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.

Objective To investigate the influencing factors of the course of perioperative prophylactic antibiotics in patients undergoing total hip arthroplasty,and explore management strategies for enhancing perioperative prophylactic medication administration.Methods The clinical data for patients undergoing total hip arthroplasty at Affiliated Hospital of Chengdu University from January,2020 to September,2024 were retrospectively collected.Patients were divided into a 24 h group and a 48-72 h group based on the duration of prophylactic antibacterial therapy.The general characteristics,surgical-related indicators,preoperative and postoperative laboratory test results,and surgical outcome measures between the two groups of patients were compared.Multivariate Logistic regression analysis was performed to identify influencing factors associated with prolonged duration of prophylactic antibacterial therapy.Results A total of 126 patients who underwent total hip arthroplasty were enrolled,including 74 cases in the 24 h group and 52 cases in the 48-72 h group.Univariate analysis results showed that there were statistically significant differences in the following indicators between the two groups:surgical cause,surgical duration,intraoperative blood loss,drainage duration of plasma drainage tubes,preoperative white blood cell count,and preoperative neutrophil count(P<0.05).The results of multivariate Logistic regression analysis showed that the reason for surgery and the duration of plasma drain tube drainage were the influencing factors of antimicrobial treatment course for total hip arthroplasty(P<0.05).The results of receiver operating characteristic curve analysis showed that the prediction model(constructed based on the drainage time of plasma drainage tube)for prophylactic antimicrobial treatment course to 48-72 h was 0.721.When the drainage time of plasma drainage tubes was≥40.56 h,the risk of requiring prophylactic antimicrobial therapy for an extended course of 48-72 h increased significantly.Conclusion The patient's surgical reason and the duration of plasma drain drainage may be related to the prophylactic antimicrobial course of more than 24 hours.Clinical pharmacists may utilize this parameter as a patient-specific characteristic,with the support of information systems,the hierarchical patient management can be implemented,thereby enhancing the effectiveness of medication surveillance and progressively elevating the 24 h discontinuation rate of perioperative prophylactic antibiotics.

Objective To explore the characteristics and influencing factors of drug-induced liver injury(DILI)associated with the postoperative use of propacetamol,and to provide guidance for rational clinical medication.Methods A retrospective analysis was conducted on hospitalized patients who underwent surgical treatment and were administered propacetamol from January 2022 to June 2024.Cases were screened based on established inclusion and exclusion criteria.Statistical analyses were performed on patients'demographic data,medication information,liver function indicators before and after medication,comorbid conditions,and concomitant medications to assess the incidence and influencing factors of propacetamol-related DILI.A multivariate Logistic regression analysis was conducted to identify related risk factors.Results A total of 7,579 patients were sampled,of which 2,114 met the inclusion criteria.Among them,531 patients(25.1%)experienced DILI,primarily presenting with abnormal liver function indicators.This included elevated alanine aminotransferase in 379 cases(71.4%),elevated aspartate aminotransferase in 197 cases(37.1%),elevated alkaline phosphatase in 209 cases(39.4%),and elevated total bilirubin in 92 cases(17.3%).Univariate analysis revealed that there were significant differences in gender,height,age,weight,body mass index(BMI),duration of propacetamol use,total medication dosage,concomitant use of hepatic-metabolized antibiotics,and history of liver disease between the DILI group and non-DILI group(P<0.05).Multivariate Logistic regression analysis showed that patient gender,BMI,total propacetamol dosage,liver-related diseases,and concomitant use of hepatic-metabolized antibiotics as independent risk factors for DILI(P<0.05).Conclusion The use of propacetamol for postoperative analgesia presents a risk for liver injury,and the risk is particularly pronounced in males,obesity,high-dose dosing,patients with underlying hepatic disease,and comorbid hepatic metabolism of antimicrobial drug use.It is recommended to strengthen the monitoring of liver function in clinical application,strictly control the dosage and duration of treatment,and avoid co-administration with hepatotoxic drugs to ensure the safety of drug use.

Objective To investigate the clinical efficacy and safety of wentong guasha combined with herbal enema in the treatment of acute attack of chronic pelvic inflammatory disease.Methods From January 2023 to December 2024,patients with acute attack of chronic pelvic inflammatory disease diagnosed and treated at Foshan Women and Children Hospital Affiliated to Guangdong Medical University were selected and randomly divided into an experimental group and a control group.The control group received herbal enema therapy,while the experimental group received additional wentong guasha therapy on the basis of the control group's treatment.Both groups were treated for two weeks.The clinical efficacy,safety outcomes,as well as Visual Analog Scale(VAS)scores for pain and Pittsburgh Sleep Quality Index(PSQI)scores before treatment and after the 3rd and 7th days of treatment were compared between the two groups.Results A total of 120 patients were included,with 60 cases in each group.After treatment,the total effective rate was 90.00%in the experimental group and 76.67%in the control group,showing a statistically significant difference between the two groups(P<0.05).On the 3rd day of treatment,the VAS score of the experimental group was significantly lower than that of the control group(P<0.05).By the 7th day of treatment,both the VAS and PSQI scores of the experimental group were significantly lower than those of the control group(P<0.05).No adverse reactions were observed in either group.Conclusion Compared with herbal enema therapy,wentong guasha combined with herbal enema demonstrated more significant clinical efficacy in patients with acute attack of chronic pelvic inflammatory disease,markedly reduced pain scores,improved sleep quality,and showed good safety,indicating its potential value for clinical promotion and application.

Objective The aim is to understand the common scenarios of non-medical use of prescription opioids(NMUPO)and analyze the potential facilitating and hindering factors in the regulatory process of NMUPO from the perspective of healthcare professionals.Methods Healthcare professionals in local hospitals were surveyed through a two-stage purposive sampling from June to August 2022 in Ningbo,China.The survey was conducted using a semi-structured questionnaire on topics,and thematic analysis were used to identify and summarise key themes and patterns.Results A total of 75 participants were included,the average age was(43.9±7.2)years,and 54(72.0%)were male.The most common NMUPO scenarios involved middle-aged males pretending acute severe pain to obtain injectable opioids.The facilitating and hindering factors related to the regulation of NMUPO can be categorized into three types:institutional governance,technical support,and individual behaviors.At the institutional level,facilitating factors included strict national prescribing policies and local"narcotic drug card"systems,while barriers comprised incomplete lists of controlled substances.At the technological support level,facilitating factors included the establishment of regional health information platforms,while barriers included the lack of standardized prescription guidelines and diagnostic decision-support tools.At the individual level,facilitating factors included the public's cautious attitude toward drug misuse,while barriers included strained doctor-patient relationships.Conclusion China still faces significant challenges in addressing NMUPO and urgently needs to improve the existing regulatory system.It is recommended that reforms be carried out in areas such as pharmaceutical control mechanisms,drug treatment and rehabilitation services,preventive health education activities,and the optimized use of health information systems.

Objective To explore the correlation between glycemic control and complexity of drug treatment regimens in elderly patients with type 2 diabetes mellitus.Methods A retrospective,cross-sectional study was conducted to collect the elderly patients with type 2 diabetes mellitus who were hospitalized in the Department of Endocrinology at the Geriatric Hospital of Nanjing Medical University from June 2022 to December 2024.The clinical characteristics and medication compliance of the patients were recorded through pharmaceutical consultations.The medication regimen complexity index(MRCI)and diabetes-specific medication regimen complexity index(D-MRCI)were calculated for each patient.Patients were divided into the target-achieving group and the non-target-achieving group based on whether their blood glucose met the criteria.Univariate analysis and multivariate Logistic regression analysis were used to identify the factors associated with adequate blood glucose control.Results A total of 152 patients were included,123(80.9%)had poorer glycemic control,31.6%exhibited good medication adherence,and 76.3%demonstrated good adherence to diabetes medications.The mean total MRCI score was(25.90±8.63),while the median D-MRCI score was 9.00(5.25,11.75),with 44.7%of patients classified as having high D-MRCI scores(D-MRCI>9).The results of Spearman correlation analysis indicated that the number of medications used by patients was highly correlated with the MRCI score(r=0.899,P<0.001),while the number of diabetes medications used was highly correlated with the D-MRCI score(r=0.705,P<0.001).Univariate analysis results revealed that high complexity diabetes medication regimen,duration of diabetes,the number of types of antidiabetic drugs,and the number of injectable antidiabetic medications were associated with glycemic control(P≤0.05).Multivariate analysis results showed that,high diabetes medication complexity was an independent risk factor for inadequate blood glucose control[OR=4.119,95%CI(1.121,15.139),P=0.033].Conclusion Higher D-MRCI(>9)was associated with poorer glycemic control.Simplifying medication regimens and optimizing medication management strategies may improve patient outcomes.

Objective To analyze the burden and trend of musculoskeletal diseases(including gout,low back pain,neck pain,osteoarthritis,and rheumatoid arthritis)in China from 1990 to 2021,and to provide reference for formulating and adjusting prevention strategies for musculoskeletal diseases.Methods The Global Burden of Disease(GBD)in 2021 database was used to analyze the status and trend of the incidence and disability-adjusted life years(DALYs)rate of musculoskeletal diseases in China.Annual percentage change(EAPC)was used to comprehensively evaluate the trend of the burden of musculoskeletal diseases from 1990 to 2021.Gender and age-specific incidence and DALYs rate of musculoskeletal diseases were analyzed.Results In 2021,the number of cases of gout,low back pain,neck pain,osteoarthritis,and rheumatoid arthritis in China was 3,079,836,43,374,995,10,292,099,11,652,721,and 247,307,respectively.Among the 5 major musculoskeletal conditions,low back pain had the greatest incidence and DALYs rate.From 1990 to 2021,the age-standardized incidence of gout,osteoarthritis,and rheumatoid arthritis showed an upward trend,that of neck pain remained relatively stable,and that of low back pain showed a downward trend.The age-standardized DALYs rates of gout and osteoarthritis showed an increasing trend,that of neck pain and rheumatoid arthritis remained relatively stable,and that of low back pain showed a decreasing trend.The results of the stratified analysis by gender and age indicated that,the age-standardized incidence rate and age-standardized DALYs rate of gout were higher in men than in women,while the age-standardized incidence rate and age-standardized DALYs rate of low back pain,neck pain,osteoarthritis,and rheumatoid arthritis were higher in women than in men.The age groups with the burden of the five major musculoskeletal diseases were relatively consistent,mainly in the 40-75 years old.Conclusion From 1990 to 2021,the disease burden of gout,osteoarthritis,and rheumatoid arthritis increased significantly in China,while the disease burden of neck pain remained relatively stable,while the disease burden of low back pain showed a certain improvement.In addition,the burden of musculoskeletal diseases in China varies greatly by gender and age.Targeted intervention measures should be implemented as soon as possible based on the stratification results by gender and age,and health education and basic healthcare should be improved to effectively reduce the burden of musculoskeletal diseases.

Objective To systematically review the efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease(GERD).Methods PubMed,Embase,Web of Science,Cochrane Library,SinoMed,CNKI,VIP,and WanFang Data databases were electronically searched to collect randomized controlled trials(RCTs)on tegoprazan for GERD treatment from inception to January 1,2025.Two researchers independently screened the literature,extracted data and assessed the risk of bias of the included studies.Meta-analysis was performed using RevMan 5.4 software and Stata 16 software.Results A total of 7 RCTs were included,involving 1,329 patients.The results of Meta-analysis showed that there was no statistically significant difference in the overall effective rate between the tegoprazan group and the control group(placebo or proton pump inhibitors)[RR=1.08,95%CI(0.99,1.17),P=0.07].There was also no statistically significant difference in the cure rate between the tegoprazan group and the control group(proton pump inhibitors)[RR=0.99,95%CI(0.96,1.02),P=0.53].Comparing the incidence of treatment-emergent adverse events(TEAE)and serious adverse events(SAE)during treatment between the tegoprazan group and the control group,no statistically significant differences were found[TEAE:RR=0.90,95%CI(0.62,1.32),P=0.60;SAE:RR=0.61,95%CI(0.26,1.48),P=0.28].In terms of specific adverse event,the incidence of abnormal liver function was significantly higher in the tegoprazan group compared to the control group[RR=7.60,95%CI(1.40,42.27),P=0.02],while the incidence of other adverse reactions showed no significant differences(P>0.05).Conclusion Tegoprazan has relatively good overall efficacy and safety in the treatment of GERD,and its efficacy is similar to that of proton pump inhibitors,which can be used as an alternative treatment for proton pump inhibitors.Due to the limited quality and quantity of the included studies,more high-quality RCTs are needed to verify the above conclusion.

Objective To evaluate the efficacy,safety,and economic efficiency of toripalimab therapy for advanced esophageal cancer by rapid health technology assessment(rHTA),so as to provide clinical reference for drug use.Methods PubMed,Embase,Cochrane Library,CNKI,WanFang Data,VIP databases and official websites of health technology assessment institutions were electronically searched to collect high-quality clinical evidence and economic evaluation literature of toripalimab therapy for advanced esophageal cancer from inception to September 30,2025.Two reviewers independently identified studies,extracted data,assessed the quality of included studies,then the results were summarised and analysed using qualitative descriptive methods.Results A total of 18 articles were included,including 9 systematic reviews/Meta-analysis and 9 economic studies.In terms of efficacy,compared with the simple chemotherapy regimen,the combination chemotherapy regimen of toripalimab could significantly prolong the overall survival(OS)and progression free survival(PFS)of patients with advanced esophageal cancer,while improving the objective response rate(ORR)of patients.In terms of safety,there was no significant difference in the incidence of serious adverse events and overall adverse events between combination chemotherapy with toripalimab and chemotherapy alone.Moreover,compared with other immunotherapy combination therapies,the incidence of adverse events in combination chemotherapy with toripalimab was lower.In terms of economy,the combination of toripalimab and chemotherapy not only improves the clinical symptoms of advanced esophageal cancer patients,but also offers economic advantages.Conclusion Toripalimab is effective,safe and economical in the treatment of advanced esophageal cancer.

Objective To evaluate the efficacy,safety and cost-effectiveness of avatrombopag for treating primary immune thrombocytopenia(ITP)by rapid health technology assessment(rHTA),to provide evidence-based basis for clinical decision-making.Methods PubMed,Cochrane Library,Web of Science,Embase,CNKI,WanFang Data and the official website of health technology assessment(HTA)agency were electronically searched to collect systematic reviews/Meta-analyses,pharmacoeconomic literature,and HTA reports of avatrombopag for the treatment of ITP from inception to May 31,2025.Two reviewers independently screened studies,extracted data,assessed the quality of included studies,and qualitatively analyzed the result.Results A total of 12 studies were included,including 10 systematic reviews/Meta-analyses,1 pharmacoeconomic study and 1 HTA report.In terms of effectiveness,compared with placebo,treatment with avatrombopag significantly elevated platelet response,durable platelet response,early platelet response,and platelet count,reduction in use of concomitant ITP medication(P<0.05),and there was no significant difference in the need for remedial measures during the treatment period(P>0.05).Avatrombopag was also superior to eltrombopag,romiplostim,rituximab alone or in combination with recombinant human thrombopoietin(rhTPO)for platelet response(P<0.05).In terms of safety,there was no significant difference in the incidence of adverse events,serious adverse events,bleeding events and thrombotic events when comparing avatrombopag to placebo,eltrombopag,romiplostim and rituximab for the treatment of ITP(P>0.05).Economic study showed that avatrombopag has an economic advantage compared to eltrombopag and romiplostim,but it does not have economic advantages compared with observation and rescue.Conclusion Compared with placebo or other second-line treatments for ITP,avatrombopag has good efficacy and no significant differences in safety.Regarding economics,avatrombopag demonstrates greater cost-effectiveness than eltrombopag and romiplostim.However,due to its higher price,it does not have economic advantages compared to observation and rescue.Future economic research should be conducted domestically.