1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Failure analysis and structural optimization of water-based sliding bearings for aerospace applications
Chunmei WEI ; WangXi ; Yingbin LI ; Dewen YIN ; Zhenguo ZHANG ; Hualin SHI
Space Medicine & Medical Engineering 2025;36(3):246-249
The long service life and high reliability of SiC sliding bearings are crucial for the long-term normal operation of aerospace power equipment.In response to the fracture phenomenon observed in the sliding bearing assembly of a certain delivery pump during operation,this paper analyzes the issue from the perspectives of stress characteristics and thermal expansion effects,proposing a structural optimization design method based on temperature coefficient compensation.The research indicates that the primary cause of bearing fracture is the difference in thermal expansion coefficients between the bearing and the metal rotor under elevated temperatures,leading to axial loosening of the bearing.Additionally,the gap between the bearing and the pin,combined with unstable lubrication of the friction pair,exacerbates bearing stalling and pin impact,ultimately causing cracks and localized chipping.By optimizing the bearing structure and employing a rubber pad for torque transmission,this issue has been successfully resolved.The improved structure demonstrated high reliability and stability in bench tests,providing important theoretical and technical references for the design of bearings under similar extreme operating conditions.
3.Construction of motion sickness clinical model and diagnosis model based on blood index
Qiwei XIE ; Jiali TU ; Yaowen WANG ; Weimin ZHANG ; Hou SHI ; Yan WANG ; Hualin ZHU
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(7):435-439
OBJECTIVE To construct a clinical model of motion sickness(MS),provide a relatively objective diagnostic model for MS research,and provide a basis for further clinical intervention of the disease.METHODS A total of 60 subjects were included and divided into experimental group and control group according to the presence or absence of MS.The MS clinical model was established using SRM-IV rotating chair.Peripheral blood was collected before and after acceleration exposure,and the contents of adrenocorticotropic hormone(ACTH),growth hormone(GH),prolactin(PRL),follicle stimulating hormone(FSH),luteinizing hormone(LH),thyroid stimulating hormone(TRH)and gastrin-17(G-17),acetylcholine(ACH)and 5-hydroxytryptamine(5-HT)were detected,Graybiel scale was used to evaluate the severity of MS.The correlation between MS symptoms and signs and peripheral blood indexes was analyzed by multiple linear regression,and the diagnostic model was established.construct a clinical model of MS and a diagnostic model based on blood parameters,so as to provide a reliable clinical model and an objective diagnostic model for MS research,and to provide a basis for further clinical intervention of the disease.RESULTS After acceleration exposure,the Graybiel scores,ACH,5-HT,ACTH,GH and PRL levels in peripheral blood of the experimental group were higher than those before exposure,and were significantly different from those of the control group(P<0.001).There was no significant difference in FSH,LH,TRH and G-17 between the two groups before and after acceleration exposure(P>0.05).Multi-index combined diagnostic model:Graybiel scores=-9.32+0.131×ACTH+0.055×ACH+0.041×5-HT.CONCLUSION The levels of ACH,5-HT,ACTH,GH and PRL increased during the onset of MS.The multi-index combined diagnosis model can provide a certain basis for the objective diagnosis of MS in clinical practice.
4.Association between hearing loss and physical performance in patients on maintenance hemodialysis
Weifeng FAN ; Xiaojing ZHONG ; Qing WU ; Lihong ZHANG ; Zhenhao YANG ; Yong GU ; Qi GUO ; Xiaoyu CHEN ; Chen YU ; Kun ZHANG ; Wei DING ; Hualin QI ; Junli ZHAO ; Liming ZHANG ; Suhua ZHANG ; Jianying NIU
Kidney Research and Clinical Practice 2024;43(3):358-368
The correlation between hearing loss (HL) and physical performance in patients receiving maintenance hemodialysis (MHD) remains poorly investigated. This study explored the association between HL and physical performance in patients on MHD. Methods: This multicenter cross-sectional study was conducted between July 2020 and April 2021 in seven hemodialysis centers in Shanghai and Suzhou, China. The hearing assessment was performed using pure-tone average (PTA). Physical performance was assessed using the Timed Up and Go Test (TUGT), handgrip strength, and gait speed. Results: Finally, 838 adult patients (male, 516 [61.6%]; 61.2 ± 2.6 years) were enrolled. Among them, 423 (50.5%) had mild to profound HL (male, 48.6% and female, 53.4%). Patients with HL had poorer physical performance than patients without HL (p < 0.001). TUGT was positively correlated with PTA (r = 0.265, p < 0.001), while handgrip strength and gait speed were negatively correlated with PTA (r = –0.356, p < 0.001 and r = –0.342, p < 0.001, respectively). Physical performance in patients aged <60 years showed significant dose-response relationships with HL. After adjusting for confounders, the odds ratios (95% confidence intervals) for HL across the TUGT quartiles (lowest to highest) were 1.00 (reference), 1.15 (0.73–1.81), 1.69 (1.07–2.70), and 2.87 (1.69–4.88) (p for trend = 0.005). Conclusion: Lower prevalence of HL was associated with a faster TUGT and a stronger handgrip strength in patients on MHD.
5.The Construction of an Intrauterine Diagnosis and Treatment System and Comprehensive Lifecycle Health Service of Congenital Heart Disease: Xinhua Hospital Model
Shiwei JIANG ; Jiajun YE ; Hualin WANG ; Jian WANG ; Sun CHEN ; Yongjun ZHANG ; Qing DU ; Ling YANG ; Lei WANG ; Kun SUN
Cardiology Discovery 2023;03(3):191-202
With the growing influence of slow population growth and population aging, China has established the birth policy and issued a series of documents to promote maternal and fetal health and improve the birth rate. With the increase in prevalence of birth defects, timely diagnosis and intervention in utero provide possibilities to reduce unnecessary abortions and offer better prognosis. Congenital heart disease (CHD), as one of the most common congenital birth defects, is the leading cause of mortality in patients aged <5 years, and brings a heavy burden to both the affected families and society. Fetuses with CHD are associated with an increased risk of pregnancy-related complications and premature birth, and children with CHD typically face growth and developmental problems even after the correction of malformation. Therefore, management including diagnosis, treatment, and rehabilitation throughout the fetal period into childhood and even adulthood is essential for children with CHD. Based on the rapid advances in intrauterine and perinatal medicine and an in-depth collaboration among obstetrics and pediatrics, a novel diagnosis and treatment system has been established for the management of CHD in the past 2 decades in Shanghai Xinhua Hospital. This Intrauterine Diagnosis and Treatment System and Comprehensive Lifecycle Health Service of Congenital Heart Disease model provides prenatal diagnosis, intrauterine intervention, delivery room service and neonatal therapies, and postintrauterine rehabilitation for children with CHD. We have developed a four-dimensional spatiotemporal image correlation echocardiography and a three-dimensional cardiac virtual endoscopy system for the intrauterine diagnosis of CHD, dramatically raising the diagnostic utility. Our innovative and independent newborn-intervention technique has effectively reduced the re-intervention rate in patients with pulmonary atresia with intact ventricular septum and critical pulmonary stenosis. In 2018, Xinhua Hospital independently performed the case of fetal aortic valvuloplasty in Asia through a multidepartment collaborative effort. All children treated in this system achieved biventricular circulation and a better long-term postoperative outcome. We also have conducted postoperative rehabilitation therapy to promote the development and health of children with CHD. The practice of Xinhua model has reduced unnecessary abortion of CHD fetuses, reduced the mortality rate associated with critical CHD, and improved the mid- and long-term prognosis in CHD, which is essential to promote the fertility level and children’s health. Furthermore, translational medicine platform and the birth cohort Early Life Plan was constructed to explore the origins of major developmental diseases and establish an early intervention model in CHD. This practice of assessment of the intrauterine system has been expanded to other congenital defects in Xinhua Hospital, and sequential treatment of more than 2,000 cases has been completed to date. Based on practice in intrauterine management of CHD and other diseases, the concept of Intrauterine Pediatrics was proposed as a first to emphasize early prevention and intervention of childhood diseases and promote a comprehensive lifecycle service for children. The development and evolution of this system requires further attention not only from researchers but also from the government and global medical communities.
6.The Construction of an Intrauterine Diagnosis and Treatment System and Comprehensive Lifecycle Health Service of Congenital Heart Disease: Xinhua Hospital Model
Shiwei JIANG ; Jiajun YE ; Hualin WANG ; Jian WANG ; Sun CHEN ; Yongjun ZHANG ; Qing DU ; Ling YANG ; Lei WANG ; Kun SUN
Cardiology Discovery 2023;03(3):191-202
With the growing influence of slow population growth and population aging, China has established the birth policy and issued a series of documents to promote maternal and fetal health and improve the birth rate. With the increase in prevalence of birth defects, timely diagnosis and intervention in utero provide possibilities to reduce unnecessary abortions and offer better prognosis. Congenital heart disease (CHD), as one of the most common congenital birth defects, is the leading cause of mortality in patients aged <5 years, and brings a heavy burden to both the affected families and society. Fetuses with CHD are associated with an increased risk of pregnancy-related complications and premature birth, and children with CHD typically face growth and developmental problems even after the correction of malformation. Therefore, management including diagnosis, treatment, and rehabilitation throughout the fetal period into childhood and even adulthood is essential for children with CHD. Based on the rapid advances in intrauterine and perinatal medicine and an in-depth collaboration among obstetrics and pediatrics, a novel diagnosis and treatment system has been established for the management of CHD in the past 2 decades in Shanghai Xinhua Hospital. This Intrauterine Diagnosis and Treatment System and Comprehensive Lifecycle Health Service of Congenital Heart Disease model provides prenatal diagnosis, intrauterine intervention, delivery room service and neonatal therapies, and postintrauterine rehabilitation for children with CHD. We have developed a four-dimensional spatiotemporal image correlation echocardiography and a three-dimensional cardiac virtual endoscopy system for the intrauterine diagnosis of CHD, dramatically raising the diagnostic utility. Our innovative and independent newborn-intervention technique has effectively reduced the re-intervention rate in patients with pulmonary atresia with intact ventricular septum and critical pulmonary stenosis. In 2018, Xinhua Hospital independently performed the case of fetal aortic valvuloplasty in Asia through a multidepartment collaborative effort. All children treated in this system achieved biventricular circulation and a better long-term postoperative outcome. We also have conducted postoperative rehabilitation therapy to promote the development and health of children with CHD. The practice of Xinhua model has reduced unnecessary abortion of CHD fetuses, reduced the mortality rate associated with critical CHD, and improved the mid- and long-term prognosis in CHD, which is essential to promote the fertility level and children’s health. Furthermore, translational medicine platform and the birth cohort Early Life Plan was constructed to explore the origins of major developmental diseases and establish an early intervention model in CHD. This practice of assessment of the intrauterine system has been expanded to other congenital defects in Xinhua Hospital, and sequential treatment of more than 2,000 cases has been completed to date. Based on practice in intrauterine management of CHD and other diseases, the concept of Intrauterine Pediatrics was proposed as a first to emphasize early prevention and intervention of childhood diseases and promote a comprehensive lifecycle service for children. The development and evolution of this system requires further attention not only from researchers but also from the government and global medical communities.
7.Molecular diagnosis and treatment of meningiomas: an expert consensus (2022).
Jiaojiao DENG ; Lingyang HUA ; Liuguan BIAN ; Hong CHEN ; Ligang CHEN ; Hongwei CHENG ; Changwu DOU ; Dangmurenjiapu GENG ; Tao HONG ; Hongming JI ; Yugang JIANG ; Qing LAN ; Gang LI ; Zhixiong LIU ; Songtao QI ; Yan QU ; Songsheng SHI ; Xiaochuan SUN ; Haijun WANG ; Yongping YOU ; Hualin YU ; Shuyuan YUE ; Jianming ZHANG ; Xiaohua ZHANG ; Shuo WANG ; Ying MAO ; Ping ZHONG ; Ye GONG
Chinese Medical Journal 2022;135(16):1894-1912
ABSTRACT:
Meningiomas are the most common primary intracranial neoplasm with diverse pathological types and complicated clinical manifestations. The fifth edition of the WHO Classification of Tumors of the Central Nervous System (WHO CNS5), published in 2021, introduces major changes that advance the role of molecular diagnostics in meningiomas. To follow the revision of WHO CNS5, this expert consensus statement was formed jointly by the Group of Neuro-Oncology, Society of Neurosurgery, Chinese Medical Association together with neuropathologists and evidence-based experts. The consensus provides reference points to integrate key biomarkers into stratification and clinical decision making for meningioma patients.
REGISTRATION
Practice guideline REgistration for transPAREncy (PREPARE), IPGRP-2022CN234.
Humans
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Meningioma/pathology*
;
Consensus
;
Neurosurgical Procedures
;
Meningeal Neoplasms/pathology*
8.Expression and Clinical Significance of TM9SF3 in Lung Adenocarcinoma
Hualin YU ; Yinghua XU ; Mingwei WANG ; Shuguang LI ; Wenwen ZHANG ; Jinsong YANG ; Wei LI
Cancer Research on Prevention and Treatment 2022;49(11):1146-1152
Objective To investigate the expression and clinical significance of TM9SF3 in lung adenocarcinoma (LUAD). Methods TCGA and GEPIA databases were used to screen the differentially-expressed TM9SF family molecules and analyze their effects on patient prognosis with LUAD. The expression and localization of TM9SF3 in LUAD patients were verified by a human proteomic mapping database, Western blot assay, and polymerase chain reaction assay. Herein, the GSEA was used for the signal pathway enrichment analysis of TM9SF3-related genes. Meanwhile, the TIMER database and CIBERSORT algorithm were used to analyze the correlation between differentially-expressed TM9SF3 and the degree of immune cell infiltration. Results The expression of TM9SF3 in LUAD was significantly increased and had a significant adverse effect on the prognosis of LUAD patients. In addition, immunoblotting and polymerase chain reaction confirmed that TM9SF3 was highly expressed in LUAD. Meanwhile, the genes related to TM9SF3 expression were mainly enriched in cell signaling pathways regulating immune cell activity. The expression of TM9SF3 was significantly correlated with the expression changes of six immune cells. Conclusion TM9SF3 is differentially expressed in LUAD and may be used as a potential prognostic marker for LUAD patients. TM9SF3 can also change the level of immune cell infiltration in LUAD patients and is expected to be a new potential target for LUAD immunotherapy.
9.Recent advance in correlation between bilirubin and schizophrenia
Shuangyang ZHANG ; Haishan WU ; Wenbin GUO ; Qian CHEN ; Cuirong ZENG ; Ting CAO ; Bikui ZHANG ; Hualin CAI
Chinese Journal of Neuromedicine 2022;21(5):528-532
Recently, accumulating evidence suggests that high bilirubin level is involved in the pathophysiology of schizophrenia. High bilirubin level during early childhood may increase the risk of being suffered from schizophrenia after adulthood, and schizophrenia patients with high bilirubin level have aggravated psychiatric symptoms. As compared with other psychiatric patients and general population, schizophrenia patients usually have relatively higher bilirubin level; high bilirubin level is associated with acute psychotic states, positive symptoms, and poor prognosis in patients with schizophrenia. This article reviews the relation between bilirubin and schizophrenia and its potential pathophysiological mechanism in order to provide a new direction for the study of schizophrenia pathogenesis and auxiliary diagnosis.
10.circRNA_000926 regulates proliferation and apoptosis of cervical cancer cells by targeting miR-411-5p
WANG Na ; ZHANG Xia ; LI Miao ; ZHANG Hualin ; WANG Yujing
Chinese Journal of Cancer Biotherapy 2022;29(3):189-194
[摘 要] 目的:探讨环状RNA _000926(circ_000926)对宫颈癌细胞增殖和凋亡的影响及其作用机制。方法: 收集2019年5月至2020年9月河北医科大学第一医院手术切除的30例宫颈癌患者的癌及癌旁组织标本,以及人宫颈癌细胞HeLa、SiHa和正常宫颈细胞Ect1/E6E7,用qPCR法检测组织和细胞中circ_000926和miR-411-5p的表达水平。将circ_000926过表达质粒及空白质粒、circ_000926小干扰RNA及阴性对照寡核苷酸、miR-411-5p mimic和阴性对照质粒分别转染HeLa和SiHa细胞,分为pc-circ_000926组、pc-NC组、si-circ_000926组、si-NC组、miR-411-5p mimic组和miR-NC组。通过CCK-8法检测转染细胞的增殖活力,TUNEL法检测细胞的凋亡水平。通过双荧光素酶报告基因实验验证circ_000926与miR-411-5p之间的靶向关系,WB法检测细胞中Ki67、BAX、Caspase-3和Caspase-9蛋白的表达。结果: 与癌旁组织和Ect1/E6E7细胞相比,宫颈癌组织和HeLa、SiHa细胞中circ_000926表达显著升高、miR-411-5p表达显著降低(均P<0.01)。与pc-NC组相比,pc-circ_000926组细胞增殖活力显著增强、细胞凋亡率显著降低(均P<0.01),细胞中miR-411-5p表达显著降低、Ki67蛋白表达显著升高,BAX、Caspase-3、Caspase-9蛋白表达显著降低(均P<0.01)。与si-NC组相比,si-circ_000926组细胞增殖活力显著降低、细胞凋亡率显著升高(均P<0.01),细胞中miR-411-5p表达显著升高、Ki67蛋白表达显著降低,BAX、Caspase-3和Caspase-9蛋白表达显著升高(均P<0.01)。双荧光素酶报告基因实验结果证实circ_000926靶向负向调控miR-411-5p表达,过表达miR-411-5p可逆转过表达circ_000926对宫颈癌细胞增殖和凋亡的作用。结论: circ_000926通过靶向吸附miR-411-5p促进宫颈癌细胞的增殖,并抑制细胞凋亡。

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