4.Clinical research and characteristic analysis of patients with advanced colorectal cancer treated with Yinyang Gongji Pills and capecitabine.
Lei WANG ; Chao-Yue YAO ; Jie-Ru ZHAN ; Xiao-Xia SUN ; Zhong-Xin YU ; Xiao-Ya LIANG ; Jian WANG ; Xue GONG ; Da-Rong WEI
China Journal of Chinese Materia Medica 2025;50(5):1404-1411
Yinyang Gongji Pills have the effects of strengthening the body resistance to eliminate pathogenic factors, removing stasis, and reducing swelling, which is a commonly used traditional Chinese medicine(TCM) formula for treating intestinal accumulation. A real-world, registered, and single-arm clinical trial was conducted to observe the clinical efficacy and safety of Yinyang Gongji Pills combined with capecitabine in the treatment of advanced colorectal cancer and analyze the clinical characteristics of the patients. A total of 60 patients with advanced colorectal cancer who refused or could not tolerate standard treatment of western medicine were included in the study. They were treated with Yinyang Gongji Pills combined with capecitabine until disease progression or intolerable adverse events occurred. The main observation indicators were progression-free survival(PFS) and safety. The treatment effects of the patients under different baseline characteristics were analyzed. The clinical trial has found that the median PFS of all enrolled patients was 7.3 months, with 30.1% of patients having a PFS exceeding 12.0 months. Layered analysis showed that the median PFS of patients with the onset site being the colon and rectum were respectively 8.4 and 4.7 months. The median PFS of patients with high, medium, and low tumor burden were respectively 7.0, 4.7, and 10.8 months. The median PFS of patients with wild-type and mutant-type RAS/BRAF were respectively 7.9 and 6.9 months. The median PFS of patients with KPS scores ≥80 and ≤70 were respectively 7.9 and 6.5 months. The median PFS of patients treated with Yinyang Gongji Pills for ≥6, 3-6, and ≤3 months were respectively 8.0, 5.2, and 4.2 months. The median PFS of patients with spleen, kidney, liver, and lung syndrome differentiation in TCM were respectively 8.3, 6.7, 7.3, and 5.6 months. The median PFS of patients with TCM pathological factors including phlegm, dampness, and blood stasis were respectively 7.0, 7.3, and 6.5 months. Common adverse reactions include anemia, decreased white blood cells, decreased appetite, fatigue, and hand foot syndrome, with incidence rates being respectively 44.2%, 34.6%, 42.3%, 32.7%, and 17.3%. The results showed that the combination of Yinyang Gongji Pills and capecitabine demonstrated potential clinical efficacy and good safety in this study. The patients have clinical characteristics such as low tumor burden, onset site at the colon, KPS scores ≥ 80, long duration of oral TCM, and TCM syndrome differentiation including spleen or liver.
Humans
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Capecitabine/adverse effects*
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Colorectal Neoplasms/mortality*
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Drugs, Chinese Herbal/adverse effects*
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Male
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Middle Aged
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Female
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Aged
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Adult
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Treatment Outcome
5.Quality evaluation of psychological distress assessment tools for cancer patients based on COSMIN guidelines
Lu SUN ; Wanqiu MA ; Lina WANG ; Jing DA ; Lei QIAN ; Jing XU
Chinese Journal of Modern Nursing 2025;31(22):3001-3009
Objective:To evaluate the quality of psychological distress assessment tools for cancer patients and provide evidence for clinical nurses in selecting appropriate instruments.Methods:A systematic literature search was conducted in China National Knowledge Infrastructure, VIP, Wanfang Data, China Biology Medicine disc, Embase, Cochrane Library, Medline, Web of Science, and PubMed from database inception to May 27, 2024, to identify studies on psychological distress assessment tools for cancer patients. Two reviewers independently screened the literature and extracted data based on inclusion and exclusion criteria. The quality of the included tools was evaluated using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guideline, and the quality grading was made using a modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.Results:A total of 25 articles involving 21 assessment tools were included. None of the tools reported measurement error, responsiveness, or hypothesis testing. Among them, 3 instruments: Chinese version of the Cancer Distress Scales for Adolescent and Young Adults (CDS-AYA-C), Chinese version of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and the Chinese version of the Short Demoralization Scale (DS-Ⅱ-C) were given grade A recommendations. The remaining 18 tools received grade B recommendations.Conclusions:The CDS-AYA-C, MAX-PC, and DS-Ⅱ-C demonstrated relatively balanced measurement properties and can be temporarily recommended for assessing psychological distress in cancer patients. However, further validation of their methodological quality and psychometric properties is needed. It is also recommended to develop culturally adapted psychological distress assessment tools for cancer patients in China.
6.Quality evaluation of psychological distress assessment tools for cancer patients based on COSMIN guidelines
Lu SUN ; Wanqiu MA ; Lina WANG ; Jing DA ; Lei QIAN ; Jing XU
Chinese Journal of Modern Nursing 2025;31(22):3001-3009
Objective:To evaluate the quality of psychological distress assessment tools for cancer patients and provide evidence for clinical nurses in selecting appropriate instruments.Methods:A systematic literature search was conducted in China National Knowledge Infrastructure, VIP, Wanfang Data, China Biology Medicine disc, Embase, Cochrane Library, Medline, Web of Science, and PubMed from database inception to May 27, 2024, to identify studies on psychological distress assessment tools for cancer patients. Two reviewers independently screened the literature and extracted data based on inclusion and exclusion criteria. The quality of the included tools was evaluated using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guideline, and the quality grading was made using a modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.Results:A total of 25 articles involving 21 assessment tools were included. None of the tools reported measurement error, responsiveness, or hypothesis testing. Among them, 3 instruments: Chinese version of the Cancer Distress Scales for Adolescent and Young Adults (CDS-AYA-C), Chinese version of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and the Chinese version of the Short Demoralization Scale (DS-Ⅱ-C) were given grade A recommendations. The remaining 18 tools received grade B recommendations.Conclusions:The CDS-AYA-C, MAX-PC, and DS-Ⅱ-C demonstrated relatively balanced measurement properties and can be temporarily recommended for assessing psychological distress in cancer patients. However, further validation of their methodological quality and psychometric properties is needed. It is also recommended to develop culturally adapted psychological distress assessment tools for cancer patients in China.
7.Dosimetric effect of calculation grid size on stereotactic body radiation therapy of lung cancer in helical tomotherapy planning system
Xia-Yu HANG ; Wan-Rong JIANG ; Yi-Kun LI ; Jun HU ; Yan ZHANG ; Ruo-Qi CAO ; Nan XU ; Lei WANG ; Jin-Da ZHOU ; Xiang-Dong SUN
Chinese Medical Equipment Journal 2024;45(2):52-57
Objective To investigate the dosimetric effects of different calculation grid size(CGS)in helical tomotherapy(HT)planning system on stereotactic body radiation therapy(SBRT)for non-small cell lung cancer(NSCLC).Methods Nine NSCLC patients receiving radiation therapy for the first time at some hospital from March 2019 to December 2022 were selected as the subjects.SBRT planning was carried out through the HT system with three different CGS plans(Fine,Normal,and Coarse)and the same pitch,modulation factor(MF)and optimization conditions,and the target area indexes of the three CGS plans were compared including conformity index(CI),homogeneity index(HI),dosimetric parameters of the organ at risk(OAR),point dose verification pass rate,treatment time,number of monitor units and Sinograms.SPSS 22.0 was used for statistical analysis.Results For target area HI,there weres significant differences between CGS Fine plan and Coarse plan and between CGS Normal plan and Coarse plan(P<0.05),while no statistical differences were found between CGS Fine plan and Normal plan(P>0.05).For target area CI,there were significant differences between CGS Fine plan and Coarse plan(P<0.05),while no statistical differences were found between CGS Fine plan and Normal plan and between CGS Normal plan and Coarse plan(P>0.05).For OAR dosimetric parameters,CGS Fine plan and Coarse plan had significant differences in heart Dmax and Dmean,esophageal Dmax and Dmean,V5,V20,V30 and Dmean of the whole lung and affected lung,V5 and Dmax of the affected lung and heart V10 and V30(P<0.05),CGS Normal plan and Coarse plan had obvious differences in esophageal Dmax(P<0.05),and the remained dosimetric parameters were not statistically significant(P>0.05).Fine,Normal and Coarse plans had the point dose verifica-tion pass rates being 0.96%,1.50%and 1.77%,respectively.In terms of treatment time and number of monitor units,there were significant differences between Fine plan and Coarse plan(P<0.05)while no statistical differences were found between Fine and Normal plans and between Normal and Coarse plans(P>0.05).Sinograms analyses showed Fine plan had evenly distributed segment color gradient,Coarse plan had areas of very dark and very light color gradients and Normal plan was somewhere in between.Conclusion Low CGS has to be used as much as possible to obtain accurate dose distribution during SBRT planning for NSCLC patients,which contributes to the execution of the radiation therapy plan and the prevention of ad-verse effects.[Chinese Medical Equipment Journal,2024,45(2):52-57]
8.Effect of ureteral wall thickness at the site of ureteral stones on the clinical efficacy of ureteroscopic lithotripsy
Wei PU ; Jian JI ; Zhi-Da WU ; Ya-Fei WANG ; Tian-Can YANG ; Lyu-Yang CHEN ; Qing-Peng CUI ; Xu XU ; Xiao-Lei SUN ; Yuan-Quan ZHU ; Shi-Cheng FAN
Journal of Regional Anatomy and Operative Surgery 2024;33(12):1077-1081
Objective To investigate the effect of varying ureteral wall thickness(UWT)at the site of ureteral stones on the clinical efficacy of ureteroscopic lithotripsy(URL).Methods The clinical data of 164 patients with ureteral stones in our hospital were retrospectively analyzed.According to different UWT,the patients were divided into the mild thickening group(84 cases,UWT<3.16 mm),the moderate thickening group(31 cases,UWT 3.16 to 3.49 mm),and the severe thickening group(49 cases,UWT>3.49 mm),and the differences of clinical related indicators among the three groups were compared.Results The incidence of postoperative renal colic and leukocyte disorder in the mild thickening group and the moderate thickening group were lower than those in the severe thickening group,and the differences were statistically significant(P<0.05).The postoperative catheterization time in the mild thickening group and the moderate thickening group were shorter than that in the severe thickening group,and the incidences of secondary lithotripsy,residual stones and stone return to kidney in the mild thickening group and the moderate thickening group were lower than those in the severe thickening group,with statistically significant differences(P<0.05).The length of hospital stay and hospitalization cost in the mild thickening group and the moderate thickening group were shorter/less than those in the severe thickening group,with statistically significant differences(P<0.05).Conclusion With the increase of UWT(especially when UWT>3.49 mm),the incidence of postoperative complications and hospitalization cost of URL increase to varying degrees,and the surgical efficacy decreases.In clinical work,UWT measurement holds potential value in predicting the surgical efficacy and complications of URL.
9.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
10.Effects of miR-21-5p exosomes from human umbilical cord mesenchymal stem cells on apoptosis of granular cells
Shengrong DU ; Lei YANG ; Yan SUN ; Yunhong LIN ; Qingfen CHEN ; Lincui DA ; Pengyu HUANG ; Beihong ZHENG
Chinese Journal of Reproduction and Contraception 2024;44(9):930-937
Objective:To explore the effects of miR-21-5p exosomes derived from human umbilical cord mesenchymal stem cells on apoptosis of human granular cells.Methods:A granular cell apoptosis model was constructed by treating KGN cells with different concentrations (0 μmol/L, 30 μmol/L, 60 μmol/L, and 100 μmol/L) of phosphoramide nitrogen mustard for 48 h. The mRNA and protein levels of bax and bcl2 were detected using qPCR and Western blotting, respectively. The apoptosis rate was measured using flow cytometry to screen for the optimal concentration of phosphoramide nitrogen mustard for constructing an apoptosis model. Hsa-miR-21-5p overexpression plasmid was used for instantaneously transfecting human umbilical cord mesenchymal stem cells, and the expression level of hsa-miR-21-5p was detected by qPCR. The miR-21-5p exosomes were separated and identified by flow cytometry and electron microscope. Different concentrations (5 μg/mL, 10 μg/mL and 15 μg/mL) of miR-21 exosomes were added into successful KGN cell apoptosis model to overexpress miR-21. The mRNA and protein levels of bax and bcl2 were detected using qPCR and Western blotting, respectively. PKH-26 was used to trace the position of human granular cells. Results:The levels of bax mRNA and protein in KGN cells treated with 60 μmol/L phosphoramide nitrogen mustard were significantly higher than those in the 0 μmol/L phosphoramide nitrogen mustard group (all P<0.001), while the levels of bcl2 mRNA and protein were significantly higher than those in the 0 μmol/L phosphoramide nitrogen mustard group ( P=0.005, P<0.001). The apoptosis rate of KGN cells after 60 μmol/L phosphoramide nitrogen mustard intervention was (38.10±2.90)%, while the apoptosis rate of KGN cells after 30 μmol/L phosphoramide nitrogen mustard intervention was (16.75±2.55)%, they were all significantly higher than that of the 0 μmol/L phosphoramide nitrogen mustard intervention group ( P=0.020, P=0.006). Hsa-miR-21-5p was transiently transfected into human umbilical cord blood mesenchymal stem cells, and the expression of has-miR-21-5p was higher than that in control group detected by qPCR ( P<0.001). The positive rate of surface protein CD9, CD63 and CD81 was 14.9%, 16.4% and 31.4%. The exosome was observed as "tea tray" or "concave hemisphere" by electron microscope. The exosome labeled by PKH-26 entered the granular cells and exerted biological effects. There was no statistically significant difference in bax mRNA expression levels between the 5 μg/mL, 10 μg/mL, and 15 μg/mL empty plasmid exosomes groups and the 60 μmol/L phosphoramide nitrogen mustard group (all P>0.05). However, the expression levels of bax mRNA in the 5 μg/mL, 10 μg/mL, and 15 μg/mL miR-21-5-p exosomes groups were lower than those in the 60 μmol/L phosphoramide nitrogen mustard group ( P=0.008, P=0.003, P<0.001). However, there was no statistically significant difference in the expression of bcl2 mRNA among the groups (all P>0.05). From the perspective of protein levels, there was no statistically significant difference in BAX protein expression between the 5 μg/mL, 10 μg/mL, and 15 μg/mL empty exosomes groups and 60 μmol/L phosphoramide nitrogen mustard group (all P>0.05), while the 5 μg/mL, 10 μg/mL, and 15 μg/mL miR-21-5-p exosomes groups showed a decrease in BAX protein expression compared with the 60 μmol/L phosphoramide nitrogen mustard group, and the differences were statistically significant (all P<0.001). However, there was no statistically significant difference in the expression of BCL2 protein among the intervention groups (all P>0.05). Conclusion:Hsa-miR-21-5p exosomes derived from human umbilical cord blood mesenchymal stem cells can effectively exert the anti-apoptotic effect.

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