Research Of Normative Application On Traditional Chinese Medicine Injection

Objective:Based on 5 kinds of TCM injections Xiyanping injection, Tanreqing injection, Danhong injection, Yiqifumai injection, Dazhuhngjingtian injection, effectiveness, safety, three aspects of the demonstration research, find the problems existing in the Chinese medicine injection in clinical application, combining with the latest database data, analysis the clinical each link and the factors influencing the reasonable application of traditional Chinese medicine injection, and further improve product quality for the enterprise provides the basis for revision instruction, for the relevant departments of the decision-making and provide support for Chinese medicine injection listed again after evaluation methods, to explore traditional Chinese medicine injection listed again after evaluation methods, finally to develop traditional Chinese medicine injection clinical practice guidelines, to guide clinical rational use of traditional Chinese medicine injection.Methods:1、Refer to documents of each type injection from time to market to the first half of 2013, the production technology of various varieties of traditional Chinese medicine injection, effective ingredients, usage and dosage, pharmacological effects, toxicology, pharmacokinetics, taboo and matters needing attention in recent research progress, combining with the leaflet, induction and summary.2、Clinical efficacy studies: the basic research of literature retrieval to filter results, looking for all varieties of traditional Chinesemedicine injection effectivenessofrandomized controlled trials(randomizedcontrolledtrial, R CT) literature, classified according to disease type, formulate corresponding and exclusion criteria, in accordance with the standard of RCT screening, the final RCT number > 5 references disease Meta analysis. RCT 5 or less disease, descriptive analysis. 3、Safety studies: the hospital focused on monitoring research,spontaneous reporting research, literature research in three different ways respectively for each type injection of all about adverse reactions to filter in the literature, combined with the ana lysis method of data mining, analysis of induction and summary, find out the related factors affecting traditional Chinese medicineinjection.Results : Research on the basic information : the enterprise provides the instructions have projects in lack of phenomenon, the description of the adverse reactions and "taboo" is simple, also does not have to classify adverse reaction type; 5 kinds of TCM injections in the manual are not on a "specia l population medicine"(children and the elderly medication, pregnant women and nursing mothers) and "pharmacokinetic" related description, by means of literature retrieval to complement and perfect the specification in the project; Status quo of clinical application of research: the centralized monitoring method and HIS system data mining two methods respectively, the red and the other four kinds of the status quo of clinical use of injection analysis, use of men more than women, mostly the Han nationalit, Danhong injection and Yiqifumai injection for people over the age of 60, more than large strain of rhodiola injection for more middle-aged, and Xiyanping injection used in children under the age of seven, clinical application should be widely distributed, involving various departments and combination with other drugs is very common, in addition to the Tanreqing drugs used frequency is higher, the other four injection combined frequency is highest is antiplatelet drugs, which are related to the function of each injection attending. effectiveness research: 5 kinds of clinical application of Chinese medicine injection effectiveness literature retrieval results indicate that go beyond the scope specified in the instructions for the function of attending, Meta a nalysis and summary of RCT, by reference to new level 9 evidence of evidence-based medicine, credible evidence for indications for grading, marked using the "nurture" is divided into 1 ~ 5 a level of credibility, of five kinds of traditional Chinese medici ne injection current can be used in the clinical treatment of disease by star ratings; Safety studies: through the centralized monitoring and spontaneous reporting method respectively to Danhong injection and other four kinds of injection safety influence factors analysis, combined with literature research summary of Danhong injection ADR information comprehensive centralized monitoring data of patients, and HIS system of the extracted data does not include ADR information, Dan hong injection adverse reaction, female patients were significantly more than male patients, the elderly, adverse reactions with speed hair style is given priority to, mainly skin damage of the system, and its main performance is the rash and itch, less damage. Logistic analysis showed that Danhong injection of adverse reactions occurred in female patients, and drug, food allergies, the patients with a history of allergic disease, the need to pay more attention to the other four kinds of fluids are the most common adverse reactions of skin and its accessories damage, adverse reaction is fast hairstyle, more tend to occur at the beginning of the drug after 30 minutes, the most adverse reactions are mild or moderate, can fully recover after discontinuation or symptomatic treatment.Conclusion:Useing Chinese medicine injection should follow the principle s of safety, effective, economic and appropriate.indications should be controled Strictly, "disease" and "syndrome differentiation" medicine, the combination of both to disease, and differentiation;, a detailed understanding of the history of allergy in patients with medication before, Strict dose and dripping speed; Treatment and solvent properly; Strengthening supervision; Special populations and the first use of patients use carefully, espeacilly pregnant. the research results show that the research results of Danhong injection is the most comprehensive and detailed, and the rest of the four kinds of traditional Chinese medicine injection results relatively missing. Therefore, the safety evaluation of traditional Chinese medicine injection is one of the ideal methods of centralized monitoring method, can reflect the authenticity of the clinical application of Chinese medicine injection.