1.Effect of Zishen Tongguan Formula on "Gut-prostate" Axis of Rats with Chronic Non-bacterial Prostatitis Based on 16S rDNA Sequencing
Xiran LI ; Mengjiao CHEN ; Kaiping ZOU ; Chenguang ZHAO ; Xingbin DAI ; Xiaoqing ZHANG ; Shun LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):63-71
ObjectiveBased on the theory of "gut-prostate" axis, this study explored the effects and mechanisms of Zishen Tongguan formula and Cinnamomi Cortex in the formula in treating rats with chronic non-bacterial prostatitis(CNP) by detecting the levels of inflammatory factors, and the composition and structure of intestinal flora in CNP rats. MethodsEight out of 42 SD rats were randomly selected as the normal group, and the remaining rats were injected with carrageenan to prepare the CNP model. After successful modeling, 32 rats were randomly divided into the model group, Ningmitai capsule group(0.50 g·kg-1), Zishen Tongguan formula group(2.00 g·kg-1), and the Phellodendri Chinensis Cortex-Anemarrhenae Rhizoma pair group(PCC-AR group, 2.00 g·kg-1), with 8 rats in each group. The administered groups were given the corresponding medicinal solution by gavage, and the normal and model groups were intragastrically administered with an equal volume of normal saline, once a day for 14 consecutive days. The prostate tissues of rats were collected and subjected to hematoxylin-eosin(HE) staining and Masson staining to observe the pathological changes of the tissues in each group. Enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of related inflammatory factors in rat serum, and 16S rDNA sequencing was used to analyze the abundance and diversity changes of gut microbiota before and after administration, and species difference analysis was performed. ResultsAll the administered groups could alleviate the inflammatory symptoms of CNP rats, increase the expression levels of anti-inflammatory factors and decrease the expression levels of pro-inflammatory factors, with the most sIgnificant effect observed in the Zishen Tongguan formula group. Compared with the normal group, the expression levels of interleukin(IL)-8, hypersensitive C-reactive protein(hs-CRP), immunoglobulin(Ig)M, secretory IgA (sIgA), and inducible nitric oxide synthase(iNOS) were sIgnificantly increased in the model group(P<0.01). Compared with the model group, the expression levels of the above inflammatory factors in all administered groups were significantly reduced(P<0.01). When compared with the PCC-AR group, the Zishen Tongguan formula group showed a significant decrease in transforming growth factor(TGF)-β1 expression level(P<0.05) and a significant increase in IgM expression level(P<0.01). The results of gut microbiota analysis showed that, compared with the PCC-AR group, at the order level, the Zishen Tongguan formula group significantly reduced the relative abundance of conditional pathogens such as Bacteroidales, Acidaminococcales, Rhodospirillales, Clostridiales, and Elusimicrobiales(P<0.01). And at the genus level, the Zishen Tongguan formula group significantly decreased the relative abundance of pathogenic microbiota such as Lachnospira and Bacteroides(P<0.01) and significantly increased the relative abundances of beneficial microbiota such as Ruminococcus and Lactobacillus(P<0.01). ConclusionZishen Tongguan formula can reduce the level of harmful intestinal bacteria, increase the level of beneficial intestinal bacteria, down-regulate the expression of serum inflammatory factors, and the small amount of Cinnamomi Cortex in the formula may play a key role in the treatment of CNP with this formula.
2.Effect of Zishen Tongguan Formula on "Gut-prostate" Axis of Rats with Chronic Non-bacterial Prostatitis Based on 16S rDNA Sequencing
Xiran LI ; Mengjiao CHEN ; Kaiping ZOU ; Chenguang ZHAO ; Xingbin DAI ; Xiaoqing ZHANG ; Shun LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):63-71
ObjectiveBased on the theory of "gut-prostate" axis, this study explored the effects and mechanisms of Zishen Tongguan formula and Cinnamomi Cortex in the formula in treating rats with chronic non-bacterial prostatitis(CNP) by detecting the levels of inflammatory factors, and the composition and structure of intestinal flora in CNP rats. MethodsEight out of 42 SD rats were randomly selected as the normal group, and the remaining rats were injected with carrageenan to prepare the CNP model. After successful modeling, 32 rats were randomly divided into the model group, Ningmitai capsule group(0.50 g·kg-1), Zishen Tongguan formula group(2.00 g·kg-1), and the Phellodendri Chinensis Cortex-Anemarrhenae Rhizoma pair group(PCC-AR group, 2.00 g·kg-1), with 8 rats in each group. The administered groups were given the corresponding medicinal solution by gavage, and the normal and model groups were intragastrically administered with an equal volume of normal saline, once a day for 14 consecutive days. The prostate tissues of rats were collected and subjected to hematoxylin-eosin(HE) staining and Masson staining to observe the pathological changes of the tissues in each group. Enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of related inflammatory factors in rat serum, and 16S rDNA sequencing was used to analyze the abundance and diversity changes of gut microbiota before and after administration, and species difference analysis was performed. ResultsAll the administered groups could alleviate the inflammatory symptoms of CNP rats, increase the expression levels of anti-inflammatory factors and decrease the expression levels of pro-inflammatory factors, with the most sIgnificant effect observed in the Zishen Tongguan formula group. Compared with the normal group, the expression levels of interleukin(IL)-8, hypersensitive C-reactive protein(hs-CRP), immunoglobulin(Ig)M, secretory IgA (sIgA), and inducible nitric oxide synthase(iNOS) were sIgnificantly increased in the model group(P<0.01). Compared with the model group, the expression levels of the above inflammatory factors in all administered groups were significantly reduced(P<0.01). When compared with the PCC-AR group, the Zishen Tongguan formula group showed a significant decrease in transforming growth factor(TGF)-β1 expression level(P<0.05) and a significant increase in IgM expression level(P<0.01). The results of gut microbiota analysis showed that, compared with the PCC-AR group, at the order level, the Zishen Tongguan formula group significantly reduced the relative abundance of conditional pathogens such as Bacteroidales, Acidaminococcales, Rhodospirillales, Clostridiales, and Elusimicrobiales(P<0.01). And at the genus level, the Zishen Tongguan formula group significantly decreased the relative abundance of pathogenic microbiota such as Lachnospira and Bacteroides(P<0.01) and significantly increased the relative abundances of beneficial microbiota such as Ruminococcus and Lactobacillus(P<0.01). ConclusionZishen Tongguan formula can reduce the level of harmful intestinal bacteria, increase the level of beneficial intestinal bacteria, down-regulate the expression of serum inflammatory factors, and the small amount of Cinnamomi Cortex in the formula may play a key role in the treatment of CNP with this formula.
3.Prevalence of Schistosoma japonicum infections in wild rodents in key areas during the elimination phase
Chao LÜ ; Xiaojuan XU ; Jiajia LI ; Ting FENG ; Hai ZHU ; Yifeng LI ; Ling XU ; Zhihong FENG ; Huiwen JIANG ; Xiaoqing ZOU ; Wenjun WEI ; Zhiqiang QIN ; Yang HONG ; Shiqing ZHANG ; Jing XU
Chinese Journal of Schistosomiasis Control 2025;37(5):475-481
Objective To investigate the prevalence of Schistosoma japonicum infections in wild rodents in schistosomiasis-endemic areas of China, so as to provide insights into formulation of technical guidelines for monitoring of and the precise control strategy for S. japonicum infections in wild rodents during the elimination phase. Methods Two administrative villages where schistosomiasis was historically highly prevalent were selected each from Dongzhi County, Anhui Province, and Duchang County, Jiangxi Province as study villages. Wild rodents were captured from study villages with baited traps or cages at night in June and September, 2021. The number of rodents captured was recorded, and the rodent species was characterized based on morphologi-cal characteristics. Liver tissues were sampled from captured rodents for macroscopical observation of the presence of egg granu- lomas, and S. japonicum infection was detected simultaneously using liver tissue homogenate microscopy, examinations of mesenteric tissues for parasites, and modified Kato-Katz thick smear technique (Kato-Katz technique). A positive S. japonicum infection was defined as detection of S. japonicum eggs or adult worms by any of these methods. The rate of wild rodent capture and prevalence of S. japonicum infections in wild rodents were compared in different study villages and at different time periods, and the detection of S. japonicum infections in wild rodents was compared by different assays. Results The overall rate of wild ro- dent capture was 8.28% (237/2 861) in Dongzhi County, and the wild rodent capture rates were 9.24% (133/1 439) and 7.31% (104/1 422) in two study villages (χ2 = 3.503, P = 0.061), and were 8.59% (121/1 409) and 7.99% (116/1 452) in June and September, 2021, respectively (χ2 = 0.337, P = 0.561). The overall rate of wild rodent capture was 3.72% (77/2 072) in Duchang County, and the wild rodent capture rates were 6.91% (67/970) and 0.91% (10/1 102) in two study villages (χ2 = 51.901, P < 0.001), and were 4.13% (39/945) and 3.37% (38/1 127) in June and September, 2021, respectively (χ2 = 0.815, P = 0.365). Rattus norvegicus was the predominant rodent species captured in both counties, accounting for 70.04% (166/237) of all captured wild rodents in Dongzhi County and 88.31% (68/77) in Duchang County. No S. japonicum infection was detected in wild rodents captured in Duchang County. Nevertheless, the overall prevalence of S. japonicum infections was 51.05% (121/237) in wild rodents captured in Dongzhi County, with prevalence rates of 50.38% (67/133) and 51.92% (54/104) in two study villages (χ2 = 0.098, P = 0.755), and 54.31% (63/116) and 47.93% (58/121) in September and June, 2021, respectively (χ2 = 0.964, P = 0.326). Of 237 wild rodents captured in Dongzhi County, there were 140 (59.07%) rodents with visible hepatic egg granulomas, 117 (49.47%) tested positive for S. japonicum eggs by liver tissue homogenate microscopy, 34 (14.35%) tested positive for S. japonicum eggs with Kato-Katz technique; however, no adult S. japonicum worms were detected in mesenteric tissues. In addition, hepatic egg granulomas were found in all wild rodents tested positive for S. japonicum eggs with liver tissue homogenate microscopy. Conclusions The rate of wild rodent capture and prevalence of S. japonicum infection in wild rodents vary greatly in schistosomiasis-endemic areas of China, and the prevalence of S. japonicum infection is slightly higher in wild rodents captured in autumn than in summer. Liver tissue is recommended as the preferred sample for surveillance of S. japonicum infection in wild rodents, and a combination of macroscopical observation of hepatic egg granulomas and liver tissue homogenate microscopy may be a standard method for surveillance of S. japonicum infection in wild rodents.
4.Development of a grading diagnostic model for schistosomiasis-induced liver fibrosis based on radiomics and clinical laboratory indicators
Zhaoyu GUO ; Juping SHAO ; Xiaoqing ZOU ; Qinping ZHAO ; Peijun QIAN ; Wenya WANG ; Lulu HUANG ; Jingbo XUE ; Jing XU ; Kun YANG ; Xiaonong ZHOU ; Shizhu LI
Chinese Journal of Schistosomiasis Control 2024;36(3):251-258
Objective To investigate the feasibility of developing a grading diagnostic model for schistosomiasis-induced liver fibrosis based on B-mode ultrasonographic images and clinical laboratory indicators. Methods Ultrasound images and clinical laboratory testing data were captured from schistosomiasis patients admitted to the Second People’s Hospital of Duchang County, Jiangxi Province from 2018 to 2022. Patients with grade I schistosomiasis-induced liver fibrosis were enrolled in Group 1, and patients with grade II and III schistosomiasis-induced liver fibrosis were enrolled in Group 2. The machine learning binary classification tasks were created based on patients’radiomics and clinical laboratory data from 2018 to 2021 as the training set, and patients’radiomics and clinical laboratory data in 2022 as the validation set. The features of ultrasonographic images were labeled with the ITK-SNAP software, and the features of ultrasonographic images were extracted using the Python 3.7 package and PyRadiomics toolkit. The difference in the features of ultrasonographic images was compared between groups with t test or Mann-Whitney U test, and the key imaging features were selected with the least absolute shrinkage and selection operator (LASSO) regression algorithm. Four machine learning models were created using the Scikit-learn repository, including the support vector machine (SVM), random forest (RF), linear regression (LR) and extreme gradient boosting (XGBoost). The optimal machine learning model was screened with the receiver operating characteristic curve (ROC), and features with the greatest contributions to the differentiation features of ultrasound images in machine learning models with the SHapley Additive exPlanations (SHAP) method. Results The ultrasonographic imaging data and clinical laboratory testing data from 491 schistosomiasis patients from 2019 to 2022 were included in the study, and a total of 851 radiomics features and 54 clinical laboratory indicators were captured. Following statistical tests (t = −5.98 to 4.80, U = 6 550 to 20 994, all P values < 0.05) and screening of key features with LASSO regression, 44 features or indicators were included for the subsequent modeling. The areas under ROC curve (AUCs) were 0.763 and 0.611 for the training and validation sets of the SVM model based on clinical laboratory indicators, 0.951 and 0.892 for the training and validation sets of the SVM model based on radiomics, and 0.960 and 0.913 for the training and validation sets of the multimodal SVM model. The 10 greatest contributing features or indicators in machine learning models included 2 clinical laboratory indicators and 8 radiomics features. Conclusions The multimodal machine learning models created based on ultrasound-based radiomics and clinical laboratory indicators are feasible for intelligent identification of schistosomiasis-induced liver fibrosis, and are effective to improve the classification effect of one-class data models.
5.Examining core symptoms and influencing factors of patients with gastric cancer undergoing chemotherapy:the role of Traditional Chinese Medicine constitutional traits
Yanling ZOU ; Yi LI ; Ziyan ZHANG ; Xun LI ; Lihua YANG ; Xiaoqing WANG ; Juan GAO ; Huiyun GUAN ; Peibei DUAN
Chinese Journal of Nursing 2024;59(18):2238-2243
Objective To investigate the incidence and severity of symptoms in patients with gastric cancer who received chemotherapy,we constructed a symptom network to explore core symptoms and bridge symptoms.Furthermore,the study explores the association between core symptoms and Traditional Chinese Medicine(TCM)constitutions.Methods Patients with gastric cancer who received chemotherapy in the medical oncology and surgical oncology department from March to August 2023 were selected for the study using a convenience sampling method.The MD Anderson Symptom Inventory Gastrointestinal Cancer was used for evaluating gastrointestinal symptoms and their severity among patients receiving chemotherapy for gastric cancer,as well as assessing the classification of TCM constitution among patients.The symptom network model was constructed using the R programming language,and the central index was analyzed to determine the core symptoms and bridge symptoms.Binary logistic regression analysis was employed to assess the association between different physical conditions and the occurrence of core symptoms.Results A total of 346 electronic questionnaires were collected,with 340 valid ones,and the effective recovery rate was 98.3%.The 3 most prevalent and severe symptoms among the 340 patients with gastric cancer were fatigue(85.59%),lack of appetite(82.35%),and taste alteration(81.18%).The centrality index results indicated that grief exhibited the highest intensity,medium,and compactness centrality values(rs=8.23,rb=2.00,rc=0.03),making it the core symptom of this condition.Sleep disorders,lack of appetite,drowsiness,and taste alteration were identified as bridging symptoms with bridge intensities of 0.74,0.76,0.99,and 0.94 respectively.The results of Spearman correlation analysis showed that there was a positive correlation between sadness and qi-deficiency constitution,phlegm-dampness constitution(P<0.05).The phlegm-dampness constitution was positively correlated with the taste alterations(P<0.05).Conclusion In patients with gastric cancer,fatigue emerges as the most prominent symptom,while sadness assumes the core symptom.Additionally,sleep disorder,lack of appetite,drowsiness,and taste alteration are bridge symptoms.According to the principles of TCM constitution,qi-deficiency and phlegm-dampness are constitutions associated with a higher risk of experiencing sadness,and phlegm-dampness is a constitution associated with a higher risk of taste changes.Nurses can integrate core symptoms and TCM constitutions characteristics to optimize the strategies for symptom intervention.
6.Clinical Predominance Disease of Traditional Chinese Medicine: Gastroesophageal Reflux Disease
Ping WANG ; Fengyun WANG ; Yu LAN ; Lingyun ZHANG ; Xiaoqing LI ; Kun WANG ; Xiujing SUN ; Zhanfeng YAN ; Xiulan ZHANG ; Demin LI ; Hongmei WU ; Xiaohong LI ; Xiaoke LI ; Jianqin YANG ; Dawei ZOU ; Xiaoxiao ZHANG ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(12):199-208
Gastroesophageal reflux disease (GERD) is a frequently and commonly occurring disease in clinic. In recent decades, with the development in pathophysiology and drug researches, modern medicine has achieved remarkable progress and results in diagnosis and treatment. However, the treatments for non-erosive reflux disease, refractory gastroesophageal reflux disease, proton pump inhibitor resistance, overlap of disease symptoms, and extraesophageal symptoms are limited and ineffective. Traditional Chinese medicine (TCM) was widely used in clinical practice, which has been proved effective in relieving symptoms and improving the quality of life. Sponsored by China Association of Chinese Medicine (CACM) and undertaken by the Spleen and Stomach Disease Branch of CACM, "the 12th Youth Salon of Clinical Predominance Disease Series (GERD)" invited 18 authoritative digestive experts of TCM and western medicine to discuss "the difficulties of clinical diagnosis and treatment of GERD and TCM advantages". The focus issues such as modern medical diagnosis and treatment achievements and contributions, improvement and maintenance of symptoms, response to overlapping disease symptoms, reduction and withdrawal of acid suppressors, and treatment of extra-esophageal symptoms were discussed in depth. TCM and western medicine exchanged and complemented each other's strengths, combing the difficulties of modern medical diagnosis and treatment, which clarified the positioning and advantages of TCM and provided guidance for clinical and scientific research.
7.Efficacy and cost-effectiveness analysis of probiotics in initial Helicobacter pylori eradication therapy
Yuexi ZHANG ; Xiaoqing ZOU ; Zuoyan WU
Chinese Journal of General Practitioners 2023;22(7):722-727
Objective:To analyze the efficacy and cost-effectiveness of probiotics in initial Helicobacter pylori ( H. pylori) eradication therapy. Methods:A total of 267 patients with positive H. pylori infection were randomly assigned to two groups, the control group ( n=133) received a 14-day bismuth agent quadruple therapy and the study group ( n=144) received conventional quadruple therapy plus probiotics from January 2020 to August 2021. Eradication status was assessed 4-12 weeks after treatment. The H.pylori eradication rate, adverse reactions, and cost-effectiveness were compared between the two groups. Results:The H.pylori eradication rate was higher in study group than that in the control group in intention-to-treat (ITT) (80.6%(108/134), 95% CI:73.8%-87.4% vs. 68.4%(91/133), 95% CI:60.4%-76.4%, P=0.022) and per-protocol (83.1%(108/130), 95% CI:76.5%-89.6% vs. 72.2%(91/126), 95% CI:64.3%-80.2%, P=0.037). The incidence of adverse effects in the study group was lower than that in the control group (8.2%(11/134) vs. 18.8%(25/133), χ 2=6.415, P=0.011). Cost-effectiveness analysis showed that compared with the control group, the incremental cost-effectiveness ratio (ICER) of the study group was 1 010.49 yuan. The single factor sensitivity analysis showed that the H.pylori eradication rate of the study group had a greater impact on the results, followed by that of the control group and the cost of bifidobacterium quadruplex viable tablets. The probability sensitivity analysis showed that when the willingness to pay value (WTP) was 2 500 yuan, the probability that the probiotics combined with the bismuth agent quadruple therapy group was more cost-effective than the simple bismuth agent quadruple therapy group was 91.2%. Conclusion:As initial Helicobacter pylori treatment, probiotics combined with the bismuth agent quadruple scheme has a higher eradication rate and a lower incidence of adverse events than the bismuth agent quadruple scheme.
8.Diagnostic value of a combined serology-based model for minimal hepatic encephalopathy in patients with compensated cirrhosis
Shanghao LIU ; Hongmei ZU ; Yan HUANG ; Xiaoqing GUO ; Huiling XIANG ; Tong DANG ; Xiaoyan LI ; Zhaolan YAN ; Yajing LI ; Fei LIU ; Jia SUN ; Ruixin SONG ; Junqing YAN ; Qing YE ; Jing WANG ; Xianmei MENG ; Haiying WANG ; Zhenyu JIANG ; Lei HUANG ; Fanping MENG ; Guo ZHANG ; Wenjuan WANG ; Shaoqi YANG ; Shengjuan HU ; Jigang RUAN ; Chuang LEI ; Qinghai WANG ; Hongling TIAN ; Qi ZHENG ; Yiling LI ; Ningning WANG ; Huipeng CUI ; Yanmeng WANG ; Zhangshu QU ; Min YUAN ; Yijun LIU ; Ying CHEN ; Yuxiang XIA ; Yayuan LIU ; Ying LIU ; Suxuan QU ; Hong TAO ; Ruichun SHI ; Xiaoting YANG ; Dan JIN ; Dan SU ; Yongfeng YANG ; Wei YE ; Na LIU ; Rongyu TANG ; Quan ZHANG ; Qin LIU ; Gaoliang ZOU ; Ziyue LI ; Caiyan ZHAO ; Qian ZHAO ; Qingge ZHANG ; Huafang GAO ; Tao MENG ; Jie LI ; Weihua WU ; Jian WANG ; Chuanlong YANG ; Hui LYU ; Chuan LIU ; Fusheng WANG ; Junliang FU ; Xiaolong QI
Chinese Journal of Laboratory Medicine 2023;46(1):52-61
Objective:To investigate the diagnostic accuracy of serological indicators and evaluate the diagnostic value of a new established combined serological model on identifying the minimal hepatic encephalopathy (MHE) in patients with compensated cirrhosis.Methods:This prospective multicenter study enrolled 263 compensated cirrhotic patients from 23 hospitals in 15 provinces, autonomous regions and municipalities of China between October 2021 and August 2022. Clinical data and laboratory test results were collected, and the model for end-stage liver disease (MELD) score was calculated. Ammonia level was corrected to the upper limit of normal (AMM-ULN) by the baseline blood ammonia measurements/upper limit of the normal reference value. MHE was diagnosed by combined abnormal number connection test-A and abnormal digit symbol test as suggested by Guidelines on the management of hepatic encephalopathy in cirrhosis. The patients were randomly divided (7∶3) into training set ( n=185) and validation set ( n=78) based on caret package of R language. Logistic regression was used to establish a combined model of MHE diagnosis. The diagnostic performance was evaluated by the area under the curve (AUC) of receiver operating characteristic curve, Hosmer-Lemeshow test and calibration curve. The internal verification was carried out by the Bootstrap method ( n=200). AUC comparisons were achieved using the Delong test. Results:In the training set, prevalence of MHE was 37.8% (70/185). There were statistically significant differences in AMM-ULN, albumin, platelet, alkaline phosphatase, international normalized ratio, MELD score and education between non-MHE group and MHE group (all P<0.05). Multivariate Logistic regression analysis showed that AMM-ULN [odds ratio ( OR)=1.78, 95% confidence interval ( CI) 1.05-3.14, P=0.038] and MELD score ( OR=1.11, 95% CI 1.04-1.20, P=0.002) were independent risk factors for MHE, and the AUC for predicting MHE were 0.663, 0.625, respectively. Compared with the use of blood AMM-ULN and MELD score alone, the AUC of the combined model of AMM-ULN, MELD score and education exhibited better predictive performance in determining the presence of MHE was 0.755, the specificity and sensitivity was 85.2% and 55.7%, respectively. Hosmer-Lemeshow test and calibration curve showed that the model had good calibration ( P=0.733). The AUC for internal validation of the combined model for diagnosing MHE was 0.752. In the validation set, the AUC of the combined model for diagnosing MHE was 0.794, and Hosmer-Lemeshow test showed good calibration ( P=0.841). Conclusion:Use of the combined model including AMM-ULN, MELD score and education could improve the predictive efficiency of MHE among patients with compensated cirrhosis.
9.Epidemiological characteristics, diagnosis, treatment and prognosis of gallbladder cancer in China: a report of 6 159 cases
Xuheng SUN ; Yijun WANG ; Wei ZHANG ; Yajun GENG ; Yongsheng LI ; Tai REN ; Maolan LI ; Xu'an WANG ; Xiangsong WU ; Wenguang WU ; Wei CHEN ; Tao CHEN ; Min HE ; Hui WANG ; Linhua YANG ; Lu ZOU ; Peng PU ; Mingjie YANG ; Zhaonan LIU ; Wenqi TAO ; Jiayi FENG ; Ziheng JIA ; Zhiyuan ZHENG ; Lijing ZHONG ; Yuanying QIAN ; Ping DONG ; Xuefeng WANG ; Jun GU ; Lianxin LIU ; Yeben QIAN ; Jianfeng GU ; Yong LIU ; Yunfu CUI ; Bei SUN ; Bing LI ; Chenghao SHAO ; Xiaoqing JIANG ; Qiang MA ; Jinfang ZHENG ; Changjun LIU ; Hong CAO ; Xiaoliang CHEN ; Qiyun LI ; Lin WANG ; Kunhua WANG ; Lei ZHANG ; Linhui ZHENG ; Chunfu ZHU ; Hongyu CAI ; Jingyu CAO ; Haihong ZHU ; Jun LIU ; Xueyi DANG ; Jiansheng LIU ; Xueli ZHANG ; Junming XU ; Zhewei FEI ; Xiaoping YANG ; Jiahua YANG ; Zaiyang ZHANG ; Xulin WANG ; Yi WANG ; Jihui HAO ; Qiyu ZHANG ; Huihan JIN ; Chang LIU ; Wei HAN ; Jun YAN ; Buqiang WU ; Chaoliu DAI ; Wencai LYU ; Zhiwei QUAN ; Shuyou PENG ; Wei GONG ; Yingbin LIU
Chinese Journal of Digestive Surgery 2022;21(1):114-128
Objective:To investigate the epidemiological characteristics, diagnosis, treat-ment and prognosis of gallbladder cancer in China from 2010 to 2017.Methods:The single disease retrospective registration cohort study was conducted. Based on the concept of the real world study, the clinicopathological data, from multicenter retrospective clinical data database of gallbladder cancer of Chinese Research Group of Gallbladder Cancer (CRGGC), of 6 159 patients with gallbladder cancer who were admitted to 42 hospitals from January 2010 to December 2017 were collected. Observation indicators: (1) case resources; (2) age and sex distribution; (3) diagnosis; (4) surgical treatment and prognosis; (5) multimodality therapy and prognosis. The follow-up data of the 42 hospitals were collected and analyzed by the CRGGC. The main outcome indicator was the overall survival time from date of operation for surgical patients or date of diagnosis for non-surgical patients to the end of outcome event or the last follow-up. Measurement data with normal distribu-tion were represented as Mean±SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M( Q1, Q3) or M(range), and com-parison between groups was conducted using the U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. Univariate analysis was performed using the Logistic forced regression model, and variables with P<0.1 in the univariate analysis were included for multivariate analysis. Multivariate analysis was performed using the Logistic stepwise regression model. The life table method was used to calculate survival rates and the Kaplan-Meier method was used to draw survival curves. Log-rank test was used for survival analysis. Results:(1) Case resources: of the 42 hospitals, there were 35 class A of tertiary hospitals and 7 class B of tertiary hospitals, 16 hospitals with high admission of gallbladder cancer and 26 hospitals with low admission of gallbladder cancer, respectively. Geographical distribution of the 42 hospitals: there were 9 hospitals in central China, 5 hospitals in northeast China, 22 hospitals in eastern China and 6 hospitals in western China. Geographical distribution of the 6 159 patients: there were 2 154 cases(34.973%) from central China, 705 cases(11.447%) from northeast China, 1 969 cases(31.969%) from eastern China and 1 331 cases(21.611%) from western China. The total average number of cases undergoing diagnosis and treatment in hospitals of the 6 159 patients was 18.3±4.5 per year, in which the average number of cases undergoing diagnosis and treatment in hospitals of 4 974 patients(80.760%) from hospitals with high admission of gallbladder cancer was 38.8±8.9 per year and the average number of cases undergoing diagnosis and treatment in hospitals of 1 185 patients(19.240%) from hospitals with low admission of gallbladder cancer was 5.7±1.9 per year. (2) Age and sex distribution: the age of 6 159 patients diagnosed as gallbladder cancer was 64(56,71) years, in which the age of 2 247 male patients(36.483%) diagnosed as gallbladder cancer was 64(58,71)years and the age of 3 912 female patients(63.517%) diagnosed as gallbladder cancer was 63(55,71)years. The sex ratio of female to male was 1.74:1. Of 6 159 patients, 3 886 cases(63.095%) were diagnosed as gallbladder cancer at 56 to 75 years old. There was a significant difference on age at diagnosis between male and female patients ( Z=-3.99, P<0.001). (3) Diagnosis: of 6 159 patients, 2 503 cases(40.640%) were initially diagnosed as gallbladder cancer and 3 656 cases(59.360%) were initially diagnosed as non-gallbladder cancer. There were 2 110 patients(34.259%) not undergoing surgical treatment, of which 200 cases(9.479%) were initially diagnosed as gallbladder cancer and 1 910 cases(90.521%) were initially diagnosed as non-gallbladder cancer. There were 4 049 patients(65.741%) undergoing surgical treatment, of which 2 303 cases(56.878%) were initially diagnosed as gallbladder cancer and 1 746 cases(43.122%) were initial diagnosed as non-gallbladder cancer. Of the 1 746 patients who were initially diagnosed as non-gallbladder cancer, there were 774 cases(19.116%) diagnosed as gallbladder cancer during operation and 972 cases(24.006%) diagnosed as gallbladder cancer after operation. Of 6 159 patients, there were 2 521 cases(40.932%), 2 335 cases(37.912%) and 1 114 cases(18.087%) undergoing ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) examination before initial diagnosis, respec-tively, and there were 3 259 cases(52.914%), 3 172 cases(51.502%) and 4 016 cases(65.205%) undergoing serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis, respectively. One patient may underwent multiple examinations. Results of univariate analysis showed that geographical distribution of hospitals (eastern China or western China), age ≥72 years, gallbladder cancer annual admission of hospitals, whether undergoing ultrasound, CT, MRI, serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis were related factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.45, 1.98, 0.69, 0.68, 2.43, 0.41, 1.63, 0.41, 0.39, 0.42, 95% confidence interval as 1.21-1.74, 1.64-2.40, 0.59-0.80, 0.60-0.78, 2.19-2.70, 0.37-0.45, 1.43-1.86, 0.37-0.45, 0.35-0.43, 0.38-0.47, P<0.05). Results of multivariate analysis showed that geographical distribution of hospitals (eastern China or western China), sex, age ≥72 years, gallbladder cancer annual admission of hospitals and cases undergoing ultrasound, CT, serum CA19-9 examination before initially diagnosis were indepen-dent influencing factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.36, 1.42, 0.89, 0.67, 1.85, 1.56, 1.57, 0.39, 95% confidence interval as 1.13-1.64, 1.16-1.73, 0.79-0.99, 0.57-0.78, 1.60-2.14, 1.38-1.77, 1.38-1.79, 0.35-0.43, P<0.05). (4) Surgical treatment and prognosis. Of the 4 049 patients undergoing surgical treatment, there were 2 447 cases(60.435%) with complete pathological staging data and follow-up data. Cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb were 85(3.474%), 201(8.214%), 71(2.902%), 890(36.371%), 382(15.611%), 33(1.348%) and 785(32.080%), respectively. The median follow-up time and median postoperative overall survival time of the 2 447 cases were 55.75 months (95% confidence interval as 52.78-58.35) and 23.46 months (95% confidence interval as 21.23-25.71), respectively. There was a significant difference in the overall survival between cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb ( χ2=512.47, P<0.001). Of the 4 049 patients undergoing surgical treatment, there were 2 988 cases(73.796%) with resectable tumor, 177 cases(4.371%) with unresectable tumor and 884 cases(21.833%) with tumor unassessable for resectabi-lity. Of the 2 988 cases with resectable tumor, there were 2 036 cases(68.139%) undergoing radical resection, 504 cases(16.867%) undergoing non-radical resection and 448 cases(14.994%) with operation unassessable for curative effect. Of the 2 447 cases with complete pathological staging data and follow-up data who underwent surgical treatment, there were 53 cases(2.166%) with unresectable tumor, 300 cases(12.260%) with resectable tumor and receiving non-radical resection, 1 441 cases(58.888%) with resectable tumor and receiving radical resection, 653 cases(26.686%) with resectable tumor and receiving operation unassessable for curative effect. There were 733 cases not undergoing surgical treatment with complete pathological staging data and follow-up data. There was a significant difference in the overall survival between cases not undergoing surgical treatment, cases undergoing surgical treatment for unresectable tumor, cases undergoing non-radical resection for resectable tumor and cases undergoing radical resection for resectable tumor ( χ2=121.04, P<0.001). (5) Multimodality therapy and prognosis: of 6 159 patients, there were 541 cases(8.784%) under-going postoperative adjuvant chemotherapy and advanced chemotherapy, 76 cases(1.234%) under-going radiotherapy. There were 1 170 advanced gallbladder cancer (pathological staging ≥stage Ⅲa) patients undergoing radical resection, including 126 cases(10.769%) with post-operative adjuvant chemotherapy and 1 044 cases(89.231%) without postoperative adjuvant chemo-therapy. There was no significant difference in the overall survival between cases with post-operative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.23, P=0.629). There were 658 patients with pathological staging as stage Ⅲa who underwent radical resection, including 66 cases(10.030%) with postoperative adjuvant chemotherapy and 592 cases(89.970%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.05, P=0.817). There were 512 patients with pathological staging ≥stage Ⅲb who underwent radical resection, including 60 cases(11.719%) with postoperative adjuvant chemotherapy and 452 cases(88.281%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemo-therapy and cases without post-operative adjuvant chemo-therapy ( χ2=1.50, P=0.220). Conclusions:There are more women than men with gallbladder cancer in China and more than half of patients are diagnosed at the age of 56 to 75 years. Cases undergoing ultrasound, CT, serum CA19-9 examination before initial diagnosis are independent influencing factors influencing initial diagnosis of gallbladder cancer patients. Preoperative resectability evaluation can improve the therapy strategy and patient prognosis. Adjuvant chemotherapy for gallbladder cancer is not standardized and in low proportion in China.
10.Influencing factors and nomogram prediction model of pregnancy outcome of patients with vaginal bleeding after IVF/ICSI-ET
Damin Zhu ; Huijuan Zou ; Jing Wang ; Cong Ma ; Xiaoqing Peng ; Danyang Li ; Yangfan Zhou ; Yulu Yang ; Yunxia Cao ; Xiaofeng Xu
Acta Universitatis Medicinalis Anhui 2022;57(7):1171-1176
Objective:
To investigate the risk factors affecting the occurrence of complications in patients with vaginal bleeding after in vitro fertilization/intracytoplasmic sperm injection embryo transfer(IVF/ICSI-ET) and the construction of nomogram prediction model.
Methods:
A total of 272 patients with threatened abortion after IVF/ICSI-ET were retrospectively analyzed in this study. They were divided into the live birth group and abortion group according to the final outcome of pregnancy. Patient characteristics were evaluated using the chi-square test, independent-samples Student's t-test or Wilcoxon rank sum test. A nomogram was created to predict the pregnancy outcome of women with threatened abortion who received IVF/ICSI using multivariate logistic regression coefficients.
Results:
There was no significant difference in the basic data, percentage of frozen embryos, treatment method, number of embryos transferred, high-quality embryo rate, and embryo implantation rate of the live birth group and abortion group(P>0.05). There were significant differences in body mass index, the onset of vaginal bleeding time after transplantation, serum levels of hCG and progesterone on 14 th day after embryo-transfer, and the number of gestational sacs between the two groups(P<0.05). After multivariate logistic regression analysis, the onset of vaginal bleeding time after transplantation and serum hCG levels on 14 th day after transfer were statistically significant(P<0.05). The nomogram was established based on the above indicators, with an area under the curve of 0.710 for the nomogram. The area under the ROC curve of our nomogram was better than the area under the ROC curve of a single risk factor(AUC of bleeding time after embryo-transfer: 0.644, AUC of serum hCG14:0.625).
Conclusion
The nomogram model established based on the onset of vaginal bleeding time after embryo-transfer and serum hCG value on 14 th day after embryo-transfer can better predict pregnancy outcome of patients with threatened abortion after IVF/ICSI-ET.


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