| Purpose:To figure out the condition and characteristics of advers reactions (ADRs) of traditional Chinese patent medicine and provide reasonable suggestions to avoid such ADR and evidence for the clinical use.Method:This study is a retrospective study of 5188 ADR of traditional Chinese patent medicine of PLA Medicine ADR Monitoring Center from 2009 to 2013. The result is accomplished by statistical analysis of patient information,drug information, system-organs damaged by the ADR, types of severe ADR of the TCM involved.Comparatively analyzing the characteristics and regularity of the occurrence of TCM injections and non-injections, in-depth exploring the pertinence measures to prevent ADR caused by TCM prescriptions.Result:Among the 5188 case reports on ADR induced by traditional Chinese patent medicine, senile patients accounted for 34.46%;Involving 3743 cases of traditional Chinese medicine (TCM) injections,1445 cases of non-injections (1334 cases of which are oral medicine).The system-organ damages are mainly in skin and appendixes (31.16%), gastrointestinal system (17.78%), and the all-body system (17.22%); Of all the 3743 case reports of ADR induced by TCM injections, the damage is mainly in skin and appendixes (32.07%).Of all reports on ADR induced by TCM non-injections, the damage is mainly in gastrointestinal system (33.97).The top three TCM prescriptions causing serious ADR are Guanxinsuhe pill (kidney damage), Heshouwu(liver damage) and Shenmai injection (allergic shock).ADR induced by TCM injections mostly occur within 30 min after oral administration with a proportion of 54.07%; whereas no intensive time window was observed in ADR induced by TCM non-injections. ADR induced by TCM injections cause relatively higher risk of systemic damage, whereas ADR induced by TCM non-injections caused higher risk of damage in liver and kidney functions, Serious ADR induced by TCM injections only account for 2.83%(106 cases), whereas TCM non-injections exhibit 11.83%(171 cases).Conclusion:Medical personnel should pay attention to the use of drugs and monitoring of medicine. Personalized medicine is necessary, while prolonged administration and the first large dosage should be avoided on the consideration of the specific population, such as senior citizens, whose physical characteristic and underlying disease are required to be taken into consideration; doctors should try to follow the principle that "if oral medication is available, drugs taken by intramuscular injection is the second choice; if neither of the two ways is appropriate, medication should be given by intravenous infusion" 30 minutes are the paramount time window while monitoring the ADR of TCM injection. Doctors and nurses should keep a close eye on the patients’reaction. Drug discontinuance and First-aid measures are nesessary as soon as the occurrence of ADR.Since the proportion of serious ADR induced by TCM non-injections is much higher than that by TCM injections, we should pay more attention to the TCM non-injections in clinical use; patients should avoid taking TCM prescriptions in an arbitrary way, especially for those who have already experienced serious ADR and those drug requiring long-term use. Educational efforts on drug safety should be provided; in order to increase public awareness of the drug safety of orally administered TCM prescriptions.Hospital Centralized Monitoring should be conducted on the TCM prescriptions with serious ADR (including anaphylactic shock, hepatorenal demage), such as Guanxinsuhe pill, Heshouwu and Shenmai injection, in order to investigate the underlying mechanism and reduce the possibility of serious ADR as well as ensure the medicine safety. Through analysis serious ADR report from PLA Medicine ADR Monitoring Center and two serious cases caused by emulsion injection of Seminal oil and Liujunzi pills,we had a deep understanding about ADR of Traditional Chinese Patent Medicines from theory to practice. And the fundamental was set up for ADR prevention and rational drug use. |
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