Objective To compare the difference in risk of drug-induced liver injury(DILI)between Runzao Zhiyang capsules and loratadine tablets.Methods Based on electronic medical records obtained through active drug safety monitoring in China,a retrospective cohort study was conducted to collect clinical data of patients who took oral Runzao Zhiyang capsules or loratadine tablets between January 1,2004,and December 31,2021.After balancing the confounding factors with a 1∶1 propensity score,the logistic regression model was used to analyze the risk of DILI between the two groups.Additionally,the sensitivity analysis of the data before matching and after inverse probability weighting method was conducted.Results A total of 31 636 patients were included,with 26 840 patients taking Runzao Zhiyang capsules orally.After matching there were 4 072 patients in each group,the risk of DILI in the Runzao Zhiyang capsules group was significantly lower than in the loratadine tablets group(0.12％vs.0.83％),OR=0.15(95％CI 0.06 to 0.38).Before matching and after inverse probability weighting,the incidence of DILI in the Runzao Zhiyang capsules group was still lower than that in the loratadine tablets group,and the difference was statistically significant(P＜0.001).Conclusion Runzao Zhiyang capsules have a better safety profile in terms of liver injury compared to the loratadine tablets.The hepatotoxicity of Polygonum multiflorum and its preparations should be scientifically evaluated and rationally treated to ensure medication safety and health.

Objective To understand the incidence and characteristics of adverse drug reactions(ADRs)of carbapenems,explore the relevant risk signals,and provide a reference for clinically safe drug use.Methods All spontaneous reports of carbapenem drug-related ADRs from January 2008 to October 2022 in the Adverse Drug Reaction Monitoring Center,PLA General Hospital's ADR database were retrieved,and information such as patients'general conditions,involved systems and organs damage,and the names of ADRs involved were retrospectively analysed.Using the reporting odd ratio method,the proportional reporting ratio method,the Medicines and Healthcare Products Regulatory Agency method,and information component method to obtain risk signals of carbapenem antimicrobial drug-related ADR.Results A total of 2 642 ADR reports of carbapenems were reported,of which 410 serious ADR reports(15.52％)were serious ADR reports,five cabapenem antimirobial drug species were mainly involved.In descending order of composition were imipenem cilastatin(51.28％),meropenem(32.13％),biapenem(8.10％),ertapenem(7.68％),and panipenem(0.79％).The male to female ratio of patients was 1.74:1,with the most age＞60 years(59.69％).A total of 14"drug-ADR name"combinations generated risk signals in all four data mining methods,with meropenem being the most signals,and imipenem cilastatin and ertapenem had a high number of reported ADR in nervous system.Conclusion The results of risk signal mining are basically consistent with the known carbapenem ADR information,during the use of carbapenem antimicrobial drugs in the clinic,it is recommended to monitor patients'liver and kidney functions as well as blood biochemical indexes,so as to strengthen the awareness of vigilance in the clinical use of carbapenem antimicrobial drugs,and timely recognize and deal with ADRs in a timely manner,and to avoid the occurrence of serious ADRs.

Objective To study adverse drug events(ADEs)of busulfan the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),and to mine the potential ADE signals,so as to provide reference for the safe drug use in clinical practice.Methods Data from the first quarter of 2004 to the first quarter of 2023 were retrieved from the FAERS database,and ADE records for busulfan as a primary suspect drug were obtained through data cleaning and standardization of target drug names.Risk signals for busulfan ADEs were mined based on the reporting odds ratio method,the proportional reporting ratio method,and Medicines and Healthcare Products Regulatory Agency method.The information component method was used to assess the intense of the risk signals.The ADEs were systematically classified according to Medical Dictionary for Regulatory Activities(MedDRA),and two ranking sequence of busulfan ADEs were generated by signal occurrence frequency and signal intense,respectively.Results A total of 20 326 ADE records were collected,involving 5 615 patients with 556 related ADE signals,of which 117 were newly reported as compared to those in the drug instruction of busulfan.Male patients accounted for a higher proportion than female patients(40.71％vs.30.74％).The main population of patients were younger than 18 years old(31.56％).The reports were most reported by physicians(33.71％)and other health professionals(24.35％)as well as pharmacists(23.86％),mainly from the United States(29.69％),Japan(15.78％),and France(11.79％).The top five ADEs in terms of occurrence frequency were busulfan use in unapproved indications,hepatic veno-occlusive disease(HVOD),mucosal inflammation,cytomegalovirus infection,and graft versus host disease.The top five ADEs in terms of signal intense were HVOD,acute graft versus host disease,veno-occlusive disease,graft versus host disease,and chronic graft versus host disease.The ADE signals involves 23 system organ classes.The top three SOCs in terms of the number of ADE signals were infections/infestations,investigations and neoplasms benign/malignant/unspecified(include cysts and polyps).Conclusion When busulfan is used in clinic,attention should be paid to its adverse events in hepatic veno-occlusive disease,infections,graft versus host disease,neurotoxicity,and venous thromboembolism,which are likely to cause serious consequences.The clinical pharmacists can assist clinicians to make prevention plans in case of busulfan ADEs,so as to improve the safety of busulfan use in clinic.

Objective To evaluate the cost-effectiveness of enzalutamide in the treatment of metastatic prostate cancer from the perspective of healthcare in China.Methods Based on the published phase Ⅲ randomized controlled trial(ENZAMET),the disease process of metastatic prostate cancer was classified into three states:progression-free survival,progression survival and death,and the model period was defined as 28 days,and the study period was lifelong,and a Markov model was established to evaluate the cost-effectiveness of the treatment of enzalutamide versus standard antiandrogen drugs in metastatic prostate cancer.Setting the willingness-to-pay(WTP)threshold at 3 times our 2022 gross domestic product(GDP)per capita and the robustness of the model analysis was verified by sensitivity analysis.Results Compared to the control group standard antiandrogen therapy,the incremental effect of enzalutamide was 0.92 quality-adjusted life years(QALYs),the incremental cost was 311 863.30 yuan,and the incremental cost-effectiveness ratio(ICER)was 338 981.85 yuan/QALY,which was higher than WTP threshold(257 094 yuan/QALY).The results of univariate sensitivity analyses showed that the total cost of the enzalutamide group,the PFS utility value,the cost of the PD status of enzalutamide group,and the unit price of enzalutamide had a greater impact on the model results.The results of the probabilistic sensitivity analysis suggested that the enzalutamide treatment regimen was not economical within the willingness-to-pay threshold of 3 times our 2022 GDP per capita.Conclusion Compared with the standard anti-androgen drugs,enzalutamide does not offer a cost-effectiveness advantage in the treatment of metastatic prostate cancer.

Objective To evaluate economics of Bailing capsules combined with western medicine conventional treatment compared with western medicine conventional treatment in diabetic kidney disease.Methods Meta-analysis was performed to investigate clinical efficacy and safety of Bailing capsules combined with western medicine conventional treatment(Bailing capsules group)compared with western medicine conventional treatment(control group)in diabetic kidney disease.From the perspective of health system in China,cost-effectiveness analysis was conducted by establishing a decision tree model.After the efficacy and safety results were obtained by meta-analysis,the short-term economics of the two treatment regimens were comprehensively evaluated.The efficacy index was the total effective rate and the time horizon was 3 months.One-way sensitivity analysis,probabilistic sensitivity analysis and scenario analysis were used to evaluate the robustness of the results.Results A total of 34 RCTs involving 3 114 patients were included in meta-analysis.The results of meta-analysis showed that when the treatment time was 3 months,the total effective rate of Bailing capsules group was higher than that of control group(RR=1.32,95％CI 1.25 to 1.39,P＜0.001),while its safety was similar to control group.Cost-effectiveness analysis showed that compared with the conventional western medicine treatment alone,the ICER value of Bailing capsule combined with western medicine conventional treatment was 5 223 yuan,and sensitivity analysis showed that the dosage of Bailing capsules and the total effective rate of the two therapies had great influence on the results.When the willingness-to-pay value was higher than 5 150 yuan,the probability of Bailing capsules combined with western medicine conventional treatment was more economical than 50％.Conclusion When time horizon was 3 months,compared with western medicine conventional treatment,Bailing capsules combined with western medicine conventional treatment is more economical for patients with diabetic kidney disease who are willing to pay more than 5 150 yuan.

Objective To understand the cognition status of high-alert medications among medical staffs in Chongming District of Shanghai,and to explore its influencing factors and improvement countermeasures,so as to provide references for safe clinical use and effective control of such drugs.Methods Convenient sampling method was used to investigate among medical staffs in 9 hospitals in Chongming District from March to May 2022,the survey content included general information of medical staff and their awareness of high-alert medications.The orderly multi-classification logistic regression was used to analyze the influencing factors of the cognition of high-alert medications among medical staffs.Results A total of 605 valid questionnaires were collected,including 263 from doctors and 342 from nurses.The results of univariate analysis showed that there were significant differences in the grade distribution of high-alert medications management knowledge scores among doctors of different gender,education background and whether to partcipate in in-hospital training(P＜0.05).There were significant differences in the grade distribution of high-alert medications management knowledge scores among nurses with different education background,hospital level and whether to partcipate in in-hospital training(P＜0.05).There was significant differences in the grade distribution of high-alert medications pharmacy knowledge scores whether doctors participated in in-hospital training(P＜0.05).There were significant differences in the grade distribution of high-alert medications pharmacy knowledge scores among nurses with different education background,professional title,working years and whether to partcipate in in-hospital training(P＜0.05).The results of multi-factor Logistic analysis showed that whether doctors had participated in in-hospital training was an influential factor for and high-alert medications management knowledge score level(OR=0.003,95％CI 0.000 to 0.023,P＜0.001),high-alert medications pharmacy knowledge score level(OR=0.252,95％CI 0.147 to 0.431,P＜0.001).Whether nurses participated in in-hospital training(OR=0.022,95％CI 0.010 to 0.048,P＜0.001)and hospital level(OR=3.353,95％CI 1.639 to 6.855,P=0.001)were the influencing factors of nurses'high-alert medications management knowledge score level,and education background(OR=4.933,95％CI 1.452 to 16.760,P=0.011)and whether nurses participated in in-hospital training(OR=0.414,95％CI 0.239 to 0.717,P=0.002)were the influencing factors of nurses'high-alert medications pharmacy knowledge score level.Conclusion The cognition of high-alert medications among medical staffs in Chongming District is at a medium level on the whole.It is suggested to improve their cognitive ability and risk prevention awareness by improving their education,strengthening the knowledge education and training of high-alert medications,and homogenizing management,so as to ensure the safety of clinical drugs.

Objective To compare the efficacy and safety of different Chinese patent medicines in the treatment of benign prostatic hyperplasia(BPH)by Bayesian network Meta-analysis.Methods PubMed,EMbase,Cochrane Library,CNKI,SinoMed,WanFang Data and VIP databases were electronically searched to collect randomized controlled trials(RCTs)of Chinese patent medicine in the treatment of BPH from inception to January 1,2023.Two researchers independently screened the literature,extracted data,and assessed the risk of bias of the included studies.Bayesian network Meta-analysis was performed using Stata 15.0 and GeMTC 14.3 software.Results A total of 51 RCTs involving 12 kinds of Chinese patent medicines and 4 927 patients were included.The results of direct Meta-analysis showed that Chinese patent medicine combined with conventional western medicine was superior to conventional western medicine alone in reducing international prostate symptom score(MD=-4.44,95％CI-5.09 to-3.79,P＜0.001),improving maximum urinary flow rate(MD=3.16,95％CI 2.71 to 3.61,P＜0.001),reducing residual urine volume(MD=-8.27,95％CI-9.62 to-6.92,P＜0.001)and prostate volume(MD=-3.89,95％CI-4.60 to-3.18,P＜0.001).The results of the network Meta-analysis showed that the Longbishu capsules combined with conventional western medicine had the best effect in reducing the international prostate symptom score.In terms of improving maximum urinary flow rate,Xialiqi capsules combined with conventional western medicine had the best effect.Zegui Longshuang capsules combined with conventional western medicine had the best effect in reducing residual urine volume.In terms of reducing prostate volume,Relinqing granules combined with conventional western medicine had the best effect.The incidence of adverse reactions in the Chinese patent medicine combined with conventional western medicine group(8.27％)was lower than that in the conventional western medicine group(11.98％).Conclusion The existing evidence shows that compared with conventional western medicine alone,Chinese patent medicine combined with conventional western medicine is better than conventional western medicine alone in improving various clinical symptoms of BPH,and has better safety.Various proprietary Chinese patent medicines have different therapeutic focuses,and individualized medication can be used according to the specific symptoms of BPH patients in clinical treatment.Limited by the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.

Objective To systematically review the effectiveness of perioperative oral probiotics in hepatic resection patients,and provide evidence-based clinical evidence.Methods PubMed,Cochrane Library,Web of Science,EMbase,SinoMed,WanFang Data,CNKI and VIP databases were electronically searched to collect randomized controlled trials(RCTs)on perioperative oral probiotics in hepatectomized patients from inception to June 30,2023.Two reviewers independently screened literature,extracted data and assessed the risk of bias of the included studies.Meta-analysis was performed by RevMan 5.4 software.Results A total of 10 RCTs were included,including 715 patients.The Meta-analysis showed that compared to placebo or blank controls,the incidence of postoperative infections in oral probiotic patients(RR=0.60,95％CI 0.48 to 0.74,P＜0.001),serum endotoxin levels(MD=-0.88,95％CI-1.53 to-0.22,P=0.009),cumulative antibiotic use(MD=-1.48,95％CI-2.17 to-0.78,P＜0.001),AST levels(MD=-9.68,95％CI-11.36 to-8.01,P＜0.001),ALT levels(MD=-21.24,95％CI-34.81 to-7.68,P=0.002),TBiL levels(SMD=-0.70,95％CI-0.95 to-0.45,P＜0.001),CRP levels(SMD=-0.52,95％CI-0.91 to-0.13,P=0.009),procalcitonin levels(MD=-0.19,95％CI-0.32 to-0.05,P=0.006),IL-6 levels(MD=-7.30,95％CI-14.26 to-0.33,P=0.04),and the first flatus time(MD=-1.16,95％CI-1.51 to-0.82,P＜0.001),hospital stay(MD=-0.62,95％CI-0.83 to-0.41,P＜0.001),hospitalisation costs(SMD=-0.65,95％CI-0.95 to-0.34,P＜0.001)were lower.Conclusion Current evidence shows that perioperative oral probiotics can significantly reduce the postoperative infection rate and decrease the release of inflammatory factors in liver resection patients,promote the recovery of postoperative hepatic and gastrointestinal functions,and shorten the length of hospital stay and costs.Due to the limited quality and quantity of the included studies,more high quality studies are needed to verify the above conclusion.

Objective To systematically evaluate the efficacy and safety of hydroxychloroquine(HCQ)in obstetric antiphospholipid syndrome(OAPS).Methods PubMed,Embase,Cochrane Library,Web of Science,SinoMed,Wanfang Data,CNKI,and VIP databases were searched electronically to collect clinical research on HCQ treatment for OAPS from inception to January 31,2023.Two researchers independently screened the literature,extracted data,and assessed the risk of bias of the included studies,Meta-analysis and GRADE evaluation were performed using RevMan 5.4 software and GRADE Profile 3.6 softwares.Results Five cohort studies and three randomized controlled trias(RCTs)were included,with a total of 644 OAPS patients(732 pregnancies).The results of Meta-analysis showed that compared with conventional treatment,HCQ supplementation significantly increased the live birth rate of OAPS(RR=1.29,95％CI 1.10 to 1.51,P=0.001),the negative conversion rate of lupus anticoagulant(RR=1.29,95％CI 1.13 to 1.47,P＜0.001),the anticardiolipin antibody negative conversion rate(RR=1.27,95％CI 1.12 to 1.45,P＜0.001)and the anti-β2 glycoprotein I antibody negative conversion rate(RR=1.31,95％CI 1.12 to 1.52,P＜0.001),the rate of early abortion(＜10 weeks)was significantly reduced(RR=0.31,95％CI 0.10 to 0.93,P=0.04).However,there was no significant difference between the two groups in reducing the rate of premature birth,late abortion(＞10 weeks)and the incidence of preeclampsia(P＞0.05).In terms of safety analysis,two studies described HCQ adverse effects including skin reactions and dry eyes,symptoms are mild.Three RCTs were used to compare the incidence of adverse reactions between the two groups,the incidence of adverse reaction of HCQ group was lower than that of control group(RR=0.40,95％CI 0.25 to 0.66,P＜0.001),and no serious adverse reactions occurred in both groups.The sensitivity analysis results were robust and reliable.The results of GRADE evaluation showed that the quality of index evidence included in this study were low or very low,with weak recommendations.Conclusion HCQ can significantly improve the live birth rate of OAPS and the negative conversion rate of antiphospholipid antibody,and reduce the fetal abortion rate before 10 weeks with fewer adverse reactions,but there is insufficient evidence to reduce the incidence of premature birth,fetal abortion after 10 weeks and preeclampsia.Due to the limited number and quality of included studies,the above conclusions need to be confirmed by more high-quality studies.

To introduce a strategy for a case of severe pneumonia caused by carbapenem-resistant Klebsiella pneumonia,which have failed to treat with tigecycline combined with meropenem,ceftazidime avibactam,and ceftazidime avibactam combined with aztreonam.Clinical pharmacist made anti-infective regimen based on colistin sulfate drip(750 000 units,ivd,q12h,first dose of 1.5 million units)and atomization(250 000 units,q12h)combined with tigecycline(100 mg,ivd,q12h,first dose 200 mg)according to patient's clinical manifestations,renal function,the dynamic changes of infection indicators,metagenomics next-generation sequencing results and the PK/PD characteristics of the anti-bacterial drugs.The anti-infection regimens(intravenous plus aerosolized colistin combined with tigecycline)proposed by the clinical pharmacist were adopted by doctors and the pneumonia was effectively controlled.Clinical pharmacists played an effective role in the clinical healthcare team by tracking frontier of antibacterial drugs,which fully embodied the professional value in optimizing treatment regimens of intractable infections.