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.The Effects of Tai Chi Training on Bone Density,Bone Turnover Markers,and Heart Rate Variability in High-Risk Osteoporosis Population
Jiaming LIN ; Chao LI ; Wei ZHAO ; Jun ZHOU ; Xiaoying CHEN ; Xiangyu XI ; Haijun HE ; Baohong MI ; Yuefeng CHEN ; Weiheng CHEN
Journal of Traditional Chinese Medicine 2025;66(15):1566-1571
ObjectiveTo explore the effects of the Tai Chi training on bone density, bone turnover markers, and heart rate variability for people with high-risk osteoporosis, and to provide evidence for the prevention of osteoporosis at early stage. MethodsSixty-six cases of people with high risk of osteoporosis were included, and they were divided into 33 cases each in the intervention group and the control group using the random number table method. The control group received osteoporosis health education three times a week, and the intervention group received Tai Chi training under the guidance of a trainer three times a week for 40 mins each time on the basis of the control group, and both groups were intervened for 12 weeks. Dual-energy X-ray absorptiometry was used to measure the bone density of L1~L4 vertebrae, bilateral femoral necks and bilateral total hips in the two groups before and after the intervention; enzyme-linked immunosorbent assay was used to determine bone turnover markers before and after the intervention, including pro-collagen type Ⅰ pro-amino-terminal prepropyl peptide (P1NP) and β-collagen type Ⅰ cross-linking carboxy-terminal peptide (β-CTX). Seven cases with good compliance in the intervention group were selected. After wearing the heart rate sensor, they successively performed Tai Chi training and walking activities recommended by the guideline for 20 mins each, and the heart rate variability (HRV) during exercise was collected, including time-domain indexes such as standard deviation of normal sinus intervals (SDNN), root-mean-square of the difference between adjacent RR intervals (RMSSD), frequency-domain metrics such as low-frequency power (LF), high-frequency power (HF), and low-frequency/high-frequency power ratio (LF/HF), as well as nonlinear metrics such as approximate entropy (ApEn), sample entropy (SampEn). ResultsFinally, 63 cases were included in the outcome analysis, including 30 cases in the intervention group and 33 cases in the control group. After the intervention, the differences of L1~L4 vertebrae, bone density of bilateral femoral neck and bilateral total hip in the intervention group were not statistically significant when compared with those before intervention (P>0.05), while the bone density of all parts of the control group decreased significantly compared with that before intervention (P<0.05), and the difference in the bone density of the L1~L4 vertebrae, bilateral femoral neck, and the right total hip before and after the intervention of the intervention group was smaller than that of the control group (P<0.05). The differences in P1NP and β-CTX between groups before and after intervention was not statistically significant (P>0.05). Compared with walking exercise, LF decreased, HF increased and LF/HF decreased during Tai Chi exercise (P<0.05); the time domain indexes and non-linear indexes between groups had no statistically significant difference (P>0.05). ConclusionTai Chi exercise can maintain lumbar, hip, and femoral bone density and improve sympathetic/parasympathetic balance in people at high risk for osteoporosis, but cannot significantly improve bone turnover markers.
6.Boosting with Omicron-specific mRNA vaccine or historical SARS-CoV-2 vaccines elicits discriminating immune responses against Omicron variants.
Yi WU ; Xiaoying JIA ; Namei WU ; Xinghai ZHANG ; Yan WU ; Yang LIU ; Minmin ZHOU ; Yanqiong SHEN ; Entao LI ; Wei WANG ; Jiaming LAN ; Yucai WANG ; Sandra CHIU
Acta Pharmaceutica Sinica B 2025;15(2):947-962
Booster vaccinations are highly recommended in combating the SARS-CoV-2 Omicron variant and its subvariants. However, the optimal booster vaccination strategies and related immune mechanisms with different prior vaccinations are under-revealed. In this study, we systematically evaluated the immune responses in mice and hamsters with different prime-boost regimens before their protective efficacies against Omicron were detected. We found that boosting with Ad5-nCoV, SWT-2P or SOmicron-6P induced significantly higher levels of neutralization activities against Omicron variants than CoronaVac and ZF2001 by eliciting stronger germinal center (GC) responses. Specifically, SOmicron-6P induced even stronger antibody responses against Omicron variants in CoronaVac and Ad5-nCoV-primed animals than non-Omicron-specific vaccines but with limited differences as compared to Ad5-nCoV and SWT-2P. In addition, boosting with a specific vaccine has the potential to remodel the existing immune profiles. These findings indicated that adenovirus-vectored vaccines and mRNA vaccines would be more effective than other types of vaccines as booster shots in combating Omicron infections. Moreover, the protective efficacies of the vaccines in booster vaccinations are highly related to GC reactions in secondary lymphatic organs. In summary, these findings provide timely important information on prime-boost regimens and future vaccine design.
7.Pharmaceutical practice in the treatment of one case of ventilator-associated pneumonia caused by extensively drug-resistant Klebsiella pneumoniae
Minglu YUAN ; Wei ZENG ; Genzhu WANG ; Xiaoying WANG ; Zhongdong LI
Chinese Journal of Pharmacoepidemiology 2025;34(6):708-714
This article reports a postcraniotomy patient with renal insufficiency and electrolyte imbalance who developed ventilator-associated pneumonia caused by extensively drug-resistant Klebsiella pneumoniae.According to the patient's pathophysiological characteristics,bacterial epidemiological characteristics,and bacterial culture results,combined with the latest guidelines and the pharmacokinetic/pharmacodynamic characteristics of antibiotics,a full-dose ceftazidime/avibactam regimen was initially suggested by the clinical pharmacist,and which was adopted by doctor.When the effect of ceftazidime/avibactam was poor and no guideline-recommended alternatives were available,the clinical pharmacist,in conjunction with clinical experience,proposed a combination therapy of colistin sulfate and tigecycline,with the implementation of adverse reaction monitoring and mucin sulfate blood concentration monitoring.Finally,the pneumonia was effectively controlled,the inflammatory indicators such as temperature and the white blood cell count returned to normal,no adverse drug reactions occurred,and the patient was successfully transferred to the rehabilitation institution.Clinical pharmacists stay updated on the latest medication knowledge both domestically and internationally,recommend advanced drug treatment protocols for clinical practice,assist in managing severe infections,and play an important role in the clinical team.
8.Photobiomodulation in Parkinson patients:A scoping review
Yandong ZHAO ; Xiaojing LI ; Wei DENG ; Xiaoying ZHANG
Chinese Journal of Nervous and Mental Diseases 2025;51(5):303-309
This study systematically analyzed the clinical applications of photobiomodulation(PBM)therapy in Parkinson disease(PD)patients using a scoping review methodology,with the aim of summarizing treatment protocols,outcome measures,and therapeutic effects to provide references for subsequent clinical research and treatment.A comprehensive search was conducted across Web of Science,PubMed,Embase,Cochrane Library,CNKI,and Wanfang,ultimately including 13 studies.The results indicate that PBM therapy can effectively improve motor symptoms,non-motor symptoms,and brain structure in PD patients,serving as a beneficial supplement to conventional treatments.However,there remains a scarcity of large-sample randomized controlled trials(RCTs),along with significant variations in the selected treatment parameters.Therefore,further investigations with larger sample sizes and extended durations are required to validate its therapeutic efficacy.
9.Expert consensus on holistic integrative management of oropharyngeal squamous cell carcinoma
Moyi SUN ; Zongxuan HE ; Qianwei NI ; Xiaoying LI ; Lin KONG ; Qing XI ; Wei GUO ; Zhangui TANG ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Jie ZHANG ; Jichen LI ; Yue HE ; Chunjie LI ; Lizheng QIN ; Kai YANG ; Bing HAN ; Yan SUN ; Haijun LU ; Xiaohong ZHAN ; Dapeng HAO ; Kai SONG ; Haoyue XU ; Lingxue BU ; Jieying LI ; Man HU ; Mingjin XU ; Yun LI ; Wei SHANG
Journal of Practical Stomatology 2025;41(3):293-304
Oropharyngeal squamous cell carcinoma(OPSCC)is a malignant tumor originating from the squamous epithelium of the oro-pharyngeal mucosa,accounting for more than 90%of oropharyngeal malignancies.In recent years,human papillomavirus(HPV)infec-tion has become one of the primary etiological factors of oropharyngeal squamous carcinoma.The incidence of HPV-associated oropharyn-geal squamous carcinoma has been rising annually,with a noticeable trend toward younger populations,posing a significant threat to hu-man health.Due to the distinct biological behavior and clinical characteristics of HPV-associated oropharyngeal squamous carcinoma com-pared to its non-HPV-related counterpart,the diagnostic and treatment strategies for oropharyngeal squamous carcinoma have undergone substantial changes.Prevention and screening for oropharyngeal squamous carcinoma are of critical importance.The diagnostic and treat-ment process involves multi-disciplinary collaboration,including oral and maxillofacial surgery,otolaryngology,head and neck surgery,oncology,radiology and pathology.Based on evidence from clinical practice,a comprehensive,integrated diagnostic and therapeutic ap-proach has been established,centered around the concept of"prevention,screening,diagnosis,treatment,and rehabilitation",covering the entire patient lifecycle and providing a valuable reference for clinical practice.
10.Guidelines for the Digital Ancient Books of TCM Indexing
Weina ZHANG ; Bing LI ; Bin LI ; Jing XIE ; Yan DONG ; Wei LONG ; Chuchu ZHANG ; Tong WEI ; Sihong LIU ; Yang WU ; Hongtao LI ; Lin TONG ; Guangkun CHEN ; Fei DONG ; Rui WANG ; He LU ; Meng LI ; Jingpeng DENG ; Tengfei WANG ; Xiaoying LI ; Di ZHANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(3):1-11
Guidelines for Digital Ancient Books of TCM Indexing(T/CIATCM 119-2024)is based on the theoretical knowledge,disciplinary methods,and practical applications of TCM classical cataloging.Taking digital ancient books of TCM as the object,it systematically reveals the content of TCM knowledge,which is an essential indexing processing standard for building an intelligent retrieval system for TCM ancient books,and can provide support for the deep development and innovative utilization of TCM knowledge.It can not only promote the co-construction and sharing of ancient book resources in the TCM industry,but also promote the standardization construction and application of TCM information.This standard specifies the principles,methods,and examples of free indexing of digital ancient books of TCM based on their original content.It is applicable to the indexing and processing of digital ancient books of TCM for TCM professional libraries and related institutions,and to the data processing and construction of various types of TCM ancient book databases.

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