1.Construction of the research question system of the Guideline for the Management of Therapeutic Drug Monitoring based on modified Delphi method
Rong DUAN ; Liyan MIAO ; Zhengxiang LI
China Pharmacy 2026;37(10):1241-1245
OBJECTIVE To construct a research question system of the Guideline for the Management of Therapeutic Drug Monitoring (hereinafter referred to as the Guideline ), so as to provide the basis for the formulation of the Guideline . METHODS Based on literature research and expert interviews, the questionnaire about research questions of the Guideline was initially constructed. Through the modified Delphi method, the online questionnaire survey and expert consensus meeting were conducted among the Guideline development experts to determine the research question system of the Guideline . RESULTS A total of 59 questionnaires were distributed, and 52 valid questionnaires were collected. The positive coefficient of experts was 88.14%. The experts came from 21 provinces/autonomous regions/municipalities directly under the central government, covering multidisciplinary experts related to therapeutic drug monitoring, all of whom held senior professional titles. After one round of survey, a consensus was reached on the research questions, and a research question framework encompassing four research parts was constructed, including: indications for conducting therapeutic drug monitoring (4 first-level research questions,10 second-level research questions, 31 third-level research questions); therapeutic drug monitoring technical process (3 first-level research questions, 9 second-level research questions, 13 third-level research questions); result interpretation and clinical application (3 first-level research questions and 3 second-level research questions); quality control (8 first-level research questions and 12 second-level research questions). The importance scores for the four parts ranged from 4.71 to 4.88, with full-score rates all no less than 73.08%. The expert authori ty coefficients were all no less than 0.90, the coefficients of variation of importance scores were all no higher than 0.11, and Kendall’s W ranged from 0.464 to 0.626 (all P <0.05). CONCLUSIONS The constructed research question system has high authority, scientificity, and reliability, laying a foundation for the standardized formulation of the Guideline .
2.Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis
Rong DUAN ; Zhengxiang LI ; Xiaocong ZUO ; Rongsheng ZHAO ; Ruigang HOU ; Chunsheng YANG ; Guoyan QI
China Pharmacy 2026;37(9):1113-1121
OBJECTIVE To provide standardized guidance for the rational clinical use of antibody-based drugs for the treatment of myasthenia gravis, and to enhance the evidence-based system of guidelines and consensus in this field. METHODS The consensus expert team consisted of 71 multidisciplinary experts from 28 provinces/autonomous regions/municipalities directly under the Central Government. Evidence was systematically retrieved through multiple databases, drug package inserts, and official websites of international and national health administrative authorities, drug regulatory agencies, healthcare security departments, and related industry associations, up to April 30, 2025. Evidence was graded according to the 2014 version of JBI pre-grading system for evidence from intervention studies. Based on full consideration of the current best evidence and multidisciplinary expert experience, the expert consensus recommendations were formulated using a modified Delphi method. RESULTS The Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis standardized the key points of whole-process pharmaceutical management for four antibody-based drugs approved for marketing in the mainland of China for the treatment of myasthenia gravis (efgartigimod alfa, efgartigimod alfa/hyaluronidase, eculizumab, and rozanolixizumab). It formulated 37 expert consensus recommendations covering nine pharmaceutical management aspects: drug suitability selection, medication in special populations, administration methods, drug storage, therapeutic drug monitoring and pharmacogenetic testing, immunization management, drug interactions, pharmaceutical care, and off-label drug use. CONCLUSIONS Based on the current best evidence and multidisciplinary expert experience, this consensus establishes a whole-process management framework for antibody-based drugs for the treatment of myasthenia gravis, from clinical application to pharmaceutical management. It provides a scientific basis for the rational and precise use of these drugs in clinical practice, effectively promotes the enhancement of pharmaceutical management efficiency, and helps improve the overall therapeutic benefits for patients.
3.Guidelines for the management of therapeutic drug monitoring
Zhengxiang LI ; Liyan MIAO ; Rong DUAN ; Xiaocong ZUO ; Xianglin ZHANG ; Zhuo WANG ; Miao YAN ; Lingli ZHANG ; Rongsheng ZHAO ; Suodi ZHAI ; Guobiao GAO ; Jinhui TIAN
China Pharmacy 2026;37(11):1381-1392
OBJECTIVE To further standardize the technical operations and management processes throughout therapeutic drug monitoring (TDM), clarify the clinical value of TDM implementation, improve the scientific validity and reliability of monitoring results, and provide a solid reference basis for the formulation and optimization of clinical individualized precision dosing regimens. METHODS The Guidelines for the Management of Therapeutic Drug Monitoring were formulated in accordance with the latest definition of guidelines by the Institute of Medicine of the National Academies and the standard guideline development methodology of the World Health Organization, and in compliance with the requirements of the appraisal of guidelines for research and evaluation. A modified Delphi method was adopted to establish the research question system; evidence-based medicine research methods were applied to systematically search multiple databases to screen the latest and most comprehensive evidence. Evidence was graded and evaluated based on the evidence grading system of the Chinese Evidence-Based Medicine Center, and the grading criteria for recommendation strength from the Oxford Centre for Evidence-Based Medicine were used to determine the recommendation strength. The recommendation opinions were formed through multidisciplinary expert consensus. RESULTS The Guidelines for the Management of Therapeutic Drug Monitoring cover four core modules, including TDM application indications, technical procedures, result interpretation and clinical application, and quality control, involving 18 primary research questions, 34 secondary research questions, and yield 82 recommendations. CONCLUSIONS The guidelines systematically standardize the key technical links and management requirements of the whole TDM process, provide scientific and operable standardized tools, help improve the standardization level of TDM work, promote the translation of monitoring results into clinical decision-making, and provide strong support for precision personalized medicine and ensuring the safety and rationality of medication use.
4.Effects and mechanisms of oliceridine fumarate on postoperative cognitive dysfunction in elderly rats through TLR4/NF-κB pathway
Dong XIE ; Xiaoying GENG ; Yushan ZHU ; Zhengxiang LI ; Hengjie YUAN
China Pharmacy 2026;37(11):1434-1439
OBJECTIVE To investigate the effects and mechanisms of oliceridine fumarate (TRV130) in improving postoperative cognitive dysfunction (POCD) in elderly rats based on the Toll-like receptor 4 (TLR4)/nuclear factor-κB (NF-κB) pathway. METHODS Rats were randomly divided into the control group (normal saline), the model group (normal saline), the TRV130 group (2.8 mg/kg), the TLR4/NF-κB pathway inhibitor (TAK-242) group (3 mg/kg), the β -arrestin inhibitor (Barbadin) group (3 mg/kg), and the traditional opioid drug (morphine) group (2.8 mg/kg), with 15 rats in each group. Except for the control group, POCD models were established in all other groups. From the first day after surgery, drugs/normal saline were administered via caudal vein injection once daily for 3 consecutive days. After the last administration, the pathological damage of hippocampal tissue was observed; the cognitive function, serum inflammatory factor levels, hippocampal neurons apoptosis rate, and the expression of ionized calcium-binding adapter molecule 1 (Iba-1), glial fibrillary acidic protein (GFAP), and TLR4/NF-κB pathway-related mRNA and protein in hippocampal tissue were detected. RESULTS In the model group, the neurons in the CA1 region of the hippocampus were disordered and sparse, with decreased number, pyknotic and fragmented nuclei accompanied by inflammatory cell infiltration. Compared with the control group, the escape latency, serum levels of tumor necrosis factor α (TNF-α), interleukin-6 (IL-6), and IL-1β, hippocampal neurons apoptosis rate, average fluorescence intensities of Iba-1 and GFAP, mRNA expression levels of TLR4 and NF-κB p65, and their protein expression/phosphorylation levels in hippocampal tissue were significantly increased/elevated in the model group ( P <0.05); the time spent in the target quadrant and the number of platform crossings were significantly shortened/decreased ( P <0.05). Compared with the model group, the cognitive function, pathological, inflammatory, and apoptosis-related indicators were significantly improved in the TRV130 group, TAK-242 group, and Barbadin group ( P <0.05); the mRNA expression levels of TLR4 and NF-κB p65 and their protein expression/phosphorylation levels were significantly decreased in the TRV130 group and TAK-242 group ( P <0.05). CONCLUSIONS TRV130 may improve POCD in elderly rats by inhibiting the TLR4/NF-κB pathway and alleviating postoperative central nervous system inflammatory responses.
5.Survey of current status of prevention and control of traditional Chinese medicine diagnosis and treatment technique-related infections in Jiangsu Province
Xuan WU ; Jing KONG ; Zihan SUN ; Ge QIU ; Shanshan XU ; Quan CHEN ; Li RUI ; Zhengxiang DAI
Chinese Journal of Nosocomiology 2025;35(9):1385-1390
OBJECTIVE To understand the current status of prevention and control of traditional Chinese medicine(TCM)diagnosis and treatment technique-related infections in various grades of hospitals in Jiangsu Province so as to provide bases for management departments to put forward the norms.METHODS The questionnaire was de-signed by the methods such as Delphic correspondence,the current status of prevalence,prevention and control of TCM diagnosis and treatment technique-related infections among the health care workers in the hospitals of Jiang-su Province was investigated by using convenience sampling method.RESULTS A total of 508 questionnaires were collected from 13 cities of Jiangsu Province.The results showed that the TCM treatment room(63.64%)was the most common operation site for minimally invasive TCM diagnosis and treatment techniques,the bedside(62.50%)of the patients was the major operation site for Chinese medicine enema,and the central sterile supply department(55.31%)was the preferred choice of cleaning and disinfection site for daily recycled TCM apparatu-ses.'One person used for once,airing and preparing for later use after cleaning and disinfection for once'was the major approach taken for the cleaning and disinfection of Gua Sha boards(82.45%)and TCM pots(87.50%).67.87%of the health care workers said that they wound cleaned and disinfected the medical apparatuses of dress-ing,ironing and fumigation every time after the use.The natural ventilation and ultraviolet light(50.39%)was the major method that was taken for the ventilation and disinfection of the treatment rooms for TCM operations.Quick-drying hand disinfectant and non-touch hand-washing equipment(39.37%)were the most commonly e-quipped hand hygiene facilities.CONCLUSIONS The prevention and control of TCM diagnosis and treatment tech-nique-related infections and the health care workers' capabilities for prevention and control of the infection have made remarkable progress in the various grades of hospitals in Jiangsu Province.However,there is still room for further improvement,and the standardized management and construction should be completed so as to safeguard the TCM diagnosis and treatment techniques.
6.Investigation of plague sources in the border port areas of Longchuan County, Yunnan Province in 2022
Zhengxiang LIU ; Yuqiong LI ; Mei HONG ; Wei LIANG ; Qiuxiang YANG ; Shilong YANG ; Cuicui ZHAO ; Zihou GAO ; Zongti SHAO
Chinese Journal of Endemiology 2025;44(6):467-471
Objective:To investigate the host and vector composition of pestis and the epidemic situation of pestis among animals in the border port areas of Longchuan County, Yunnan Province.Methods:In September 2022, a survey was conducted on rodents and their surface parasitic fleas in the border port areas of Longchuan County, according to three habitat types: residential areas, agricultural areas, and forest-shrubbery areas. Samples of murine animals organs and their surface parasitic fleas were collected for isolation and identification of Yersinia pestis. Blood samples of plague indicating animals, such as murine animals, dogs and cats were collected, and serum plague F1 antibody was detected by indirect hemagglutination assay. Meanwhile, a retrospective investigation was conducted on the occurrence of self dead rats, sick rats, and suspected cases in the local area from 2018 to 2022 through interviews with farmers. Results:A total of 168 murine animals belonging to 3 orders, 5 families, 10 genera, and 11 species were captured in three habitats in Longchuan County. Among them, the capture rate in residential areas was 5.00% (30/600), with Rattus tanezumi and Suncus murinus as dominant species, with a composition ratio of 50.00% (15/30). The capture rate in agricultural areas was 9.67% (122/1 262), with Rattus tanezumi and Suncus murinus as dominant species, with a composition ratio of 50.82% (62/122) and 44.26% (54/122), respectively. The capture rate in the forest-shrubbery areas was 6.25% (16/256), with Hylomys suillus and Eothenomys eleusis as dominant species, with a composition ratio of 37.50% (6/16) and 31.25% (5/16), respectively. Among the captured murine animals, 20 individuals carried 52 parasitic fleas, belonging to 2 species of 2 genera and 2 families. The total flea infection rate was 11.90% (20/168), and the total flea index was 0.31 (52/168). The dominant specie was Xenopsylla cheopis (90.38%, 47/52). The flea infection rate in residential areas was 33.33% (10/30), and the flea index was 1.23 (37/30). The flea infection rate in agricultural areas was 7.38% (9/122), and the flea index was 0.11 (14/122). The flea infection rate in the forest-shrubbery areas was 6.25% (1/16), and the flea index was 0.06 (1/16). The samples of murine animals and their parasitic fleas obtained were isolated and cultured by Yersinia pestis, and the results were negative. A total of 144 serum samples from murine animals, dogs and cats were separated, and no F1 antibody against pestis was detected. According to interviews and investigations, no abnormal situations such as a large number of self dead rats, sick rats, and suspected cases were found from 2018 to 2022. Conclusions:No plague epidemic has been found in the border port areas of Longchuan County recently. The main host of plague, Rattus tanezumi, and the main vector, Xenopsylla cheopis, remain the dominant species in this area.
7.Survey of current status of prevention and control of traditional Chinese medicine diagnosis and treatment technique-related infections in Jiangsu Province
Xuan WU ; Jing KONG ; Zihan SUN ; Ge QIU ; Shanshan XU ; Quan CHEN ; Li RUI ; Zhengxiang DAI
Chinese Journal of Nosocomiology 2025;35(9):1385-1390
OBJECTIVE To understand the current status of prevention and control of traditional Chinese medicine(TCM)diagnosis and treatment technique-related infections in various grades of hospitals in Jiangsu Province so as to provide bases for management departments to put forward the norms.METHODS The questionnaire was de-signed by the methods such as Delphic correspondence,the current status of prevalence,prevention and control of TCM diagnosis and treatment technique-related infections among the health care workers in the hospitals of Jiang-su Province was investigated by using convenience sampling method.RESULTS A total of 508 questionnaires were collected from 13 cities of Jiangsu Province.The results showed that the TCM treatment room(63.64%)was the most common operation site for minimally invasive TCM diagnosis and treatment techniques,the bedside(62.50%)of the patients was the major operation site for Chinese medicine enema,and the central sterile supply department(55.31%)was the preferred choice of cleaning and disinfection site for daily recycled TCM apparatu-ses.'One person used for once,airing and preparing for later use after cleaning and disinfection for once'was the major approach taken for the cleaning and disinfection of Gua Sha boards(82.45%)and TCM pots(87.50%).67.87%of the health care workers said that they wound cleaned and disinfected the medical apparatuses of dress-ing,ironing and fumigation every time after the use.The natural ventilation and ultraviolet light(50.39%)was the major method that was taken for the ventilation and disinfection of the treatment rooms for TCM operations.Quick-drying hand disinfectant and non-touch hand-washing equipment(39.37%)were the most commonly e-quipped hand hygiene facilities.CONCLUSIONS The prevention and control of TCM diagnosis and treatment tech-nique-related infections and the health care workers' capabilities for prevention and control of the infection have made remarkable progress in the various grades of hospitals in Jiangsu Province.However,there is still room for further improvement,and the standardized management and construction should be completed so as to safeguard the TCM diagnosis and treatment techniques.
8.Analysis on the occurrence and influencing factors of adverse drug reactions during long-term therapy with vedolizumab in patients with inflammatory bowel diseases
Dong XIE ; Xiaocang CAO ; Hengjie YUAN ; Zhengxiang LI
Adverse Drug Reactions Journal 2025;27(4):193-199
Objective:To analyze the occurrence and influencing factors of adverse reactions in patients with inflammatory bowel disease (IBD) during the long-term treatment with vedolizumab (VDZ).Methods:The study was a retrospective observational design. The study subjects were selected from patients who long-termly used VDZ to treat moderate-to-severe active IBD in Tianjin Medical University General Hospital from February 1, 2021 to December 31, 2023. Clinical data of patients were collected through the hospital system of clinical pharmacy management, including general information, IBD condition, VDZ maintenance treatment plan, combination of drugs, laboratory test results, etc. The adverse reactions of VDZ were screened and their clinical manifestations, severity, intervention and outcomes were analyzed descriptively. The patients were divided into 2 groups according to whether VDZ adverse reactions occurred, and the differences in clinical data between them were compared; the influencing factors of adverse reactions were analyzed by multivariate logistic regression method.Results:A total of 142 patients were included in the study, including 81 males and 61 females, aged (37.6±6.4) years with a range from 18 to 57 years. There were 103 patients (72.5%) developed VDZ adverse reactions, which mainly involved skin (52 patients, account for 50.5%), digestive system (33 patients, account for 32.0%) and respiratory system (18 patients, account for 17.5%). All 103 patients did not stop VDZ treatment, and the adverse reaction symptoms disappeared or were relieved after symptomatic treatments. Compared with patients without VDZ adverse reactions, the age of patients with VDZ adverse reactions were higher [(39.5±5.4) years vs. (32.4±6.7) years], and the proportions of patients with chronic relapsing clinical type [65.0%(67/103) vs. 41.0%(16/39)], severe disease activity [60.2%(62/103) vs. 33.3%(13/39)], combined drug use [67.0%(69/103) vs. 46.2%(18/39)], and injecting VDZ once every 4 weeks during maintenance treatment [27.2%(28/103) vs. 10.3%(4/39)] in the group were larger, with statistical significance (all P<0.05). Multivariate logistic regression analysis showed that the chronic relapsing clinical type [odds ratio ( OR)=1.012, 95% confidence interval ( CI): 1.001-1.028, P=0.002], severe disease activity ( OR=1.096, 95% CI: 1.010-1.158, P=0.040), combination drugs ( OR=1.035, 95% CI: 1.003-1.122, P=0.041), VDZ maintenance therapy injection interval of 4 weeks ( OR=1.014, 95% CI: 1.002-1.113, P=0.005) were the risk factors for VDZ adverse reactions. Conclusions:Among IBD patients receiving long-term treatment of VDZ, the incidence of adverse reactions of VDZ was 72.5%, mainly involving skin, digestive system and respiratory system. Symptomatic treatments could be given, and the prognosis was good. Patients with chronic relapsing clinical type, severe disease activity, combination therapy, and shorter VDZ maintenance injection interval were at higher risk of adverse reactions.
9.A survey and analysis on disease self-management status among patients with chronic obstructive pulmonary disease
Yueqiong LIU ; Yunfen NIU ; Guili SHANG ; Zhengde LIU ; Zhengxiang GU ; Yin LI ; Xianghe LI
Chinese Journal of Primary Medicine and Pharmacy 2025;32(7):1013-1018
Objective:To investigate the disease self-management status of patients with chronic obstructive pulmonary disease (COPD) and its influential factors, providing evidence for the development of effective management strategies.Methods:A total of 483 patients with chronic obstructive pulmonary disease (COPD) who received treatment at Wenshan People's Hospital from April 2023 to April 2024 were included in this study. Their disease self-management status was assessed, and one-way analysis of variance and multiple linear regression analysis were conducted to identify the factors influencing patients' self-management abilities.Results:Among the 483 patients studied, only 2.9% (14/483) showed a complete understanding of their disease, while 21.12% (102/483) had some understanding of how to manage it. Only 34.38% (166/483) of the patients used inhalants outside the hospital as required, of which only 40.96% (68/166) used them regularly as required by doctors, and 60.84% (101/106) of the patients inhaled correctly. One-way analysis of variance and multiple linear regression analysis results showed that the factors affecting patients' self-management included COPD classification, smoking, life satisfaction, disease self-cognition, exercise habits, lung function, and gender ( t = 2.35, -2.22, -5.76, 4.37, -2.22, 5.09, -3.64, all P < 0.05). Conclusions:Patients with COPD exhibit poor disease self-management awareness and medication compliance. Patient's ability to self-manage their disease is associated with COPD classification, lung function, smoking, exercise habits, gender, life satisfaction, and disease self-cognition. Therefore, it is essential to develop appropriate intervention measures based on these factors, focusing on enhancing patients' self-management awareness and abilities to improve their quality of life.
10.Minocycline-induced increased intracranial pressure in a child
Longxi PENG ; Zhengxiang LI ; Hengjie YUAN
Adverse Drug Reactions Journal 2025;27(8):502-504
A 12-year-old male child with severe pneumonia received anti-infection therapy with cefoperazone sodium and sulbactam sodium (3 g by intravenous infusion, once every 8 hours) and minocycline (100 mg twice daily orally). After 8 days, the child experienced severe headache, accompanied by blurred vision and nausea. The head magnetic resonance imaging and 4-hour video electroencephalogram showed no abnormalities in the child. Cerebrospinal fluid pressure measured by lumbar puncture was 220 mmH 2O, and cerebrospinal fluid biochemistry and routine examination showed no abnormalities. After excluding intracranial infection, toxic encephalopathy, intracranial hemorrhage, and space-occupying lesions, it was considered that the increase of intracranial pressure was caused by minocycline. After discontinuing minocycline and administering symptomatic treatments such as mannitol, nonsteroidal anti-inflammatory drugs for 3 days, his headache was relieved. At 1-week and 1-month follow-up, no abnormal symptoms such as headache recurred in the child.

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