According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, and the total number has reached 387. 245 pharmaceutical excipients monographs have been revised, of which 109 monographs have only textual revisions and 136 monographs have substantive revisions. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

ObjectiveTo systematically organize the relevant research on the treatment of uterine fibroids with Xiaojie'an capsules through clinical evidence evaluation and comprehensive value analysis in the "6+1" dimension，highlighting the efficacy and characteristics of Xiaojie'an capsules. MethodsBased on evidence-based medicine，epidemiology，pharmacoeconomics，health technology assessment （HTA）， and other methodologies，this study adopted qualitative and quantitative evaluation methods. Through a questionnaire survey，official website data information，published literature， and secondary evaluation of real world data，a total of "6+1" dimensions were used to build an evaluation system for the safety，effectiveness，economy，innovation，suitability，accessibility of Chinese patent medicines， and characteristics of traditional Chinese medicines. Results① Safety：From January 2009 to March 2023，the National Adverse Drug Reaction Monitoring Center reported 159 cases （248 cases） of general adverse reactions and four cases of serious adverse reactions to Xiaojie'an capsules，all of which were classified as general adverse reactions after expert judgment. Through literature search，a total of 6 865 patients were treated with Xiaojie'an capsules，of which 26 articles reported adverse reactions to Xiaojie'an capsules，resulting in a total of 244 adverse reactions. The clinical manifestations of adverse reactions to Xiaojie'an capsules include nausea，vomiting，stomach discomfort，diarrhea，rash，itching，dizziness，headache，insomnia，etc. The prognosis was good， and the drug surveillance system was sound. Based on the evaluation of known risks and sufficient evidence，in terms of known risk assessment， according to the monitoring results of the spontaneous reporting system （SRS）， there were four cases of serious adverse reactions to Xiaojie'an capsules. After expert discussion， the four cases of serious adverse reactions were finally judged as general adverse reactions， and the known risks were considered to be small in combination with the known risk evaluation criteria. According to the types of studies carried out on Xiaojie'an capsules （randomized controlled trial and its systematic review， SRS data analysis， real world human experience studies， and non-clinical safety studies） and the evaluation criteria of sufficient evidence， it was considered that Xiaojie'an capsules had sufficient evidence. The safety evidence of this variety was sufficient， and the result was confirmed. ② Effectiveness： Meta-analysis results showed that the combination of Xiaojie'an capsules and Mifepristone tablets had better clinical efficacy compared to Mifepristone tablets alone and had a better effect in reducing the maximum uterine fibroid volume. Due to limitations and imprecision caused by downgrading factors，the quality of evidence was evaluated as Grade C. Based on comprehensive effectiveness evidence and value evaluation，the effectiveness evidence of this variety was relatively sufficient， and the results were clear ③ Economy：The economic evaluation results showed that treating one more patient with uterine fibroid required an additional cost of 5 438.57 yuan by using the combination of Xiaojie'an capsules and Mifepristone tablets，which was lower than the patient's willingness to pay （36 883 yuan according to 2022 National Bureau of Statistics data）. This suggested that compared with using Mifepristone tablets alone，the combination of Xiaojie'an capsules and Mifepristone tablets had a certain economy. The sensitivity analysis results were relatively robust，indicating that this variety had good economy ④ Innovation：Currently，most traditional Chinese medicine treatments for uterine fibroids advocate the method of attacking evil，which can easily harm the body. However，Xiaojie'an capsules not only soften and disperse nodules but also balance supporting the body and supplementing deficiency. The comprehensive evaluation showed sufficient evidence of the innovation of this variety，and the results were confirmed. ⑤ Suitability： The service information of Chinese patent medicines derived from the drug was complete，and the questionnaire survey results showed that the drug was suitable for clinicians，nurses，pharmacists， and patients in multiple dimensions such as individual compliance，system， and management. The comprehensive evaluation of the suitability of the product had sufficient evidence and clear results. ⑥ Accessibility：The daily cost of Xiaojie'an capsules was 16.97 yuan，and the treatment cost was 407.16 yuan. It was affordable for urban residents and rural residents and was available for sale in 23 provinces， cities，municipalities，and autonomous regions across the country. The medicinal resources were abundant and sustainably supplied，and there was sufficient evidence of accessibility with clear results. ⑦ Characteristics of traditional Chinese medicine：Xiaojie'an capsules were derived from the classic Dai medicine formula of Dr. CHEN Benshan，a renowned Dai doctor，and they have been clinically used for over 20 years. Dai medicine originated from Xishuangbanna，Yunnan province，with the core theory of "four pagodas and five elements". The comprehensive evaluation showed that this variety exhibited significant characteristics of traditional Chinese medicine. ⑧ Comprehensive evaluation of clinical value：Based on the "6+1" dimensions mentioned above，combined with the multi-criteria decision analysis （MCDA） model and calculations using CSC v2.0 software，the results showed that there was sufficient evidence for the clinical value of Xiaojie'an capsules，and the results were clear. ConclusionThe comprehensive evaluation of Xiaojie'an capsules has sufficient evidence of safety and innovation，and the results are confirmed. The evidence of effectiveness，suitability，and accessibility is relatively sufficient，with clear results. The economy is good，and the characteristics of traditional Chinese medicine are prominent. The comprehensive evaluation of clinical value believes that there is sufficient evidence of the clinical value of Xiaojie'an capsules，and the results are clear. In the future，it is recommended to focus on clinical value， conduct high-quality and effective research that is in line with the characteristics of traditional Chinese medicine， and improve acute toxicity testing to provide a scientific and objective basis for clinical efficacy and safety research.

Objective:To investigate the current situation of the use of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension, which should aid the development of TIPS in China.Methods:The China Portal Hypertension Alliance (CHESS) initiated this study that comprehensively investigated the basic situation of TIPS for portal hypertension in China through network research. The survey included the following: the number of surgical cases, main indications, the development of Early-TIPS, TIPS for portal vein cavernous transformation, collateral circulation embolization, intraoperative portal pressure gradient measurement, commonly used stent types, conventional anticoagulation and time, postoperative follow-up, obstacles, and the application of domestic instruments.Results:According to the survey, a total of 13 527 TIPS operations were carried out in 545 hospitals participating in the survey in 2021, and 94.1% of the hospital had the habit of routine follow-up after TIPS. Most hospitals believed that the main indications of TIPS were the control of acute bleeding (42.6%) and the prevention of rebleeding (40.7%). 48.1% of the teams carried out early or priority TIPS, 53.0% of the teams carried out TIPS for the cavernous transformation of the portal vein, and 81.0% chose routine embolization of collateral circulation during operation. Most of them used coils and biological glue as embolic materials, and 78.5% of the team routinely performed intraoperative portal pressure gradient measurements. In selecting TIPS stents, 57.1% of the hospitals woulel choose Viator-specific stents, 57.2% woulel choose conventional anticoagulation after TIPS, and the duration of anticoagulation was between 3-6 months (55.4%). The limitation of TIPS surgery was mainly due to cost (72.3%) and insufficient understanding of doctors in related departments (77.4%). Most teams accepted the domestic instruments used in TIPS (92.7%).Conclusions:This survey shows that TIPS treatment is an essential part of treating portal hypertension in China. The total number of TIPS cases is far from that of patients with portal hypertension. In the future, it is still necessary to popularize TIPS technology and further standardize surgical indications, routine operations, and instrument application.

Objective To compare the synergies between the transcutaneous needle electrodes and the ETT surface electrodes used for neurological surveillance in thyroidology,and explore how to identify and protect recurrent laryngeal nerve and vagus nerve when the patient is not suitable for oral plug or surface electrodes are failure.Methods To collect and analyze the clinical data of 32 patients undergoing surgical treatment for thyroid disease,a total of 40 neurons of the recurrent laryngeal nerves and vagus nerves were monitored,and the amplitude and latency were recorded using ETT surface electrodes and transcutaneous needle electrodes for nerve monitoring,respectively.SPSS 26.0 software was used for statistical analysis,paired t-tests were used to analyze and compare the latency periods,and the rank sum test was used to analyze whether there is a difference in the amplitude obtained from stimulation of transcutaneous needle electrodes and ETT surface electrodes.Results When the transcutaneous needle electrodes were used in thyroid surgery,we identified all the nerves,obtained two-phase electrical signals similar to the latency and amplitude of the ETT surface electrodes,and could effectively identify the recurrent laryngeal nerve and vagus nerve[(3.22±0.50)ms vs.(3.85±1.00)ms,P＜0.05]through the incapacity period,with no obvious difference in the monitoring effect from the ETT surface electrodes[(3.04±0.58)ms vs.(3.89±1.07)ms,P＜0.05].At the same time,the visualization and safety of transcutaneous needle electrodes were higher,with great advantages.Conclusion Transcutaneous needle electrodes can effectively assist in identifying and protecting the recurrent laryngeal nerve and vagus nerve,and thus are an important supplement to ETT surface electrodes.

Objective To monitor the susceptibility of clinical isolates to antimicrobial agents in tertiary hospitals in major regions of China in 2022.Methods Clinical isolates from 58 hospitals in China were tested for antimicrobial susceptibility using a unified protocol based on disc diffusion method or automated testing systems.Results were interpreted using the 2022 Clinical &Laboratory Standards Institute(CLSI)breakpoints.Results A total of 318 013 clinical isolates were collected from January 1,2022 to December 31,2022,of which 29.5％were gram-positive and 70.5％were gram-negative.The prevalence of methicillin-resistant strains in Staphylococcus aureus,Staphylococcus epidermidis and other coagulase-negative Staphylococcus species(excluding Staphylococcus pseudintermedius and Staphylococcus schleiferi)was 28.3％,76.7％and 77.9％,respectively.Overall,94.0％of MRSA strains were susceptible to trimethoprim-sulfamethoxazole and 90.8％of MRSE strains were susceptible to rifampicin.No vancomycin-resistant strains were found.Enterococcus faecalis showed significantly lower resistance rates to most antimicrobial agents tested than Enterococcus faecium.A few vancomycin-resistant strains were identified in both E.faecalis and E.faecium.The prevalence of penicillin-susceptible Streptococcus pneumoniae was 94.2％in the isolates from children and 95.7％in the isolates from adults.The resistance rate to carbapenems was lower than 13.1％in most Enterobacterales species except for Klebsiella,21.7％-23.1％of which were resistant to carbapenems.Most Enterobacterales isolates were highly susceptible to tigecycline,colistin and polymyxin B,with resistance rates ranging from 0.1％to 13.3％.The prevalence of meropenem-resistant strains decreased from 23.5％in 2019 to 18.0％in 2022 in Pseudomonas aeruginosa,and decreased from 79.0％in 2019 to 72.5％in 2022 in Acinetobacter baumannii.Conclusions The resistance of clinical isolates to the commonly used antimicrobial agents is still increasing in tertiary hospitals.However,the prevalence of important carbapenem-resistant organisms such as carbapenem-resistant K.pneumoniae,P.aeruginosa,and A.baumannii showed a downward trend in recent years.This finding suggests that the strategy of combining antimicrobial resistance surveillance with multidisciplinary concerted action works well in curbing the spread of resistant bacteria.

Objective To investigate the distribution and antimicrobial resistance profiles of the common pathogens isolated from urine from 2015 to 2021 in the CHINET Antimicrobial Resistance Surveillance Program.Methods The bacterial strains were isolated from urine and identified routinely in 51 hospitals across China in the CHINET Antimicrobial Resistance Surveillance Program from 2015 to 2021.Antimicrobial susceptibility was determined by Kirby-Bauer method,automatic microbiological analysis system and E-test according to the unified protocol.Results A total of 261 893 nonduplicate strains were isolated from urine specimen from 2015 to 2021,of which gram-positive bacteria accounted for 23.8％(62 219/261 893),and gram-negative bacteria 76.2％(199 674/261 893).The most common species were E.coli(46.7％),E.faecium(10.4％),K.pneumoniae(9.8％),E.faecalis(8.7％),P.mirabilis(3.5％),P.aeruginosa(3.4％),SS.agalactiae(2.6％),and E.cloacae(2.1％).The strains were more frequently isolated from inpatients versus outpatients and emergency patients,from females versus males,and from adults versus children.The prevalence of ESBLs-producing strains in E.coli,K.pneumoniae and P.mirabilis was 53.2％,52.8％and 37.0％,respectively.The prevalence of carbapenem-resistant strains in E.coli,K.pneumoniae,P.aeruginosa and A.baumannii was 1.7％,18.5％,16.4％,and 40.3％,respectively.Lower than 10％of the E.faecalis isolates were resistant to ampicillin,nitrofurantoin,linezolid,vancomycin,teicoplanin and fosfomycin.More than 90％of the E.faecium isolates were ressitant to ampicillin,levofloxacin and erythromycin.The percentage of strains resistant to vancomycin,linezolid or teicoplanin was＜2％.The E.coli,K.pneumoniae,P.aeruginosa and A.baumannii strains isolated from ICU inpatients showed significantly higher resistance rates than the corresponding strains isolated from outpatients and non-ICU inpatients.Conclusions E.coli,Enterococcus and K.pneumoniae are the most common pathogens in urinary tract infection.The bacterial species and antimicrobial resistance of urinary isolates vary with different populations.More attention should be paid to antimicrobial resistance surveillance and reduce the irrational use of antimicrobial agents.

Objective To understand the distribution and changing resistance profiles of clinical isolates of Enterococcus in hospitals across China from 2015 to 2021.Methods Antimicrobial susceptibility testing was conducted for the clinical isolates of Enterococcus according to the unified protocol of CHINET program by automated systems,Kirby-Bauer method,or E-test strip.The results were interpreted according to the Clinical & Laboratory Standards Institute(CLSI)breakpoints in 2021.WHONET 5.6 software was used for statistical analysis.Results A total of 124 565 strains of Enterococcus were isolated during the 7-year period,mainly including Enterococcus faecalis(50.7％)and Enterococcus faecalis(41.5％).The strains were mainly isolated from urinary tract specimens(46.9％±2.6％),and primarily from the patients in the department of internal medicine,surgery and ICU.E.faecium and E.faecalis strains showed low level resistance rate to vancomycin,teicoplanin and linezolid(≤3.6％).The prevalence of vancomycin-resistant E.faecalis and E.faecium was 0.1％and 1.3％,respectively.The prevalence of linezolid-resistant E.faecalis increased from 0.7％in 2015 to 3.4％in 2021,while the prevalence of linezolid-resistant E.faecium was 0.3％.Conclusions The clinical isolates of Enterococcus were still highly susceptible to vancomycin,teicoplanin,and linezolid,evidenced by a low resistance rate.However,the prevalence of linezolid-resistant E.faecalis was increasing during the 7-year period.It is necessary to strengthen antimicrobial resistance surveillance to effectively identify the emergence of antibiotic-resistant bacteria and curb the spread of resistant pathogens.

Objective To examine the changing antimicrobial resistance profile of Enterobacter spp.isolates in 53 hospitals across China from 2015 t0 2021.Methods The clinical isolates of Enterobacter spp.were collected from 53 hospitals across China during 2015-2021 and tested for antimicrobial susceptibility using Kirby-Bauer method or automated testing systems according to the CHINET unified protocol.The results were interpreted according to the breakpoints issued by the Clinical & Laboratory Standards Institute(CLSI)in 2021(M100 31st edition)and analyzed with WHONET 5.6 software.Results A total of 37 966 Enterobacter strains were isolated from 2015 to 2021.The proportion of Enterobacter isolates among all clinical isolates showed a fluctuating trend over the 7-year period,overall 2.5％in all clinical isolates amd 5.7％in Enterobacterale strains.The most frequently isolated Enterobacter species was Enterobacter cloacae,accounting for 93.7％(35 571/37 966).The strains were mainly isolated from respiratory specimens(44.4±4.6)％,followed by secretions/pus(16.4±2.3)％and urine(16.0±0.9)％.The strains from respiratory samples decreased slightly,while those from sterile body fluids increased over the 7-year period.The Enterobacter strains were mainly isolated from inpatients(92.9％),and only(7.1±0.8)％of the strains were isolated from outpatients and emergency patients.The patients in surgical wards contributed the highest number of isolates(24.4±2.9)％compared to the inpatients in any other departement.Overall,≤ 7.9％of the E.cloacae strains were resistant to amikacin,tigecycline,polymyxin B,imipenem or meropenem,while ≤5.6％of the Enterobacter asburiae strains were resistant to these antimicrobial agents.E.asburiae showed higher resistance rate to polymyxin B than E.cloacae(19.7％vs 3.9％).Overall,≤8.1％of the Enterobacter gergoviae strains were resistant to tigecycline,amikacin,meropenem,or imipenem,while 10.5％of these strains were resistant to polycolistin B.The overall prevalence of carbapenem-resistant Enterobacter was 10.0％over the 7-year period,but showing an upward trend.The resistance profiles of Enterobacter isolates varied with the department from which they were isolated and whether the patient is an adult or a child.The prevalence of carbapenem-resistant E.cloacae was the highest in the E.cloacae isolates from ICU patients.Conclusions The results of the CHINET Antimicrobial Resistance Surveillance Program indicate that the proportion of Enterobacter strains in all clinical isolates fluctuates slightly over the 7-year period from 2015 to 2021.The Enterobacter strains showed increasing resistance to multiple antimicrobial drugs,especially carbapenems over the 7-year period.

Objective To understand the changing distribution and antimicrobial resistance profiles of Proteus,Morganella and Providencia in hospitals across China from January 1,2015 to December 31,2021 in the CHINET Antimicrobial Resistance Surveillance Program.Methods Antimicrobial susceptibility testing was carried out following the unified CHINET protocol.The results were interpreted in accordance with the breakpoints in the 2021 Clinical & Laboratory Standards Institute(CLSI)M100(31 st Edition).Results A total of 32 433 Enterobacterales strains were isolated during the 7-year period,including 24 160 strains of Proteus,6 704 strains of Morganella,and 1 569 strains of Providencia.The overall number of these Enterobacterales isolates increased significantly over the 7-year period.The top 3 specimen source of these strains were urine,lower respiratory tract specimens,and wound secretions.Proteus,Morganella,and Providencia isolates showed lower resistance rates to amikacin,meropenem,cefoxitin,cefepime,cefoperazone-sulbactam,and piperacillin-tazobactam.For most of the antibiotics tested,less than 10％of the Proteus and Morganella strains were resistant,while less than 20％of the Providencia strains were resistant.The prevalence of carbapenem-resistant Enterobacterales(CRE)was 1.4％in Proteus isolates,1.9％in Morganella isolates,and 15.6％in Providencia isolates.Conclusions The overall number of clinical isolates of Proteus,Morganella and Providencia increased significantly in the 7-year period from 2015 to 2021.The prevalence of CRE strains also increased.More attention should be paid to antimicrobial resistance surveillance and rational antibiotic use so as to prevent the emergence and increase of antimicrobial resistance.