ABSTRACT
Multiple methods should be incorporated into the research on pharmacovigilance of traditional Chinese medicine(TCM for a comprehensive and objective evaluation. The arrival of the era of medical big data allows it to be deeply integrated into medical research. The real world study(RWS) represented by hospital information system(HIS) provides a data basis for exploring the pharmacovigilance of TCM. Prescription sequence analysis(PSA) and prescription sequence symmetry analysis(PSSA) developed based on the former serve as a methodological basis for clinical safety evaluation of Chinese patent medicines after marketing. By collating the related studies of HIS, PSA and PSSA and employing the propensity score matching( PSM) method and nested case-control study(NCCS), this paper formed a HIS-, PSA-and PSSA-based technical system for clinical safety evaluation of Chinese patent medicines in the real world, in order to provide a methodological demonstration for the future research on the pharmacovigilance of TCM.
Subject(s)
Case-Control Studies , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pharmacovigilance , Prescriptions , Sequence AnalysisABSTRACT
Traditional Chinese medicine (TCM) injections are very useful in the treatment of acute and severe diseases due to their rapid onset. While, adverse drug reactions (ADRs) of TCM injections is an important problem, how to quickly detect ADRs signal of TCM injections is a key and difficult issue to make sure the safely application of TCM injections.Prescription sequence symmetry analysis (PSSA) is an effective surveillance tool for drug associated ADRs, through examining the distribution of marker drugs (potentially used for managing ADRs), before and after initiation of index drugs, PSSA can evaluate the causal association of index drugs and ADRs. PSSA can quickly detect ADRs signal based on medical electronic databases or prescription databases, which is suitable for the rapid emergence of ADRs for TCM injections. We described the basic principle and worldwide researches of PSSA, then we introduced the research methods when using PSSA to analyze the three aspects of ADRs for TCM injections. At present, when we use PSSA to detect ADRs signals in electronic prescription databases in China, we still need to think about the number of patients, structure and combination of data. With the development of medical electronic databases in China, PSSA can be more used to detect ADRs signal.
ABSTRACT
Objective To study the association between statins use and liver-injury through prescription sequence symmetry analysis (PSSA) and evaluate the feasibility of the method to be used in Chinese Medical Insurance Database.Methods The data of the patients who prescribed both statins and liver-proactive drugs in Chinese Basic Medical Insurance Database in 2013 were selected as study subjects to calculate the adjusted sequence ratio (ASR) with signal detection methods to determine the study parameters and investigate the potential association between statins use and liver-injury.Results In 5 649 individuals which met the inclusion criteria,the washout period was set as one month and interval period was set as 60 days.The overall ASR of statins was 1.471(95％CI:1.395-1.550),the ASR of atorvastatin was 1.419 (95％CI:1.335-1.508),the ASR of simvastatin was 1.307 (95％CI:1.164-1.467).The positive signal was strong in 30 days interval period.Conclusions PSSA indicated that there might be potential association between statins use and liver-injury,especially the uses of atorvastatin and simvastatin.This signal detection method may be a fast and effective method in drug safety evaluation and can be used in Chinese Medical Insurance Database.
ABSTRACT
Objective To study the association between statins use and liver-injury through prescription sequence symmetry analysis (PSSA) and evaluate the feasibility of the method to be used in Chinese Medical Insurance Database.Methods The data of the patients who prescribed both statins and liver-proactive drugs in Chinese Basic Medical Insurance Database in 2013 were selected as study subjects to calculate the adjusted sequence ratio (ASR) with signal detection methods to determine the study parameters and investigate the potential association between statins use and liver-injury.Results In 5 649 individuals which met the inclusion criteria,the washout period was set as one month and interval period was set as 60 days.The overall ASR of statins was 1.471(95％CI:1.395-1.550),the ASR of atorvastatin was 1.419 (95％CI:1.335-1.508),the ASR of simvastatin was 1.307 (95％CI:1.164-1.467).The positive signal was strong in 30 days interval period.Conclusions PSSA indicated that there might be potential association between statins use and liver-injury,especially the uses of atorvastatin and simvastatin.This signal detection method may be a fast and effective method in drug safety evaluation and can be used in Chinese Medical Insurance Database.