Research On Clinical Safety Re-evaluation Of Post-marketing Kudiezi Injection

Objective:Understanding Kudiezi injection adverse reaction/event of the general rules, performance,types and incidence, influencing factors and its clinical characteristics. Thus providing reference for the rational use of drugs for clinical doctors, providing data support for the enterprise to modify the specification, objectively evaluate the safety of clinical drug of Kudiezi injection to guide and regulate the basis for rational drug use.Methods:Retrieving domestic medical literature databases, analyzing the safety literature of Kudiezi Injection, descriptiving statistics analysis Kudiezi injection on the incidence of adverse reactions, the occurrence of type and clinical manifestations of the situation; using a prospective and Registration type hospital centralized monitoring study, Exploring the clinical medicine Kudiezi injection characteristics, the incidence of adverse reactions, the influence factors and mechanism of allergic reaction.Results:(1)Literature analysis Kudiezi injection caused by the adverse reactions/events to systemic reaction, respiratory and circulatory system is the most common. Clinical manifestations are mainly allergic reaction, chest tightness, shortness of breath, nausea, vomiting, heart palpitations, increased blood pressure, skin rash, headache, dizziness, chills and fever;(2)There were 3 cases of adverse reaction/event in the period of monitoring to observe the Kudiezi injection in 801 patients, the adverse reaction rate was 0.12%. Clinical manifestations were palpitation, heart tired, rash, itching and belong to general adverse reactions.(3)Kudiezi injection registration type intensive hospital monitoring, There were indications for the existence of super-specification, drug concentration and drug treatment courses in clinical,and variety and complexity of combination medication.Conclusion:Kudiezi injection is widely used in the clinical application of treatment for indications other than disease,and clinical safety is better, It’s for pharmaceutical companies to expand its indications, modify the specification to provide reference and research directions.In order to make rational use of Kudiezi injection and reduce the possibility of a variety of adverse reactions/events, medical workers should pay attention to the following aspects in the clinical work:strictly in accordance with the requirements of the instruction indications, dosage, menstruum. using a combination of western medicine/traditional chinese medicine must be careful.asking in detail about the patients with a history of allergies before treatment, allergies should be used with caution or disable.Strengthening the medication guide for special populations(the elderly, children, women, patients with a variety of merger).Pay attention to the changes in the distribution of liquid liquid infusion and transfusion at room temperature and with other drugs before and after use. suspicious adverse events/reaction should refer to the relevant domestic and foreign standards. of reporting and timely and effective symptomatic treatment.