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
Comparative Study[Comparison and analysis of clinical safety evaluation methods for parenterally administered Chinese medicine].
Parenterally administered Chinese medicine is widely applied in clinic. It particularly plays an important role in the treatment of cardiovascular and cerebrovascular disease, acute infectious diseases and malignant tumors. With the expansion of the scope of the clinical application of parenterally administered Chinese medicine adverse event reports also increase day by day. ⋯ Parenterally administered Chinese medicine accounted for more than half of the total number of adverse reactions to Chinese medicine. Therefore, it is essential that epidemiological methods are used to analyze the national database for all references to parenterally administered Chinese medicine. Our research aims to analyze the advantages and disadvantages of various safety monitoring methods for parenterally administered Chinese medicine and offer guidance in safety evaluation analysis.
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Zhongguo Zhong Yao Za Zhi · Sep 2013
[Analysis and thinking on status of quality standard of ethnic medicine].
The establishing and improving of quality standards for ethnic medicine have close relation with the safety and efficacy of clinical medicine. It is significant to promote the modernization and industrialization of ethnic medicine. This paper summarized the present status of quality standards for ethnic medicine, and pointed out the deficiency of ethnic medicine; the origin of medicinal materials was not clear and varieties were confused; the safety research of mineral drug was weak and so on. ⋯ Further, much attention should be payed to protection of natural medicinal resources and sustainable utilization. Lastly, modern chemical analysis technology shouled be used during the research process on the basis of ethnic characteristics. It will promote the establishment and improvement of quality standards for ethnic medicine and will be benificial to modernization and industrialization development of ethnic medicine.
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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).
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Zhongguo Zhong Yao Za Zhi · Sep 2013
[Research on early warning signals of adverse drug reactions to parenterally administered xiyanping based on spontaneous reporting system (SRS) data].
This article focused on early warning signals regarding the safety of parenterally administered Xiyanping. The study data was obtained from reports made between 2005-2012 from the national spontaneous reporting system (SRS). Proportion reporting ratio (PRR) and Bayesian confidence propagation neural network (BCPNN) algorithms were used to analyse: erythra, pruritus, anaphylactoid reactions and shiver with cold, these 4 adverse drug reactions had a total count of more than 500 events. ⋯ Pruritus was an early warning signal in the second season of 2009, and anaphylactoid reaction was an early warning signal in the fourth season of 2011 and in the second season of 2012. There was however no early warning signal indicated by shiver with cold. This data indicates that erythra maybe an adverse drug reactions to parenterally administered Xiyanping, and if the incidence rate of pruritus and anaphylactoid reaction rises attention should be paid to its safety.
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Zhongguo Zhong Yao Za Zhi · Sep 2013
[Study of analysis 1 390 adverse drug reactions cases of parenterally administered dengzhan xixin based on China's spontaneous response system].
Adverse drug reaction (ADR) monitoring of spontaneous reporting system (SRS) data to detect signals, is the main method of pharmacovigilance by China food and drug administration (CFDA). This study conducted a data analysis of 1 390 ADR cases of parenterally administered Dengzhan Xixin based on China SRS data collected between Jan, 2009 and Dec, 2012. The proportional reporting ratio method (PRR) and Bayesian confidence propagation neural network method (BCPNN) were used for data mining analysis. ⋯ With damage to skin and its accessories 55 forming the highest percentage of ADRs. When propensity score method to control for confounding factors, PRR method and BCPNN methods were applied, headache, dizziness, palpitation, and chills were ADRs warning signals. Due to the limitation of the SRS data, the results still need to be combined with other research to form a comprehensive body of safety evidence, and to guide the rational clinical use and reduce risks.