1.Clinical Observation of Dangui Siwei Yin Cell-Wall Broken Powder in Treating Degenerative Lumbar Spinal Stenosis with Qi Deficiency and Blood Stasis Syndrome
Zhaoyuan ZHANG ; Long CHEN ; Zhouhang ZHENG ; Hua SHEN ; Miaoling LIU ; Yanling LIANG ; Weixuan CHEN ; Yu ZHANG
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(11):2720-2727
Objective To evaluate the clinical efficacy of Dangui Siwei Yin cell-wall broken powder in the treatment of degenerative lumbar spinal stenosis(DLSS)with qi deficiency and blood stasis syndrome.Methods A randomized controlled trial was conducted on 72 patients with qi deficiency and blood stasis-typed DLSS admitted to Guangdong Second Traditional Chinese Medicine Hospital(Huangpu Hospital)from November 2023 to January 2025.Patients were randomly divided into a cell-wall broken powder group and a traditional midicinal slice group(36 cases each)using a random number table method.Both groups received conventional western treatment(oral administration of Etoricoxib Tablets and Mecobalamin Tablets).Additionally,the cell-wall broken powder group was treated with Dangui Siwei Yin cell-wall broken powder,while the traditional midicinal slice group received traditional decoction of Dangui Siwei Yin.Both groups underwent a 1-week treatment course.Changes in Visual Analogue Scale(VAS)of pain scores,Oswestry Disability Index(ODI)scores,and Japanese Orthopaedic Association(JOA)lumbar function scores were observed before and after treatment.Clinical efficacy and medication safety were evaluated.Results(1)After one week of treatment,the total effective rate was 88.89%(32/36)in the cell-wall broken powder group and 75.00%(27/36)in the traditional midicinal slice group.The intergroup comparison(by chi-square test)showed that the efficacy in the cell-wall broken powder group was superior to the traditional midicinal slice group(P<0.05).(2)After treatment,VAS and ODI scores were significantly decreased in both groups(P<0.05),while JOA scores significantly increased(P<0.05).The cell-wall broken powder group demonstrated superior improvements in VAS and ODI reduction and JOA elevation compared to the traditional midicinal slice group(P<0.05).(3)The adverse reaction rate was 8.33%(3/36)in the cell-wall broken powder group and 11.11%(4/36)in the traditional midicinal slice group,with no statistically significant difference(P>0.05).Conclusion Compared with traditional midicinal slice,Dangui Siwei Yin cell-wall broken powder exhibit better efficacy in alleviating low back and leg pain and improving lumbar function in qi deficiency and blood stasis-typed DLSS patients.This study provides evidence-based medical support for the clinical application and further development of cell-wall broken powder formulations in traditional Chinese medicine.
2.Impact of lymph node dissection extent on survival in intrahepatic cholangiocarcinoma at different anatomical sites
Weixuan XIE ; Yang BAI ; Huaisheng XU ; Yifeng PU ; Lin WANG ; Zheng FANG ; Qingzhou ZHU ; Kunlun LUO
Chinese Journal of General Surgery 2025;34(8):1680-1687
Background and Aims:The incidence of intrahepatic cholangiocarcinoma(ICC)has been increasing in recent years.Due to its insidious onset and low rate of early diagnosis,radical resection remains the only potential curative treatment.Lymph node metastasis is a major adverse prognostic factor in ICC,but the scope and therapeutic value of lymphadenectomy remain controversial.Previous studies suggest that patients with central ICC may derive greater survival benefit from lymphadenectomy than those with peripheral ICC.Preoperative assessment of lymph node status mainly relies on imaging,but its accuracy is limited.This study aimed to investigate the prognostic impact of lymphadenectomy in ICC patients at different anatomical sites to inform surgical decision-making.Methods:A retrospective analysis was conducted on 220 ICC patients who underwent radical resection at the 904th Hospital of the Joint Logistic Support Force of the PLA from May 2016 to May 2021.The cohort included 126 males and 94 females,with a mean age of(56.76±13.15)years.Patients were categorized into peripheral ICC(n=144)and central ICC(n=76)groups.Clinical characteristics,albumin-bilirubin(ALBI)grade,preoperative risk of lymph node metastasis,number of lymph nodes dissected,lymph node metastasis status,and postoperative survival outcomes were compared.Subgroup analyses were conducted to assess the prognostic value of the number of lymph nodes dissected under different risk stratifications.Results:Significant differences were observed between peripheral and central ICC in ALBI grade(x2=9.952,P=0.002),preoperative lymph node metastasis risk(x2=6.166,P=0.014),number of lymph nodes dissected(x2=4.167,P=0.042),and lymph node metastasis rate(x2=7.331,P=0.007).The 3-year overall survival(OS)rate was higher in peripheral ICC(31.94%)than in central ICC(15.79%)(x2=13.890,P<0.001).Among central ICC patients,those with ≥6 lymph nodes dissected had better 3-year OS than those with<6(16.89%vs.13.04%,x2=3.894,P=0.048).In the high-risk subgroup of central ICC,≥6 lymph nodes dissected was also associated with improved 3-year OS compared with<6(15.62%vs.11.11%,x2=3.962,P=0.047).In contrast,the number of lymph node dissections had no significant prognostic impact in peripheral ICC or in patients classified as low risk.Conclusion:Patients with peripheral ICC had a better prognosis than those with central ICC.Adequate lymphadenectomy(≥6 nodes)improved survival and enhanced staging accuracy in central ICC patients at high risk of lymph node metastasis,highlighting the importance of preoperative risk assessment for optimizing surgical strategies.
3.Predictive factors and prognostic value of textbook outcomes after radical resection for intrahepatic cholangiocarcinoma
Biyuan ZHANG ; Weixuan XIE ; Yang BAI ; Zheng FANG ; Kunlun LUO ; Xue MEI ; Haiting XU ; Zhihua ZHOU ; Qingzhou ZHU
Chinese Journal of General Surgery 2025;34(8):1688-1695
Background and Aims:Radical resection is the only potentially curative treatment for intrahepatic cholangiocarcinoma(ICC),yet the high recurrence rate results in poor prognosis.In recent years,"textbook outcome"(TO)has been proposed as a comprehensive quality metric,but its association with prognosis remains unclear.This study aimed to analyze the risk factors influencing the achievement of TO after radical resection of ICC and to explore the relationship between TO and survival.Methods:A retrospective analysis was conducted on the clinical data of 180 ICC patients who underwent radical resection at the 904th Hospital of the Joint Logistic Support Force of the PLA between February 2018 and February 2023.Univariate and multivariate Logistic regression analyses were performed to identify risk factors associated with TO,and survival analysis was carried out using the Kaplan-Meier method and Log-rank test.Results:Of the 180 patients,66 achieved TO.Multivariate Logistic regression analysis indicated that preoperative total bilirubin>22 μmol/L,preoperative CA19-9>35 U/mL,maximum tumor diameter>5 cm,poor tumor differentiation,microvascular invasion(MVI),and lymph node metastasis were independent risk factors for failing to achieve TO(all P<0.05).Survival analysis demonstrated that patients who achieved TO had a significantly longer median survival compared with those who did not(36 months vs.16 months,P<0.001).Conclusion:Preoperative total bilirubin>22 μmol/L,preoperative CA19-9>35 U/mL,maximum tumor diameter>5 cm,poor tumor differentiation,MVI,and lymph node metastasis are independent risk factors for not achieving TO after radical resection of ICC.Patients who achieved TO exhibited markedly longer survival,suggesting that TO not only reflects perioperative treatment quality but also serves as an important prognostic indicator.Greater attention to these risk factors and optimization of perioperative management may improve the likelihood of achieving TO and enhance long-term outcomes.
4.Impact of lymph node dissection extent on survival in intrahepatic cholangiocarcinoma at different anatomical sites
Weixuan XIE ; Yang BAI ; Huaisheng XU ; Yifeng PU ; Lin WANG ; Zheng FANG ; Qingzhou ZHU ; Kunlun LUO
Chinese Journal of General Surgery 2025;34(8):1680-1687
Background and Aims:The incidence of intrahepatic cholangiocarcinoma(ICC)has been increasing in recent years.Due to its insidious onset and low rate of early diagnosis,radical resection remains the only potential curative treatment.Lymph node metastasis is a major adverse prognostic factor in ICC,but the scope and therapeutic value of lymphadenectomy remain controversial.Previous studies suggest that patients with central ICC may derive greater survival benefit from lymphadenectomy than those with peripheral ICC.Preoperative assessment of lymph node status mainly relies on imaging,but its accuracy is limited.This study aimed to investigate the prognostic impact of lymphadenectomy in ICC patients at different anatomical sites to inform surgical decision-making.Methods:A retrospective analysis was conducted on 220 ICC patients who underwent radical resection at the 904th Hospital of the Joint Logistic Support Force of the PLA from May 2016 to May 2021.The cohort included 126 males and 94 females,with a mean age of(56.76±13.15)years.Patients were categorized into peripheral ICC(n=144)and central ICC(n=76)groups.Clinical characteristics,albumin-bilirubin(ALBI)grade,preoperative risk of lymph node metastasis,number of lymph nodes dissected,lymph node metastasis status,and postoperative survival outcomes were compared.Subgroup analyses were conducted to assess the prognostic value of the number of lymph nodes dissected under different risk stratifications.Results:Significant differences were observed between peripheral and central ICC in ALBI grade(x2=9.952,P=0.002),preoperative lymph node metastasis risk(x2=6.166,P=0.014),number of lymph nodes dissected(x2=4.167,P=0.042),and lymph node metastasis rate(x2=7.331,P=0.007).The 3-year overall survival(OS)rate was higher in peripheral ICC(31.94%)than in central ICC(15.79%)(x2=13.890,P<0.001).Among central ICC patients,those with ≥6 lymph nodes dissected had better 3-year OS than those with<6(16.89%vs.13.04%,x2=3.894,P=0.048).In the high-risk subgroup of central ICC,≥6 lymph nodes dissected was also associated with improved 3-year OS compared with<6(15.62%vs.11.11%,x2=3.962,P=0.047).In contrast,the number of lymph node dissections had no significant prognostic impact in peripheral ICC or in patients classified as low risk.Conclusion:Patients with peripheral ICC had a better prognosis than those with central ICC.Adequate lymphadenectomy(≥6 nodes)improved survival and enhanced staging accuracy in central ICC patients at high risk of lymph node metastasis,highlighting the importance of preoperative risk assessment for optimizing surgical strategies.
5.Predictive factors and prognostic value of textbook outcomes after radical resection for intrahepatic cholangiocarcinoma
Biyuan ZHANG ; Weixuan XIE ; Yang BAI ; Zheng FANG ; Kunlun LUO ; Xue MEI ; Haiting XU ; Zhihua ZHOU ; Qingzhou ZHU
Chinese Journal of General Surgery 2025;34(8):1688-1695
Background and Aims:Radical resection is the only potentially curative treatment for intrahepatic cholangiocarcinoma(ICC),yet the high recurrence rate results in poor prognosis.In recent years,"textbook outcome"(TO)has been proposed as a comprehensive quality metric,but its association with prognosis remains unclear.This study aimed to analyze the risk factors influencing the achievement of TO after radical resection of ICC and to explore the relationship between TO and survival.Methods:A retrospective analysis was conducted on the clinical data of 180 ICC patients who underwent radical resection at the 904th Hospital of the Joint Logistic Support Force of the PLA between February 2018 and February 2023.Univariate and multivariate Logistic regression analyses were performed to identify risk factors associated with TO,and survival analysis was carried out using the Kaplan-Meier method and Log-rank test.Results:Of the 180 patients,66 achieved TO.Multivariate Logistic regression analysis indicated that preoperative total bilirubin>22 μmol/L,preoperative CA19-9>35 U/mL,maximum tumor diameter>5 cm,poor tumor differentiation,microvascular invasion(MVI),and lymph node metastasis were independent risk factors for failing to achieve TO(all P<0.05).Survival analysis demonstrated that patients who achieved TO had a significantly longer median survival compared with those who did not(36 months vs.16 months,P<0.001).Conclusion:Preoperative total bilirubin>22 μmol/L,preoperative CA19-9>35 U/mL,maximum tumor diameter>5 cm,poor tumor differentiation,MVI,and lymph node metastasis are independent risk factors for not achieving TO after radical resection of ICC.Patients who achieved TO exhibited markedly longer survival,suggesting that TO not only reflects perioperative treatment quality but also serves as an important prognostic indicator.Greater attention to these risk factors and optimization of perioperative management may improve the likelihood of achieving TO and enhance long-term outcomes.
6.The application value and predictors of 18F-PSMA PET/CT on the metastatic lesions of prostate cancer with tPSA≤20 ng/mL
Anqi ZHENG ; Zhuonan WANG ; Weixuan DONG ; Yunxuan LI ; Lei LI ; Dalin HE ; Kaijie WU ; Xiaoyi DUAN
Journal of Modern Urology 2024;29(1):23-28
【Objective】 To explore the application value of 18F-PSMA PET/CT on the detection of metastatic lesions of prostate cancer with serum total prostate specific antigen (tPSA) ≤20 ng/mL and the predictive variables affecting the imaging results, and to establish a predictive nomogram for the metastasis of prostate cancer. 【Methods】 The imaging, pathological, serum and clinical data of 175 pathologically confirmed prostate cancer patients who underwent 18F-PSMA PET/CT examination during Jan.2020 and Oct.2021 were retrospectively collected.The patients were divided into metastatic group and non-metastatic group according to PET/CT imaging results, and the positive detection rate of metastatic lesions was calculated.The independent influencing factors of 18F-PSMA PET/CT in the positive detection of metastatic lesions were determined with univariate and multivariate logistic regression analyses.The predictive nomogram was established. 【Results】 Of the 175 patients, metastatic lesions were detected in 78 cases and not detected in 97 cases, with a detection rate of 44.6% (78/175).There were statistically significant differences between the metastatic group and the non-metastatic group in urinary tract symptoms, androgen deprivation treatment (ADT) at the time of PET/CT examination and the risk level of Gleason score (GS) (P<0.05).Univariate logistic regression showed that urinary tract symptoms(OR=3.64, P<0.001), GS risk (OR=3.96, P<0.001) and concurrent ADT treatment (OR=3.71, P<0.001) were associated with the positive detection rate of metastatic lesions.Multivariate Logistic regression showed that urinary tract symptoms (OR=3.19, P=0.002), GS high-risk group (OR=2.95, P=0.005) and concurrent ADT treatment (OR=3.27, P=0.001) were independent predictors of positive detection rate. 【Conclusion】 The probability of metastasis in newly diagnosed prostate cancer patients with tPSA≤20 ng/mL is high.18F-PSMA PET/CT is of high value for the early detection of metastasis.Urinary tract symptoms, GS high-risk group and concurrent ADT treatment are independent predictors of metastatic lesions.The predictive nomogram can help assist clinical optimization of imaging examination path.
7.Characteristics of Emergency Health Systems Guidance Based on AGREE-HS
Danping ZHENG ; Wei YANG ; Nannan SHI ; Dongfeng WEI ; An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Zhaoshuai YAN ; Weixuan BAI ; Xinghua XIANG ; Yaxin TIAN ; Mengyu LIU ; Huamin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):137-148
This study used the Appraisal of Guidelines Research & Evaluation-Health Systems (AGREE-HS) to demonstratively compare 34 global coronavirus disease-2019 (COVID-19) health systems guidance documents (HSGs) and 6 World Health Organization (WHO) standard HSGs. The comparison involved topic, participants, methods, recommendations, and implementability, with the aim of exploring the characteristics of emergency HSGs. The results showed that the emergency HSGs had an overall average score of 49%, with topic having the highest score, recommendations having the second highest score, and participants having the lowest score. The standard HSGs had an overall average score of 79%, with high scores in all items. The emergency HSGs had lower scores in participants, methods, recommendations, and implementability than the standard HSGs (P<0.001), while the COVID-19 emergency HSGs developed by the WHO had higher score in topic than the standard HSGs (P<0.05). Compared with those released by countries, the COVID-19 emergency HSG developed by the WHO showed superiority in all items and overall scores (P=0.000 2). This indicates that emergency HSGs, represented by the COVID-19 emergency HSG, place equal emphasis on topic and recommendations as standard HSGs but have low requirements in terms of expert participation, evidence support, and comprehensive consideration in the time- and resource-limited context. They have the characteristics of prominent topics, clear purposes, orientation to demand, keeping up with the latest evidence, flexible adjustment, and timeliness, emphasizing immediate implementation effects, weakening long-term effects, and focusing on comprehensive benefits. Additionally, developers, types, and report completeness are important influencing factors.
8.Characteristics of Developing Methods for Emergency Health Systems Guidance Based on AGREE-HS
Danping ZHENG ; Wei YANG ; Dongfeng WEI ; Nannan SHI ; Lin TONG ; An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Weixuan BAI ; Xinghua XIANG ; Mengyu LIU ; Huamin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):149-156
The scientific rigor and efficacy of methodologies employed in drafting emergency health systems guidance documents (HSGs) are paramount in guaranteeing the quality, reliability, and applicability of HSGs. According to the Appraisal of Guidelines for Research and Evaluation- Health Systems (AGREE-HS), we demonstratively assessed both global coronavirus disease-2019 (COVID-19) emergency HSGs and World Health Organization (WHO) standard HSGs to uncover the core attributes of methods employed in the development of emergency HSGs. Our evaluation findings revealed that across the five assessment items of AGREE-HS, methods in the 34 emergency HSGs evaluated ranked third, trailing behind topic and recommendations. Notably, criterion 2 (the best available and most contextually relevant evidence is considered) received the highest score, whereas criterion 5 (evidence of cost and cost-effectiveness of the potential options is described) scored the lowest. Compared with the WHO standard HSGs, the COVID-19 emergency HSGs exhibited low scores in methods (P<0.05), which was reflected in nine criteria (P<0.05), especially in criteria 1 (systematic and transparent methods are used to identify and review the evidence) and 9 (systematic and transparent methods are used to agree upon the final recommendations). Among the COVID-19 emergency HSGs, that developed by the WHO achieved higher scores in eight out of all nine criteria, excluding criterion 8 (P<0.05). The clinically relevant emergency HSGs had higher scores in the criteria 3 (the evidence base is current) and 8 (the rationale behind the recommendations is clear) than other types of emergency HSGs. Collectively, the methodology for developing emergency HSGs, represented by the COVID-19 emergency HSG, underscores evidence orientation and integrates expert consensus. It is characterized by adaptable evidence synthesis strategies, streamlined evidence review protocols, and contextual relevance, all of which are influenced by external, internal, and implementation-specific factors.
9.Characteristics of Participants for Developing Emergency Health Systems Guidance Based on AGREE-HS
An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Danping ZHENG ; Weixuan BAI ; Wei YANG ; Dongfeng WEI ; Nannan SHI ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):157-163
The formulation method of emergency health systems guidance (HSG) is crucial, directly impacting the efficiency and effectiveness of responses in emergencies. A scientifically sound, systematic, and easily executable guidance document can assist health institutions at all levels in quickly coordinating resources, standardizing emergency response processes, and safeguarding public health. This study employed the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS) to analyze the characteristics of participants in developing emergency HSGs represented by the COVID-19 emergency HSG. The results showed that in the 34 HSGs included in this study, the item participants received the lowest score. Within this item, criterion 1 (diversity of development group) scored the highest (3.13±1.55), while criterion 5 (prevention of funding agency influence) scored the lowest (1.21±0.47). There were differences (P<0.05) in measures taken to mitigate funding agency influence between the six standard HSGs developed by the World Health Organization (WHO) and the four emergency HSGs. Additionally, differences (P<0.05) existed in the development group members, background, conflicts of interest, and preventive measures between the six WHO standard HSGs and the 34 emergency HSGs, as well as between the HSGs developed by the WHO and those developed by countries. The participants in developing emergency HSGs were influenced by various factors, including limited time for guideline development, modes of participation, scarce evidence, and uncertainties in expected outcomes. There is a need to downplay extensive requirements concerning the composition of group members, institutional diversity, and conflicts of interest, emphasizing the roles of key participants like government officials and professionals who can provide rapid, practical guidance in emergency situations.
10.Characteristics of Implementability of Emergency Health Systems Guidance Based on AGREE-HS
Fangqi LIU ; Mengyu LIU ; Danping ZHENG ; An LI ; Xue CHEN ; Gezhi ZHANG ; Dongfeng WEI ; Wei YANG ; Weixuan BAI ; Yong LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):250-256
Guidance implementation acts as a bridge between theory and practice,enabling the rapid expansion of their impact and application. This study demonstratively evaluated emergency health systems guidance documents (HSG),represented by the COVID-19 emergency HSG,based on the item implementability of the Appraisal of Guidelines for Research and Evaluation-Health Systems (AGREE-HS),aiming to explore the characteristics of implementability in emergency HSG. The evaluation results indicated that the COVID-19 emergency HSG had a low mean score in implementability,which ranked just above the item participants. Criterion 2 (costs and resource considerations for implementing the recommendations) received the highest mean score of 4.29,while criterion 9 (systematic evaluation of implementation) received the lowest mean score of 1.34. The emergency HSG formulated by the World Health Organization(WHO) and those formulated by various countries showed no difference (P=0.114) in criterion 1 (barriers and facilitators to implementation) but had differences (P<0.05) regarding the average item scores and the scores of the remaining criteria. The WHO standard HSG had high overall scores and had differences (P<0.05) in both the mean item scores and the scores of the nine criteria when compared with the emergency HSG. The global/national HSG showed differences in scores of criterion 1 (barriers and facilitators to implementation) compared with the both clinically relevant HSG and material support HSG (P<0.05). Emergency HSG prioritized considerations of implementation costs,resources,and flexibility in terms of implementability,while de-emphasizing aspects such as stakeholder opinions,dissemination strategies,and evaluation of HSG. This may be attributed to the context in which emergency HSG are formulated,given the inherent flexibility and variability of emergency health events. The developers should comprehensively consider the needs and characteristics related to the implementability of emergency HSG during the formulation process.

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