1.Mechanism of Electroacupuncture Alleviating Inflammatory Pain in Rats by Regulating ErbB Subtypes in the Spinal Dorsal Horn
Yuxin WU ; Shuxin TIAN ; Zhengyi LYU ; Dingru JI ; Xingzhen LI ; Yue DONG ; Binyu ZHAO ; Yi LIANG ; Jianqiao FANG
Journal of Traditional Chinese Medicine 2026;67(1):69-78
ObjectiveTo observe the changes in the levels of different subtypes of epidermal growth factor receptor (ErbB), namely ErbB1, ErbB2, ErbB3, and ErbB4, in the spinal dorsal horn of inflammatory pain model rats, and to explore their mechanism of mediating hyperalgesia as well as the intervention mechanism of electroacupuncture at "Zusanli (ST 36)" and "Kunlun (BL 60)". MethodsThe study was divided into five parts. In experiment 1, 14 Sprague Dawley (SD) rats were randomly divided into control and inflammatory pain group (7 rats each group) to observe the pain behavior and the protein expression of different ErbB receptor subtypes in the spinal dorsal horn. In experiment 2, 30 rats were randomly divided into control group 1, inflammatory pain group 1, and low-, medium-, and high-concentration TX1-85-1 groups, with 6 rats in each group, to observe the effect of inhibiting spinal ErbB3 on inflammatory pain. In experiment 3, 12 rats were randomly divided into control virus group and ErbB3 knockdown virus group, with 6 rats in each group, to observe the effect of knocking down ErbB3 in the spinal dorsal horn on inflammatory pain. In experiment 4, 44 rats were randomly divided into control group 2, inflammatory pain group 2, electroacupuncture group, and sham electroacupuncture group, with 11 rats in each group, to observe the effect of electroacupuncture. In experiment 5, 40 rats were randomly divided into control group 3, inflammatory pain group 3, electroacupuncture group 1, and electroacupuncture + NRG1 group, with 10 rats in each group, to observe the effect of activating ErbB3 on electroacupuncture. A rat model of inflammatory pain was established by subcutaneous injection of 100 μl of complete Freund's adjuvant into the sole of the unilateral hind foot of SD rats. Rats in the low-, medium-, and high-concentration TX1-85-1 groups were intrathecally injected with ErbB3 inhibitor TX1-85-1 on day 5 to day 7 after modeling. Rats in the ErbB3 knockdown virus group were injected with ErbB3 knockdown virus packaged with adenovirus vector-based short hairpin RNA (shRNA) into the spinal dorsal horn in situ 3 weeks before modeling. Rats in each electroacupuncture group received electroacupuncture at bilateral "Zusanli (ST 36)" and "Kunlun (BL 60)" from day 1 to day 7 after modeling, with dense-sparse waves at a frequency of 2 Hz/100 Hz and a current of 0.5-1.5 mA for 30 minutes once a day. Rats in the electroacupuncture + NRG1 group were intrathecally injected with ErbB3 ligand recombinant human neuregulin-1 (NRG1) after electroacupuncture intervention from day 5 to day 7 after modeling. The mechanical withdrawal threshold and thermal withdrawal latency of rats were measured on day 1, 3, 5, and 7 after modeling to evaluate behavior, and Western Blot was used to detect the protein and phosphorylation levels of each ErbB subtype in the spinal dorsal horn. ResultsCompared with the control group, rats in the inflammatory pain group showed decreased mechanical withdrawal threshold and thermal withdrawal latency of rats, and increased expression of phosphorylated ErbB3 (p-ErbB3) protein in the spinal dorsal horn on days 1, 3, 5, and 7 after modeling (P<0.01). On day 5 and day 7 after modeling, compared with the inflammatory pain group 1, the mecha-nical withdrawal threshold and thermal withdrawal latency of rats in the medium- and high-concentration TX1-85-1 groups increased, and the expression of p-ErbB3 protein decreased (P<0.05). On day 1, 3, 5, and 7 after modeling, compared with the control virus group, the mechanical withdrawal threshold and thermal withdrawal latency of rats in the ErbB3 knockdown virus group increased (P<0.05). On day 5 and day 7 after modeling, compared with the inflammatory pain group 2 and the sham electroacupuncture group, the mechanical withdrawal threshold and thermal withdrawal latency of rats in the electroacupuncture group increased, and the expression of p-ErbB3 protein decreased (P<0.05). On day 5 and day 7 after modeling, compared with the electroacupuncture + NRG1 group, the mechanical withdrawal threshold and thermal withdrawal latency of rats in the electroacupuncture group 1 increased (P<0.05). ConclusionThe p-ErbB3 in the spinal dorsal horn involved in hyperalgesia in rats with inflammatory pain, and electroacupuncture at "Zusanli (ST 36)" and "Kunlun (BL 60)" can alleviate inflammatory pain by inhibiting the expression of p-ErbB3 protein in the spinal dorsal horn of rats.
2.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
3.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
4.Mesenchymal stromal cell-derived extracellular vesicles alleviate immune checkpoint inhibitor-related pneumonitis by regulating macrophage inflammasome activation
XIAO Shuyan1,2 ; XUE Fengyuan1 ; JI Yinmin3 ; LYU Yahui1 ; DONG Yi1,2 ; HU Yi2,3
Chinese Journal of Cancer Biotherapy 2026;33(5):521-527
[摘 要] 目的:探讨间充质基质细胞来源细胞外囊泡(MSC-EV)对小鼠免疫检查点抑制剂相关肺炎(CIP)模型的改善作用及分子机制。方法:选取Foxp3DTR小鼠,皮下接种MC38小鼠结肠癌细胞,待肿瘤生长至可触及后,随机分为3组(每组n = 6):①对照组;②CIP模型组[接种MC38细胞后腹腔注射白喉毒素(DT)及anti-PD-1抗体,构建Treg细胞耗竭联合anti-PD-1抗体诱导的小鼠CIP模型];③MSC-EV干预组(CIP模型基础上,经鼻滴注MSC-EV干预,剂量109个/只,每3天1次,共2次)。体内实验采用H-E染色观察肺组织病理损伤,测定肺干湿比评估肺水肿程度,ELISA检测支气管肺泡灌洗液(BALF)中IL-1β、IL-6及TNF-α水平,流式细胞术检测BALF中Ly6G⁺粒细胞浸润比例,监测肿瘤体积评价抗肿瘤疗效。体外实验采用DiO荧光标记观察细胞外囊泡(EV)被骨髓来源巨噬细胞摄取的情况,WB法检测NOD样受体家族含Pyrin域蛋白3(NLRP3)炎症小体关键蛋白(剪切型GSDMD、成熟型IL-1β)的表达水平。结合GEO数据库miRNA测序数据(GSE69909)、Dicer敲低及miR-21/miR-125抑制剂干预揭示潜在机制。结果:MSC-EV经鼻滴注可减轻CIP模型小鼠肺部炎症损伤,降低BALF中IL-1β、IL-6、TNF-α水平及Ly6G⁺粒细胞浸润比例(P < 0.05),且不削弱anti-PD-1抗体的抗肿瘤疗效。体外DiO标记示踪显示MSC-EV可被巨噬细胞摄取,WB法检测结果显示,MSC-EV可降低NLRP3炎症小体关键活化蛋白(剪切型GSDMD、成熟型IL-1β)水平(P < 0.05)。体外实验中,Dicer敲低后制备的MSC-EV 对巨噬细胞IL-1β的下调作用减弱(P < 0.05)。miRNA测序显示miR-21、miR-125在MSC-EV中高表达,抑制miR-21或miR-125后,相应MSC-EV对巨噬细胞IL-1β剪切的抑制作用降低(P < 0.05)。结论:MSC-EV通过其携带的miR-21和miR-125等miRNA发挥抗炎效应,其机制可能与抑制巨噬细胞NLRP3炎症小体活化有关,可有效改善CIP且不影响免疫检查点抑制剂的抗肿瘤疗效。
5.Optimization of Rh blood group antigen precision transfusion strategy across multiple hospital campuses by PDCA circle
Qiming YING ; Luyan CHEN ; Kedi DONG ; Yiwen HE ; Yating ZHAN ; Yexiaoqing YANG ; Feng ZHAO ; Dingfeng LYU
Chinese Journal of Blood Transfusion 2025;38(1):106-111
[Objective] To explore the effectiveness of applying the PDCA (Plan-Do-Check-Act) cycle to enhance the compatibility rate of five Rh blood group antigen phenotypes between donors and recipients across multiple hospital campuses. [Methods] Clinical blood transfusion data from May to July 2022 were selected. Specific improvement measures were formulated based on the survey results, and the PDCA cycle management model was implemented from August 2022. The post-intervention phase spanned from August 2022 to October 2023. The Rh phenotype compatibility rate, the detection rate of Rh system antibodies, and the proportion of Rh system antibodies among unexpected antibodies were compared between the pre-intervention phase (May to July 2022) and the post-intervention phase. [Results] After the continuous improvement with the PDCA cycle, the compatibility rate for the five Rh blood group antigen phenotypes between donors and recipients from August to October 2023 reached 81.90%, significantly higher than the 70.54% recorded during the pre-intervention phase (May to July 2022, P<0.01), and displayed a quarterly upward trend (β=0.028, P<0.05). The detection rate of Rh blood group system antibodies (β=-9.839×10-5, P<0.05) and its proportion among all detected antibodies (β=-0.022, P<0.05) showed a quarterly decreasing trend, both demonstrating a negative correlation with the enhanced compatibility rate (r values of -0.981 and -0.911, respectively; P<0.05). [Conclusion] The implementation of targeted measures through the PDCA cycle can effectively increase the compatibility rate of five Rh blood group antigen phenotypes between donors and recipients, reduce the occurrence of unexpected Rh blood group antibodies, thereby lowering the risk of transfusion and enhancing the quality and safety of medical care.
6.Evaluation of cardiac involvement in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis using echocardiography combined with electrocardiography
Aiqing LU ; Ling CHEN ; Xiuyun SUN ; Xin DONG ; Xiaoyan LI ; Yongcun SUN ; Shaowen LYU ; Long YU ; Yong ZHANG
Chinese Journal of Radiological Health 2025;34(4):534-539
Objective To evaluate cardiac involvement in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) using echocardiography combined with electrocardiography. Methods A retrospective analysis was performed on the detailed medical records of AAV patients treated in Jining First People’s Hospital between January 2020 and December 2024. Eighty patients were enrolled in the AAV group, and the risk of heart disease was compared between the AAV group and a control group with 80 subjects matched for age, sex, and cardiovascular disease risk factors. Results Electrocardiographic abnormalities were observed in 78.75% of patients in the AAV group, while significant electrocardiographic abnormalities only occurred in symptomatic patients in the control group. There were no differences in left atrial enlargement or interventricular septal thickening between the AAV group and the control group. The overall left ventricular systolic function in the AAV group was lower than that in the control group (8.75% vs. 0). The incidence of reduced diastolic function in the AAV group was significantly higher than that in the control group (37.5% vs. 15%). The incidence rates of tricuspid regurgitation, mitral regurgitation, aortic regurgitation, and pericardial effusion in the AAV group were significantly higher than those in the control group. Pericardial thickening, aortic stenosis, pulmonary hypertension, and rare periaortic granulomas were found in the AAV group, but not in the control group. Conclusion Echocardiography and electrocardiography are important examination methods for evaluating cardiac involvement in AAV. These methods have key roles in disease screening, diagnosis and treatment, follow-up, and prognosis judgment.
7.Exploratory Study on the Impact of Intestinal Fungi on the Progression of Heart Failure in Patients with Chronic Kidney Disease
Shuting LI ; Lili DONG ; Xinlei YANG ; Lin LYU ; Fukai LIU
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1236-1243
To investigate the role of intestinal fungi in the progression of heart failure (HF) associated with chronic kidney disease (CKD). This study consisted of two parts. The first part was a clinical study. Fecal samples from CKD patients (CKD group), CKD patients with HF (CKD+HF group), and healthy individuals (healthy control group) were subjected to 18S rRNA sequencing to compare differences in intestinal fungal microbiota among the three groups. The second part was an animal experiment. Male C57BL/6J mice were randomly divided into a control group (fed a standard diet), a CKD group (fed a 0.2% adenine diet), and a CKD+amphotericin B group (fed a 0.2% adenine diet+0.5 mg/L amphotericin B in drinking water), with 10 mice in each group. After successful modeling, cardiac function and histomorphological differences among the three groups were compared by assessing exercise tolerance, left ventricular ejection fraction (LVEF), left ventricular shortening fraction (LVFS), serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, and histological examinations (HE staining and Masson staining) of cardiac tissue. The clinical study revealed that compared with the healthy control group ( Intestinal fungi may be associated with the progression of HF in CKD patients. Depletion of intestinal fungi could potentially ameliorate cardiac remodeling and delay the onset and progression of HF. Intestinal fungi may serve as a novel therapeutic target for HF in CKD patients.
8.Trends of diabetes in Beijing, China.
Aijuan MA ; Jun LYU ; Zhong DONG ; Li NIE ; Chen XIE ; Bo JIANG ; Xueyu HAN ; Jing DONG ; Yue ZHAO ; Liming LI
Chinese Medical Journal 2025;138(6):713-720
BACKGROUND:
The global rise in diabetes prevalence is a pressing concern. Despite initiatives like "The Healthy Beijing Action 2020-2030" advocating for increased awareness, treatment, and control, the specific situation in Beijing remains unexplored. This study aimed to analyze the trends in diabetes prevalence, awareness, treatment, and control among Beijing adults.
METHODS:
Through a stratified multistage probability cluster sampling method, a series of representative cross-sectional surveys were conducted in Beijing from 2005 to 2022, targeting adults aged 18-79 years. A face-to-face questionnaire, along with body measurements and laboratory tests, were administered to 111,943 participants. Data from all survey were age- and/or gender-standardized based on the 2020 Beijing census population. Annual percentage rate change (APC) or average annual percentage rate change (AAPC) was calculated to determine prevalence trends over time. Complex sampling logistic regression models were employed to explore the relationship between various characteristics and diabetes.
RESULTS:
From 2005 to 2022, the total prevalence of diabetes among Beijing adults aged 18-79 years increased from 9.6% (95% CI: 8.8-10.4%) to 13.9% (95% CI: 13.1-14.7%), with an APC/AAPC of 2.1% (95% CI: 1.1-3.2%, P <0.05). Significant increases were observed among adults aged 18-39 years and rural residents. Undiagnosed diabetes rose from 3.5% (95% CI: 3.2-4.0%) to 7.2% (95% CI: 6.6-7.9%) with an APC/AAPC of 4.1% (95% CI: 0.5-7.3%, P <0.05). However, diabetes awareness and treatment rates showed annual declines of 1.4% (95% CI: -3.0% to -0.2%, P <0.05) and 1.3% (95% CI: -2.6% to -0.2%, P <0.05), respectively. The diabetes control rate decreased from 21.5% to 19.1%, although not statistically significant (APC/AAPC = -1.5%, 95% CI: -5.6% to 1.9%). Overweight and obesity were identified as risk factors for diabetes, with ORs of 1.65 (95% CI: 1.38-1.98) and 2.48 (95% CI: 2.07-2.99), respectively.
CONCLUSIONS
The prevalence of diabetes in Beijing has significantly increased between 2005 and 2022, particularly among young adults and rural residents. Meanwhile, there has been a concerning decrease in diabetes awareness and treatment rates, while control rates have remained stagnant. Regular blood glucose testing, especially among adults aged 18-59 years, should be warranted. Furthermore, being male, elderly, overweight, or obese was associated with higher diabetes risk, suggesting the needs for targeted management strategies.
Humans
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Middle Aged
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Male
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Female
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Adolescent
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Young Adult
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Cross-Sectional Studies
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Diabetes Mellitus/epidemiology*
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Beijing/epidemiology*
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Prevalence
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China/epidemiology*
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Surveys and Questionnaires
9.Organizational Readiness for Change and Factors Influencing the Implementation of Shared Medical Appointment for Diabetes in Primary Healthcare Institutions
Wei YANG ; Yiyuan CAI ; Jiajia CHEN ; Run MAO ; Lang LINGHU ; Sensen LYU ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2025;16(2):479-491
The success of implementation research is closely tied to the institution's pre-implementation readiness. This study aims to explore the organizational readiness for change (ORC) and its influencing factors on primary healthcare settings in the implementation of the "Shared Medical Appointment for Diabetes (SMART) in China: design of an optimization trial" and to enhance ORC and provide insights to support the effective implementation of the program. Qualitative interviews and quantitative surveys were conducted to evaluate the ORC level and its influencing factors in 12 institutions implementing the SMART program. The Scale for Assessing the Institution's Readiness to Implement Evidence-Based Practices was utilized to measure ORC levels. Qualitative interviews were conducted among change implementers to gather information regarding the status of influencing factors. Thematic analysis was applied to extract factors from the interview data, and an assessment questionnaire was developed to measure the perceived impact of these factors. A fuzzy-set qualitative comparative analysis (fsQCA) method was employed to identify the influencing factors of ORC and pathways leading to high-level ORC. Seventy implementers from 12 institutions, encompassing administrators, clinicians, and health managers, participated in the interviews and surveys. The median and interquartile of the ORC scores were 105.20 (101.23, 107.33). The fsQCA indicated that a clear understanding of specific tasks and responsibilities, the active engagement of key participants, sufficient preliminary preparation, and the use of audits and feedback mechanisms were critical pathways to a high-level ORC. Conversely, institutions lacking key participants, preliminary preparation, or marginal influence demonstrated a low-level ORC. Before implementing innovation, Coherence and Cognitive Participation were identified as critical factors in influencing ORC. Strong leadership from key participants played pivotal role in enhancing readiness for change and was essential for improving implementation fidelity and overall program success.
10.Analysis on Quality Standard of Hedyotis Herba Dispensing Granules Based on Standard Decoction
Jinghua ZHANG ; Nana WU ; Yanan LYU ; Guiyun CAO ; Jiacheng XU ; Yongqiang LIN ; Xiaodi DONG ; Jinxin LI ; Zhaoqing MENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):210-217
ObjectiveTo establish the specific chromatogram and quantitative analysis of multi-components by single-marker(QAMS) based on linear calibration using two reference substances(LCTRS), explore the consistency between Hedyotis Herba dispensing granules and standard decoction, and evaluate the quality of the dispensing granules. MethodsHigh performance liquid chromatography(HPLC) specific chromatogram was established based on 15 batches of Hedyotis Herba standard decoction and 10 batches of the dispensing granules, and LCTRS was used to locate chromatographic peaks. The actual retention times of 7 characteristic peaks in the specific chromatogram was measured on 24 different types of C18 columns, taking deacetyl asperulosidic acid and asperulosidic acid as the dual standard compounds, the retention times of the other 5 characteristic peaks were predicted and validated. Based on this, QAMS was developed to determine the contents of four components(deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester, asperulosidic acid, and p-coumaric acid). Then, the relative correction factors of deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester and p-coumaric acid were calculated using the reference peak of asperulosidic acid in the dual standard compounds, and each component was quantified accordingly. Finally, the consistency between the dispensing granules and standard decoction was assessed by taking extract rate of the standard decoction, consistency of the specific chromatograms, contents and transfer rates of the indicator components as indexes, and the quality of the dispensing granules was evaluated. ResultsThere were 7 common peaks in the characteristic chromatogram of samples of Hedyotis Herba standard decoction and the dispensing granules, and four of them were identified by reference standards, namely deacetyl asperulosidic acid(peak 1), deacetyl asperulosidic acid methyl ester(peak 3), asperulosidic acid(peak 6) and p-coumaric acid(peak 7). The similarity between the dispensing granules and the standard decoction was >0.9. The absolute deviation in the predicted retention time for each component by LCTRS was lower than that of the relative retention time method. The extract rate of the 15 batches of Hedyotis Herba standard decoction ranged from 7.89% to 14.60%, the contents of deacetyl asperulosidic acid, deacetyl asperulosidic acid methyl ester, asperulosidic acid and p-coumaric acid were 6.62-19.70, 3.83-17.99, 1.57-6.69, 1.62-4.52 mg·g-1, and the transfer rates of these components from decoction pieces to the standard decoction were 22.89%-39.60%, 34.03%-62.24%, 24.25%-43.70%, and 40.58%-73.71%, respectively. The extract rate, index component contents and transfer rates from decoction pieces to the three batches of Hedyotis Herba dispensing granules(P1-P3), produced by manufacturer A, were similar to those of the standard decoction prepared from the same batch of decoction pieces, and all fell within the specified range. The contents of the 4 indicator components in 7 batches of the dispensing granules(P4-P10) from manufacturers B-E were all within the range of the content converted from the standard decoction based on the quantity of the dispensing granules. ConclusionThe established specific chromatogram and QAMS based on LCTRS are reasonable and reliable. Based on the evaluation indicators of standard decoction yield, consistency of specific chromatograms, contents and transfer rates of the four index components, the 10 batches of Hedyotis Herba dispensing granules from various manufacturers have exhibited good consistency with the standard decoction, indicating that the current production process is relatively reasonable.

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