Comparative Study On Four Kinds Of Post-marketing Safety Assessment Methods Of Danhong Injection

It is traditional Chinese medicine injections(TCMI) learning from modern Western medicine technology research and development of innovative dosage forms, has become an integral part of health care and an important means of treatment. But as the injection, compared with oral preparations rapid onset, stronger, and the corresponding higher risk, TCMI adverse reaction/event case reports accounted for the overall Chinese case reports of 72.64%, urgent to carry out TCMI post-marketing safety studies. But there is no market for TCMI method after the safety studies, restricted to carry out relevant research.Western innovation around the international market after a series of drug safety issues, recognizing that the real world after the listing of the importance of clinical safety studies, which produced a corresponding "Pharmacoepidemiology" new disciplines. Learn from this project, "Pharmacoepidemiology" method to carry out post-marketing safety of TCMI of the pilot study conducted to explore post-marketing safety of TCMI method of study in order to establish TCMI post-marketing safety norms.ObjectivesIn this study, hospital central monitoring method, chart review, literature study, four methods of self-reporting method Danhong injection adverse reactions, comparing different methods Danhong differences in adverse reaction injection in order to establish conduct post-marketing safety of TCMI Evaluation of appropriate methods for conducting post-marketing safety of TCMI provide the basis for research.Methods1. Centralized monitoring methodAs the main hospital pharmacists, the development of monitoring norms and standards, the doctors, nurses, patient knowledge of the multi-center clinical observation methods for monitoring the safety of the hospital Danhong injection, and the relevant monitoring data using statistical software SPSS 15.0 Analysis and processing.2. Chart review methodBased patient records using Danhong injection, in accordance with the focus on quality control standard monitoring method and data entry procedures, accurately extract the cases of the use of information Danhong injection, aggregated data for statistical analysis, post-marketing Danhong injection adverse reaction Objective description.3. Literature studyAccording to SFDA to develop a "Drug Literature Evaluation Guidelines", determine the safety of traditional Chinese medicine injections of post-marketing evaluation of the literature program; had to retrieve the relevant period of time after the listing Danhong injection literature clinical observation, collection, compilation and analysis of the patient's basic information and Security-related information, post-marketing safety of its objective evaluation.4. Spontaneous reporting methodHenan Province Food and Drug Administration based on adverse drug reaction spontaneous reporting systems, Henan Province, collected within the period of monitoring adverse reactions Danhong injection and type the number of cases during the period of the monitoring sales Danhong injection and patients in Henan province, the average usage Estimated number of people using Danhong Injection calculated Danhong Injection ADR incidence. Result1. Centralized monitoring method1.1 The monitoring of the hospital to monitor the use of six Danhong injection 4532 cases hospitalized patients and found 45 cases of adverse reaction rate was 9.93‰, are occasional side effects.1.2 Types of adverse reactions to circulation, skin, nervous system, intestinal bile mainly spiritual and other adverse reactions, the main clinical manifestations of rash, itching, dizziness, headache, phlebitis, a total of 77 episodes.2. Case Review Act2367 cases of hospitalized patients Danhong injection adverse reactions occurred in 8 patients, adverse reaction rate was 3.38‰; adverse reactions seen in the skin, facial features, nervous system, manifested as rashes, itching, dizziness, headache, tinnitus, fever, pain, etc. A total of 10 cases3. Spontaneous reporting method Henan Province, the spontaneous reporting of adverse drug reactions collected during systematic monitoring of adverse reactions Danhong injection in 21 patients, estimating the same period the number of people using Danhong injection was 31,340 people, of adverse reactions was 21/31340=0.67‰4. Literature study4.1 Literature study involved observation Danhong injection cases 20,575 cases,106 cases of adverse reactions, adverse reaction rate was 5.15‰.4.2 Danhong injection adverse reactions mainly in the nervous system,1.56‰, the circulatory system accounted for 1.27‰,1.17‰skin and intestinal bile accounted for about 0.78‰, consistent with the instructions; gingival bleeding, hemorrhagic dermatitis, hypotension, elevated aminotransferases Adverse reactions to new discoveries.Conclusion:Centralized monitoring method can be used as traditional Chinese medicine injections re-evaluation of post-marketing safety of the major research methods, the spontaneous reporting methods can make the necessary supplement.