1.External review of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis: a cross-sectional survey
Lingling YU ; Shuang LIU ; Zaiwei SONG ; Qiusha YI ; Yu ZHANG ; Liyan MIAO ; Zhenlin ZHANG ; Chunli SONG ; Yaolong CHEN ; Lingli ZHANG ; Rongsheng ZHAO
China Pharmacy 2025;36(9):1025-1029
OBJECTIVE To assess the scientific rigor, clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis (hereinafter referred to as the Guideline) through external review, in order to further revise and improve the Guideline recommendations. METHODS This study employed a cross-sectional survey research design, a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis (including clinical doctors, clinical pharmacists, and nurses) as well as patients or their family members. External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation,clarity and feasibility of the 32 preliminary recommendations in the Guideline. RESULTS A total of 90 external review subjects from 15 hospitals were collected, including 45 clinical doctors, 15 clinical pharmacists, 15 nurses and 15 patients or their family members. The overall appreciation degree of recommendations was 99.38%, the overall clarity degree of recommendations was 98.92%, and the overall feasibility degree of recommendations was 99.65%. At the same time, 111 subjective suggestions were collected, which provided an important reference for the further improvement of the Guideline recommendations. Based on the above feedback, the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion, and finally determined 32 recommendations. CONCLUSIONS The external review provides an important basis for the final formation of the Guideline, further improves the scientific rigor, clarity and feasibility of the recommendations, and ensures the standardization, practicality and implementability of the Guideline.
2.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
3.Literature case analysis of drug-induced liver injury induced by GLP-1 receptor agonists
Menghua ZHANG ; Ying ZHU ; Ziyang WU ; Yanhua WANG ; Xiangzun XIONG ; Liyan MIAO
China Pharmacy 2025;36(20):2561-2565
OBJECTIVE To investigate the clinical characteristics of drug-induced liver injury (DILI) induced by glucagon- like peptide-1 receptor agonists (GLP-1RAs), and to provide a reference for safe clinical medication. METHODS Using search terms such as “GLP-1”“GLP-1RAs”“semaglutide” “drug-induced liver injury”, relevant studies from PubMed, Embase, the Cochrane Library, CNKI, Wanfang Data and VIP were retrieved. Descriptive analysis was performed on cases of DILI induced by GLP-1RAs. RESULTS A total of 11 studies, comprising 11 patients, were included. Among them, 4 were male (36.4%) and 7 were female (63.6%). Patient ages ranged from 17 to 64 years; 5 patients (45.5%) were between 50 and 65 years old. Six patients were treated for diabetes, and five for weight loss. Ten patients had underlying diseases. The shortest time to the onset of DILI was 5 days after medication, while the longest was approximately 180 days. The DILIs induced by GLP-1RAs were mainly hepatocellular injury type (6 cases); severity levels included severe (3 cases), moderate (6 cases), and mild (2 cases). Gastrointestinal symptoms and jaundice were the most common clinical manifestations. The association between DILI and GLP- 1RAs was assessed as “probable” in 10 cases and “possible” in 1 case. All 11 patients improved after drug discontinuation and (or) corresponding treatment. CONCLUSIONS DILI induced by GLP-1RAs is relatively concentrated in patients aged 50-65, with a higher incidence in females. The risk may be further increased in patients with underlying diseases. Clinical use of these agents should enhance pharmaceutical care, including identification of high-risk populations and patient education (especially symptom recognition). When relevant symptoms appear, the drug should be discontinued immediately, with liver-protective therapy initiated when necessary, to ensure patient safety of drug use.
4.Evidence-based guideline for the management of clinical application of biosimilars in China (2024 edition)
Zaiwei SONG ; Yang HU ; Lingling YU ; Jun ZHU ; Lingli ZHANG ; Yu ZHANG ; Liyan MIAO ; Suodi ZHAI ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1933-1945
OBJECTIVE To provide standardized guidance for the clinical application and management of biosimilars, and promote their widespread and rational use in clinical treatment. METHODS The design, planning, and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China (2024 Edition) followed the WHO Handbook for Guideline Development (2nd edition), which fully considered the best current evidence from evidence-based medicine, multidisciplinary expert experience, and patient preferences and values. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China (2024 Edition) presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments, patient education, pre-treatment regimen before administration, and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.
5.Comparison of Target- and IgG-Enrichment Strategies to Measure Adalimumab Concentrations in Human Plasma Using an Immunocapture-Liquid Chromatography-High-Resolution Mass Spectrometry Platform
Xiaoliang DING ; Shengxiong ZHU ; Linsheng LIU ; Xiaoxue LIU ; Kouzhu ZHU ; Liyan MIAO
Annals of Laboratory Medicine 2024;44(5):463-466
6.Comparison of Target- and IgG-Enrichment Strategies to Measure Adalimumab Concentrations in Human Plasma Using an Immunocapture-Liquid Chromatography-High-Resolution Mass Spectrometry Platform
Xiaoliang DING ; Shengxiong ZHU ; Linsheng LIU ; Xiaoxue LIU ; Kouzhu ZHU ; Liyan MIAO
Annals of Laboratory Medicine 2024;44(5):463-466
7.Comparison of Target- and IgG-Enrichment Strategies to Measure Adalimumab Concentrations in Human Plasma Using an Immunocapture-Liquid Chromatography-High-Resolution Mass Spectrometry Platform
Xiaoliang DING ; Shengxiong ZHU ; Linsheng LIU ; Xiaoxue LIU ; Kouzhu ZHU ; Liyan MIAO
Annals of Laboratory Medicine 2024;44(5):463-466
8.Comparison of Target- and IgG-Enrichment Strategies to Measure Adalimumab Concentrations in Human Plasma Using an Immunocapture-Liquid Chromatography-High-Resolution Mass Spectrometry Platform
Xiaoliang DING ; Shengxiong ZHU ; Linsheng LIU ; Xiaoxue LIU ; Kouzhu ZHU ; Liyan MIAO
Annals of Laboratory Medicine 2024;44(5):463-466
9.Formulation and Analysis on the Standard of Pharmacy Administration in Emergencies
Jingjing RAO ; Jiancun ZHEN ; Wei ZHANG ; Dan MEI ; Liyan MIAO ; Mingkang ZHONG ; Shen GAO ; Rongsheng ZHAO ; Hanqiu ZHAN
Herald of Medicine 2024;43(7):1070-1074
The pharmacy department of medical institutions assumes important responsibilities in the emergency response work.The standard of pharmacy administration in emergencies is formulated based on the principles of scientificity,versatility,instructiveness,and operability,through sorting out problems,collecting opinions and expert argumentation.This standard has 49 standards of 9 key elements from three aspects:emergency mechanism,emergency support,and emergency services.This article aims to introduce the construction method and formulation process of the pharmacy administration in emergency standards,and analyzes the content,to guide for improving emergency response ability of the medical institutions'pharmacy department in emergency events.
10.Formulation and Analysis on the Standard of Automation and Information Technology
Xun YU ; Jiancun ZHEN ; Liyan MIAO ; Zongqi CHENG ; Wei ZHANG ; Rongsheng ZHAO ; Lan ZHANG ; Xiaoyang LU ; Jian ZHANG ; Dong LIU ; Aizong SHEN ; Weihua LAI ; Jingcheng HE
Herald of Medicine 2024;43(7):1074-1078
To improve patient-centered pharmaceutical management and pharmaceutical service capabilities in the pharmaceutical department of medical institutions,automation and information technology are indispensable.The Pharmacy Administration-Automation and Information Technology is one of the social organization standards of the Chinese Hospital Association as part 4-4 of Pharmaceutical Administration and Pharmaceutical Practice in Healthcare,which standardizes 32 key elements in four aspects:basic requirements for automation construction in medical institutions,construction of automation hardware equipment,construction of intelligent information platform,and quality management and continuous improvement.It can be used to guide medical institutions at all levels to select and optimize pharmacy automation equipment and information platforms.This article introduced the construction methods and contents of the pharmacy automation and information technology standards,to deepen the understanding of peers on this standard and promote its implementation.This article aimed to promote the modernization,informatization,and intelligence of pharmaceutical services in medical institutions,and improve the quality and efficiency of overall medical pharmaceutical administration and service.

Result Analysis
Print
Save
E-mail