Toxicogenomics (TGx) refers to a set of technologies that assess genome-wide responses after toxic agent exposure. Altered gene expression patterns that are caused by specific exposures reveal how toxicants may disrupt cellular processes and lead to side effects. Development and application of " omics" technology facilitate the toxicogenomic research which sharing and interpretation of the enormous amount of biological information generated in toxicologic field. In recent years TGx has been widely valued and successfully applied as an effective research tool to evaluate the toxic effects of traditional Chinese medicine (TCM). Here we reviewed current progress in the field of TGx and focused on its application in traditional Chinese medicine safety evaluation, especially in revealing the mechanism, finding potential toxic biomarkers and studying compatibility detoxification of TCM.
Medicine, Chinese Traditional ; adverse effects ; Safety ; Toxicogenetics

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.
Medicine, Chinese Traditional/adverse effects* ; Social Change

Improve the Medication methods and the efficacy of Chinese medicines with western medicines. Read the according article, compare the advantage and disadvantge of Chinese medicines and western medicines interaction and describe the mechanism of medicines in effect. It shows that using Chinese medicines with western medicines have more disadvantage than adavntage. The clinical Chinese medicines with western medicines should according physical properties and pharmacological effects of drug at first, after taking, general the interval is from 1 hour to 3 hours to prevent medicine has physical reactions or toxicity in stomach, ensure taking medicines safety.
Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Medicine ; methods ; Medicine, Chinese Traditional ; adverse effects ; methods

The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.
Humans ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.
Humans ; Injections ; Medicine, Chinese Traditional ; adverse effects ; standards ; Quality Control

There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed'by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and indicative for evidence evaluation for harm.
Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

At the premise of ensuring efficacy and minimizing adverse reactions as far as possible, it doesn't achieve to the treatment purpose at the cost of physiological function injury in normal tissue, which is the characteristic of the symptoms and signs targeted theory of the formula corresponding to syndromes in traditional Chinese medicine (TCM). The occurrence of the adverse reactions of Chinese and western drugs is related to formula not corresponding to syndromes to a large extent. It is beneficial to minimizing the occurrence of the adverse reactions when the indication of western drugs is screened in the macroscopic level for patients by using the idea of formula corresponding to syndromes for reference.
Drugs, Chinese Herbal ; adverse effects ; pharmacology ; Humans ; Medicine, Chinese Traditional ; adverse effects

Traditional Chinese medicine injections have advantages on cardiovascular, respiratory critical treatment fields that cannot be irreplaceable by chemical medicines. In particular, they show good clinical efficacy in critical and severe cases caused by viral infection. However, in recent years, traditional Chinese medicine injections have frequently caused serious adverse effects and even fatalities, which made the safety of traditional Chinese medicine injections doubtful. This is mainly resulted from the quality of drugs themselves and rational clinical administration. Therefore, this essay summarizes literature materials starting from the development history of traditional Chinese medicine injections and suggests rationally using traditional Chinese medicine injections under the guidance with traditional Chinese medicine theories.
Animals ; Drug Therapy ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Medicine, Chinese Traditional ; adverse effects

The Chinese herbs have been used for thousands years, their effects were certified in clinic. The compatibility of Chinese medicine prescriptions is the basis principle in clinical application. In order to enhance efficacy and reduce toxicity, reasonable compatibility of the Chinese herbs is the main method for the safety and effective use. However, it is not clear about its mechanism. So it is necessary to study their mechanisms by using the modern pharmacological technology. At present, there are some studies on the mechanisms of the compatibility relating with toxicity or adverse effect attenuation, for instance, reducing the dose of toxic Chinese herbs, changing their pharmacokinetic parameter and resisting the damage to human body system. In this paper, we planed to review the attenuation mechanism of the prescription compatibility from relevant studies.
Drug Prescriptions ; Drug Therapy ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Medicine, Chinese Traditional ; adverse effects

Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.
China ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Hypersensitivity/etiology* ; Injections ; Medicine, Chinese Traditional/adverse effects*