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
[Real-world analysis of concurrent diseases and medicine use among patients with insomnia].
This study aims to explore and analyze the condition of concurrent diseases and medicine use of traditional Chinese medicine (TCM) and western medicine among the patients with insomnia. One thousand and sxity seven cases of data from 20 national hospitals' hospital information system (HIS) databases were collected. The frequent concurrent diseases included hypertension (26.9%), brain blood supply insufficiency (24.93%), cerebral infarction (19.49%), blood lipoprotein disturbance (15.28%), coronary heart disease (14.15%), headache (10.68%), chronic gastritis (8.81%), type 2 diabetes mellitus (7.87%), depressive disorder (7.4%) and anxiety disorder (6.65%). ⋯ Among all combined uses, the most frequent western drug use was alprazolam and olanzapine, while combined use of hypnotic drug and Huoxuehuayu formula is the most frequent. This study concludes that the concurrent diseases mainly include cardio-cerebrovascular diseases, metabolic disorders and anxiety-depression disorders, with increasing tendency of diseases types by ages, especially for cardio-cerebrovascular diseases. The most frequently-used hypnotic is alprazolam in the insomnia patients, and it is worth being concerned about the off-label use of olanzapine as an antipsychotic for the treatment of insomnia However, due to the fact that all cases data are from the inpatients, these findings have some limitations.
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Zhongguo Zhong Yao Za Zhi · Sep 2014
[Analysis about characteristics of drug used in clinical for ischemic stroke patients based on hospital electronic medical database].
There are many different kinds of drugs which can treat ischemic stroke. This study aims to analyze the clinical treatment of ischemic stroke using Chinese and western medicines and their combination scheme. Data abstracted from 15 national 3a grad hospitals' hospital information system (HIS) databases were collected, then were used frequencies to find the common used drug and type, and were used association rules to anylizs the common combined medication scheme of Chinese and western medicines. ⋯ The drug combination of aspirin, twenty five pearl pill, Danhong and Xueshuaitong injection were the most frequently used group and its confidence coefficient is 97.5%. The type combination of blood-activating and stasis-dissolving prescription, thrombolytic drug, insulin and vasodilator was the most commonly used group and its confidence coefficient is 97.424%. This study concludes that the drug combination of aspirin, twenty five pearl pill, Danhong and Xueshuaitong injection and the type combination of blood-activating and stasis-dissolving prescription, thrombolytic drug, insulin and vasodilator were commonly used in clinical.
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Zhongguo Zhong Yao Za Zhi · Sep 2014
[Problems in quality standard research of new traditional Chinese medicine compound].
The new traditional Chinese medicine compound is the main part of the research of new drug of traditional Chinese medicine (TCM), and the new Chinese herbal compound reflects the characteristics of TCM theory. The new traditional Chinese medicine compound quality standard research is one of the main content of pharmaceutical research, and is also the focus of the new medicine pharmaceutical evaluation content. ⋯ The quality of new traditional Chinese medicine compound quality standard is not only itself can be solved, but quality standards is to ensure the key and important content of product quality, improving the quality of products cannot do without quality standards. With the development of science and technology, on the basis of quality by design under the guidance of the concept, new traditional Chinese medicine compound quality standard system will be more scientific, systematic and perfect.
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Zhongguo Zhong Yao Za Zhi · Sep 2014
[Analysis of questionable allergic factors to kudiezi injection--nested case control study using hospital information system data].
This study aims to assess if adverse drug reactions (ADRs) to Kudiezi injection are allergic in origin. Hospital information system (HIS) data from 18 hospitals in China were used to carry out a nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving Kudiezi injection. ⋯ Based on this current research, condition on admission as well as the concomitant use of some other drugs may be the risk factors in suspected cases of allergic reactions. However, further research for verification is required. This study can provide guidance for safe clinical practice in using Kudiezi injection.
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Zhongguo Zhong Yao Za Zhi · Sep 2014
[Common questions and suggestions of evaluation for NDA of TCM].
According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. ⋯ Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.