1.Association between the diurnal rhythm amplitude of choroidal blood flow index and the progression of spherical equivalent and axial length in children
Ye YANG ; Zhiyang LIN ; Ziwei ZHOU ; Meixiao SHEN
International Eye Science 2025;25(5):858-862
AIM:To explore the relationship between the amplitude of diurnal variations in the choroidal vascular index(CVI)and annual changes in spherical equivalent(SE)and axial length in school-aged children.METHODS: Prospective study. Totally 39 cases(39 eyes)of Chinese school-age children aged 7 to 12 that diagnosed as emmetropia and myopia and error of refraction at optometry clinics of Eye Hospital, Wenzhou Medical University from July to August 2021 were selected. While 33 cases(33 eyes)were finally included, with 6 cases of loss to 1 a follow-up. A total of 16 cases(16 eyes)with annual growth of SE<0.5 D and 17 cases(17 eyes)with annual growth of SE≥0.5 D were divided into a non-progression group and progression group, respectively. Swept-source optical coherence tomography(SS-OCT)and custom choroidal analysis software were used to longitudinally observe diurnal variations in CVI of subjects, and the association between CVI diurnal amplitude and annual changes in SE and axial length was analyzed.RESULTS:It showed no significant correlation between the CVI diurnal amplitude at 1 mm from the fovea and annual changes in SE of the non-progressive group(P=0.65), while in the progression group, the CVI diurnal amplitude at 1 mm from the fovea was negatively correlated with annual changes in SE(P=0.048). However, no significant correlation was identified between CVI diurnal amplitude and annual changes in axial length in either group(all P>0.05). The diurnal amplitude of the CVI at the 1 mm foveal center had an effect on annual SE progression(P=0.039). Conversely, the diurnal amplitude of axial length, the annual changes in axial length, and the maximum or minimum time of CVI demonstrated significant associations with SE progression(all P> 0.05).CONCLUSION: Diurnal variations in CVI amplitude are associated with SE progression in school-aged children, providing a basis for further understanding the choroid-related changes in the process of myopia onset and progression.
2.Precise nanoscale fabrication technologies, the "last mile" of medicinal development.
Ye BI ; Sensen XIE ; Ziwei LI ; Shiyan DONG ; Lesheng TENG
Acta Pharmaceutica Sinica B 2025;15(5):2372-2401
Nanotechnologies seek to overcome inherent deficiencies of conventional diagnosis and treatment, which attracted sustained attention and a limited number of nanomedicines approved by the FDA. However, the critical gaps in clinical translation remain, and nanomedicines that were initially heralded as magic bullets have yet to reach their realistic potential. The major obstacles of fabrication technologies may be overlooked in the nanoparticles' journey. Suboptimal manufacturing strategies partly hampered the inefficient transformation. In this review, we discuss the nanoparticle manufacturing strategies of "Top-Down" and "Bottom-Up" on precise nanoscale fabrication, including artificial intelligence introduced to guided nanomedicine fabrication for accelerating the transformation. Re-engineering existing nanomedicine fabrication, individual manufacturing, and modular technology might highlight the dilemmas of nanomedicines to meet their initial expectations.
3.Expedited program and utilization for anticancer drug approval in China and the United States
Qi ZHU ; Huiyao HUANG ; Anqi YU ; Xinyu MENG ; Ye LENG ; Hong FANG ; Ziwei LI ; Yu TANG ; Ji LI ; Ning LI
Chinese Journal of Oncology 2024;46(9):904-910
Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P<0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.
4.Machine-learning-based models assist the prediction of pulmonary embolism in autoimmune diseases: A retrospective, multicenter study
Ziwei HU ; Yangyang HU ; Shuoqi ZHANG ; Li DONG ; Xiaoqi CHEN ; Huiqin YANG ; Linchong SU ; Xiaoqiang HOU ; Xia HUANG ; Xiaolan SHEN ; Cong YE ; Wei TU ; Yu CHEN ; Yuxue CHEN ; Shaozhe CAI ; Jixin ZHONG ; Lingli DONG
Chinese Medical Journal 2024;137(15):1811-1822
Background::Pulmonary embolism (PE) is a severe and acute cardiovascular syndrome with high mortality among patients with autoimmune inflammatory rheumatic diseases (AIIRDs). Accurate prediction and timely intervention play a pivotal role in enhancing survival rates. However, there is a notable scarcity of practical early prediction and risk assessment systems of PE in patients with AIIRD.Methods::In the training cohort, 60 AIIRD with PE cases and 180 age-, gender-, and disease-matched AIIRD non-PE cases were identified from 7254 AIIRD cases in Tongji Hospital from 2014 to 2022. Univariable logistic regression (LR) and least absolute shrinkage and selection operator (LASSO) were used to select the clinical features for further training with machine learning (ML) methods, including random forest (RF), support vector machines (SVM), neural network (NN), logistic regression (LR), gradient boosted decision tree (GBDT), classification and regression trees (CART), and C5.0 models. The performances of these models were subsequently validated using a multicenter validation cohort.Results::In the training cohort, 24 and 13 clinical features were selected by univariable LR and LASSO strategies, respectively. The five ML models (RF, SVM, NN, LR, and GBDT) showed promising performances, with an area under the receiver operating characteristic (ROC) curve (AUC) of 0.962-1.000 in the training cohort and 0.969-0.999 in the validation cohort. CART and C5.0 models achieved AUCs of 0.850 and 0.932, respectively, in the training cohort. Using D-dimer as a pre-screening index, the refined C5.0 model achieved an AUC exceeding 0.948 in the training cohort and an AUC above 0.925 in the validation cohort. These results markedly outperformed the use of D-dimer levels alone.Conclusion::ML-based models are proven to be precise for predicting the onset of PE in patients with AIIRD exhibiting clinical suspicion of PE.Trial Registration::Chictr.org.cn: ChiCTR2200059599.
5.Expedited program and utilization for anticancer drug approval in China and the United States
Qi ZHU ; Huiyao HUANG ; Anqi YU ; Xinyu MENG ; Ye LENG ; Hong FANG ; Ziwei LI ; Yu TANG ; Ji LI ; Ning LI
Chinese Journal of Oncology 2024;46(9):904-910
Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P<0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.
6.Application of Mendelian randomization analysis in exploring the etiology of nonalcoholic fatty liver disease
Ziwei GUO ; Qingjuan WU ; Yongan YE ; Lanyu CHEN ; Wenliang LYU
Journal of Clinical Hepatology 2024;40(3):589-593
Nonalcoholic fatty liver disease (NAFLD) is an abnormal lipid metabolic disorder of the liver characterized by accumulation of a large amount of lipids in the liver, and it is currently the most common liver disease around the world. Mendelian randomization (MR) incorporates genomic data into traditional epidemiological study designs to infer the causal relationship between exposure factors and disease risk. In recent years, MR has been widely used in studies on inference of the etiology of NAFLD. This article systematically summarizes the advances in the application of MR in NAFLD research, so as to provide new ideas for understanding the nature of the disease and scientific interventions.
7.Diagnosis and treatment of 131 adult patients with bronchopulmonary sequestration: A retrospective analysis
Xiaobo GU ; Qiankun CHEN ; Ziwei WAN ; Cong YE ; Yuming ZHU ; Shijian DU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(01):105-110
Objective To explore the safety and feasibility of uni-portal video-assisted thoracic surgery (VATS) for the treatment of bronchopulmonary sequestration (BPS). Methods The clinical data of BPS patients with surgical resection in Shanghai Pulmonary Hospital from February 2010 to June 2021 were reviewed. The patients were divided into a VATS group and a thoracotomy group according to the operation method. The operation time, intraoperative blood loss, hospital stay and postoperative complication rate were compared between the two groups. The VATS group was subdivided into a uni-portal VATS group and a multi-portal VATS group for subgroup analysis. Results Finally 131 patients were enrolled, including 62 males and 69 females with an average age of 39.3±13.2 years. There were 103 patients in the VATS group and 28 patients in the thoracotomy group. A total of 104 patients were diagnosed with left lower BPS, 26 with right lower BPS and 1 with bilateral lower BPS. The main symptom was cough (88 patients, 67.2%). There were 119 patients diagnosed by thoracic enhanced CT before operation. Compared with the thoracotomy group, the operation time was not statistically different (P=0.717), but the blood loss was less, the rate of postoperative complication was lower and hospital stay was shorter in the VATS group (P<0.05). The rate of conversion to open surgery in the uni-portal VATS group and multi-portal VATS group was 11.8% and 13.5%, respectively. Meanwhile, patients in the uni-portal VATS group had shorter operation time and postoperative hospital stay, less blood loss and lower postoperative complication rate than those in the multi-portal VATS group (P<0.05). Conclusion In order to improve the rate of diagnosis, the lung enhanced CT scan should be selected as an optimal noninvasive method in adult suspected patients (especially those with solid cystic and solid lesions in the lower lobe). Uni-portal VATS is a safe and feasible method for BPS which can be widely promoted.
8.A case of propriospinal myoclonus with typical axial convulsions during sleep
Ziwei GONG ; Fen WANG ; Ye WANG
Chinese Journal of Nervous and Mental Diseases 2024;50(3):152-155
Propriospinal myoclonus(PSM)is a rare painless movement disorder characterized by recurrent axial myoclonus during the wake and sleep transition periods.The recurrent muscle twitches during the hypnotic period severely affect the patient's sleep.In this paper,we reported a case of typical PSM.The patient was treated for involuntary limb shaking before sleep for more than 1 year,and no significant positive signs were found after physical examination in hospital.After perfecting video polysomnography and polymyography,he was diagnosed as having idiopathic PSM,and he responded well to 1/3 of clonazepam tablets,suggesting the necessity of video polysomnography and polymyography in the diagnosis of PSM.
9.Relationship between changes in female reproductive status and objective sleep measures:a study based on polysomnography
Ziwei GONG ; Liying DENG ; Ye WANG
Journal of Apoplexy and Nervous Diseases 2024;41(3):219-223
Objective To compare the general conditions, clinical characteristics, and polysomnographic features of patients before, around, and after menopause.Methods Participants were divided into premenopausal, perimenopausal, and postmenopausal groups by the age of 45 years and 55 years. General conditions, clinical characteristics, and polysomnographic indicators were compared across these groups.Results A total of 316 patients before, around, and after menopause were included in this study. There were no significant between-group differences in the body mass index, smoking and alcohol consumption rates, sleep latency, sleep duration, sleep efficiency, and the durations and proportions of deep and light sleep. The perimenopausal and postmenopausal groups showed significantly increased nocturnal awakenings and significantly decreased nocturnal oxygen saturation compared with the premenopausal group. The apnea-hypopnea index (AHI) differed significantly between the three groups, showing an increasing trend.Conclusion Changes in reproductive status do not alter objective sleep duration and efficiency, and subjective perception contributes more to sleep disturbances around menopause. Changes in nocturnal sleep continuity, the AHI, and nocturnal minimum oxygen saturation suggest complex neuro-molecular mechanisms underlying the effects of hormonal variations on sleep in women.
Perimenopause
10.Effect of sleep on brain clearing metabolites: thinking based on lymphoid system
Sha WANG ; Chunmei LONG ; Ziwei GONG ; Ye WANG
Chinese Journal of Neurology 2023;56(1):101-105
Disruption of the structure of regular sleep is a common cause of neurodegenerative diseases such as Alzheimer′s disease and Parkinson′s disease, and its pathogenesis may be related to the deposition of waste products in the central nervous system. The glymphatic pathway, which is essentially a periarterial cerebrospinal fluid inflow pathway and peripheral venous clearance pathway, is functionally dependent on interstitial bulk flow coupling supported by aquaporin-4 on the astrocyte end-foot, also known as the lymphoid glial system. The glymphatic pathway, which removes waste proteins from the brain, is active primarily during sleep, and sleep quality declines with age, while the glymphatic pathway system also deteriorates with age, suggesting a relationship between sleep disturbances and symptom progression in neurodegeneration, and glymphatic system as a link closely links the two. The interaction of sleep, aging, metabolic waste and glymphatic pathway reticulation provides new clues to the pathogenesis of central nervous system degenerative diseases, and the glymphatic pathway may constitute a new target on treatment. The recent research progress on the effects of sleep and sleep disorders on the circulation of the glymphatic system, and proposes the possibility of sleep intervention to slow down the impairment of the lymphoid system function or even restore the function of the lymphoid system and thus improve the disease development process were reviewed in this paper.

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