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Asia-Pacific Association for the Study of the Liver published the guidelines on management of ascites in liver disease in May 2023, which introduces the diagnosis, differential diagnosis, and treatment of ascites, hyponatremia, hepatic hydrothorax, and hepatorenal syndrome in patients with liver cirrhosis and acute-on-chronic liver failure. This article summarizes the main recommendations in the guidelines, so as to provide a reference for the treatment of ascites in patients with liver diseases in China.
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ObjectiveTo investigate the efficacy of percutaneous transhepatic variceal embolization (PTVE) alone or in combination with partial splenic embolization (PSE) in the treatment of portal hypertensive hemorrhage in liver cirrhosis through a meta-analysis. MethodsThis study was conducted according to PRISMA guideline, with a PROSPERO registration number of CRD42023396690. Wanfang Med Online, CNKI, CBM, VIP Databases, PubMed, Embase, the Cochrane Library, and Web of Science databases were searched for articles on PTVE alone or in combination with PSE in the treatment of portal hypertensive hemorrhage in liver cirrhosis published up to December 23, 2022. The articles were selected based on inclusion and exclusion criteria, and related data were extracted. The RevMan 5.4.1 statistical analysis software was used to perform the meta-analysis. ResultsEight articles were finally included, with a total sample size of 592 cases, among which there were 316 cases in the PTVE+PSE group and 276 cases in the PTVE group. The meta-analysis showed that compared with the PTVE group, the PTVE+PSE group had significantly lower postoperative portal vein pressure (standardized mean difference [SMD]=-1.75, 95% confidence interval [CI]: -2.33 to -1.16, P<0.05), postoperative diameter of the portal vein (SMD=-0.87, 95%CI: -1.64 to -0.10, P<0.05), postoperative rebleeding rate (odds ratio [OR]=0.17, 95%CI: 0.11 — 0.28, P<0.05), mortality rate (OR=0.13, 95%CI: 0.04 — 0.37, P<0.05), and incidence rate of postoperative portal hypertensive gastrointestinal disease (OR=0.17, 95%CI: 0.07 — 0.45, P<0.05], as well as a significantly higher postoperative platelet level (SMD=0.79, 95%CI: 0.52 — 1.06, P<0.05), while there were no significant differences between the two groups in the incidence rates of postoperative ascites. ConclusionCompared with PTVE alone, PTVE combined with PSE can effectively reduce the rebleeding rate and mortality rate of portal hypertensive hemorrhage in liver cirrhosis, the incidence rate of portal hypertensive gastrointestinal disease, and portal vein pressure, and it can also shorten the diameter of the portal vein and increase platelet level. Therefore, it is an effective interventional method for the treatment of portal hypertension hemorrhage in liver cirrhosis.
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Objective:To investigate the current situation of the use of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension, which should aid the development of TIPS in China.Methods:The China Portal Hypertension Alliance (CHESS) initiated this study that comprehensively investigated the basic situation of TIPS for portal hypertension in China through network research. The survey included the following: the number of surgical cases, main indications, the development of Early-TIPS, TIPS for portal vein cavernous transformation, collateral circulation embolization, intraoperative portal pressure gradient measurement, commonly used stent types, conventional anticoagulation and time, postoperative follow-up, obstacles, and the application of domestic instruments.Results:According to the survey, a total of 13 527 TIPS operations were carried out in 545 hospitals participating in the survey in 2021, and 94.1% of the hospital had the habit of routine follow-up after TIPS. Most hospitals believed that the main indications of TIPS were the control of acute bleeding (42.6%) and the prevention of rebleeding (40.7%). 48.1% of the teams carried out early or priority TIPS, 53.0% of the teams carried out TIPS for the cavernous transformation of the portal vein, and 81.0% chose routine embolization of collateral circulation during operation. Most of them used coils and biological glue as embolic materials, and 78.5% of the team routinely performed intraoperative portal pressure gradient measurements. In selecting TIPS stents, 57.1% of the hospitals woulel choose Viator-specific stents, 57.2% woulel choose conventional anticoagulation after TIPS, and the duration of anticoagulation was between 3-6 months (55.4%). The limitation of TIPS surgery was mainly due to cost (72.3%) and insufficient understanding of doctors in related departments (77.4%). Most teams accepted the domestic instruments used in TIPS (92.7%).Conclusions:This survey shows that TIPS treatment is an essential part of treating portal hypertension in China. The total number of TIPS cases is far from that of patients with portal hypertension. In the future, it is still necessary to popularize TIPS technology and further standardize surgical indications, routine operations, and instrument application.
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Transjugular intrahepatic portosystemic shunt (TIPS) has been recommended as a treatment method for cirrhotic portal hypertension in domestic and foreign guidelines, but there is still uncertainty in its therapeutic efficacy. More and more studies have shown that TIPS combined with collateral vessel embolization (TIPS+E) has certain advantages in the treatment of gastroesophageal variceal bleeding in liver cirrhosis. This article reviews the major studies on TIPS+E in China and globally, summarizes related recommendations in guidelines and the current status of clinical application, and proposes the issues that need to be solved, such as indication, hemodynamic criteria, and selection of materials for embolization, and large-sample multicenter randomized controlled trials are needed for further clarification.
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Gastric varices (GV) is one of the complications of portal hypertension, it has a lower incidence than esophageal varices, but bleeding from GV is not easy to control, and GV is associated with a high rebleeding rate and high mortality. GV has different characteristics of vascular anatomy and hemodynamics from esophageal varices, with a unique corresponding clinical management strategy. In order to deepen the understanding of GV hemodynamic characteristics and develop an individualized treatment strategy for GV bleeding, Digestive Minimally Invasive Intervention Collaborative Group, Chinese Society of Gastroenterology, Chinese Medical Association invited experts in this field to develop this consensus.
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According to the current domestic laws and regulations of the medical devices classification management, combined with the characteristics of digital therapeutics products and the existing status of classification management of medical software products in China, and drawing on international classification management experience, this study discusses and analyzes the attribute definition and classification of digital therapeutics software products, with a view to provide reference for the classification management of digital therapeutics software products.
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China , SoftwareABSTRACT
Objective:To investigate the feasibility and safety of endoscopic ultrasound (EUS)-guided intrahepatic portal vein puncture through jugular vein implantation in transjugular intrahepatic portosystemic shunt (TIPS).Methods:As research subjects, 5 beagle dogs were anesthetized, and EUS was placed through the jugular vein to observe the intrahepatic portal vein. Under real-time guidance, the portal vein was punctured and a stent was placed to complete the TIPS.Results:Among the 5 beagles, EUS was unable to be placed in 1 due to the small diameter of the external jugular vein, and it was implanted successfully in 4 others through the external jugular vein who underwent real-time guidance of portal vein puncture. Subsequent stent placement and balloon dilation were completed. All animals survived after the experiment.Conclusion:EUS-guided intrahepatic portal vein puncture through jugular vein implantation is safe and feasible in TIPS.
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Here, we took base construction of neurosurgery as example to discuss and analyze according to requirements and evaluation indexes of base construction in Xinqiao Hospital, and put forward the specific objectives, measures and implementations of base construction. Foremost, we summarized experiences and overcame shortcomings through interpreting and implementing scheme of our base construction, which would help to improve the construction of standardized residency training base in China.
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Objective:To observe whether α1 adrenergic receptor (α1AR) blocker can reduce and antagonize portal hypertension caused by α1AR activation in rats, and to provide a new approach for the clinical treatment of portal hypertension.Methods:Phenylephrine was chosen as α1AR agonist, and alfuzosin was used as α1AR blocker. The route of administration was portal vein injection, and the pressure was measured by trans-portal vein puncture. According to random number table, 32 male Sprague-Dawley rats were divided into 4 groups: control group, portal hypertension model group, alfuzosin treatment group and alfuzosin prevention group. The portal venous pressure (PVP) was measured in all rats before administration. The rats in the control group were injected with 0.9% sodium chloride solution (1 L/g), and the rats in portal hypertension model group were injected with phenylephrine(1.5 μg/g), and the PVP of the above two groups was measured again at 5 and 10 min after injection. The rats in alfuzosin treatment group were injected with phenylephrine(1.5 μg/g), PVP was measured again at 5 min after administration, and then the rats were given alfuzosin(0.9 μg/g), PVP was measured again at 5 min after administration. The rats in alfuzosin prevention group were injected with alfuzosin(0.9 μg/g), PVP was measured at 1 min after administration, and then the rats were given phenylephrine(1.5 μg/g), PVP was measured again at 1, 5 and 10 min after phenylephrine injection respectively. One way analysis of variance and Dunnett- t test were used for statistical analysis. Results:The portal vein puncture was successfully performed in 4, 6, 8 and 5 rats in the control group, portal hypertension model group, alfuzosin treatment group and alfuzosin prevention group, respectively. The PVP of rats in portal hypertension model group at 5 and 10 min after phenylephrine injection was (18.045±7.636) and (15.515±5.440) mmHg (1 mmHg = 0.133 kPa), respectively, which were both higher than that before administration ((8.452±2.830) mmHg), and the differences were statistically significant ( t=2.89 and 2.82, both P<0.05). At 5 min after alfuzosin injection, the PVP of rats in the alfuzosin treatment group was (10.088±3.743) mmHg, which was lower than that of rats at 5 min after phenylephrine injection ((16.146±4.324) mmHg) and that of portal hypertension model group at 10 min after phenylephrine injection, and the differences were statistically significant ( t=3.00 and 2.22, both P<0.05). There were no significant differences in PVP in the alfuzosin prevention group before administration, at 1 min after injection of alfuzosin, and at 1, 5 and 10 min after injection of phenylephrine (all P > 0.05). Conclusions:α1AR is an important factor involved in the regulation of PVP, and its blockers can reduce and antagonize the portal hypertension caused by α1AR activation, which is of great significance in the prevention and treatment of portal hypertension progression in liver cirrhosis.
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ObjectiveTo investigate the technical success rate and outcome of transjugular intrahepatic portosystemic shunt (TIPS) in preventing esophageal variceal rebleeding in patients with portal vein thrombosis (PVT) after splenectomy. MethodsA retrospective analysis was performed for the clinical data of 46 patients with PVT after splenectomy who were admitted to Shandong Provincial Hospital from December 2009 to January 2017 and underwent TIPS to prevent esophageal variceal rebleeding. According to the success or failure of TIPS, the patients were divided into TIPS success group with 38 patients and TIPS failure group with 8 patients. The two groups were compared in terms of postoperative variceal rebleeding, stent dysfunction, hepatic encephalopathy (HE), and survival. The paired t-test was used for comparison of continuous data between two groups, and the chi-square test was used for comparison of categorical data between two groups. The Kaplan-Meier curve was used to analyze variceal rebleeding-free rate, stent patency rate, HE-free rate, and survival rate, and the log-rank test was used for comparison of cumulative rebleeding-free rate and cumulative survival rate. ResultsThe technical success rate of TIPS was 82.6%. There were significant differences in 6-, 12-, and 24-month cumulative rebleeding-free rates between the TIPS success group and the TIPS failure group (94.3%/89.8%/89.8% vs 85.7%/85.7%/28.6%, χ2=4.563, P=0.033). In the TIPS success group, the 6-, 12-, and 24-month cumulative stent patency rates were 79.3%, 74.3%, and 69.0%, respectively, and the 6-, 12-, and 24-month cumulative HE-free rates after TIPS were 72.1%, 55.5%, and 55.5%, respectively. There were significant differences in 6-, 12-, and 24-month cumulative survival rates between the TIPS success group and the TIPS failure group (94.0%/94.0%/86.2% vs 714%/71.4%/71.4%, χ2=4.988, P=0.026). ConclusionTIPS is a safe and feasible method for preventing esophageal variceal rebleeding in patients with PVT after splenectomy, and TIPS combined with a percutaneous transhepatic approach may promote technical success.
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OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
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China , United States , United States Food and Drug AdministrationABSTRACT
Esophageal and gastric variceal bleeding (EGVB) is a serious complication of portal hypertension, and it is necessary to control the progression of esophageal and gastric varices in clinical practice and prevent and treat EGVB; however, the mortality rate associated with variceal rupture and bleeding remains high at present. As for clinical treatment, risk classification of patients should be performed based on clinical and hemodynamic features and individualized treatment should be adopted, taking into account the balance of "embolization, shunt, and perfusion" of portal hypertension, so as to improve the clinical outcome and prognosis of patients with liver cirrhosis.
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We strive to explore a student-centered evaluation system focused on improving students' learning efficiency and learning effect. Through classroom questioning, discussion of difficult cases, new progress report, question bank test, writing of clerkship notes, simulated inquiry between students with bedside inquiry, physical examination between students with bedside physical examination, operation training of basic clinical skills, direct observation and evaluation of clinical skills, mini-clinical exercise evaluation, graduation examination and other measures, an evaluation system for promoting learning by class evaluation, clerkship evaluation and practice evaluation has been established to cultivate the connotation construction of medical moral quality and clinical practice ability of medical students, and further promote the mastery of basic theoretical knowledge and clinical operation skills. By comparing the results of the phased examination for medical practitioners, the passing rate of 2018 is significantly higher than that of 2017, with 23.31% increased passing rate of theoretical results, and 0.79% increased passing rate of skills operation results. It can be seen that the evaluation system for promoting learning has played a guiding role in the teaching practice of clinical courses in our hospital.
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Objective To evaluate the efficacy and safety of X-ray guided endoscopic gastrojejunostomy using stent in treatment of malignant gastric outlet obstruction ( GOO ) . Methods Six hospitalized patients with malignant GOO underwent X-ray guided endoscopic gastrojejunostomy using stent in the department of gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University between March 2017 and June 2017. The technical success rate, clinical success rate, procedure time, adverse events and follow-up were recorded and analyzed in this retrospective study. Results The stent was successfully placed in the 6 patients with 100% ( 6/6) technical success rate. The mean procedure time was 91. 7±51. 8 min. After the procedure, all patients were fed liquid or semi-liquid diet, and the GOO score system was increased from 0-1 before operation to 2-3 after operation. The clinical success rate was 100%(6/6). Peritonitis was observed in 2 patients during operation, and resolved by abdominal drainage. Gastrointestinal bleeding occurred in 1 patient after operation, which was resolved with conservative treatment. During a mean follow-up period of 78. 6 days (range 32-100 days), there was no recurrence of obstruction symptoms except that 1 patient died because of tumor progress 60 days after procedure. Conclusion The X-ray guided endoscopic gastrojejunostomy using stent is feasible and safe to treat malignant GOO with a reliable short-term efficacy.
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The formation of cirrhotic portal hypertension depends on the increase in intrahepatic vascular resistance and the state of hyperdynamic circulation. The specific effect of carvedilol in reducing intrahepatic vascular resistance has a better effect in alleviating portal hypertension in theory. This article summarizes the known and possible mechanisms of carvedilol in reducing portal hypertension and reviews the latest research advances in the role of carvedilol in the treatment of cirrhotic portal hypertension. It is pointed out that carvedilol is expected to become the core drug in the treatment of cirrhotic portal hypertension, and statins may be their best partner.
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Based on the developing situation of Computer Aided Diagnosis/Detection (CAD) software, considering the domestic and international regulation of CAD software, according to current Medical Device Classification Catalog and related laws of China Food and Drug Administration (CFDA), this paper investigated and analyzed the classification of CAD software, and provided technical suggestion on classifying principle of CAD software applying Artificial Intelligence (AI) or other advanced technology from medical device regulation scope, for the reference of regulatory and technical departments.
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Artificial Intelligence , China , Diagnosis, Computer-Assisted , Radiographic Image Interpretation, Computer-Assisted , SoftwareABSTRACT
A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.
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China , Equipment Safety , Equipment and Supplies , United States , United States Food and Drug AdministrationABSTRACT
By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.
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Equipment and Supplies , Classification , European Union , Government Regulation , IndustryABSTRACT
Liver fibrosis is a pathological process in which chronic liver disease develops into liver cirrhosis. It is caused by diffuse proliferation of liver fibrous tissue on the basis of extensive necrosis of liver cells, resulting in destruction of the normal structure and blood supply of liver lobules. In the process of liver fibrosis, platelets aggregate in the sinusoids to form microthrombi, which may promote liver fibrosis. This article briefly describes the relationship between platelets and liver fibrosis and reviews the latest advances in anticoagulant therapy for improving liver function and liver fibrosis score. The molecular mechanism of anticoagulant therapy remains to be studied, and safe and effective anticoagulants may provide a new approach for the treatment of liver fibrosis.
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Objective@#To study the epidemiologic and genetic characteristics of coxackievirus A6(CV-A6) strains isolated in Shenyang.@*Methods@#Enterovirus strains positive for neither enterovirus A71 (EV-A71) nor CV-A16 were isolated from Shenyang during 2013 to 2017 to screen for CV-A6 isolates by real-time PCR. The entire sequences of viral genes encoding VP1 of CV-A6 positive samples were amplified and sequenced. The phylogenetic analysis was performed.@*Results@#CV-A6 strains accounted for 27.83% (575/2 066) of the non-EV-A71 and non-CV-A16 enterovirus strains isolated in Shenyang during the years 2013 to 2017. And CV-A6 strains were the predominant enterovirus strains with positive rate of 68.38 % (240/351) in 2015. The CV-A6 isolates from Shenyang during 2013 to 2017 could be classified into the cluster D3a in the phylogenetic tree. Subtype D3a.1 strains circulated during 2013 to 2014 and subtype D3a.2 strains circulated during 2015 to 2017.@*Conclusions@#CV-A6 strains were the predominant enterovirus strains among non-EV-A71 and non-CV-A16 enterovirus strains circulated in Shenyang from 2013 to 2017. The CV-A6 isolates from Shenyang during 2013 to 2017 could be classified into the cluster D3a in the phylogenetic tree and subtype D3a.2 strains were evolved from subtype D3a.1 strains.