1.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.
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.Analysis of clinical characteristics and prognostic factors of 51 patients with multiple sclerosis in Suzhou area
Benyu QIAO ; Xiaoke WU ; Wenli SONG ; Keru LI ; Houde LI ; Yu JIANG ; Jinru ZHANG ; Xiaodong XU ; Dongqin CHEN ; Yongjun CAO ; Yanlin ZHANG
Chinese Journal of Immunology 2025;41(3):680-685
Objective:To explore clinical characteristics of multiple sclerosis(MS)patients in Suzhou,and to analyze main factors affecting their prognosis.Methods:General data,clinical symptoms,cerebrospinal fluid and imaging examinations of 51 MS patients admitted to Department of Neurology of the Second Hospital of Soochow University from July 31,2009 to July 31,2021 were retrospectively analyzed,and main factors affecting their prognosis were discussed.Results:Average age of onset of 51 MS patients was(43.3±15.6)years old,female accounted for 56.9%,male/female=1/1.3.Adult onset MS(AOMS)accounted for 62.8%,male/female=1/1.7;late onset MS(LOMS)accounted for 37.2%,male/female=1/0.9.Relapsing remitting MS(RRMS)accounted for 76.5%,and chronic onset accounted for 60.8%.Average annual recurrence rate was 8.8%.The first symptoms were numbness and weakness of limbs.Dizziness and numbness were more common in patients without recurrence after diagnosis of MS,and limb weak-ness and numbness were more common in patients with recurrence.Among lesions of MRI,62.7%(32/51)of periventricular involve-ment,52.9%(27/51)of spinal cord involvement,51.0%(26/51)of infratentorial involvement.Proportion of subtentorial and spinal cord(cervical,thoracic)involved were significantly higher in patients with recurrent MS than without recurrence.Values of albumin,IgG,IgA and IgM in cerebrospinal fluid increased with increase of recurrence times.EDSS score of male was higher than female,and LOMS score was higher than AOMS.MS patients without relapse had a low EDSS score,and median EDSS score at current follow-up was 0(0,1.00)score.MS score with relapse was relatively high,and median EDSS score at current follow-up was 2.75(0.25,7.25)score.Conclusion:MS patients with chronic onset are more common,with a high proportion of LOMS,and proportion of males increases with increasing age of onset.High EDSS score at first onset,cervical,thoracic and subtentorial lesions,increased values of cerebrospinal fluid albumin,IgG,IgA,IgM,age at first onset(50+years old),male associate with poor MS prognosis.
4.Analysis of clinical characteristics and prognostic factors of 51 patients with multiple sclerosis in Suzhou area
Benyu QIAO ; Xiaoke WU ; Wenli SONG ; Keru LI ; Houde LI ; Yu JIANG ; Jinru ZHANG ; Xiaodong XU ; Dongqin CHEN ; Yongjun CAO ; Yanlin ZHANG
Chinese Journal of Immunology 2025;41(3):680-685
Objective:To explore clinical characteristics of multiple sclerosis(MS)patients in Suzhou,and to analyze main factors affecting their prognosis.Methods:General data,clinical symptoms,cerebrospinal fluid and imaging examinations of 51 MS patients admitted to Department of Neurology of the Second Hospital of Soochow University from July 31,2009 to July 31,2021 were retrospectively analyzed,and main factors affecting their prognosis were discussed.Results:Average age of onset of 51 MS patients was(43.3±15.6)years old,female accounted for 56.9%,male/female=1/1.3.Adult onset MS(AOMS)accounted for 62.8%,male/female=1/1.7;late onset MS(LOMS)accounted for 37.2%,male/female=1/0.9.Relapsing remitting MS(RRMS)accounted for 76.5%,and chronic onset accounted for 60.8%.Average annual recurrence rate was 8.8%.The first symptoms were numbness and weakness of limbs.Dizziness and numbness were more common in patients without recurrence after diagnosis of MS,and limb weak-ness and numbness were more common in patients with recurrence.Among lesions of MRI,62.7%(32/51)of periventricular involve-ment,52.9%(27/51)of spinal cord involvement,51.0%(26/51)of infratentorial involvement.Proportion of subtentorial and spinal cord(cervical,thoracic)involved were significantly higher in patients with recurrent MS than without recurrence.Values of albumin,IgG,IgA and IgM in cerebrospinal fluid increased with increase of recurrence times.EDSS score of male was higher than female,and LOMS score was higher than AOMS.MS patients without relapse had a low EDSS score,and median EDSS score at current follow-up was 0(0,1.00)score.MS score with relapse was relatively high,and median EDSS score at current follow-up was 2.75(0.25,7.25)score.Conclusion:MS patients with chronic onset are more common,with a high proportion of LOMS,and proportion of males increases with increasing age of onset.High EDSS score at first onset,cervical,thoracic and subtentorial lesions,increased values of cerebrospinal fluid albumin,IgG,IgA,IgM,age at first onset(50+years old),male associate with poor MS prognosis.
5.Effect of Fuzheng Ruanjian Anticancer Formula on malignant biological behaviors of hepatocellulars carcinoma HepG2 cells by regulating Akt/MDM2/P53 signaling pathway
Jing LOU ; Lei ZHAO ; Yanjie ZHU ; Shuaiqiang YUAN ; Fei WANG ; Hangzhou ZHANG ; Jiaojiao XU ; Xiaoke YU ; Liufa HOU
Journal of Jilin University(Medicine Edition) 2024;50(6):1654-1663
Objective:To discuss the effect of Fuzheng Ruanjian Anticancer Formula on the malignant biological behaviors of the hepatocellular carcinoma HepG2 cells by requlating protein kinase B(Akt)/murine double minute 2(MDM2)/P53 signaling pathway.Methods:The HepG2 cells were treated with 0,0.05,0.10,0.20,0.40,0.80,1.60,3.20,and 6.40 g·mL-1 Fuzheng Ruanjian Anticancer Formula for 48 h.CCK-8 method was used to detect the survival rates of the HepG2 cells in various groups,and the concentrations of Fuzheng Ruanjian Anticancer Formula for the subsequent experiments were screened.The HepG2 cells were divided into control group,low dose of Fuzheng Ruanjian Anticancer Formula group(0.2 g·mL-1),medium dose of Fuzheng Ruanjian Anticancer Formula group(0.4 g·mL-1),high dose of Fuzheng Ruanjian Anticancer Formula group(0.8 g·mL-1),SC79 group(8 mg·L-1 SC79),and high dose of Fuzheng Ruanjian Anticancer Formula+SC79 group(0.8 g·mL-1 Fuzheng Ruijian Anticancer Formula+8 mg·L-1 SC79).CCK-8 method was used to detect the proliferation activities of the HepG2 cells in various groups;clone formation assay was used to detect the clone formation rates of the HepG2 cells in various groups;flow cytometry was used to detect the apoptotic rates of the HepG2 cells in various groups;Transwell chamber assay was used to detect the numbers of migration and invasion HepG2 cells in various groups;Western blotting method was used to detect the expression levels of proliferating cell nuclear antigen(PCNA),cysteine aspartate specific proteinase(Caspase-3),matrix metalloproteinase(MMP)-2,MMP-9,phosphorylated Akt(p-Akt),phosphorylated MDM2(p-MDM2),and P53 proteins in the HepG2 cells in various groups.Results:As the increasing of concentrations of Fuzheng Ruanjian Anticancer Formula(0,0.05,0.10,0.20,0.40,0.80,1.60,3.20,and 6.40 g·mL-1),the surival rates of the HepG2 cells were gradually decreased(P<0.05),and 0.2,0.4,and 0.8 g·mL-1 Fuzheng Ruanjian Anticancer Formula were selected for the subsequent experiments.The CCK-8 assay results showed that compared with control group,the proliferation activities of the HepG2 cells in low,medium,and high doses of Fuzheng Ruanjian Anticancer Formula groups were significantly decreased(P<0.05),in a dose-dependent manner,while the proliferation activity of the cells in SC79 group was significantly increased(P<0.05).Compared with high dose of Fuzheng Ruanjian Anticancer Formula group,the proliferation activity of the HepG2 cells in high dose of Fuzheng Ruanjian Anticancer Formula+SC79 group was significantly increased(P<0.05).The clone formation assay results showed that compared with control group,the clone formation rates of the HepG2 cells in low,medium,and high doses of Fuzheng Ruanjian Anticancer Formula groups were significantly decreased(P<0.05)in a dose-dependent manner,while the clone formation rate of the cells in SC79 group was significantly increased(P<0.05);compared with high dose of Fuzheng Ruanjian Anticancer Formula group,the clone formation rate of the cells in high dose of Fuzheng Ruanjian Anticancer Formula+SC79 group was significantly increased(P<0.05).The flow cytometry results showed that compared with control group,the apoptotic rates of the HepG2 cells in low,medium,and high doses of Fuzheng Ruijian Anticancer Formula groups were significantly increased(P<0.05)in a dose-dependent manner,while the apoptotic rate of the cells in SC79 group was significantly decreased(P<0.05);compared with high dose of Fuzheng Ruanjian Anticancer Formula group,the apoptotic rate of the cells in high dose of Fuzheng Ruanjian Anticancer Formula+SC79 group was significantly decreased(P<0.05).The Transwell chamber assay results showed that compared with control group,the numbers of migration and invasion HepG2 cells in low,medium,and high doses of Fuzheng Ruanjian Anticancer Formula groups were significantly decreased(P<0.05)in a dose-dependent manner,while the numbers of migration and invasion cells in SC79 group were significantly increased(P<0.05);compared with high dose of Fuzheng Ruanjian Anticancer Formula group,the numbers of migration and invasion HepG2 cells in high dose of Fuzheng Ruanjian Anticancer Formula+SC79 group were significantly increased(P<0.05).The Western blotting results showed that compared with control group,the expression levels of PCNA,MMP-2,MMP-9,p-Akt,and p-MDM2 proteins in the cells in low,medium,and high doses of Fuzheng Ruanjian Anticancer Formula groups were significantly decreased(P<0.05)in a dose-dependent manner,while the expression levels of Caspase-3 and P53 proteins were significantly increased(P<0.05)in a dose-dependent manner,while the expression levels of PCNA,MMP-2,MMP-9,p-Akt,and p-MDM2 proteins in the cells in SC79 group were significantly increased(P<0.05),and the expression levels of Caspase-3 and P53 proteins were significantly decreased(P<0.05);compared with high dose of Fuzheng Ruanjian Anticancer Formula group,the expression levels of PCNA,MMP-2,MMP-9,p-Akt,and p-MDM2 proteins in the cells in high dose of Fuzheng Ruanjian Anticancer Formula+SC79 group were significantly increased(P<0.05),while the expression levels of Caspase-3 and P53 proteins were significantly decreased(P<0.05).Conclusion:Fuzheng Ruanjian Anticancer Formula may inhibit the proliferation,migration,and invasion of the HepG2 cells and promote the apoptosis,and its mechanism may be related to suppressing the Akt/MDM2 signaling pathway and upregulating the P53 proteim expression.
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.Multivariate analysis and prediction model construction for live birth in patients with long-acting follicular phase in fresh single embryo transfer cycle
Bingnan REN ; Xiaoke ZHANG ; Wei ZHENG ; Junwei ZHANG ; Xiaona YU ; Yichuan GUAN
Chinese Journal of Reproduction and Contraception 2023;43(9):887-897
Objective:To explore risk factors associated with the live birth in patients with long-acting follicular phase in fresh single embryo transfer cycle and to construct nomogram prediction model for providing a reference for clinical decision-making and individualized treatment.Methods:An assisted reproduction population-based retrospective cohort analysis of the clinical data of 2 795 patients with long-acting follicular phase in fresh single embryo transfer cycle who underwent in vitro fertilization/intracytoplasmic sperm injection and embryo transfer (IVF/ICSI-ET) was performed in the Reproductive Center of the Third Affiliated Hospital of Zhengzhou University from January 2017 to December 2020. These patients were randomly divided into modeling group and validation group according to 3∶1. Univariate and multivariate logistic regression were used to screen potential risk factors for newborn live birth after fresh single embryo transfer. The nomogram model was established according to the regression coefficients. Besides, area under the receiver operator characteristic (ROC) curve, calibration curve and decision curve analysis were used to evaluate the discrimination and calibration of the model. Results:Through multiple logistic regression analysis, female age, progestational polycystic ovary syndrome (PCOS), the level of progestrogen on the day of human chorionic gonadotropin (hCG) injection, high-quality embryo rate, type of embryos transferred were independent risk factors associated with live birth. Stratified analysis found age ≥36 years together with the level of progestrogen ≥5.20 nmol/L on the day of hCG injection could reduce the probability of live birth signally, and statistically significant interaction was found ( P=0.043). The level of progestrogen ≥5.20 nmol/L on the day of hCG injection together with high-quality embryo rate <59.60% could reduce the probability of live birth signally, and statistically significant interaction was found ( P=0.010). The area under the curve (AUC) of modeling group and validation group was 0.637 (95% CI: 0.615-0.658) and 0.617 (95% CI: 0.579-0.654), respectively. The calibration curve showed that the predicted value of the model was in good agreement with the actual value. The decision curve analysis indicated the most benefical clinical effect with the nomogram for live birth under threshold probabilities of 24.05%-68.75%, it had a good diagnostic value for clinical decision. Conclusion:Female age, progestational PCOS, the level of progestrogen on the day of hCG injection, high-quality embryo rate, type of embryos transferred were independent risk factors associated with live birth in patients with long-acting follicular phase in fresh single embryo transfer cycle. Female age ≥36 years and high-quality embryo rate <59.60% together with the level of progestrogen ≥5.26 nmol/L on the day of hCG injection respectively could reduce the probability of live birth. The nomogram predictive model based on the above factors contribute to predict the probability of live birth.
8.Multivariate analysis and prediction model construction for live birth in patients with long-acting follicular phase in fresh single embryo transfer cycle
Bingnan REN ; Xiaoke ZHANG ; Wei ZHENG ; Junwei ZHANG ; Xiaona YU ; Yichuan GUAN
Chinese Journal of Reproduction and Contraception 2023;43(9):887-897
Objective:To explore risk factors associated with the live birth in patients with long-acting follicular phase in fresh single embryo transfer cycle and to construct nomogram prediction model for providing a reference for clinical decision-making and individualized treatment.Methods:An assisted reproduction population-based retrospective cohort analysis of the clinical data of 2 795 patients with long-acting follicular phase in fresh single embryo transfer cycle who underwent in vitro fertilization/intracytoplasmic sperm injection and embryo transfer (IVF/ICSI-ET) was performed in the Reproductive Center of the Third Affiliated Hospital of Zhengzhou University from January 2017 to December 2020. These patients were randomly divided into modeling group and validation group according to 3∶1. Univariate and multivariate logistic regression were used to screen potential risk factors for newborn live birth after fresh single embryo transfer. The nomogram model was established according to the regression coefficients. Besides, area under the receiver operator characteristic (ROC) curve, calibration curve and decision curve analysis were used to evaluate the discrimination and calibration of the model. Results:Through multiple logistic regression analysis, female age, progestational polycystic ovary syndrome (PCOS), the level of progestrogen on the day of human chorionic gonadotropin (hCG) injection, high-quality embryo rate, type of embryos transferred were independent risk factors associated with live birth. Stratified analysis found age ≥36 years together with the level of progestrogen ≥5.20 nmol/L on the day of hCG injection could reduce the probability of live birth signally, and statistically significant interaction was found ( P=0.043). The level of progestrogen ≥5.20 nmol/L on the day of hCG injection together with high-quality embryo rate <59.60% could reduce the probability of live birth signally, and statistically significant interaction was found ( P=0.010). The area under the curve (AUC) of modeling group and validation group was 0.637 (95% CI: 0.615-0.658) and 0.617 (95% CI: 0.579-0.654), respectively. The calibration curve showed that the predicted value of the model was in good agreement with the actual value. The decision curve analysis indicated the most benefical clinical effect with the nomogram for live birth under threshold probabilities of 24.05%-68.75%, it had a good diagnostic value for clinical decision. Conclusion:Female age, progestational PCOS, the level of progestrogen on the day of hCG injection, high-quality embryo rate, type of embryos transferred were independent risk factors associated with live birth in patients with long-acting follicular phase in fresh single embryo transfer cycle. Female age ≥36 years and high-quality embryo rate <59.60% together with the level of progestrogen ≥5.26 nmol/L on the day of hCG injection respectively could reduce the probability of live birth. The nomogram predictive model based on the above factors contribute to predict the probability of live birth.
9.Correlations between genomic and transcriptome characteristics and immune in hepatocellular carcinoma
Journal of International Oncology 2022;49(5):302-306
Hepatocellular carcinoma is a common malignant tumor in China, and its global incidence continues to rise and the mortality rate is high. Aberrations in the liver genome lead to malignant transformation of cells and the development of hepatocellular carcinoma, which are also potential therapeutic targets. Different immune cell components in the hepatocellular carcinoma microenvironment, such as tumor-associated macrophages, neutrophils, can promote tumor progression, and cytotoxic T lymphocytes can destroy tumor cells. Different characteristic gene phenotypes in cells can promote or inhibit immune tolerance, which can explain the potential reasons for the sensitivity or resistance of hepatocellular carcinoma patients to immunotherapy, and provide a reference for the exploration of new immunotherapy targets. Further deepening the understanding of the genomic and transcriptomic features in hepatocellular carcinoma and its correlation with immunotherapy can provide new ideas for clinical diagnosis and treatment.
10.A multicenter research on validation and improvement of the intelligent verification criteria for routine urinalysis
Li WANG ; Xiaoke HAO ; Dagan YANG ; Li JIANG ; Chengming SUN ; Weifeng SHI ; Yong WU ; Wei WU ; Jiayun LIU ; Weiyi XU ; Juan ZHANG ; Liping YANG ; Lijuan JIANG ; Jinling YUAN ; Jing JIN ; Gangqiang WANG ; Qian YU ; Zhigang XIONG ; Chenyu WANG ; Shuna JIANG ; Jinfeng LIAO ; Bei HE ; Wei CUI
Chinese Journal of Laboratory Medicine 2020;43(8):794-801
Objective:A multi-center and large sample volume study was conducted on the verification and improvement of the early established criteria for intelligent routine urinalysis validation (including the microscopic review rules and manual validation rules, referred to as intelligent criteria for short), in order to improve the clinical application of this intelligent criteria.Methods:A total of 31 456 urine specimens were collected from the inpatients and outpatients in six hospitals in China, from March to September 2019. Firstly, 3105 specimens were analyzed for preliminary verification and improvement of the intelligent criteria based on the results of the microscopic examination and manual validation. Secondly, 28 351 specimens were used to verify the clinical application of the improved intelligent criteria. All samples were manually validated as reference.Results:The approval inconsistency rate of the manual validation rules in the original intelligent criteria was 8.59% (202/2 352), and the interception inconsistency rate was 8.84% (208/2 352). The false negative rate and the microscopic review rate of the microscopic review rules were similar to the previous results. Based on an in-depth analysis of big data and the discussions by senior technicians from eight hospitals, one microscopic review rules and four manual validation rules were added, meanwhile two manual validation rule was deleted. The manual validation standards were unified. Finally, the intelligent criteria was improved. Based on the improved intelligent criteria, for microscopic review rules, the false positive rate, false negative rate (misdiagnosis rate), and microscopic review rate did not change significantly, which were 14.72% (457/3 105), 4.06% (126/3 105), and 24.73% (768/3 105), respectively. The approval inconsistency rate and the interception inconsistency rate of manual validation rules were both reduced to 0; the total manual validation rate of the intelligent criteria was 50.89% (1 580/3 105), and the auto-validation rate was 49.11% (1 525/3 105). The large sample volume verification results were consistent with the preliminary verification results of the improved intelligent criteria.Conclusion:This multi-center and large sample volume study had shown that the improved intelligent criteria had better clinical performance.

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