Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
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Zhongguo Zhong Yao Za Zhi · Sep 2014
[Apply association rules to analysis adverse drug reactions of shuxuening injection based on spontaneous reporting system data].
This research based on the analysis of spontaneous reporting system (SRS) data which the 9 601 case reports of Shuxuening injection adverse drug reactions (ADR) in national adverse drug reaction monitoring center during 2005-2012. Apply to the association rules to analysis of the relationship between Shuxuening injection's ADR and the characteristics of ADR reports were. We found that ADR commonly combination were "nausea + breath + chills + vomiting", "nausea + chills + vomiting + palpitations", and their confidence level were 100%. ⋯ The ADR's occurred had little related with solvent. It is showed that the Shuxuening injection occurred of ADR mainly related to drug composition. So Shuxuening injection used in clinical need to closely observation, and focus on the ADR reaction, and to do a good job of drug risk management.
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Zhongguo Zhong Yao Za Zhi · Sep 2014
Review[Systematic review of efficacy and safety of shenmai injection for chronic heart failure].
The paper is to evaluate the efficacy and safety of Shenmai injection for chronic heart failure, retrieving the Pubmed, CBM, CNKI, Wanfang database and VIP database to comprehensively collect all types research report of Shenmai injection for chronic heart failure (CHF). Particularly wishing to point out, randomized controlled trials are include for the evaluation of effectiveness, which are statistically analyzed and evaluated by Rev-Man 5. 2. ⋯ However, HR is almost no improvement. Meanwhile, serious ADR/AE of Shenmai injection for CHF isn't appear.
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Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. ⋯ Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.
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Zhongguo Zhong Yao Za Zhi · Sep 2014
[Discussion on research and development of new traditional Chinese medicine preparation process based on idea of QbD].
Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. ⋯ TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.
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Zhongguo Zhong Yao Za Zhi · Sep 2014
[Analysis of clinical use of shuxuening injection in treatment of cerebral infarction based on real world].
To know the characteristics of Shuxuening injection used on cerebral infarction patients in clinical practice, 6 053 cases of Hospital information system (HIS) data from 20 hospitals were analyzed. Using the basic description method and association rules to analysis the data. By analysis the data we found that the average age of cerebral infarction patients who used Shuxuening injection is 67.96, 83.94% of patients were aged 46-80. ⋯ When it comes to two drug combinations, it always combined with cinepazide maleate injection and aspirin (8.178%), nicergoline capsules and aspirin (7.63%). Therefore, based on existing data, we give the conclusion that for the treatment of cerebral infarction Shuxuening injection is mainly used for older patients, and is often combination with similar pharmacological effects chemical drugs, which is complied with the guidelines. However, the wrong dose is still exist, doctors should realize the hiding risk.