Fifteen Years Of Adverse Reactions Of Clinical Trials Of Coronary Heart Disease And Angina Pectoris

Purpose：By large sample, multiple data, high quality evaluation ClinicalResearch to retrospective analysis of angina pectoris medicine clinical trialsand the incidence of adverse reactions related factors,such as route ofadministration, drug treatment, dosage, medication volume, allergies and so on,analysis the safety of drug use.Material and method：Collection of42projects by the State Food and DrugAdministration identified45clinical trials organization the auspices of andparticipation in the1999-201315years of angina pectoris medicine clinicaltrials, project summary/statistical reports of adverse reactions (ADR)statistical analysis.Results：1.Collection of angina pectoris chinese medicine clinical trials42items,a total of12,341cases.8326cases in which the new Chinese medicine group,ADR were58cases, ADR incidence rate of0.70%; Positive control group4015cases,ADR total of30cases, ADR incidence rate of0.75%;2.In the42projects on Chinese medicine group, intravenous administrationof14projects, ADR incidence rate of0.83%; oral administration of28projects,ADR incidence rate of0.62%. In the38projects on positive control groupintravenous administration of14projects, ADR incidence rate of1.00%; oraladministration of28projects, ADR incidence rate of0.60%. Chinese drug groupand positive control group oral dosage form drug adverse reactions capsuleshighest incidence.3.In the new Chinese medicine group, Treatment>1month ADR highest incidence (1.70%), treatment≤two weeks ADR lowest incidence (0.56%). In the positivecontrol group, Treatment>1month ADR highest incidence (1.30%), treatment≤two weeks ADR lowest incidence (0.66%).4. In the new Chinese medicine group,100g <dose≤150g ADR highest incidence(0.98%),150g <dose≤200g ADR lowest incidence (0.41%). In the positive controlgroup,50g <dose≤100g ADR highest incidence (0.93%),100g <dose≤150gADR lowest incidence (0.52%).5. When serving only Chinese medicine the ADR incidence was0.63%, whileincreased simulated agent that increased drug volume the ADR incidence was0.79%.When serving only positive medicine the ADR incidence was0.69%, while increasedsimulated agent that increased drug volume the ADR incidence was0.86%.6. In the new Chinese medicine group, patients with previous history ofallergy the ADR incidence was0.91%, patients with no previous history of allergythe ADR incidence was0.51%. In the positive control group, patients withprevious history of allergy the ADR incidence was0.83%,patients with no previoushistory of allergy the ADR incidence was0.60%.7.Angina Chinese medicine clinical trials involving the drug group ADR organ-the most common digestive system to (36.50%), followed by skin and itsappendages (25.40%);positive control group ADR organ involvement-the mostcommon digestive system to (32.30%) followed by the nervous system (22.58%).8. Angina Chinese medicine clinical trials of new drugs group accounted forup to mild degree of ADR (79.37%), to take measures to continue to use is morecommon (66.67%), ADR results in remission majority (50.8%), followed by thedisappearance (47.62%). ADR causal determination may/suspicious account forthe majority (77.78%). Positive drug control group accounted for at most a milddegree of ADR (67.74%), to take measures to continue to use the more common(77.42%), ADR results in the disappearance of the majority (58.06%), ADR causaldetermination may/suspicious account for the majority (77.78%). Conclusion：1. Angina pectoris and the number of clinical trials of traditional Chinesemedicine clinical trial program with Qi deficiency syndrome dominated mostcommon.2. Angina medicine administered intravenously in clinical trials theincidence of ADR more than oral administration incidence of ADR.3. Angina medicine incidence of ADR in clinical trials and experimentaltreatment, medication volume positively correlated with the number of treatmentno significant correlation between the dose of medication.4. Allergies prone to adverse reactions.5. Angina pectoris in clinical trial ADR cumulative organ-the most commonto the digestive system.6.Angina medicine mild degree of clinical trials ADR representing up to takemeasures in order to continue to use is more common, ADR results in remissiondisappear majority, may determine the causal/suspicious accounting for themost.7. The incidence of adverse reactions in clinical trial patients with anginapectoris quite new Chinese medicine group and positive control group.