1.A Meta-Analysis on the Efficacy and Safety of Xihuang Pill/Capsule( 西黄丸/胶囊) as an Adjuvant to Radio⁃therapy and Chemotherapy in the Treatment of Malignant Digestive Tract Tumors
Mengyi LI ; Lei ZHANG ; Lijun WANG ; Xing GAO
Journal of Traditional Chinese Medicine 2025;66(9):912-919
ObjectiveTo evaluate the efficacy and safety of Xihuang Pill/Capsule (西黄丸/胶囊, XP/XC) as an adjuvant to radiotherapy and/or chemotherapy in the treatment of malignant digestive tract tumors. MethodsA systematic search was conducted in the China Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, VIP Database, PubMed, Web of Science, Embase, and Cochrane Library for randomized controlled trials (RCTs) published before March 6, 2024, regarding the use of XP/XC in clinical adjuvant treatment of malignant digestive tract tumors. The methodological quality of the included studies was assessed using the risk of bias assessment tool. RevMan 5.4 was used to perform a Meta-analysis on 1-year survival rate, 2-year survival rate, clinical efficacy, including objective response rate and disease control rate, Karnofsky Performance Status (KPS) score, immune markers (CD3+, CD4+, CD8+, and CD4+/CD8+ ratio), and adverse event rates (incidence of gastrointestinal reactions and bone marrow suppression). ResultsThirteen RCTs involving 962 patients were included, with 527 patients in the experimental group and 435 patients in the control group. Meta-analysis results showed that the experimental group had better outcomes than the control group in terms of 2-year survival rate [RR = 0.49, 95% CI (0.31, 0.78)], objective response rate [RR = 0.68, 95% CI (0.60, 0.77)], disease control rate [RR = 0.85, 95% CI (0.80, 0.91)], and immune markers CD3+ [MD = -7.99, 95% CI (-9.12, -6.86)], CD4+ [MD = -5.42, 95% CI (-7.11, -3.74)], and CD4+/CD8+ ratio [MD = -0.26, 95% CI (-0.32, -0.20)] (P<0.05). However, no statistically significant differences were found between the experimental and control groups in terms of 1-year survival rate [RR = 0.91, 95% CI (0.73, 1.14)], KPS [MD = -3.73, 95% CI (-8.67, 1.21)], CD8+ [MD = -0.53, 95% CI (-1.45, 0.39)], incidence of gastrointestinal reactions [RR = 0.82, 95% CI (0.46, 1.46)], and incidence of bone marrow suppression [RR = 0.93, 95% CI (0.72, 1.20)] (P>0.05). ConclusionCompared with radiotherapy/chemotherapy alone, the combination of XP/XC with radiotherapy/chemotherapy can effectively improve clinical efficacy and 2-year survival rate, enhance immune function, and achieve similar adverse event rates as radiotherapy/chemotherapy alone in patients with malignant digestive tract tumors.
2.Clinical Research on Guizhi Fulingwan in Treatment of Ovarian Cancer: A Review
Muxin GUAN ; Jiaxing FENG ; Mengyi ZHU ; Yu WANG ; Xiaoke WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):296-303
Ovarian cancer (OC) is a common gynecological malignant tumor in clinical practice. In the early stage,it is often asymptomatic,while in the late stage,it mainly presents with non-specific symptoms such as abdominal distension,poor appetite,and dull abdominal pain. Some patients may also have cachexia such as weight loss and anemia. Early diagnosis is difficult,and the mortality rate ranks first among gynecological malignant tumors,making OC a major challenge in clinical treatment. The classic Chinese medicine formula Guizhi Fulingwan comes from the Jingui Yaolue and has the effects of promoting blood circulation,removing blood stasis,and reducing abdominal lumps. In recent years,it has been widely used to treat OC with good results. This article summarized the clinical application of Guizhi Fulingwan in the treatment of OC from two aspects:The analysis of its basic prescriptions and clinical research. In terms of basic prescriptions,the formula has the ability to promote blood circulation,remove blood stasis,and reduce abdominal lumps. It can exert therapeutic effects considering both water and blood aspects and reduce abdominal lumps, with characteristics of simultaneous Yang warming and heat clearing and parallel supplementation and elimination. Through the methods of "circulation" and "supplementation", it strengthens the body,dispels evil,and eliminates underlying symptoms. In clinical studies,Guizhi Fulingwan can be applied to various stages of patients with OC,which not only promotes the recovery of the body after OC surgery but also can be combined with chemotherapy and immunotherapy to synergistically treat advanced OC and enhance treatment efficacy. In addition,the formula can also alleviate various adverse reactions caused by chemotherapy,with high safety,improve patients' quality of life,prolong survival,and optimize tumor control effects. Based on the above analysis,this article elaborated on the current clinical research status of Guizhi Fulingwan combined with Western medicine in the treatment of OC and proposed suggestions and improvements to address the shortcomings in current clinical research,so as to provide reference for the clinical application of this formula in the treatment of OC and the construction of a combined traditional Chinese and Western medicine treatment model.
3.Clinical Research on Guizhi Fulingwan in Treatment of Ovarian Cancer: A Review
Muxin GUAN ; Jiaxing FENG ; Mengyi ZHU ; Yu WANG ; Xiaoke WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):296-303
Ovarian cancer (OC) is a common gynecological malignant tumor in clinical practice. In the early stage,it is often asymptomatic,while in the late stage,it mainly presents with non-specific symptoms such as abdominal distension,poor appetite,and dull abdominal pain. Some patients may also have cachexia such as weight loss and anemia. Early diagnosis is difficult,and the mortality rate ranks first among gynecological malignant tumors,making OC a major challenge in clinical treatment. The classic Chinese medicine formula Guizhi Fulingwan comes from the Jingui Yaolue and has the effects of promoting blood circulation,removing blood stasis,and reducing abdominal lumps. In recent years,it has been widely used to treat OC with good results. This article summarized the clinical application of Guizhi Fulingwan in the treatment of OC from two aspects:The analysis of its basic prescriptions and clinical research. In terms of basic prescriptions,the formula has the ability to promote blood circulation,remove blood stasis,and reduce abdominal lumps. It can exert therapeutic effects considering both water and blood aspects and reduce abdominal lumps, with characteristics of simultaneous Yang warming and heat clearing and parallel supplementation and elimination. Through the methods of "circulation" and "supplementation", it strengthens the body,dispels evil,and eliminates underlying symptoms. In clinical studies,Guizhi Fulingwan can be applied to various stages of patients with OC,which not only promotes the recovery of the body after OC surgery but also can be combined with chemotherapy and immunotherapy to synergistically treat advanced OC and enhance treatment efficacy. In addition,the formula can also alleviate various adverse reactions caused by chemotherapy,with high safety,improve patients' quality of life,prolong survival,and optimize tumor control effects. Based on the above analysis,this article elaborated on the current clinical research status of Guizhi Fulingwan combined with Western medicine in the treatment of OC and proposed suggestions and improvements to address the shortcomings in current clinical research,so as to provide reference for the clinical application of this formula in the treatment of OC and the construction of a combined traditional Chinese and Western medicine treatment model.
4.In vitro study of immunocompatibility of humanized genetically modified pig erythrocytes with human serum
Leijia CHEN ; Mengyi CUI ; Xiangyu SONG ; Kai WANG ; Zhibo JIA ; Liupu YANG ; Yanghui DONG ; Haochen ZUO ; Jiaxiang DU ; Dengke PAN ; Wenjing XU ; Hongbo REN ; Yaqun ZHAO ; Jiang PENG
Organ Transplantation 2024;15(3):415-421
Objective To investigate the differences and the immunocompatibility of wild-type (WT), four-gene modified (TKO/hCD55) and six-gene modified (TKO/hCD55/hCD46/hTBM) pig erythrocytes with human serum. Methods The blood samples were collected from 20 volunteers with different blood groups. WT, TKO/hCD55, TKO/hCD55/hCD46/hTBM pig erythrocytes, ABO-compatible (ABO-C) and ABO-incompatible (ABO-I) human erythrocytes were exposed to human serum of different blood groups, respectively. The blood agglutination and antigen-antibody binding levels (IgG, IgM) and complement-dependent cytotoxicity were detected. The immunocompatibility of two types of genetically modified pig erythrocytes with human serum was evaluated. Results No significant blood agglutination was observed in the ABO-C group. The blood agglutination levels in the WT and ABO-I groups were higher than those in the TKO/hCD55 and TKO/hCD55/hCD46/hTBM groups (all P<0.001). The level of erythrocyte lysis in the WT group was higher than those in the ABO-C, TKO/hCD55 and TKO/hCD55/hCD46/hTBM groups. The level of erythrocyte lysis in the ABO-I group was higher than those in the TKO/hCD55 and TKO/hCD55/hCD46/hTBM groups (both P<0.01). The pig erythrocyte binding level with IgM and IgG in the TKO/hCD55 group was lower than those in the WT and ABO-I groups. The pig erythrocyte binding level with IgG and IgM in the TKO/hCD55/hCD46/hTBM group was lower than that in the WT group and pig erythrocyte binding level with IgG was lower than that in the ABO-I group (all P<0.05). Conclusions The immunocompatibility of genetically modified pig erythrocytes is better than that of wild-type pigs and close to that of ABO-C pigs. Humanized pig erythrocytes may be considered as a blood source when blood sources are extremely scarce.
5.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT
Fuqiang ZHANG ; Ziteng HU ; Yujing ZHANG ; Lijiao YAN ; Juyi WANG ; Cehan ZHANG ; Jiaqi CHEN ; Mengyi WANG ; Shuoming LIU ; Xinyi XIE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):185-191
ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine (CPM) with internationally recognized tools the appraisal of guidelines for research and evaluation (AGEREE) Ⅱ and reporting items for practice guidelines in healthcare (RIGHT), thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI, VIP, Wanfang and Sinomed were searched for CPM guidelines, as well as medlive.cn, websites of China Association of Chinese Medicine and Chinese Medical Association, and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools, and consistency tests were performed using Interclass Correlation Coefficient, and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally, 140 CPM guidelines were included, of which 51 were disease-oriented and 89 were drug-oriented, all of which were issued by China. For 51 disease-oriented CPM guidelines, the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity, and the lowest was 26.80% for application; for 89 drug-oriented CPM guidelines, the highest average score was 55.62% for scope and purpose, and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist, the highest reporting rate was 68.26% for background, and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines; the highest reporting rate was 61.31% for background, and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ (rigour of development, clarity of presentation, editorial independence), as well as four domains of RIGHT checklist (basic information, evidence, funding and declaration and management of interests, and other areas). ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist, and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines, thereby guiding the clinical use of CPM in a better way.
6.Research report of living donor kidney harvesting in Bama miniature pigs with six gene modified
Yong XU ; Xiangyu SONG ; Heng’en WANG ; Shujun YANG ; Zhibo JIA ; Hao WEI ; Shengfeng CHEN ; Mengyi CUI ; Yanling REN ; Jiang PENG ; Shengkun SUN
Organ Transplantation 2024;15(2):229-235
Objective To summarize the experience and practical value of living donor kidney harvesting in Bama miniature pigs with six gene modified. Methods The left kidney of Bama miniature pigs with six gene modified was obtained by living donor kidney harvesting technique. First, the ureter was occluded, and then the inferior vena cava and abdominal aorta were freed. During the harvesting process, the ureter, renal vein and renal artery were exposed and freed in sequence. The vascular forceps were used at the abdominal aorta and inferior vena cava, and the renal artery and vein were immediately perfused with 4℃ renal preservation solution, and stored in ice normal saline for subsequent transplantation. Simultaneously, the donor abdominal aorta and inferior vena cava gap were sutured. The operation time, blood loss, warm and cold ischemia time, postoperative complications and the survival of donors and recipients were recorded. Results The left kidney of the genetically modified pig was successfully harvested. Intraoperative bleeding was 5 mL, warm ischemia time was 45 s, and cold ischemia time was 2.5 h. Neither donor nor recipient pig received blood transfusion, and urinary function of the kidney transplanted into the recipient was recovered. The donor survived for more than 8 months after the left kidney was resected. Conclusions Living donor kidney harvesting is safe and reliable in genetically modified pigs. Branch blood vessels could be processed during kidney harvesting, which shortens the process of kidney repair and the time of cold ischemia. Living donor kidney harvesting contributes to subsequent survival of donors and other scientific researches.
7.New hope for clinical blood transfusion:xenotransfusion based on gene-edited pigs
Mengyi CUI ; Leijia CHEN ; Yuanyuan LI ; Kai WANG ; Shengfeng CHEN ; Boyao YANG ; Xiangyu SONG ; Zhibo JIA ; Haochen ZUO ; Wenjing XU ; Jiang PENG
Chinese Journal of Blood Transfusion 2024;37(5):607-612
Although blood banks based on human blood can provide blood transfusions for the wounded timely and effec-tively,scientific research has never given up on finding new blood sources due to the restrictions of human blood sources.With the application of transgenic technology and the successful breeding of gene-edited pigs,gene-edited pig blood as a po-tential source of clinical transfusion has attracted wide attention.Now there are preclinical studies showing the feasibility of transfusing gene-edited pig red blood cells into primates.This paper discusses the related research and future development of xenogeneic transfusion of porcine red blood cells by gene editing.
8.Repeatability and Reproducibility of a New Ocular Biometer Based on Partial Coherence Interferometry and Its Agreement with IOL Master 500
Shuoshuo CHEN ; Zhengfei YANG ; Zixuan LI ; Guitong YE ; Xiao YANG ; Mengyi WANG
Journal of Sun Yat-sen University(Medical Sciences) 2024;45(3):484-492
[Objective]To assess the repeatability(intra-operator variability)and reproducibility(inter-operator variability)of a new partial coherence interferometry(PCI)-based ocular biometer,Myopia Master,and its agreement with IOL Master 500 for measuring axial length(AL)and corneal curvature(K)in children aged 8-12 years.[Methods]The same operator measured school children with the Myopia Master and the IOL Master 500 in random order to assess agreement.Additionally,some of these children received measurements from another operator using the Myopia Master to assess repeatability and reproducibility.AL,flat keratometry(Kf),steep keratometry(Ks),mean keratometry(Km),J0 and J45 were analyzed.The repeatability and reproducibility were assessed by the within-subject standard deviation(Sw),test-retest repeatability(TRT),coefficient of variation(CoV)and intra-class correlation coefficient(ICC).The agree-ment between the Myopia Master and the IOL Master 500 was assessed by Bland-Altman plots and 95%limits of agree-ment(LoA).[Results]Both repeatability and reproducibility of the Myopia Master were high for AL measurements(Sw=0.02 mm,ICC=0.999;Sw=0.04 mm,ICC=0.998),but moderate for K measurements(Sw range,0.04 to 0.12 D,ICC range,0.861 to 0.991;Sw range,0.06 to 0.20 D,ICC range,0.835 to 0.992).There were significant mean differences be-tween the Myopia Master and the IOL Master 500 in measurements of AL(-0.01±0.04)mm,Kf(-0.09±0.15)D,Ks(-0.47±0.40)D,and Km(-0.28±0.23)D,J0(0.18±0.20)D and J45(-0.01±0.12)D.[Conclusions]The Myopia Master provided high repeatability and reproducibility for AL measurements in schoolchildren with myopia,but the Myopia Master and the IOL Master 500 cannot be used interchangeably in measuring AL and K.
9.Development of evidence-based practice protocols for post-stroke insomnia
Xinqi WANG ; Ying ZHU ; Mengyi CAI ; Meijie ZHANG ; Weiying ZHANG
Chinese Journal of Practical Nursing 2024;40(24):1841-1847
Objective:To develop a post-stroke insomnia (PSI) evidence-based nursing practice protocol to provide reference for the implementation of insomnia nursing in stroke patients.Methods:In January 2022, a research team was formed. Based on evidence-based principles, systematically searched and summarized high-quality evidence of Western medicine care and Chinese medicine care related to PSI to develop the first draft of the evidence-based nursing practice protocol for PSI, invited medical experts and nursing experts in the field of stroke care, medical treatment, research and teaching, and the protocol was revised through 2 rounds of Delphi expert consultation to form the final draft of the protocol.Results:A total of 15 experts were invited, 3 males and 12 females; 2 between 31 and 40 years of age, 6 between 41 and 50 years of age, and 7 between 51 and 60 years of age.The positive coefficient for both rounds of expert consultation was 100% and the expert authority coefficient was 0.89; the Kendall coordination coefficients for the importance and feasibility scores of the entries in the 2 rounds expert consultation were 0.188 and 0.146, 0.224 and 0.188 (all P<0.01). The PSI evidence-based nursing practice protocol included 27 entries in 6 dimensions: assessment of sleep quality, diagnosis of PSI, development of an individualized plan, non-pharmacological interventions, Chinese medicine nursing interventions, preparation for discharge and follow-up. Conclusions:The PSI evidence-based nursing practice protocol is scientific, reliable and applicable, and can provide a reference for the nursing practice of PSI patients.
10.Study on the pattern of pulmonary vascular remodeling in patients with chronic obstructive pulmonary disease based on artificial intelligence technology
Mengyi SONG ; Rui LI ; Ronghua WANG ; Linning E
Chinese Journal of Radiology 2024;58(8):813-821
Objective:To explore the pattern of pulmonary vascular remodeling in patients with chronic obstructive pulmonary disease (COPD) using artificial intelligence technology based on chest CT images.Methods:This was a cross-sectional study. The clinical and imaging data of 257 patients with stable COPD who underwent chest high resolution CT (HRCT) and pulmonary function tests (PFT) from January 2018 to October 2022 at Shanxi Bethune Hospital were retrospectively analyzed. In addition, 28 healthy individuals with normal HRCT and PFT were collected in the same period as a control group. According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) grading criteria, COPD patients were classified into 31 cases of GOLD 1, 116 cases of GOLD 2, 82 cases of GOLD 3, and 28 cases of GOLD 4. FACT digital lung software was used to automatically segment the pulmonary arteries and pulmonary veins of all the cases, and to calculate the relevant pulmonary vascular parameters, including total lung volume (TLV), vessel volumes at all levels [cross-sectional area less than 5 mm 2 (CSA <5), between 5 and 10 mm 2 (CSA 5-10), and more than 10 mm 2 (CSA >10)], number of vascular branches, and vascular density (pulmonary vascular volume/TLV). Percentage of emphysema (%LAA) and pulmonary artery diameter/aortic diameter (PAD/AD) were calculated for all cases. ANOVA or Kruskal-Wallis H test was used for multiple intergroup comparisons, and LSD test or Bonferroni correction was used for within-group pairwise comparisons. Spearman correlation test was conducted to examine the relationship between CT pulmonary vascular parameters and pulmonary function parameters, as well as %LAA, in both the control group and the COPD group. Results:Differences in age, body mass index, pulmonary function parameters, %LAA and PAD/AD were statistically significant among the 5 groups ( P<0.001). Differences in overall pulmonary vascular density parameters were statistically significant among the 5 groups ( P<0.05). Differences in pulmonary arterial density parameters among the 5 groups with CSA <5, CSA 5-10, and CSA >10 were statistically significant ( P<0.05). The pulmonary arterial density values of GOLD 1 CSA <5, CSA 5-10 and CSA >10 were higher than those of the control group, and then showed a decreasing trend with the increase of COPD severity. The differences in pulmonary venous density parameters among the 5 groups with CSA< 5, CSA 5-10, and CSA >10 were statistically significant ( P<0.001), and the CSA 5-10 pulmonary venous density was higher in GOLD 1 patients than in the control group, and the remaining pulmonary venous densities showed a gradual decreasing trend with the increase in the severity of COPD. The number of arterial and venous vascular branches/TLV tended to decrease in the control group, GOLD 1, GOLD 2, GOLD 3, and GOLD 4 patients ( P<0.001). Pulmonary vascular density parameters were positively correlated with all PFT parameters ( r=0.138-0.510, P<0.05), and negatively correlated with %LAA ( r=-0.340--0.671, P<0.001); PAD/AD was negatively correlated with PFT parameters ( r=-0.208--0.286, P<0.001) and positively correlated with %LAA ( r=0.131, P<0.05). Conclusion:Various pulmonary vascular density parameters can be quantitatively analyzed by artificial intelligence technology based on chest CT images, which can reveal the changing pattern of pulmonary vascular remodeling in COPD patients.

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