1.Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine
Runze WANG ; Xuehan WEI ; Xiaoying CHEN ; Yingqian ZHANG ; Jin SUN ; Chunli LU
Journal of Traditional Chinese Medicine 2026;67(9):926-934
Traditional Chinese medicine (TCM) clinical trials face challenges such as low participant compliance, insufficient geographical coverage, and cost-effectiveness imbalances. Decentralized clinical trials (DCT), enabled by digital technology for remote data collection and monitoring, offer a new direction for TCM clinical trial research. This article systematically reviews three novel clinical trial design models. Combining the holistic concept and indivi-dualized treatment characteristics of TCM, it analyzes the challenges currently faced in TCM DCT practice, including the digitization and standardization of TCM theory, data security, privacy protection and patient engagement difficu-lties, insufficient ethical review and regulatory system adaptation, inadequate personnel training, and a shortage of interdisciplinary talent. Addressing these challenges, the article proposes methodological recommendations for DCT implementation that align with the principles of TCM diagnosis and treatment. These recommendations include promoting the intelligentization and standardization of TCM practices, constructing a full-chain data security and privacy protection system, improving the ethical framework and clarifying regulatory responsibilities, and cultivating and building interdisciplinary talent and capabilities, which provide theoretical and technical references for establishing standardized DCT practices in TCM.
2.Challenges and Recommendations for Implementing Key Technologies in Decentralized Clinical Trials of Traditional Chinese Medicine
Runze WANG ; Xuehan WEI ; Xiaoying CHEN ; Yingqian ZHANG ; Jin SUN ; Chunli LU
Journal of Traditional Chinese Medicine 2026;67(9):926-934
Traditional Chinese medicine (TCM) clinical trials face challenges such as low participant compliance, insufficient geographical coverage, and cost-effectiveness imbalances. Decentralized clinical trials (DCT), enabled by digital technology for remote data collection and monitoring, offer a new direction for TCM clinical trial research. This article systematically reviews three novel clinical trial design models. Combining the holistic concept and indivi-dualized treatment characteristics of TCM, it analyzes the challenges currently faced in TCM DCT practice, including the digitization and standardization of TCM theory, data security, privacy protection and patient engagement difficu-lties, insufficient ethical review and regulatory system adaptation, inadequate personnel training, and a shortage of interdisciplinary talent. Addressing these challenges, the article proposes methodological recommendations for DCT implementation that align with the principles of TCM diagnosis and treatment. These recommendations include promoting the intelligentization and standardization of TCM practices, constructing a full-chain data security and privacy protection system, improving the ethical framework and clarifying regulatory responsibilities, and cultivating and building interdisciplinary talent and capabilities, which provide theoretical and technical references for establishing standardized DCT practices in TCM.
3.Rapid Qualitative Analysis Methods and Their Application in Implementation Science
Xuehan WEI ; Xiaoying CHEN ; Runze WANG ; Yingqian ZHANG ; Xuehan LIU ; Jin SUN ; Guoyan YANG ; Wei XIAO ; Chunli LU
Medical Journal of Peking Union Medical College Hospital 2026;17(2):546-556
Implementation science (IS) aims to systematically analyze and address the real-world gaps from evidence to practice and the influencing factors of the context. It is necessary to carry out qualitative research to gather relevant implementation outcomes. Nevertheless, traditional qualitative analysis has issues such as consuming a great deal of time and energy, and it is unable to promptly provide the crucial data required for implementation science research. The Rapid Qualitative Analysis (RQA) method, through semi-structured interviews and the adoption of techniques such as immediate data condensation and matrix analysis, can effectively shorten the cycle of qualitative data collection and data processing. RQA can promptly identify social determinants of health such as structural barriers, facilitators, and the behavioral characteristics of target groups. It provides a real-time basis for public health decision-making, the interpretation of complex social phenomena, and the process and effectiveness evaluation of research projects. Although RQA is difficult to conduct in-depth theoretical analysis based on grounded theory, its efficiency and flexibility make it the preferred tool for large-scale and time-sensitive research. Thus, it has been widely applied in implementation science research. This paper sorts out the core concepts and commonly used technical methods of RQA, as well as the differences between RQA and traditional qualitative analysis. It also explores the applications of RQA in intervention optimization, process evaluation, and implementation outcome evaluation. By integrating specific cases, this paper clarifies its application value in the field of implementation science. In the future, it is advisable to explore the integration of RQA with technologies such as artificial intelligence and big data, in order to bridge the gap between the transformation of scientific research achievements into practice. Under circumstances of limited resources or tight time constraints, RQA can be used to efficiently conduct implementation science research, providing convenient and scientific methodological and technical support for accelerating evidence-based practice.
4.Clinical study of salvage second allogeneic hematopoietic stem cell transplantation in 17 cases
Wenqiong WANG ; Wei LIU ; Huihui LIU ; Xiaoying YANG ; Shuanglian XIE ; Hongtao LING ; Yiming ZHAO ; Yujun DONG
Organ Transplantation 2026;17(1):124-132
Objective To summarize and analyze the efficacy and influencing factors of second allogeneic hematopoietic stem cell transplantation (allo-HSCT) for acute leukemia relapsing after the first allo-HSCT. Methods Clinical data of 17 patients with acute leukemia who underwent second allo-HSCT at Peking University First Hospital from January 2005 to December 2024 were retrospectively analyzed. Results Among the 17 patients, 7 achieved long-term disease-free survival after second transplantation. The median progression-free survival after successful second transplantation was 7 months (range 8 days to 69 months). The relapse fatality was 24%, and the transplant-related fatality was 35%. Conclusions Second transplantation is an effective treatment for relapsed and refractory acute leukemia, but the relapse fatality and transplant-related fatality remain high. Patient age, time of relapse after the first transplantation and disease status before second transplantation are all factors that affect the efficacy of second transplantation. Younger age, late relapse and complete remission of disease before second transplantation are all beneficial for long-term disease-free survival after second transplantation.
5.Association of adverse childhood experiences with psychopathology, sleep, and cognitive function in children: the mediating role of putamen volume
Mengting ZHANG ; Min XIE ; Jiashuo ZHANG ; Xiaoying MA ; Menghan WEI ; Yubing YIN ; Yang CHEN ; Yulu WU ; Qiang WANG
Sichuan Mental Health 2026;39(3):263-273
BackgroundAdverse childhood experiences (ACEs) are strong predictors of psychopathology across the lifespan, exerting extensive adverse effects on physical and mental health during early development. While ACEs increase the risk of childhood psychopathology, sleep quality and impair cognitive function, the early neurobiological mechanisms mediating ACE-induced cognitive impairment remain unclear. ObjectiveTo explore the association between ACEs exposure and the risk of psychopathology, sleep disorders, and cognitive function, and to examine the mediating role of the putamen volume in the relationship between ACEs and cognitive function from a neurodevelopment perspective. MethodsData were obtained from the Adolescent Brain Cognitive Development (ABCD) study, comprising 10 572 children aged 9 to 10. Participants were categorized into five groups based on the cumulative score of ACEs reported by their parents and the children themselves: no-exposure group (0 types of ACEs), the one-exposure group, the two-exposure group, the three-exposure group, and the high-risk exposure group (≥ 4 types of ACEs). Logistic regression analysis was employed to evaluate the association between ACEs and psychopathological symptoms [T score of the Child Behavior Checklist (CBCL) ≥ 65]. Multiple linear regression analysis was ultilized to analyze the correlations between ACEs and the scores of the Sleep Disturbance Scale for Children (SDSC), the NIH Toolbox Cognition Battery (NIHTB-CB), as well as the multiple structures in the cerebral cortex and subcortex. The Bootstrap method was applied to test the mediating effect of the putamen volume between ACEs and neurocognitive function. ResultsAfter adjusting for confounders, ACEs cumulative score was correlated with children's psychopathological symptoms in a dose-response manner. Compared with the no-exposed group, the high-risk exposure group had a 2.08-fold (OR=2.080, 95% CI: 1.401–3.088) increased risk of internalizing problems and a 3.13-fold (OR=3.132, 95% CI: 1.703–5.760) increased risk of externalizing problems, and the risk of conduct problems was 4.68 times that of the no-exposed group (OR=4.681, 95% CI: 2.528–8.669). ACEs cumulative score positively predicted the total score of SDSC (β=0.080, 95% CI: 0.059–0.102), with relatively stronger predictive effects on sleep-wake transition disorder (β=0.086, 95% CI: 0.063–0.109) and sleep onset and maintenance disorder (β=0.066, 95% CI: 0.043–0.089). In terms of neurocognition and brain structure, ACEs cumulative score negatively predicted the overall cognitive composite score (β=-0.025, 95% CI: -0.050–-0.001), the crystallized cognitive composite score (β=-0.035, 95% CI: -0.060–-0.010), the volume of the left putamen nucleus (β=-0.025, 95% CI: -0.046– 0.003), and the volume of the right putamen nucleus (β=-0.023, 95% CI: -0.044– 0.003). The total putamen volume played a partial mediating role between ACEs and the overall cognitive composite score, the effect value was -0.002 (95% CI: -0.004–-0.001), accounting for 7.49% of the total effect. ConclusionACEs exposure may increase the risk of psychopathological and sleep disturbances in children and may impair neurocognitive function. Reduced putamen volume may serve a potential neurobiological pathway underlying the impact of ACEs on childhood cognition. [Funded by National Natural Science Foundation of China-Young Scientists Program (number, 82401763); Sichuan University West China Hospital Full-time Postdoctoral Research and Development Fund Project (number, 2023HXBH084)]
6.Ultra-long-distance single-port robotic-assisted laparoscopic renal cyst decortication using a domestic robotic system:a case report
Xiaofeng WU ; Liru CHEN ; Yu FENG ; Wei ZHANG ; Linhui WANG ; Xiaoying LU
Academic Journal of Naval Medical University 2025;46(11):1510-1513
Objective To summarize the operation experience of 1 case of ultra-long-distance single-port robotic-assisted laparoscopic renal cyst decortication using a domestic robotic system,and provide references for the development of long-distance telesurgery.Methods The procedure was performed using a domestically produced single-port robotic system.The distance between the main control end and the patient end was 2 400 km.The operation was conducted remotely via a 5G network and a 100 Mbps dedicated line provided by China Telecom.The surgeon controlled the robotic arm remotely.Results The surgery was completed smoothly within a duration of 32 min.The real-time latency was(90±20)ms.Blood loss during the operation was 10 mL,and no drainage tube was placed.The patient recovered smoothly and returned to the ward without any complications.Conclusion It is safe and feasible for the domestically produced single-port robotic system to implement ultra-long-distance telesurgery.This approach facilitates the decentralization of advanced medical resources and helps mitigate disparities in healthcare access.
7.Epidemiological characteristics of respiratory syncytial virus among inpatients in a children′s hospital in Shenzhen City from 2020 to 2023
Xiaojuan LUO ; Wei WANG ; Zhenmin REN ; Xiaoying FU ; Yunsheng CHEN ; Wenjian WANG ; Yanmin BAO ; Yuejie ZHENG ; Ke CAO ; Jiehua CHEN
Chinese Journal of Preventive Medicine 2025;59(4):484-489
This study analyzed the epidemiological characteristics and trends of respiratory syncytial virus (RSV) infections among inpatients with acute respiratory infections (ARI) in a children′s hospital in Shenzhen City inpatients from 2020 to 2023. From January 2020 to December 2023, multiple reverse transcription polymerase chain reaction (RT-PCR) combined with capillary electrophoresis fragment analysis technology was used to detect the nucleic acids of 12 respiratory pathogens, including RSV, in hospitalized children diagnosed with ARI. The patients were divided into six age groups: 0 to <6 months, 6 months to <1 year, 1 to <2 years, 2 to <5 years, 5 to <10 years, and 10 to <18 years. A total of 53 033 children were tested, including 6 830 RSV positive cases, with an overall positivity rate of 12.88%. The annual RSV positivity rates from 2020 to 2023 were 20.04%, 16.18%, 4.89%, and 13.33%, respectively, with statistically significant differences between the years ( χ2=1 185.994, P<0.001). The positive rate of RSV detection decreased with increasing age across all years (all P trend<0.05). From 2020 to 2023, the proportion of RSV-positive cases aged 2 to 5 years and older showed an increasing trend ( P trend<0.001 for all years). Compared to 2023, the median age of RSV-infected children was lower in 2020 ( Z=7.826, P<0.001) and 2021 ( Z=6.106, P<0.001). The proportion of severe infections requiring ICU admission did not change significantly across all years ( χ2=0.179, P=0.981). The RSV epidemic season in 2020 mainly occurred during 28-43 weeks, and in 2021, it spanned from 22-43 weeks. However, in 2022, the season was delayed until the 49th week and lasted for three weeks. In 2023, the seasonal epidemic appeared earlier, starting in the 14th week and lasting for 28 weeks. From 2020 to 2023, the rate of RSV co-infections with other pathogens (mycoplasma pneumoniae, human parainfluenza virus, human bocavirus, human coronavirus, human metapneumovirus, and influenza A) significantly increased (all P trend<0.01). In conclusion, the epidemiological characteristics of RSV infections in Shenzhen Children′s Hospital changed from 2020 to 2023. In 2022, there were only delayed, low-intensity and short-lived seasonal epidemics. However, in 2023, there was an earlier and prolonged epidemic, with increased infections in children aged 2 to 5 years and older and a rise in co-infections, while the proportion of severe infections requiring ICU admission remained unchanged.
8.Status and Associated Factors of Retained Cardiac Implantable Electronic Device Leads After Heart Transplantation and Impact on Long-term Prognosis
Xiaoying HU ; Zhongkai LIAO ; Jie HUANG ; Wei WANG ; Yunhu SONG ; Zhe ZHENG ; Sheng LIU
Chinese Circulation Journal 2025;40(4):346-351
Objectives:To assess the situation of retained cardiac implantable electronic device(CIED)leads after cardiac transplantation,the associated factors,and their impact on long-term prognosis.Methods:A retrospective analysis was conducted on 1 096 patients who underwent cardiac transplantation at Fuwai Hospital of the Chinese Academy of Medical Sciences from January 1,2005 to January 1,2022.Among them,204 patients(18.6%)received CIED therapy before cardiac transplantation.Two physicians independently reviewed the pre-and post-transplant chest X-rays to determine the presence of retained CIED leads.Logistic multivariate regression analysis was used to assess factors associated with retained CIED leads,and Kaplan-Meier survival curves were plotted to analyze the impact of retained CIED leads on long-term prognosis.Results:Among the 204 patients who received CIED therapy before cardiac transplantation,the highest proportion were those treated with implantable cardioverter defibrillator(ICD)and cardiac resynchronization therapy-defibrillator(CRT-D),accounting for 47.5%(97/204)and 40.7%(83/204),respectively.The mean duration from CIED implantation to cardiac transplantation was(45.1±40.0)months,and 38 patients(18.6%)had retained CIED leads after cardiac transplantation.The results of the logistic multivariate regression analysis showed that the duration from CIED implantation to cardiac transplantation was the only factor associated with retained CIED leads after cardiac transplantation(OR=1.020,95%CI:1.011-1.030,P=0.000).Cumulative all-cause survival rates among patients without CIED implantation(n=892),those without retained CIED leads(n=166),and those with retained CIED leads(n=38)were 88.5%,93.3%and 84.2%,respectively.Kaplan-Meier survival curve analysis showed no significant difference in cumulative all-cause survival among the three groups(log-rank P=0.643).Conclusions:In patients who received CIED implantation before cardiac transplantation,18.6%had retained leads after surgery.The duration from CIED implantation to cardiac transplantation is the only factor associated with lead retained after cardiac transplantation,but retained leads does not affect the outcome post heart transplantation.
9.Status and Associated Factors of Retained Cardiac Implantable Electronic Device Leads After Heart Transplantation and Impact on Long-term Prognosis
Xiaoying HU ; Zhongkai LIAO ; Jie HUANG ; Wei WANG ; Yunhu SONG ; Zhe ZHENG ; Sheng LIU
Chinese Circulation Journal 2025;40(4):346-351
Objectives:To assess the situation of retained cardiac implantable electronic device(CIED)leads after cardiac transplantation,the associated factors,and their impact on long-term prognosis.Methods:A retrospective analysis was conducted on 1 096 patients who underwent cardiac transplantation at Fuwai Hospital of the Chinese Academy of Medical Sciences from January 1,2005 to January 1,2022.Among them,204 patients(18.6%)received CIED therapy before cardiac transplantation.Two physicians independently reviewed the pre-and post-transplant chest X-rays to determine the presence of retained CIED leads.Logistic multivariate regression analysis was used to assess factors associated with retained CIED leads,and Kaplan-Meier survival curves were plotted to analyze the impact of retained CIED leads on long-term prognosis.Results:Among the 204 patients who received CIED therapy before cardiac transplantation,the highest proportion were those treated with implantable cardioverter defibrillator(ICD)and cardiac resynchronization therapy-defibrillator(CRT-D),accounting for 47.5%(97/204)and 40.7%(83/204),respectively.The mean duration from CIED implantation to cardiac transplantation was(45.1±40.0)months,and 38 patients(18.6%)had retained CIED leads after cardiac transplantation.The results of the logistic multivariate regression analysis showed that the duration from CIED implantation to cardiac transplantation was the only factor associated with retained CIED leads after cardiac transplantation(OR=1.020,95%CI:1.011-1.030,P=0.000).Cumulative all-cause survival rates among patients without CIED implantation(n=892),those without retained CIED leads(n=166),and those with retained CIED leads(n=38)were 88.5%,93.3%and 84.2%,respectively.Kaplan-Meier survival curve analysis showed no significant difference in cumulative all-cause survival among the three groups(log-rank P=0.643).Conclusions:In patients who received CIED implantation before cardiac transplantation,18.6%had retained leads after surgery.The duration from CIED implantation to cardiac transplantation is the only factor associated with lead retained after cardiac transplantation,but retained leads does not affect the outcome post heart transplantation.
10.A randomized double-blind controlled study on the effects of wearing defocus incorporated multiple segments lenses on binocular visual function and visual quality
Xiaoying LI ; Wei MA ; Yutong SONG ; Longqian LIU
Chinese Journal of Experimental Ophthalmology 2025;43(2):130-137
Objective:To evaluate the effects of wearing defocus incorporated multiple segments (DIMS) spectacle lenses on binocular visual function and visual quality in myopic children.Methods:A randomized double-blind controlled study was conducted.A total of 176 children (352 eyes) with myopia aged 6 to 15 years were enrolled in the West China Hospital of Sichuan University from January 2021 to March 2022.They were randomly divided into DIMS group of 85 cases (170 eyes) and single-vision group of 91 cases (182 eyes) wearing DIMS and single-vision lenses, respectively, using the random number table method.A total of 151 cases (302 eyes) who completed follow-up visits were included in the analysis, including 72 cases (144 eyes) in the DIMS group and 79 cases (158 eyes) in the single-vision group.Before and after 6 and 12 months of lens wear, accommodation amplitude, binocular accommodative sensitivity, distance/near horizontal eye position, and accommodative convergence/accommodation (AC/A) of subjects were measured.Changes in visual function over the year were compared between the two groups.In addition, subjective contrast sensitivity (CS) was assessed at each follow-up visit to evaluate the effect of the lenses on visual quality.The study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of West China Hospital of Sichuan University (No.2020-06).Parents or legal guardians signed written informed consent before the child's participation.Results:There were significant differences in monocular accommodation amplitude and binocular accommodation sensitivity at different time points between before and after lens wear in both groups (Wald χ2time=84.435, 48.201; both P<0.001).In both groups, monocular accommodation amplitude was decreased and the biocular accommodation sensitivity was increased at 6 and 12 months after wearing glasses compared with baseline (all P<0.001).After 12 months of lens wear, the monocular accommodation amplitude decreased by 2.68 D (95% CI: 1.60-3.75 D) in DIMS group and 2.82 D (95% CI: 1.81-3.84 D) in single-vision group.There were statistically significant differences in distance and near horizontal eye position between the two groups at different time points before and after wearing glasses (Wald χtime2=10.398, 23.947; both P<0.01).In the DIMS group, after 12 months of wearing lenses, the distance horizontal eye position drifted outward by 0.68 △(95% CI: 0.06-1.25 △) compared to baseline, with a significant difference ( P<0.05).There was 1.67 △ (95% CI: 0.15-3.20 △) outward drift at near horizontal eye position in the DIMS group and 1.73 △ (95% CI: 0.49-2.96 △) outward drift in the single-vision group compared with baseline, with significant differences (both P<0.05).There were statistically significant differences in gradient AC/A values and calculated AC/A values between the two groups at different time points before and after wearing glasses (Wald χtime2=22.001, 13.411; both P<0.01).After 12 months of wearing glasses, the gradient AC/A values significantly decreased in both groups compared to respective baseline, and the calculated AC/A values in the single-vision group showed a significant decrease compared to baseline (all P<0.05).There were no significant difference in the monocular accommodation amplitude, binocular accommodation sensitivity, distance and near horizontal eye position, gradient AC/A values and calculated AC/A values between the two groups (Wald χgroup2=2.385, 2.266, 2.070, 0.571, 0.578, 0.053; all P>0.05).There was no significant difference in the CS at 3, 6, 12, and 18 cpd spatial frequencies between the two groups at different time points before and after wearing lenses (Wald χ2group=1.104, 2.263, 1.861, 3.671; all P>0.05.Wald χ2time=2.260, 5.382, 2.573, 1.637; all P>0.05). Conclusions:Visual function performance after wearing DIMS lenses is consistent with that after wearing single-vision lenses.Wearing DIMS lenses has no obvious negative effect on the long-term visual quality in children.

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