Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
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Zhongguo Zhong Yao Za Zhi · Dec 2016
Multicenter Study[Clinical medication characteristics of Shuxuening injection in treatment of cerebral infarction research based on registration].
To understand the medication characteristics of Xingxue@Shuxuening solutions in the real world, multi-center, large-sample-size registration design method is adopted in this study. Between October 2012 and October 2015, hospitalized patients in 27 medical institutions who used Shuxuening and diagnosed as cerebral infarction were observed, including their general information, diagnosis information and medication information. Totally 9 473 cases of cerebral infarction were included, with old people as the majority, and males were slightly more men than females; they were complicated with coronary heart disease, vertebrobasilar artery insufficiency, transient brain ischemia and other cerebrovascular diseases; the medication duration was mostly within 14 days; the dosage was mainly 8-20 mL; 0.9%NS, 5%GS were the main solvent; commonly used drug combination was Ozagrel sodium injection, Shuxuetong injection, Alprostadil injection and other medicines for inhibiting platelet aggregation and blood vessel dilatation, and Cytidine diphosphate choline injection, Edaravone injection, Oxiracetam injection and other brain protective agents. The above results indicate that the clinical medication characteristics of Shuxuening are basically consistent with the package insert, except for the solvent; combined medicine is dominated by antiplatelet drugs; for old patients, various anticoagulant drugs shall selected according to their specific conditions to avoid the occurrence of adverse reactions.
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Zhongguo Zhong Yao Za Zhi · Dec 2016
[Analysis of Diemailing Kudiezi injection use in real world in 7 189 patients with cerebral infarction].
This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection(one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. ⋯ Diemailing＋Aspirin＋Alprostadil was the most common combined use in our study, but the recommended clopidogrel＋Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples, providing basic reference information for clinicians and researchers. However, efficacy was not concerned in this study, so efficacy-related information could not be explained.
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Zhongguo Zhong Yao Za Zhi · Dec 2016
Meta Analysis[Meta-analysis of Yinzhihuang oral liquid in treatment of intrahepatic cholestasis of pregnancy].
To systematically review the clinical efficacy and safety of Yinzhihuang oral liquid in the treatment of intrahepatic cholestasis of pregnancy(ICP). Literatures published by June 2016 were searched in databases, such as Medline, Pubmed, Cochrane Library, China National Knowledge Infrastructure(CNKI), Chinese Scientific Journals Full-text Database(VIP), Chinese biomedical literature database(CBM), and Wanfang Database. Randomized controlled trials(RCT) of Yinzhihuang oral liquid were collected according to the inclusion criteria, and the methodological quality of selected literatures was evaluated. ⋯ However, there was no significant difference in cesarean section rate [OR=0.93, 95%CI (0.36, 2.36), P=0.87], preterm birth rates [OR=0.63, 95%CI (0.28, 1.42), P=0.26], and neonatal asphyxia rate [OR=0.50, 95%CI (0.18, 1.43), P=0.20]. Yinzhihuang oral liquid showed better efficiency and slighter adverse reaction. However, more rigorously designed, double-blind, randomized controlled trials with large sample size and high quality are required to provide further evidences.
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Zhongguo Zhong Yao Za Zhi · Dec 2016
[Protocol of intensive hospital monitoring with long follow up and large sample: Diemailing Kudiezi injection as example].
This is a protocol of intensive hospital monitoring with long follow up and large sample of Diemailing Kudiezi injection, which aims to identify adverse drug reactions(ADRs) of Diemailing Kudiezi injection, including known incidence of adverse reactions, the incidence of new adverse reactions, the incidence of various ADR symptoms and the incidence of ADR among the sub populations; clarify the clinical features of ADRs of Diemailing Kudiezi injection; explore risk factors for ADRs; and analyze their usage in real world. After all, no existing experience about active surveillance on safety issues for postmarkeing traditional Chinese medicine injections could be used for us to learn. On the basis of references to related domestic policies and regulations as well as the design points for observational studies, we extensively solicited opinions from experts in the industry to develop this implementation protocol on monitoring research.
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Zhongguo Zhong Yao Za Zhi · Dec 2016
[Core elements of safety monitoring report of medicines(Chinese patent medicines)].
Studies on post-marketing drug surveillance have become increasingly important in recent years. In particular, many researchers for traditional Chinese medicine have paid more attention to the safety of post-marketing Chinese patent medicines. Observational studies, like cohort study, registry study, and intensive hospital monitoring, were conducted to collect data on safety information. ⋯ Besides, we consulted relevant experts in this field and formed a framework on how to report post-marketing safety studies of Chinese patent medicines. There were seven core components, namely drug, population, setting, design, quality, adverse reaction and statistics, which could be abbreviated to DPSDQAS. We introduced the framework here to provide reference for future researchers.