is not a prospective research, the information from this study should be carefully referred to.
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Zhongguo Zhong Yao Za Zhi · Sep 2013
Guideline[Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union].
Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. ⋯ In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine).
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Zhongguo Zhong Yao Za Zhi · Sep 2013
[Spontaneous reporting system data analysis of parenterally administered Shenmai].
Spontaneous reporting system (SRS) datais currently an important source of monitoring and finding ADRs signals throughout the world. This method can promptly and effectively discover ADR signals, thus preventing and avoiding ADRs effectively. Parenterally administered Shenmai has the functions of benefiting vital energy, nourishing Yin and generating body fluids, and activating the pulse. ⋯ Early warning signs of an ADR are, a feeling of suffocation (difficulty exhaling), anaphylactoid reactions and flushing. Furthermore, relevant relationships between the different factors is analysed by association rules (AR). It is found that there is a close relationship between past history of ADRs, a family history of ADRs and itching.
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Zhongguo Zhong Yao Za Zhi · Sep 2013
[Analysis of adverse reactions and pharmacovigilance research to parenterally administered shuxuening].
Parenterally administered Shuxuening is a commonly used Chinese medicine. There is a need to understand the characteristics of adverse drug reactions (ADRs) to it. 9 601 ADR cases reports were collected from the national adverse drug reaction monitoring center reported between January, 2005 and December, 2012. These included 326 serious ADR cases, accounting for 3.93% of the total. ⋯ Through the use of proportional reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) and propensity score applying generalized boosted models (GBM) to control for 17 confounding factors, analysis of the 10 kinds of ADRs found that for the ADR signals of dizziness, palpitations, phlebitis, and vomiting, BCPNN found that dizziness and phlebitis were early warning signals. This research found that in the 60-89 age group, higher dosages of parenterally administered Shuxuening gave rise to more phlebitis. This study provides important information for parenterally administered Shuxuening research, and guidance for its risk management.
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Zhongguo Zhong Yao Za Zhi · Sep 2013
[Translation and introduction of Guide to Methodological Standards in Pharmacoepidemiology].
Post-marketing pharmacovigilance of drugs has become one of the most important activities for regulatory authorities. In China, pharmacovigilance is currently receiving the attention of government, pharmaceutical industries and the public. ⋯ As advice includes: legal and ethical requirements, general aspects of study protocols, research questions, approaches to data collection, study designs and methods, statistical and epidemiological analysis plans, quality control and quality assurance, reporting of adverse events to regulatory authorities, communication of findings, and so on. The translation and introduction of this guidance can provide a useful technical and methodological reference for us to carry out the pharmacovigilance (especially for parenterally administered Chinese medicine safety monitoring).