Study On Clinical Safety Registration Of Post - Market Registration

Purpose：To obtain the occurrence rate of adverse reaction and influencing factorsof“Diemailing” Kudiziinjection; monitoring the clinical safety and to instruct application ofthe antibiotics reasonably of “Diemailing” Kudiziinjection; the characteristics and to explorethe mechanism of hypersensitivity reactions of “Diemailing” Kudiziinjection.Material and method：The study registration study is a prospective, multi center, theauthor only selected from2013January to2013September, all patients using "Diemailing"Kudiezi Injection in our hospital, clinical data were registered, record data and adversereaction. Nested nested case-control design, on the occurrence of allergic reactions in patientswith allergic group as, matching allergy group and control group is1:4. Matching factors: thesame sex, age with±5year, season, drug batch etc. Testing: Three conventional,electrocardiogram, liver and kidney function, immunoglobulin (IgM, IgG, IgA, IgE) andcytokines (IL-4, IL-13).Results：During the study period,100patients were included in the,1cases of adverse events occur,the incidence rate of adverse events was1%. The patients were female, the adverse events ofpalpitations, no other adverse reactions, application of dose was40ml, giving the withdrawalsymptoms disappeared after treatment,the original disease did not affect.Conclusion：This research is currently affiliated hospital of Liaoning University of Traditional ChineseMedicine stage study，in the small sample size, so the study on safety of Kudiezi Injection hasto be a national multi center clinical trial ended, further study of traditional Chinese medicineinjection adverse reactions incidence and Kudiezi Injection (Diemailing) type, the adversereactions occurrence characteristics and mechanism, influence factors.