1.Application Value of Scales for Symptom & Syndrome Evaluation in Spleen-Stomach Diseases Related New Drug Research and Development
Fengbin LIU ; Simeng YAO ; Ping WANG ; Liqun BIAN ; Zhengkun HOU ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(5):504-509
Symptom and syndrome efficacy evaluation scales are indispensable tools for clinical efficacy assessment in traditional Chinese medicine (TCM), and hold significant value at all stages of new drug research development for spleen and stomach diseases. These scales can provide scientific basis for clinical positioning, efficacy evaluation, and expansion of indications of new drugs. By analyzing the current hotspots and difficulties in research, this study aims to explore the important significance of these scales in the development of new drugs for spleen and stomach diseases, summarize the domestic research progress, and conduct comparative analyses with international studies. Future development trends are also discussed in order to promote the application of symptom and syndrome efficacy evaluation scales in the development of new drugs for spleen and stomach diseases and to advance the moder-nization process of TCM.
2.The Development of the PRO Scale and the Construction of the PRO Evaluation System for TCM Diseases
Qiaofeng YAN ; Fengbin LIU ; Bo WANG ; Hong LIU ; Xiaoyan PAN ; Simeng YAO ; Yuanfang CHEN
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(8):2110-2118
For TCM to go global,while carrying forward its own characteristics,it should also build a set of measurement methods recognized by the international medical field.PRO scale is more and more widely used in the field of traditional Chinese medicine because there are many confluence points between PRO scale and TCM connotation.The patient-reported outcomes measurement information system(PROMIS)provides a reference for the development of PRO scales in the field of TCM.We can learn from the methods and models relied on by PROMIS and build a PRO evaluation system for TCM diseases based on TCM culture,so as to promote the standardization,standardization and modernization of TCM.
3.The application of robot-assisted laparoscopic resection of primary retroperitoneal tumors via the abdominal approach
Ruichen ZANG ; Fengbin GAO ; Kunyu WANG ; Chen ZHANG ; Kangxin NI ; Liwei XU ; Yicheng CHEN ; Shicheng YU ; Liang MA ; Sheng CHENG ; Gonghui LI ; Guoqing DING
Chinese Journal of Surgery 2025;63(11):1059-1065
Objective:To evaluate the effect of robot-assisted laparoscopic technology via abdominal approach for patients with primary retroperitoneal tumors.Methods:A retrospective cohort analysis was conducted for the clinical data of 71 patients who underwent robot-assisted laparoscopic resection of primary retroperitoneal tumor via abdominal approach at the Department of Urology of Sir Run Run Shaw Hospital,Zhejiang University School of Medicine from January 2015 to December 2023. There were 35 male and 36 female patients. The age ( M(IQR)) was 56(21) years (range: 21 to 83 years). The median tumor diameter was 46 (31) mm (range: 15 to 134 mm). Postoperative pathology revealed 58 benign and 13 malignant cases. Patients were divided into non-adherent group ( n=47) and adherent group ( n=24) based on whether the tumor was adhered to major organs or vessels. Perioperative and postoperative situation were compared between the two groups. Data comparisons were conducted using independent samples t-test for normally distributed continuous variables, Mann-Whitney U tests for non-normally distributed data, χ2 test or Fisher′s exact test for categorical variables. Kaplan-Meier survival analysis was employed to estimate 3-year recurrence or metastasis rate and 3-year mortality rate. Results:Operative time was 120(60) minutes (range: 45 to 440 minutes), intraoperative blood loss was 50 (80) ml (range: 10 to 2 000 ml). The median change of intraoperative mean arterial pressure was 40 (19) mmHg(1 mmHg=0.133 kPa)(range: 10 to 112 mmHg). Intraoperative blood transfusion was required in 7 cases, whereas 64 cases did not necessitate transfusion. The change in hemoglobin levels before and after surgery was (17.9±13.6) g/L (range:-16 to 53 g/L), and the median change in serum creatinine levels was 2.0 (14.5) μmol/L (range:-71.0 to 100.4 μmol/L). Postoperative fasting duration was 2.0 (1.5) days (range: 1 to 6 days), and the median hospital stay was 10.0 (7.5) days (range: 4 to 24 days). No perioperative mortality occurred in any of the patients. The non-adherent group had shorter operation time, less estimated blood loss, lower blood transfusion rate, smaller delta value of hemoglobin before and after surgery, larger delta value of creatinine before and after surgery, fewer postoperative complications, shorter postoperative fasting time, and shorter length of hospital stay than the adherent group(all P<0.05), while there was no significant difference in mean arterial pressure fluctuation between the two groups ( P>0.05). Follow-up data were available for 69 patients, with a median follow-up duration of 39 (43) months (range: 4 to 88 months). Among these patients, 40 completed the 3-year follow-up. The 3-year recurrence or metastasis rate was 10.14%, and the 3-year mortality rate was 2.90%. Conclusions:Robot-assisted laparoscopic technology via abdominal approach for resection of primary retroperitoneal tumors is safe and feasible. It can also achieve secure surgical outcome for primary retroperitoneal tumors adherent to surrounding organs or vessels, albeit with increased surgical complexity and slower postoperative recovery compared to non-adherent cases.
4.Efficacy of Weiyan Tongluo Granules in Patients with Chronic Atrophic Gastritis of Spleen Deficiency and Blood Stasis Type:A Multi-Center,Double-Blind,Double-Dummy,Randomized Controlled Trial
Xiaotao JIANG ; Jie LIN ; Yushan ZOU ; Zehong YANG ; Jinglin PAN ; Zhekun XIONG ; Changlong WANG ; Yuancheng HUANG ; Shuye WANG ; Yanhua YAN ; Junhui ZHENG ; Yi WEN ; Fengbin LIU ; Peiwu LI
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(6):822-831
OBJECTIVE To evaluate the efficacy and safety of Weiyan Tongluo Granules in treating chronic atrophic gastritis(CAG)and explore its potential mechanisms.METHODS From June 2020 to December 2022,100 CAG patients with spleen defi-ciency and blood stasis syndrome were enrolled and randomly divided into a trial group(n=50)and a control group(n=50)using a random number table.The trial group received Weiyan Tongluo Granules plus a folic acid placebo,while the control group received fo-lic acid tablets plus a traditional Chinese medicine granule placebo.The treatment course for both groups was 24 weeks,with 8 and 10 dropouts in the trial and control groups,respectively.Post-treatment comparisons included OLGA/OLGIM staging reversal rates,low-grade intraepithelial neoplasia regression rate,SSDPRO-CG(Patient-Reported Outcome Scale for Chronic Gastritis in Spleen-Stomach Diseases)scores,TCM syndrome scores,and safety indicators.Serum levels of PG I,PGⅡ,PGR,and G-17 were measured via ELISA before and after treatment.Gastric mucosal p-NF-κB and CDX2 protein expression levels were analyzed by Western blot,while mRNA levels of IL-1β,IL-6,VIL1,and MUC2 were quantified via qPCR.RESULTS After treatment,the trial group showed sig-nificantly higher OLGA and OLGIM stage reversal rates than the control group(P<0.05,P<0.01),though no significant difference was observed in low-grade intraepithelial neoplasia regression.Both groups exhibited significant improvements in physiological domain scores and total SSDPRO-CG scores(P<0.01),with the trial group outperforming the control group in physiological,independence,psychological domains,and total scores(P<0.05,P<0.01).TCM syndrome scores(total and sub-items:gastric distension,pain,poor appetite,bloating)decreased significantly in both groups(P<0.01),while the trial group showed greater reductions in loose stools and dull complexion(P<0.01).After-treatment,the trial group had significantly lower TCM syndrome scores than the control group(P<0.05,P<0.01).Serum PG I,PGⅡ,PGR,G-17,gastric mucosal p-NF-κB,CDX2,and IL-1β,IL-6,VIL1,MUC2 mRNA levels improved significantly in the trial group(P<0.05,P<0.01),while the control group improved only in PGⅡ(P<0.05,P<0.01).The trial group's improvements in these biomarkers surpassed the control group's(P<0.05,P<0.01).No treatment-related adverse events occurred in either group.CONCLUSION Weiyan Tongluo Granules ameliorate gastric mucosal pathology,clinical symptoms,psychological state,and quality of life in CAG patients without significant adverse effects.Its mechanism may involve sup-pressing the NF-κB pathway to reduce IL-1β and IL-6 expression,downregulating CDX2 to inhibit VIL1 and MUC2 transcription,thereby reversing the vicious cycle of inflammation-intestinal metaplasia.
5.Efficacy of Weiyan Tongluo Granules in Patients with Chronic Atrophic Gastritis of Spleen Deficiency and Blood Stasis Type:A Multi-Center,Double-Blind,Double-Dummy,Randomized Controlled Trial
Xiaotao JIANG ; Jie LIN ; Yushan ZOU ; Zehong YANG ; Jinglin PAN ; Zhekun XIONG ; Changlong WANG ; Yuancheng HUANG ; Shuye WANG ; Yanhua YAN ; Junhui ZHENG ; Yi WEN ; Fengbin LIU ; Peiwu LI
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(6):822-831
OBJECTIVE To evaluate the efficacy and safety of Weiyan Tongluo Granules in treating chronic atrophic gastritis(CAG)and explore its potential mechanisms.METHODS From June 2020 to December 2022,100 CAG patients with spleen defi-ciency and blood stasis syndrome were enrolled and randomly divided into a trial group(n=50)and a control group(n=50)using a random number table.The trial group received Weiyan Tongluo Granules plus a folic acid placebo,while the control group received fo-lic acid tablets plus a traditional Chinese medicine granule placebo.The treatment course for both groups was 24 weeks,with 8 and 10 dropouts in the trial and control groups,respectively.Post-treatment comparisons included OLGA/OLGIM staging reversal rates,low-grade intraepithelial neoplasia regression rate,SSDPRO-CG(Patient-Reported Outcome Scale for Chronic Gastritis in Spleen-Stomach Diseases)scores,TCM syndrome scores,and safety indicators.Serum levels of PG I,PGⅡ,PGR,and G-17 were measured via ELISA before and after treatment.Gastric mucosal p-NF-κB and CDX2 protein expression levels were analyzed by Western blot,while mRNA levels of IL-1β,IL-6,VIL1,and MUC2 were quantified via qPCR.RESULTS After treatment,the trial group showed sig-nificantly higher OLGA and OLGIM stage reversal rates than the control group(P<0.05,P<0.01),though no significant difference was observed in low-grade intraepithelial neoplasia regression.Both groups exhibited significant improvements in physiological domain scores and total SSDPRO-CG scores(P<0.01),with the trial group outperforming the control group in physiological,independence,psychological domains,and total scores(P<0.05,P<0.01).TCM syndrome scores(total and sub-items:gastric distension,pain,poor appetite,bloating)decreased significantly in both groups(P<0.01),while the trial group showed greater reductions in loose stools and dull complexion(P<0.01).After-treatment,the trial group had significantly lower TCM syndrome scores than the control group(P<0.05,P<0.01).Serum PG I,PGⅡ,PGR,G-17,gastric mucosal p-NF-κB,CDX2,and IL-1β,IL-6,VIL1,MUC2 mRNA levels improved significantly in the trial group(P<0.05,P<0.01),while the control group improved only in PGⅡ(P<0.05,P<0.01).The trial group's improvements in these biomarkers surpassed the control group's(P<0.05,P<0.01).No treatment-related adverse events occurred in either group.CONCLUSION Weiyan Tongluo Granules ameliorate gastric mucosal pathology,clinical symptoms,psychological state,and quality of life in CAG patients without significant adverse effects.Its mechanism may involve sup-pressing the NF-κB pathway to reduce IL-1β and IL-6 expression,downregulating CDX2 to inhibit VIL1 and MUC2 transcription,thereby reversing the vicious cycle of inflammation-intestinal metaplasia.
6.The Development of the PRO Scale and the Construction of the PRO Evaluation System for TCM Diseases
Qiaofeng YAN ; Fengbin LIU ; Bo WANG ; Hong LIU ; Xiaoyan PAN ; Simeng YAO ; Yuanfang CHEN
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(8):2110-2118
For TCM to go global,while carrying forward its own characteristics,it should also build a set of measurement methods recognized by the international medical field.PRO scale is more and more widely used in the field of traditional Chinese medicine because there are many confluence points between PRO scale and TCM connotation.The patient-reported outcomes measurement information system(PROMIS)provides a reference for the development of PRO scales in the field of TCM.We can learn from the methods and models relied on by PROMIS and build a PRO evaluation system for TCM diseases based on TCM culture,so as to promote the standardization,standardization and modernization of TCM.
7.The application of robot-assisted laparoscopic resection of primary retroperitoneal tumors via the abdominal approach
Ruichen ZANG ; Fengbin GAO ; Kunyu WANG ; Chen ZHANG ; Kangxin NI ; Liwei XU ; Yicheng CHEN ; Shicheng YU ; Liang MA ; Sheng CHENG ; Gonghui LI ; Guoqing DING
Chinese Journal of Surgery 2025;63(11):1059-1065
Objective:To evaluate the effect of robot-assisted laparoscopic technology via abdominal approach for patients with primary retroperitoneal tumors.Methods:A retrospective cohort analysis was conducted for the clinical data of 71 patients who underwent robot-assisted laparoscopic resection of primary retroperitoneal tumor via abdominal approach at the Department of Urology of Sir Run Run Shaw Hospital,Zhejiang University School of Medicine from January 2015 to December 2023. There were 35 male and 36 female patients. The age ( M(IQR)) was 56(21) years (range: 21 to 83 years). The median tumor diameter was 46 (31) mm (range: 15 to 134 mm). Postoperative pathology revealed 58 benign and 13 malignant cases. Patients were divided into non-adherent group ( n=47) and adherent group ( n=24) based on whether the tumor was adhered to major organs or vessels. Perioperative and postoperative situation were compared between the two groups. Data comparisons were conducted using independent samples t-test for normally distributed continuous variables, Mann-Whitney U tests for non-normally distributed data, χ2 test or Fisher′s exact test for categorical variables. Kaplan-Meier survival analysis was employed to estimate 3-year recurrence or metastasis rate and 3-year mortality rate. Results:Operative time was 120(60) minutes (range: 45 to 440 minutes), intraoperative blood loss was 50 (80) ml (range: 10 to 2 000 ml). The median change of intraoperative mean arterial pressure was 40 (19) mmHg(1 mmHg=0.133 kPa)(range: 10 to 112 mmHg). Intraoperative blood transfusion was required in 7 cases, whereas 64 cases did not necessitate transfusion. The change in hemoglobin levels before and after surgery was (17.9±13.6) g/L (range:-16 to 53 g/L), and the median change in serum creatinine levels was 2.0 (14.5) μmol/L (range:-71.0 to 100.4 μmol/L). Postoperative fasting duration was 2.0 (1.5) days (range: 1 to 6 days), and the median hospital stay was 10.0 (7.5) days (range: 4 to 24 days). No perioperative mortality occurred in any of the patients. The non-adherent group had shorter operation time, less estimated blood loss, lower blood transfusion rate, smaller delta value of hemoglobin before and after surgery, larger delta value of creatinine before and after surgery, fewer postoperative complications, shorter postoperative fasting time, and shorter length of hospital stay than the adherent group(all P<0.05), while there was no significant difference in mean arterial pressure fluctuation between the two groups ( P>0.05). Follow-up data were available for 69 patients, with a median follow-up duration of 39 (43) months (range: 4 to 88 months). Among these patients, 40 completed the 3-year follow-up. The 3-year recurrence or metastasis rate was 10.14%, and the 3-year mortality rate was 2.90%. Conclusions:Robot-assisted laparoscopic technology via abdominal approach for resection of primary retroperitoneal tumors is safe and feasible. It can also achieve secure surgical outcome for primary retroperitoneal tumors adherent to surrounding organs or vessels, albeit with increased surgical complexity and slower postoperative recovery compared to non-adherent cases.
8.Research progress on animal models for the evaluation of diarrhea-predominant irritable bowel syndrome
Jiahe ZHANG ; Wang ZHU ; Danting SHEN ; Xiling YANG ; Fengbin LIU ; Qiuke HOU
Acta Laboratorium Animalis Scientia Sinica 2024;32(2):238-247
Irritable bowel syndrome(IBS)is one of the most common functional gastrointestinal disorders,of which diarrhea-predominant IBS(IBS-D)accounts for the largest proportion.The pathogenesis of IBS-D is complicated and diverse,and there is currently a lack of clinically effective drugs.The establishment of animal models is an essential tool for further studies of the disease mechanisms,evaluation of clinical efficacy,and drug development,and the preparation and evaluation standards of models are important factors affecting the quality of the research.Based on the currently accepted pathogenesis of IBS-D and the previous modeling experience of our research group,this review systematically summarizes the evaluation method used in animal models of IBS-D in terms of diarrhea observation,visceral sensitivity tests,and intestinal motility tests,to provide a reference for future studies.
9.Preparation of human SET8 monoclonal antibody and its effect on hepatocellular carcinoma cell proliferation,apoptosis,and cell cycle
Yingnan WANG ; Jianhua WU ; Chensi WU ; Fengbin ZHANG ; Ruixing ZHANG ; Zhanjun GUO
Chinese Journal of Comparative Medicine 2024;34(12):70-76
Objective To prepare human SET8 monoclonal antibody and explore its effects on the proliferation,apoptosis,and cell cycle of hepatoma cells,and to evaluate its anti-tumor effect in mouse models of hepatocellular carcinoma.Methods We immunized mice with human SET8 polypeptide fragment and screened and fused B cells and myeloma cells to establish a hybridoma cell line that stably secreted SET8 monoclonal antibody.Production was expanded by intraperitoneal injection into mice and the collection and purification of ascites.We investigated the effects of SET8 monoclonal antibody on the proliferation,apoptosis,cell cycle,and apoptosis-related protein expression of hepatocellular carcinoma cells by CCK-8,flow cytometry,and Western blot,respectively.Finally,we constructed a mouse model of human hepatocellular carcinoma by cell transplantation to evaluate the inhibitory effect of SET8 monoclonal antibody on tumor growth in vivo.Results Human SET8 monoclonal antibody significantly inhibited the viability of Huh-7 and Mahlavu hepatoma cells at concentrations of 50 and 100 μg/mL,in a concentration-dependent manner(P<0.05).Flow cytometry analysis showed that SET8 monoclonal antibody,paclitaxel,and their combination significantly increased the apoptosis rate of Mahlavu cells compared with the blank control group,with the combination group having the greatest effect(P<0.05).SET8 monoclonal antibody also induced Mahlavu cell cycle arrest in S and G2 phases and reduced G1 phase cells.Western blot analysis showed that the monoclonal antibody increased the expression of the apoptosis-related proteins Bax and Caspase-3(P<0.05).SET8 monoclonal antibody,alone or in combination with paclitaxel,also effectively inhibited the proliferation of hepatocellular carcinoma cells in nude mice,with the combination therapy having the most significant effect(P<0.05).Conclusions The prepared human SET8 monoclonal antibody effectively inhibited the proliferation and promoted the apoptosis of hepatocellular carcinoma cells,and showed good anti-tumor effects in mice.
10.Preparation of human SET8 monoclonal antibody and its effect on hepatocellular carcinoma cell proliferation,apoptosis,and cell cycle
Yingnan WANG ; Jianhua WU ; Chensi WU ; Fengbin ZHANG ; Ruixing ZHANG ; Zhanjun GUO
Chinese Journal of Comparative Medicine 2024;34(12):70-76
Objective To prepare human SET8 monoclonal antibody and explore its effects on the proliferation,apoptosis,and cell cycle of hepatoma cells,and to evaluate its anti-tumor effect in mouse models of hepatocellular carcinoma.Methods We immunized mice with human SET8 polypeptide fragment and screened and fused B cells and myeloma cells to establish a hybridoma cell line that stably secreted SET8 monoclonal antibody.Production was expanded by intraperitoneal injection into mice and the collection and purification of ascites.We investigated the effects of SET8 monoclonal antibody on the proliferation,apoptosis,cell cycle,and apoptosis-related protein expression of hepatocellular carcinoma cells by CCK-8,flow cytometry,and Western blot,respectively.Finally,we constructed a mouse model of human hepatocellular carcinoma by cell transplantation to evaluate the inhibitory effect of SET8 monoclonal antibody on tumor growth in vivo.Results Human SET8 monoclonal antibody significantly inhibited the viability of Huh-7 and Mahlavu hepatoma cells at concentrations of 50 and 100 μg/mL,in a concentration-dependent manner(P<0.05).Flow cytometry analysis showed that SET8 monoclonal antibody,paclitaxel,and their combination significantly increased the apoptosis rate of Mahlavu cells compared with the blank control group,with the combination group having the greatest effect(P<0.05).SET8 monoclonal antibody also induced Mahlavu cell cycle arrest in S and G2 phases and reduced G1 phase cells.Western blot analysis showed that the monoclonal antibody increased the expression of the apoptosis-related proteins Bax and Caspase-3(P<0.05).SET8 monoclonal antibody,alone or in combination with paclitaxel,also effectively inhibited the proliferation of hepatocellular carcinoma cells in nude mice,with the combination therapy having the most significant effect(P<0.05).Conclusions The prepared human SET8 monoclonal antibody effectively inhibited the proliferation and promoted the apoptosis of hepatocellular carcinoma cells,and showed good anti-tumor effects in mice.

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