1.Break the domestic public hospital clinical research evaluation system under the background of"five only"
Xiaowen CHEN ; Yongkai ZHU ; Yingyan ZHENG ; Yuhui LIN ; Peng SHI ; Liyuan HAN ; Pin JIA ; Rui DONG
Modern Hospital 2024;24(3):465-468,492
Objective The purpose of this article is to summarize and review the current status of the construction of clinical research evaluation systems in domestic public hospitals,identify existing problems in the evaluation system,and propose development strategies and suggestions.Methods Retrieved relevant articles,dissertations and policies from the past five years(2018-2022),screened the titles,viewed the full texts of 52 selected papers and their references,and summarized them.Results The"five-only"indicators have long been an important indicator for evaluating clinical research in public hospitals,but in today's scientific research environment and policy environment,the"five-only"evaluation system has revealed its utilitarian draw-backs and gradually evolved into a hindrance to scientific research.It is urgent to break through the"five-only"orientation and establish a clinical research evaluation system oriented towards"transforming and applying transformation of scientific research achievements".Conclusion The evaluation system for clinical research should break the previous"five-only"evaluation model based on quantity-oriented scientific research evaluation.We can draw on the framework of the research output,influence,and environment indicators in the UK's REF Excellence Framework model,combine the American APT system and the Chinese STEM indicator dimensions,explore multi-outcome evaluation,integrate developmental indicators,and continuously improve the indica-tor system and application methods in practice to promote the development of clinical research in public hospitals.
2.The Chinese guideline for management of snakebites
Lai RONGDE ; Yan SHIJIAO ; Wang SHIJUN ; Yang SHUQING ; Yan ZHANGREN ; Lan PIN ; Wang YONGGAO ; Li QI ; Wang JINLONG ; Wang WEI ; Ma YUEFENG ; Liang ZIJING ; Zhang JIANFENG ; Zhou NING ; Han XIAOTONG ; Zhang XINCHAO ; Zhang MAO ; Zhao XIAODONG ; Zhang GUOQIANG ; Zhu HUADONG ; Yu XUEZHONG ; Lyu CHUANZHU
World Journal of Emergency Medicine 2024;15(5):333-355
In 2009,the World Health Organization included snakebite on the list of neglected tropical diseases,acknowledging it as a common occupational hazard for farmers,plantation workers,and others,causing tens of thousands of deaths and chronic physical disabilities every year.This guideline aims to provide practical information to help clinical professionals evaluate and treat snakebite victims.These recommendations are based on clinical experience and clinical research evidence.This guideline focuses on the following topics:snake venom,clinical manifestations,auxiliary examination,diagnosis,treatments,and prevention.
3.Effects of Huayu Xiaozheng Granules on Angiogenesis and Invasion in Trophoblast Cells with Overexpression of MiR-210 and Under Hypoxia
Wen-Jing LU ; Shuo YUAN ; Jia-Han QIU ; Pin QIU ; Gao-Pi DENG
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(11):2992-2998
Objective To observe the effect of Huayu Xiaozheng Granules on angiogenesis and invasion in trophoblast cells with overexpression of miR-210 and under hypoxia.Methods HTR-8/SVneo cells were cultured in vitro,a miR-210 overexpression model was established by transfection,and a chemical hypoxia model was established by CoCl2 method.The blank group,miR-210 overexpression group,miR-210 overexpression-negative group,miR-210 overexpression+Chinese medicine group,hypoxia+Chinese medicine group and Chinese medicine group in experiment were set up.Western Blot method was used to detect protein expressions of hypoxia-inducible factor 1α(HIF-1α),vascular endothelial growth factor(VEGF),and invasion-associated factors[matrix metalloproteinase 9(MMP-9)and tissue inhibitors of matrix metalloproteinase 1(TIMP-1)]in HTR-8/SVneo cells.Results Compared with the blank group,the protein expression levels of HIF-1α,VEGF,MMP-9,TIMP-1 and MMP-9/TIMP-1 ratio were increased in the miR-210 overexpression group(P<0.05);compared with the miR-210 overexpression group,the HIF-1α,VEGF,MMP-9,TIMP-1 protein expression levels and MMP-9/TIMP-1 ratio in the miR-210 overexpression-negative group,miR-210 overexpression+Chinese medicine group,hypoxia+Chinese medicine group and Chinese medicine group were all decreased(P<0.05),and the decrease effects in Chinese medicine group was especially obvious;compared with the miR-210 overexpression+Chinese medicine group,the protein expression levels of HIF-1α,VEGF,MMP-9,TIMP-1 and MMP-9/TIMP-1 ratio in hypoxia+Chinese medicine group and Chinese medicine group were all decreased(P<0.05);compared with the hypoxia+Chinese medicine group,the above indicators were decreased in the Chinese medicine group(P<0.05).Conclusion Huayu Xiaozheng Granules can negatively regulate the increased angiogenesis and invasion of trophoblast cells with miR-210 overexpression and under hypoxia,which may be one of the action mechanisms of its treatment for tubal pregnancy.
4.Neuro-pathological study of intrathalamic neurovirulence test of poliomyelitis vaccine in rhesus macaques
Pin YU ; Yanfeng XU ; Yunlin HAN ; Wenjie ZHAO ; Chuan QIN
Chinese Journal of Comparative Medicine 2024;34(6):47-53
Objective To study the effect and pathological mechanisms of the neuro-immune response to viral encephalomyelitis caused by virulence reversion following the intrathalamic neurovirulence test for poliomyelitis vaccine in rhesus macaques.Methods Stock solutions(≥7000 lgCCID50/L)of inactivated polio vaccines(Vero cells)of type I,type Ⅱ,and type Ⅲ Sabin strains and 10-1 dilution of each type of polio vaccine were given to macaques,which were subjected to a intrathalamic neurovirulence test.Using immunohistochemical method,the pathological changes caused by polio,as determined by the distribution of CD 155 and CD4+receptor T lymphocytes,CD20+B lymphocytes,and CD68+microglia,were detected.Results Lesions were observed on the virulence-reverted polio cases.Inflammatory cell infiltration,neuronal degeneration and necrosis,satellite phenomena,perivascular cuffing,and glial cell proliferation were observed in the spinal cord.The inflammatory cells in the perivascular cuffing and proliferative glial nodules were mainly CD4+T lymphocytes,CD20+B lymphocytes,and CD68+microglia.There was no significant difference in the distribution of the poliovirus receptor CD 155 in the neurons and glial cells of monkeys with and without polio,and no expression was observed in their vascular endothelial cells.Conclusions Polio caused by virulence reversion of the intrathalamic neurovirulence test is viral encephalomyelitis.
5.Taiwan Association for the Study of the Liver-Taiwan Society of Cardiology Taiwan position statement for the management of metabolic dysfunction- associated fatty liver disease and cardiovascular diseases
Pin-Nan CHENG ; Wen-Jone CHEN ; Charles Jia-Yin HOU ; Chih-Lin LIN ; Ming-Ling CHANG ; Chia-Chi WANG ; Wei-Ting CHANG ; Chao-Yung WANG ; Chun-Yen LIN ; Chung-Lieh HUNG ; Cheng-Yuan PENG ; Ming-Lung YU ; Ting-Hsing CHAO ; Jee-Fu HUANG ; Yi-Hsiang HUANG ; Chi-Yi CHEN ; Chern-En CHIANG ; Han-Chieh LIN ; Yi-Heng LI ; Tsung-Hsien LIN ; Jia-Horng KAO ; Tzung-Dau WANG ; Ping-Yen LIU ; Yen-Wen WU ; Chun-Jen LIU
Clinical and Molecular Hepatology 2024;30(1):16-36
Metabolic dysfunction-associated fatty liver disease (MAFLD) is an increasingly common liver disease worldwide. MAFLD is diagnosed based on the presence of steatosis on images, histological findings, or serum marker levels as well as the presence of at least one of the three metabolic features: overweight/obesity, type 2 diabetes mellitus, and metabolic risk factors. MAFLD is not only a liver disease but also a factor contributing to or related to cardiovascular diseases (CVD), which is the major etiology responsible for morbidity and mortality in patients with MAFLD. Hence, understanding the association between MAFLD and CVD, surveillance and risk stratification of MAFLD in patients with CVD, and assessment of the current status of MAFLD management are urgent requirements for both hepatologists and cardiologists. This Taiwan position statement reviews the literature and provides suggestions regarding the epidemiology, etiology, risk factors, risk stratification, nonpharmacological interventions, and potential drug treatments of MAFLD, focusing on its association with CVD.
6.Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program
Ming-Ying LU ; Chung-Feng HUANG ; Chao-Hung HUNG ; Chi‐Ming TAI ; Lein-Ray MO ; Hsing-Tao KUO ; Kuo-Chih TSENG ; Ching-Chu LO ; Ming-Jong BAIR ; Szu-Jen WANG ; Jee-Fu HUANG ; Ming-Lun YEH ; Chun-Ting CHEN ; Ming-Chang TSAI ; Chien-Wei HUANG ; Pei-Lun LEE ; Tzeng-Hue YANG ; Yi-Hsiang HUANG ; Lee-Won CHONG ; Chien-Lin CHEN ; Chi-Chieh YANG ; Sheng‐Shun YANG ; Pin-Nan CHENG ; Tsai-Yuan HSIEH ; Jui-Ting HU ; Wen-Chih WU ; Chien-Yu CHENG ; Guei-Ying CHEN ; Guo-Xiong ZHOU ; Wei-Lun TSAI ; Chien-Neng KAO ; Chih-Lang LIN ; Chia-Chi WANG ; Ta-Ya LIN ; Chih‐Lin LIN ; Wei-Wen SU ; Tzong-Hsi LEE ; Te-Sheng CHANG ; Chun-Jen LIU ; Chia-Yen DAI ; Jia-Horng KAO ; Han-Chieh LIN ; Wan-Long CHUANG ; Cheng-Yuan PENG ; Chun-Wei- TSAI ; Chi-Yi CHEN ; Ming-Lung YU ;
Clinical and Molecular Hepatology 2024;30(1):64-79
Background/Aims:
Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1–3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy.
Methods:
We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment.
Results:
The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset.
Conclusions
Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.
7.Metformin and statins reduce hepatocellular carcinoma risk in chronic hepatitis C patients with failed antiviral therapy
Pei-Chien TSAI ; Chung-Feng HUANG ; Ming-Lun YEH ; Meng-Hsuan HSIEH ; Hsing-Tao KUO ; Chao-Hung HUNG ; Kuo-Chih TSENG ; Hsueh-Chou LAI ; Cheng-Yuan PENG ; Jing-Houng WANG ; Jyh-Jou CHEN ; Pei-Lun LEE ; Rong-Nan CHIEN ; Chi-Chieh YANG ; Gin-Ho LO ; Jia-Horng KAO ; Chun-Jen LIU ; Chen-Hua LIU ; Sheng-Lei YAN ; Chun-Yen LIN ; Wei-Wen SU ; Cheng-Hsin CHU ; Chih-Jen CHEN ; Shui-Yi TUNG ; Chi‐Ming TAI ; Chih-Wen LIN ; Ching-Chu LO ; Pin-Nan CHENG ; Yen-Cheng CHIU ; Chia-Chi WANG ; Jin-Shiung CHENG ; Wei-Lun TSAI ; Han-Chieh LIN ; Yi-Hsiang HUANG ; Chi-Yi CHEN ; Jee-Fu HUANG ; Chia-Yen DAI ; Wan-Long CHUNG ; Ming-Jong BAIR ; Ming-Lung YU ;
Clinical and Molecular Hepatology 2024;30(3):468-486
Background/Aims:
Chronic hepatitis C (CHC) patients who failed antiviral therapy are at increased risk for hepatocellular carcinoma (HCC). This study assessed the potential role of metformin and statins, medications for diabetes mellitus (DM) and hyperlipidemia (HLP), in reducing HCC risk among these patients.
Methods:
We included CHC patients from the T-COACH study who failed antiviral therapy. We tracked the onset of HCC 1.5 years post-therapy by linking to Taiwan’s cancer registry data from 2003 to 2019. We accounted for death and liver transplantation as competing risks and employed Gray’s cumulative incidence and Cox subdistribution hazards models to analyze HCC development.
Results:
Out of 2,779 patients, 480 (17.3%) developed HCC post-therapy. DM patients not using metformin had a 51% increased risk of HCC compared to non-DM patients, while HLP patients on statins had a 50% reduced risk compared to those without HLP. The 5-year HCC incidence was significantly higher for metformin non-users (16.5%) versus non-DM patients (11.3%; adjusted sub-distribution hazard ratio [aSHR]=1.51; P=0.007) and metformin users (3.1%; aSHR=1.59; P=0.022). Statin use in HLP patients correlated with a lower HCC risk (3.8%) compared to non-HLP patients (12.5%; aSHR=0.50; P<0.001). Notably, the increased HCC risk associated with non-use of metformin was primarily seen in non-cirrhotic patients, whereas statins decreased HCC risk in both cirrhotic and non-cirrhotic patients.
Conclusions
Metformin and statins may have a chemopreventive effect against HCC in CHC patients who failed antiviral therapy. These results support the need for personalized preventive strategies in managing HCC risk.
9.Clinical Characteristics, Genetic Features, and Long-Term Outcome of Wilson’s Disease in a Taiwanese Population: An 11-Year Follow-Up Study
Sung-Pin FAN ; Yih-Chih KUO ; Ni-Chung LEE ; Yin-Hsiu CHIEN ; Wuh-Liang HWU ; Yu-Hsuan HUANG ; Han-I LIN ; Tai-Chung TSENG ; Tung-Hung SU ; Shiou-Ru TZENG ; Chien-Ting HSU ; Huey-Ling CHEN ; Chin-Hsien LIN ; Yen-Hsuan NI
Journal of Movement Disorders 2023;16(2):168-179
Objective:
aaWilson’s disease (WD) is a rare genetic disorder of copper metabolism, and longitudinal follow-up studies are limited. We performed a retrospective analysis to determine the clinical characteristics and long-term outcomes in a large WD cohort.
Methods:
aaMedical records of WD patients diagnosed from 2006–2021 at National Taiwan University Hospital were retrospectively evaluated for clinical presentations, neuroimages, genetic information, and follow-up outcomes.
Results:
aaThe present study enrolled 123 WD patients (mean follow-up: 11.12 ± 7.41 years), including 74 patients (60.2%) with hepatic features and 49 patients (39.8%) with predominantly neuropsychiatric symptoms. Compared to the hepatic group, the neuropsychiatric group exhibited more Kayser-Fleischer rings (77.6% vs. 41.9%, p < 0.01), lower serum ceruloplasmin levels (4.9 ± 3.9 vs. 6.3 ± 3.9 mg/dL, p < 0.01), smaller total brain and subcortical gray matter volumes (p < 0.0001), and worse functional outcomes during follow-up (p = 0.0003). Among patients with available DNA samples (n = 59), the most common mutations were p.R778L (allelic frequency of 22.03%) followed by p.P992L (11.86%) and p.T935M (9.32%). Patients with at least one allele of p.R778L had a younger onset age (p = 0.04), lower ceruloplasmin levels (p < 0.01), lower serum copper levels (p = 0.03), higher percentage of the hepatic form (p = 0.03), and a better functional outcome during follow-up (p = 0.0012) compared to patients with other genetic variations.
Conclusion
aaThe distinct clinical characteristics and long-term outcomes of patients in our cohort support the ethnic differences regarding the mutational spectrum and clinical presentations in WD.
10.Comparison of modified "double flaps" pyeloplasty and traditional pyeloplasty in the treatment of special types of hydronephrosis in children
Ce HAN ; Huixia ZHOU ; Pin LI ; Xuexue LYU ; Ran ZHUO ; Yang ZHAO ; Weiwei ZHU ; Tao GUO
Chinese Journal of Urology 2023;44(1):42-46
Objective:To compare the efficacy of modified "double flaps" pyeloplasty and traditional dismembered pyeloplasty in the treatment of special types of hydronephrosis with small pelvis and long proximal ureteral stricture in children.Methods:The data of 39 children with special types of hydronephrosis treated in Seventh Medical Center, General Hospital of PLA from June 2018 to June 2019 were retrospectively analyzed. Among them, 33 were boys and 6 were girls. The median age of the patients was 12.0(4.5, 63.5) months. Nine of them had left hydronephrosis and four children had right hydronephrosis. These patients with small pelvis existed the characteristics that the anteroposterior diameter of pelvis was smaller than 2.5 cm and these patients existed the symptom of hematuria, flank pain or recurrent urinary tract infection with the imaging revealing ureteral obstruction. The length of proximal ureteral stenosis ranged from 2.0 to 4.0 cm. Among 39 cases, 19 cases were operated with modified "double flaps" pyeloplasty, which was the modified "double flaps" pyeloplasty group. 20 cases were operated with traditional Anderson-Hynes pyeloplasty, which was traditional pyeloplasty group. The technique of modified "double flaps" pyeloplasty mainly included that the renal pelvis was cut into double flaps, the inferior flap was anastomosed with the spatulated ureter and the superior was covered, so that the length and caliber of the ureter were partial extended. The median age of two groups were 12.0 (6.0, 44.0) months and 12.0 (4.8, 62.8) months respectively, the anterior and posterior diameter of renal pelvis were (2.8±0.8)cm and (2.6±0.6)cm respectively, and split renal function were (36.7±5.1)% and (36.0±6.8)% respectively. There were no statistically significant differences in above parameters between the two groups( P>0.05). The clinical efficacy of the two groups were compared by collecting and comparing the operation related data and postoperative follow-up data. Results:The operation of 39 children in this study was successfully completed without conversion to open surgery.The operation time of "double flap" pyeloplasty group and traditional pyeloplasty group were (142.6±9.6) min and (124.5±8.6) min respectively, and the intraoperative anastomosis time were (56.1±7.2) min and (47.6±4.8) min respectively. There were significant difference in operation time and intraoperative anastomosis time between the two groups( P<0.05). Thirty-nine children were followed up normally without loss. The mean follow-up time was (27.7±2.5) months after surgery. In the "double flaps" pyeloplasty group, 2 cases suffered with fever who were diagnosed as urinary tract infection and improved after antibiotic treatment. In the traditional pyeloplasty group, 2 cases suffered with fever who were diagnosed as urinary tract infection and improved after antibiotic treatment. Two children had flank pain during follow-up to more than one year and the examination revealed that the anteroposterior diameter of the renal pelvis gradually increased. So surgery were performed again and the two children recovered. There were no significant differences in complication rate (2/19 and 4/20) and short-term surgical success rate(19/19 and 18/20) between the two groups ( P>0.05). Conclusions:The operation time and anastomosis time of the modified "double flap" technique for treating hydronephrosis are longer than those of the traditional method. But in the treatment of special types of hydronephrosis with small renal pelvis or long proximal ureteral stricture, it may have application prospects in reducing complications.

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