1.Key points of the international Kyoto guidelines for the management of intraductal papillary mucinous neoplasm of the pancreas (2023)
Jiasu LI ; Hongxin SUN ; Zhaoshen LI
Journal of Clinical Hepatology 2024;40(3):478-482
Recently, the International Association of Pancreatology published a revised edition of the guidelines for the management of intraductal papillary mucinous neoplasm (IPMN) of the pancreas. The guidelines mainly focus on five topics, i.e., revision of “high-risk stigmata” and “worrisome features”, surveillance of unresected IPMN, surveillance after resection of IPMN, revision of pathological aspects, and research on molecular markers in cyst fluid, in order to provide the best evidence-based reference for clinical practice. This article makes an excerpt of the key points in the guidelines.
2.A phase Ⅱ clinical study of the efficacy and safety of antaitasvir phosphate combined with yiqibuvir for the treatment of chronic hepatitis C in adults
Lai WEI ; Hongxin PIAO ; Jinglan JIN ; Shufen YUAN ; Xuan AN ; Jia SHANG ; Wenhua ZHANG ; Jiabao CHANG ; Tong SUN ; Yujuan GUAN ; Bo NING ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2024;32(7):637-642
Objective:To evaluate the efficacy and safety of antaitasvir phosphate 100 mg or 200 mg combined with yiqibuvir for 12 weeks in patients with various genotypes of chronic hepatitis C, without cirrhosis or compensated stage cirrhosis.Methods:Patients with chronic hepatitis C (without cirrhosis or compensated stage cirrhosis) were randomly assigned to the antaitasvir phosphate 100 mg+yiqibuvir 600 mg group (100 mg group) or the antaitasvir phosphate 200 mg+yiqibuvir 600 mg group (200 mg group) in a 1∶1 ratio. The drugs were continuously administered once a day for 12 weeks and observed for 24 weeks after drug withdrawal. The drug safety profile was assessed concurrently with the observation of the sustained virological response (SVR12) in the two patient groups 12 weeks following the drug cessation. The intention-to-treat concept was used to define as closely as possible a full analysis set, including all randomized cases who received the experimental drug at least once. The safety set was collected from all subjects who received the experimental drug at least once (regardless of whether they participated in the randomization group) in this study. All efficacy endpoints and safety profile data were summarized using descriptive statistics. The primary efficacy endpoint was SVR12. The primary analysis was performed on a full analysis set. The frequency and proportion of cases were calculated in the experimental drug group (antaitasvir phosphate capsules combined with yiqibuvir tablets) that achieved "HCV RNA
3.Hepatocellular carcinoma prediction model performance decreases with long-term antiviral therapy in chronic hepatitis B patients
Xiaoning WU ; Xiaoqian XU ; Jialing ZHOU ; YaMeng SUN ; Huiguo DING ; Wen XIE ; Guofeng CHEN ; Anlin MA ; HongXin PIAO ; Bingqiong WANG ; Shuyan CHEN ; Tongtong MENG ; Xiaojuan OU ; Hwai-I YANG ; Jidong JIA ; Yuanyuan KONG ; Hong YOU
Clinical and Molecular Hepatology 2023;29(3):747-762
Background/Aims:
Existing hepatocellular carcinoma (HCC) prediction models are derived mainly from pretreatment or early on-treatment parameters. We reassessed the dynamic changes in the performance of 17 HCC models in patients with chronic hepatitis B (CHB) during long-term antiviral therapy (AVT).
Methods:
Among 987 CHB patients administered long-term entecavir therapy, 660 patients had 8 years of follow-up data. Model scores were calculated using on-treatment values at 2.5, 3, 3.5, 4, 4.5, and 5 years of AVT to predict threeyear HCC occurrence. Model performance was assessed with the area under the receiver operating curve (AUROC). The original model cutoffs to distinguish different levels of HCC risk were evaluated by the log-rank test.
Results:
The AUROCs of the 17 HCC models varied from 0.51 to 0.78 when using on-treatment scores from years 2.5 to 5. Models with a cirrhosis variable showed numerically higher AUROCs (pooled at 0.65–0.73 for treated, untreated, or mixed treatment models) than models without (treated or mixed models: 0.61–0.68; untreated models: 0.51–0.59). Stratification into low, intermediate, and high-risk levels using the original cutoff values could no longer reflect the true HCC incidence using scores after 3.5 years of AVT for models without cirrhosis and after 4 years of AVT for models with cirrhosis.
Conclusions
The performance of existing HCC prediction models, especially models without the cirrhosis variable, decreased in CHB patients on long-term AVT. The optimization of existing models or the development of novel models for better HCC prediction during long-term AVT is warranted.
4.Study on clearance of chlorfenapyr via blood purification (a case analysis)
Na MENG ; Yu GONG ; Yingli JIN ; Yiqing SUN ; Hongxin ZHANG ; Yingping TIAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(11):840-843
This paper analyzed the clinical data of a patient with acute oral emamectin·chlorfenapyr poisoning, and discussed the effect of blood purification therapy on chlorfenapyr poisoning. Chlorfenapyr was detected in the blood, urine, ultrafiltrate and plasma exchange fluid of the patient, and the concentrations of chlorfenapyr poison gradually decreased with time. Blood purification has a certain effect on chlorfenapyr, and early blood purification may be an effective measure to treat chlorfenapyr poisoning.
5.Study on clearance of chlorfenapyr via blood purification (a case analysis)
Na MENG ; Yu GONG ; Yingli JIN ; Yiqing SUN ; Hongxin ZHANG ; Yingping TIAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(11):840-843
This paper analyzed the clinical data of a patient with acute oral emamectin·chlorfenapyr poisoning, and discussed the effect of blood purification therapy on chlorfenapyr poisoning. Chlorfenapyr was detected in the blood, urine, ultrafiltrate and plasma exchange fluid of the patient, and the concentrations of chlorfenapyr poison gradually decreased with time. Blood purification has a certain effect on chlorfenapyr, and early blood purification may be an effective measure to treat chlorfenapyr poisoning.
6.A novel portable endoscopy system for upper gastrointestinal examination: a multicenter clinical study
Ting ZHANG ; Chunping ZHU ; Wenbin ZOU ; Enqiang LINGHU ; Wen WANG ; Yunfeng WANG ; Hongxin SUN ; Yuqiong LI ; Xiaoju SU ; Aiqiao FANG ; Zantao WANG ; Yinsuan JIANG ; Zhuan LIAO ; Zhaoshen LI
Chinese Journal of Digestive Endoscopy 2022;39(2):96-102
Objective:To evaluate the performance, efficacy and safety of a novel portable endoscopy system for upper gastrointestinal examination.Methods:A multicentered, open-label, randomized, non-inferiority controlled study was conducted in 3 clinical research centers from June 2019 to June 2020, and a total of 90 outpatients admitted to Department of Gastroenterology were randomly assigned to the trial group ( n=44) undergoing portable endoscopy and the control group ( n=46) undergoing Olympus endoscopy. The examination success rate, image quality, performance, overall operation satisfaction rate, biopsy success rate and adverse events of the two groups were compared. Results:The examination success rates of the trial group and the control group were 97.73% (43/44) and 100.00% (46/46) respectively with a difference of -2.27% (95% CI: -6.68%-2.13%), higher than the set non-inferiority margin of -10%. Rates of good and excellent image quality were 100% in both groups, and the difference of 0 was higher than the set non-inferiority margin of -10%. There was no significant difference in the rate of good and excellent performance of the operating system between the two groups [97.67% (42/43) VS 100.00% (46/46), P=0.483]. There was significant difference in the overall satisfactory rate of the operation between the two groups [86.05% (37/43) VS 100.00% (46/46), P=0.011]. A total of 9 cases underwent endoscopic biopsy, including 5 cases in the trial group and 4 cases in the control group. The biopsy channels in both groups were smooth and the biopsy were successfully completed. There was no significant difference in adverse event rate between the two groups [25.00% (11/44) VS 10.87%(5/46), χ2=3.07, P=0.080]. All adverse events disappeared in 48 hours, and no severe adverse events or device defect events occurred. Conclusion:The novel portable endoscopic system is comparable to Olympus endoscopic system in terms of the operating performance, the image quality and safety. Therefore, this system is safe and effective for upper gastrointestinal examination.
7.Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study
Huiyun ZHU ; Xue PAN ; Li ZHANG ; Hongxin SUN ; Huizhen FAN ; Zhongwei PAN ; Caibin HUANG ; Zhenwang SHI ; Jin DING ; Qi WANG ; Yiqi DU ; Nonghua LYU ; Zhaoshen LI
Chinese Medical Journal 2022;135(24):2941-2949
Background::The pharmacokinetic and clinical behaviors of many proton pump inhibitors (PPIs) in peptic ulcer treatment are altered by CYP2C19 genetic polymorphisms. This non-inferiority study evaluated the efficacy and safety of the novel PPI anaprazole compared with rabeprazole. We also explored the influence of Helicobacter pylori ( H. pylori) infection status and CYP2C19 polymorphism on anaprazole. Methods::In this multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled, phase III study, Chinese patients with duodenal ulcers were randomized 1:1 to receive rabeprazole 10 mg + anaprazole placebo or rabeprazole placebo + anaprazole 20 mg once daily for 4 weeks. The primary efficacy endpoint was the 4-week ulcer healing rate assessed by blinded independent review. Secondary endpoints were the proportion of patients with improved overall and individual duodenal ulcer symptoms at 4 weeks. Furthermore, exploratory subgroup analysis of the primary endpoint by H. pylori status and CYP2C19 polymorphism was conducted. Adverse events were monitored for safety. Non-inferiority analysis was conducted for the primary endpoint. Results::The study enrolled 448 patients (anaprazole, n = 225; rabeprazole, n = 223). The 4-week healing rates were 90.9% and 93.7% for anaprazole and rabeprazole, respectively (difference, -2.8% [95% confidence interval, -7.7%, 2.2%]), demonstrating non-inferiority of anaprazole to rabeprazole. Overall duodenal ulcer symptoms improved in 90.9% and 92.5% of patients, respectively. Improvement rates of individual symptoms were similar between the groups. Healing rates did not significantly differ by H. pylori status or CYP2C19 genotype for either treatment group. The incidence of treatment-emergent adverse events was similar for anaprazole (72/220, 32.7%) and rabeprazole (84/219, 38.4%). Conclusions::The efficacy of anaprazole is non-inferior to that of rabeprazole in Chinese patients with duodenal ulcers.Registration::ClinicalTrials.gov, NCT04215653.
8.Expert consensus on measurement and clinical application of serum HBV RNA in patients with chronic HBV infection
Yanna LIU ; Rong FAN ; Ruifeng YANG ; Shi LIU ; Jie WANG ; Hao LIAO ; Chao QIU ; Rui DENG ; Hongxin HUANG ; Peng HU ; Sujun ZHENG ; Wenhong ZHANG ; Xiangmei CHEN ; Hongsong CHEN ; Jian SUN ; Fengmin LU
Chinese Journal of Hepatology 2022;30(5):505-512
Since the discovery of circulating hepatitis B virus (HBV) RNA in the peripheral blood of patients with chronic hepatitis B in 1996, a growing number of studies have focused on clarifying the biological characteristics and clinical application value of serum HBV RNA. This consensus mainly summarizes the research progress of serum HBV RNA existing profiles, quantitative detection methods, and current clinical applications. In order to better apply this indicator for the clinical management of patients with chronic HBV infection, recommendations on quantitative detection target regions, detection results, and clinical applications are put forward.
9.Arthroscopy-assisted reduction and internal fixation via traditional anterolateral approach for posterolateral tibial plateau fractures
Ming LI ; Qiuyan HAO ; Xiangxun CAO ; Hongxin WANG ; Faqing WAN ; Shoumi SUN ; Shugao LI ; Ruibin LI ; Qian ZHANG
Chinese Journal of Orthopaedic Trauma 2021;23(11):975-981
Objective:To evaluate the arthroscopy-assisted reduction and internal fixation (ARIF) via the traditional anterolateral approach for the treatment of posterolateral tibial plateau fractures (PTPF).Methods:A retrospective study was conducted of the 79 patients with PTPF who had been treated from March 2014 to February 2020 at Department of Articular Surgery, Linyi Central Hospital. They were 37 males and 42 females, aged from 17 to 71 years (average, 46.0 years). According to treatment methods, they were assigned into an ARIF group (37 cases) and a control group (42 cases). The ARIF group was treated by ARIF via the traditional anterolateral approach and the ARIF varied according to the extents of articular collapse and split and displacement of fracture fragments. The control group was treated by traditional reduction and internal plate fixation of the proximal tibia. The 2 groups were compared in terms of operation time, blood loss, iliac bone grafting, hospitalization time, follow-up time, Hospital for Special Surgery (HSS) score, maximum flexion and extension, fracture healing time, Rassmussen functional and anatomical scores, visual analogue scale (VAS) pain score and complications.Results:There was no statistically significant difference in the general data between the 2 groups, showing comparability ( P>0.05). All patients were followed up for 6 to 18 months (average, 11.4 months). The operation time [(48.9±8.2) min], blood loss [(73.1±20.8) mL], hospitalization time [(9.3±2.5) d], and fracture healing time [(12.5±1.8) weeks] in the ARIF group were all significantly less than those in the control group [(55.2±9.9) min, (100.8±30.3) mL, (11.8±2.8) d and (15.1±2.1) weeks] while the HSS score [(93.5±4.6) points], maximum flexion angle (107.8°±10.4°) and Rassmussen functional score [(27.1±1.8) points] in the ARIF group were significantly higher than those in the control group [(88.4±7.4) points, 100.4°±10.0° and (26.1±2.4) points] (all P<0.05). There was no significant difference between the 2 groups in iliac bone grafting, follow-up time, maximum extension angle, Rassmussen anatomical score, VAS score, or rate of complications (all P>0.05). Conclusions:Compared with traditional surgery, ARIF which varies with the extents of articular collapse and split and displacement of fracture fragments may lead to shorter operation time, reduced surgical trauma and more accurate reduction of the articular surface. Therefore, it can be an additional choice in the treatment of PTPF.
10.Short-term efficacy of combination of 125I seed brachytherapy and cetuximab in postoperation recurrent rectum cancer
Jian WANG ; Xikun ZHANG ; Bin WANG ; Shancheng LI ; Lin SUN ; Wen SUN ; Liang HAO ; Hongxin NIU
Chinese Journal of Digestion 2019;39(5):337-341
Objective To evaluate the short-term efficacy of combination of 125 I seed brachytherapy and cetuximab in postoperation recurrent rectum cancer.Methods From July 2014 to June 2018,at Affiliated Hospital of Shandong Academy of Medical Sciences,57 patients with postoperation recurrent rectal cancer were recruited.According to therapy the patients were divided into two groups:the radiotherapy group (30 cases) treated with radioactive 125I seeds alone and the combination treatment group (27 cases) treated with combination of radioactive 125I seeds and cetuximab.The tumor size,pain relief and adverse reactions were observed in both groups.Chi-square test were performed for statistical analysis.Results After treatment for six months,the total efficacy rate and local control rate of combination treatment group were 54.2% (13/24) and 87.5% (21/24),respectively;and which were higher than those of radiotherapy group (17.9%,5/28 and 39.3%,11/28),and the differences were statistically significant (x2 =15.01 and 2.55,both P < 0.05).At one month after treatment,the pain relief rate of radiotherapy group and combination treatment group was 70.0% (21/30) and 85.2% (23/27),respectively,and there was no statistically significant difference between the two groups (P > 0.05).After treatment for six months,the rates of adverse reactions of radiotherapy group and combination treatment group were 46.7 % (14/30) and 63.0% (17/27),respectively,there was no statistically significant difference between the two groups (P > 0.05).The symptoms of patients with radiation injury significantly improved after symptomatic treatment.Conclusion The short-term efficacy of combination of 125 I seed brachytherapy and cetuximab is better than that of 125 I seed brachytherapy alone in patients with postoperation recurrent rectum cancer.

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