Pharmacovigilance impact research(PIR),as an important application field of pharmacoepidemiology,has attracted continuous attention in recent years from drug regulatory authorities,pharmaceutical manufacturers,and the academic community both domestically and internationally.This paper provides an interpretation of PIR based on the Guide for Methodology in Pharmacoepidemiologic Research(2nd edition).First,an overview of the implications of PIR will be provided,focusing on the pathways of pharmacovigilance activities and the significant importance of conducting PIR.Second,it reviews commonly used study designs and presents illustrative case examples.Building on this,the specific statistical considerations relevant to PIR were discussed.Finally,the challenges and prospects of conducting pharmacovigilance impact studies in a scientific and standardized manner are summarized.Compared with the previous edition,the 2nd edition has expanded the application scenarios of pharmacoepidemiology to include new areas such as PIR.Drawing on the guideline content and practical experience,this paper provides a detailed introduction and case analysis of PIR,serving as a reference for researchers engaged in this field.

Pharmacovigilance impact research(PIR),as an important application field of pharmacoepidemiology,has attracted continuous attention in recent years from drug regulatory authorities,pharmaceutical manufacturers,and the academic community both domestically and internationally.This paper provides an interpretation of PIR based on the Guide for Methodology in Pharmacoepidemiologic Research(2nd edition).First,an overview of the implications of PIR will be provided,focusing on the pathways of pharmacovigilance activities and the significant importance of conducting PIR.Second,it reviews commonly used study designs and presents illustrative case examples.Building on this,the specific statistical considerations relevant to PIR were discussed.Finally,the challenges and prospects of conducting pharmacovigilance impact studies in a scientific and standardized manner are summarized.Compared with the previous edition,the 2nd edition has expanded the application scenarios of pharmacoepidemiology to include new areas such as PIR.Drawing on the guideline content and practical experience,this paper provides a detailed introduction and case analysis of PIR,serving as a reference for researchers engaged in this field.

Hyponatremia is common in the attack of acute intermittent porphyria(AIP), which can cause epilepsy, coma and other adverse events and endanger the life of patients. Carbohydrate loading therapy is applied to control the attack of AIP in the clinic. But the application of glucose can exacerbate hyponatremia. It is difficult for clinicians to effectively correct hyponatremia while treating AIP with glucose. We reported a case of AIP whose refractory hyponatremia was corrected with short-term low-dose tolvaptan to improve knowledge in management.

At present,the various levels of safety evaluations of traditional Chinese medical (TCM) injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.

Objective To analyze risk signals of liver injuries related to nonsteroidal anti-inflammatory drugs( NSAID)and application of reporting odds ratio( ROR)in data mining. Methods A search of adverse drug reaction( ADR ) reports in Beijing of national monitoring system of adverse drug reaction from January 1st 2013 to December 31st 2013 was conducted using keywords "liver" and "gallbladder" . Of these filtered reports,the cases whose causal relationship of drugs and liver injuries was judged as"positive","likely",or "possible" were enrolled into liver injury group and the rest cases were all enrolled into non-liver injury group. Using NSAID as the target drugs and the other drugs as non-target, ROR and its 95% confidence interval( CI)of liver injuries related to NSAID were calculated according to formula of ROR. The lower limit of 95% CI >1 was regarded as suggestive of ADR signal. Results After removing duplication,14 657 patients were enrolled in the study,which comprised liver injury group 626 patients including 35 cases of liver injuries due to NSAID and non-liver injury group 14 031 patients. Of the 35 patients with liver injuries related to NSAID,30 patients were associated with single-preparation NSAID and 6 patients were associated with compound-preparation. The ROR levels and their 95% CI of single-preparation NSAID,compound-preparation NSAID,and general NSAID were respectively 1. 78 (1. 22-2. 61),1. 80(0. 78-4. 15),and 1. 76(1. 24-2. 51). Both of the lower limits of 95% CI of live injuries related to single-preparation NSAID and general NSAID were higher than 1 and there were ADR signals. Thirty-seven kinds of drugs were involved by 35 cases of liver injuries. Of them,the ROR levels and their 95% CI of single-preparation parecoxib, single-preparation aspirin, compound-preparation ibuprofen and pseudoephedrine,and compound-preparation parace-tamol and amantadine hydrochloride were respectively 8. 00(2. 03-27. 78),2. 45(1. 43-4. 21),22. 00(1. 40-359. 32),and 11. 22(1. 02-123. 94) and there were ADR signals. Conclusions Attention should be paid to liver injuries related to NSAID. The method of ROR can help analyze ADR signals and provide useful early-warning of drug safety.

Objective To analyze risk signals of liver injuries related to nonsteroidal anti-inflammatory drugs( NSAID)and application of reporting odds ratio( ROR)in data mining. Methods A search of adverse drug reaction( ADR ) reports in Beijing of national monitoring system of adverse drug reaction from January 1st 2013 to December 31st 2013 was conducted using keywords "liver" and "gallbladder" . Of these filtered reports,the cases whose causal relationship of drugs and liver injuries was judged as"positive","likely",or "possible" were enrolled into liver injury group and the rest cases were all enrolled into non-liver injury group. Using NSAID as the target drugs and the other drugs as non-target, ROR and its 95% confidence interval( CI)of liver injuries related to NSAID were calculated according to formula of ROR. The lower limit of 95% CI >1 was regarded as suggestive of ADR signal. Results After removing duplication,14 657 patients were enrolled in the study,which comprised liver injury group 626 patients including 35 cases of liver injuries due to NSAID and non-liver injury group 14 031 patients. Of the 35 patients with liver injuries related to NSAID,30 patients were associated with single-preparation NSAID and 6 patients were associated with compound-preparation. The ROR levels and their 95% CI of single-preparation NSAID,compound-preparation NSAID,and general NSAID were respectively 1. 78 (1. 22-2. 61),1. 80(0. 78-4. 15),and 1. 76(1. 24-2. 51). Both of the lower limits of 95% CI of live injuries related to single-preparation NSAID and general NSAID were higher than 1 and there were ADR signals. Thirty-seven kinds of drugs were involved by 35 cases of liver injuries. Of them,the ROR levels and their 95% CI of single-preparation parecoxib, single-preparation aspirin, compound-preparation ibuprofen and pseudoephedrine,and compound-preparation parace-tamol and amantadine hydrochloride were respectively 8. 00(2. 03-27. 78),2. 45(1. 43-4. 21),22. 00(1. 40-359. 32),and 11. 22(1. 02-123. 94) and there were ADR signals. Conclusions Attention should be paid to liver injuries related to NSAID. The method of ROR can help analyze ADR signals and provide useful early-warning of drug safety.