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.Molecular Characteristics of Prognosis and Chemotherapy Response in Breast Cancer: Biomarker Identification Based on Gene Mutations and Pathway
Liyan LI ; Hongwei LYU ; Qian CHEN ; Yating BAI ; Jing YU ; Ruigang CAI
Journal of Breast Cancer 2025;28(2):61-71
Purpose:
This study aimed to investigate the molecular characteristics associated with better prognosis in breast cancer.
Methods:
We performed targeted sequencing of 962 genes in 56 samples, categorizing them into long-term and short-term survival groups as well as chemotherapy-sensitive and chemotherapy-resistant groups for further analyses.
Results:
The results indicated that the tumor mutational burden values were significantly higher in the short-term survival and chemotherapy-resistant groups (p = 0.008 and p = 0.003, respectively). Somatic mutation analysis revealed that the mutation frequencies of BCL9L and WHSC1 were significantly lower in the long-term survival group than those in the short-term survival group (p = 0.029 and p = 0.024, respectively). CREB-regulated transcription coactivator 1 (CRTC1) mutations occurred significantly more frequently in the chemotherapy-resistant group (p = 0.027) and were associated with shorter progression-free survival (p = 0.036).Signature weighting analysis showed a significant increase in Signature.3, which is associated with homologous recombination repair deficiency in the chemotherapy-sensitive group (p = 0.045). Conversely, signatures related to effective DNA repair mechanisms, Signature.1 and Signature.15, were significantly reduced (p = 0.002 and p < 0.001, respectively). Kyoto Encyclopedia of Genes and Genomes pathway analysis indicated that gene mutations were significantly enriched in the JAK-STAT signaling pathway.
Conclusion
This study, through intergroup comparative analysis, found that immunotherapy (using programmed death 1/programmed death-ligand 1 inhibitors) may improve the prognosis of patients with short survival and chemotherapy resistance. Additionally, the study revealed that mutations in BCL9L and WHSC1 could serve as biomarkers for breast cancer prognosis, while CRTC1 mutations and Signature.3 could predict chemotherapy response. The study also found that the JAK-STAT pathway might be a potential therapeutic target for chemotherapy resistance. Therefore, this study identifies molecular characteristics that influence the prognosis of breast cancer patients, providing important theoretical insights for the development of personalized treatment strategies.
3.Molecular Characteristics of Prognosis and Chemotherapy Response in Breast Cancer: Biomarker Identification Based on Gene Mutations and Pathway
Liyan LI ; Hongwei LYU ; Qian CHEN ; Yating BAI ; Jing YU ; Ruigang CAI
Journal of Breast Cancer 2025;28(2):61-71
Purpose:
This study aimed to investigate the molecular characteristics associated with better prognosis in breast cancer.
Methods:
We performed targeted sequencing of 962 genes in 56 samples, categorizing them into long-term and short-term survival groups as well as chemotherapy-sensitive and chemotherapy-resistant groups for further analyses.
Results:
The results indicated that the tumor mutational burden values were significantly higher in the short-term survival and chemotherapy-resistant groups (p = 0.008 and p = 0.003, respectively). Somatic mutation analysis revealed that the mutation frequencies of BCL9L and WHSC1 were significantly lower in the long-term survival group than those in the short-term survival group (p = 0.029 and p = 0.024, respectively). CREB-regulated transcription coactivator 1 (CRTC1) mutations occurred significantly more frequently in the chemotherapy-resistant group (p = 0.027) and were associated with shorter progression-free survival (p = 0.036).Signature weighting analysis showed a significant increase in Signature.3, which is associated with homologous recombination repair deficiency in the chemotherapy-sensitive group (p = 0.045). Conversely, signatures related to effective DNA repair mechanisms, Signature.1 and Signature.15, were significantly reduced (p = 0.002 and p < 0.001, respectively). Kyoto Encyclopedia of Genes and Genomes pathway analysis indicated that gene mutations were significantly enriched in the JAK-STAT signaling pathway.
Conclusion
This study, through intergroup comparative analysis, found that immunotherapy (using programmed death 1/programmed death-ligand 1 inhibitors) may improve the prognosis of patients with short survival and chemotherapy resistance. Additionally, the study revealed that mutations in BCL9L and WHSC1 could serve as biomarkers for breast cancer prognosis, while CRTC1 mutations and Signature.3 could predict chemotherapy response. The study also found that the JAK-STAT pathway might be a potential therapeutic target for chemotherapy resistance. Therefore, this study identifies molecular characteristics that influence the prognosis of breast cancer patients, providing important theoretical insights for the development of personalized treatment strategies.
4.Molecular Characteristics of Prognosis and Chemotherapy Response in Breast Cancer: Biomarker Identification Based on Gene Mutations and Pathway
Liyan LI ; Hongwei LYU ; Qian CHEN ; Yating BAI ; Jing YU ; Ruigang CAI
Journal of Breast Cancer 2025;28(2):61-71
Purpose:
This study aimed to investigate the molecular characteristics associated with better prognosis in breast cancer.
Methods:
We performed targeted sequencing of 962 genes in 56 samples, categorizing them into long-term and short-term survival groups as well as chemotherapy-sensitive and chemotherapy-resistant groups for further analyses.
Results:
The results indicated that the tumor mutational burden values were significantly higher in the short-term survival and chemotherapy-resistant groups (p = 0.008 and p = 0.003, respectively). Somatic mutation analysis revealed that the mutation frequencies of BCL9L and WHSC1 were significantly lower in the long-term survival group than those in the short-term survival group (p = 0.029 and p = 0.024, respectively). CREB-regulated transcription coactivator 1 (CRTC1) mutations occurred significantly more frequently in the chemotherapy-resistant group (p = 0.027) and were associated with shorter progression-free survival (p = 0.036).Signature weighting analysis showed a significant increase in Signature.3, which is associated with homologous recombination repair deficiency in the chemotherapy-sensitive group (p = 0.045). Conversely, signatures related to effective DNA repair mechanisms, Signature.1 and Signature.15, were significantly reduced (p = 0.002 and p < 0.001, respectively). Kyoto Encyclopedia of Genes and Genomes pathway analysis indicated that gene mutations were significantly enriched in the JAK-STAT signaling pathway.
Conclusion
This study, through intergroup comparative analysis, found that immunotherapy (using programmed death 1/programmed death-ligand 1 inhibitors) may improve the prognosis of patients with short survival and chemotherapy resistance. Additionally, the study revealed that mutations in BCL9L and WHSC1 could serve as biomarkers for breast cancer prognosis, while CRTC1 mutations and Signature.3 could predict chemotherapy response. The study also found that the JAK-STAT pathway might be a potential therapeutic target for chemotherapy resistance. Therefore, this study identifies molecular characteristics that influence the prognosis of breast cancer patients, providing important theoretical insights for the development of personalized treatment strategies.
5.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.
6.Effect of high-frequency repetitive transcranial magnetic stimulation combined with fluvoxamine treatment on improving depression, impulsivity, and self-injury levels in adolescent patients with depression
Penghao XU ; Yan WANG ; Liyan MAO ; Yu XU
Chinese Journal of Primary Medicine and Pharmacy 2024;31(9):1368-1372
Objective:To investigate the effect of high-frequency repetitive transcranial magnetic stimulation combined with fluvoxamine treatment on improving depression, impulsivity, and self-injury levels in adolescent patients with depression.Methods:A total of 124 adolescent patients with depression who received treatment at the Department of Psychiatry, The Third Hospital of Quzhou, China from January 2022 to November 2023 were included in this study. The patients were randomly divided into a control group and an observation group, with 62 patients per group, using the random number table method. Patients in the control group received treatment with fluvoxamine, while patients in the observation group underwent high-frequency repetitive transcranial magnetic stimulation and treatment with fluvoxamine. Clinical efficacy and the scores of the Hamilton Depression Scale, Hamilton Anxiety Scale, the Barratt Impulsiveness Scale-ll revised version, and the Non-Suicidal Self-Injury Assessment Tool revised version were compared between the two groups.Results:The total response rate in the observation group was 90.32% (56/62), which was significantly higher than that in the control group [72.58% (45/62), χ2 = 6.46, P < 0.05]. After treatment, scores of the Hamilton Depression Scale and Hamilton Anxiety Scale in the observation group were (12.08 ± 1.97) points and (11.58 ± 1.59) points, respectively, which were significantly lower than those in the control group [(16.42 ± 2.33) points, (14.42 ± 1.94) points, t = -8.28, -18.61, both P < 0.05]. After treatment, the scores of the Barratt Impulsiveness Scale-ll revised version and Non-Suicidal Self-Injury Assessment Tool revised version in the observation group were significantly lower than those in the control group [(28.25 ± 3.91) points, (9.23 ± 2.12) points, t = 5.42, 9.44, both P < 0.05]. Conclusion:High-frequency repetitive transcranial magnetic stimulation combined with fluvoxamine treatment can significantly reduce depressive symptoms, impulsivity, and self-injury levels in adolescent patients with depression.
7.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.
8.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.
9.The effect of silica in soil on the extraction of biological evidence DNA at the crime scene using the silica bead method
Lu LU ; Zehua GAO ; Tianquan WU ; Liyan YU ; Shenbing GU ; Dongtao JIA
Chinese Journal of Forensic Medicine 2024;39(1):112-114
Objective To study the effect of silica in soil on the extraction of biological evidence DNA at the crime scene using the silica bead method.Methods Mud suspension and diluted blood were mixed to prepare biological samples mixed with dust and soil,which is to simulate biological evidence at the crime scene.Cell lysis was performed using heating lysis and guanidine salt chemical lysis,respectively.DNA was extracted using the silica bead method,amplified by PCR using Identifiler Plus kit and detected by capillary electrophoresis.The electrophoresis results were compared.Using mud suspension instead of silica beads to extract diluted blood DNA to validate the effect of silica in soil on the extraction of biological evidence DNA at crime scene using silica beads method.Results The complete STR loci were obtained after the extraction and amplification of 4 μL,20 μL dilute blood mixed with mud and lysed with heating cracking,whoes average peak heights arel 969.7±376.9 RFU and 9 706.7±349.8 RFU.For the 4 μL dilute blood mixed with mud guanidine salt chemical lysis,it cannot obtain complete STR loci after extraction and amplification.20 μL dilute blood mixed with mud guanidine salt was chemically cleaved and amplified to obtain complete STR loci with an average peak height of 1 899.8±801.3 RFU.After extraction and amplification by mud suspension instead of silica beads to extract 20 μL diluted blood DNA,complete STR loci were obtained.Conclusion Silicon dioxide in soil can bind to DNA in the presence of guanidine salts,leading to a decrease in the efficiency of recovering on-site biological evidence DNA using the silicon bead method.
10.Efficacy and safety of nivolumab in the treatment of non-small cell lung cancer:a meta-analysis
Liyan LIU ; Xiaocui YU ; Chuanduo SUN
Journal of Pharmaceutical Practice and Service 2024;42(10):451-456
Objective To systematically evaluate the efficacy and safety of nivolumab in the treatment of non-small cell lung cancer.Methods PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),Weipu Chinese Science and Technology Journal Database,Wanfang Medical Database were searched for articles published from the establishment of the database to March 2023.Published randomized controlled clirical trials of nivolumab in the treatment of patients with non-small cell lung cancer were selected,overall survival,progression-free survival,and adverse reaction rate as outcome indicators were used.A meta-analysis using STATA version 13.1 statistical software was conducted.Results A total of 8 phase Ⅲrandomized controlled trials involving 4 945 subjects were included.Compared with the traditional chemotherapy group,patients in the nivolumab group had significantly reduced risk of death in terms of overall survival(HR=0.73,95%CI=0.65-0.82,P<0.05),and in terms of progression-free survival,nivolumab significantly reduced the risk of recurrence compared with the traditional chemotherapy group(HR=0.74,95%CI=0.63-0.88,P<0.05).In terms of safety,there was no significant difference between the nivolumab group and the traditional chemotherapy group for diarrhea,but the incidence of nausea,neutropenia,anemia,decreased appetite,and fatigue in the nivolumab group was lower than that in the traditional chemotherapy group.However,it should be worth noting that the incidence of immune-related adverse events such as rash was higher in the nivolumab group than in the traditional chemotherapy group,and the difference was statistically significant(OR=3.85,95%CI=2.05-6.25,P<0.05).Conclusion Compared to traditional chemotherapy,the efficacy and safety of nivolumab in the treatment of non-small cell lung cancer were better,but the risk of immune-related adverse events increased.

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