1.Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin CUI ; Hongchun ZHANG ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xuefeng YU ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):218-224
As an exclusive Miao medicine of Honwing Pharma (Guizhou) Co. Ltd., Yifei Zhike capsules are both a prescription drug and an over-the-counter (OTC) drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs, as well as relieving cough and reducing phlegm, Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis, pulmonary tuberculosis, and other diseases. However, there is insufficient understanding of their efficacy, suitable syndromes, and safety in clinical practice, with a lack of relevant expert consensus on clinical application. To standardize their clinical application, 30 experts from the fields of respiratory medicine, pharmacy, and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules (Consensus for short) through evidence-based medicine methods. The Consensus clarified the syndrome characteristics, disease stages, dosages, treatment courses, combined medication, and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis, it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients, increase the sputum smear conversion rate, and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections, Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile, recommendations for specific usage, dosages, and treatment courses were given for different diseases, and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety, the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions, and pregnant women and women during menstruation were prohibited from using it. In addition, modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However, further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules, which helps to improve clinical efficacy and reduce medication risks.
2.Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin CUI ; Hongchun ZHANG ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xuefeng YU ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):218-224
As an exclusive Miao medicine of Honwing Pharma (Guizhou) Co. Ltd., Yifei Zhike capsules are both a prescription drug and an over-the-counter (OTC) drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs, as well as relieving cough and reducing phlegm, Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis, pulmonary tuberculosis, and other diseases. However, there is insufficient understanding of their efficacy, suitable syndromes, and safety in clinical practice, with a lack of relevant expert consensus on clinical application. To standardize their clinical application, 30 experts from the fields of respiratory medicine, pharmacy, and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules (Consensus for short) through evidence-based medicine methods. The Consensus clarified the syndrome characteristics, disease stages, dosages, treatment courses, combined medication, and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis, it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients, increase the sputum smear conversion rate, and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections, Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile, recommendations for specific usage, dosages, and treatment courses were given for different diseases, and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety, the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions, and pregnant women and women during menstruation were prohibited from using it. In addition, modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However, further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules, which helps to improve clinical efficacy and reduce medication risks.
3.Compilation Instructions for Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin LI ; Hongchun ZHANG ; Xuefeng YU ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xin CUI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):143-148
The compilation instructions for the Expert Consensus on Clinical Application of Yifei Zhike Capsules systematically expound the development background, methodological framework, and core achievements of this consensus. In view of the problems existing in the clinical application of Yifei Zhike Capsules, such as insufficient efficacy evidence and lack of standardized syndrome differentiation, the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences took the lead and collaborated with 21 tertiary grade-A hospitals and research institutions across China to form a multidisciplinary expert group (comprising 30 experts in clinical medicine, pharmacy, and methodology). The compilation work was carried out in strict accordance with the World Health Organization (WHO) guidelines, the GB/T 1.1-2020 standard, and the writing specifications for the explanatory notes of expert consensus on clinical application of Chinese patent medicines. Through systematic literature retrieval (including 32 studies, with 24 clinical studies), Grading of Recommendations Assessment, Development and Evaluations (GRADE)-based evidence grading, and multiple rounds of discussions using the nominal group method (25 experts voted to determine 17 clinical questions), 5 evidence-based recommendations and 11 expert consensus suggestions were formed. It is clarified that this medicine (Yifei Zhike Capsules) is applicable to the treatment of expectoration/hemoptysis in acute and chronic bronchitis and the adjuvant treatment of pulmonary tuberculosis. It is recommended that it can be used alone or in combination with anti-tuberculosis drugs. The safety evaluation shows that this medicine mainly induces the following adverse reactions: mild gastrointestinal reactions (such as nausea and abdominal pain) and rashes. The contraindicated populations include pregnant women and women during menstruation. The compilation process of the consensus underwent three rounds of expert letter reviews, two rounds of peer reviews, and quality control assessments to ensure methodological rigor and clinical applicability. In addition, through policy alignment, academic promotion, and a dynamic revision mechanism, the standardization of clinical application was promoted, providing a demonstration for the evidence-based transformation of characteristic therapies of Miao medicine.
4.Study on the risk for cerebrovascular disease among subtypes of middle-aged and elderly type 2 diabetes mellitus patients aged between 35‒74 years in Shanghai suburbs
Chengjun ZHANG ; Qiu XIAO ; Zhenqiu LIU ; Chen SUO ; Tiejun ZHANG ; Genming ZHAO ; Yanfeng JIANG ; Kelin XU ; Xingdong CHEN
Shanghai Journal of Preventive Medicine 2024;36(12):1148-1156
ObjectiveTo classify subtypes among middle-aged and elderly type 2 diabetes mellitus (T2DM) patients aged between 35‒74 years in Shanghai suburbs, to compare their characteristics and analyze incidence risk for cerebrovascular disease among these subtypes, so as to promote personalized and precise treatment of T2DM. MethodsA total of 7 792 patients with T2DM who completed a baseline survey from 2016 and 2019 were selected as the research subjects, based on the data from a natural population cohort and biobank in Shanghai suburbs. Patients were stratified by gender and clustered into subtypes using k-means method based on baseline parameters including the age at T2DM diagnosis, body mass index (BMI), fasting blood glucose, and triglyceride to high-density lipoprotein cholesterol ratio (TG/HDL-C). Patients were followed up until March 31, 2023. Multivariate Cox regression models were used to analyze the association between subtypes and incidence risk for cerebrovascular disease, and those with cerebrovascular disease within 1 year of follow-up survey were excluded from sensitivity analysis. ResultsAmong the 7 792 patients with T2DM, 3 615 were males and 4 177 were females. Stratified by gender, 4 subgroups were identified through k-means clustering analysis, namely poor blood glucose control subgroup, severe insulin-resistant subgroup, younger onset subgroup, and older onset subgroup. The median follow-up time was 4.30 years, during which 1 960 cerebrovascular disease events were observed (844 in males, 1 116 in females). After adjusting for smoking, alcohol consumption, weekly exercise, family history of diabetes mellitus, and duration of diabetes mellitus, among male patients, the incidence risk for cerebrovascular disease was lower in the younger onset subgroup (HR=0.59, 95%CI: 0.48‒0.73, P<0.001), poor blood glucose control subgroup (HR=0.81, 95%CI: 0.65‒1.00, P=0.046), and severe insulin-resistant subgroup (HR=0.61, 95%CI: 0.50‒0.75, P<0.001), compared to the older onset subgroup. While among female patients, the incidence risk for cerebrovascular disease was also lower in the younger onset subgroup (HR=0.68, 95%CI: 0.57‒0.80, P<0.001), poor blood glucose control subgroup (HR=0.73, 95%CI: 0.60‒0.89, P=0.002), and severe insulin-resistant subgroup (HR=0.72, 95%CI: 0.61‒0.85, P<0.001), compared to the older onset subgroup. Results of the sensitivity analysis were consistent with the main findings. ConclusionAmong middle-aged and elderly T2DM patients in suburban Shanghai, both male and female patients have the highest incidence risk for cerebrovascular disease in the older onset subgroup. Subtyping of T2DM patients can help to identify the high-risk populations of cerebrovascular disease.
5.Discussion on Pathogenesis of Skeletal Muscle Cell Ferroptosis and Syndrome Differentiation and Treatment of Type 2 Diabetes Mellitus Sarcopenia Based on"Spleen Governing Transportation and Transportation and Governing Muscle"
Pin LI ; Ningzi ZANG ; Chengjun GONG ; Weiying DUAN ; Shuang ZHANG ; Libin ZHAN ; Tianshu GAO ; Jing LYU
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(7):1668-1674
The aging disease associated with type 2 diabetes mellitus(T2DM)is a hot research topic in the field of diabetes at present.Sarcopenia has become the third major complication of T2DM after microvascular and macrovascular diseases,which could lead to the occurrence and development of various adverse events such as fracture,disability,and dysfunction.The spleen belongs to the earth,is in the middle jiao,governs transportation and transformation,and governs muscle.The functional activities of the spleen manifesting in normal transformation and transportation,the distribution of cereal essence,and the nourishment of muscles are necessary for normal physiological functions to be exerted.Recent studies have shown that skeletal muscle cell ferroptosis plays an important role in the pathogenesis of T2DM sarcopenia.Based on the theory of"spleen governing transportation and transportation and governing muscle",this study explores the pathogenesis of T2DM sarcopenia from the perspectives of the pathogenesis of"dysfunction of spleen in transportation,deficiency of cereal essence,obstruction of dampness and turbidity,and muscle dystrophy"in traditional Chinese medicine and the pathological mechanism of"skeletal muscle cell ferroptosis"in modern medicine.It summarizes the principles of traditional Chinese medicine prevention and treatment for T2DM sarcopenia based on the spleen,to provide theoretical support for enriching the theoretical connotation of spleen visceral state,as well as basic research and clinical trials on the prevention and treatment of T2DM sarcopenia with traditional Chinese medicine.
6.Establishment of a risk prediction model for cerebrogenic multiple organ dysfunction syndrome in patients with acute cerebral hemorrhage
Huaibiao WU ; Hao ZHANG ; Chengjun GUO
Chinese Critical Care Medicine 2024;36(9):966-971
Objective:To construct and validate a predictive model for the risk of cerebrogenic multiple organ dysfunction syndrome (CMODS) in patients with acute cerebral hemorrhage.Methods:Clinical data of 93 patients with acute cerebral hemorrhage admitted to Wannan Rehabilitation Hospital from January 2019 to June 2023 were retrospectively analyzed. Data included baseline information, disease severity score, laboratory examination indicators, cerebral hemorrhage status, treatment status, etc. Patients were divided into CMODS group and non-CMODS group according to whether CMODS occurred during hospitalization. The clinical data of the two groups were compared. Multivariate Logistic regression was used to analyze the risk factors of CMODS in patients with acute cerebral hemorrhage. A nomogram model was constructed to predict the risk of CMODS in patients with acute cerebral hemorrhage, and the model was validated. Receiver operator characteristic curve (ROC curve) was used to evaluate the predictive efficiency of nomogram model for CMODS in patients with acute cerebral hemorrhage.Results:A total of 93 patients with acute cerebral hemorrhage were enrolled, including 26 patients in CMODS group and 67 patients in non-CMODS group. Compared with the non-CMODS group, the ratio of diabetes, acute physiological and chronic health evaluationⅡ(APACHEⅡ)≥35 score, cerebral hemorrhage volume ≥30 mL, endotoxemia, and national institutes of health stroke scale (NIHSS) and intracranial pressure of patients in the CMODS group were significantly higher, while the Glasgow coma score (GCS) was significantly lower and the length of hospital stay was significantly longer, with statistically significant differences (all P < 0.05). Multivariate Logistic regression analysis showed that diabetes mellitus [odds ratio ( OR) = 3.615, 95% confidence interval (95% CI) was 1.487-8.785, P = 0.000], APACHEⅡscore ( OR = 4.697, 95% CI was 1.933-11.416, P = 0.000), endotoxemia ( OR = 4.577, 95% CI was 1.883-11.123, P = 0.000), and cerebral hemorrhage volume ( OR = 4.039, 95% CI was 1.662-9.816, P = 0.000) were the risk factors for CMODS in patients with acute cerebral hemorrhage. Taking the above risk factors as predictive variables, a nomogram prediction model was established. The verification results of the nomogram model showed that the C index was 0.804 (95% CI was 0.768-0.841), and the calibration curve was close to the ideal curve with good fit ( P > 0.05). ROC curve results showed that the sensitivity and specificity of the nomogram model in predicting CMODS in patients with acute cerebral hemorrhage were 76.92%, 86.57%, respectively, and the area under the ROC curve (AUC) was 0.855 (95% CI was 0.776-0.935). Conclusions:Diabetes mellitus, APACHEⅡscore, endotoxemia and intracerebral hemorrhage are risk factors for CMODS in patients with acute cerebral hemorrhage. The risk prediction model based on these risk factors is effective in evaluating the risk of CMODS in patients with acute cerebral hemorrhage.
7.Study on the sensitivity of a volumetric modulated arc therapy plan verification equipment on multi-leaf collimator opening and closing errors and its gamma pass rate limit.
Jinyou HU ; Lian ZOU ; Shaoxian GU ; Ningyu WANG ; Fengjie CUI ; Shengyuan ZHANG ; Chu'ou YIN ; Yunzhu CAI ; Chengjun GOU ; Zhangwen WU
Journal of Biomedical Engineering 2023;40(1):133-140
To investigate the γ pass rate limit of plan verification equipment for volumetric modulated arc therapy (VMAT) plan verification and its sensitivity on the opening and closing errors of multi-leaf collimator (MLC), 50 cases of nasopharyngeal carcinoma VMAT plan with clockwise and counterclockwise full arcs were randomly selected. Eight kinds of MLC opening and closing errors were introduced in 10 cases of them, and 80 plans with errors were generated. Firstly, the plan verification was conducted in the form of field-by-field measurement and true composite measurement. The γ analysis with the criteria of 3% dose difference, distance to agreement of 2 mm, 10% dose threshold, and absolute dose global normalized conditions were performed for these fields. Then gradient analysis was used to investigate the sensitivity of field-by-field measurement and true composite measurement on MLC opening and closing errors, and the receiver operating characteristic curve (ROC) was used to investigate the optimal threshold of γ pass rate for identifying errors. Tolerance limits and action limits for γ pass rates were calculated using statistical process control (SPC) method for another 40 cases. The error identification ability using the tolerance limit calculated by SPC method and the universal tolerance limit (95%) were compared with using the optimal threshold of ROC. The results show that for the true composite measurement, the clockwise arc and the counterclockwise arc, the descent gradients of the γ passing rate with per millimeter MLC opening error are 10.61%, 7.62% and 6.66%, respectively, and the descent gradients with per millimeter MLC closing error are 9.75%, 7.36% and 6.37%, respectively. The optimal thresholds obtained by the ROC method are 99.35%, 97.95% and 98.25%, respectively, and the tolerance limits obtained by the SPC method are 98.98%, 97.74% and 98.62%, respectively. The tolerance limit calculated by SPC method is close to the optimal threshold of ROC, both of which could identify all errors of ±2 mm, while the universal tolerance limit can only partially identify them, indicating that the universal tolerance limit is not sensitive on some large errors. Therefore, considering the factors such as ease of use and accuracy, it is suggested to use the true composite measurement in clinical practice, and to formulate tolerance limits and action limits suitable for the actual process of the institution based on the SPC method. In conclusion, it is expected that the results of this study can provide some references for institutions to optimize the radiotherapy plan verification process, set appropriate pass rate limit, and promote the standardization of plan verification.
Humans
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Radiotherapy, Intensity-Modulated
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Immune Tolerance
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Nasopharyngeal Carcinoma
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ROC Curve
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Nasopharyngeal Neoplasms/radiotherapy*
8.Mechanism of "Sanyang" combined therapy of traditional Chinese medicine in alleviating colonic injury in mice induced by influenza virus based on transcriptome sequencing technique
Yanan ZHANG ; Jun YAN ; Liqiong SONG ; Yuanming HUANG ; Chang LIU ; Guoxing LIU ; Jintong LI ; Yue ZHANG ; Mingzhe WANG ; Zhiguang ZHAI ; Chengxiang WANG ; Lishan ZHANG ; Chengjun BAN ; Wenbo XU ; Miao CHENG
Chinese Journal of Experimental and Clinical Virology 2023;37(2):159-167
Objective:To explore the mechanism of Ma-Xing Shi-Gan decoction combined with Xiao-Chai-Hu decoction (hereinafter referred to as " Sanyang combined treatment" ) in alleviating colon injury in mice infected with influenza virus by transcriptome sequencing technique.Methods:The mouse model of colonic injury caused by influenza virus was induced by intranasal drip of influenza A virus H1N1 suspension. The mice were divided into Control group, Model group, and Sanyang combined treatment (SCT) group. Model group and SCT group were fed with PBS and Ma-Xing Shi-Gan decoction combined with Xiao-Chai-Hu decoction respectively. Seven days later, the colon tissues of each group were taken, the colon length and pathological damage were observed, and the transcriptome was sequenced to screen the significantly different genes between the SCT group and model group for Gene Ontology (GO), Kyoto Encyclopedia of Genes and Genomes (KEGG) and Gene Set Enrichment Analysis(GSEA).Results:After the therapy with SCT, the length of the colon of mice was significantly improved and the pathological injury of the colon was reduced. There are 92 differentially expressed genes between the SCT group and the model group. GO analysis indicated that the differential genes were enriched in biological processes such as regulation of cytokine and chemokine production, inflammatory response, defense response, immune response, regulation of NF-κB inducing kinase(NIK)/Nuclear factor-κB(NF-κB) signal and Mitogen-activated protein kinase(MAPK) cascade, as well as cell components related to intestinal barrier such as brush border membrane, brush border and microvilli. KEGG analysis indicated that the differential genes were enriched in Toll-like receptor signaling pathway, intestinal immune network for IgA production, complement and coagulation cascade, and Peroxisome proliferator-activated receptor(PPAR) signaling pathway. GSEA indicated that the intestinal immune network for IgA production, PPAR signaling pathway, propionic acid metabolism and butyrate metabolism were significantly up-regulated after the intervention with SCT, while apoptosis and MAPK signaling pathway were significantly down-regulated.Conclusions:Sanyang combined therapy can protect the intestinal tract of mice infected with influenza virus mainly through immunity, inflammation and metabolism pathways.
9.A multi-center survey of medical staffs′ cognition and management of prolonged mechanical ventilation in pediatric intensive care unit
Pan LIU ; Zhengzheng ZHANG ; Yi ZHANG ; Hengmiao GAO ; Hong REN ; Dong QU ; Wei XU ; Chengjun LIU ; Hongjun MIAO ; Li HUANG ; Zihao YANG ; Furong ZHANG ; Yibing CHENG ; Guoping LU ; Weiming CHEN
Chinese Pediatric Emergency Medicine 2022;29(5):347-352
Objective:To investigate the status of cognition and clinical management of prolonged mechanical ventilation(PMV) among medical staffs in pediatric intensive care unit(PICU) in China, and in order to improve the awareness of PICU medical staffs on PMV and standardize the management of PMV.Methods:The cross-sectional study was conducted with doctors and nurses in PICUs of the collaborative group as the survey objects from July 12 to September 12, 2020.The questionnaire was issued, collected and checked by the Children′s Hospital of Fudan University.Results:(1) PMV related settings: Nine out of eleven hospitals had established PMV multidisciplinary teams, respiratory techniques such as diaphragm ultrasound and airway peak flow monitoring could be respectively executed in 72.7% and 36.4% of PICU.Pulmonary rehabilitation techniques such as airway clearance techniques, induced spirometer exercise, external diaphragm pacemaker stimulation, transfer bed exercise, balloon blowing, hyperbaric oxygen therapy could be respectively executed in 100.0%, 9.1%, 9.1%, 9.1%, 27.3% and 27.3% of PICU, respectively.(2) The cognitive status quo of children′s PMV: The most medical staffs agreed with the view that PMV referred to the children′s continuous mechanical ventilation for more than two weeks.Sixty percent of medical staffs believed that children with PMV had basic central nervous system diseases, and 62.7% of medical staffs believed that the most common causes of difficulty in PMV weaning was abnormal brain function.(3) The cognitive status quo of the children′s PMV management in PICU: Respondents believed that the most commonly used mechanical ventilation mode was synchronized intermittent mandatory ventilation+ pressure support ventilation in children′s PMV during stable disease.Ninety-two percent of medical staffs performed the spontaneous breathing test when weaning.And 58.7% of the respondents agreed to perform tracheotomy for the children during 3 to 4 weeks of mechanical ventilation.More than half of medical staffs would execute diaphragm function assessment, bedside rehabilitation training, nutritional assessment, analgesia and sedation assessment for children with PMV.(4) The cognitive status quo of the children′s PMV management of transition from hospital to family: 54.5% of PICU provided family care training to the family members before the children were discharged from the hospital.One center established the PMV specialized outpatient clinic.45.5% of PICU would follow up these discharged children one month later.Conclusion:At present, PICU medical staffs have different awareness of children′s PMV related problems in China.And children′s PMV lacks a systematic plan regarding diagnosis, treatment and management.
10.Technical points of 4K laparoscopic intersphincteric resection of low rectal cancer
Linfeng GAO ; Chuan LI ; Xiaosong WANG ; Fan ZHANG ; Chengjun TAN ; Peiwu YU ; Bo TANG
Chinese Journal of Digestive Surgery 2021;20(S1):63-66
Intersphincteric resection (ISR) is a limited sphincter preserving surgery for low rectal cancer. The 4K laparoscopic system has the advantage of enhancing the accurate recognition of anatomical structures for operators. The authors investigate the imaging evaluation and technical standard of 4K laparoscopic ISR of low rectal cancer through surgical examples.

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