Signal Detection of Adverse Drug Reactions by Prescription Sequence Symmetry Analysis (PSSA) - Using Antipsychotic Drugs as Example

論文翻譯標題: 運用處方對稱分析法建立藥物不良反應偵測模式-以抗精神病藥物為例
  • 賴 嘉鎮

學生論文: Doctoral Thesis


Background: The strengths of prescription sequence symmetry analysis (PSSA) characterized with case-only based and within individual comparisons include efficient computation high sensitivity less selection bias and confounding factors and least requirement in data privacy With these advantages PSSA could be an excellent tool for signal detection in Taiwan post-market surveillance (PMS) system Objective: This study aimed to use antipsychotic drugs as example to establish signal detection of adverse drug reactions by PSSA The study was divided into three parts: establishments and validation of PSSA by testing the association between antipsychotics and extrapyramidal symptom (EPS); the application of PSSA on detecting safety signal of sulpiride; and we evaluated the safety signal (antipsychotics and oral ulcerations) obtained from the second part by using retrospectively cohort study design and to test the robustness of the results Results: We tested extrapyramidal syndrome and the results were consistent with a meta-analysis of 150 clinical studies which confirmed the validity of using PSSA to evaluate therapeutic risk of antipsychotics When applying PSSA to detect the safety signal we found sulpiride to be associated with an increased risk the use of additional drugs for managing adverse effects including stomatological dermatological and musculoskeletal or joint side effects constipation and pneumonia And one of the aforementioned safety signal stomatological adverse events were further confirmed by using retrospective cohort design that we found olanzapine quetiapine risperidone amisulpride and sulpiride posed a higher risk of oral ulcerations compared with haloperidol who newly initiated antipsychotic therapy Conclusion: By using antipsychotics as an example we demonstrated that PSSA is an efficient tool for signal detection with accurate and reproducible results The PSSA could be routinely executed in Taiwan PMS system
獎項日期2015 七月 30
監督員Yea-Huei Kao (Supervisor)