2.Apply association rules to analysis adverse drug reactions of shuxuening injection based on spontaneous reporting system data.
Wei YANG ; Yan-Ming XIE ; Yong-Yang XIANG
China Journal of Chinese Materia Medica 2014;39(18):3616-3620
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 and the case reports information commonly combination were "itching, and glucose and sodium chloride Injection, and generally ADR report, and normal dosage", "palpitation, and glucose and sodium chloride injection, and normal dosage, and new report", "chills, and generally ADR report, and normal dosage, and 0.9% sodium chloride injection", and their confidence level were 100% too. The results showed that patients using Shuxuening injection occurred most of ADRs were systemic damage, skin and its accessories damage, digestive system damage, etc. And most of cases were generally and new reports, and patients with normal dosage. 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.
Adverse Drug Reaction Reporting Systems
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Drug-Related Side Effects and Adverse Reactions
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diagnosis
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Drugs, Chinese Herbal
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adverse effects
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Female
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Humans
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Male
4.Common questions and suggestions of evaluation for NDA of TCM.
Xiu-Jing MA ; Yong-Wen ZHANG ; Chang-Ming YANG
China Journal of Chinese Materia Medica 2014;39(17):3395-3398
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. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. 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.
China
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Drug Approval
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legislation & jurisprudence
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Drug Evaluation
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legislation & jurisprudence
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Humans
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Legislation, Drug
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Medicine, Chinese Traditional
5.Recent advances of nasal natural killer/T-cell lymphoma.
Yong LIU ; Hai-yu YANG ; Ming-zhi LU
Chinese Journal of Pathology 2005;34(12):809-812
7.Inflammatory response and immune regulation of high mobility group box-1 protein in treatment of sepsis
World Journal of Emergency Medicine 2010;1(2):93-98
Sepsis is an infection induced systemic inflammatory response syndrome and is a major cause of morbidity as well as mortality in intensive care units. A growing body of evidence suggests that the activation of a proinflammatory cascade is responsible for the development of immune dysfunction, susceptibility to severe sepsis and septic shock. The present theories of sepsis as a dysregulated inflammatory response and immune function, as manifested by excessive release of inflammatory mediators such as high mobility group box 1 protein (HMGB1), are supported by increasing studies employing animal models and clinical observations of sepsis. HMGB1, originally described as a DNA-binding protein and released passively by necrotic cells and actively by macrophages/monocytes, has been discovered to be one of essential cytokines that mediates the response to infection, injury and inflammation. A growing number of studies still focus on the inflammation-regulatory function and its contribution to infectious and inflammatory disorders, recent data suggest that HMGB1 formation can also markedly influence the host cell-mediated immunity, including T lymphocytes and macrophages. Here we review emerging evidence that support extracellular HMGB1 as a late mediator of septic complications, and discuss the therapeutic potential of several HMGB1-targeting agents in experimental sepsis. In addition, with the development of traditional Chinese medicine in recent years, it has been proven that traditional Chinese herbal materials and their extracts have remarkable effective in treating severe sepsis. In this review, we therefore provide some new concepts of HMGB1-targeted Chinese herbal therapies in sepsis.
8.TIGAR promotes proliferation and invasiveness of lung cancer cells
Ming ZHAO ; Jing FENG ; Yong LIU ; Linglin YANG
International Journal of Laboratory Medicine 2016;37(6):754-755
Objective To study the role of P53 target gene TIGAR on proliferation ,migration and invasion of lung cancer cells . Methods siRNA was introduced to knock down TIGAR in A 549 cells .Proliferation was detected by CCK-8 .The ability of migra-tion and invasion was measured by and ,respectively .was used to evaluate the expression levels of related proteins .Results Knock-down of TIGAR reduced the proliferation rate (P< 0 .05) ,inhibited the ability of migration and invasion ,decreased expression levels of MMP-2 and MM P-9 .Conclusion TIGAR promotes proliferation ,migration and invasiveness of lung cancer cells .
9.Effect of endomorphin on colonic electromyography activity in endomorphin cathartic colon rats
Xiang YAN ; Jin-Yang WANG ; Yong-Ming LIU ; Jing WANG ;
Chinese Journal of Geriatrics 2000;0(04):-
Objective To determine the effect of endomorphin (EM) on colonic electromyography activity and investigate the pathogenesis of slow transit constipation (STC). Methods An experimental rat model of slow transit constipation was constructed by contract laxatives mixed with the feed. The changes of colonic electromyography and reaction to endomorphin 1 and endomorphin 2 were examined. Results Compared with the control group, the frequency and amplitude of slow wave in cathartic colon rats were decreased significantly. Endomorphin 1 and endomorphin 2 significantly decreased the amplitudes of slow wave, but did not change the frequencies of slow wave. The effect of endomorphin 1 was more pronounced than that of endomorphin 2, which could be reversed by the morphine antagonist Naloxone in concentration-dependent manner. Endomorphin could not block the stimulating effect of acetylcholine. Conclusions Endomorphin can influence the colonic electromyography activity and intestine motility of cathartic colon rats, and may be involved in the pathologic mechanism of slow transit constipation.
10.Experimental comparative study of CTA and DSA in detecting delayed cerebral vasospasm in rabbit model
Yong WANG ; Ming ZHONG ; Xianxi TAN ; Yunjun YANG ; Weijian CHEN
Journal of Interventional Radiology 2006;0(09):-
Objective To analyze the accuracy,sensitivity and safety of multidetector CT angiography(MDCTA) and DSA;furthermore to explore the clinical value of MDCTA in studying the delayed cerebral vasospasm(DCVS) .Methods Delayed cerebral vasospasm was induced in 17 rabbits by injection of autologuous blood into the cisterna magna and followed by a second injection 24 hours later.MDCTA and DSA were carried out at the 7th day before and after the procedure in order to obtain the data of vascular diameter changes for comparative study.Results The basilar artery diameters detected by MDCTA were shown preoperatively as(1.55 ? 0.14) mm and postoperatively as(0.95 ? 0.20) mm;and detected by DSA as(1.61 ? 0.19) mm and(1.00 ? 0.17) mm postoperatively;showing statistically equivalence between the two methods.Conclusions MDCTA is recommended as a reliable,rapid,and minimally invasive diagnostic method,providing a new technique for the delayed cerebral vasospasm research.