1.Formulation and interpretation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage(Reference)
Lijuan YANG ; Quanzhi LI ; Kejing WANG ; Xiaofen YE ; Zining WANG ; Xuelian YAN ; Liang HUANG ; Juan LI ; Jiancun ZHEN
China Pharmacy 2025;36(11):1301-1305
The writing of pharmacist-managed clinics documents (hereinafter referred to as “outpatient medication record”) is a necessary part of pharmacist-managed clinics service. Outpatient medication record is an important carrier to reflect the quality of pharmacist-managed clinics service. The Chinese Hospital Association Pharmaceutical Specialized Committee was entrusted by the Pharmaceutical Administration Department of the National Health Commission to lead the formulation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage (Reference) (hereinafter referred to as Guidelines) according to the compilation method of group standards and the technical route of “documentation combing→framework establishment→draft writing→opinion collection→Guidelines formation”. The Guidelines standardizes the basic requirements of pharmacist-managed clinics record management and the basic content of record, and provides a general template and two specialized templates including pregnant and lactating pharmacist-managed clinics record template and cough and asthma pharmacist-managed clinics record template, which provides a reference for medical institutions to write pharmacist-managed clinics record. This paper introduces the formulation process of Guidelines and analyzes the key contents of Guidelines, which is helpful for the application practice of Guidelines and further improves the quality of pharmacist-managed clinics work.
2.Construction of a prediction efficacy model for PD-1 inhibitor in advanced esophageal squamous cell carcinoma
Shanshan WU ; Xiaojie HUANG ; Xiaochun XIE ; Shaokai HUANG ; Lina HUANG ; Xiaofen WANG
China Pharmacy 2025;36(17):2154-2159
OBJECTIVE To develop a prediction model for durable clinical benefit (DCB) in patients with advanced esophageal squamous cell carcinoma (ESCC) receiving programmed death-1 (PD-1) inhibitor. METHODS The clinical data of patients with advanced ESCC who received PD-1 inhibitor in Jieyang People’s Hospital were retrospectively collected between January 2020 to December 2023. Predictors were screened by least absolute shrinkage and selection operator (Lasso) regression, and a multivariable Logistic regression model was developed to predict DCB. A nomogram was constructed based on the model. Internal validation of the prediction model was performed by using the Bootstrap method, and the model was evaluated by the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis. RESULTS A total of 91 patients with advanced ESCC were included. The results of Lasso regression combined with Logistic regression analysis indicated that the baseline lymphocyte monocyte ratio (LMR) [odds ratio (OR)=1.97, 95% confidence interval (CI): 1.15-3.36, P=0.013], albumin (ALB) content (OR=1.35, 95%CI: 1.13-1.60, P<0.001), body mass index (BMI) category 1 [normal vs. low: OR= 0.28, 95%CI (0.09-0.96), P=0.042], BMI category 2 [overweight-obesity vs. low: OR=0.08, 95%CI (0.01-0.59), P=0.013], and treatment regimen [monotherapy vs. monotherapy combination therapy: OR=0.07, 95%CI (0.01-0.50), P=0.008] were predictive factors for patients with advanced ESCC to achieve DCB when treated with PD-1 inhibitor. A prediction model was constructed based on the above indicators. Internal validation of the model using the Bootstrap method showed an area under the curve of 0.831 (95%CI: 0.746-0.904), with specificity of 74.4% and sensitivity of 75.0%. The Hosmer-Lemeshow test yielded χ2= 9.930, P=0.270, and the calibration curve slope was close to 1. The decision curve analysis demonstrated that the model exhibited good clinical utility within a threshold range of 0.1 to 1.0. CONCLUSIONS The prediction model based on baseline LMR, ALB content, BMI, and treatment regimen demonstrates robust predictive performance and clinical utility for assessing therapeutic efficacy of PD-1 inhibitor in the treatment of advanced ESCC.
3.Barriers of online consulting services by dental specialist nurses based on theoretical domains framework: a qualitative study
Fang HUANG ; Qian LIU ; Ye QIN ; Hualin LU ; Qin LING ; Xiaofen LIU
Chinese Journal of Modern Nursing 2024;30(2):228-232
Objective:To explore the barriers of online consulting services by dental specialist nurses, so as to provide theoretical basis for constructing an online service model of dental specialist nurses.Methods:This study was a qualitative study. Based on the theoretical domains framework (TDF), an interview outline was developed. From January to February 2023, purposive sampling was used to select 12 nurses from Shanghai Stomatological Hospital who participated in online consulting services for dental specialist nursing as the research subject, and semi-structured interviews were conducted on the nurses. According to the relevant fields of TDF, the transcribed data was sorted and the interview data was analyzed using the Colaizzi 7-step analysis method.Results:A total of three themes and eight sub-themes were extracted, including ability barriers (low level of dental knowledge, lack of written communication skills), environmental barriers (insufficient special publicity and promotion, inadequate standardized service standards and processes, limited online consulting platform functions, distributed appointment resources), and goal barriers (low sense of professional value, incomplete performance evaluation system) .Conclusions:The relevant management departments of hospitals should standardize the management system of online consulting services by dental specialist nurses and optimize the process of online consulting services by dental specialist nurses. At the same time, dental specialist nurses should enhance their abilities, provide high-quality online consulting services for patients, and improve patients ' satisfaction with online consulting.
4.Establishment of ultra-performance liquid chromatography-tandem mass spectrometry method for assay of tobramycin in human serum and its use in a pharmacokinetic study of tobramycin inhalation in bronchiectasis patients
Yu WANG ; Xiaoyong XU ; Xiaolan HUANG ; Xiaofen LIU ; Yaxin FAN ; Jiali HU ; Hailan WU ; Jing ZHANG ; Beining GUO
Chinese Journal of Infection and Chemotherapy 2024;24(5):545-552
Objective To establish an ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)method for determination of tobramycin in human serum,and examine the utility of the method in a clinical pharmacokinetic study of tobramycin inhalation.Methods Serum samples were pretreated by solid phase extraction with tobramycin-D12 as internal standard.Chromatographic separation was performed on a TitankHilic(2.1 mm × 100 mm,3 μm)column.The mobile phase consisted of0.1%formic acid-acetonitrile and 0.1%formic acid aqueous solution at a flow rate of 0.4 mL/min.Electrospray ionization source and multiple reaction monitoring(MRM)scanning were used for monitoring the quantitative ion pairs with m/z 468.3→m/z 163.3(tobramycin)and m/z 480.6→m/z 166.2(tobramycin-D12).The established method was investigated in terms of selectivity,interaction,concomitant medication,standard curve and lower limit of quantitation,precision and accuracy,recovery,matrix effect,and stability of tobramycinin.Results The linear range of tobramycin was 0.050 0-10.0 mg/L(R2=0.999 5).The intra-and inter-batch precision was satisfactory(coefficient of variation[CV]≤3.6%).The accuracy ranged from-0.4%to 6.0%.The matrix effect factor(MF)in human serum samples(including hemolysis and lipemia)ranged from 92.2%to 94.9%(CV≤2.7%).The recovery of tobramycinin was 79.5%-81.9%in serum samples,while the recovery of internal standard was 78.9%.The analyte was stable in serum samples for 72 h at room temperature and for 274 days at-20℃/-70℃.The pharmacokinetic study of tobramycin inhalation in bronchiectasis patients showed that after continuous administration of tobramycin 300 mg twice a day to 3 patients,the mean Cmax of tobramycin was(0.72±0.61)mg/L on Day 1 and(0.76±0.73)mg/L on Day 28,respectively.The corresponding Tmax was(1.83±0.61)h and(1.50±0.50)h,respectively.Conclusions The UPLC-MS/MS method established in this study is sensitive,accurate and rapid.It is successfully applied to the clinical pharmacokinetic study of tobramycin inhalation.The method may be suitable for therapeutic drug monitoring of tobramycin in clinical practice.
5.Summary of the best evidence for external auditory canal irrigation in patients with cerumen embolism
Ruya YUAN ; Wei XU ; Xiaolu YANG ; Yanling DENG ; Xiaochang HUANG ; Xiaofen LI ; Chengcheng LIU ; Lijing HU
Chinese Journal of Modern Nursing 2024;30(31):4234-4240
Objective:To summarize the best evidence for external auditory canal irrigation in patients with cerumen embolism.Methods:The clinical decisions, guidelines, systematic reviews, expert consensus, group standards, evidence summaries, and randomized controlled trials regarding external auditory canal irrigation in patients with cerumen embolism were retrieved from databases and websites such as BMJ Best Practice, UpToDate, Guidelines International Network, National Institute for Health and Clinical Excellence, Joanna Briggs Institute Evidence-Based Health Care Center Database, PubMed, Embase, China National Knowledge Infrastructure, WanFang data, and China Biology Medicine disc. The search period was from database establishment to February 15, 2023. Six researchers screened the literature, evaluated the methodological quality, and extracted and summarized the best evidence for external auditory canal irrigation in patients with cerumen embolism.Results:A total of nine articles were included, including one clinical decision, two guidelines, two systematic reviews, one group standard, and three randomized controlled trials. Sixteen pieces of evidence were summarized from six aspects of operators: pre-operation evaluation and preparation, operation process, post-operation handling, health education, and adverse reactions during operation.Conclusions:This paper summarizes the best evidence for external auditory canal irrigation in patients with cerumen embolism. Medical and nursing staff should carefully select and apply evidence based on clinical scenarios and patient's wishes.
6.Clinical distribution and drug resistance analysis of carbapenem-resistant Pseudomonas aeruginosa from 2018 to 2022
China Modern Doctor 2024;62(16):70-73
Objective The clinical distribution characteristics and drug resistance of carbapenem-resistant Pseudomonas aeruginosa(CRPA)were analyzed to provide reference for clinical anti-infection treatment.Methods The data of hospitalized patients with Pseudomonas aeruginosa(PA)cultured and isolated from Enze Hospital,Taizhou Enze Medical Center(Group)from January 2018 to December 2022 were retrospectively analyzed,and the clinical departments,specimen types,patient ages and sensitivity to commonly used antibiotics for CRPA strains were statistically analyzed.Results A total of 1660 strains of PA were collected,of which 314 strains(18.92%)were CRPA.The detection rate of CRPA strains was the highest in 2018.The detection departments were mainly intensive medicine,respiratory and critical care medicine.The specimen types were mainly sputum.The age of patients was mainly between 61-80 years old.According to the drug sensitivity,there were small fluctuations in the resistance rates of CRPA strains to common antibacterial drugs.The resistance rate of piperacillin was lower than 40%,while the resistance rate of ticarcillin/clavulanate was consistently higher than 50%.The resistance rates of aminoglycosides and piperacillin/tazobactam were lower than 15%.Conclusion From 2018 to 2022,the detection rate of CRPA strains decreased first and then increased.The resistance rate of piperacillin/tazobactam was lower than 15%in past 5 years,so it can be preferred for clinical empirical treatment.
7.Analyses on clinical characteristics and related factors of treatment outcomes in patients with nontuberculous mycobacterial pulmonary disease
Qiuju ZHOU ; Xiaofen HUANG ; Yingying CAI
China Modern Doctor 2024;62(21):16-20
Objective By analyzing the clinical characteristics and related factors of treatment outcomes in patients with nontuberculous mycobacterial pulmonary disease(NTM-PD)in Taizhou,this study provided reference for the management,diagnosis and treatment of NTM-PD.Methods Clinical characteristics of 167 patients with NTM-PD isolated in Taizhou Hospital of Zhejiang Province from January 2016 to December 2021 were retrospectively analyzed.The differences in clinical characteristics were compared between cured group and failed group of 83 cases with Mycobacterium avium complex pulmonary disease(MAC-PD).Results MAC-PD was the most common species among the 167 cases of NTM-PD,accounting for 94.6%,88 patients were treated.The cure rate was 47.7%.Compared with cured group,the patients in failed group had statistical differences in body mass index(BMI)≤ 18.5kg/m2,acid-fast bacilli smear-positive,combined with previous pulmonary tuberculosis,imaging with fibrous-cavernous type and unstandardized medication(P<0.05).Conclusion MAC-PD is the most common among NTM-PD patients in Taizhou.BMI ≤ 18.5kg/m2,acid-fast bacilli smear-positive,combined with previous pulmonary tuberculosis,imaging with fibrous-cavernous type and unstandardized medication of MAC-PD were more difficult to treat.
8.Chinese consensus guidelines for therapeutic drug monitoring of polymyxin B, endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society.
Xiaofen LIU ; Chenrong HUANG ; Phillip J BERGEN ; Jian LI ; Jingjing ZHANG ; Yijian CHEN ; Yongchuan CHEN ; Beining GUO ; Fupin HU ; Jinfang HU ; Linlin HU ; Xin LI ; Hongqiang QIU ; Hua SHAO ; Tongwen SUN ; Yu WANG ; Ping XU ; Jing YANG ; Yong YANG ; Zhenwei YU ; Bikui ZHANG ; Huaijun ZHU ; Xiaocong ZUO ; Yi ZHANG ; Liyan MIAO ; Jing ZHANG
Journal of Zhejiang University. Science. B 2023;24(2):130-142
Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans
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Anti-Bacterial Agents/therapeutic use*
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China
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Drug Monitoring/methods*
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Polymyxin B
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Practice Guidelines as Topic
9.Analysis of biliary microbiota in experimental pigs before and after enteral extended biliary stents implantation
Xiaofen XU ; Zhuo CHENG ; Xiu'e YAN ; Hong CHANG ; Yaopeng ZHANG ; Wei ZHENG ; Wenzheng LIU ; Yingchun WANG ; Kuo ZHANG ; Yonghui HUANG
Chinese Journal of Digestive Endoscopy 2023;40(6):472-477
Objective:To compare the changes of biliary microbiota after enteral extended biliary stents (EEBS) implantation with that of conventional plastic stents in animal experiment, and to preliminarily investigate its possible mechanism in preventing stents occlusion.Methods:A total of 12 healthy Bama minipigs were randomly assigned to the conventional plastic stent group ( n=6) and the EEBS group ( n=6) using simple random method. The bile samples of all pigs were collected before stents implantation and 4 weeks after stents placement. The biliary microbiota composition and diversity before and after different stents implantation were analyzed by 16S rRNA gene sequencing and compared. Results:No complications including acute cholangitis, perforation, bleeding, or death occurred in 12 pigs. Eight days after stents implantation, stents were out of bile duct in all pigs under endoscopy, while the bile samples were collected again for analysis. The main composition of biliary microbiota at the phylum level were Proteobacteria, Firmicutes and Bacteroidota. Alpha-diversities revealed the Shannon ( P=0.004) and Simpson index ( P=0.008) significantly decreased in the conventional stent group after stents placement, and Bata diversity analysis also showed a significant difference in microbial composition (Anosim: R=0.514 8, P=0.011). There was no significant difference in Observed species index ( P=0.095), Chao1 index ( P=0.136), Shannon index ( P=0.353), Simpson index ( P=0.227) or Bata diversity (Anosim: R=0.059 3, P=0.187) in the EEBS group before and after stents placement. LEfSe algorithm indicated Bacteroides_ fragilis and Proteobacteria- Gammaproteobacteria- Enterobacterales- Enterobacteriaceae- scherichia_ Shigella- Escherichia_ coli significantly increased in the conventional stent group, and Desulfobacterota- Desulfovibrionia- Desulfovibrionales- Desulfovibrionaceae- Bilophila significantly increased in the EEBS group after stents placement. Conclusion:The biliary microbiota change slightly after EEBS implantation in the short-term, and EEBS may prevent duodenobiliary reflux by prolonging the reflux path.
10.Chloroplast Genome Structure of Stemona tuberosa and Phylogenetic Analysis Based on PacBio Sequencing
Yan LIAN ; Feng HUANG ; Wentao ZHU ; Xiaofen LIU ; Hao WU ; Guihua JIANG ; Xianmei YIN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(14):123-132
ObjectiveTo obtain high-quality chloroplast genome information on Stemona tuberosa and clarify its structure, sequence features, and phylogenetic status. MethodThe Illumina NovaSeq 6000 and PacBio RS Ⅱ platforms were used for library construction and sequencing of S. tuberosa, respectively. The data from both sequencing platforms were combined and subjected to bioinformatics analysis for genome assembly and base correction, resulting in a high-quality chloroplast genome. Subsequently, sequence features, repetitive sequences, gene diversity, and phylogeny were analyzed. ResultThe chloroplast genome size of S. tuberosa was determined to be 154 379 bp. The structure of the chloroplast genome followed the typical quadripartite circular form, consisting of a pair of inverted repeat regions (IRs) with a length of 27 074 bp, a small single-copy region (SSC) of 17 924 bp, and a large single-copy region (LSC) of 82 307 bp. The average GC content was 37.86%. A total of 121 genes were annotated, including 30 tRNA genes, four rRNA genes, and 87 protein-coding genes. Among them, six tRNA genes and 12 protein-coding genes contained introns. In the chloroplast genome of S. tuberosa, 49 long repetitive sequences and 59 single-nucleotide simple sequence repeats (SSRs) were identified. Comparative analysis of chloroplast genomes among four Stemona species revealed high diversity in the ycf1 and ndhF genes. The phylogenetic tree constructed based on the chloroplast genome showed consistent classification with the current taxonomic status of S. tuberosa. ConclusionThe high-quality chloroplast genome of S. tuberosa was successfully assembled, providing valuable information on the structure and sequence features of chloroplast genomes in four Stemona species, including S. tuberosa. These findings lay a foundation for the identification, evolution, and phylogenetic studies of medicinal plants in the genus Stemona.

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